IFS PACsecure En

IFS PACsecureStandard for auditing quality andsafety of packaging materials

Version 1October 2012© IFS, October 2012

IFS publishes information, opinions and bulletins to its best knowledge, but cannot takeany responsibility for any mistakes, omissions or possibly misleading information in itspublications, especially in this document.

The Standard owner of the present document is:

IFS Management GmbHAmWeidendamm 1A10117 BerlinGermany

Managing Director: Stephan TrompAG Charlottenburg HRB 136333 BVAT-N°: DE278799213

Bank: Berliner SparkasseBank code number: 10050000Account number: 190029765IBAN number: DE96100500000190029765BIC-/Swift-Code: BE LA DE BE

All rights reserved. All publications are protected under international copyright laws.With-out the expressed written consent of the IFS Standard owner any kind of unauthorised useis prohibited and subject to legal action.This also applies to the reproduction with a photo-copier, the inclusion into an electronic database/software, or the reproduction on CD-Rom.

No translation may be made without official permission by the IFS Standard owner.

The IFS PACsecure is available online via:www.ifs-certification.com

Or by Mail, Fax and E-mail:IFS Management GmbHAmWeidendamm 1A10117 BerlinGermany

Phone: +49-(0)30-726250-74Fax: +49-(0)30-726250-79E-mail: [email protected]

GERMANY | BERLINIFS Management GmbHAmWeidendamm 1AD-10117 BerlinPhone: +49(0)3072625074Fax: +49(0)3072625079E-mail: [email protected]

FRANCE | PARISIFS Office ParisFCD12, rue EulerF-75008 ParisPhone: +33(0)144439916Fax: +33(0)147205353E-mail: [email protected]

ITALY | MILANIFS Office MilanFederdistribuzioneVia Albricci 8I-20122 MilanoPhone: +39(0)289075150Fax: +39(0)26551169E-mail: [email protected]

POLAND |WARSAWIFS Office Central & Eastern Europeul. Serwituty 25PL-02-233WarsawPhone: +48601957701E-mail: [email protected]

BRAZIL | DOURADOSRepesentante IFS BrasilCaroline NowakBR-79824 Dourados, MSPhone: +55(67)81514560E-mail: [email protected]

CHINA | HEFEIStarFarmRoom 2301, C building,Fortune Plaza No. 278 Suixi Road, 230041,Hefei, Anhui, ChinaPhone: +86(0)5515666069Fax: +86(0)5515681376E-mail: [email protected]

[email protected]

USA | ST. LOUISIFS Americas1610 Des Peres Road, Suite 150St. Louis, MO 63131USAPhone: +13146864610Fax: +13146864602E-mail: [email protected]

CONTACT DETAILS OF THE IFS OFFICES

CONTACT DETAILS OF THE PACKAGINGASSOCIATION OF CANADA (PAC)

THE PACKAGINGASSOCIATION | CANADA1 Concorde Gate, Suite 607Toronto ONM3C 3N6CanadaPhone: +14164907860E-mail: [email protected]

IFS PACsecure

Standard for auditing quality andsafety of packaging materials

Version 1October 2012

© IFS, October 2012

International Featured Standards · IFS PACsecure ·Version 1 3

ACKNOWLEDGEMENTS

IFS is pleased to acknowledge the essential support provided by the followingexperts:

James D Downham President & CEO of PAC,The Packaging Association of CanadaLarry Dworkin PAC, The Packaging Association of CanadaLarry Shortt L&G Shortt Solutions Limited, CanadaThomas Maiwald real,- SB-Warenhaus GmbH, GermanyDr. Andrea Niemann-Haberhausen Det NorskeVeritas, Germany

IFS likes to thank all all companies who contributed in the developmentof the PACsecure Standard, which is the basis for the IFS PACsecure Standard:

Acorn PackagingAgriculture and Agrifood CanadaAgropur Division NatrelAlcan PackagingAlte-RegoAtlantic PackagingBall Packaging ProductsBericapBothwell CheeseBrewers Association of CanadaBright Cheese House,TheCadbury Adams CanadaCanadian Corrugated Case AssociationCanadian Council of Grocery DistributorsCanadian Food Inspection AgencyCanadian General Standards BoardCanadian Plastics Industry AssociationCanAmera FoodsCanbra Foods LimitedCentral GraphicsChantler PackagingCiom/NovacoteCoca-ColaCousins CurrieCrown PackagingDainty FoodsDare Foods Ellis PackagingFoodCon

GayLea FoodsGeneral Mills CanadaGraham PackagingGraphic PackagingGuelph FoodTechnology CentreHealth CanadaHigh Liner FoodsIan Britt and AssociatesJM SmuckerJones PackagingKraft CanadaKraft Foods GlobalLabeladLangen PackagingLoblaw BrandsMaple Leaf Consumer FoodsMaple Lodge FarmsMcCain FoodsMultiPakMinute Maid Company Canada,TheNestle CanadaNorampacOwens-Illinois Glass ContainersOld Dutch FoodsOntario Ministry of Agriculture andFoodPackaging Association of CanadaPackall

Parmalat CanadaPeel Plastics ProductsPlasticapPolytainersPrimex Packaging ServicesR.A. Miller & Co.Reinhart FoodsRichards PackagingRobinhood MultifoodsRopakSandler ConsultingSaputo Bakery DivisionSaxco CanadaScott Paper LimitedSilgan PlasticsSmucker Foods of CanadaSmurfit MBISobeysSonocoSpecialty PaperTetra Pak CanadaThe Packaging GroupTWDTechnologiesW.G. Pro ManufacturingWC ParchmentWG CorporateWinPakTechnologies


4 International Featured Standards · IFS PACsecure ·Version 1

IFS is grateful to the members of the IFS International Technical Com-mittee and the associated national working groups in France, Germany,Italy and United States. The IFS PACsecure Standard is the result of theinternational partnership between IFS and the Packaging Association ofCanada.

Members of the IFS International Technical Committee

Andrea Artoni CONAD, on behalf of ANCD (Associazone Nazionale Coopera-tive tra Dettaglianti), Italy

Sabrina Bianchini Det NorskeVeritas, ItalyYvan Chamielec EMC Distribution – Groupe Casino, FranceFayçal Bellatif Eurofins certification, FranceRoberta Denatale/Eleonora Pistochini Auchan, on behalf of Federdistribuzione, ItalyGerald Erbach METRO AG, GermanyJean-François Feillet Meralliance, FranceCécile Gillard-Kaplan Groupe Carrefour, FranceAlmudena Hernandez AENOR, SpainLuc Horemans Scamark – Groupement Leclerc, FranceDr. Horst Lang Globus SB-Warenhaus Holding GmbH & Co. KG, GermanyJoachim Mehnert DQS, GermanyPatricia Menendez/Maria López deMontenegro Dia Group, SpainDr. Angela Moritz REWE Group; REWE-Zentral-AG, GermanyAlberto Peiró Mercadona, SpainBizhan Pourkomailian Mc Donalds Europe, United KingdomHorst Roeser COOP, SwitzerlandNuria Sanz Levia El Corte Ingles, SpainSergio Stagni COOP, on behalf of ANCC (Associazone Nazionale Cooperative

Consumatori), ItalyStephen Thome Dawn Food Products, USADr. Bert Urlings Vion Food, The NetherlandsKarin Voß EDEKA Zentrale AG & Co. KG, GermanyRomanWißner HARIBO GmbH & Co. KG, GermanyStefano Zardetto Voltan, Italy

IFS Team

George Gansner Marketing/Business Development DirectorDr. Helga Hippe Quality Assurance Management DirectorSeon Kim Shop ManagerChristin Kluge Quality Assurance Project ManagerNina Lehmann Project Manager Academy/Marketing/CommunicationsStéphanie Lemaitre Technical DirectorLucie Leroy Project ManagerClemens Mahnecke Technical Project ManagerMarek Marzec Business Consultant Central/Eastern EuropeCaroline Nowak Representative, South AmericaKsenia Otto Office ManagerSabine Podewski Project Manager Auditor Approval/ExaminationMaria Thalmann Project ManagerSerenaVenturi Project ManagerStephan Tromp Managing Director



Table of contents

Part 1: Audit Protocol

1 The history of International Featured Standards andIFS PACsecure Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2.1 Purpose and contents of the audit protocol . . . . . . . . . . . . . . . 12

2.2 Extraordinary information to the certification bodyby the certified company . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

2.3 General requirements for the quality and product safetymanagement system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3 Types of audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.1 Initial audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.2 Follow-up audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.3 Renewal audit (for recertification) . . . . . . . . . . . . . . . . . . . . . . . . 14

3.4 Extension audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

4 Scope of the audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

5 The certification process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

5.1 Preparation of an audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

5.2 Certification body selection – contractual arrangements . . 18

5.3 Duration of an audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

5.4 Drawing up an audit time schedule . . . . . . . . . . . . . . . . . . . . . . 20

5.5 Evaluation of requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215.5.1 Scoring a requirement as a deviation . . . . . . . . . . . . . . . . . . . . 215.5.2 Scoring a requirement as a non-conformity . . . . . . . . . . . . . . 225.5.2.1 Major . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225.5.2.2 KO (Knock out) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235.5.3 Scoring a requirement with N/A (not applicable) . . . . . . . . . 24

5.6 Determination of the audit frequency . . . . . . . . . . . . . . . . . . . . 24

5.7 Audit report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245.7.1 Structure of the audit report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245.7.2 The different steps for the audit report . . . . . . . . . . . . . . . . . . . 255.7.2.1 Drawing up the pre-report of the audit and the outline

of the action plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255.7.2.2 Company’s completion of the corrective action plan . . . . . . 265.7.2.3 Auditor validation of the action plan . . . . . . . . . . . . . . . . . . . . . 275.7.3 Further rules about the audit report . . . . . . . . . . . . . . . . . . . . . . 27



5.7.3.1 Link between two consecutive audit reports (initial andrenewal audits) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

5.8 Scoring and conditions for issuing audit reportand certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

5.8.1 Specific management of the audit process in case oneor several KO’s has/have been scored with D duringthe audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

5.8.2 Specific management of the audit process in case one orseveral Major non-conformity(ies) has/have been issued . 29

5.8.3 Specific management of the audit process in casethe final score is <75% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

5.8.4 Specific management of the audit process in caseof multi-site companies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

6 Awarding the certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

6.1 Deadlines for awarding certificate . . . . . . . . . . . . . . . . . . . . . . . . 32

6.2 Certification cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

6.3 Information about conditions of withdrawal of certificate . 33

7 Distribution and storage of the audit report . . . . . . . . . . . . . . 34

8 Supplementary action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

9 Appeal and complaints procedure . . . . . . . . . . . . . . . . . . . . . . . 34

10 Ownership and usage of the IFS PACsecure logo . . . . . . . . . 35

11 Review of the Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

12 IFS Integrity Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

12.1 Preventive quality assurance actions . . . . . . . . . . . . . . . . . . . . . 37

12.2 Quality assurance actions after complaint notification . . . . 38

12.3 Sanctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

ANNEX 1Clarification for the scope application of the differentIFS Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

ANNEX 2Certification process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

ANNEX 3Product scopes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

ANNEX 4Flow chart for management of KO scored with D and Majornon-conformities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44



Part 2: List of audit requirements

1 Senior Management Responsibility . . . . . . . . . . . . . . . . . . . . . . 46

1.1 Corporate policy/Corporate principles . . . . . . . . . . . . . . . . . . . 46

1.2 Corporate structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

1.3 Customer focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

1.4 Management review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

2 Quality and Packaging Material Safety Management System 52

2.1 Quality management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 522.1.1 Documentation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 522.1.2 Record keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

2.2 Packaging Material Safety Management . . . . . . . . . . . . . . . . . 552.2.1 Hazard analysis and risk assessment system . . . . . . . . . . . . . 552.2.2 Hazard analysis and/or risk assessment team . . . . . . . . . . . . 562.2.3 Hazard analysis and risk assessment . . . . . . . . . . . . . . . . . . . . 57

3 Resource Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

3.1 Human resources management . . . . . . . . . . . . . . . . . . . . . . . . . . 60

3.2 Human resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 613.2.1 Personnel hygiene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 613.2.2 Working conditions and protective clothing for personnel,

contractors and visitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 623.2.3 Procedures applicable to infectious diseases . . . . . . . . . . . . . 64

3.3 Training and instruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

3.4 Sanitary facilities, equipment for personnel hygiene andstaff facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

4 Planning and Production Process . . . . . . . . . . . . . . . . . . . . . . . . 67

4.1 Contract agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

4.2 Specifications and formulas/configurations . . . . . . . . . . . . . . 684.2.1 Specifications and other legally required documentation . 684.2.2 Formula/configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

4.3 Product development/Product modification/Modificationof production processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

4.4 Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 714.4.1 General purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 714.4.2 Trade of packaging materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

4.5 Product wrapping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

4.6 Factory location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

4.7 Factory Exterior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

4.8 Plant layout and process flows . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

4.9 Constructional requirements for production and storageareas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

4.9.1 Constructional requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 774.9.2 Walls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77



4.9.3 Floors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 774.9.4 Ceilings/Overheads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 784.9.5 Windows and other openings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 784.9.6 Doors and gates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 794.9.7 Lighting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 794.9.8 Air conditioning/Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 804.9.9 Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 804.9.10 Compressed air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

4.10 Cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

4.11 Waste disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

4.12 Risk of foreign material, metal, broken glass and wood . . . 85

4.13 Pest monitoring/Pest control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

4.14 Receipt of goods and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

4.15 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

4.16 Maintenance and repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

4.17 Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

4.18 Traceability (including GMOs and allergens) . . . . . . . . . . . . . . 94

4.19 Allergens and specific conditions of production . . . . . . . . . . 96

5 Measurements, Analysis, Improvements . . . . . . . . . . . . . . . . . 96

5.1 Internal audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

5.2 Site factory inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

5.3 Process validation and control . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

5.4 Calibration, adjustment and checking of measuringand monitoring devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

5.5 Control of quantity/filling quantity . . . . . . . . . . . . . . . . . . . . . . . 100

5.6 Product analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

5.7 Product quarantine (blocking/hold) and product release . . 103

5.8 Management of complaints from authorities and customers 103

5.9 Management of incidents, product withdrawal, productrecall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

5.10 Management of non-conformities and non conformingproducts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

5.11 Corrective actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

6 Packaging material defense/Food defense and externalinspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

6.1 Defense assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

6.2 Site Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

6.3 Personnel &Visitor Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

6.4 External Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

ANNEX 1GLOSSARY/DEFINITIONS LIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112



Part 3: Requirements for Accreditation Bodies,Certification Bodies and AuditorsIFS accreditation and certification process

0 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

1 Requirements for the Accreditation Bodies . . . . . . . . . . . . . . 119

1.1 General requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

1.2 The training of the accreditation committee(or competent person) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

1.3 Competences of the assessor of the accreditation body . . 120

1.4 Frequency of the assessments of certification bodies . . . . . 120

1.5 Accreditation of an internationally-active certification body 121

1.6 Conditions for recovering accreditation after withdrawalor suspension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

1.7 Transfer of certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

2 Requirements for the Certification Bodies . . . . . . . . . . . . . . . . 122

2.1 ISO/IEC 17065 IFS accreditation process . . . . . . . . . . . . . . . . . . 122

2.2 Signing of contract with the proprietor of IFS . . . . . . . . . . . . . 122

2.3 Certification decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

2.4 Certification bodies’ responsibilities for IFS PACsecuretrainers and the IFS PACsecure auditors (includingfreelancers) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

2.5 Specific requirements for IFS PACsecure trainers . . . . . . . . . 125

3 Requirements for IFS PACsecure auditors . . . . . . . . . . . . . . . . 126

3.1 Conversion of auditors to get the IFS PACsecure version 1auditor approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

3.2 Requirements for new IFS PACsecure auditors . . . . . . . . . . . 1263.2.1 Requirements before applying for the IFS PACsecure

examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1263.2.2 General requirements for auditors when applying for

IFS PACsecure examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

3.3 IFS examination process (for new auditors, as specifiedin chapter 3.2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

3.4 Maintenance of auditors’ qualification (for both types ofauditors, as specified in chapters 3.1 and 3.2) . . . . . . . . . . . . 129

3.5 Scope extension for IFS-approved auditors . . . . . . . . . . . . . . . 130

3.6 Audit team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1303.6.1 General rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1303.6.2 Specific rules for audit team and auditing 3 consecutive

times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

ANNEX 1Product scopes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132



Part 4: Reporting and IFS Audit Portal

0 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

1 Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

1.1 Audit overview (Annex 1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

1.2 Audit report (Annex 2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

1.3 Action plan (Annex 3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

1.4 Minimum requirements for IFS PACsecure certificate(Annex 4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

2 The IFS Audit Portal and the IFS Database(www.ifs-certification.com) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

ANNEX 1Final Audit Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

ANNEX 2Detailed Audit Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

ANNEX 3Action plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

ANNEX 4Certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146


International Featured Standards · IFS PACsecure · Version 1 Part 1 11

Part 1: Audit Protocol

1 The history of International FeaturedStandards and IFS PACsecure Standard

Supplier audits have been a permanent feature of retailer’s systems andprocedures for many years. Until 2003 they were performed by thequality assurance departments of the individual retailers, wholesalersand food services. The ever-rising demands of consumers, the increas-ing liabilities of retailers, wholesalers and food services, the increasingof legal requirements and the globalisation of product supply, all madeit essential to develop a uniform quality assurance and food safetyStandard. Also, a solution had to be found to reduce the time associ-ated with a multitude of audits for involved stakeholders.

The associated members of the German retail federation – Handelsver-band Deutschland (HDE) – and of its French counterpart – Fédérationdes Entreprises du Commerce et de la Distribution (FCD) – drew up aquality and food safety standard for retailer branded food productsnamed the IFS Food, the first Standard of the IFS family, which isintended to allow the assessment of suppliers’ food safety and qualitysystems in accordance with a uniform approach. This Standard is nowmanaged by IFS Management GmbH, a company owned by FCD andHDE, and applies to all the post-farm gate stages of food processing.IFS Food Standard has been benchmarked with GFSI Guidance Docu-ment and is recognised by GFSI (Global Food Safety Initiative).

The first version implemented (version 3) of the IFS Standard wasdeveloped by the HDE and launched in 2003. In January 2004, anupdated version, version 4, was designed and introduced in collabora-tion with the FCD. Within 2005/2006, the Italian retail associations alsojoined the International Food Standard and the development of version5 was a collaboration of retail federations from France, Germany andItaly as well as retailers from Switzerland and Austria.

For IFS Food version 6, the International Technical Committee and theFrench, German and Italian working groups have been actively involved,in addition to retailers, stakeholders and representatives of industry,food services and certification bodies. During the development of IFSFood version 6, IFS gained input from a recently formed IFS NorthAmerican working group and retailers from Spain, Asia and SouthAmerica.

Based on this experience, the IFS PACsecure Standard is a new one inthe IFS (International Featured Standards) family covering another partof the supply chain.


12 Part 1 International Featured Standards · IFS PACsecure · Version 1

The fundamental objectives of IFS PACsecure, as well as for other IFSStandards, are:

– to establish a common standard with a uniform evaluation sys-tem,

– to work with accredited certification bodies and qualified IFSapproved auditors,

– to ensure comparability and transparency throughout the entiresupply chain,

– to reduce costs and time for both suppliers and retailers,

– to meet GFSI requirements.

As announced on February 15th 2012, IFS Management GmbH, owner ofthe GFSI benchmarked IFS Food Standard, IFS Logistics and other sup-ply chain Standards, together with The Packaging Association of Can-ada (PAC), have joined to bring the world’s foremost packaging stand-ard for primary and secondary packaging to the industry.

PACsecure was created by PAC to provide packaging manufacturersand converters the ability to certify primary and secondary packagingmaterials for the food industry. However, the IFS PACsecure Standard isapplicable to all kinds of packaging materials. Developed by a technicalworking group made up of some of North America’s largest globalpackaging and food manufacturers, the Standard is now managed by ajoint effort of the PAC through their technical expertise and know-howin the packaging industry and IFS and its global network of food safetyand quality standards infrastructure.

2 Introduction

2.1 Purpose and contents of the audit protocol

This audit protocol describes the specific requirements made on theorganisations involved in IFS PACsecure audits.

The purpose of the protocol is to define the criteria to be followed by acertification body performing audits against the IFS requirements, andin accordance with the accreditation norm ISO/IEC 17065.

It also details the procedures to be observed by the companies beingaudited, and clarifies the rationale of auditing them. Only accreditedcertification bodies to ISO/IEC 17065 for the scope of IFS PACsecure,and which have signed an agreement with the scheme owner can per-form audits against the IFS PACsecure Standard and can issue IFS PAC-secure certificates. The IFS requirements for certification bodies areclearly described in Part 3 of this document.



2.2 Extraordinary information to the certification bodyby the certified company

In accordance with ISO/IEC Guide 65, the company shall inform its cer-tification body about any change or information indicating that theproducts may no longer comply with the requirements of the certifica-tion system (e.g. recall, alert on products, etc.). For IFS, this informationshall be made within 3 working days.

2.3 General requirements for the quality and productsafety management system

In general, when auditing in accordance with IFS, the auditor assessesif the various elements of a company’s quality and product safety man-agement system are documented, implemented, maintained, and con-tinuously improved. The auditor shall examine the following elements:

– organisational structure in relation to responsibility, authority,qualification and job description,

– documented procedures and the instructions concerning theirimplementation,

– inspection and testing: specified requirements and definedacceptance/tolerance criteria,

– actions to be taken in case of non-conformities,

– investigation of the causes of non-conformities and the imple-mentation of corrective actions,

– conformity analysis of safety and quality data and review ofimplementation in practice,

– handling, storage and retrieval of quality and packaging mate-rial safety records, such as traceability data, document control.

All processes and procedures shall be clear, concise and unambiguousand the personnel responsible shall understand the principles of thequality and product safety management system.

The quality and product safety management system is based on thefollowing methodology:

– to identify the processes needed for the quality and productsafety management system,

– to determine the sequence and interaction of these processes,

– to determine the criteria and methods required to ensure theeffective operation and control of these processes,

– to ensure the availability of information necessary to supportthe operation and monitoring of these processes,



– to measure, monitor and analyse these processes, and imple-ment the necessary action to achieve planned results and con-tinuous improvement.

3 Types of audit

3.1 Initial audit

An initial audit is a company’s first audit to IFS PACsecure. It is per-formed at a time and date agreed between the company and the selectedcertification body. During this audit the entire company is assessed,both in relation to its documentation and the processes themselves.During the audit, all criteria of the IFS requirements shall be assessedby the auditor. In the case of a pre-audit, the auditor who performs thisaudit shall be different from the auditor who performs the initial audit.

3.2 Follow-up audit

A follow-up audit is required in a specific situation when the results ofthe audit (an initial audit or a renewal audit) have been insufficient toallow the award of the certificate (see chart N° 6). During the follow-upaudit, the auditor focuses on the implementation of the actions taken tocorrect the Major non-conformity determined during the previous audit.The follow-up audit shall be performed within a six months period fromthe date of the previous audit. In general, the auditor who performedthe audit where a Major non-conformity has been identified shall per-form the follow up audit.

If the Major non-conformity is related to production failure(s), the fol-low up audit shall be performed at least 6 weeks after the previous auditand no later than 6 months after the previous audit. For other kinds offailures (e.g. documentation), the certification body is responsible forthe determination of the date of the follow-up audit.

If there is no follow-up audit performed after 6 months from the date ofthe previous audit, then a complete new audit is necessary.

In the event that the follow-up audit establishes that requirementsremain inadequate, a complete new audit is necessary. The eliminationof Major non-conformities shall always be established by an on-sitevisit by the auditor.

3.3 Renewal audit (for recertification)

Renewal audits are those which are performed after the initial audit.The period in which a renewal audit shall be performed is shown on thecertificate. A renewal audit involves a full and thorough audit of a com-



pany resulting in the issue of a new certificate. During the audit, all cri-teria of the IFS requirements shall be assessed by the auditor. Particularattention is paid to the deviations and non-conformities identified dur-ing the previous audit, as well as to the effectiveness and implementa-tion of corrective actions and preventive measures laid down in thecompany’s corrective action plan.

Note: corrective action plans from the previous audit shall always beassessed by the auditor, even if the previous audit has been performedmore than one year ago. Therefore, audited companies shall alwaysinform their certification body if they have already been IFS certified inthe past.

The date of the renewal audit shall be calculated from the date of theinitial audit and not from the date of issue of the certificate. Further-more, the renewal audit can be scheduled at earliest 8 weeks before andat latest 2 weeks after the renewal audit due date (see also section 6.2).Companies are responsible for maintaining their certification. The certi-fication bodies shall contact companies in advance in order to set a datefor a new audit.

In general, the expected date of each audit shall be uploaded in the IFSAudit Portal, in the diary function and at latest 2 weeks (14 calendardays) before the audit due date (it is possible to change the date shortterm).

3.4 Extension audit

In specific situations, such as new products and/or processes to beincluded in the audit scope or each time the audit scope would need tobe updated on the certificate, then, for an IFS PACsecure certified com-pany, it is not necessary to perform a complete new audit, but to organ-ise an on-site extension audit during the validity period of the existingcertificate. The certification body is responsible for determining relevantrequirements to be audited and relevant audit duration. The extensionaudit shall be performed by the auditor who performed the “normal”audit. The report of this extension audit shall be represented as anannex adjoined with the current audit report. Conditions for passing theextension audit (relative score ≥75%) are the same as normal one, butonly focused on specific requirements which have been audited; theoriginal audit score does not change.

If the extension audit demonstrates compliance, the certificate shall beupdated with the new scope and uploaded in the Audit Portal.

The updated certificate shall keep the same due date of end of validityas the current certificate.

If, during the extension audit, a Major non-conformity or a KO (KnockOut non-conformity) has been identified, the full audit is failed and thecurrent certificate shall be suspended as described in 5.8.1 and 5.8.2.



4 Scope of the audit

IFS PACsecure is a Standard for auditing primary and secondary pack-aging material manufacturers and converters.

Although initially developed for food contact packaging material manu-facturers (e.g. plastic foils for vegetables, cans for beverages, paperwrapping for flour, etc.) IFS PACsecure is also applicable to non-foodcontact packaging materials, such as:

– packaging materials for products intended to be used on theskin (e.g. cosmetic products),

– packaging materials for products not intended to be used onthe skin (e.g. household products, consumer goods, hardware,etc.).

The Standard can only be used when packaging material is “processed”,converted or printed and applies both to B to B and B to C businesses.As a result, IFS PACsecure shall not apply to the following activities:

– importation (offices, e.g. typical broker companies)

– transport, storage and distribution.

For clarification of the scope determination between IFS PACsecure andother IFS Standards (Food, Broker, Logistics, Cash & Carry/Wholesaleand HPC) please see Annex 1.

If the company trades packaging materials as finished products and if itwants to include them in the audit scope, the suppliers of these prod-ucts shall themselves be IFS PACsecure certified (if the trade productsare under the same product scope) or certified under a comparablescheme (if the trade products are under a different product scope) andthe specific requirements in the audit check-list (Part 2) related to tradeof packaging materials (4.4.2.1 to 4.4.2.3) shall be fulfiled. If this is notthe case, those products shall be excluded from the certificate and thecertificate shall mention: “trade activity is not included”.

If the above mentioned requirements are fulfiled, those traded packag-ing materials shall clearly be specified on the certificate, detailing theproduct scope(s), and specified in the report, both in the audit scopeand in the company profile.

The scope of the audit shall be defined and agreed between the com-pany and the certification body before the audit takes place. The scopeshall be clearly and unambiguously stated in the contract between thecompany and the certification body, in the audit report and on the cer-tificate.

The audit shall be performed at a time to ensure the full scope of prod-ucts and processes, as mentioned in the report and on the certificate,can be effectively assessed.

If, between two certification audits, new processes or products different



from those included in the scope of the current IFS PACsecure audit areimplemented, the certified company shall immediately inform its certi-fication body, who shall perform a risk assessment to decide whetheran extension audit should be performed or not (see also 3.4). The resultsof this risk assessment, based on hygiene and safety risks, shall bedocumented.

The audit shall be specific to the site where all the processing of theproducts is undertaken. Where decentralised structures exist and theaudit of a certain location is insufficient for gaining a complete view ofthe company’s processes, then all other relevant facilities shall also beincluded in the audit. Full details shall be documented within the com-pany profile in the audit report.

The audit scope shall include the complete activity of the company (i.e.the same kind of production on several lines for products under indus-try brands and retailer/wholesaler brands). The scope shall be reviewedand agreed at the beginning of the audit after an initial risk assessment.Furthermore, the scope can be modified after the risk assessment (forinstance, if a further activity interferes with the one concerned by theaudit scope).

The audit scope shall make reference to the audited product scope(s)corresponding to the type of packaging materials being processed/con-verted during the audit (see Annex 3).

If, under exceptional circumstances, the company decides to excludespecific product ranges (product lines) from the scope of the audit, thenthis shall be clearly noted and included in the audit report and on theIFS PACsecure certificate.

Auditing of multi-location companies with central managementIf defined processes are centrally organised in a company with severalproduction sites (e.g. purchasing, personnel management, complaintmanagement), the central managing site – headquarter – shall also beaudited and relevant audited requirements outcome shall be consid-ered in the audit reports of each production site.

Note: Each production site shall be audited separately in a period ofmaximum 12 months after the central managing site and shall have itsown audit report and certificate. Each site shall be mentioned in therelevant contract. If the central managing site does not have any pro-duction activity, this site cannot be IFS certified as an independent com-pany. The time for auditing the central managing site shall be describedin the company profile of the report.

The audit of the managing site shall always take place before the auditof each production site in order to have a preliminary overview.

Note: If it is not possible to perform an audit at the managing site, thenit shall be ensured that, during the audit of the production site, all nec-essary information from the managing site is available (e.g. a repre-sentative of the managing site should attend at the audit(s) of the pro-duction site(s)).



5 The certification process

5.1 Preparation of an audit

Before being audited, the company shall review all requirements of theIFS PACsecure Standard in detail. On the day of the audit, the currentversion of the Standard shall be available at the site being audited. Thecompany is responsible for acquiring the current version of the Stand-ard. In order to prepare for an initial audit, a company may carry out apre-audit, which is only intended to be used in-house. The pre-auditcannot include any recommendations.

If the audit is not an initial audit, the company shall also inform thecertification body so that the auditor can check the corrective actionplan from the previous audit.

The expected date for the initial or renewal audit shall be communi-cated to the IFS offices via the IFS Audit Portal. This shall be the respon-sibility of the certification body.

5.2 Certification body selection – contractualarrangements

In order to undertake the IFS PACsecure audit, the company shallappoint a certification body which is approved to perform such audits.It is the responsibility of the company to verify that the certificationbody is accredited for IFS PACsecure certification.

Only those IFS approved certification bodies – which shall be accreditedto ISO/IEC 17065 for IFS PACsecure and shall have signed a contractwith IFS (see Part 3) – can carry out IFS PACsecure audits and issuecertificates. The list of all IFS international approved certification bod-ies, by country, is available on the website www.ifs-certification.com.

Certification bodies can have auditors qualified for one or several prod-uct scopes. Confirmation of the product scopes for which the certifica-tion body can perform audits shall be obtained from the individual cer-tification body.

IFS PACsecure audits can be carried out by an audit team only if allmembers of the audit team are IFS approved auditors. Additionalrequirements for audit teams are described in detail in Part 3 of theStandard, chapter 3.6.

An auditor is not allowed to perform more than 3 consecutives audits ofthe same company’s site (whatever the time between audits); rules incase of audit team are also detailed in Part 3, chapter 3.6.

A contract shall exist between the company and the certification bodydetailing the scope of the audit, the duration and reporting require-



ments. The contract shall have a reference to Integrity Program (seechapter 12), in relation to the possibility of on-site audits organized byQuality Assurance Management of the IFS offices.

The audit shall take place when products of the audit scope are beingprocessed/converted.

The audit shall preferably be carried out in the language of the companybeing audited and the certification body shall make every attempt toappoint an auditor whose native language or main working language isthe language of the company. If this is not possible, the audit should becarried out in English language. Furthermore, languages used by theauditor for leading an audit – others than native language – shall beapproved by IFS offices prior to undertaking audits (see also Part 3).Nevertheless, and in all cases, the audit report, certificate and actionplan shall be written in English language.

5.3 Duration of an audit

The certification bodies have an appropriate system for estimating theminimum time needed for an audit.

A number of factors, which are detailed in the contract between thecertification body and the company, play a role in determining the timerequired for a comprehensive audit. They include:

– the size of the site

– the type of production/conversion process

– the scope of the audit

– the number of production lines involved

– the number of personnel employed at the site

– the number of non-conformities found in the previous audit.

Experience shows that the minimum audit duration on site shall be2 working days. Exceptions to this requirement, including decreasinglinked to multi-site companies, shall be precisely explained by the certi-fication body/the auditor on the first page of the report, in the “com-pany profile” field.

The audit duration might be extended, depending on the above factors.If the auditor estimates that additional time is necessary, the audit dura-tion shall be extended.

The above-mentioned requirements shall apply equally to renewalaudits, which shall be considered as completely new audits.

A normal audit day duration is 8 hours.



Independently from audit duration, besides on-site audit, preparation ofthe audit shall be at least 2 hours.

1/3 of the audit duration shall be spent, as a minimum, in the produc-tion/converting area of the site.

Additionally, time for generation of the audit report is typically 0,5 days.

Note 1: For multi-location companies, audit duration could be decreasedby a maximum of 0,5 days, if requirements have already been auditedat the central managing site.

Note 2: For an audit team, the minimum audit duration shall be 1 day.In addition to the calculated audit time, minimum 2 hours shall beadded. This additional time shall be allocated to the team and not to anindividual auditor for common tasks (e.g. opening and closing meeting,discussion about audit findings, etc.).

See also Part 3, chapter 3.6 about audit team.

5.4 Drawing up an audit time schedule

The certification body shall provide the audit time schedule. The audittime schedule includes appropriate details concerning the scope cov-ered and the complexity of the audit. The audit time schedule shall besufficiently flexible to respond to any unexpected events which mayarise during the site inspection activity within the certification audit.The audit time schedule takes into consideration a review of the auditreport and action plan relating to the previous audit, whatever the datewhen the previous audit has been performed. It also specifies which ofthe company’s products or product ranges are to be audited. The com-pany can only be audited at a time when it is actually producing/con-verting the products specified in the scope of the audit. The audit timeschedule shall be sent to the auditee before the audit, to ensure availa-bility of responsible persons at the day of the audit.

In case of an audit team, the audit time schedule shall clearly indicatewhich auditor performs which part of the audit.

If the IFS PACsecure audit is performed in combination with anotherstandard/norm, the audit time schedule shall clearly indicate when eachstandard or part of it has been audited.

The audit shall be scheduled based on the following steps:

– the opening meeting

– the evaluation of existing quality and product safety systems;achieved by checking documentation (HACCP/risk assessment,quality management documentation)



– the on-site inspection and interviewing of the personnel

– the final conclusions drawn from the audit

– the closing meeting.

The company will assist and co-operate with the auditor during theaudit. As part of the audit, personnel from different levels of manage-ment are interviewed. It is advisable that the company’s senior manag-ers are present at the opening and closing meetings so that any devia-tions and non-conformities can be discussed.

The auditor(s) who conduct(s) the audit will assess all the requirementsof IFS PACsecure which are relevant to the company’s structure andfunction.

During the closing meeting, the auditor (or lead auditor in the case of anaudit team) shall present all findings and discuss all deviations andnon-conformities which have been identified. As specified by ISO/IEC17065, the auditor may only issue a provisional assessment of compa-ny’s status during the closing meeting. The certification body shall issuea provisional audit report and outline an action plan to the company,which shall be used as a basis for drawing up corrective actions for thedetermined deviations and non-conformities.

The certification body is responsible for making the certification deci-sion and the preparation of the formal audit report after the receipt ofthe completed action plan. The issue of the certificate is dependent onthe audit results and on agreement on an appropriate action plan.

5.5 Evaluation of requirements

The auditor assesses the nature and significance of any deviation ornon-conformity. In order to determine whether compliance with arequirement of IFS PACsecure has been met, the auditor has to evaluateevery requirement in the Standard. There are different levels to rank thefindings.

5.5.1 Scoring a requirement as a deviation

In IFS PACsecure there are 4 scoring possibilities. Scoring with:

A: Full compliance with the requirement specified in the Standard

B: Almost full compliance with the requirement specified in the Stand-ard, but a small deviation was found

C: Only a small part of the requirement has been implemented

D: The requirement in the Standard has not been implemented



Points are awarded for each requirement according to the followingchart:

Chart N°1: Scoring

Result Explanation Points

A Full compliance 20 points

B (deviation) Almost full compliance 15 points

C (deviation) Small part of the requirement has been imple-mented

5 points

D (deviation) Requirement has not been implemented –20 points

The auditor shall explain all scorings with B, C and D in the audit report.

In addition to this scoring, the auditor can decide to give the company a“KO” or a “Major” non-conformity that will subtract points from thetotal amount. These possibilities are explained within the next chapters.

5.5.2 Scoring a requirement as a non-conformity

In IFS, there are two (2) kinds of non-conformities which are Major andKO. Both will lead to a subtraction of points from the total amount. If thecompany gets at least one of these non-conformities, the certificatecannot be awarded.

5.5.2.1 Major

A Major is defined as follows:A Major non-conformity can be given to any requirement which is notdefined as KO requirement.

When there is a substantial failure to meet the requirements of theStandard, which includes product safety and/or the legal requirementsof the production and destination countries. A Major can also be givenwhen the identified non-conformity can lead to a serious health hazard.

A Major will subtract 15% of the possible total amount of points.

Chart N° 2: Evaluation of a Major

Evaluation Scoring Result

Major 15% of possible total amount issubtracted

No certificate awarding ispossible

See also section 5.8 for the general management of audit process incase of Major non-conformity(ies).



5.5.2.2 KO (Knock out)

In IFS, there are specific requirements which are designated as KOrequirements (KO – Knock Out).

If during the audit the auditor establishes that these requirements arenot fulfiled by the company, this results in non-certification.

In IFS PACsecure the following 9 requirements are defined as KOrequirements:

1.2.4 Responsibility of the senior management

3.2.1.2 Personnel hygiene

4.2.1.2 Raw material specifications

4.2.2.1 Product formula compliance

4.12.1 Foreign material management

4.18.1 Traceability system

5.1.1 Internal audits

5.9.2 Procedure for withdrawal and recall

5.11.2 Corrective actions

KO requirements shall be evaluated according to the following scoringrules:

Chart N° 3: Scoring for a KO requirement

Result Explanation Awarded scores



C (deviation) Small part of the requirementis implemented

No “C” scoring is possible

KO (= D) The requirement is notimplemented

50% of the possible total amountof points is subtracted => Nocertificate awarding is possible

Important noteA “C” scoring is not possible for KO requirements. In this respect, theauditor can only use A, B or D (= KO).

When a KO requirement has been scored as “D”, 50% of the possibletotal amount of points will be subtracted automatically meaning thatthe company is “not approved” for IFS PACsecure certification.

A KO cannot be scored with N/A, except KO 4.2.2.1.

See also section 5.8 for the general management of audit report in caseof one or several KO requirements.



5.5.3 Scoring a requirement with N/A (not applicable)

When the auditor decides that a requirement is not applicable for acompany, the auditor has to use as scoring:

N/A: Not applicable and provide a short explanation in the audit report.

N/A scoring is possible for any requirements of the IFS PACsecure auditchecklist, except for KO requirements (exception for KO 4.2.2.1).

N/A requirements shall not be included in the outline action plan, butthey shall be listed in a separate table in the audit report.

If there are a significant number of requirements which are deemed asnot applicable, using a total points score for the audit may be mislead-ing; however, the scoring system for IFS PACsecure is based on a per-centage of the total available score and it is this which is used to decidethe status of the site i.e. foundation or higher level.

5.6 Determination of the audit frequency

For all products and for all certification levels, the audit frequency forIFS PACsecure audits is 12 months, starting from the date of the auditand not the date of issue the certificate. Further regulations are describedin 6.2 (certification cycle).

5.7 Audit report

Following each audit, a full written report shall be prepared in the agreedformat (see Part 4).

5.7.1 Structure of the audit report

The audit report shall provide transparency and confidence to the readerand will be completed by the auditor. The audit report is subdivided intodifferent sections.

– General information about the company with compulsory fields(see Part 4)

– General audit result with detailed description of the scope

– General summary in a tabular format for all chapters. The resultof the audit will specify the level and percentage

– General summary of all chapters and comments about followup of corrective actions implemented from the previous audit

– Observations on KO requirements and Major non-conformities



– Summary of all established deviations and non-conformitiesfor each chapter (1 to 6)

– Separate list (including explanations) of all requirements evalu-ated with N/A (not applicable)

All deviations (B, C, D) and KO requirements scored with a B, non-con-formities (Major, KO requirement scored with a D) identified during theaudit, are presented in a separate action plan. Following the allocationof a grade, non-conformities and deviations, the company has to pro-duce a corrective action plan. In this way, the reader of the report cansee the non-conformities and deviations, and also the corrective actionsthat the company is initiating.

5.7.2 The different steps for the audit report

5.7.2.1 Drawing up the pre-report of the audit and the outline of theaction plan

The auditor shall explain all non-conformities (KO requirements scoredwith a D and Majors), all deviations (B, C, D) and KO requirementsscored with a B, and all requirements that are found N/A.

The action plan shall include all the requirements which are not evalu-ated with A or N/A. The outline action plan shall conform to the outlineaction plan as specified in Part 4, Annex 3. It shall include the elementsof the chart N° 4.

The auditor shall complete all of field A in chart N° 4 explaining andjustifying the deviations and non-conformities finding before sendingthe company the outline action plan and the pre-report of the audit.

The certification body or the auditor shall send the company both thepre-report of the audit and the outline action plan within two weeks ofthe audit date.

Note: If the auditor identified deviations during the audit and theaudited company has already planned corrective actions, the deviationsshall be noted in the audit report and a comment shall be added indicat-ing the company has already planned corrective actions.



Chart N° 4: Outline action plan

Numberof therequire-ment

IFS requirement Evalua-tion

Explanation(by theauditor)

Correctiveaction(by thecompany)

ResponsibilityDate andstatus ofimplementation(by thecompany)

Release bythe auditor

Field A Field B Field C Field D

1.2.1 An organisationchart …

B

1.2.2 Competences andresponsibilities …

C

1.2.3 Job descriptionswith clearly …

D

1.2.4 KO The senior manage-ment shall ensure …

KO/D

1.2.5 Employees withinfluence …

Major

5.7.2.2 Company’s completion of the corrective action plan

The company shall enter proposed corrective actions (field B of chartN° 4) for all deviations (B, C, D) and KO requirements scored with a Band non-conformities (Major, KO requirements scored with a D) listedby the auditor.

For all evaluated deviations with score C and D, as well as non-conform-ities, Major or KO requirements scored with a B and/or a D, the com-pany shall clearly state the responsibilities and implementation dead-lines for corrective action (chart N° 4, field C). The company shall forwardthe corrective action plan to the certification body within 2 weeks ofhaving received the pre-report of the audit and the action plan layout. Ifthis deadline is not respected, the company has to undergo a completeinitial or renewal audit.

An IFS PACsecure certificate shall not be awarded unless the correctiveactions for requirements scored with a C or D, and KO requirementsscored with B, specify responsibilities and implementation dates in theaction plan.

The final decision of awarding the IFS PACsecure certificate is depend-ent both on final scoring and on relevance of corrective action plancommunicated by the company to the certification body.

The company shall always submit a written corrective action plan beforereceiving the final report and the certificate. The intention of the correc-tive action plan is for the company to strive for continuous improve-ments.



5.7.2.3 Auditor validation of the action plan

The auditor or a representative of the certification body shall validatethe relevance of the corrective actions in the last column of the actionplan before preparing the final audit report (Field D of the chart N° 4). Ifthe corrective actions are not valid or are inadequate, the certificationbody shall return the action plan to the company for completion in duetime.

5.7.3 Further rules about the audit report

5.7.3.1 Link between two consecutive audit reports (initial andrenewal audits)

When the auditor scores a requirement with C or D, corrective actionsshall be implemented before the renewal audit. This means the certifi-cation body shall read the audit report and the action plan of the previ-ous audit, even if the report was issued by another certification body.

If C and/or D scorings remain the same from one audit to the next, or ifscorings are getting worse, the auditor shall assess in accordance withthe IFS chapter related to “Corrective actions” (chapter 5.11 of the auditcheck-list, Part 2). This link between two consecutive audits ensures acontinuous improvement process.



5.8 Scoring and conditions for issuing audit report andcertificate

Chart N° 5: Scoring and awarding of certificates

Audit result Status Action company Report form Certificate

At least 1 KOscored with D

Not approved Actions and newinitial audit to beagreed upon

Report givesstatus

No

>1 Majorand/or <75%of therequirementsare fulfilled


Report givesstatus

No

Max 1 Majorand ≥75% ofthe require-ments arefulfilled

Not approvedunless furtheractions takenand validatedafter follow-up audit

Send completedaction planwithin 2 weeksof receiving thepreliminarilyreport. Follow-upaudit max.6 months afterthe audit date

Reportincludingaction plangives status

Certificate atfoundationlevel, if theMajor non-conformity isfinally solvedas controlledduring thefollow-upaudit

Total score is≥75% and<95%

Approved atfoundationIFS PACsecurelevel afterreceipt of theaction plan

Send completedaction planwithin 2 weeksof receiving thepreliminarilyreport.


Yes, certifi-cate atfoundationlevel,12 monthsvalidity

Total score is≥95%

Approved athigherIFS PACsecurelevel afterreceipt of theaction plan



Yes, certifi-cate at higherlevel,12 monthsvalidity

Note: the total score is calculated as follows:

Total number of points= (total number of IFS requirements – requirements scored with N/A)×20

Final score (in%)= number of points awarded/total number of points.

The certificate shall always be issued in English language. If requestedby the customer, it can additionally be issued in a different language.



5.8.1 Specific management of the audit process (report,certificate, uploading) in case one or several KO’shas/have been scored with D during the audit(see also Annex 4)

In case one or several KO is/are scored with D during the audit, the cur-rent IFS PACsecure certificate shall be suspended in the IFS Audit Portalby the certification body as soon as possible and a maximum 2 workingdays after the audit date.

In the database, explanation about reasons for suspending the currentcertificate shall be given in English language. Clear explanations aboutthe identified non-conformity(ies) shall be provided by giving the num-ber of involved KO requirement(s). These explanations shall be detailedand be the same as those described in the action plan.

Note: All users having access to the IFS Audit Portal and having men-tioned the respective company in their favourites list will get an e-mailnotice from the IFS Audit Portal that the current certificate has beensuspended.

In each case, the audit shall be completed and all requirements shall beevaluated in order to give the company a complete overview about itssituation.

Furthermore, it is recommended to complete the action plan forimprovement purposes.

The audit report where one or several KO requirement(s) have beenscored with D shall always be uploaded into the IFS Audit Portal (onlyfor administrative purpose, but will not be visible).

In these situations, a complete new audit shall be performed. The newaudit shall be scheduled no earlier than 6 weeks after the audit where aKO requirement was scored with D.

5.8.2 Specific management of the audit process (report,certificate, uploading) in case one or several Major non-conformity(ies) has/have been issued (see also Annex 4)

In case one or several Major non-conformity(ies) is/are issued duringthe audit, the current IFS PACsecure certificate shall be suspended inthe IFS Audit Portal by the certification body as soon as possible and amaximum 2 working days after the audit date.

In the database, explanation about reasons for suspending the currentcertificate shall be given in English language. Clear explanations aboutthe identified non-conformity(ies) shall be provided by giving the num-ber of involved requirement(s). These explanations shall be detailedand be the same as those described in the action plan.



In cases where more than one Major non-conformity have been identi-fied, a complete new audit shall be performed. The new audit shall bescheduled no earlier than 6 weeks after the audit where Major non-conformities were issued.

If the Major non-conformity is related to production failure(s), the fol-low up audit shall be performed at least 6 weeks after the previous auditand no later than 6 months after the previous audit. For other kinds offailures (e.g. documentation), the certification body is responsible forthe determination of the date of the follow-up audit.

The audit report where one or several Major non-conformity(ies)has/have been identified shall always be uploaded into the IFS AuditPortal after receiving the action plan (only for administrative purpose,but will not be visible).

Specific situation in case of follow-up audit:If a Major non-conformity has been identified with a total score of 75%or above and then resolved, and if the audit result is deemed positive:

The certification body shall mention on the updated audit report:

– in the “date” section: specify the date of the follow up audit inaddition to the date of audit when the Major non-conformitywas identified,

– in the “final result of audit” section: specify that a follow upaudit has taken place and that the Major non-conformity hasbeen solved,

– in the “observations regarding KO non-conformities andMajors” section explain on which requirement the Major non-conformity has been solved.

· The company cannot be certified with higher level even if thefinal total score is equal or more than 95%.

· The same valid date of the certificate remains in the certifica-tion cycle as described in 6.2.

· It shall be defined on the certificate the date of initial auditand date of follow up audit.

· If it was during an initial audit, the longest certificate validdue date is calculated using initial audit date, plus one yearand 8 weeks.

Example:Initial audit date 1: 01. October, 2012Date of issue of certificate: 26. November, 2012Certificate valid until: 25. November, 2013Renewal date(audit where Major has been issued) 2: 25. September, 2013Follow up audit: 03. December, 2013Latest date of validity of the certificate: 25. November, 2014.



The report (first of the audit with the estimated Major, then updatedwith results of follow up audit) shall be uploaded into the IFS AuditPortal after performing the follow up audit with the proviso that theMajor non-conformity is finally solved.

5.8.3 Specific management of the audit process in case thefinal score is <75%

In these situations, the certification is failed and a complete new auditshall be performed. The new audit shall be scheduled no earlier than 6weeks after the audit where the final score was <75%.

5.8.4 Specific management of the audit process in case ofmulti-site companies

All KO requirements shall be audited at all sites even if some of themare partly managed at the central managing site.

In the audit report of each site, only the audit date of the respective siteshall be mentioned; the audit date of managing site is not additionallynecessary.

In case that a Major non-conformity or a KO scored with D has beenissued during the audit of the central managing site, all audited produc-tion sites are also affected and the certificates of these sites shall besuspended (according the procedure described above).

After a successful audit of the central managing site (or after positivefollow-up after a Major was issued in the central managing site), thecertificates of the production sites can be reinstated. Depending uponwhich non-conformity has been issued in the central managing site, anew audit of the production sites may also be necessary.

6 Awarding the certificate

A certificate shall be issued to one specific site.

Detailed minimum mandatory information to be published on the IFSPACsecure certificate is determined in Part 4.

Note: the final audit score, in percentage, can also be published on thecertificate, if required by customer and/or audited company.



6.1 Deadlines for awarding certificate

The certification body is responsible for the decision to award or notaward the IFS PACsecure certificate. The decision is made by person(s)other than those who have carried out the audit. The certification shallbe valid effectively from the date of issue stated on the certificate itselfand shall end after 12 months. The date for the renewal audit shall becalculated from the date of the initial audit, not from the date of issuethe certificate. If the audit is not performed in due time, the retailers orother users will be informed via the Audit Portal.

The time between the date of the audit and the awarding of certificate isdetermined as follows:

– 2 weeks to draw up the pre-report of the audit

– 2 weeks for the company to respond to the deviations and non-conformities (i.e. draw up the action plan)

– 2 weeks for the auditor to check the proposed corrective actions,for the certification procedure and upload of the audit report,the action plan and the certificate to the Audit Portal.

In total: 6 weeks between the date of audit and uploading the auditreport to the Audit Portal and awarding the certificate:

– Target time: 6 weeks,

– Maximum time: 8 weeks.

6.2 Certification cycle

Even if the renewal audit due date changes every year and does notcompletely correspond to the anniversary date, the certificate validitydate shall remain the same each year. Due date of the certificate isdetermined as follows: initial audit date + 8 weeks.

This allows to avoid gaps between two (2) consecutive certificates andto avoid that a company scheduling the audit earlier loses some monthsof certificate validity.

Example:Initial audit date: 01. October, 2012Date of issue of certificate: 26. November, 2012Certificate valid until: 25. November, 2013

Renewal audit date: 25. September, 2013Certificate valid until: 25. November, 2014 (independently from

the renewal audit date).



Chart N° 6: Certification cycle

Note: the certificate shall always be edited on the basis of a certificationdecision and after the several steps of certification decision accordingto ISO/IEC 17065.

Ideally, the renewal audit shall be performed within eight (8) weeks ofthe date of expiry of certificate to have enough time for the severalsteps of the certification process.

The renewal audit shall be scheduled at earliest eight (8) weeks beforeand at latest two (2) weeks after the audit due date (due date is anniver-sary date of the initial audit). If this is not the case, or if the several stepsof the certification process were not completed in time, the certificatecannot be renewed with the “due date” but with the actual new date;this will lead to a break in the certification.

In the example above, this means that the audit shall never be sched-uled before 06. August and after 15. October.

The previous audit report remains a further eight (8) weeks (after auditdue date) on the Audit Portal, but if the renewal audit takes place laterthan described above, the report will be automatically inactivated fromthe IFS Audit Portal.

6.3 Information about conditions of withdrawal ofcertificate

Withdrawal of certificate by the certification body is only permitted incase of any information indicating that the product may no longer com-ply with the requirements of the certification system (ISO/IEC 17065).

The only exception of this rule may be related to the non-payment ofthe current audit by the certified company.

The contract between certification body and audited company shall beharmonized with the certification cycle (see above chart N° 6).

IA:01.10. 2012

IA: Initial auditRA: Renewal auditC: Issue a certificate valid until

RA:25.09.2013

C:25.11.2013

C:25.11.2014

C:25.11.2015

RA:05. 10.2014

< 12 months >12 months

= 12 months =12 months

Oct.2012

Nov. Sept.2013

O Nov.D J F MAM J J A D J F MAM J J A S Oct.2014

Nov. D J F MAM J J A S



7 Distribution and storage of the auditreport

Audit reports shall remain the property of the company and shall not bereleased, in whole or part, to a third party without the company’s priorconsent (except where required by law). This consent for distribution ofthe audit report must be in writing and can be granted by the companyvis-à-vis the certification body and/or vis-à-vis the relevant user. Thecertification body shall keep a copy of the audit report. The audit reportshall be stored safely and securely for a period of five years.

Access conditions to information about audit reports are fully detailedin Part 4.

8 Supplementary action

The decision on the level of supplementary actions required on thebasis of the certificate shall be made at the discretion of the individualbuying organisation.

9 Appeal and complaints procedure

The certification body shall have documented procedures for the con-sideration and resolution of appeals against the results of an audit.These procedures shall be independent of the individual auditor andwill be considered by senior management of the certification body.Appeals will be finalised within 20 working days of receiving informa-tion from the auditee.

The certification body shall have documented general procedures forhandling complaints received from the companies and/or other relevantparties. An initial response will be given within ten (10) working days ofreceiving the complaint. A letter confirming receipt of the complaint willbe issued within a maximum of five (5) working days. A full writtenresponse will be given after the completion of a full and thorough inves-tigation into a complaint.

For the handling of complaints received by the IFS offices, the basis forthe complaint management is described in the IFS framework agree-ment with certification bodies:

– If the complaint relates to the quality of the content of IFS PAC-secure audits or IFS PACsecure audit reports, IFS offices requirethe certification body to provide a statement on the cause andthe measures introduced to rectify the problem within 2 weeks.



– If the complaint relates to administrative errors, e.g. in IFS PAC-secure audit reports, IFS PACsecure certificates or in the IFSdatabase, IFS offices ask the certification body to provide astatement and rectify the problem within one (1) week. Thestatement shall be issued in writing by e-mail or post.

10 Ownership and usage of theIFS PACsecure logo

The copyright of IFS PACsecure and the registered trademark is fullyowned by the IFS Management GmbH. The IFS PACsecure logo can bedownloaded via the secured section of the IFS Audit Portal.

Furthermore, the below terms and conditions shall be checked by theauditor during the audit and results of this check shall be described inthe company profile of the audit report as a compulsory field (see Part 4,section 1.1). If the auditor identifies during an audit that the companydoes not fulfil the conditions of logo usage, the auditor shall note it inthe company profile of the audit report and shall inform the IFS officesaccordingly.

Terms and conditions for using the IFS PACsecure logo and communi-cation about the IFS PACsecure certification

ApplicationThese terms and conditions apply for both IFS PACsecure and all IFSlogos in general.

Form, design and colour of the IFS PACsecure logoWhen used, the IFS PACsecure logo must comply with the form andcolour of the scale drawing. If it is used in documents, black and whiteprint is also permitted.

The IFS PACsecure logo can be used in print, physical and electronicform, and in films, providing the forms and formats are respected. Thesame conditions apply to the use of the logo as a stamp.

Restriction of comment and interpretationsWhen an IFS PACsecure certified company, an IFS PACsecure support-ing company or an IFS PACsecure certification body publishes docu-ments bearing the IFS logo, comment and interpretations referring tothe IFS shall be clearly identifiable as such.

Use of the IFS PACsecure logo in promotional materialAn IFS PACsecure certified company, an IFS PACsecure supportingcompany (broker, food manufacturer, retailer, logistics provider orwholesaler) which accepts IFS PACsecure certificates from their suppli-ers or service providers, or an IFS certification body may use the IFS



logo for promotional reasons and publish information about IFS certifi-cation provided that it is not visible on final product packaging whichare available to the end-consumer (B to C business).

Companies which provide products and/or services to IFS certified orsupporting companies, but which are not themselves IFS certified (e.g.manufacturers of devices, clothing, cleaning materials or service pro-viders which would like to promote that their products and/or serviceshelp to fulfil the IFS requirements) must ask for express written permis-sion to IFS Management GmbH to use the IFS PACsecure logo and/orany other IFS logo(s).

The IFS PACsecure logo and information about the certification may beused in correspondence with relevant IFS users. Presentations mention-ing IFS on the internet are only permitted if they are in a direct link withproduct safety (e.g. within information about the safety/quality man-agement system).

The IFS PACsecure logo may be displayed on any kind of general com-munication (e.g. exhibitions for business contacts, brochures, genericarticles about packaging, product safety and quality management ingeneral, vehicles). The IFS PACsecure Standard was developed in orderto assure the product safety and quality.

It must be ensured that all information concerning certifications refersclearly to IFS. The IFS logo may not be used in presentations having noclear connection to IFS.

Further restriction on the use of the IFS PACsecure logoThe IFS PACsecure logo shall not be used in a way that could showintent that the IFS owner is responsible for the certification decision.Furthermore, the same applies for opinions and interpretations whichcould be deriven from it. In the event of suspension or withdrawal of theIFS PACsecure certification, the certified company has to immediatelystop the inclusion of the IFS logo on its documents or other associatedmaterial and cease all communications regarding IFS. The audited com-pany must demonstrate that they have complied with these require-ments.

Communication of the IFS PACsecure certificationAll the above mentioned rules apply to any communication regardingIFS PACsecure. This also means that using the wordmarks “IFS”, “Inter-national Featured Standards”, or “IFS PACsecure” or similar is notallowed when communicating on finished products, which are availableto the end-consumer.



11 Review of the Standard

The Review Committee needs to demonstrate control of the quality andcontent of the Standard and will review annually the Standard and theProtocol to ensure that they are still in compliance with their require-ments. The Review Committee shall be formed with all participantsinvolved in the audit process: the representatives of retailers, repre-sentatives of the industry, of (non) food services and of certificationbodies. The objective of the Review Committee is to share experiences,discuss and decide about the changes to the Standard, the requirementsof the audit report and training.

12 IFS Integrity Program

The IFS Integrity Program launched in early 2010 includes differentmeasures to assure the quality of the IFS certification scheme, with afocus on the review of audits conducted by the IFS certification bodiesand their auditors.

There are two cornerstones of this program:

12.1 Preventive quality assurance actions

Quality assurance activities monitor the entire IFS system. Surveillanceaudits at the certification body offices and on-site supplier audits arecarried out on a regular basis in order to assess the IFS system. Theseaudits are undertaken regardless of whether or not a complaint hasbeen made. The sampling for these surveillance audits is based on arandom selection process and by use of objective criteria. These criteriaare both economic criteria (e.g. number of issued certificates) and qual-ity criteria (e.g. the review and analyses of IFS certification processesand corresponding reports).

A surveillance office audit of a certification body (CB) takes place at theaccredited certification body’s premises to verify the correct applicationof the IFS regulations at the certification body offices and to promotecontinuous improvement.

Additionally, surveillance on-site supplier audits at certified companiesmay be undertaken. In general, surveillance on-site supplier audits areannounced 48 hours before the audit date. In these audits the documen-tation reviewed in the office audit of the certification body, or in the IFSdatabase, is compared with the real situation found at the company.

Witness audits can also be performed. In this case, Integrity auditorsassess an IFS PACsecure auditor during a real IFS PACsecure audit.



12.2 Quality assurance actions after complaintnotification

A detailed complaint management process analyzes all necessary infor-mation. Retailers or any other interested parties have the right to for-ward any possible non-conformity to IFS for investigation as part of theIntegrity Program.

The IFS Offices collect complaints concerning IFS PACsecure audits,reports, certificates or other circumstances in which the integrity ofthe IFS brand is in question. Retailers, certification bodies, employeesof IFS-certified companies or any person can use the complaint formon the IFS website www.ifs-certification.com or can send an e-mail [email protected] to inform IFS about a cer-tain issue. In addition to any complaints received, IFS also analyses theIFS database using analytical tools in order to identify any deficiencies.If IFS Quality Assurance Management is informed of significant discrep-ancies between the results of an IFS PACsecure audit and a subsequentretailer audit, this will be investigated within the complaint manage-ment process as described below.

The IFS Offices will gather all necessary information in order to investi-gate the cause of the complaint and to establish if there are deficienciesby certified companies, accredited certification bodies or IFS-approvedauditors in meeting IFS requirements. Appropriate steps are taken tofully investigate a complaint, which may include a request to a certifica-tion body to carry out internal investigations and provide a statementon the outcome of their investigations to IFS.

In the event that a complaint cannot be successfully resolved by theinvestigation undertaken by the certification body, an on-site investiga-tion audit will be undertaken at the certified company(s). In general,investigation audits are announced 48 hours before the audit date,however in special cases unannounced audits are undertaken.

Witness audits can also be performed. In this case, Integrity auditorsassess an IFS PACsecure auditor during a real IFS PACsecure audit.

Audits carried out as part of the Integrity Program are conducted byauditors employed by IFS and completely independent of the auditees.

12.3 Sanctions

If, following a complaint or preventive quality assurance actions, thecause of a deficiency has been found to be the fault of a certificationbody and/or an auditor, IFS will forward all necessary informationanonymously to an independent Sanction Committee. The SanctionCommittee, which is made up of a lawyer and participants from indus-try, retailers and certification bodies, shall make a decision on whethera breach exists and on its severity.



Sanctions will be issued to the certification body and/or its auditors ifthe Sanction Committee concludes that a breach has been committed.The type of sanction depends on the number of breaches previouslycommitted by the auditor and/or the certification body as well as thelevel of severity of such breaches. IFS Management informs the appro-priate accreditation body if a breach for a certification body and/or foran auditor has been established.

All these procedures are laid down in the contract between IFS andeach certification body and all stakeholders of the IFS system areinformed of the process. The IFS Integrity Program strengthens the reli-ability of the IFS scheme by checking the implementation of the IFSStandard in practice.

Chart N° 7: Summary of IFS Integrity Program activities

Integrity Program

Complaintmanagement

Preventive QAmeasures

Surveillanceaudits

On-sitesupplier

audit

IFS qualitymanagement

sufficient evidenceat hand/breach

likely

Investigationaudits

Witnessaudit

CB officeaudit

CB officeaudit

On-sitesupplier

audit

Chairmanlawyer

Participantfrom retailers

Participant fromthe industry

Sanction committee

Participant from CBswithout right to vote

Witnessaudit



ANNEX 1: Clarification for the scope applicationof the different IFS Standards

IFS PACsecure is a Standard for auditing food and non-food packagingmaterial manufacturers and converters and only concerns packagingprocessing and/or converting companies.

IFS Food is a Standard for auditing food product suppliers/manufactur-ers and only concerns food processing companies or companies thatpack loose food products. IFS Food shall be used when a product is“processed” or when there is a hazard for product contamination dur-ing the primary packing.

IFS Logistics is a Standard for auditing companies whose activities arelogistics oriented for food and non-food products, as well as packagingmaterials, such as transport, storage, distribution, loading/unloading,etc. It applies to all types of activities: delivery by road, rail or ship; fro-zen/refrigerated products or ambient stable products.

Clarifications/examples of scope application between IFS PACsecureand IFS Logistics:

– IFS Logistics only concerns logistics activities where compa-nies have a physical contact with already processed/convertedpackaging materials (transport, storage and/or distribution,transport and storage of pallets). When the processing com-pany has its own logistics and/or transport department/activi-ties (storage and distribution), it is included in the IFS PACse-cure under the specific sub-chapter about transport or storage.

Note: If the logistics operation owned by the processing com-pany is situated in the same location as the company, and if thecompany or the customer wishes to get this operation IFSLogistics certified, an IFS Logistics audit can be performed.

In this case, the following requirements shall be fulfiled:

· the logistics operation is only used for already packed pack-aging materials,

· in case of two (2) certificates (IFS PACsecure and Logistics),the respective scopes of each audit and certificate shall beclearly defined,

· the requirements of IFS PACsecure concerning transport andstorage shall be anyway evaluated during the IFS PACsecureaudit,

· an IFS PACsecure audit of the processing company shall beperformed; IFS Logistics is an additional audit,

· all relevant documents shall be located at the platform.

– If logistics and/or transport activities are outsourced by the pro-cessing company, the requirements specified in the appropri-



ate chapter of IFS PACsecure about storage and transport shallbe clearly defined in the respective contract, or IFS Logisticsapplies.

IFS Broker is a Standard for auditing companies such as trade agencies,brokers or any other companies that do not take physical possession ofthe products or material (e.g. which do not have warehouses, packingstations or truck fleet, but are legal entities with mailboxes, offices etc.).The Standard applies to food, packaging and household and personalcare products.

Matrix for the determination of the right IFS Standard

N° Main activity of the company International Featured Standards

IFSFood

IFSHPC

IFSLog. 2

IFSBroker

IFSC&C/W.

IFSPACsecure

1 Food processing(when products are processed or as soon asthere is a hazard for product contamination)

X

2 HPC processing(when products are processed or as soon asthere is a hazard for product contamination)

X

3 Food, Non-Food, HPC, packaging materialslogistics activitiesLogistics activities only as service, no tradingactivities(when companies have a physical contactwith already primary packed products oronly for specific unpacked goods, such asmeat carcasses or bulk/tanker transport(glucose syrup, milk, grain, etc.)

X

4 Food, HPC, packaging trading withoutproduct contact(when no physical possession of products,only purchase – sale from an office, nologistics activities)

X

5 Cash & Carry/Wholesale(when distribution of products, small amountof processing activities can be included,under specific requirements)

X

6 Packaging materials processing/converting(when packaging products are processed/converted)

X

Combined certification

7 Food/HPC/packaging material trading andFood/HPC/packaging material logisticsCombined audit for trading AND logisticsactivities, with a specific combined check-list

X X



ANNEX 2: Certification process

Voluntary: Pre-Audit

Together withcertification body:· Determination of

the audit date· Determination of

audit times· Definition of the

audit scope

Determination ofMajors, KO – Audit

not approved

Action plan andpreliminary audit

report sent toaudited company

Voluntary comple-tion of the actionplan and return to

the certification body

Finalisation of theaction plan and

report – upload intothe IFS Audit portal

No certificate

Action plan andpreliminary audit

report sent toaudited company

Corrective actions ofthe non-conformities

which have led tothe Major within

6 months

Validation of thecorrective actionsby the certification

body

Determination of1 Major and particu-lar circumstances –

Not approved beforefurther actions

Suspensionof the

currentcertificate

Suspensionof the

currentcertificate

4. Selection by the company of the IFS certification body(accredited and approved).

Quotation, decision and signature of contract

3. Evaluation of the current status by the company

2. Reading of the respective copy of IFS Standard

1. Decision by the company to get certified againstthe IFS Standard

6. Closing meetingInformation about the determined non-conformities

Opening meeting – Evaluation of the documentation –Site assessment and interviews of employees – Creation of the audit conclusions

5. Audit planning and preparationRealisation of the audit on-site at the determined date,

by an auditor competent in the relevant scopes

7. Preparation of a preliminary audit report andpreparation of action plan by the auditor (2 weeks)

12. Awarding of certificate and sending of the final reportto the audited company

11. Certification decision, determinationof the certificate validity by the certification body

10. Proofreading of the completed action plan by thecertification body/auditor

Checking the complete audit report and action plan(with mandatory review) by the certification body

9. Return of the fulfilled action planto the certification body/auditor (2 weeks)

8. Completion of the action plan and determinationof corrective actions by the audited company (2 weeks)

13. Uploading of the audit data’s into the IFS Audit portal(audit details, report, action plan and certificate)

by the certification body

14. Three months before the audit expires, a reminderwill be sent to the company by the IFS Audit portal for

scheduling a new audit with the certification body.The audit shall be scheduled no later than the renewal

audit date scheduled in the certificate.



ANNEX 3: Product scopes

In IFS PACsecure version 1, all activities of the company are related toproduct scopes as follows:

Table 1: Product scopes

1. Flexible packaging

2. Rigid plastic

3. Paper

4. Metal

5. Glass

6. Other natural materials

Multi component packaging materials (e.g. Tetra Pak) have to beassigned based on the material which is the main component of thematerial. The main component of multi component packaging materi-als shall be mentioned in the scope of the audit on the report.

Materials to be considered as “other natural materials” are, for exam-ple wood, clay, cork, jute, textiles, banana leaves, etc.



ANNEX 4: Flow chart for management of KOscored with D and Major non-conformities

Uploading final IFS report in portal (visible):In case of follow up audit:– Define in the “date” section date of initial audit and date of

follow up audit– Define in the “final result of audit” section that a follow audit

has taken place and that the Major has been solved– In the “observations regarding KO and Majors”, explain on

which requirement Major has been solvedThe company can not be certified with higher level, even if thefinal score is ≥95%Date of end of validity of certificate based on date of initial audit

Follow-up audit, if <6 monthsbetween audit where Majorwas issued and next audit(earliest after six (6) weeks

in case of failure concerningproduction activities)

Full new audit, scheduled not earlierthan six (6) weeks after the audit

where non-conformity(ies) was/wereidentified

Uploading report in IFS portal(not visible)

Uploading final IFS report in portal(visible)

Recommended: completion of theaction plan by the audited companyand return to the certification body

within two (2) weeks

Send preliminary report and actionplan template to the audited company

Positive auditresult

Positive auditresult

Timeperiod to the

next auditTimeperiod to the

next audit

Auditresult

Not approved

Suspension of the current certificate,max. two (2) working days after audit

dateInserting the explanations in English

about non-conformity(ies) in IFS portal

>1 Major and/or <75% orMore than one Major or

One or several KO’s scored with D

Uploading report in IFS portal(not visible)

Initial audit, if >6 monthsbetween audit where Majorwas issued and next audit

Mandatory: completion of the actionplan by the audited company and

return to the certification body withintwo (2) weeks

Send preliminary report and actionplan template to the audited company

Suspension of the current certificate,max. two (2) working days after audit

dateInserting the explanations in Englishabout non conformity in IFS portal

1 Major and ≥75% of the require-ments are fulfilled =>15% of the total

possible amount is subtracted

Not approved unless further actionsare taken and validated after follow-

up audit

IFS PACsecure audit



Part 2: List of audit requirements

The following list contains the IFS PACsecure auditing requirements.

The below chart demonstrates the connection between IFS PACsecureand PACsecure Prerequisite Program requirements. Additionally, thereare examples given on questions auditors should ask (5th column) andexamples for KO or Major scoring (6th column).

The PACsecure Packaging Material Manufacturer & Converter GenericFood Safety Prerequisite Program (PP) contains foundation require-ments on documentation, management and food safety program main-tenance, and considers current packaging industry practices. The IFSPACsecure was developed taking into account this Program.

PACsecure documents, workbooks and plans (Packaging MaterialManufacturer & Converter Generic Food Safety Prerequisite Program,HACCP Workbooks and HACCP Plans) can be obtained from the Packag-ing Association of Canada. These documents can assist, for example, inimplementing HACCP for a specific packaging material manufacturer,like e.g. manufacturers of flexible packaging and may be used as indus-try guidelines as mentioned in requirement 2.2.1.1



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

1S

enio

rM

anag

emen

tR

esp

on

sib

ility

5.0

1.1

Co

rpo

rate

po

licy/

Co

rpo

rate

pri

nci

ple

s

1.1.

1T

he

sen

ior

man

agem

ent

shal

ldra

wu

pan

dim

ple

men

ta

corp

ora

tep

olic

y.T

his

shal

lco

nsi

der

asa

min

imu

m:

–cu

sto

mer

focu

s–

envi

ron

men

talr

esp

on

sib

ility

–su

stai

nab

ility

–et

hic

san

dp

erso

nn

elre

spo

nsi

bili

ty–

pro

du

ctre

qu

irem

ents

(in

clu

des

:p

rod

uct

safe

ty,q

ual

ity,

leg

alit

y,p

roce

ssan

dsp

ecifi

cati

on

).T

he

corp

ora

tep

olic

ysh

allb

eco

mm

un

icat

edto

alle

mp

loye

es.

5.0

Man

agem

ent

com

mit

-m

ent

toth

efo

od

safe

tysy

stem

isre

qu

ired

.Th

ism

ayb

ed

emo

nst

rate

db

yth

ed

evel

op

men

tan

dap

pro

valo

fa

foo

dsa

fety

po

licy

or

oth

erst

atem

ents

of

com

mit

-m

ent

toth

efo

od

safe

tysy

stem

.

–H

ow

and

wh

ere

isco

rpo

rate

po

licy

do

cum

ente

d?

–W

hat

are

the

con

ten

tso

fth

eco

rpo

rate

po

licy?

–H

ow

was

corp

ora

tep

olic

yco

mm

un

icat

edto

alle

mp

loye

es?

–<c

orp

ora

tep

olic

y>,<

po

ster

s><d

ocu

-m

ente

dev

iden

ceo

fco

rpo

rate

po

licy

com

mu

nic

atio

n>

En

viro

nm

enta

lres

po

nsi

bili

tyan

dsu

stai

n-

abili

tyar

ein

clu

ded

inth

eIF

SPA

Cse

cure

Sta

nd

ard

,eve

nif

itis

ap

acka

gin

gm

ater

ial

safe

tyan

dq

ual

ity

stan

dar

d,i

no

rder

toin

itia

te/d

evel

op

inco

mp

anie

sp

roce

sses

of

awar

enes

sfo

rb

oth

top

ics.

1.1.

2T

he

corp

ora

tep

olic

ysh

allh

ave

ob

ject

ives

spec

ifyi

ng

resp

on

sib

iliti

esan

dti

mel

ines

app

rop

riat

efo

rth

esi

zean

dco

mp

lexi

tyo

fth

eo

rgan

izat

ion

.

–W

hat

sho

rt,m

ediu

man

dlo

ng

term

qu

alit

yo

bje

ctiv

esar

ead

dre

ssed

?–

Ho

war

eth

eo

bje

ctiv

esat

tain

ed?

–W

hat

isth

eti

me

fram

eto

atta

inth

eo

bje

ctiv

es?

–W

ho

isre

spo

nsi

ble

for

ob

ject

ives

atta

in-

men

t?–

Wh

atac

tio

ns

are

take

nb

ysp

ecifi

cd

epar

tmen

ts,e

.g.p

urc

has

e,to

atta

inth

eo

bje

ctiv

es?

–<w

ritt

enre

view

mee

tin

gm

inu

tes>

,<l

ist

of

atte

nd

ees

atre

view

mee

tin

g>,

<qu

alit

yo

bje

ctiv

es>



1.1.

3Fr

om

the

corp

ora

tep

olic

y,th

eq

ual

ity

and

pac

kag

ing

mat

eria

lsa

fety

ob

ject

ives

shal

lbe

com

mu

ni-

cate

dto

the

emp

loye

esin

the

resp

ec-

tive

dep

artm

ents

and

shal

lbe

effe

ctiv

ely

imp

lem

ente

d.

–W

hat

qu

alit

yo

bje

ctiv

esar

ed

efin

ed?

–A

reth

ese

ob

ject

ives

kno

wn

by

con

cern

edem

plo

yees

?–

Wh

atto

ols

are

use

dto

mea

sure

that

the

ob

ject

ives

hav

eb

een

atta

ined

?–

<lis

to

fat

ten

dee

sat

revi

ewm

eeti

ng

>,<m

ailin

glis

to

fre

view

mee

tin

gm

inu

tes>

,

1.1.

4T

he

sen

ior

man

agem

ent

shal

len

sure

that

the

ach

ieve

men

to

fal

lob

ject

ives

isre

gu

larl

yre

view

ed,a

sa

min

imu

mat

leas

to

nce

aye

ar.

–W

hen

iso

bje

ctiv

eac

hie

vem

ent

revi

ewed

?–

Ho

wo

ften

isth

isre

view

per

form

ed?

–<r

evie

w>,

<rev

iew

min

ute

s>,

<in

tern

alau

dit

rep

ort

>

Th

ere

isb

asic

ally

no

revi

ew/o

ther

rati

ng

of

ob

ject

ives

avai

lab

le.

1.1.

5A

llre

leva

nt

info

rmat

ion

rela

ted

top

acka

gin

gm

ater

ials

afet

yan

dq

ual

ity

shal

lbe

com

mu

nic

ated

effe

ctiv

ely

and

ina

tim

ely

man

ner

toth

ere

leva

nt

per

son

nel

.

–H

ow

isre

leva

nt

info

rmat

ion

tran

smit

ted

toco

nce

rned

per

son

s?–

<po

ster

s>,<

dis

trib

uti

on

of

mee

tin

gm

inu

tes>

Ap

acka

gin

gm

ater

ial

safe

tyan

d/o

rle

gal

ity

issu

eo

ccu

rsd

ue

tom

issi

ng

com

mu

nic

a-ti

on

wit

hin

the

com

pan

y.

1.2

Co

rpo

rate

stru

ctu

re

1.2.

1A

no

rgan

isat

ion

char

tsh

allb

eav

aila

ble

sho

win

gth

est

ruct

ure

of

the

com

pan

y.

–Is

ano

rgan

isat

ion

char

tav

aila

ble

?–

Ho

wis

the

org

anis

atio

nst

ruct

ure

d?

–<o

rgan

isat

ion

char

t>

1.2.

2C

om

pet

ence

san

dre

spo

nsi

bili

ties

,in

clu

din

gd

epu

tati

on

of

resp

on

sib

il-it

ysh

allb

ecl

earl

yla

idd

ow

n.

–Fo

rw

hic

hp

osi

tio

ns

do

wri

tten

job

des

crip

tio

ns

exis

t?–

Wh

atis

reg

ula

ted

inth

ejo

bd

escr

ipti

on

s?–

Wh

o,f

or

exam

ple

sub

stit

ute

sQ

Am

an-

ager

du

rin

gh

isab

sen

ce?

–<r

esp

on

sib

ility

des

crip

tio

nfo

rim

po

rtan

tke

yst

aff

“ded

icat

edto

asp

ecifi

cp

erso

n”,

e.g

.QA

Man

ager

,Pro

du

ctio

nM

anag

er,

Sh

ift

Lead

er…

>

Wh

ena

pac

kag

ing

mat

eria

lSaf

ety

and

Leg

alit

yis

sue

occ

urs

du

eto

failu

reto

defi

ne

resp

on

sib

iliti

esfo

rex

isti

ng

com

pan

yre

gu

lati

on

s.

1.2.

3Jo

bd

escr

ipti

on

sw

ith

clea

rly

defi

ned

resp

on

sib

iliti

essh

alle

xist

and

shal

lb

eap

plic

able

for

emp

loye

esw

ho

sew

ork

has

anef

fect

on

pro

du

ctre

qu

irem

ents

.

5.0

For

each

pre

req

uis

ite

pro

gra

man

dH

AC

CP

Pla

nth

ere

spo

nsi

bili

tyfo

rco

mp

lyin

gw

ith

the

req

uir

emen

tso

fth

isst

and

ard

isas

sig

ned

toa

com

pet

ent

emp

loye

e.

–W

hat

isth

eco

nte

nt

of

the

job

des

crip

-ti

on

s?–

For

wh

ich

po

siti

on

sd

ojo

bd

escr

ipti

on

sex

ist?



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

1.2.

4K

OK

ON

°1:

Th

ese

nio

rm

anag

emen

tsh

alle

nsu

reth

atem

plo

yees

are

awar

eo

fth

eir

resp

on

sib

iliti

esre

late

dto

pac

kag

ing

mat

eria

lsaf

ety

and

qu

alit

yan

dth

atm

ech

anis

ms

are

inp

lace

tom

on

ito

rth

eef

fect

ive-

nes

so

fth

eir

op

erat

ion

.Su

chm

ech

anis

ms

shal

lbe

clea

rly

iden

ti-

fied

and

do

cum

ente

d.

5.0

Th

eau

tho

rity

tod

evel

op

,im

ple

men

tan

dm

ain

tain

the

pre

req

uis

ite

pro

gra

ms

will

be

esta

blis

hed

by

man

agem

ent.

–H

ow

isit

ensu

red

that

emp

loye

eskn

ow

thei

rre

spo

nsi

bili

ties

?–

Ho

wd

oes

sen

ior

man

agem

ent

ensu

reth

atem

plo

yees

kno

wth

eir

resp

on

sib

ili-

ties

?–

Wh

ois

resp

on

sib

lefo

rp

acka

gin

gm

ate-

rial

safe

ty?

Wh

ense

nio

rm

an-

agem

ent

do

esn

oth

ing

toen

sure

that

emp

loye

eskn

ow

thei

rre

spo

nsi

bili

ties

.W

hen

du

rin

gth

eau

dit

the

Au

dit

or

has

evid

ence

that

key

emp

loye

esar

en

ot

awar

eo

fth

eir

resp

on

sib

iliti

esan

dth

isle

ads

toa

pac

kag

ing

mat

eria

lsa

fety

and

/or

leg

alit

yis

sue.

1.2.

5E

mp

loye

esw

ith

infl

uen

ceo

np

rod

uct

req

uir

emen

tssh

allb

eaw

are

of

thei

rre

spo

nsi

bili

ties

,an

dsh

allb

eab

leto

dem

on

stra

teth

eir

un

der

stan

din

go

fth

eir

resp

on

sib

iliti

es.

5.0

Key

per

son

nel

and

resp

on

sib

iliti

esw

illb

eid

enti

fied

inth

ew

ritt

enp

rog

ram

.

–<i

nte

rvie

wo

fat

leas

t:Q

SM

D,p

erso

nre

spo

nsi

ble

for

lab

elin

g/p

rin

tin

g,p

erso

nre

spo

nsi

ble

for

pro

du

ctd

evel

op

men

t,p

erso

nre

spo

nsi

ble

for

pro

du

ctio

n,

per

son

resp

on

sib

lefo

rm

on

ito

rin

gC

P’s

>

Key

emp

loye

esar

en

ot

awar

eo

fth

eir

resp

on

sib

iliti

es.

1.2.

6T

he

com

pan

ysh

allh

ave

anIF

SPA

Cse

cure

rep

rese

nta

tive

no

min

ated

by

sen

ior

man

agem

ent.

–W

ho

isth

eIF

SPA

Cse

cure

rep

rese

nta

tive

?–

Wh

atar

eth

ere

spo

nsi

bili

ties

of

the

IFS

PAC

secu

rere

pre

sen

tati

ve?

–Is

the

fun

ctio

no

fth

eIF

SPA

Cse

cure

rep

rese

nta

tive

clea

rly

laid

do

wn

?–

<jo

bd

escr

ipti

on

>,<o

rgan

izat

ion

char

t>

No

IFS

PAC

secu

rere

pre

sen

tati

veex

ists

.

1.2.

7T

he

sen

ior

man

agem

ent

shal

lp

rovi

de

suffi

cien

tan

dre

leva

nt

reso

urc

esto

mee

tth

ep

rod

uct

req

uir

emen

ts.

–H

ow

wer

eth

en

eces

sary

reso

urc

esd

efin

ed?

–

Wh

ense

nio

rm

an-

agem

ent

do

esn

’tp

rovi

de

eno

ug

hre

sou

rces

and

this

lead

sto

ap

acka

gin

gm

ater

ials

afet

yan

d/o

rle

gal

ity

issu

e.



1.2.

8T

he

dep

artm

ent

resp

on

sib

lefo

rq

ual

ity

and

pac

kag

ing

mat

eria

lsa

fety

man

agem

ent

shal

lhav

ea

dir

ect

rep

ort

ing

rela

tio

nsh

ipto

the

sen

ior

man

agem

ent.

–W

ho

isth

eQ

Sm

anag

er?

–To

wh

om

do

esth

eQ

Sm

anag

erre

po

rt?

–<j

ob

des

crip

tio

n>,

<org

aniz

atio

nch

art>

1.2.

9T

he

com

pan

ysh

alle

nsu

reth

atal

lp

roce

sses

(do

cum

ente

dan

du

nd

ocu

-m

ente

d)

are

kno

wn

by

the

rele

van

tp

erso

nn

elan

dar

eap

plie

dco

nsi

st-

entl

y.

–W

hat

crit

eria

are

use

dto

ensu

rep

roce

ssco

ntr

ol?

–W

hat

isd

on

eto

ensu

reth

atp

roce

sses

are

kno

wn

tore

leva

nt

per

son

nel

(in

cl.

per

man

ent

staf

fan

dte

mp

ora

ry/s

easo

nal

wo

rker

s)?

Pro

cess

esca

nb

eu

nd

erst

oo

das

ISO

pro

cess

es(s

eeal

soch

apte

r2.

3,P

art

1o

fth

est

and

ard

)

Wh

enke

yp

erso

nn

elh

ave

no

pro

cess

kno

wle

dg

ean

dth

isle

ads

toa

pac

kag

ing

mat

eria

lsaf

ety

and

/or

leg

alit

yis

sue.

1.2.

10T

he

com

pan

ysh

allh

ave

asy

stem

inp

lace

toen

sure

that

itis

kep

tin

form

edo

fal

lrel

evan

tle

gis

lati

on

on

pac

kag

ing

mat

eria

lsaf

ety

and

qu

alit

yis

sues

,sci

enti

fic

and

tech

ni-

cald

evel

op

men

tsan

din

du

stry

cod

eso

fp

ract

ice.

–H

ow

do

esm

anag

emen

ten

sure

that

all

rele

van

tp

acka

gin

gsa

fety

law

sar

ein

pla

cean

dkn

ow

n?

–H

ow

do

esm

anag

emen

ten

sure

that

pu

rch

ased

pro

du

cts

com

ply

wit

hal

lre

leva

nt

leg

isla

tio

n?

–H

ow

do

esm

anag

emen

ten

sure

that

man

ufa

ctu

red

pro

du

cts

com

ply

wit

hal

lre

leva

nt

leg

isla

tio

n?

–,<t

rain

ing

>

Wh

enab

sen

ceo

fle

gal

kno

wle

dg

ean

din

form

atio

no

nre

leva

nt

law

sle

adto

ap

acka

gin

gm

ater

ial

safe

tyan

d/o

rle

gal

ity

issu

e.

1.2.

11T

he

com

pan

ysh

alli

nfo

rmit

scu

sto

m-

ers,

asso

on

asp

oss

ible

,of

any

issu

ere

late

dto

pro

du

ctsp

ecifi

cati

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

tati

on

inp

arti

cula

ro

fal

lno

n-c

on

form

ity(

ies)

iden

tifi

edb

yco

mp

eten

tau

tho

riti

esre

late

dto

pro

du

cts

wh

ich

cou

ldh

ave,

has

or

has

had

ad

efin

edim

pac

to

nsa

fety

and

/or

leg

alit

yo

fre

spec

tive

pro

du

cts.

Th

isco

uld

incl

ud

e,b

ut

are

no

tlim

ited

toca

uti

on

ary

issu

es.

For

exam

ple

,if

reg

ula

tory

bo

die

sco

me

toth

eco

mp

any

and

iden

tify

that

som

eth

ing

isw

ron

g(r

elat

edto

leg

alit

y/q

ual

ity

/saf

ety)

on

ap

riva

tela

bel

pro

du

ct,t

he

com

pan

ysh

all

info

rmth

ere

leva

nt

cust

om

erac

cord

ing

ly.I

fth

isp

rod

uct

isal

som

anu

fact

ure

dfo

ro

ther

cust

om

ers

and

ifth

eid

enti

fied

dev

iati

on

/n

on

-co

nfo

rmit

yal

soh

asan

imp

act

on

the

oth

erp

riva

tela

bel

s,th

eco

mp

any

shal

lals

oin

form

thes

eo

ther

rele

van

tcu

sto

mer

s.

1.3

Cu

sto

mer

focu

s

1.3.

1A

do

cum

ente

dp

roce

du

resh

allb

ein

pla

ceto

iden

tify

fun

dam

enta

lnee

ds

and

exp

ecta

tio

ns

of

cust

om

ers.

–H

ow

are

cust

om

ern

eed

san

dex

pec

ta-

tio

ns

iden

tifi

ed?

–H

ow

oft

enar

eth

ese

iden

tifi

ed?

<qu

esti

on

nai

re/s

urv

eyre

gar

din

gcu

s-to

mer

nee

ds

and

exp

ecta

tio

ns>



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

1.3.

2T

he

resu

lts

of

this

pro

ced

ure

shal

lbe

eval

uat

edan

dco

nsi

der

edto

det

er-

min

eq

ual

ity

and

pac

kag

ing

mat

eria

lsa

fety

ob

ject

ives

.

–W

hat

wer

eth

ere

sult

so

fth

ela

stcu

s-to

mer

surv

ey?

<an

alys

iso

fcu

sto

mer

surv

eys>

–H

ow

thes

ere

sult

sw

ere

eval

uat

edre

gar

din

gq

ual

ity

ob

ject

ives

?<q

ual

ity

ob

ject

ives

>–

Hav

eid

enti

fied

nee

ds

infl

uen

ceo

nth

ep

rod

uct

ion

pro

cess

?<s

urv

eyan

alys

es>

1.4

Man

agem

ent

revi

ew

1.4.

1S

enio

rm

anag

emen

tsh

alle

nsu

reth

atth

eq

ual

ity

and

pac

kag

ing

mat

eria

lsaf

ety

man

agem

ent

sys-

tem

sar

ere

view

edat

leas

tan

nu

ally

or

mo

refr

equ

entl

yif

chan

ges

occ

ur.

Su

chre

view

ssh

allc

on

tain

,at

leas

t,re

sult

so

fau

dit

s,cu

sto

mer

feed

-b

acks

,pro

cess

com

plia

nce

and

pro

du

ctco

nfo

rmit

y,st

atu

so

fp

reve

nti

vean

dco

rrec

tive

acti

on

s,fo

llow

up

acti

on

sfr

om

pre

vio

us

man

agem

ent

revi

ews,

chan

ges

that

cou

ldaf

fect

the

pac

kag

ing

mat

eria

lsa

fety

and

qu

alit

ym

anag

emen

tsy

stem

san

dre

com

men

dat

ion

sfo

rim

pro

vem

ent.

6.1

6.6

Man

agem

ent

will

det

erm

ine

the

inte

rnal

acti

viti

esre

qu

ired

toen

sure

the

req

uir

emen

tso

fth

isst

and

ard

are

met

.

Th

efo

od

safe

typ

ro-

gra

msh

allb

ere

view

edat

leas

to

nce

per

year

toas

sess

ifit

is:

–C

urr

ent.

Th

atis

,it

refl

ects

fact

ors

incl

ud

ing

,bu

tn

ot

limit

edto

:·

Ap

plic

able

stan

d-

ard

s.·

Op

erat

ion

al/P

roce

ss/

Mat

eria

lch

ang

es.

·O

rgan

izat

ion

chan

ges

.·

Sci

enti

fic

dev

elo

p-

men

ts.

–Im

ple

men

ted

.–

Mai

nta

ined

.

Res

ult

so

fth

ere

-ass

ess-

men

tar

eu

sed

tou

pd

ate,

mai

nta

ino

rim

pro

veth

efo

od

safe

tysy

stem

.

–W

hen

isth

eq

ual

ity

and

safe

tym

anag

e-m

ent

syst

emre

view

edan

dev

alu

ated

?–

Ho

wo

ften

was

the

syst

emre

view

edla

stye

ar?

–W

hat

was

the

resu

lto

fth

ere

view

?<r

evie

wre

po

rt>

–D

oes

the

man

agem

ent

revi

ewta

kein

toco

nsi

der

atio

n,a

sa

min

imu

m,t

he

asse

ss-

men

to

fth

efo

llow

ing

:·

do

cum

ents

fro

mth

ep

revi

ou

sm

anag

e-m

ent

revi

ew,

·re

sult

sfr

om

inte

rnal

and

exte

rnal

aud

its,

asw

ella

sin

spec

tio

ns,

·p

erfo

rman

cein

dic

ato

rsfo

rcu

sto

mer

s,co

mp

lain

tsan

dw

ith

dra

wal

s/re

calls

,·

inci

den

ts,c

orr

ecti

veac

tio

ns,

resu

lts

ou

to

fsp

ecifi

cati

on

san

dn

on

-co

nfo

rmin

gm

ater

ials

,·

pro

cess

per

form

ance

and

pro

du

ctco

mp

lian

ce,

·re

view

of

haz

ard

anal

ysis

/ris

kas

sess

men

tsy

stem

and

chan

ges

whi

chm

ayaf

fect

qua-

lity

and

pac

kag

ing

mat

eria

lsaf

ety

syst

em,

·ev

olu

tio

ns

of

scie

nti

fic

info

rmat

ion

rela

ted

top

rod

uct

s,·

imp

rove

men

to

fq

ual

ity

syst

emef

fici

ency

and

pro

du

ctio

np

roce

ss,

·im

pro

vem

ent

of

pro

du

ct,r

elat

edto

cust

om

erre

qu

irem

ents

,·

need

sin

reso

urce

s(in

clud

ing

inve

stm

ents

)?

Wh

enth

eq

ual

ity

man

agem

ent

syst

emis

no

tre

view

edre

gu

larl

yan

dth

ere

isn

oas

sura

nce

that

itw

ork

sp

rop

erly

.



1.4.

2T

his

revi

ewsh

alli

ncl

ud

eth

eev

alu

a-ti

on

of

mea

sure

sfo

rth

eco

ntr

olo

fth

eq

ual

ity

and

pac

kag

ing

mat

eria

lsa

fety

man

agem

ent

syst

eman

dfo

rth

eco

nti

nu

ou

sim

pro

vem

ent

pro

cess

.

6.1

Th

efr

equ

enci

eso

fco

mp

leti

ng

acti

viti

esw

illb

ees

tab

lish

edan

dw

illen

sure

the

effe

ctiv

eim

ple

men

tati

on

and

mai

nte

nan

ceo

fth

ep

acka

gin

gm

ater

ial

safe

tysy

stem

.

Bas

edo

nth

ere

view

resu

lt,h

ave

any

acti

on

sfo

rim

pro

vem

ent

bee

nta

ken

?

1.4.

3T

he

com

pan

ysh

alli

den

tify

and

revi

ewre

gu

larl

y(e

.g.b

yin

tern

alau

dit

so

ro

n-s

ite

insp

ecti

on

)th

ein

fras

tru

ctu

ren

eed

edto

ach

ieve

con

form

ity

top

rod

uct

req

uir

emen

ts.

Th

issh

alli

ncl

ud

e,as

am

inim

um

,th

efo

llow

ing

:–

bu

ildin

gs

–su

pp

lysy

stem

s–

mac

hin

esan

deq

uip

men

t–

tran

spo

rt.

Th

ere

sult

so

fth

ere

view

shal

lbe

con

sid

ered

,wit

hd

ue

con

sid

erat

ion

tori

sk,f

or

inve

stm

ent

pla

nn

ing

.

–W

hen

isin

fras

tru

ctu

re(b

uild

ing

,mac

hin

-er

y,tr

ansp

ort

)ev

alu

ated

?–

Wh

atw

asth

ere

sult

of

infr

astr

uct

ure

eval

uat

ion

?<a

ud

itre

po

rt>

–W

ho

eval

uat

edin

fras

tru

ctu

re?

–W

hat

wer

eth

ere

sult

so

fth

ein

fra-

stru

ctu

reas

sess

men

t?<c

orr

ecti

veac

tio

ns>

<in

vest

men

tp

lan

>–

Wer

eth

ere

sult

su

sed

for

furt

her

infr

a-st

ruct

ure

pla

nn

ing

?

–W

hat

risk

sw

ere

iden

tifi

edac

cord

ing

toth

ere

sult

so

fin

fras

tru

ctu

reas

sess

men

t?<h

azar

dan

alys

is>

–W

hata

rein

fras

truc

ture

rela

ted

inve

stm

ents

for

the

nea

rfu

ture

?

Wh

enin

fras

tru

ctu

reis

no

tev

alu

ated

and

ther

efo

rea

risk

for

leg

alit

y,sa

fety

and

qu

alit

yo

fp

rod

uct

so

ccu

rs.

1.4.

4T

he

com

pan

ysh

alli

den

tify

and

revi

ewre

gu

larl

y(e

.g.b

yin

tern

alau

dit

so

ro

n-s

ite

insp

ecti

on

)th

ew

ork

envi

ron

men

tn

eed

edto

ach

ieve

con

form

ity

top

rod

uct

req

uir

emen

ts.

Th

issh

alli

ncl

ud

e,as

am

inim

um

the

follo

win

g:

–st

aff

faci

litie

s–

envi

ron

men

talc

on

dit

ion

s–

hyg

ien

icco

nd

itio

ns

–w

ork

pla

ced

esig

n–

exte

rnal

infl

uen

ces

(e.g

.no

ise,

vib

rati

on

).T

he

resu

lts

of

the

revi

ewsh

allb

eco

nsi

der

ed,w

ith

du

eco

nsi

der

atio

nto

risk

for

inve

stm

ent

pla

nn

ing

.

–W

hen

isth

ew

ork

envi

ron

men

t(s

taff

faci

li-ti

es,e

nvi

ron

men

talc

on

dit

ion

s,sa

fety

and

secu

rity

atw

ork

,hyg

ien

icco

nd

itio

ns,

wo

rkp

lace

des

ign

etc.

)ev

alu

ated

?–

Wh

atw

asth

ere

sult

of

wo

rken

viro

nm

ent

eval

uat

ion

?<a

ud

itre

po

rt>

–W

ho

eval

uat

edw

ork

envi

ron

men

t?–

Wh

atw

ere

the

resu

lts

of

the

wo

rken

viro

nm

ent

asse

ssm

ent?

<co

rrec

tive

acti

on

s>

–W

ere

the

resu

lts

use

dfo

rfu

rth

erw

ork

envi

ron

men

tp

lan

nin

g?

<in

vest

men

tp

lan

>–

Wh

atri

sks

wer

eid

enti

fied

acco

rdin

gto

the

resu

lts

of

the

wo

rken

viro

nm

ent

asse

ssm

ent?

<haz

ard

anal

ysis

>–

Wh

atar

ew

ork

envi

ron

men

tre

late

din

vest

men

tsfo

rth

en

ear

futu

re?

<in

vest

men

tp

lan

>

Wh

enw

ork

envi

ron

-m

ent

isn

ot

eval

uat

edan

dth

eref

ore

ari

skfo

rle

gal

ity,

safe

tyan

dq

ual

ity

of

pro

du

cts

occ

urs

.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

2Q

ual

ity

and

Pac

kag

ing

Mat

eria

lS

afet

yM

anag

emen

tS

yste

m

2.1

Qu

alit

ym

anag

emen

t

2.1.

1D

ocu

men

tati

on

req

uir

emen

ts4.

1C

on

tro

lof

Do

cum

ents

Do

cum

ents

are

crea

ted

and

mai

nta

ined

toen

-su

reth

eef

fect

ive

dev

el-

op

men

t,im

ple

men

ta-

tio

n,m

ain

ten

ance

and

imp

rove

men

to

fth

efo

od

safe

tysy

stem

.A

do

cum

ent

con

tro

lp

roce

du

reis

esta

blis

hed

that

will

defi

ne

ho

wd

ocu

men

tsar

e:–

Ap

pro

ved

.–

Rev

iew

ed,r

evis

edan

du

pd

ated

.–

Rem

ain

leg

ible

and

easi

lyid

enti

fiab

le.

–Id

enti

fied

,in

clu

din

gcu

rren

tst

atu

s(e

.g.

revi

sio

nle

vel)

.–

Mai

nta

ined

socu

rren

tve

rsio

ns

are

avai

lab

lefo

ru

sean

du

nin

ten

d-

edu

seis

pre

ven

ted

.E

ach

pre

req

uis

ite

pro

-g

ram

req

uir

esp

rop

erdo

cum

enta

tion

ofth

epr

o-g

ram

elem

ents

and

sup

-p

ort

ing

info

rmat

ion

in-

clud

ing,

butn

otlim

ited

to:

–S

tan

dar

do

per

atin

gp

roce

du

res.

–Fo

rms.

–C

hec

klis

ts.

–C

orr

ecti

veA

ctio

nR

epo

rts.

–Fo

od

Saf

ety

Pro

gra

mR

eass

essm

ent.



2.1.

1.1

Th

esy

stem

of

pac

kag

ing

mat

eria

lsa

fety

and

qu

alit

ym

anag

emen

tsh

all

be

do

cum

ente

dan

dim

ple

men

ted

,an

dsh

allb

ere

tain

edin

on

elo

cati

on

(pac

kag

ing

mat

eria

lsaf

ety

and

qu

alit

ym

anu

alo

rel

ectr

on

icd

ocu

-m

ente

dsy

stem

).

4.1

–W

her

eis

do

cum

enta

tio

nco

nce

rnin

gth

eq

ual

ity

syst

emfo

rq

ual

ity

assu

ran

cean

dp

acka

gin

gm

ater

ials

afet

yre

tain

ed?

<pro

ced

ure

for

do

cum

ent

con

tro

l>

Wh

enth

ere

isn

oq

ual

ity

syst

emfo

rq

ual

ity

assu

ran

cean

dp

acka

gin

gm

ater

ial

safe

tyin

pla

ce.

2.1.

1.2

Ad

ocu

men

ted

pro

ced

ure

shal

lexi

stfo

rth

eco

ntr

olo

fd

ocu

men

tsan

dth

eir

amen

dm

ents

.

4.1

–W

hat

rule

sex

ist

reg

ard

ing

do

cum

ent

con

tro

l?–

Do

the

do

cum

ents

hav

ean

iden

tifi

cati

on

cod

e?–

Ho

wis

the

iden

tifi

cati

on

cod

est

ruct

ure

d?

–H

ow

can

are

visi

on

be

iden

tifi

ed?

–W

ho

isre

spo

nsi

ble

for

chan

ges

<pro

ced

ure

for

do

cum

ents

>

Wh

end

ocu

men

tsd

on

ot

stat

ecl

earl

yw

hic

hex

ist,

are

inu

sean

dva

lid.

2.1.

1.3

All

do

cum

ents

shal

lbe

clea

rly

leg

ible

,un

amb

igu

ou

san

dco

mp

re-

hen

sive

.Th

eysh

allb

eav

aila

ble

tore

leva

nt

per

son

nel

atal

ltim

es.

4.1

–A

real

ldo

cum

ents

leg

ible

?–

Are

the

do

cum

ents

un

amb

igu

ou

s?–

Are

the

do

cum

ents

avai

lab

leat

the

rig

ht

pla

ces?

Als

oaf

ter

offi

ceh

ou

rs?

–H

ow

do

rele

van

tem

plo

yees

hav

eac

cess

tod

ocu

men

ts?

–H

ow

are

do

cum

ent

chan

ges

com

mu

ni-

cate

dto

rele

van

tem

plo

yees

?–

Are

ther

ean

yd

istr

ibu

tio

nlis

tsfo

rd

ocu

men

ts?

<exa

mp

les>

,,

<dis

trib

uti

on

lists

>

Wh

end

ocu

men

tsar

eu

nav

aila

ble

and

this

end

ang

ers

leg

alit

y,sa

fety

or

qu

alit

yo

fth

ep

rod

uct

.

2.1.

1.4

All

do

cum

ents

wh

ich

are

nec

essa

ryfo

rco

mp

lian

cew

ith

the

pro

du

ctre

qu

irem

ents

shal

lbe

avai

lab

lein

thei

rla

test

vers

ion

.

4.1

–H

ow

isd

ocu

men

tva

lidit

yid

enti

fied

?–

Ho

wis

iten

sure

dth

ato

nly

valid

do

cu-

men

tsar

ein

circ

ula

tio

n?

Wh

envo

id/o

bso

lete

or

ou

t-o

fd

ate

do

cu-

men

tsar

en

ot

iden

ti-

fied

assu

chan

dth

us

end

ang

erle

gal

ity,

safe

tyo

rq

ual

ity.

2.1.

1.5

Th

ere

aso

nfo

ran

yam

end

men

tsto

do

cum

ents

crit

ical

for

the

pro

du

ctre

qu

irem

ents

shal

lbe

reco

rded

.

4.1

–A

reth

ere

aso

ns

for

any

amen

dm

ents

tod

ocu

men

ts,c

riti

calf

or

the

pro

du

ctre

qu

irem

ents

reco

rded

?<e

xam

ple

s>

2.1.

2R

eco

rdke

epin

g

2.1.

2.1

All

rele

van

tre

cord

sn

eces

sary

for

the

pro

du

ctre

qu

irem

ents

shal

lbe

com

ple

te,d

etai

led

and

mai

nta

ined

and

shal

lbe

avai

lab

leo

nre

qu

est.

4.2

Rec

ord

sar

ees

tab

lish

edto

pro

vid

eo

bje

ctiv

eev

i-d

ence

of

con

form

ity

toth

ere

qu

irem

ents

of

the

foo

dsa

fety

pro

gra

m.

–W

hat

reco

rds

exis

t?–

Are

the

reco

rds

com

ple

te?

–A

reth

ere

cord

sav

aila

ble

?

Wh

enin

suffi

cien

to

rn

ore

cord

sar

em

ade

and

thu

sen

dan

ger

leg

alit

y,sa

fety

or

qu

alit

y.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

2.1.

2.2

Rec

ord

ssh

allb

ele

gib

lean

dg

enu

-in

e.T

hey

shal

lbe

mai

nta

ined

ina

way

that

sub

seq

uen

tm

anip

ula

tio

no

fre

cord

sis

pro

hib

ited

.

4.2

Ap

roce

du

reis

esta

b-

lish

edth

atw

illd

efin

eh

ow

foo

dsa

fety

rela

ted

reco

rds

are

mai

nta

ined

soth

atth

eyar

e:–

Leg

ible

.–

Rea

dily

iden

tifi

able

and

retr

ieva

ble

.–

Au

dit

able

.–

Pro

tect

edan

dst

ore

dto

pre

ven

td

amag

eo

rd

eter

iora

tio

n.

–S

tore

dfo

ran

app

ro-

pri

ate

rete

nti

on

per

iod

.–

Pro

per

lyd

isp

ose

d.

Rec

ord

sin

clu

de,

bu

tar

en

ot

limit

edto

,co

mp

lete

d:

–Fo

rms.

–C

hec

klis

ts.

–S

ervi

ceA

gre

emen

tsan

dC

on

trac

ts.

–C

orr

ecti

veA

ctio

nR

epo

rts.

–Fo

od

Saf

ety

Pro

gra

mR

eass

essm

ent.

–A

rere

cord

sp

lau

sib

le?

–A

rere

cord

sle

gib

le?

–W

hat

kin

do

fas

sura

nce

isg

iven

that

reco

rds

can

no

tb

esu

bse

qu

entl

ym

anip

u-

late

d?

–A

reth

ere

cord

sre

view

edb

ya

sup

ervi

-so

r?

Wh

enre

cord

sar

eill

egib

lean

dth

eref

ore

no

evid

ence

exis

tsfo

rle

gal

lyre

qu

ired

chec

ks/i

nsp

ecti

on

s.

2.1.

2.3

All

reco

rds

shal

lbe

kep

tin

acco

rd-

ance

wit

hle

gal

req

uir

emen

tsan

dfo

ra

min

imu

mo

fo

ne

year

afte

rth

ere

com

men

ded

con

vert

ing

tim

e.Fo

rp

rod

uct

sw

hic

hh

ave

no

reco

m-

men

ded

con

vert

ing

tim

e,th

ed

ura

tio

no

fre

cord

keep

ing

shal

lbe

just

ified

and

this

just

ifica

tio

nsh

allb

ed

ocu

men

ted

.

4.2

–W

her

ear

ere

cord

sst

ore

d?

–W

ho

sto

res

reco

rds?

–H

ow

lon

gar

ere

cord

ske

pt?

On

wh

atb

asis

wer

ere

cord

sto

rag

eti

mes

defi

ned

?–

For

pro

du

cts

wit

ha

sho

rtre

com

men

ded

con

vert

ing

tim

e,w

asre

cord

sto

rag

eti

me

defi

nit

ion

bas

edo

nh

azar

dan

alys

is?

Ifa

reco

mm

end

edco

nve

rtin

gti

me

isd

efin

ed,c

orr

esp

on

din

gre

cord

ssh

allb

eav

aila

ble

atle

ast

un

tilt

hat

dat

e.,<h

azar

dan

alys

is>

Wh

enre

cord

sar

en

ot

sto

red

inac

cord

ance

tole

gal

req

uir

emen

ts.



2.1.

2.4

An

yam

end

men

tsto

reco

rds

shal

lo

nly

be

carr

ied

ou

tb

yau

tho

rize

dp

erso

ns.

4.1

–H

ow

are

amen

dm

ents

tore

cord

sca

rrie

do

ut?

–W

ho

isau

tho

rize

dto

mak

eam

end

men

ts?

–H

ow

are

amen

dm

ents

auth

ori

zed

?

Wh

ena

gen

eral

pro

ble

mex

ists

reg

ard

ing

reco

rdch

ang

es/a

men

d-

men

tsin

the

com

-p

any.

2.1.

2.5

Rec

ord

ssh

allb

ese

cure

lyst

ore

dan

dea

sily

acce

ssib

le.

–W

hat

isth

ep

roce

ssin

pla

ceto

mak

ed

ocu

men

tsan

dd

ata

avai

lab

lean

dre

adab

le?

<bac

kup

syst

em>,

<sto

rag

eco

nd

itio

n>

2.2

Pac

kag

ing

Mat

eria

lSaf

ety

Man

age-

men

t

2.2.

1H

azar

dan

alys

isan

dri

skas

sess

men

tsy

stem

See

gen

eric

HA

CC

Pm

od

els

PAC

secu

re

2.2.

1.1

Th

eb

asis

of

the

com

pan

y’s

pac

kag

-in

gm

ater

ials

afet

yco

ntr

ols

yste

msh

allb

ea

fully

imp

lem

ente

d,

syst

emat

ican

dco

mp

reh

ensi

veh

azar

dan

alys

isan

d/o

rri

skas

sess

-m

ent

syst

em,b

ased

up

on

the

Co

dex

Alim

enta

riu

sp

rin

cip

les

or

on

ind

ust

ryg

uid

elin

es.I

tsh

allt

ake

into

acco

un

tan

yle

gal

req

uir

emen

tso

fth

ep

rod

uct

ion

and

des

tin

atio

nco

un

trie

sw

hic

hm

ayg

ob

eyo

nd

such

pri

nci

ple

s.T

he

haz

ard

anal

ysis

and

/or

risk

asse

ssm

ent

syst

emsh

all

be

imp

lem

ente

dat

each

pro

du

ctio

nsi

te.

–T

he

com

pan

y’s

haz

ard

anal

ysis

/ris

kas

sess

men

tp

lan

isb

ased

on

wh

atp

rin

cip

les?

–H

asev

ery

site

/pla

nt

ase

par

ate

haz

ard

anal

ysis

/ris

kas

sess

men

tp

lan

?–

Wh

ich

spec

ific

reg

ula

tio

ns

are

take

nca

reo

fin

haz

ard

anal

ysis

/ris

kas

sess

men

tp

lan

?<

haz

ard

anal

ysis

pla

n>

–ar

eth

ele

gal

req

uir

emen

tso

fth

ed

esti

na-

tio

nco

un

try

are

kno

wn

,esp

ecia

llyth

ela

bel

ing

reg

ula

tio

n?

Ifth

ere

isn

oh

azar

dan

alys

is/r

isk

asse

ss-

men

tp

lan

.If

leg

alre

qu

irem

ents

are

no

tin

clu

ded

inh

azar

dan

alys

is/r

isk

asse

ssm

ent

pla

nIf

ther

eis

no

haz

ard

anal

ysis

/ris

kas

sess

-m

ent

pla

nfo

rea

chin

div

idu

alsi

te/p

lan

t.

2.2.

1.2

Th

eh

azar

dan

alys

isan

d/o

rri

skas

sess

men

tsy

stem

shal

lco

ver

all

raw

mat

eria

ls,p

rod

uct

so

rp

rod

uct

gro

up

sas

wel

las

ever

yp

roce

ssfr

om

go

od

sin

tod

isp

atch

,in

clu

din

gp

rod

uct

dev

elo

pm

ent

and

pro

du

ctp

acka

gin

g.

–D

oes

haz

ard

anal

ysis

/ris

kas

sess

men

tp

lan

cove

ral

lpro

du

ctg

rou

ps

and

pro

cess

esin

cl.p

rod

uct

dev

elo

pm

ent

and

pro

du

ctw

rap

pin

gm

ater

ial?

–W

hic

hp

roce

sses

are

per

form

ed?

<pro

du

ctg

rou

po

verv

iew

>,<fl

ow

char

t>

Wh

enth

eh

azar

dan

alys

is/r

isk

asse

ss-

men

tp

lan

do

esn

ot

cove

ral

lpro

du

ctg

rou

ps

and

pro

-ce

sses

.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

2.2.

1.3

Th

eco

mp

any

shal

len

sure

that

the

haz

ard

anal

ysis

and

/or

risk

asse

ss-

men

tsy

stem

isb

ased

up

on

scie

nti

fic

liter

atu

re,o

rte

chn

ical

veri

fied

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

ns

rela

tin

gto

the

man

ufa

ctu

red

pro

du

cts

and

pro

ced

ure

s.T

his

shal

lbe

mai

nta

ined

inlin

ew

ith

new

tech

nic

alp

roce

ssd

evel

op

men

t.

–Is

the

haz

ard

anal

ysis

/ris

kas

sess

men

tp

lan

bas

edu

po

nsc

ien

tifi

clit

erat

ure

or

tech

ni-

cally

veri

fied

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

ns

rela

tin

gto

the

man

ufa

ctu

red

pro

du

cts

and

pro

ced

ure

s?–

Ho

war

en

ewte

chn

ical

dev

elo

pm

ents

take

nca

reo

f?<r

efer

ence

so

fu

sed

liter

atu

re,e

tc.>

–D

oes

the

haz

ard

anal

ysis

/ris

kas

sess

men

tsy

stem

mee

tal

lap

plic

able

reg

ula

tory

req

uir

emen

tso

fth

eco

un

try

inw

hic

hit

ises

tab

lish

ed,i

ncl

ud

ing

the

req

uir

edan

dap

plic

able

risk

asse

ssm

ents

and

sup

po

rt-

ing

do

cum

enta

tio

n?

(Wh

ere

app

licab

le,s

uch

reg

ula

tory

req

uir

e-m

ents

will

sup

erce

de

req

uir

emen

tso

fth

est

and

ard

.Rel

ated

toC

anad

ian

and

US

law

,ce

rtai

nfo

rms

and

form

ats

are

req

uir

ed.)

Wh

enh

azar

dan

aly-

sis/

risk

asse

ssm

ent

pla

nis

no

tb

ased

on

scie

nti

fic

liter

atu

reo

rte

chn

ical

lyve

rifi

edd

ata

abo

ut

pro

du

cts

and

pro

cess

esan

dth

eref

ore

cau

ses

ap

acka

gin

gm

ater

ial

safe

tyo

rle

gal

ity

risk

.

2.2.

1.4

Th

eh

azar

dan

alys

isan

d/o

rri

skas

sess

men

tsy

stem

shal

lbe

revi

ewed

and

nec

essa

rych

ang

essh

allb

em

ade

wh

enan

ym

od

ifica

tio

nis

mad

ein

the

pro

du

ct,p

roce

sso

ran

yst

ep.

Ho

war

ep

rod

uct

dev

elo

pm

ent/

pro

du

ctm

od

ifica

tio

nan

dh

azar

dan

alys

isin

terc

on

-n

ecte

d?

2.2.

2H

azar

dan

alys

isan

d/o

rri

skas

sess

-m

ent

team

2.2.

2.1

Ass

emb

leh

azar

dan

alys

isan

d/o

rri

skas

sess

men

tte

amT

he

haz

ard

anal

ysis

and

/or

risk

asse

ssm

ent

team

shal

lbe

mu

ltid

isci

-p

linar

yan

din

clu

de

op

erat

ion

alst

aff.

Per

son

nel

app

oin

ted

ash

azar

dan

aly-

sis

and

/or

risk

asse

ssm

ent

team

mem

ber

ssh

allh

ave

spec

ific

kno

wl-

edg

eo

fh

azar

dan

alys

isan

d/o

rri

skas

sess

men

t,p

rod

uct

and

pro

cess

kno

wle

dg

ean

dth

eas

soci

ated

haz

ard

s.W

her

eco

mp

eten

tkn

ow

l-ed

ge

isn

ot

avai

lab

le,e

xter

nal

exp

ert

advi

cesh

allb

eo

bta

ined

.

–W

ho

ism

emb

ero

fth

eh

azar

dan

alys

is/

risk

asse

ssm

ent

team

?–

Wh

ich

dep

artm

ents

/fu

nct

ion

sar

ein

clu

ded

inth

eh

azar

dan

alys

is/r

isk

asse

ssm

ent

team

?–

Ho

ww

asq

ual

ifica

tio

nfo

rh

azar

dan

aly-

sis/

risk

asse

ssm

ent

team

mem

ber

ship

veri

fied

?<e

vid

ence

sfo

red

uca

tio

n,

adva

nce

dtr

ain

ing

>–

Wh

ath

azar

ds

are

con

nec

ted

toth

ep

rod

uct

?–

Do

esa

con

trac

tex

ist

wit

han

exte

rnal

exp

ert?

<ser

vice

con

trac

t>

Alt

ho

ug

hth

ere

isa

lack

of

pro

du

ctkn

ow

led

ge

no

exte

rnal

exp

ert

has

bee

nco

nsu

lted

and

this

resu

lts

inp

acka

g-

ing

mat

eria

lsaf

ety

and

leg

alit

yri

sk.



2.2.

2.2

Th

ose

resp

on

sib

lefo

rth

ed

evel

op

-m

ent

and

mai

nte

nan

ceo

fth

eh

azar

dan

alys

isan

d/o

rri

skas

sess

men

tsy

stem

shal

lhav

ean

inte

rnal

team

lead

eran

dsh

allh

ave

rece

ived

adeq

uat

etr

ain

ing

inth

eap

plic

atio

no

fth

eh

azar

dan

alys

isan

d/o

rri

skas

sess

men

tp

rin

cip

les.

–W

hat

isth

eco

nte

nt

of

ah

azar

dan

aly-

sis/

risk

asse

ssm

ent

trai

nin

gco

urs

e?<h

azar

dan

alys

istr

ain

ing

pro

ofs

>–

Wh

enw

asth

ela

sth

azar

dan

alys

is/r

isk

asse

ssm

ent

trai

nin

gco

urs

eh

eld

?<t

rain

ing

evid

ence

s>–

Wh

op

arti

cip

ated

inth

eh

azar

dan

aly-

sis/

risk

asse

ssm

ent

trai

nin

gco

urs

e?<t

rain

ing

evid

ence

s>

2.2.

2.3

Th

eh

azar

dan

alys

isan

d/o

rri

skas

sess

men

tte

amsh

allh

ave

stro

ng

sen

ior

man

agem

ent

sup

po

rtan

dsh

allb

ew

ellk

no

wn

and

esta

blis

hed

acro

ssth

ew

ho

lefa

cilit

y.

–W

ho

ism

emb

ero

fth

eh

azar

dan

aly-

sis/

risk

asse

ssm

ent

team

?–

Isth

ete

amw

ellk

no

wn

acro

ssth

eco

mp

any?

Ho

ww

asit

ann

ou

nce

d?

<jo

bd

escr

ipti

on

s>,<

team

mat

rix>

,,,<r

esu

lto

fh

azar

dan

alys

isre

wie

win

clu

de

inM

anag

emen

tre

view

>,<a

ttri

bu

tio

no

fre

sou

rces

>

Wh

enn

oh

azar

dan

alys

is/r

isk

asse

ss-

men

tte

amex

ists

or

no

per

son

has

bee

nap

po

inte

dh

azar

dan

alys

iste

amle

ader

.

2.2.

3H

azar

dan

alys

isan

dri

skas

sess

men

tS

eeg

ene-

ric

HA

CC

Pm

od

els

PAC

secu

re

2.2.

3.1

Des

crib

ep

rod

uct

Th

eas

sess

men

tsh

allm

ake

refe

r-en

ceto

the

full

des

crip

tio

no

fth

ep

rod

uct

incl

ud

ing

alla

pp

licab

lere

leva

nt

info

rmat

ion

on

pro

du

ctsa

fety

such

as:

–co

mp

osi

tio

n(r

awm

ater

ials

,re

wo

rk,r

epro

cess

ing

,rec

ycle

dw

aste

etc.

),–

ph

ysic

al,c

hem

ical

and

mic

rob

io-

log

ical

par

amet

ers,

–m

eth

od

so

ftr

eatm

ent,

–w

rap

pin

g,l

abel

ing

,–

du

rab

ility

(sh

elf

life)

,–

con

dit

ion

sfo

rst

ora

ge

and

met

ho

do

ftr

ansp

ort

.

Form

1–

Do

esa

com

ple

tep

rod

uct

des

crip

tio

nex

ist

for

each

pro

du

ct?

–W

hat

isin

clu

ded

inth

ep

rod

uct

des

crip

-ti

on

?

<pro

du

ctsp

ecifi

cati

on

>

Wh

enth

ere

are

no

pro

du

ctd

escr

ipti

on

sfo

rea

chp

rod

uct

.W

hen

pro

du

ctd

escr

ipti

on

sd

on

ot

pro

vid

ees

sen

tial

pro

du

ctd

ata.

Wh

enes

sen

tial

info

rmat

ion

do

esn

ot

mat

chle

gis

lati

on

(e.g

.m

igra

tio

nte

stva

lues

).



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

2.2.

3.2

Iden

tify

inte

nd

edu

seT

he

inte

nd

edu

seo

fth

ep

rod

uct

shal

lb

ed

escr

ibed

inre

lati

on

toth

eex

pec

ted

use

of

the

pro

du

ctb

yth

eco

nsu

mer

,tak

ing

into

acco

un

tvu

lner

able

gro

up

so

fco

nsu

mer

s.

Form

1–

Wh

atis

the

inte

nd

edu

seo

fth

ep

rod

uct

by

cust

om

er?

–W

hat

isth

ein

ten

ded

use

of

the

pro

du

ctb

yfi

nal

con

sum

er?

–A

reth

ere

any

rest

rict

ion

sfo

ru

sag

e?

Wh

enth

ere

isa

pac

kag

ing

mat

eria

lsa

fety

risk

for

con

-su

mer

sd

ue

tola

cko

fd

efin

itio

nfo

ru

sag

e.

2.2.

3.3

Co

nst

ruct

flo

wd

iag

ram

Ap

roce

ssfl

ow

dia

gra

msh

allb

eev

alu

ated

agai

nst

each

pro

du

ct,o

rp

rod

uct

gro

up

,an

dfo

ral

lvar

iati

on

so

fth

ep

roce

sses

and

sub

-pro

cess

es.

Form

3–

Are

flo

wch

arts

avai

lab

lefo

ral

lpro

du

cts?

–A

reth

efl

ow

char

tsd

ated

?<fl

ow

char

tsfo

ral

lpro

du

cts>

Flo

wch

arts

are

un

avai

lab

lefo

ran

yo

fth

ep

rod

uct

s,ch

arts

or

are

no

tco

nfo

rmto

the

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

n.

2.2.

3.4

On

-sit

eco

nfi

rmat

ion

of

the

flo

wd

iag

ram

Th

eri

skas

sess

men

tte

amsh

all

revi

ewth

ep

roce

sses

atal

lop

erat

ion

stag

esag

ain

stth

efl

ow

dia

gra

m.

Wh

ere

app

rop

riat

e,am

end

men

tso

fth

ed

iag

ram

will

be

mad

e.

Form

3–

Was

the

flo

wch

art

con

firm

edd

uri

ng

ah

azar

dan

alys

is/r

isk

asse

ssm

ent

mee

tin

g?

<mee

tin

gm

inu

tes>

Wh

enfl

ow

char

tsar

en

ot

valid

ated

.

2.2.

3.5

Co

nd

uct

ah

azar

dan

alys

isan

dri

skas

sess

men

tfo

rea

chst

epA

nas

sess

men

tsh

allb

eav

aila

ble

of

allp

hys

ical

,ch

emic

alan

db

iolo

gic

alh

azar

ds

that

may

reas

on

ably

be

exp

ecte

d.

Form

3,5,

6,7

–D

oes

ah

azar

dan

alys

is/r

isk

asse

ssm

ent

exis

tfo

rea

chst

ep?

<haz

ard

anal

ysis

>–

Do

esit

incl

ud

eev

ery

haz

ard

?–

Wh

ich

bio

log

ical

,ph

ysic

alan

dch

emic

alh

azar

ds

can

be

exp

ecte

d?

<haz

ard

anal

ysis

>

Wh

ena

haz

ard

anal

ysis

/ris

kas

sess

-m

ent

was

no

tp

erfo

rmed

for

each

step

.W

hen

haz

ard

sw

ere

no

tp

rop

erly

asse

ssed

or

no

tal

lsig

nifi

can

th

azar

ds

wer

eta

ken

into

acco

un

tan

da

safe

tyis

sue

exis

ts.

2.2.

3.5.

1T

he

haz

ard

anal

ysis

shal

ldem

on

-st

rate

the

mo

tiva

tio

nif

ah

azar

dis

ari

sk,t

akin

gin

toac

cou

nt

the

likel

iho

od

of

har

mto

the

con

sum

eran

dth

ep

ote

nti

alse

veri

tyo

fd

amag

e(e

ffec

t,p

ote

nti

alco

nse

qu

ence

s).

–D

oes

ah

azar

dan

alys

isfo

ral

lpro

du

ctg

rou

ps

incl

ud

ing

har

man

dlik

elih

oo

dex

ist?

<haz

ard

anal

ysis

>

Wh

en,d

ue

tola

cko

fa

haz

ard

anal

ysis

,asa

fety

risk

exis

ts.



2.2.

3.5.

2A

llri

sks

that

nee

dsp

ecifi

cm

on

ito

r-in

gan

d/o

rp

reve

nti

veac

tio

ns

shal

lb

eid

enti

fied

asC

on

tro

lPo

ints

(CP

).C

lear

limit

san

dre

gis

trat

ion

of

the

risk

iden

tifi

cati

on

shal

lbe

avai

lab

le.

4.1

6.5

Form

3,5,

6,7,

8

Eac

hp

rere

qu

isit

ep

rog

ram

req

uir

esp

rop

erd

ocu

men

tati

on

of

the

pro

gra

mel

e-m

ents

and

sup

po

rtin

gin

form

atio

nin

clu

din

g,

bu

tn

ot

limit

edto

:–

Sta

nd

ard

op

erat

ing

pro

ced

ure

s.–

Form

s.–

Ch

eckl

ists

.–

Co

rrec

tive

Act

ion

Rep

ort

s.–

Foo

dS

afet

yP

rog

ram

Rea

sses

smen

t.C

han

ges

toth

ep

rere

q-

uis

ite

pro

gra

ms

will

be

revi

ewed

and

app

rove

db

yau

tho

rize

dp

erso

nn

el.

–W

hic

hC

Ps

wer

ed

efin

ed?

–H

ow

man

yC

Ps

exis

t–

Isa

clea

rlim

itd

efin

edfo

rea

chC

P?

–W

hat

clea

rlim

its

are

defi

ned

?–

Ho

ww

ere

the

crit

ical

limit

sd

eter

min

ed?

<haz

ard

anal

ysis

><fl

ow

char

t><d

ecis

ion

tree

>

Wh

enth

ere

are

no

clea

rlim

its

for

each

CP

or

they

are

insu

ffici

ent

and

this

cau

ses

asa

fety

risk

.

2.2.

3.5.

3Fo

ral

lris

ksth

atar

eid

enti

fied

asC

on

tro

lPo

ints

(CP

)to

man

age

the

iden

tifi

edri

sk,t

he

com

pan

ysh

all

imp

lem

ent,

mai

nta

inan

dd

ocu

men

tsp

ecifi

cp

reve

nti

vem

easu

res

and

mo

nit

ori

ng

pro

ced

ure

s.R

eco

rds

of

mo

nit

ori

ng

shal

lbe

mai

nta

ined

for

are

leva

nt

per

iod

.

Form

3,5,

6,7,

8–

Ho

war

eC

Ps

mo

nit

ore

d?

–A

reth

eC

Ps

un

der

con

tro

l?–

Ho

wis

the

mo

nit

ori

ng

of

each

CP

do

cum

ente

d?

–W

ho

do

cum

ents

?–

Are

dat

e,ti

me,

resp

on

sib

leem

plo

yee

and

resu

lt/r

ead

ing

do

cum

ente

d?

–H

ow

lon

gw

illre

cord

sb

est

ore

d?

–W

her

ear

ere

cord

sst

ore

d?

–W

hic

hp

rere

qu

isit

em

easu

res

are

do

cu-

men

ted

?–

Ho

war

eth

em

easu

res

do

cum

ente

d?

<haz

ard

anal

ysis

><fl

ow

char

t>,

<dec

isio

ntr

ee>,

<pre

req

uis

ite

mea

sure

s>

Wh

enC

Ps

wer

en

ot

iden

tifi

edas

such

and

/or

they

are

no

tu

nd

erp

erm

anen

tco

ntr

ols

oth

ata

safe

tyri

skex

ists

.

2.2.

3.6

Est

ablis

hco

rrec

tive

acti

on

sFo

rea

chC

Pco

rrec

tive

acti

on

ssh

all

be

esta

blis

hed

.In

case

the

mo

nit

or-

ing

ind

icat

esth

ata

par

ticu

lar

CP

isn

ot

un

der

con

tro

l,ad

equ

ate

corr

ec-

tive

acti

on

ssh

allb

eta

ken

and

do

cum

ente

d.S

uch

corr

ecti

veac

tio

ns

shal

lals

ota

kein

toac

cou

nt

any

no

n-c

on

form

ing

pro

du

cts.

Form

10–

Wh

atco

rrec

tive

acti

on

sex

ist

for

each

CP

?–

Wh

enw

asa

corr

ecti

veac

tio

nca

rrie

do

ut?

–W

her

ear

eco

rrec

tive

acti

on

sd

ocu

-m

ente

d?

–W

ho

do

cum

ents

the

take

nco

rrec

tive

acti

on

s?<C

Pre

cord

s><c

orr

ecti

veac

tio

ns>

Wh

enth

ere

are

no

corr

ecti

veac

tio

ns

defi

ned

or

no

corr

ec-

tive

acti

on

sar

eta

ken

.W

hen

corr

ecti

veac

tio

ns

are

no

td

ocu

men

ted

.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

2.2.

3.7

Est

ablis

hve

rifi

cati

on

pro

ced

ure

sP

roce

du

res

of

veri

fica

tio

nsh

allb

ees

tab

lish

edto

con

firm

that

the

risk

man

agem

ent

syst

emis

effe

ctiv

e.V

erifi

cati

on

of

the

risk

man

agem

ent

syst

emsh

allb

ep

erfo

rmed

atle

ast

on

cea

year

.Exa

mp

les

of

veri

fica

tio

nac

tivi

ties

incl

ud

e:–

inte

rnal

aud

its,

–an

alys

is,

–sa

mp

ling

,–

eval

uat

ion

s,–

com

pla

ints

by

auth

ori

ties

and

cust

om

ers.

Th

ere

sult

so

fth

isve

rifi

cati

on

shal

lb

ein

corp

ora

ted

into

the

risk

man

-ag

emen

tsy

stem

.

6.2

Form

10V

erifi

cati

on

acti

viti

esar

eco

mp

lete

dfo

rea

chp

rere

qu

isit

ep

rog

ram

toco

nfi

rmth

atth

ep

rog

ram

sar

e:–

Pro

per

lyim

ple

-m

ente

d.

–A

deq

uat

ely

mai

n-

tain

ed.

–S

uit

able

toth

eo

per

atio

ns

of

that

esta

blis

hm

ent

inco

ntr

olli

ng

iden

tifi

edfo

od

safe

tyh

azar

ds.

Ver

ifica

tio

nac

tivi

ties

may

incl

ud

e,b

ut

are

no

tlim

ited

to:

–In

tern

alIn

spec

tio

ns.

–D

ocu

men

tre

view

.–

Inte

rnal

Au

dit

s.–

Ext

ern

alA

ud

its,

Ass

essm

ents

,In

spec

tio

ns.

–E

nd

pro

du

ctte

stin

g.

–H

ow

oft

enis

the

haz

ard

anal

ysis

/ris

kas

sess

men

tp

lan

veri

fied

?–

Wh

atw

asth

ed

ate

of

the

last

veri

fica

tio

n?

–W

hat

was

the

resu

lto

fth

ela

stve

rifi

ca-

tio

n?

–D

oes

the

haz

ard

anal

ysis

/ris

kas

sess

men

tp

lan

refl

ect

the

resu

lts

of

the

veri

fica

tio

n?

–W

hat

was

the

last

dat

ew

hen

the

haz

ard

anal

ysis

/ris

kas

sess

men

tp

lan

was

chan

ged

?<a

ud

itre

po

rts

or

oth

erre

po

rts

for

valid

atio

n>

Wh

enn

ove

rifi

cati

on

was

carr

ied

ou

tan

dth

isle

ads

toa

safe

tyri

sk.

2.2.

3.8

Est

ablis

hd

ocu

men

tati

on

Do

cum

enta

tio

nsh

allb

eav

aila

ble

,co

veri

ng

allp

roce

sses

,pro

ced

ure

s,m

easu

res

and

reco

rds.

Do

cum

enta

-ti

on

and

reco

rdke

epin

gsh

allb

eap

pro

pri

ate

toth

en

atu

rean

dsi

zeo

fth

eco

mp

any.

4.1

Do

cum

ents

are

crea

ted

and

mai

nta

ined

toen

sure

the

effe

ctiv

ed

evel

op

men

t,im

ple

-m

enta

tio

n,m

ain

te-

nan

cean

dim

pro

ve-

men

to

fth

efo

od

safe

tysy

stem

.

–W

hat

haz

ard

anal

ysis

/ris

kas

sess

men

tp

lan

rela

ted

do

cum

ents

exis

t?–

Do

thes

ed

ocu

men

tsin

clu

de

pro

cess

es,

pro

ced

ure

san

dre

sult

s?

,<re

cord

s>,

<pro

du

ctd

escr

ipti

on

s>,

<haz

ard

anal

ysis

>,<r

isk

asse

ssm

ent>

Wh

enh

azar

dan

aly-

sis/

risk

asse

ssm

ent

pla

nis

no

tsu

ffici

entl

yd

ocu

men

ted

and

this

lead

sto

ale

gal

ity

issu

e.

3R

eso

urc

eM

anag

emen

t

3.1

Hu

man

reso

urc

esm

anag

emen

t



3.1.

1A

llp

erso

nn

elp

erfo

rmin

gw

ork

that

affe

cts

pro

du

ctsa

fety

,leg

alit

yan

dq

ual

ity

shal

lhav

eth

ere

qu

ired

com

pet

ence

by

edu

cati

on

,wo

rkex

per

ien

cean

d/o

rtr

ain

ing

,co

mm

en-

sura

tew

ith

thei

rro

le,b

ased

on

haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ciat

edri

sks.

D1.

1.1

1–

Ho

wis

itas

sure

dth

atn

ewem

plo

yees

hav

eth

eri

gh

tca

pab

iliti

esfo

rth

ejo

b?

Wh

en,d

ue

tola

cko

fed

uca

tio

n,e

xper

ien

ceo

rtr

ain

ing

the

leg

alit

yo

rsa

fety

of

the

pro

du

ctis

jeo

par

diz

ed.

3.2

Hu

man

reso

urc

es

3.2.

1P

erso

nn

elh

ygie

ne

3.2.

1.1

Th

ere

shal

lbe

do

cum

ente

dre

qu

ire-

men

tsre

lati

ng

top

erso

nn

elh

ygie

ne.

Th

ese

incl

ud

e,as

am

inim

um

,th

efo

llow

ing

fiel

ds:

–p

rote

ctiv

ecl

oth

ing

–h

and

was

hin

gan

dd

isin

fect

ion

–ea

tin

gan

dd

rin

kin

g–

smo

kin

g–

acti

on

sto

be

take

nin

case

of

cuts

or

skin

abra

sio

ns

–fi

ng

ern

ails

,jew

elry

and

per

son

alb

elo

ng

ing

s–

hai

ran

db

eard

s.T

he

req

uir

emen

tssh

allb

eb

ased

on

haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ciat

edri

sks

inre

lati

on

top

rod

uct

and

pro

cess

.

D1.

1.1

D2.

1.1

/2

2,3,

4–

Wh

atis

the

po

licy

reg

ard

ing

per

son

alh

ygie

ne?

<hyg

ien

eru

les

for

emp

loye

es>

–T

he

rule

sre

gar

din

gp

erso

nn

elh

ygie

ne

incl

ud

eh

and

clea

nin

g,f

oo

d,b

ever

ages

and

oth

erm

ater

ial,

smo

kin

g,h

and

ling

of

inju

ries

,fin

ger

nai

lsan

dje

wel

ry,h

air

and

bea

rds?

–A

reth

eru

les

bas

edo

na

haz

ard

anal

ysis

?<h

azar

dan

alys

is>

–W

her

eis

ital

low

edto

smo

ke?

–H

ow

sho

uld

lesi

on

sb

etr

eate

d/c

ove

red

?–

Wh

atki

nd

so

fh

air

rest

rain

tsar

en

eed

edin

wh

ich

area

s?E

xam

ple

of

resu

ltfr

om

the

haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ciat

edri

sks:

ifg

love

sar

eu

sed

,th

enh

and

dis

infe

ctio

nis

no

tre

qu

ired

for

low

risk

pro

du

ctio

n.

Wh

enin

suffi

cien

tru

les

for

per

son

alh

ygie

ne

cau

sea

safe

tyri

sk.

Wh

enn

oco

rres

po

nd

-in

gh

azar

dan

alys

isex

ists

.

3.2.

1.2

KO

KO

N°

2:T

he

req

uir

emen

tsfo

rp

erso

nn

elh

ygie

ne

shal

lbe

inp

lace

and

app

lied

by

allr

elev

ant

per

son

-n

el,c

on

trac

tors

and

visi

tors

.

–H

ow

isth

eh

ygie

ne

po

licy

com

mu

nic

ated

?<h

ygie

ne

rule

sfo

rem

plo

yees

>–

Are

per

son

nel

hyg

ien

eru

les

also

follo

w-

edb

yex

tern

alse

rvic

ep

rovi

der

s/w

ork

men

and

visi

tors

?<h

ygie

ne

rule

sfo

rvi

sito

rs>

–H

ow

isit

assu

red

that

exte

rnal

per

son

skn

ow

the

rele

van

th

ygie

ne

rule

s?<h

ygie

ne

rule

sfo

rvi

sito

rs>

Wh

en,d

uri

ng

the

aud

itm

ajo

rvi

ola

tio

ns

of

the

rule

sar

eid

enti

fied

that

lead

toa

safe

tyri

sk.

3.2.

1.3

Co

mp

lian

cew

ith

per

son

nel

hyg

ien

ere

qu

irem

ents

shal

lbe

chec

ked

reg

ula

rly.

–H

ow

are

emp

loye

esm

on

ito

red

du

rin

gw

ork

?<h

and

swab

test

s,et

c.>

–Is

emp

loye

eco

mp

lian

ceto

hyg

ien

eru

les

chec

ked

on

are

gu

lar

bas

is?

<min

ute

ssi

tein

spec

tio

n>,

<lis

to

fid

enti

fied

failu

res>

,etc

.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

3.2.

1.4

Vis

ible

jew

elry

(in

cl.p

ierc

ing

)an

dw

atch

essh

alln

ot

be

wo

rn.A

ny

exce

pti

on

ssh

allh

ave

bee

nco

mp

re-

hen

sive

lyev

alu

ated

by

haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ci-

ated

risk

sin

rela

tio

nto

pro

du

ctan

dp

roce

ss.T

his

shal

lbe

effe

ctiv

ely

man

aged

.

D1.

1.1

D2.

1.1

D1.

2.1

2,3

1 3

–Is

ital

low

edto

use

jew

elry

and

wat

ches

inp

rod

uct

ion

area

s?–

Isal

low

ance

bas

edo

nri

skh

azar

dan

alys

is?

<haz

ard

anal

ysis

>

Wh

enw

eari

ng

jew

elry

or

aw

atch

cau

ses

ap

acka

gin

gm

ater

ialo

rem

plo

yee

safe

tyri

sk.

3.2.

1.5

Cu

tsan

dsk

inab

rasi

on

ssh

allb

eco

vere

db

ya

colo

red

pla

ster

/ban

d-

age

(dif

fere

nt

fro

mth

ep

rod

uct

colo

r)—

con

tain

ing

am

etal

stri

p,

wh

ere

app

rop

riat

e—

and

inca

seo

fh

and

inju

ries

,in

add

itio

nto

ap

last

er/b

and

age,

asi

ng

leu

seg

love

shal

lbe

wo

rn.

D2.

2.1

–31,

2,3

–W

hat

colo

ris

pla

ster

and

wh

ere

isit

use

d?

–D

oes

the

pla

ster

con

tain

am

etal

stri

p?

–W

hat

isan

emp

loye

ere

qu

ired

too

bse

rve

inca

seo

fh

and

inju

ry?

<per

son

nel

hyg

ien

eru

les>

Wh

enh

and

inju

ries

ensu

ea

pro

du

ctsa

fety

risk

(e.g

.an

un

cove

red

pu

rule

nt

wo

un

dth

atco

mes

into

con

tact

wit

hth

ep

rod

uct

).

3.2.

2W

ork

ing

con

dit

ion

san

dp

rote

ctiv

ecl

oth

ing

for

per

son

nel

,co

ntr

acto

rsan

dvi

sito

rs

3.2.

2.1

Co

mp

any

pro

ced

ure

ssh

alle

xist

toen

sure

that

allp

erso

nn

el,c

on

trac

tors

and

visi

tors

are

awar

eo

fth

eru

les

reg

ard

ing

the

man

agem

ent

of

wea

rin

gan

dch

ang

ing

of

pro

tect

ive

clo

thin

gin

spec

ified

area

sin

acco

rd-

ance

wit

hp

rod

uct

req

uir

emen

ts.

D2.

1.1

–21,

2–

Wh

atar

eth

eru

les

reg

ard

ing

pro

tect

ive

clo

thin

g?

<per

son

nel

hyg

ien

eru

les>

–A

reth

ep

rote

ctiv

ecl

oth

ing

rule

sb

ased

on

haz

ard

anal

ysis

?<h

azar

dan

alys

is>

–W

hen

mu

stp

rote

ctiv

ecl

oth

ing

be

chan

ged

?–

exam

ple

so

far

eas:

cate

rin

g,c

han

gin

gro

om

s,sm

oki

ng

area

,to

ilets

,etc

.

Wh

enth

ela

cko

fp

rote

ctiv

ecl

oth

ing

ensu

esa

pro

du

ctsa

fety

risk

.

3.2.

2.2

Inw

ork

area

sw

her

ew

eari

ng

hea

dg

ear

and

/or

bea

rdsn

oo

d(c

ove

r-in

gs)

isre

qu

ired

,th

eh

air

shal

lbe

cove

red

com

ple

tely

,so

that

pro

du

ctco

nta

min

atio

nis

pre

ven

ted

.

D2.

1.2

1–

Inw

hic

hp

rod

uct

ion

area

sis

wea

rin

go

fp

rote

ctiv

eh

ead

gea

ran

d/o

rb

eard

sno

od

man

dat

ory

?–

Wh

atki

nd

of

hea

dg

ear

isu

sed

?–

Ho

wsh

allh

ead

gea

rb

eu

sed

?

Wh

enin

corr

ect

wea

rin

go

rab

sen

ceo

fh

ead

gea

ran

d/o

rb

ear

sno

od

ensu

esa

pro

du

ctsa

fety

risk

.



3.2.

2.3

Cle

arly

defi

ned

usa

ge

rule

ssh

all

exis

tfo

rw

ork

area

s/ac

tivi

ties

wh

ere

itis

req

uir

edto

wea

rg

love

s(c

olo

red

dif

fere

ntl

yfr

om

the

pro

du

ctco

lor)

.C

om

plia

nce

wit

hth

ese

rule

ssh

allb

ech

ecke

do

na

reg

ula

rb

asis

.

D2.

1.2

–In

wh

ich

pro

du

ctio

nar

eas

isw

eari

ng

of

glo

ves

man

dat

ory

?–

Wh

atki

nd

so

fg

love

sar

eu

sed

?W

hen

mu

stg

love

sb

ech

ang

ed?

–H

ow

isth

eco

mp

lian

cew

ith

thes

eru

les

chec

ked

?<o

nsi

tein

spec

tio

ns>

Wh

enm

issi

ng

or

un

clea

ng

love

sen

sue

ap

rod

uct

safe

tyri

sk.

3.2.

2.4

Su

itab

lep

rote

ctiv

ecl

oth

ing

shal

lbe

avai

lab

lein

suffi

cien

tq

uan

tity

for

each

emp

loye

e,w

hen

req

uir

ed.

–H

ow

man

yp

rote

ctiv

esu

its/

un

ifo

rms

are

atth

ed

isp

osa

lof

each

emp

loye

e?–

Ho

wo

ften

isan

emp

loye

esu

pp

ose

dto

chan

ge

his

/her

pro

tect

ive

suit

/un

ifo

rm?

Wh

enem

plo

yees

do

no

th

ave

pro

tect

ive

clo

thin

gan

dth

eref

ore

ap

rod

uct

con

tam

ina-

tio

nri

skex

ists

.

3.2.

2.5

Wh

enre

qu

ired

,all

pro

tect

ive

clo

thin

gsh

allb

eth

oro

ug

hly

and

reg

ula

rly

lau

nd

ered

.Haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ciat

edri

sks,

tog

eth

erw

ith

con

sid

erat

ion

giv

ento

the

pro

cess

esan

dp

rod

uct

so

fth

eco

mp

any

shal

ldet

erm

ine

ifcl

oth

ing

shal

lbe

was

hed

by

aco

ntr

act

lau

nd

ry,o

nsi

tela

un

dry

or

by

the

emp

loye

e.

–H

ow

isp

rote

ctiv

ecl

oth

ing

lau

nd

ered

?–

Are

ther

ean

yem

plo

yees

wh

ola

un

der

thei

rp

rote

ctiv

ecl

oth

ing

ath

om

e?–

Isp

rote

ctiv

ecl

oth

esla

un

der

ing

bas

edo

na

haz

ard

anal

ysis

?<h

azar

dan

alys

is>

Wh

enin

suffi

cien

tla

un

der

ing

ensu

esa

pro

du

ctco

nta

min

a-ti

on

risk

.

3.2.

2.6

Gu

idel

ines

shal

lexi

stfo

rla

un

der

ing

of

pro

tect

ive

clo

thin

gan

da

pro

ce-

du

resh

allb

ein

pla

cefo

rch

ecki

ng

its

clea

nlin

ess,

wh

enre

qu

ired

.

–H

ow

isth

ela

un

der

ing

pro

ced

ure

chec

ked

for

effe

ctiv

enes

s?–

Wh

atg

uid

elin

esex

ist

reg

ard

ing

pro

tec-

tive

clo

thes

lau

nd

erin

g?

<per

son

nel

hyg

ien

eru

les>

3.2.

2.7

Sen

ior

man

agem

ent

shal

len

sure

haz

ard

ou

sw

ork

ing

con

dit

ion

sth

atco

uld

cau

sein

juri

esto

per

son

nel

are

iden

tifi

edan

dp

reve

nti

vem

easu

res

are

man

aged

.

Ho

wth

eg

oo

dw

ork

ing

con

dit

ion

of

per

son

nel

isfo

llow

ed?

Ho

war

ep

erso

nn

elin

form

ed?

3.2.

2.8

Th

eco

mp

any

shal

lrev

iew

that

pre

ven

tive

mea

sure

sto

ensu

rep

erso

nn

elsa

fety

rela

ted

toh

azar

d-

ou

sw

ork

ing

con

dit

ion

sar

eef

fect

ive,

inlin

ew

ith

app

licab

lele

gis

lati

on

or

reco

gn

ized

con

ven

tio

ns.

Do

esan

insp

ecti

on

pla

nex

ist?

<rep

ort

of

insp

ecti

on

>



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

3.2.

3P

roce

du

res

app

licab

leto

infe

ctio

us

dis

ease

s

3.2.

3.1

Th

ere

shal

lbe

wri

tten

and

com

mu

ni-

cate

dm

easu

res

for

per

son

nel

,co

ntr

acto

rsan

dvi

sito

rsto

dec

lare

any

infe

ctio

us

dis

ease

wh

ich

may

hav

ean

imp

act

on

pac

kag

ing

mat

eria

lsaf

ety.

Inca

seo

fd

ecla

rati

on

of

infe

ctio

us

dis

ease

,act

ion

ssh

allb

eta

ken

ino

rder

tom

inim

ize

risk

of

con

tam

inat

ion

of

pro

du

cts.

D2.

1.1

–2D

2.2.

1–3

1,2

1,2,

3,4,

5–

Ho

wsh

allp

erso

nn

elan

dvi

sito

rsb

ehav

ein

case

or

susp

icio

no

fan

infe

ctio

us

dis

ease

?–

Ho

wis

iten

sure

dth

atp

erso

nn

elan

dvi

sito

rskn

ow

the

gu

idel

ines

?<v

isit

ors

hyg

ien

eru

les>

Wh

end

ue

toan

emp

loye

e’s

infe

ctio

us

dis

ease

ap

rod

uct

safe

tyri

skis

giv

enan

dn

op

reve

nti

vest

eps

are

take

nb

yth

eco

mp

any.

3.3

Trai

nin

gan

din

stru

ctio

n

3.3.

1T

he

com

pan

ysh

alli

mp

lem

ent

do

cum

ente

dtr

ain

ing

and

/or

inst

ruc-

tio

np

rog

ram

sw

ith

resp

ect

toth

ep

rod

uct

req

uir

emen

tsan

dth

etr

ain

ing

nee

ds

of

the

emp

loye

esb

ased

on

thei

rjo

ban

dsh

alli

ncl

ud

e:–

trai

nin

gco

nte

nts

–tr

ain

ing

freq

uen

cy–

emp

loye

e’s

task

–la

ng

uag

es–

qu

alifi

edtr

ain

er/t

uto

r–

eval

uat

ion

met

ho

do

log

y.

D1.

2.1

–47.

0D

1/D

2D

1.1.

1

1,2,

3

1,2,

3,4,

5

–W

ho

isre

spo

nsi

ble

for

trai

nin

g?

<tra

inin

gev

iden

ces>

–W

hat

are

the

evid

ence

sfo

rth

etr

ain

er’s

qu

alifi

cati

on

?–

Wh

atw

asth

eco

nte

nt

of

the

last

trai

nin

gse

ssio

n?

<tra

inin

gp

rog

ram

>–

Ho

war

efo

reig

nem

plo

yees

trai

ned

/in

stru

cted

?–

Wh

op

arti

cip

ates

inth

etr

ain

ing

sess

ion

s?–

Ho

war

eth

ein

stru

ctio

nn

eces

siti

esfo

rea

chem

plo

yee

det

erm

ined

?–

Ho

wo

ften

are

trai

nin

gse

ssio

ns

hel

d?

<tra

inin

gsc

hed

ule

>

Wh

end

ue

tola

cko

rin

suffi

cien

ttr

ain

ing

ap

rod

uct

safe

tyo

rle

gal

ity

risk

exis

ts.

Wh

enle

gal

lyre

qu

ired

pac

kag

ing

mat

eria

lsaf

ety

inst

ruct

ion

sar

en

ot

un

der

take

n.

3.3.

2T

he

do

cum

ente

dtr

ain

ing

and

/or

inst

ruct

ion

shal

lap

ply

toal

lper

son

-n

el,i

ncl

ud

ing

seas

on

alan

dte

mp

o-

rary

wo

rker

san

dem

plo

yees

fro

mex

tern

alco

mp

anie

s,em

plo

yed

inth

ere

spec

tive

wo

rkar

ea.U

po

nem

plo

y-m

ent,

and

bef

ore

com

men

cin

gw

ork

,th

eysh

allb

etr

ain

edin

acco

rdan

cew

ith

the

do

cum

ente

dtr

ain

-in

g/i

nst

ruct

ion

pro

gra

ms.

D1.

2.1–

41,

2,3,

7–

Are

pro

spec

tive

emp

loye

es(i

ncl

.sea

-so

nal

and

tem

po

rary

wo

rker

s)tr

ain

ed/i

nst

ruct

edu

po

nem

plo

ymen

t?–

Wh

ich

emp

loye

esar

etr

ain

ed/i

nst

ruct

edu

po

nem

plo

ymen

t?W

hat

isth

eco

nte

nt

of

thes

ein

stru

ctio

ns?

<tra

inin

gev

iden

ces>



3.3.

3R

eco

rds

shal

lbe

avai

lab

leo

fal

ltr

ain

ing

/in

stru

ctio

nev

ents

,sta

tin

g:

–lis

to

fp

arti

cip

ants

(th

issh

all

incl

ud

eth

eir

sig

nat

ure

)–

dat

e–

du

rati

on

–co

nte

nts

of

trai

nin

g–

nam

eo

ftr

ain

er/t

uto

r.T

her

esh

allb

ea

pro

ced

ure

or

pro

gra

min

pla

ceto

pro

veth

eef

fect

iven

ess

of

the

trai

nin

gan

d/o

rin

stru

ctio

np

rog

ram

s.

D1.

2.1

–45,

7–

Wh

ich

trai

nin

gco

urs

esar

eu

nd

erta

ken

?–

Are

ther

ean

ysp

ecia

ltra

inin

gco

urs

es?

–A

retr

ain

ing

cou

rses

do

cum

ente

d?

–W

hat

has

bee

nd

ocu

men

ted

?–

Hav

ep

arti

cip

ants

sig

ned

the

trai

nin

gp

roo

fs?

–H

ow

oft

enar

eh

ygie

ne

trai

nin

gse

ssio

ns

hel

d?

–W

hat

was

the

con

ten

to

fth

ela

sth

ygie

ne

trai

nin

gse

ssio

n?

<tra

inin

gev

iden

ces>

No

trai

nin

gp

roo

fsex

ist

toco

nfi

rmth

atem

plo

yees

wer

etr

ain

ed/i

nst

ruct

ed.

3.3.

4T

he

con

ten

tso

ftr

ain

ing

and

/or

inst

ruct

ion

shal

lbe

revi

ewed

and

up

dat

edre

gu

larl

yan

dta

kein

toac

cou

nt

com

pan

y’s

spec

ific

issu

es,

pac

kag

ing

mat

eria

lsaf

ety,

pac

kag

ing

mat

eria

lrel

ated

leg

alre

qu

irem

ents

and

pro

du

ct/p

roce

ssm

od

ifica

tio

ns.

D1.

2.1

–44,

5–

Ho

war

etr

ain

ing

con

ten

tsre

view

ed?

<rev

iew

test

>–

Wh

enar

etr

ain

ing

con

ten

tsre

view

ed?

–W

hen

was

the

late

sttr

ain

ing

con

ten

tu

pd

ate

do

ne?

–W

hat

was

the

con

ten

to

fth

ela

test

up

dat

e?<a

ud

itre

sult

s>–

spec

ific

issu

es:n

on

-co

nfo

rmit

ites

,fai

lure

,co

mp

lain

ts,e

tc

Du

rin

gth

eo

n-s

ite

aud

itev

iden

cew

asg

iven

that

emp

loye

esd

idn

ot

act

acco

rdin

gto

kno

wle

dg

etr

ans-

mit

ted

inth

etr

ain

ing

sess

ion

san

dth

isle

adto

ap

rod

uct

safe

tyri

sk.

3.4

San

itar

yfa

cilit

ies,

equ

ipm

ent

for

per

son

nel

hyg

ien

ean

dst

aff

faci

litie

s

3.4.

1T

he

com

pan

ysh

allp

rovi

de

staf

ffa

cilit

ies,

wh

ich

shal

lbe

pro

po

rtio

nal

insi

ze,e

qu

ipp

edfo

rth

en

um

ber

of

per

son

nel

and

des

ign

edan

do

per

-at

edso

asto

min

imiz

ep

acka

gin

gm

ater

ials

afet

yri

sks.

Su

chfa

cilit

ies

shal

lbe

kep

tin

clea

nan

dg

oo

dco

nd

itio

n.

A3.

1.2

7.0

A3

A3.

1.1

A3.

1.2

4 1,2,

31,

2,3,

4,5,

6,7,

8,9

–H

ow

man

yem

plo

yees

are

ther

e?–

Do

they

hav

eac

cess

toa

cafe

teri

a?–

Are

ther

elo

cker

-ro

om

s?–

Wh

ere

are

the

rest

roo

ms?

–A

reth

ere

bat

hin

gfa

cilit

ies?

<pla

nt

lay-

ou

t>–

Sta

fffa

cilit

ies

=e.

g.c

han

gin

gro

om

,sm

oki

ng

area

,din

ing

roo

m,e

tc.

Wh

enso

cial

faci

litie

sar

eu

nd

ereq

uip

ped

or

are

ou

to

fp

rop

ort

ion

toth

en

um

ber

of

emp

loye

esso

that

asa

fety

issu

ear

ises

.

3.4.

2T

he

risk

of

pro

du

ctco

nta

min

atio

nb

yfo

reig

nm

ater

ialf

rom

staf

ffa

cilit

ies

shal

lbe

eval

uat

edan

dm

inim

ized

.C

on

sid

erat

ion

shal

lals

ob

eg

iven

tofo

od

and

oth

erm

ater

ialb

rou

gh

tto

wo

rkb

yp

erso

nn

elan

dp

erso

nal

bel

on

gin

gs.

–M

ayem

plo

yees

bri

ng

foo

dan

do

ther

mat

eria

lfro

mh

om

e?–

May

emp

loye

esta

kem

edic

ine

alo

ng

toth

eir

wo

rkp

lace

?–

Do

esa

haz

ard

anal

ysis

exis

tre

gar

din

gfo

reig

nm

ater

ialf

rom

soci

alfa

cilit

ies?

<haz

ard

anal

ysis

>



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

3.4.

3T

her

esh

allb

ein

pla

ceru

les

and

faci

litie

sto

ensu

reth

eco

rrec

tm

anag

emen

tfo

rp

erso

nn

elb

elo

ng

-in

gs

and

for

foo

dan

do

ther

mat

eria

lb

rou

gh

tto

wo

rkb

yp

erso

nn

el,f

oo

dco

min

gfr

om

din

ing

roo

man

dfr

om

ven

din

gm

ach

ines

.Th

efo

od

and

oth

erm

ater

ials

hal

lon

lyb

est

ore

dan

d/o

ru

sed

ind

esig

nat

edar

eas.

3.4.

4T

he

com

pan

ysh

allp

rovi

de

suit

able

chan

gin

gro

om

sfo

rp

erso

nn

el,

con

trac

tors

and

visi

tors

.Wh

ere

nec

essa

ry,o

utd

oo

rcl

oth

ing

and

pro

tect

ive

clo

thin

gsh

allb

est

ore

dse

par

atel

y.

A3.

1.2

7,8

–A

reth

ere

lock

er-r

oo

ms

for

emp

loye

esan

dvi

sito

rsw

ith

sep

arat

ion

for

ou

tdo

or

and

pro

tect

ive

clo

thin

g?

3.4.

5To

ilets

shal

lno

th

ave

dir

ect

acce

ssto

anar

eaw

her

ep

acka

gin

gm

ater

ial

pro

du

cts

are

han

dle

d.T

he

toile

tssh

allb

eeq

uip

ped

wit

had

equ

ate

han

dw

ash

ing

faci

litie

s.S

anit

ary

faci

litie

ssh

allh

ave

adeq

uat

en

atu

ral

or

mec

han

ical

ven

tila

tio

n.M

ech

ani-

cala

irfl

ow

fro

ma

con

tam

inat

edar

eato

acl

ean

area

shal

lbe

avo

ided

.

A3.

1.2

A3.

1.1

6 3–

Do

toile

tso

pen

dir

ectl

yin

top

rod

uct

ion

area

s?W

hen

toile

tex

hau

s-ti

on

po

ses

aco

nta

mi-

nat

ion

risk

.

3.4.

6A

deq

uat

eh

and

hyg

ien

efa

cilit

ies

shal

lb

ep

rovi

ded

atac

cess

po

ints

toan

dw

ith

inp

rod

uct

ion

area

s,as

wel

las

atst

aff

faci

litie

s.B

ased

on

haz

ard

ana-

lysi

san

das

sess

men

to

fas

soci

ated

risk

s,fu

rth

erar

eas

(e.g

.wra

pp

ing

area

)sh

allb

esi

mila

rly

equ

ipp

ed.

A3.

1.1

1,2

–A

reth

ere

eno

ug

hh

and

was

hin

gfa

cilit

ies

avai

lab

leat

the

entr

ance

top

roce

ssin

gar

eas

and

inso

cial

area

s?

Wh

ena

con

tam

ina-

tio

np

rob

lem

occ

urs

du

eto

lack

of

han

dw

ash

ing

faci

litie

s.

3.4.

7H

and

was

hin

gfa

cilit

ies

shal

lpro

vid

eas

am

inim

um

:–

run

nin

gp

ota

ble

wat

erat

anap

pro

pri

ate

tem

per

atu

re–

liqu

idso

ap–

app

rop

riat

eeq

uip

men

tfo

rh

and

dry

ing

.

A3.

1.1

1–

Are

allh

and

was

hin

gfa

cilit

ies

pro

vid

edw

ith

app

rop

riat

eeq

uip

men

tfo

rh

and

dry

ing

and

liqu

idso

ap?

–A

real

lhan

dw

ash

ing

faci

litie

sp

rovi

ded

wit

hru

nn

ing

po

tab

lew

ater

atan

app

ro-

pri

ate

tem

per

atu

re?



3.4.

8If

nec

essa

ry,f

ollo

win

gad

dit

ion

alre

qu

irem

ents

reg

ard

ing

han

dh

ygie

ne

shal

lals

ob

ep

rovi

ded

:–

han

dco

nta

ct-f

ree

fitt

ing

s–

han

dd

isin

fect

ion

–ad

equ

ate

hyg

ien

eeq

uip

men

ts–

sig

nag

eh

igh

ligh

tin

gh

and

hyg

ien

ere

qu

irem

ents

–w

aste

con

tain

erw

ith

han

dco

nta

ct-

free

op

enin

g.

A2.

1.1

1,2,

3,4,

5–

Are

alla

reas

wh

ere

du

eto

risk

asse

ss-

men

tex

ten

ded

hyg

ien

ere

qu

irem

ents

are

nec

essa

ryeq

uip

ped

wit

hh

and

was

hin

gfa

cilit

ies

wit

hh

and

con

tact

-fre

efi

ttin

gs,

han

dd

isin

fect

ion

dev

ices

and

sig

ns

or

pic

tog

ram

s?<s

ign

s/p

icto

gra

ms>

Wh

ena

con

tam

ina-

tio

np

rob

lem

occ

urs

du

eto

lack

of

app

ro-

pri

ate

han

dw

ash

ing

faci

litie

s.

3.4.

9B

ased

on

haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ciat

edri

sks,

ther

esh

allb

ea

pro

gra

mto

con

tro

lef

fect

iven

ess

of

han

dh

ygie

ne.

A3.

1.1

2

3.4.

10C

han

gin

gro

om

ssh

allb

ese

par

ated

fro

mp

rod

uct

ion

area

and

shal

lbe

situ

ated

soth

atth

eyal

low

dir

ect

acce

ssto

the

area

sw

her

ep

acka

gin

gm

ater

ialp

rod

uct

sar

eh

and

led

.B

ased

on

haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ciat

edri

sks,

exce

pti

on

ssh

allb

eju

stifi

edan

dm

anag

ed.

A3.

1.2

6–

Do

lock

er-r

oo

ms

giv

ed

irec

tac

cess

top

roce

ssin

gar

eas?

–H

ow

isp

rote

ctiv

ecl

oth

ing

han

dle

dd

uri

ng

bre

aks/

inte

rval

s?–

Do

esa

haz

ard

anal

ysis

exis

tfo

rlo

cker

-ro

om

sw

ith

no

dir

ect

acce

ssto

pro

cess

-in

gar

eas?

<haz

ard

anal

ysis

>

Wh

ena

con

tam

ina-

tio

no

ccu

rsd

ue

tolo

cker

-ro

om

loca

tio

nw

hic

hle

ads

top

acka

gin

gm

ater

ial

pro

du

ctsa

fety

pro

ble

m.

3.4.

11W

her

eth

eh

azar

dan

alys

isan

das

sess

men

to

fas

soci

ated

risk

ssh

ow

the

nec

essi

ty,c

lean

ing

faci

litie

ssh

all

be

avai

lab

lean

du

sed

for

bo

ots

,sh

oes

and

furt

her

pro

tect

ive

clo

thin

g.

–A

reth

ere

clea

nin

gfa

cilit

ies

for

bo

ots

and

pro

tect

ive

apro

ns?

4P

lan

nin

gan

dP

rod

uct

ion

Pro

cess

4.1

Co

ntr

act

agre

emen

t

4.1.

1T

he

req

uir

emen

tsw

hic

har

ed

efin

edb

etw

een

the

con

trac

tp

artn

ers

shal

lb

ees

tab

lish

ed,a

gre

edu

po

nan

dre

view

edco

nce

rnin

gth

eir

acce

pt-

abili

tyb

efo

rea

sup

ply

agre

emen

tis

con

clu

ded

.All

clau

ses

rela

ted

toq

ual

ity

and

pac

kag

ing

mat

eria

lsa

fety

shal

lbe

kno

wn

and

com

mu

ni-

cate

dto

each

rele

van

td

epar

tmen

t.

–W

hat

assu

ran

ces

are

giv

enth

atcu

sto

mer

req

uir

emen

tsan

do

wn

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

ns

are

inac

cord

ance

wit

hea

cho

ther

?–

Do

wri

tten

sup

ply

agre

emen

tsw

ith

cust

om

ers

exis

t?–

Do

spec

ific

cust

om

erre

qu

irem

ents

for

pu

rch

ased

pro

du

cts

exis

t?–

Wh

och

ecks

and

app

rove

ssp

ecifi

cati

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

tati

on

s?–

Wh

oen

sure

sth

atth

ep

rop

erra

wm

ater

i-al

sar

eav

aila

ble

wh

enev

ern

eed

ed?

Wh

enth

ere

are

no

app

rove

dsp

ecifi

ca-

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

-ti

on

san

dn

ocl

arit

yex

ists

ifre

qu

ired

pro

du

ctca

nb

ed

eliv

ered

.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.1.

2C

han

ges

of

exis

tin

gco

ntr

actu

alag

reem

ents

shal

lbe

do

cum

ente

dan

dco

mm

un

icat

edb

etw

een

the

con

trac

tp

artn

ers.

–H

ow

isit

ensu

red

that

cust

om

ers

are

info

rmed

abo

ut

pro

du

ctch

ang

es?

–W

ho

chec

ksan

dap

pro

ves

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

ns?

4.2

Sp

ecifi

cati

on

san

dfo

rmu

las/

con

fig

u-

rati

on

s

4.2.

1S

pec

ifica

tio

ns

and

oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

n

4.2.

1.1

Sp

ecifi

cati

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

tati

on

shal

lbe

avai

lab

lean

din

pla

cefo

ral

lfin

ish

edp

rod

uct

s.T

hey

shal

lbe

up

tod

ate,

un

amb

igu

ou

san

db

ein

com

plia

nce

wit

hle

gal

and

cust

om

erre

qu

ire-

men

ts.

–H

ow

are

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

ns

com

pile

d,

chec

ked

and

app

rove

d?

–A

reth

ere

spec

ifica

tio

ns

or

oth

erle

gal

req

uir

edd

ocu

men

tati

on

sfo

ral

lfin

alp

rod

uct

s?–

Ho

war

eu

pto

dat

esp

ecifi

cati

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

tati

on

sre

cog

-n

izab

le?

<sp

ecifi

cati

on

so

ro

ther

leg

alre

qu

ired

do

cum

enta

tio

n>

Wh

enn

ot

alls

pec

ifi-

cati

on

sfo

rfi

nal

pro

du

cts

are

up

tod

ate

and

inco

nfo

rm-

ance

wit

hle

gal

req

uir

emen

ts.

4.2.

1.2

KO

KO

N°

3:S

pec

ifica

tio

ns

or

oth

erle

gal

req

uir

edd

ocu

men

tati

on

shal

lb

eav

aila

ble

and

inp

lace

for

allr

awm

ater

ials

(raw

mat

eria

ls,a

dd

itiv

es,

inks

,ad

hes

ives

,so

lven

ts,w

rap

pin

gm

ater

ials

,rew

ork

).S

pec

ifica

tio

ns

shal

lbe

up

tod

ate,

un

amb

igu

ou

san

db

ein

com

plia

nce

wit

hle

gal

req

uir

emen

tsan

d,i

fex

isti

ng

,wit

hcu

sto

mer

req

uir

emen

ts.

Form

2–

Are

spec

ifica

tio

ns

or

oth

erle

gal

req

uir

edd

ocu

men

tati

on

avai

lab

lefo

ral

lraw

mat

eria

ls,a

dd

itiv

es,i

nks

,ad

hes

ives

,so

lven

ts,w

rap

pin

gm

ater

iala

nd

rew

ork

?–

Wh

atas

sura

nce

isg

iven

that

spec

ifica

-ti

on

san

do

ther

leg

ally

req

uir

edd

ocu

-m

enta

tio

nar

efo

llow

ed?

<evi

den

ceo

fsp

ecifi

cati

on

com

plia

nce

,e.

g.l

abre

sult

s>–

Wh

atas

sura

nce

isg

iven

that

spec

ifica

-ti

on

sar

ein

con

form

ance

wit

hle

gal

req

uir

emen

ts?

–W

ho

wri

tes,

chec

ksan

dap

pro

ves

spec

ifica

tio

ns?

Wh

enn

ot

allr

awm

ater

ials

,ad

dit

ives

,in

ks,a

dh

esiv

es,

solv

ents

,wra

pp

ing

mat

eria

lsan

dre

wo

rkh

ave

spec

ifica

tio

ns

or

oth

erle

gal

req

uir

edd

ocu

men

tati

on

.W

hen

spec

ifica

tio

ns

do

no

tco

mp

lyw

ith

leg

alre

qu

irem

ents

.

4.2.

1.3

Wh

ere

req

uir

edb

ycu

sto

mer

s,p

rod

uct

spec

ifica

tio

ns

shal

lbe

form

ally

agre

ed.



4.2.

1.4

Sp

ecifi

cati

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

tati

on

and

/or

thei

rco

nte

nts

shal

lbe

pro

vid

edin

the

rele

van

tlo

cati

on

and

acce

ssib

leto

allr

elev

ant

per

son

nel

.

–W

ho

has

acce

ssto

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

n?

Wh

enke

yem

plo

yees

do

no

th

ave

acce

ssto

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

nan

da

pro

du

ctsa

fety

and

/or

leg

alre

qu

irem

ent

issu

een

sues

.

4.2.

1.5

Th

ere

shal

lbe

ap

roce

du

refo

rth

ecr

eati

on

,th

em

od

ifica

tio

nan

dap

pro

valo

fsp

ecifi

cati

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

tati

on

for

allp

arts

of

the

pro

cess

,wh

ich

shal

lin

clu

de

the

pre

limin

ary

acce

pta

nce

of

the

cust

om

er,i

fsp

ecifi

cati

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

tati

on

hav

eb

een

agre

edw

ith

cust

om

ers.

–W

ho

wri

tes,

amen

ds,

chec

ksan

dap

pro

ves

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

n?

Wh

ensp

ecifi

cati

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

ta-

tio

nar

eu

sed

bu

th

ave

no

tb

een

pro

per

lyap

pro

ved

and

itis

no

tcl

ear

ifth

eyca

nb

eco

mp

lied

wit

h.

4.2.

1.6

Th

esp

ecifi

cati

on

/oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

nco

ntr

ol

pro

ced

ure

shal

lin

clu

de

the

up

dat

eo

ffi

nis

hed

pro

du

ctsp

ecifi

cati

on

inca

seo

fan

ym

od

ifica

tio

n:

–o

fra

wm

ater

ial

–o

ffo

rmu

la/c

on

fig

ura

tio

n–

of

pro

cess

wit

hin

flu

ence

on

the

fin

alp

rod

uct

s–

of

wra

pp

ing

mat

eria

lwit

hin

flu

-en

ceo

nth

efi

nal

pro

du

cts.

4.2.

2Fo

rmu

la/c

on

fig

ura

tio

n

4.2.

2.1

KO

N°

4:W

her

eth

ere

are

cust

om

erag

reem

ents

inre

lati

on

toth

ep

rod

uct

form

ula

/co

nfi

gu

rati

on

and

tech

no

log

ical

req

uir

emen

ts,t

hes

esh

allb

eco

mp

lied

wit

h.

–W

hat

assu

ran

ceis

giv

enth

atsp

ecifi

edco

nfi

gu

rati

on

isfo

llow

ed?

–H

ow

isco

nfi

gu

rati

on

com

plia

nce

chec

ked

?–

Ifn

osp

ecifi

cte

chn

olo

gic

alre

qu

irem

ents

and

/or

form

ula

sar

eag

reed

bet

wee

nth

eco

ntr

act

par

tner

s,th

efo

rmu

lao

fth

esu

pp

lier

isth

eb

asis

.In

this

case

the

req

uir

emen

tsh

allb

era

ted

wit

hN

/A.

Wh

enth

ere

isev

i-d

ence

that

con

fig

ura

-ti

on

and

fin

ish

edp

rod

uct

spec

ifica

tio

ns

do

no

tfi

tto

get

her

.W

hen

du

rin

ga

trac

e-ab

ility

test

ther

eis

evid

ence

that

agre

edu

po

nco

nfi

gu

rati

on

isn

ot

com

plie

dw

ith

.

4.3

Pro

du

ctd

evel

op

men

t/P

rod

uct

mo

difi

cati

on

/Mo

difi

cati

on

of

pro

du

ctio

np

roce

sses

Th

ere

qu

irem

ents

for

pro

du

ctd

evel

op

men

th

ave

tob

ech

ecke

dev

enif

ther

ear

eo

nly

pro

du

ctm

od

ifica

tio

ns

(new

ing

red

ien

tu

sed

,ch

ang

esin

pac

kag

ing

)o

rm

od

ifica

-ti

on

so

fp

rod

uct

ion

pro

cess

es.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.3.

1A

pro

ced

ure

for

pro

du

ctd

evel

op

-m

ent

shal

lbe

inp

lace

wh

ich

inco

r-p

ora

tes

the

haz

ard

anal

ysis

pri

nci

-p

les,

inac

cord

ance

wit

hth

eH

AC

CP

and

/or

risk

asse

ssm

ent

syst

em.

–H

ow

are

the

pro

cess

ing

pro

ced

ure

sfo

rp

rod

uct

dev

elo

pm

ent

bu

iltu

p?

–D

op

roce

ssin

gp

roce

du

res

for

pro

du

ctd

evel

op

men

tal

soco

nta

ina

haz

ard

anal

ysis

?<h

azar

dan

alys

is>

Wh

enn

op

roce

ssin

gp

roce

du

res

wer

ees

tab

lish

edfo

rp

rod

uct

dev

elo

pm

ent

and

ap

acka

gin

gm

ater

ials

afet

yan

d/o

rle

gal

issu

een

sues

.

4.3.

2P

rod

uct

form

ula

tio

n/c

on

fig

ura

tio

n,

man

ufa

ctu

rin

gp

roce

sses

,pro

cess

par

amet

ers

and

the

fulfi

lmen

to

fp

rod

uct

req

uir

emen

tssh

allb

ees

tab

lish

edan

dsh

allh

ave

bee

nas

sure

db

yfa

cto

rytr

ials

and

pro

du

ctte

stin

g.

–W

hat

do

pro

du

ctd

evel

op

men

tp

roce

-d

ure

slo

ok

like?

<pro

du

ctd

evel

op

men

tp

roce

du

res>

–W

hat

test

sar

em

ade

wh

ilea

pro

du

ctis

dev

elo

ped

?<t

est

resu

lts>

–Is

dev

elo

ped

pro

du

ctsu

bm

itte

dto

tria

lru

ns?

<tri

alru

nd

ocu

men

tati

on

>

Wh

enn

ewp

roce

ss-

ing

pro

ced

ure

s,co

nfi

gu

rati

on

san

dp

rod

uct

req

uir

emen

tsar

en

ot

ensu

red

by

test

san

dtr

ialr

un

san

den

ter

dir

ectl

yin

top

rod

uct

ion

and

this

enta

ilsa

pac

kag

ing

mat

eria

lsaf

ety

and

/or

leg

alit

yis

sue

wh

ich

can

no

tb

eco

rrec

ted

.

4.3.

3R

eco

mm

end

atio

nfo

ru

se-t

ests

or

adeq

uat

ep

roce

sses

shal

lbe

carr

ied

ou

tan

dco

nsi

der

atio

ng

iven

top

rod

uct

form

ula

tio

n/c

on

fig

ura

tio

n,

wra

pp

ing

mat

eria

l,m

anu

fact

uri

ng

and

dec

lare

dco

nd

itio

ns.

–H

ow

isre

com

men

ded

con

vert

ing

tim

ed

eter

min

ed?

<co

nve

rtin

gte

sts>

–A

rep

rod

uct

ssu

bm

itte

dto

con

vert

ing

tim

ete

sts?

<co

nve

rtin

gti

me

test

resu

lts>

Wh

enn

op

roo

ffo

rd

efin

edco

nve

rtin

gti

me

exis

tsan

da

safe

tyis

sue

can

occ

ur.

4.3.

4P

rod

uct

dev

elo

pm

ent

shal

lco

nsi

der

the

resu

lts

of

org

ano

lep

tic

asse

ss-

men

ts.

–H

ow

oft

enar

eo

rgan

ole

pti

cte

sts

mad

e?–

Wh

op

arti

cip

ates

ino

rgan

ole

pti

cte

sts?

–A

reo

rgan

ole

pti

cte

sts

do

cum

ente

d?

–H

ow

are

the

resu

lts

fro

mo

rgan

ole

pti

cte

sts

take

nin

toco

nsi

der

atio

nd

uri

ng

pro

du

ctd

evel

op

men

t?<o

rgan

ole

pti

cte

stre

sult

sev

alu

atio

n>

4.3.

5A

pro

cess

shal

lbe

inp

lace

toen

sure

that

the

fin

ish

edp

rod

uct

com

plie

sw

ith

curr

ent

leg

isla

tio

no

fd

esti

na-

tio

nco

un

try

and

cust

om

erre

qu

ire-

men

ts.

Wh

atki

nd

of

pro

cess

isim

ple

men

ted

for

leg

isla

tio

nap

pro

val?

Pro

cess

of

info

rma-

tio

ng

ath

erin

gap

pro

valp

roce

sse.

g.w

ith

cust

om

er.

–E

xpo

rtg

oes

tow

hic

hco

un

trie

s?W

hic

hco

un

trie

sh

ave

spec

ialr

equ

irem

ents

?


International Featured Standards · IFS PACsecure · Version 1 Part 2 714.

3.6

Rec

om

men

dat

ion

sfo

rh

and

ling

and

/or

use

of

the

pac

kag

ing

mat

eri-

als

shal

lbe

esta

blis

hed

.Wh

ere

app

rop

riat

e,cu

sto

mer

req

uir

emen

tssh

allb

ein

clu

ded

.

–W

ho

issu

esth

ecl

ich

es/p

rin

tin

gb

lock

app

rova

l?–

Wh

ois

sues

the

lab

els?

–W

ho

app

rove

sla

bel

s?–

Ho

wis

con

form

ity

of

the

pro

du

ctan

dla

bel

revi

ewed

?

Pro

du

ctan

dla

bel

ing

are

no

tin

con

form

ity

wit

hea

cho

ther

,th

us

crea

tin

ga

leg

alit

yp

rob

lem

.

4.3.

7T

he

pro

gre

ssan

dre

sult

so

fp

rod

uct

dev

elo

pm

ent

shal

lbe

pro

per

lyre

cord

ed.

–H

ow

are

con

vert

ing

reco

mm

end

atio

ns

and

/or

pro

du

ctu

sein

form

atio

nes

tab

-lis

hed

?–

Ho

war

eco

nve

rtin

gre

qu

irem

ents

take

nin

toco

nsi

der

atio

nd

uri

ng

pro

du

ctd

evel

op

men

t?<e

xam

ple

>

Wh

ena

safe

tyis

sue

occ

urs

du

eto

no

tta

kin

gcu

sto

mer

req

uir

emen

tsin

toac

cou

nt.

4.3.

8T

he

com

pan

ysh

alle

nsu

reth

atin

the

even

to

fch

ang

esto

pro

du

ctfo

rmu

la-

tio

n/c

on

fig

ura

tio

n,i

ncl

ud

ing

rew

ork

and

wra

pp

ing

mat

eria

l,p

roce

ssch

arac

teri

stic

sar

ere

view

edin

ord

erto

assu

reth

atp

rod

uct

req

uir

emen

tsar

eco

mp

lied

wit

h.

4.4

Pu

rch

asin

g

4.4.

1G

ener

alp

urc

has

ing

4.4.

1.1

Th

eco

mp

any

shal

lco

ntr

olp

urc

has

-in

gp

roce

sses

toen

sure

that

all

exte

rnal

lyso

urc

edm

ater

ials

and

serv

ices

,wh

ich

hav

ean

imp

act

on

pac

kag

ing

mat

eria

lsaf

ety

and

qu

alit

y,co

nfo

rmto

req

uir

emen

ts.

Wh

ere

aco

mp

any

cho

ose

sto

ou

tso

urc

ean

yp

roce

ssth

atm

ayh

ave

anim

pac

to

np

acka

gin

gm

ater

ials

afet

yan

dq

ual

ity,

the

com

pan

ysh

alle

nsu

reco

ntr

olo

ver

such

pro

cess

es.C

on

tro

lof

such

ou

tso

urc

edp

roce

sses

shal

lbe

iden

tifi

edan

dd

ocu

men

ted

wit

hin

the

pac

kag

ing

mat

eria

lsaf

ety

and

qu

alit

ym

anag

emen

tsy

stem

.

–H

ow

isit

ensu

red

that

pu

rch

ased

pro

d-

uct

san

dse

rvic

esco

nfo

rmto

spec

ifica

-ti

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

-ta

tio

no

ro

ther

leg

alre

qu

ired

do

cum

enta

tio

n?

Wh

enp

urc

has

edp

rod

uct

sd

on

ot

con

form

tosp

ecifi

ca-

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

-ti

on

and

thu

sen

tail

asa

fety

or

leg

alit

yp

rob

lem

.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.4.

1.2

Th

ere

shal

lbe

ap

roce

du

refo

rap

pro

vala

nd

mo

nit

ori

ng

of

sup

plie

rs(i

nte

rnal

and

exte

rnal

),o

uts

ou

rced

pro

du

ctio

no

rp

art

of

it.

–D

oes

anap

pro

valp

roce

du

reex

ist

for

new

sup

plie

rsan

dco

-pro

du

cer?

<su

pp

lier

pro

ced

ure

s>–

Ho

war

esu

pp

lies

mo

nit

ore

d?

–A

resu

pp

liers

gra

ded

?<s

up

plie

rg

rad

ing

syst

ems>

–H

ave

sup

plie

rsb

een

bar

red

?–

Ho

wis

ab

arre

dsu

pp

lier

iden

tifi

ed?

–H

ow

isth

eq

ual

ifica

tio

no

fsu

pp

liers

ensu

red

?

<su

pp

lier

aud

its>

<lab

test

s>–

Are

ther

ean

yco

-pro

du

cers

?<c

o-p

acke

rslis

t>–

Ho

war

eco

-pro

du

cers

mo

nit

ore

d?

–A

reco

-pro

du

cers

IFS

PAC

secu

rece

rtifi

ed?

<cer

tifi

cate

>

Wh

enth

ere

are

no

app

rova

lpro

ced

ure

sfo

rsu

pp

liers

and

this

cau

ses

asa

fety

risk

.

4.4.

1.3

Th

eap

pro

vala

nd

mo

nit

ori

ng

pro

ced

ure

shal

lco

nta

incl

ear

asse

ssm

ent

crit

eria

such

as:a

ud

its,

cert

ifica

tes

of

anal

ysis

,su

pp

lier

relia

bili

tyan

dco

mp

lain

ts,a

sw

ella

sre

qu

ired

per

form

ance

stan

dar

ds.

–H

ow

oft

enar

eex

tern

alau

dit

sm

ade?

<ext

ern

alau

dit

pla

n>

–W

hic

hcr

iter

iaar

eco

nsu

lted

for

sup

plie

ras

sess

men

t?–

Wh

ich

sup

plie

rh

asan

alys

isce

rtifi

cate

s?<a

nal

ysis

cert

ifica

tes>

–H

ow

was

the

haz

ard

anal

ysis

for

sup

plie

rap

pro

valp

erfo

rmed

?<h

azar

dan

alys

is>

No

haz

ard

anal

ysis

was

mad

e.

4.4.

1.4

Th

ere

sult

so

fsu

pp

liers

’ass

ess-

men

tssh

allb

ere

view

edre

gu

larl

yan

dth

isre

view

shal

lbe

bas

edo

nh

azar

dan

alys

isan

das

sess

men

to

fas

soci

ated

risk

s.T

her

esh

allb

ere

cord

so

fth

ere

view

san

do

fth

eac

tio

ns

take

nas

aco

nse

qu

ence

of

asse

ssm

ent.

–W

ho

revi

ews

the

resu

lts

of

sup

plie

ras

sess

men

ts?

–H

ow

oft

enar

eth

ere

sult

so

fsu

pp

lier

asse

ssm

ents

revi

ewed

?–

Wh

atac

tio

ns

are

take

naf

ter

revi

ewo

fth

ere

sult

sfo

rsu

pp

lier

asse

ssm

ents

?<a

ud

itre

sult

s>

Wh

enth

ere

sult

sfo

rsu

pp

lier

asse

ssm

ent

are

no

tta

ken

into

acco

un

tan

dth

isca

use

sa

safe

tyo

rle

gal

ity

issu

e.



4.4.

1.5

Th

ep

urc

has

edp

rod

uct

ssh

allb

ech

ecke

din

acco

rdan

cew

ith

the

exis

tin

gsp

ecifi

cati

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

tati

on

.Th

esc

hed

ule

of

thes

ech

ecks

shal

l,as

am

inim

um

,tak

ein

toac

cou

nt

the

follo

win

gcr

iter

ia;p

rod

uct

req

uir

e-m

ents

,su

pp

lier

stat

us

(acc

ord

ing

toit

sas

sess

men

t)an

dim

pac

to

fth

ep

urc

has

edp

rod

uct

so

nth

efi

nis

hed

pro

du

ct.I

fm

enti

on

edin

the

spec

ifi-

cati

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

tati

on

add

itio

nal

req

uir

edto

pic

ssh

allb

ech

ecke

d.

–H

ow

are

pu

rch

ased

pro

du

cts

and

thei

rsp

ecifi

cati

on

sre

view

ed?

<in

com

ing

pro

du

ctch

eck-

list>

<lab

test

s>–

Do

esa

test

sch

edu

leex

ist?

<tes

tsc

hed

ule

>

Wh

enp

urc

has

edp

rod

uct

sar

en

ever

chec

ked

on

com

pli-

ance

wit

hsp

ecifi

ca-

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

-ti

on

s.

4.4.

1.6

Th

ep

urc

has

edse

rvic

essh

allb

ech

ecke

din

acco

rdan

cew

ith

the

exis

tin

gsp

ecifi

cati

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

tati

on

.Th

esc

hed

ule

of

thes

ech

ecks

shal

lat

leas

tta

kein

toac

cou

nt

the

follo

win

git

ems:

serv

ice

req

uir

emen

ts,s

up

plie

rst

atu

s(a

cco

rdin

gto

its

asse

ssm

ent)

and

imp

act

of

the

serv

ice

on

the

fin

ish

edp

rod

uct

.

4.4.

2Tr

ade

of

pac

kag

ing

mat

eria

lsM

ean

pu

rch

ased

pro

du

cts,

wh

ich

hav

eb

een

alre

ady

pro

cess

edan

dw

hic

har

eb

ou

gh

tan

dst

ore

do

n-s

ite

of

the

aud

ited

com

pan

y.

4.4.

2.1

Inca

sea

com

pan

ytr

ades

pac

kag

ing

mat

eria

ls,i

tsh

allb

een

sure

dth

ata

pro

cess

for

app

rovi

ng

and

mo

nit

or-

ing

sup

plie

rsex

ists

and

isim

ple

-m

ente

d.

Ifth

eco

mp

any

trad

esp

acka

gin

gm

ater

ials

asfi

nis

hed

pro

du

cts

and

ifit

wan

tsto

incl

ud

eth

emin

the

aud

itsc

op

e,th

esu

pp

liers

of

thes

ep

rod

uct

ssh

allt

hem

-se

lves

be

IFS

PAC

secu

rece

rtifi

ed(i

fth

etr

ade

pro

du

cts

are

un

der

the

sam

ep

rod

uct

sco

pe)

or

cert

ified

un

der

aco

mp

arab

lesc

hem

e(i

fth

etr

ade

pro

du

cts

are

un

der

ad

iffe

ren

tp

rod

uct

sco

pe)

.C

om

pu

lso

ryfi

eld

inth

eco

mp

any

pro

file

:sp

ecif

yif

the

com

pan

yh

astr

ade

pro

du

cts.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.4.

2.2

Inca

seo

ftr

aded

pac

kag

ing

mat

eria

ls,

the

pro

cess

for

app

rovi

ng

and

mo

nit

ori

ng

sup

plie

rssh

allc

on

tain

clea

ras

sess

men

tcr

iter

iasu

chas

:au

dit

s,ce

rtifi

cate

so

fan

alys

is,

sup

plie

rre

liab

ility

,co

mp

lain

tsas

wel

las

req

uir

edp

erfo

rman

cest

and

ard

s.

4.4.

2.3

Inca

seo

fp

acka

gin

gm

ater

ials

for

pri

vate

lab

els,

asu

pp

lier

app

rova

lsy

stem

inac

cord

ance

wit

hcu

sto

mer

req

uir

emen

tssh

alle

xist

for

pre

-su

p-

plie

rso

ffi

nis

hed

or

sem

i-fi

nis

hed

pro

du

cts.

4.5

Pro

du

ctw

rap

pin

g

4.5.

1B

ased

on

haz

ard

anal

ysis

,ass

essm

ent

of

asso

ciat

edri

sks

and

inte

nd

edu

se,

the

com

pan

ysh

alld

eter

min

eth

eke

yp

aram

eter

sfo

rth

ew

rap

pin

gm

ater

ial.

–D

oes

ari

skas

sess

men

tal

soex

ist

for

wra

pp

ing

mat

eria

lno

tin

dir

ect

pac

kag

ing

mat

eria

lco

nta

ct,t

op

rove

the

evid

ence

of

dir

ect

neg

ativ

ein

flu

ence

on

the

pro

du

ct?

4.5.

2D

etai

led

spec

ifica

tio

ns

shal

lexi

stfo

ral

lwra

pp

ing

mat

eria

lsw

hic

hco

mp

lyw

ith

the

curr

ent

rele

van

tle

gis

lati

on

.

–H

ow

isit

ensu

red

that

wra

pp

ing

mat

eria

lco

mp

lies

wit

hcu

rren

tre

leva

nt

leg

isla

tio

n?

–W

ho

dev

elo

ps,

revi

ews

new

wra

pp

ing

mat

eria

l?–

Are

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

nav

aila

ble

for

allw

rap

pin

gm

ater

ials

use

d?

<wra

pp

ing

mat

eria

lsp

ecifi

cati

on

s>

Wra

pp

ing

mat

eria

lth

atd

oes

no

tco

mp

lyw

ith

leg

isla

tio

n.N

ot

allw

rap

pin

gm

ater

i-al

sh

ave

spec

ifica

-ti

on

s.

4.5.

3Fo

ral

lwra

pp

ing

mat

eria

lwh

ich

cou

ldh

ave

anin

flu

ence

on

pro

du

cts,

cert

i-fi

cate

so

fco

nfo

rmit

ysh

alle

xist

wh

ich

com

ply

wit

hcu

rren

tle

gal

req

uir

e-m

ents

.In

the

even

tth

atn

osp

ecifi

cle

gal

req

uir

emen

tsar

eap

plic

able

,ev

iden

cesh

allb

eav

aila

ble

tod

emo

n-

stra

teth

atw

rap

pin

gm

ater

iali

ssu

it-

able

for

use

.Th

isap

plie

sfo

rw

rap

-p

ing

mat

eria

lwh

ich

cou

ldh

ave

anin

flu

ence

on

raw

mat

eria

ls,s

emi-

pro

cess

edan

dfi

nis

hed

pro

du

cts.



4.5.

4B

ased

on

haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ciat

edri

sks,

the

com

pan

ysh

allv

erif

yth

esu

itab

ility

of

the

wra

pp

ing

mat

eria

lfo

rea

chre

leva

nt

pro

du

ct(e

.g.o

rgan

ole

pti

cte

sts,

sto

rag

ete

sts,

chem

ical

anal

y-si

s,m

igra

tio

nte

sts)

.

–H

ow

isit

ensu

red

that

wra

pp

ing

mat

eria

lsh

ave

no

neg

ativ

eef

fect

so

nth

ep

rod

uct

?–

Has

ah

azar

dan

alys

isb

een

per

form

edin

rela

tio

nto

suit

abili

tyo

fw

rap

pin

gm

ate-

rial

?<h

azar

dan

alys

is>

No

haz

ard

anal

ysis

was

mad

e.

4.5.

5T

he

com

pan

ysh

alle

nsu

reth

atth

ew

rap

pin

gu

sed

corr

esp

on

ds

toth

ep

rod

uct

bei

ng

wra

pp

ed.T

he

use

of

corr

ect

wra

pp

ing

shal

lbe

reg

ula

rly

chec

ked

.

Wh

ich

syst

emh

asth

eco

mp

any

imp

le-

men

ted

toen

sure

that

wra

pp

ing

mat

eria

lis

suit

able

and

trac

eab

le?

4.5.

6P

rin

tin

gan

dla

bel

ing

info

rmat

ion

shal

lbe

leg

ible

,in

del

ible

and

shal

lco

mp

lyw

ith

agre

edcu

sto

mer

pro

du

ctsp

ecifi

cati

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

tati

on

s.T

his

shal

lbe

reg

ula

rly

chec

ked

and

chec

kssh

allb

ed

ocu

men

ted

.

4.6

Fact

ory

loca

tio

n

4.6.

1.T

he

com

pan

ysh

alli

nve

stig

ate

tow

hat

exte

nt

the

fact

ory

envi

ron

men

t(e

.g.g

rou

nd

,air

)m

ayh

ave

anad

vers

eim

pac

to

np

rod

uct

safe

tyan

dp

rod

uct

qu

alit

y.If

pro

du

ctsa

fety

and

qu

alit

yco

uld

be

com

pro

mis

ed,

app

rop

riat

em

easu

res

shal

lbe

esta

blis

hed

.Th

eef

fect

iven

ess

of

the

esta

blis

hed

mea

sure

ssh

allb

ep

erio

dic

ally

revi

ewed

(exa

mp

les:

extr

emel

yd

ust

yai

r,st

ron

gsm

ells

).

A1.

1.1

1,4

–D

oes

alo

cati

on

inve

stig

atio

nex

ist?

Can

loca

tio

nh

ave

an

egat

ive

infl

uen

ceo

np

rod

uct

qu

alit

y?<l

oca

tio

nan

alys

is>

–W

hat

pro

tect

ive

mea

sure

sh

ave

bee

nes

tab

lish

edif

po

ten

tial

lyd

amag

ing

mat

eria

ls/s

ub

stan

ces

are

nea

rby?

<pro

tect

ive

mea

sure

s><c

orr

ecti

veac

tio

ns>

–Is

effi

cien

cyo

fp

rote

ctiv

em

easu

res

reg

ula

rly

revi

ewed

?–

Wh

ore

view

sth

eef

fici

ency

of

the

esta

b-

lish

edp

rote

ctiv

em

easu

res?

–H

ow

isef

fici

ency

of

esta

blis

hed

pro

tec-

tive

mea

sure

sre

view

ed?

Wh

enco

mp

any

surr

ou

nd

ing

sh

ave

an

egat

ive

infl

uen

ceo

np

rod

uct

(e.g

.wat

ertr

eatm

ent)

and

no

pro

tect

ive

mea

sure

sh

ave

bee

nes

tab

lish

edan

dth

eref

ore

asa

fety

pro

ble

mex

ists

.W

hen

esta

blis

hed

pro

tect

ive

mea

sure

sar

eu

ncl

ear

or

wit

hq

ues

tio

nab

leef

fi-

cien

cyan

dth

eref

ore

asa

fety

pro

ble

mex

ists

.

4.7

Fact

ory

Ext

erio

r7.

0A

1

4.7.

1T

he

fact

ory

exte

rio

rsh

allb

em

ain

-ta

ined

tob

ecl

ean

and

tid

y.A

1.1.

12

–A

refa

cto

ryex

teri

ors

tid

y?–

Are

fact

ory

exte

rio

rsre

view

edth

rou

gh

inte

rnal

aud

its?

<au

dit

resu

lts>



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.7.

2A

llex

tern

alar

eas

of

the

fact

ory

shal

lb

em

ain

tain

edin

go

od

con

dit

ion

.W

her

en

atu

rald

rain

age

isin

ad-

equ

ate,

asu

itab

led

rain

age

syst

emsh

allb

ein

stal

led

.

A1.

1.1-

23,

6,7,

8–

Are

gro

un

ds

wit

hin

the

fact

ory

pre

mis

esin

go

od

con

dit

ion

?–

Isn

atu

rald

rain

age

suffi

cien

t?–

Ifn

atu

rald

rain

age

isin

suffi

cien

t,h

asa

suit

able

dra

inag

esy

stem

bee

nin

stal

led

?

4.7.

3O

utd

oo

rst

ora

ge

shal

lbe

kep

tto

am

inim

um

.Wh

ere

go

od

sar

est

ore

do

uts

ide,

haz

ard

anal

ysis

and

asse

ss-

men

to

fas

soci

ated

risk

ssh

allb

eu

nd

erta

ken

ino

rder

toen

sure

that

ther

eis

no

risk

of

con

tam

inat

ion

or

adve

rse

effe

cto

nq

ual

ity

and

pac

kag

ing

mat

eria

lsaf

ety.

A1.

1.1

5–

Are

go

od

sst

ore

do

utd

oo

rs?

–W

hat

isst

ore

do

utd

oo

rs?

–W

hat

rule

sex

ist

for

ou

tdo

or

sto

rag

e?–

Iso

utd

oo

rst

ora

ge

bas

edo

nh

azar

dan

alys

is?

<haz

ard

anal

ysis

>

No

haz

ard

anal

ysis

exis

tsfo

ro

utd

oo

rst

ora

ge.

Go

od

su

nd

ero

utd

oo

rst

ora

ge

are

infl

u-

ence

din

aw

ayth

ata

safe

tyri

skis

giv

en(e

.g.u

np

rote

cted

pri

mar

yp

acka

gin

gm

ater

iali

ske

pt

ou

tdo

ors

,bec

om

esm

old

yan

dis

no

tb

arre

dfr

om

use

).

4.8

Pla

nt

layo

ut

and

pro

cess

flo

ws

4.8.

1P

lan

scl

earl

yd

escr

ibin

gin

tern

alfl

ow

so

ffi

nis

hed

pro

du

cts,

pac

kag

-in

gm

ater

ials

,raw

mat

eria

ls,w

aste

,p

erso

nn

el,w

ater

,etc

.sh

allb

ein

pla

ce.A

site

map

cove

rin

gal

lb

uild

ing

so

fth

efa

cilit

ysh

allb

eav

aila

ble

.

A2.

1.8

Form

41,

2,3

–H

ow

isit

ensu

red

that

cro

ss-c

on

tam

ina-

tio

nis

avo

ided

?<w

aste

elim

inat

ion

pla

n>

<per

son

nel

flo

wp

lan

><m

ater

ials

flo

wp

lan

>

<hyd

rau

licp

lan

>

Wh

enth

ere

are

no

flo

wp

lan

san

din

tern

alfl

ow

sd

on

ot

resp

ect

the

seg

reg

a-ti

on

of

pro

du

ctp

roce

sses

(e.g

.se

par

atio

no

f“d

irty

”fr

om

“cle

an”

pro

-ce

ssin

gar

eas

bu

tp

erso

nn

elcr

oss

bo

un

dar

ies

wit

ho

ut

acco

rdin

gp

rote

ctiv

ecl

oth

ing

).

4.8.

2T

he

pro

cess

flo

w,f

rom

rece

ipt

of

go

od

sto

dis

pat

ch,s

hal

lbe

inp

lace

soth

atco

nta

min

atio

no

fra

wm

ater

i-al

s,p

acka

gin

g,s

emi-

pro

cess

edan

dfi

nis

hed

pro

du

cts

isav

oid

ed.T

he

risk

of

cro

ss-c

on

tam

inat

ion

shal

lbe

min

i-m

ized

thro

ug

hef

fect

ive

mea

sure

s.

7.0

A2

A2.

1.8

4,6

–H

ow

iscr

oss

-co

nta

min

atio

nav

oid

edw

ith

infa

cto

ryp

rem

ises

?

Th

ep

roce

ssfl

ow

allo

ws

for

acr

oss

-co

nta

min

atio

nb

e-tw

een

raw

mat

eria

ls,

pac

kag

ing

mat

eria

l,h

alf-

fin

ish

edp

rod

uct

san

dfi

nis

hed

pro

du

cts.



4.8.

3In

case

of

sen

siti

vep

rod

uct

ion

area

s,th

ese

shal

lbe

op

erat

edan

dm

on

i-to

red

toen

sure

pro

du

ctsa

fety

isn

ot

com

pro

mis

ed.

–A

reth

ere

sen

siti

vear

eas?

–A

rese

nsi

tive

area

sve

nti

late

d?

–W

hat

add

itio

nal

mea

sure

sar

eta

ken

?

Wh

enve

nti

lati

on

ism

issi

ng

inse

nsi

tive

area

san

da

safe

typ

rob

lem

isg

iven

.

4.8.

4La

bo

rato

ryfa

cilit

ies

and

in-p

roce

ssco

ntr

ols

shal

lno

taf

fect

the

pro

du

ctsa

fety

.

–Is

ther

ea

lab

ora

tory

on

site

?–

Has

the

lab

ad

irec

tco

nta

ctw

ith

pro

du

c-ti

on

pre

mis

es?

–C

anla

bw

aste

(e.g

.lab

was

tew

ater

)d

irty

the

pro

du

ctio

np

rem

ises

?

<was

tew

ater

dra

inag

esy

stem

>

Wh

enp

rod

uct

safe

tyis

end

ang

ered

thro

ug

hth

ela

bo

ra-

tory

(e.g

.was

tew

ater

,air

circ

ula

tio

n,

was

ted

isp

osa

l).

4.9

Co

nst

ruct

ion

alre

qu

irem

ents

for

pro

du

ctio

nan

dst

ora

ge

area

s

4.9.

1C

on

stru

ctio

nal

req

uir

emen

ts

4.9.

1.1

Ro

om

sw

her

ep

acka

gin

gm

ater

ial

pro

du

cts

are

pre

par

ed,t

reat

ed,

pro

cess

edan

dst

ore

dsh

allb

ed

esig

ned

and

con

stru

cted

soth

atp

acka

gin

gm

ater

ials

afet

yis

ensu

red

.

A2.

1.5

–7A

1.1.

1–2

1,2

10–

Are

ther

e“d

irty

”an

d“c

lean

”ar

eas?

–A

reth

ere

app

rop

riat

est

ora

ge

roo

ms?

No

sep

arat

ion

of

“dir

ty”

and

“cle

an”

area

sev

enth

ou

gh

leg

ally

pre

scri

bed

.W

hen

ther

eis

no

com

plia

nce

wit

hle

gal

req

uir

emen

ts.

4.9.

2W

alls

4.9.

2.1

Wal

lssh

allb

ed

esig

ned

and

con

-st

ruct

edto

pre

ven

tth

eac

cum

ula

tio

no

fd

irt,

tore

du

ceco

nd

ensa

tio

nan

dm

ou

ldg

row

th,a

nd

tofa

cilit

ate

clea

nin

g.

A2.

1.5

–7A

2.1.

23 1

–A

rew

alls

mo

uld

y?E

xtre

me

mo

ldb

uild

-up

wh

ich

ensu

esa

con

tam

ina-

tio

nri

sk.

4.9.

2.2

Th

esu

rfac

eso

fw

alls

shal

lbe

ina

go

od

con

dit

ion

and

easy

tocl

ean

;th

eysh

allb

eim

per

vio

us

and

wea

r-re

sist

ant.

A2.

1.5

–7–

Ho

wo

ften

are

wal

lscl

ean

ed?

<cle

anin

gsc

hed

ule

><c

lean

ing

evid

ence

>

4.9.

2.3

Th

eju

nct

ion

sb

etw

een

wal

ls,fl

oo

rsan

dce

ilin

gs

shal

lbe

des

ign

edto

faci

litat

ecl

ean

ing

.

A2.

1.5

–7A

2.1.

22

–A

rew

all-

flo

or

jun

ctio

ns

and

corn

ers

rou

nd

ed?

4.9.

3Fl

oo

rs

4.9.

3.1

Flo

or

cove

rin

gsh

allb

ed

esig

ned

tom

eet

pro

du

ctio

nre

qu

irem

ents

and

shal

lbe

ing

oo

dco

nd

itio

nan

dea

syto

clea

n.S

urf

aces

shal

lbe

imp

ervi

-o

us

and

wea

r-re

sist

ant.

A2.

1.5

–7–

Are

flo

ors

clea

nab

le?

–H

ow

oft

enar

efl

oo

rscl

ean

ed?

<cle

anin

gsc

hed

ule

><c

lean

ing

evid

ence

>



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.9.

3.2

Th

eh

ygie

nic

dis

po

salo

fw

aste

wat

ersh

allb

een

sure

d.D

rain

age

syst

ems

shal

lbe

easy

tocl

ean

and

des

ign

edto

min

imiz

eth

eri

sko

fp

rod

uct

con

tam

inat

ion

(e.g

.in

gre

sso

fp

ests

,et

c.).

A2.

1.5

–7–

Ho

wis

was

tew

ater

dis

po

sale

nsu

red

?–

Ho

wo

ften

are

gu

llies

clea

ned

?<c

lean

ing

evid

ence

><d

rain

age

sch

edu

le>

4.9.

3.3

Wat

ero

ro

ther

liqu

ids

shal

lrea

chd

rain

age

wit

ho

ut

dif

ficu

ltie

s,u

sin

gap

pro

pri

ate

mea

sure

s.P

ud

dle

ssh

all

be

avo

ided

.

A2.

1.5

–7A

2.1.

41

–A

reth

ere

wat

ero

ro

ther

liqu

idp

ud

dle

so

nth

efl

oo

rso

fp

rod

uct

ion

area

s?

4.9.

3.4

Inp

acka

gin

gm

ater

ialh

and

ling

area

s,m

ach

iner

yan

dp

ipin

gsh

allb

ear

ran

ged

soth

atw

aste

wat

er,i

fp

oss

ible

,go

esd

irec

tly

into

ad

rain

.

A2.

1.5

–7–

Wh

ere

ism

ach

iner

yw

hic

hp

rod

uce

sa

larg

eam

ou

nt

of

was

tew

ater

loca

ted

?<m

ach

iner

yla

y-o

ut>

4.9.

4C

eilin

gs/

Ove

rhea

ds

4.9.

4.1

Cei

ling

s(o

r,w

her

en

oce

ilin

gs

exis

t,th

ein

sid

eo

fro

ofs

)an

do

verh

ead

fixt

ure

s(i

ncl

.pip

ing

,cab

lew

ay,

lam

ps

etc.

)sh

allb

eco

nst

ruct

edto

min

imiz

eth

eac

cum

ula

tio

no

fd

irt

and

shal

lno

tp

ose

any

risk

of

ph

ysic

alan

d/o

rm

icro

bio

log

ical

con

tam

inat

ion

.

A2.

1.5

–7A

1.1.

13 11

–H

ow

oft

enar

ece

ilin

gs

clea

ned

?<c

lean

ing

evid

ence

><c

lean

ing

evid

ence

>

Cei

ling

sar

eve

ryd

irty

and

dir

tca

nfa

llo

np

rod

uct

.

4.9.

4.2

Wh

ere

fals

ece

ilin

gs

are

use

d,a

nac

cess

toth

evo

idsh

allb

ep

rovi

ded

ino

rder

tofa

cilit

ate

clea

nin

g,

mai

nte

nan

cean

din

spec

tio

ns

for

pes

tco

ntr

ol.

A2.

1.5

–7–

Ho

wo

ften

are

fals

ece

ilin

gs

clea

ned

?<c

lean

ing

evid

ence

><c

lean

ing

evid

ence

>

4.9.

5W

ind

ow

san

do

ther

op

enin

gs

4.9.

5.1

Win

do

ws

and

oth

ero

pen

ing

ssh

all

be

des

ign

edan

dco

nst

ruct

edto

avo

idth

eac

cum

ula

tio

no

fd

irt

and

shal

lbe

mai

nta

ined

ing

oo

dco

nd

i-ti

on

.

A2.

1.5

–74

–C

and

irt

accu

mu

late

on

win

do

wsi

lls?


International Featured Standards · IFS PACsecure · Version 1 Part 2 794.

9.5.

2W

her

eth

ere

isri

sko

fco

nta

min

atio

n,

win

do

ws

and

roo

fg

lazi

ng

shal

lre

mai

ncl

ose

dan

dfi

xed

du

rin

gp

rod

uct

ion

.

A2.

1.5

–76

–A

rew

ind

ow

ske

pt

op

en?

Win

do

ws

are

op

enan

dn

oin

sect

gra

tin

gs

are

inp

lace

soth

atp

ests

can

ente

rp

rod

uct

ion

area

san

da

con

tam

i-n

atio

nri

skex

ists

.P

ests

are

visi

ble

.

4.9.

5.3

Wh

ere

win

do

ws

and

roo

fg

lazi

ng

are

des

ign

edto

be

op

ened

for

ven

tila

-ti

on

pu

rpo

ses,

they

shal

lbe

fitt

edw

ith

easi

lyre

mo

vab

le,g

oo

dco

nd

i-ti

on

pes

tsc

reen

so

ro

ther

mea

sure

sin

ord

erto

avo

idan

yco

nta

min

atio

n.

A2.

1.5

–7A

1.1.

15 12

–A

rew

ind

ow

sse

aled

wit

hin

sect

gra

tin

gs?

<pes

tco

ntr

ols

ched

ule

>–

Isin

teg

rity

of

gra

tin

gs

reg

ula

rly

revi

ewed

?<m

on

ito

rin

gsc

hed

ule

>

Win

do

ws

are

op

enan

dn

oin

sect

gra

tin

gs

are

inp

lace

soth

atpe

sts

can

ente

rpr

oduc

-ti

on

area

san

da

con

tam

inat

ion

risk

exis

ts.

4.9.

5.4

Inar

eas

wh

ere

un

pac

kag

edp

rod

uct

ish

and

led

,win

do

ws

shal

lbe

pro

tect

edag

ain

stb

reak

age.

A2.

1.5

–77,

8–

Ho

war

ew

ind

ow

sp

rote

cted

agai

nst

bre

akag

e?W

ind

ow

sw

ith

no

bre

akag

ep

rote

ctio

nar

ein

pro

du

ctio

nar

eas

wh

ere

un

cove

red

and

bro

ken

and

un

pac

k-ag

edp

rod

uct

sar

eh

and

led

wh

ich

ensu

esa

con

tam

inat

ion

risk

.

4.9.

6D

oo

rsan

dg

ates

4.9.

6.1

Do

ors

and

gat

essh

allb

ein

go

od

con

dit

ion

(e.g

.no

splin

teri

ng

par

ts,

flak

ing

pai

nts

or

corr

osi

on

)an

dea

syto

clea

n.

A2.

1.5.

73

–A

red

oo

rsd

amag

ed?

Do

ors

are

op

eno

rd

amag

edso

that

pes

tsca

nen

ter

pro

du

ctio

nar

eas

and

aco

nta

mi-

nat

ion

risk

exis

ts.

Pes

tsar

evi

sib

le.

4.9.

6.2

Bas

edo

nh

azar

dan

alys

isan

das

sess

men

to

fas

soci

ated

risk

sex

tern

ald

oo

rsan

dg

ates

shal

lbe

con

stru

cted

top

reve

nt

the

ing

ress

of

pes

ts;i

fp

oss

ible

,th

eysh

allb

ese

lf-c

losi

ng

.

A2.

1.5.

74

–D

oex

tern

ald

oo

rsp

reve

nt

pes

ten

tran

cein

top

rod

uct

ion

area

s?

4.9.

7Li

gh

tin

g

4.9.

7.1

All

wo

rkin

gar

eas

shal

lhav

ead

e-q

uat

elig

hti

ng

.A

2.2.

11

–W

hat

isth

eas

sura

nce

that

allw

ork

ing

area

sar

ead

equ

atel

yill

um

inat

ed?

4.9.

7.2

All

ligh

tin

geq

uip

men

tsh

allb

ep

rote

cted

by

shat

ter

pro

of

cove

rsan

din

stal

led

tom

inim

ise

the

risk

of

bre

akag

e.

A2.

2.2

1,2

–W

her

ear

efl

yki

llin

gu

nit

sm

and

ato

ry?

<fly

trap

pla

n>

–A

real

lfly

killi

ng

un

its

and

lam

ps

pro

-te

cted

by

splin

ter

shie

lds?

<lig

hti

ng

pro

tect

ors

>

Wh

enfl

ytr

aps

and

ligh

tin

gd

evic

esco

nst

itu

tea

con

tam

i-n

atio

nri

sk.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.9.

8A

irco

nd

itio

nin

g/V

enti

lati

on

4.9.

8.1

Ad

equ

ate

nat

ura

lan

d/o

rar

tifi

cial

ven

tila

tio

nsh

alle

xist

inal

lare

as.

A2.

3.1

A2.

3.3

1,2,

3,4

1,2,

3,4,

5,6,

7,8

–H

ow

isve

nti

lati

on

revi

ewed

?

4.9.

8.2

Ifve

nti

lati

on

equ

ipm

ents

are

in-

stal

led

,filt

ers

and

oth

erco

mp

on

ents

wh

ich

req

uir

ecl

ean

ing

or

rep

lace

-m

ent

shal

lbe

easi

lyac

cess

ible

.

A2.

3.1

A1.

1.1

A2.

3.3

2,3

14 7

–H

ow

are

air

filt

ers

mai

nta

ined

and

clea

ned

?<m

ain

ten

ance

sch

edu

le>

<mai

nte

nan

ced

ocu

men

tati

on

><c

lean

ing

pro

toco

ls>

Filt

ers

wh

ich

are

no

tcl

eane

das

prog

ram

med

con

stit

ute

ap

rod

uct

con

tam

inat

ion

risk

.

4.9.

8.3

Air

con

dit

ion

ing

equ

ipm

ent

and

arti

fici

ally

gen

erat

edai

rflo

wsh

alln

ot

lead

toan

yp

rod

uct

safe

tyo

rq

ual

ity

risk

s.

A2.

3.1

1–

Isth

eu

seo

fai

rd

uri

ng

pro

du

ctio

nb

ased

on

haz

ard

anal

ysis

?<h

azar

dan

alys

is>

–A

reth

ere

pro

du

ctio

nar

eas

wit

hu

nd

er-

or

ove

r-p

ress

uri

zati

on

?

Whe

nai

rsu

pply

caus

esa

con

tam

inat

ion

wh

ich

ensu

ea

pac

kag

ing

mat

eria

lsaf

ety

risk

.

4.9.

8.4

Du

stex

trac

tio

neq

uip

men

tsh

allb

ein

stal

led

inar

eas

wh

ere

con

sid

erab

leam

ou

nts

of

du

star

eg

ener

ated

.

A2.

3.3

1–

Are

ther

ear

eas

wh

ere

larg

eam

ou

nts

of

du

star

efo

rmed

?–

Do

du

stex

trac

tio

nd

evic

esex

ist

inth

ese

area

s?

4.9.

9W

ater

sup

ply

4.9.

9.1

Wat

erw

hic

his

use

das

ing

red

ien

tin

the

pro

du

ctio

np

roce

ss,o

rfo

rcl

ean

-in

g,s

hal

lco

mp

lyw

ith

leg

alre

qu

ire-

men

tsan

dsh

allb

esu

pp

lied

insu

ffici

ent

qu

anti

ty;t

his

also

app

lies

tost

eam

and

ice

use

dw

ith

inth

ep

rod

uct

ion

area

.Asu

pp

lyo

fsu

chw

ater

shal

lbe

avai

lab

leat

allt

imes

.

7.0

A4

A4.

1.1

A4.

1.1

A4.

1.2

1,2

5 1,2,

3,4,

5,6,

7

–W

her

ed

oes

wat

ersu

pp

lyco

me

fro

m?

(Cit

ysu

pp

ly,w

ellw

ater

,tan

ker)

?–

Isw

ater

dem

and

alw

ays

cove

red

?

4.9.

9.2

Rec

ycle

dw

ater

wh

ich

isu

sed

inth

ep

roce

sssh

alln

ot

po

sea

con

tam

ina-

tio

nri

sk.T

he

wat

ersh

allc

om

ply

wit

hap

plic

able

leg

alre

qu

irem

ents

for

po

tab

lew

ater

;rec

ord

so

fco

mp

li-an

cete

stin

gsh

allb

eav

aila

ble

.

A4.

1.3

–61,

2,3,

4,5

–Fo

rw

hat

pu

rpo

seis

wat

eru

sed

inth

eco

mp

any

(so

cial

faci

litie

s,cl

ean

ing

pro

ced

ure

s,p

rod

uct

ing

red

ien

t,fo

rw

ash

ing

fru

its

and

veg

etab

les)

?–

Isw

ater

trea

ted

on

site

(wat

erh

ard

nes

sco

rrec

tio

n,c

hlo

rin

atio

n,s

teri

lizat

ion

,fi

ltra

tio

n…

)?–

Are

loca

lleg

alre

qu

irem

ents

on

han

d?

–Is

wat

eran

alys

edac

cord

ing

tole

gal

req

uir

emen

ts(o

wn

wat

ersu

pp

ly,o

uts

ide

sup

ply

).D

ore

sult

sco

mp

lyw

ith

stan

d-

ard

s?<s

ever

alan

alys

isre

sult

s>

Th

ere

isev

iden

ceth

atw

ater

do

esn

ot

com

-p

lyw

ith

leg

alst

and

-ar

ds

and

isu

sed

for

clea

nin

gp

roce

du

res

of

surf

aces

ind

irec

tco

nta

ctw

ith

pac

kag

-in

gm

ater

ialo

ras

in-

gre

die

nt,

or

com

pan

yca

nn

ot

sho

wth

atw

ater

com

plie

sw

ith

req

uir

edst

and

ard

s.



Th

ech

ecki

ng

inte

rval

for

rele

van

tw

ater

safe

tyis

sues

has

bee

ncl

earl

yo

verd

raw

n.

Th

eco

mp

any

has

no

wat

eran

alys

isp

lan

even

tho

ug

hit

ism

and

ato

ryan

dw

ater

isu

sed

for

clea

nin

gp

roce

du

res

or

asan

ing

red

ien

t.

4.9.

9.3

Th

eq

ual

ity

of

wat

er,w

hat

ever

the

con

dit

ion

of

agg

reg

atio

n,s

hal

lbe

mo

nit

ore

dfo

llow

ing

ari

skb

ased

sam

plin

gp

lan

.

7.0

A4

A3.

1.2

A4.

1.1

4,5,

63,

4

–Is

wat

er,s

team

or

ice

use

d–

isa

stat

ion

mo

nit

ori

ng

inp

lace

?<m

ain

ten

ance

><a

nal

ysis

resu

lts>

–W

hat

kin

do

fp

ipin

gsy

stem

exis

ts?

Rin

g-p

ipes

,wat

er-t

anks

)–

Wh

atis

pip

ing

mad

efr

om

?–

Isan

alys

isan

dsa

mp

ling

pla

nb

ased

on

haz

ard

anal

ysis

?

Wh

enco

nta

min

ated

wat

erre

ach

esth

ep

rod

uct

du

eto

bad

con

dit

ion

so

fp

ipin

go

rim

pro

per

pip

ing

mat

eria

l.

4.9.

9.4

No

n-p

ota

ble

wat

ersh

allb

etr

ans-

po

rted

inse

par

ate,

pro

per

lym

arke

dp

ipin

g.S

uch

pip

ing

shal

lno

tb

eco

nn

ecte

dto

the

dri

nki

ng

wat

ersy

stem

,or

allo

wth

ep

oss

ibili

tyo

fre

flu

xto

con

tam

inat

ep

ota

ble

wat

erso

urc

eso

rth

efa

cto

ryen

viro

nm

ent.

A4.

1.3

–6A

2.4.

13,

41,

2–

Isd

rin

kin

gw

ater

syst

emco

mp

lete

lyse

par

ated

fro

mn

on

-po

tab

lew

ater

pip

ing

?<h

ydra

ulic

syst

emla

y-o

ut>

–W

hat

oth

ersy

stem

sar

eth

ere?

(e.g

.use

dw

ater

,co

olin

gw

ater

,wat

eru

sed

for

fire

fig

hti

ng

).–

Are

wat

ersy

stem

sp

rop

erly

mar

ked

and

wh

ere

they

are?

–A

rere

flu

xav

oid

ance

equ

ipm

ents

inst

alle

dw

her

ever

nec

essa

ry?

All

exis

tin

gw

ater

syst

ems

are

inte

rco

n-

nec

ted

,no

refl

ux

avo

idan

ceeq

uip

-m

ents

exis

t,th

eref

or

aco

nta

min

atio

nh

azar

dis

giv

en.

4.9.

10C

om

pre

ssed

air

4.9.

10.1

Th

eq

ual

ity

of

com

pre

ssed

air

that

com

esin

dir

ect

con

tact

wit

hp

acka

g-

ing

mat

eria

lor

wra

pp

ing

mat

eria

lsh

allb

em

on

ito

red

bas

edo

nh

azar

dan

alys

isan

das

sess

men

to

fas

soci

-at

edri

sks.

A2.

3.3

4

4.9.

10.2

Co

mp

ress

edai

rsh

alln

ot

po

sea

risk

of

con

tam

inat

ion

.A

2.3.

34

4.10

Cle

anin

gan

dd

isin

fect

ion



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.10

.1B

ased

on

haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ciat

edri

sks,

clea

nin

gan

dd

isin

fect

ion

sch

edu

les

shal

lbe

avai

lab

lean

dim

ple

men

ted

.T

hes

esh

alls

pec

ify:

–o

bje

ctiv

es–

resp

on

sib

iliti

es–

the

pro

du

cts

use

dan

dth

eir

inst

ruct

ion

sfo

ru

se–

the

area

sto

be

clea

ned

and

/or

dis

infe

cted

–cl

ean

ing

freq

uen

cy–

do

cum

enta

tio

nre

qu

irem

ents

–h

azar

dsy

mb

ols

(if

nec

essa

ry).

7.0

E1

E1.

1.1–

31,

2,3,

4,5,

11–

Wh

ois

inch

arg

eo

fcl

ean

ing

and

dis

infe

c-ti

on

?<c

lean

ing

sch

edu

le>

–W

hat

kin

dcl

ean

ing

pro

du

cts

and

dis

in-

fect

ants

are

use

d?

<up

tod

ate

clea

nin

gp

rod

uct

san

dd

isin

fect

ant

list>

–W

hat

mu

stb

eo

bse

rved

wh

enu

sin

gd

iffe

ren

tcl

ean

ing

pro

du

cts

and

dis

infe

ct-

ants

?–

Wh

atar

eas

are

clea

ned

and

dis

infe

cted

?<c

lean

ing

sch

edu

le>

–H

ow

oft

enar

ear

eas

clea

ned

and

dis

in-

fect

ed?

–W

her

ear

ecl

ean

ing

and

dis

infe

ctio

np

roce

du

res

do

cum

ente

d?

<cle

anin

gp

roce

du

res

do

cum

enta

tio

n>

–D

oh

azar

dsy

mb

ols

exis

t?–

Do

esa

con

trac

tex

ist

for

exte

rnal

serv

ice

pro

vid

er?

<ext

ern

alse

rvic

esco

ntr

act>

–C

lean

ing

sch

edu

les

can

incl

ud

eS

SO

P‘s

.

Wh

ena

con

tam

ina-

tio

no

fp

acka

gin

gm

ater

ialp

rod

uct

so

rto

ols

exis

tsd

ue

toth

eu

seo

fin

effi

cien

to

rw

ron

gki

nd

of

chem

ical

so

rin

effi

-ci

ent

clea

nin

gp

roce

du

res.

4.10

.2C

lean

ing

and

dis

infe

ctio

nsc

hed

ule

ssh

allb

eim

plem

ente

dan

ddo

cum

ente

d.7.

0E

1E

1.1.

1–3

4,5,

12,1

6

4.10

.3O

nly

qu

alifi

edp

erso

nn

elsh

allb

eal

low

edto

un

der

take

clea

nin

gan

dd

isin

fect

ion

.Th

ep

erso

nn

elsh

allb

etr

ain

edan

dre

trai

ned

toca

rry

ou

tth

ecl

ean

ing

sch

edu

les.

E1.

1.1–

36

–A

recl

ean

ing

per

son

nel

qu

alifi

ed?

<tra

inin

gp

roo

f>–

Ho

wo

ften

are

they

trai

ned

?–

Wh

otr

ain

sth

em?

–A

reth

ese

trai

nin

gs

do

cum

ente

d?

Wh

ena

pro

du

cto

rto

ols

con

tam

inat

ion

occ

urs

du

eto

un

trai

n-

edcl

ean

ing

per

son

-n

elo

rw

ron

gu

seo

fcl

ean

ing

pro

du

cts

or

wh

encl

ean

ing

pro

cess

isin

effi

cien

t.

4.10

.4T

he

effe

ctiv

enes

san

dsa

fety

of

the

clea

nin

gan

dd

isin

fect

ion

mea

sure

s,b

ased

on

haz

ard

anal

ysis

and

asse

ss-

men

to

fas

soci

ated

risk

s,sh

allb

eve

rifi

edan

dd

ocu

men

ted

acco

rdin

gto

asa

mp

ling

sch

edu

leb

yu

sin

gap

pro

pri

ate

pro

ced

ure

s.R

esu

ltin

gco

rrec

tive

acti

on

ssh

allb

ed

ocu

-m

ente

d.

7.0

E1

E1.

1.1–

37,

13–

Ho

war

ecl

ean

ing

and

dis

infe

ctio

nco

ntr

ols

per

form

ed?

<cle

anin

gco

ntr

ols

>–

Wh

op

erfo

rms

thes

eco

ntr

ols

?<c

lean

ing

con

tro

ls>

–H

ow

oft

enar

ecl

ean

ing

and

dis

infe

ctio

nco

ntr

ols

per

form

ed?

<cle

anin

gco

ntr

ols

>–

Wh

ere

are

clea

nin

gan

dd

isin

fect

ion

con

tro

lsd

ocu

men

ted

?

Wh

encl

ean

ing

isu

nsu

cces

sfu

lan

dth

iser

ror

isn

ot

corr

ecte

d.



–W

hen

are

corr

ecti

veac

tio

ns

exec

ute

d?

<co

rrec

tive

acti

on

s>–

Wh

oex

ecu

tes

corr

ecti

veac

tio

ns?

–W

ho

revi

ews

effe

ctiv

enes

so

fco

rrec

tive

acti

on

s?–

Wh

ere

are

corr

ecti

veac

tio

ns

do

cu-

men

ted

?

4.10

.5C

lean

ing

and

dis

infe

ctio

nsc

hed

ule

ssh

allb

ere

view

edan

dm

od

ified

,if

nec

essa

ry,i

nth

eev

ent

of

ach

ang

eto

pro

du

ct,p

roce

sso

rcl

ean

ing

equ

ipm

ent.

E1.

1.1–

38,

14–

Wh

enar

ecl

ean

ing

and

dis

infe

ctio

np

roce

du

res

valid

ated

?–

Wh

oad

apts

clea

nin

gan

dd

isin

fect

ion

pro

ced

ure

s?–

Ho

wo

ften

are

clea

nin

gan

dd

isin

fect

ion

sch

edu

les

chan

ged

?

Wh

enci

rcu

mst

ance

sh

ave

bee

nch

ang

edb

ut

no

adap

tati

on

sw

ere

mad

efo

rcl

ean

ing

and

dis

infe

c-ti

on

pro

ced

ure

san

da

con

tam

inat

ion

risk

ensu

es.

4.10

.6T

he

inte

nd

edu

seo

fcl

ean

ing

ute

nsi

lssh

allb

ecl

earl

yid

enti

fied

.Cle

anin

gu

ten

sils

shal

lbe

use

din

aw

ayto

avo

idco

nta

min

atio

n.

4.10

.7C

urr

ent

mat

eria

lsaf

ety

dat

ash

eets

(MS

DS

)an

din

stru

ctio

ns

for

use

shal

lb

eav

aila

ble

for

chem

ical

san

dcl

ean

ing

agen

ts.P

erso

nn

elre

spo

nsi

-b

lefo

rcl

ean

ing

shal

lbe

able

tod

emo

nst

rate

thei

rkn

ow

led

ge

of

such

inst

ruct

ion

s,w

hic

hsh

allb

eal

way

sav

aila

ble

on

site

.

B2.

2.1–

413

–A

rem

ater

ials

afet

yd

ata

shee

tsav

aila

ble

for

allc

lean

ing

chem

ical

s?–

Are

thes

en

oo

lder

than

two

year

s?–

Are

clea

nin

gch

emic

als

inst

ruct

ion

su

pto

dat

e?–

Ho

war

ein

stru

ctio

ns

tran

smit

ted

top

erso

nn

elin

char

ge

of

clea

nin

gp

roce

-d

ure

s?–

Wh

ere

and

wh

enca

nth

ein

stru

ctio

ns

be

insp

ecte

d?

Wh

ena

safe

tyri

sko

ccu

rsd

ue

tod

efi-

cien

tm

ater

ials

afet

yd

ata

shee

ts.

4.10

.8C

lean

ing

chem

ical

ssh

allb

ecl

earl

yla

bel

ed,u

sed

and

sto

red

app

rop

ri-

atel

y,to

avo

idco

nta

min

atio

n.

A3.

2.2

B2.

2.1–

4E

1.1.

1–3

1,2,

38,

9,10

,12,

141,

9

–H

ow

are

clea

nin

gu

ten

sils

and

chem

ical

sre

cog

niz

able

?<c

hem

ical

slis

t>–

Wh

ere

are

clea

nin

gu

ten

sils

and

chem

i-ca

lsst

ore

d?

<ch

emic

als

sto

rag

elis

t>

Wh

encl

ean

ing

ute

nsi

lsca

nb

em

ixed

up

wit

ho

ther

ute

nsi

lsan

dp

acka

gin

gm

ater

ialc

on

tam

ina-

tio

nen

sues

.W

hen

imp

rop

erst

ora

ge

can

lead

top

acka

gin

gm

ater

ial

and

oth

eru

ten

sils

con

tam

inat

ion

.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.10

.9C

lean

ing

acti

viti

essh

allb

eca

rrie

do

ut

inp

erio

ds

of

no

n-p

rod

uct

ion

.If

this

isn

ot

po

ssib

le,t

hes

eo

per

atio

ns

shal

lbe

con

tro

lled

asto

no

taf

fect

the

pro

du

ct.

A3.

2.1

E1.

1.1–

31,

2,3,

4,5,

69,

15–

Wh

ere

are

con

tain

ers

clea

ned

?–

Wh

enan

dw

her

ear

eto

ols

clea

ned

?<c

lean

ing

evid

ence

>

Th

eto

olc

lean

ing

pro

cess

isa

pro

du

ctco

nta

min

atio

np

rob

lem

;e.g

.wet

clea

nin

go

fco

nta

in-

ers

and

pal

lets

du

rin

gp

rod

uct

ion

and

nea

ru

np

rote

cted

pac

kag

-in

gm

ater

ial.

4.10

.10

Wh

ere

aco

mp

any

hir

esa

thir

d-p

arty

serv

ice

pro

vid

erfo

rcl

ean

ing

and

dis

infe

ctio

nac

tivi

ties

,all

req

uir

e-m

ents

spec

ified

wit

hin

sect

ion

4.10

shal

lbe

clea

rly

defi

ned

inth

ere

spec

tive

con

trac

t.

4.11

Was

ted

isp

osa

l

4.11

.1A

was

tem

anag

emen

tp

roce

du

resh

alle

xist

and

shal

lbe

imp

lem

ente

dto

avo

idcr

oss

con

tam

inat

ion

.

A2.

4.1

A2.

4.2

1,2,

3,4,

5,6

1,2,

3,4,

5,6,

7,8

4.11

.2A

llcu

rren

tle

gal

req

uir

emen

tsfo

rw

aste

dis

po

sals

hal

lbe

met

.–

Ho

wis

iten

sure

dth

atcu

rren

tle

gal

was

ted

isp

osa

lreq

uir

emen

tsar

em

et?

–H

ow

isw

aste

mat

eria

ldis

po

sed

of?

Wh

enle

gal

req

uir

e-m

ents

reg

ard

ing

was

ted

isp

osa

lare

no

tm

et.

4.11

.3P

acka

gin

gm

ater

ialw

aste

and

oth

erw

aste

shal

lbe

rem

ove

das

qu

ickl

yas

po

ssib

lefr

om

area

sw

her

ep

acka

g-

ing

mat

eria

lis

han

dle

d.T

he

accu

mu

-la

tio

no

fw

aste

shal

lbe

avo

ided

.

–H

ow

oft

enar

ep

acka

gin

gm

ater

ialw

aste

and

oth

erw

aste

sre

mo

ved

fro

mp

acka

g-

ing

mat

eria

lhan

dlin

gar

eas?

–W

ho

isre

spo

nsi

ble

for

was

tere

mo

val?

Wh

enw

aste

sac

cu-

mu

late

inp

acka

gin

gm

ater

ialh

and

ling

area

sw

hic

hen

sues

ap

acka

gin

gm

ater

ial

con

tam

inat

ion

risk

.

4.11

.4W

aste

colle

ctio

nco

nta

iner

ssh

allb

ecl

earl

ym

arke

d,s

uit

ably

des

ign

ed,i

ng

oo

dst

ate

of

rep

air,

easy

tocl

ean

,an

dw

her

en

eces

sary

dis

infe

cted

.

A2.

4.2

1,4,

5,6

–W

hat

kin

do

fw

aste

exis

ts?

Wh

atw

aste

sar

eco

llect

edin

sep

arat

eco

nta

iner

s?H

ow

are

was

teco

nta

iner

sm

arke

d?

Can

was

teco

nta

iner

sea

sily

be

clea

ned

?–

Ho

wo

ften

are

was

teco

nta

iner

scl

ean

ed?

<cle

anin

gp

roto

col>

Wh

enw

aste

con

tain

-er

sca

nb

em

ixed

up

wit

hp

acka

gin

gm

ater

ialc

on

tain

ers

wh

ich

ensu

esa

pac

kag

ing

mat

eria

lco

nta

min

atio

nri

sk.



4.11

.5W

aste

colle

ctio

nro

om

san

dco

nta

in-

ers

(in

cl.c

om

pac

tors

)sh

allb

ed

esig

ned

tob

eke

pt

clea

nto

min

i-m

ize

pes

tat

trac

tio

n.

A2.

4.2

A1.

1.1

7 9–

Are

was

teco

llect

ion

roo

ms

kep

tcl

ean

?–

Are

was

teco

llect

ion

roo

ms

pro

tect

edfr

om

pes

ts?

<in

teg

rate

dp

est

con

tro

l>

Wh

enw

aste

colle

c-ti

on

roo

ms

are

no

tp

rote

cted

fro

mp

est

inva

sio

ns

and

ther

eis

aco

nta

min

atio

nri

sk.

4.11

.6W

aste

shal

lbe

colle

cted

inse

par

ate

con

tain

ers

inac

cord

ance

wit

hth

ein

ten

ded

mea

ns

of

dis

po

sal.

Su

chw

aste

shal

lbe

dis

po

sed

by

auth

or-

ised

thir

dp

arti

eso

nly

.Rec

ord

so

fw

aste

dis

po

sals

hal

lbe

kep

tb

yth

eco

mp

any.

A2.

4.2

5–

Wh

atki

nd

so

fw

aste

dis

po

salr

eco

rds

exis

t?–

Wh

ois

resp

on

sib

lefo

rw

aste

dis

po

sal?

<was

ted

isp

osa

lreg

iste

r>

Wh

enw

aste

sar

ere

mo

ved

by

un

au-

tho

rize

dp

erso

ns.

4.12

Ris

ko

ffo

reig

nm

ater

ial,

met

al,

bro

ken

gla

ssan

dw

oo

d

4.12

.1K

OK

ON

°5:

Bas

edo

nh

azar

dan

alys

isan

das

sess

men

to

fas

soci

ated

risk

s,p

roce

du

res

shal

lbe

inp

lace

toav

oid

con

tam

inat

ion

wit

hfo

reig

nm

ater

ial.

Co

nta

min

ated

pro

du

cts

shal

lbe

trea

ted

asn

on

-co

nfo

rmin

gp

rod

uct

s.

–W

hat

kin

ds

of

fore

ign

mat

eria

lmay

be

fou

nd

?–

Wh

ere

fore

ign

mat

eria

lso

urc

esid

enti

fied

thro

ug

hh

azar

dan

alys

is?

<haz

ard

anal

ysis

>–

Are

stap

les

use

d?

–H

ow

are

con

tam

inat

edp

rod

uct

sh

and

led

?<s

egre

gat

ion

reco

rds>

–W

hat

isd

on

ein

case

of

gla

ssb

reak

age?

<gla

ssb

reak

age

pre

ven

tio

np

roce

du

res>

–W

hat

shal

lbe

con

sid

ered

wh

eng

lass

fixt

ure

sar

ere

pla

ced

?<g

lass

han

dlin

gp

roce

du

res>

Wh

ena

fore

ign

mat

eria

lco

nta

min

a-ti

on

occ

urs

du

eto

lack

of

haz

ard

anal

ysis

or

wh

enfo

reig

nm

ater

ial

sou

rces

are

insu

ffi-

cien

tly

con

sid

ered

.

4.12

.2In

alla

reas

,e.g

.han

dlin

go

fra

wm

ater

ials

,co

nve

rtin

g,w

rap

pin

gan

dst

ora

ge,

wh

ere

haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ciat

edri

sks

hav

eid

enti

fied

the

po

ten

tial

for

pro

du

ctco

nta

min

atio

n,t

he

use

of

wo

od

shal

lb

eex

clu

ded

.Wh

ere

the

use

of

wo

od

can

no

tb

eav

oid

ed,t

he

risk

shal

lbe

con

tro

lled

and

the

wo

od

shal

lbe

ing

oo

do

rder

and

clea

n.

–U

nd

erw

hat

circ

um

stan

ces

isth

eu

seo

fw

oo

dal

low

ed?

<haz

ard

anal

ysis

>Is

the

wo

od

ento

oli

nu

sein

go

od

and

clea

nco

nd

itio

ns?

–W

ho

insp

ects

and

ho

wo

ften

isth

ew

oo

den

too

lco

nd

itio

nin

spec

ted

?

Wh

enw

oo

dg

ets

inco

nta

ctw

ith

op

enp

rod

uct

.W

hen

wo

od

po

ses

aco

nta

min

atio

nri

skfo

rp

acka

gin

gm

ater

ial

prod

uct.

Whe

nw

oode

nto

olc

on

dit

ion

isn

ot

insp

ecte

dan

da

cont

a-m

inat

ion

risk

ensu

es.

4.12

.3W

her

em

etal

-an

d/o

ro

ther

fore

ign

mat

eria

ldet

ecto

rsar

ere

qu

ired

,th

eysh

allb

ein

stal

led

toen

sure

max

imu

mef

fici

ency

of

det

ecti

on

,in

ord

erto

avo

idsu

bse

qu

ent

con

tam

inat

ion

.D

etec

tors

shal

lbe

sub

ject

edto

reg

u-

lar

mai

nte

nan

ceto

avo

idm

alfu

nct

ion

.

–W

her

ear

eth

efo

reig

nm

ater

iald

etec

tors

inst

alle

d?

<eq

uip

men

tla

y-o

ut>

Wh

enfo

reig

nm

ater

iald

etec

tors

are

inst

alle

db

ut

late

ro

na

fore

ign

mat

eria

lris

kst

illp

ersi

sts

wh

ich

has

no

tb

een

take

nin

toac

cou

nt.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.12

.4P

ote

nti

ally

con

tam

inat

edp

rod

uct

ssh

allb

eis

ola

ted

.Acc

ess

and

acti

on

sfo

rfu

rth

erh

and

ling

or

chec

kin

gfo

rth

ese

iso

late

dp

rod

uct

ssh

allb

eca

rrie

do

ut

on

lyb

yau

tho

rize

dp

erso

nn

elac

cord

ing

tod

efin

edp

roce

du

res.

Aft

erth

isch

eck,

con

-ta

min

ated

pro

du

cts

shal

lbe

trea

ted

asn

on

-co

nfo

rmin

gp

rod

uct

s.

–A

reco

nta

min

ated

pro

du

cts

auto

mat

ical

lyis

ola

ted

?–

Wh

om

ayh

and

le/h

asac

cess

tois

ola

ted

pro

du

cts?

–H

ow

are

iso

late

dp

rod

uct

sh

and

led

?<n

on

-co

nfo

rmin

gp

rod

uct

slis

t>

Wh

ense

gre

gat

ion

do

esn

ot

wo

rk.

Wh

enis

ola

ted

pro

du

cts

re-e

nte

rp

rod

uct

ion

line

wit

ho

ut

pre

vio

us

insp

ecti

on

.

4.12

.5T

he

app

rop

riat

eac

cura

cyo

fd

etec

-to

rssh

allb

esp

ecifi

ed.C

hec

kso

fp

rop

erfu

nct

ion

of

det

ecto

rssh

allb

eca

rrie

do

ut

reg

ula

rly.

Inca

seo

fm

alfu

nct

ion

or

failu

reo

fa

met

alan

d/o

rfo

reig

nm

ater

iald

etec

tor,

corr

ecti

veac

tio

ns

shal

lbe

defi

ned

,im

ple

men

ted

and

do

cum

ente

d.

–H

ow

oft

enar

ed

etec

tora

ccu

raci

esch

ecke

d?

–W

ho

chec

ksd

etec

tor

accu

racy

?<m

etal

det

ecto

rch

eck-

list>

–W

hat

corr

ecti

veac

tio

ns

exis

tw

hen

ad

etec

tor

isd

efec

tive

?–

Are

corr

ecti

veac

tio

ns

veri

fied

?–

Are

op

erat

ion

ald

efec

tsd

ocu

men

ted

?<d

efec

t/fa

ilure

pro

toco

ls>

Wh

enp

rop

ero

per

a-ti

on

or

mea

suri

ng

accu

racy

isn

ot

chec

ked

and

afo

reig

nm

ater

ialr

isk

occ

urs

.

4.12

.6In

case

sw

her

esp

ecia

leq

uip

men

to

rm

eth

od

sar

eu

sed

tod

etec

tfo

reig

nm

ater

ial,

thes

esh

allb

ep

rop

erly

valid

ated

and

mai

nta

ined

.

–A

refi

lter

san

dsi

eves

or

oth

erte

chn

ical

or

mec

han

ical

syst

ems

like

stra

iner

s,m

agn

ets,

vacu

um

clea

ner

etc.

bei

ng

use

d?

–H

ow

oft

enar

ew

ork

ing

con

dit

ion

so

ffi

lter

so

ro

ther

tech

nic

alo

rm

ech

anic

alsy

stem

san

dsi

eves

insp

ecte

d?

–W

ho

insp

ects

/mai

nta

ins

filt

ers

and

siev

eso

ro

ther

tech

nic

alo

rm

ech

anic

alsy

stem

s?–

Wh

atis

the

con

cern

of

insp

ecti

on

?<m

ain

ten

ance

sch

edu

le>

<mo

nit

ori

ng

syst

em>

Wh

end

amag

eto

siev

eso

rfi

lter

sp

asse

sw

ith

ou

tn

oti

ced

and

this

lead

sto

afo

reig

nm

ater

ial

con

tam

inat

ion

risk

.

4.12

.7In

alla

reas

,e.g

.han

dlin

go

fra

wm

ater

ials

,co

nve

rtin

g,w

rap

pin

gan

dst

ora

ge,

wh

ere

haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ciat

edri

sks

hav

eid

enti

fied

ap

ote

nti

alp

rod

uct

con

-ta

min

atio

n,t

he

pre

sen

ceo

fg

lass

and

bri

ttle

mat

eria

lsh

allb

eex

clu

ded

.W

her

eth

ep

rese

nce

of

gla

sso

rb

ritt

lep

last

icca

nn

ot

be

avo

ided

,ap

pro

pri

-at

em

easu

res

shal

lbe

inp

lace

top

rote

ctag

ain

stb

reak

age.

–D

oes

ah

azar

dan

alys

isex

ist

con

cern

ing

con

tam

inat

ion

thro

ug

hg

lass

?<h

azar

dan

alys

is>

–W

her

eis

gla

ssu

sed

inth

ep

lan

t?–

Ho

wis

gla

ssp

rote

cted

fro

mb

reak

age?

<gla

ssre

gis

ter>

Wh

enn

oh

azar

dan

alys

ish

asb

een

con

du

cted

.W

hen

ther

eex

ists

aco

nta

min

atio

nri

skd

ue

tog

lass

usa

ge.

Wh

eng

lass

isu

np

rote

cted

and

ther

eis

aco

nta

min

a-ti

on

risk

.



4.12

.8A

llst

atio

nar

yo

bje

cts

mad

eo

fo

rin

corp

ora

tin

gg

lass

or

bri

ttle

mat

eria

lp

rese

nt

inar

eas

of

han

dlin

go

fra

wm

ater

ials

,co

nve

rtin

g,w

rap

pin

gan

dst

ora

ge

shal

lbe

liste

din

asp

ecifi

cre

gis

ter,

incl

ud

ing

det

ails

of

thei

rex

act

loca

tio

n.A

nas

sess

men

to

fth

eco

nd

itio

no

fo

bje

cts

on

the

reg

iste

rsh

allb

ep

erfo

rmed

on

are

gu

lar

bas

isan

dre

cord

ed.F

req

uen

cyo

fth

isch

eck

shal

lbe

just

ified

by

do

cum

ents

.

–Is

ther

ea

gla

ssfi

xtu

res

reg

iste

rin

clu

din

glo

cati

on

?<g

lass

reg

iste

r>–

Ho

wo

ften

and

wh

oin

spec

tsg

lass

fixt

ure

con

dit

ion

s?–

Ho

wo

ften

isg

lass

fixt

ure

sre

gis

ter

up

dat

ed?

<in

spec

tio

nre

sult

s><g

lass

reg

iste

r>

Wh

eng

lass

bre

akag

eh

app

ens

un

no

tice

dan

da

con

tam

inat

ion

risk

ensu

es.

4.12

.9B

reak

ages

of

gla

ssan

db

ritt

lem

ater

ials

hal

lbe

reco

rded

.Exc

ep-

tio

ns

shal

lbe

just

ified

and

do

cu-

men

ted

.

–Is

ever

yg

lass

bre

akag

ed

ocu

men

ted

?<g

lass

bre

akag

ere

gis

try>

–W

her

eis

gla

ssb

reak

age

do

cum

ente

d?

<gla

ssre

gis

ter>

–A

reth

ere

exce

pti

on

sto

do

cum

enta

tio

n?

Are

exce

pti

on

sb

ased

on

haz

ard

anal

ysis

?<h

azar

dan

alys

is>

Wh

enn

oh

azar

dan

alys

ish

asb

een

mad

e.

4.12

.10

Pro

ced

ure

ssh

allb

ein

pla

ced

escr

ib-

ing

the

mea

sure

sto

be

take

nin

case

of

bre

akag

eo

fg

lass

and

/or

bri

ttle

mat

eria

l.S

uch

mea

sure

ssh

all

incl

ud

eid

enti

fyin

gth

esc

op

eo

fg

oo

ds

tob

eis

ola

ted

,sp

ecif

yin

gau

tho

rize

dp

erso

nn

el,c

lean

ing

the

pro

du

ctio

nen

viro

nm

ent

and

rele

ase

of

pro

du

ctio

nlin

efo

rco

nti

nu

edp

rod

uct

ion

.

–W

hat

isd

on

ein

case

of

gla

ssb

reak

age?

–W

hat

sho

uld

be

take

nin

toac

cou

nt?

–W

ho

clea

ns

the

pro

du

ctio

nen

viro

nm

ent?

–W

ho

per

mit

sp

rod

uct

ion

con

tin

ual

?<g

lass

bre

akag

ep

reve

nti

on

pro

ced

ure

s><g

lass

bre

akag

ed

ocu

men

tati

on

>

Wh

ena

con

tam

ina-

tio

nri

skex

ists

du

eto

gla

ssb

reak

age

and

bec

ause

invo

lved

pro

du

cth

asn

ot

bee

nin

spec

ted

.

4.12

.11

Bas

edo

nh

azar

dan

alys

isan

das

sess

men

to

fas

soci

ated

risk

s,p

reve

nti

vem

easu

res

shal

lbe

inp

lace

for

han

dlin

go

fal

lkin

ds

of

con

tain

ers

inth

ep

rod

uct

ion

pro

cess

(tu

rno

ver,

blo

w,r

inse

,etc

.).

–H

asa

haz

ard

anal

ysis

bee

np

erfo

rmed

?<h

azar

dan

alys

is>

–W

hat

pre

ven

tive

mea

sure

sar

ein

pla

ce?

<pre

ven

tive

mea

sure

s>

Wh

enn

oh

azar

dan

a-ly

sis

has

bee

nm

ade.

Wh

enth

ere

exis

tsa

con

tam

inat

ion

risk

du

eto

mis

sin

gp

reve

nti

vem

easu

res.

4.12

.12

Wh

ere

visu

alin

spec

tio

nis

use

dto

det

ect

fore

ign

mat

eria

l,th

eem

plo

y-ee

ssh

allb

etr

ain

edan

do

per

ativ

ech

ang

esh

allb

ep

erfo

rmed

atan

app

rop

riat

efr

equ

ency

tom

axim

ize

effe

ctiv

enes

so

fp

roce

ss.

4.13

Pes

tm

on

ito

rin

g/P

est

con

tro

l



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.13

.1T

he

com

pan

ysh

allh

ave

ap

est

con

-tr

ols

yste

min

pla

cew

hic

his

inco

m-

plia

nce

wit

hlo

call

egal

req

uir

emen

ts,

taki

ng

into

acco

un

t,as

am

inim

um

:–

the

fact

ory

envi

ron

men

t(p

ote

nti

alp

ests

)–

site

pla

nw

ith

area

for

app

licat

ion

(bai

tm

ap)

–id

enti

fica

tio

no

fth

eb

aits

on

site

–re

spo

nsi

bili

ties

,in

-ho

use

/ext

ern

al–

use

dp

rod

uct

s/ag

ents

and

thei

rin

stru

ctio

ns

for

use

and

safe

ty–

the

freq

uen

cyo

fin

spec

tio

ns.

Th

ep

est

con

tro

lsys

tem

shal

lbe

bas

edo

nh

azar

dan

alys

isan

das

sess

-m

ent

of

asso

ciat

edri

sks.

7.0

E2

E2.

1.1

1,2,

3,4,

6–

Ho

wis

pes

tco

ntr

olo

rgan

ized

?–

Wh

ich

pes

tsar

eco

ntr

olle

d?

–W

hic

hki

nd

so

fb

aits

are

use

d?

<pes

tco

ntr

olc

hem

ical

slis

t>–

Isp

rod

uct

con

tam

inat

ion

thro

ug

hb

aits

bei

ng

pre

ven

ted

?–

Wh

ois

resp

on

sib

lefo

rp

est

con

tro

l?–

Wh

atis

insp

ecti

on

sch

edu

le?

Wh

enn

op

est

con

tro

lis

mad

e.W

hen

ap

rod

uct

con

tam

inat

ion

can

occ

ur

du

eto

un

map

ped

bai

ts.

Wh

ena

pro

du

ctsa

fety

occ

urs

du

eto

inco

rrec

tu

seo

fp

est

con

tro

lch

emic

als

or

wro

ng

lyla

ido

ut

bai

ts.

4.13

.2T

he

com

pan

ysh

allh

ave

qu

alifi

edan

dtr

ain

edin

-ho

use

staf

fan

d/o

rem

plo

yth

ese

rvic

eso

fa

qu

alifi

edex

tern

alp

rovi

der

.Wh

ere

anex

tern

alp

rovi

der

isu

sed

,th

eac

tivi

ties

req

uir

edo

nsi

tesh

allb

esp

ecifi

edin

aw

ritt

enco

ntr

act.

E2.

1.1

A1.

1.1-

24,

515

–Is

pes

tco

ntr

ole

xecu

ted

by

ow

nst

aff

mem

ber

s?–

Wh

ois

resp

on

sib

lefo

rp

est

con

tro

l?–

Wh

atki

nd

of

trai

nin

gh

asth

ere

spo

nsi

ble

per

son

?<t

rain

ing

evid

ence

>–

Isp

est

con

tro

lexe

cute

db

yex

tern

alse

rvic

esp

rovi

der

?–

Do

esa

wri

tten

con

trac

tex

ist

bet

wee

nse

rvic

esp

rovi

der

and

com

pan

y?<w

ritt

enco

ntr

act>

–W

hat

isth

eco

nte

nt

of

the

con

trac

t?–

Wh

atki

nd

of

trai

nin

gh

asth

eex

tern

alse

rvic

esp

rovi

der

?<t

rain

ing

evid

ence

>

Wh

ena

pro

du

ctco

nta

min

atio

no

ccu

rsd

ue

toin

corr

ect

han

dlin

go

fb

ait

mat

eria

l.

4.13

.3P

est

con

tro

lin

spec

tio

ns

and

resu

lt-

ing

acti

on

ssh

allb

ed

ocu

men

ted

.Im

ple

men

tati

on

of

acti

on

ssh

allb

em

on

ito

red

and

reco

rded

.

E2.

1.1

7,11

,12

–W

her

ear

ein

spec

tio

ns

and

resu

ltin

gco

rrec

tive

acti

on

sd

ocu

men

ted

?

–A

red

ocu

men

tssi

gn

edan

dd

ated

by

bo

thp

arti

es?

–W

hic

hco

rrec

tive

acti

on

sw

ere

exec

ute

dla

tely

?

Wh

enin

spec

tio

ns

are

no

td

ocu

men

ted

.



4.13

.4B

aits

,tra

ps

and

inse

ctex

term

inat

ors

shal

lbe

fun

ctio

nin

g,s

hal

lbe

insu

ffici

ent

nu

mb

ers

and

shal

lbe

pla

ced

inan

app

rop

riat

ep

osi

tio

n.

Th

eysh

allb

eco

nst

ruct

edan

dp

osi

tio

ned

asn

ot

toca

use

any

con

tam

inat

ion

risk

.

E2.

1.1

8,9,

10–

Wh

ere

are

elec

tric

alfl

yki

llers

inst

alle

d?

<fly

kille

rm

ap>

–A

real

lfly

kille

rsco

rrec

tly

wo

rkin

gan

dco

nn

ecte

d?

Wh

enfl

yki

llers

are

po

siti

on

edin

such

aw

ayth

atfl

ies

can

fall

dir

ectl

yo

np

acka

gin

gm

ater

ialp

rod

uct

s.

4.13

.5In

com

ing

del

iver

ies

shal

lbe

chec

ked

on

arri

valf

or

the

pre

sen

ceo

fp

ests

.A

ny

infe

stat

ion

shal

lbe

do

cum

ente

dan

dco

ntr

olm

easu

res

take

n.

–A

rein

com

ing

go

od

sin

spec

ted

for

pes

tco

nta

min

atio

n?

–W

her

eis

this

do

cum

ente

d?

<in

com

ing

go

od

sin

spec

tio

n>

–Is

pes

tp

rese

nce

do

cum

ente

d?

<in

com

ing

go

od

sin

spec

tio

n>

–W

hat

con

tro

lmea

sure

sar

eta

ken

wh

enp

ests

are

fou

nd

?<c

orr

ecti

veac

tio

ns>

–W

her

ear

eth

ese

con

tro

lmea

sure

sd

ocu

men

ted

?<c

orr

ecti

veac

tio

ns>

Wh

enin

com

ing

go

od

sar

en

ot

insp

ecte

dfo

rp

est

pre

sen

cean

dan

un

con

tro

lled

inva

sio

nen

sues

.

4.13

.6T

he

effe

ctiv

enes

so

fth

ep

est

con

tro

lsh

allb

em

on

ito

red

wit

hth

eh

elp

of

reg

ula

rtr

end

anal

yses

.

E2.

1.1

12

4.14

Rec

eip

to

fg

oo

ds

and

sto

rag

e7.

0B

2

4.14

.1A

llin

com

ing

go

od

s,in

clu

din

gw

rap

pin

gm

ater

ials

,sh

allb

ech

ecke

dfo

rco

nfo

rmit

yag

ain

stsp

ecifi

ca-

tio

ns/

oth

erle

gal

lyre

qu

ired

do

cu-

men

tati

on

and

toa

det

erm

ined

insp

ecti

on

pla

n.T

he

insp

ecti

on

pla

nsh

allb

eri

skb

ased

.Tes

tre

sult

ssh

all

be

do

cum

ente

d.

7.0

B2

B2.

1.1–

21,

2–

Wh

atg

oo

ds

(in

cl.s

emi-

pro

cess

edp

rod

uct

s)ar

ein

spec

ted

wh

enre

ceiv

ed?

<rec

eip

tch

ecks

>–

Wh

atis

chec

ked

wh

enre

ceiv

ed?

–Is

rece

ipt

do

cum

ente

d?

–W

ho

chec

ks?

Wh

enn

ore

ceip

tch

ecks

are

mad

e.W

hen

chec

ksd

on

ot

gu

aran

tee

leg

ally

req

uir

emen

ts.

Wh

enre

ceip

tch

ecks

do

no

tta

kein

toac

cou

nt

spec

ifica

-ti

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

ta-

tio

nre

qu

irem

ents

wh

ich

pre

ven

tth

atp

rod

uct

sfu

lfilt

hei

rg

iven

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

-ti

on

.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.14

.2T

he

sto

rag

eco

nd

itio

ns

of

raw

mat

eria

ls,s

emi-

pro

cess

edan

dfi

nis

hed

pro

du

cts

asw

ella

sw

rap

-p

ing

shal

lin

each

case

corr

esp

on

dto

pro

du

ctre

qu

irem

ents

(e.g

.pro

tect

ive

cove

rs)

and

shal

lno

tb

ed

etri

men

tal

too

ther

pro

du

cts.

7.0

B2

B2.

1.1–

2B

1.1.

1–3

B1.

2.2

B2.

3.1–

2

3,19

1–19

1 1–12

–W

her

ear

era

wm

ater

ials

,hal

ffi

nis

hed

pro

du

cts

and

pac

kag

ing

mat

eria

lsst

ore

d?

<sto

rag

ep

lan

>–

Ho

wis

cro

ss-c

on

tam

inat

ion

avo

ided

?

Wh

eng

oo

ds

are

imp

rop

erly

sto

red

and

aco

nta

min

atio

nri

sken

sues

.

4.14

.3R

awm

ater

ials

,pac

kag

ing

,sem

i-p

roce

ssed

and

fin

ish

edp

rod

uct

ssh

allb

est

ore

dso

asto

min

imiz

eth

eri

sko

fcr

oss

con

tam

inat

ion

.

B2.

1.1–

2–

Wh

ere

and

ho

war

ep

acka

gin

gm

ater

ials

and

equ

ipm

ents

sto

red

?<m

ater

ials

flo

w-d

iag

ram

>–

Ho

wis

cro

ss-c

on

tam

inat

ion

thro

ug

hp

acka

gin

gm

ater

ials

avo

ided

?<m

ater

ials

flo

w-d

iag

ram

>–

Ho

wis

retu

rno

fp

acka

gin

gm

ater

ials

toth

est

ore

roo

mre

gu

late

d?

–W

hat

kin

do

fst

ora

ge

reg

ula

tio

ns

exis

t?–

Are

pes

tsta

ken

into

acco

un

td

uri

ng

sto

rag

e?A

rep

alle

tslo

cate

dap

pro

xi-

mat

ely

1m

fro

mw

alls

?

–A

reth

ere

bai

tsla

ido

ut

inst

ora

ge

roo

ms?

<pes

tco

ntr

ols

ched

ule

>–

Are

ther

ese

nsi

tive

pro

du

cts

sto

red

?–

Wh

atki

nd

so

fp

reve

nti

vem

easu

res

are

inp

lace

for

thes

eg

oo

ds?

<pre

ven

tive

mea

sure

s>

Ap

rod

uct

con

tam

ina-

tio

nri

skis

giv

end

ue

tost

ora

ge

of

pac

kag

-in

gm

ater

ials

and

equ

ipm

ents

(e.g

.u

np

rote

cted

exte

rnal

sto

rag

eo

fp

acka

gin

gm

ater

ial)

Wh

enst

ora

ge

faci

litie

sar

en

ot

insp

ecte

dfo

rp

est

pre

sen

ce.

4.14

.4A

pp

rop

riat

est

ora

ge

faci

litie

ssh

allb

eav

aila

ble

for

the

man

agem

ent

and

sto

rag

eo

fw

ork

ing

mat

eria

ls,

pro

cess

aid

s,an

dad

dit

ives

.Th

ep

erso

nn

elre

spo

nsi

ble

for

the

man

agem

ent

of

sto

rag

efa

cilit

ies

shal

lbe

trai

ned

.

B2.

2.1–

41–

15–

Ho

war

ech

emic

als

sto

red

?–

Wh

ou

ses

chem

ical

san

dta

kes

them

ou

to

fst

ora

ge?

<res

po

nsi

bili

tylis

t>–

Are

the

chem

ical

su

sers

trai

ned

?–

Istr

ain

ing

do

cum

ente

d?

<tra

inin

gd

ocu

men

tati

on

>

Wh

ena

pac

kag

ing

mat

eria

lor

ute

nsi

lsco

nta

min

atio

no

ccu

rsd

ue

toin

app

rop

riat

est

ora

ge

con

dit

ion

s.W

hen

ap

acka

gin

gm

ater

ialo

ru

ten

sils

con

tam

inat

ion

occ

urs

du

eto

insu

ffici

ent

kno

wle

dg

e.



4.14

.5A

llp

rod

uct

ssh

allb

ecl

earl

yid

enti

-fi

ed.U

seo

fp

rod

uct

ssh

allb

eu

nd

erta

ken

inac

cord

ance

wit

hth

ep

rin

cip

les

of

Firs

tIn

/Fir

stO

ut

and

/or

Firs

tE

xpir

ed/F

irst

Ou

t.

7.0

B2

B2.

1.1–

2B

2.3.

1–2

18 7

–H

ow

is“F

IFO

”o

r“F

EFO

”en

sure

d?

Wh

eng

oo

ds

are

take

no

ut

of

sto

rag

ew

ith

ou

tco

ntr

ola

nd

ap

rod

uct

safe

tyri

sken

sues

.

4.14

.6W

her

ea

com

pan

yh

ires

ath

ird

-par

tyst

ora

ge

serv

ice

pro

vid

er,t

he

serv

ice

pro

vid

ersh

allb

esu

bje

ctto

IFS

Log

isti

csre

qu

irem

ents

.If

the

thir

dp

arty

serv

ice

pro

vid

eris

no

tce

rtifi

edto

IFS

Log

isti

cs,a

llre

leva

nt

req

uir

e-m

ents

equ

ival

ent

toth

eco

mp

any’

so

wn

war

eho

usi

ng

pra

ctic

essh

allb

efu

lfile

dan

dth

issh

allb

ecl

earl

yd

efin

edin

the

resp

ecti

veco

ntr

act.

B2.

1.1–

21

–Is

sto

rag

ele

ased

tost

ora

ge

serv

ice

pro

vid

er?

–D

oes

aco

ntr

act

exis

t?<s

ervi

cep

rovi

der

con

trac

t>–

Wh

atis

spec

ified

inth

eco

ntr

act?

–H

asst

ora

ge

serv

ice

pro

vid

eran

IFS

Log

isti

csce

rtifi

cati

on

?<c

erti

fica

teco

py>

4.15

Tran

spo

rt

4.15

.1B

efo

relo

adin

gtr

ansp

ort

veh

icle

s,th

eir

con

dit

ion

(e.g

.ab

sen

ceo

fst

ran

ge

smel

ls,h

igh

du

stlo

ad,

adve

rse

hu

mid

ity,

pes

ts,m

ou

ld)

shal

lbe

chec

ked

and

acti

on

take

n,i

fn

eces

sary

.

B1.

1.1–

3B

1.2.

21,

2,3

1–

Wh

atis

chec

ked

bef

ore

load

ing

?<e

xped

itio

nin

spec

tio

n>

–W

her

eis

insp

ecti

on

do

cum

ente

d?

–W

hat

corr

ecti

veac

tio

ns

are

take

n?

4.15

.2P

roce

du

res

top

reve

nt

con

tam

inat

ion

du

rin

gtr

ansp

ort

shal

lbe

imp

le-

men

ted

(pac

kag

ing

mat

eria

l/n

on

-p

acka

gin

gm

ater

ial/

dif

fere

nt

cate

go

-ri

eso

fg

oo

ds)

.

7.0

B1

B1.

1.1–

3–

May

go

od

sb

etr

ansp

ort

edal

on

gsi

de

wit

hn

on

pac

kag

ing

mat

eria

lpro

du

cts?

–H

ow

iscr

oss

-co

nta

min

atio

np

reve

nte

d?

Wh

ena

con

tam

ina-

tio

nca

no

ccu

rd

uri

ng

tran

spo

rt.

4.15

.3W

her

eg

oo

ds

mu

stb

etr

ansp

ort

edat

cert

ain

con

dit

ion

s,b

efo

relo

adin

g,

the

con

dit

ion

insi

de

the

veh

icle

shal

lb

ech

ecke

dan

dd

ocu

men

ted

.

–A

rep

rod

uct

sw

hic

hre

qu

ire

ace

rtai

nco

nd

itio

ns

(e.g

.hu

mid

ity

du

rin

gp

aper

tran

spo

rtat

ion

)b

ein

glo

aded

?–

Are

veh

icle

con

dit

ion

sch

ecke

dan

dd

ocu

men

ted

bef

ore

load

ing

?<e

xped

itio

nin

spec

tio

n>

–W

hat

are

the

pro

ced

ure

sw

hen

veh

icle

con

dit

ion

isn

ot

acco

rdin

gto

spec

ifica

-ti

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

-ta

tio

n?

<exp

edit

ion

insp

ecti

on

>–

Ho

wth

eco

mp

any

ensu

reth

eco

mp

lian

ceo

fco

nd

itio

ns

du

rin

gtr

ansp

ort

?

Wh

enth

ere

are

cert

ain

con

dit

ion

ssp

ecifi

cati

on

sfo

ro

utg

oin

gp

rod

uct

bu

tth

eyar

en

ot

chec

ked

bef

ore

load

ing

and

ah

ealt

his

sue

occ

urs

.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.15

.4W

her

eg

oo

ds

mu

stb

etr

ansp

ort

edat

cert

ain

con

dit

ion

sm

ain

tain

ing

thes

eco

nd

itio

ns

du

rin

gtr

ansp

ort

shal

lbe

ensu

red

and

do

cum

ente

d.

–A

reve

hic

les

equ

ipp

edw

ith

reg

iste

rin

gd

evic

es?

<reg

iste

rin

gd

evic

es>

–H

ow

isit

ensu

red

that

pro

du

cts

reac

hd

esti

nat

ion

un

der

go

od

con

dit

ion

s?

Wh

enth

ere

are

con

dit

ion

spec

ifica

-ti

on

so

ro

ther

leg

ally

req

uir

edd

ocu

men

ta-

tio

ns

for

the

pro

du

ctan

dco

nd

itio

nco

ntr

ol

isn

ot

ensu

red

du

rin

gtr

ansp

ort

soth

ata

hea

lth

issu

em

ayo

ccu

r.

4.15

.5A

deq

uat

eh

ygie

nic

req

uir

emen

tsfo

ral

ltra

nsp

ort

veh

icle

san

deq

uip

men

tu

sed

for

load

ing

/un

load

ing

(e.g

.h

ose

so

fsi

loin

stal

lati

on

s)sh

alle

xist

.T

her

esh

allb

ere

cord

so

fth

em

eas-

ure

sta

ken

.

B1.

1.1–

31,

2,3

–A

retr

ansp

ort

veh

icle

scl

ean

ed?

–W

her

ear

ecl

ean

ing

pro

ced

ure

sd

ocu

-m

ente

d?

<cle

anin

gp

roto

col>

Wh

enab

sen

ceo

fcl

ean

ing

pro

ced

ure

sen

sue

ap

rod

uct

con

tam

inat

ion

pro

ble

m.

4.15

.6Lo

adin

gan

du

nlo

adin

gar

eas

shal

lh

ave

equ

ipm

ent

inp

lace

top

rote

cttr

ansp

ort

edp

rod

uct

sfr

om

exte

rnal

infl

uen

ces.

B1.

1.1–

317

–H

ow

isg

oo

ds

rece

pti

on

org

aniz

ed?

–H

ow

islo

adin

go

rgan

ized

?E

xter

nal

infl

uen

ces:

e.g

.po

llen

,clim

ate,

etc.

4.15

.7W

her

ea

com

pan

yh

ires

ath

ird

-par

tytr

ansp

ort

serv

ice

pro

vid

er,a

llth

ere

qu

irem

ents

spec

ified

wit

hin

sect

ion

4.15

shal

lbe

clea

rly

defi

ned

inth

ere

spec

tive

con

trac

to

rth

ese

rvic

ep

rovi

der

shal

lbe

sub

ject

toIF

SLo

gis

tics

req

uir

emen

ts.

–A

reth

ere

inte

rnal

or

exte

rnal

tran

spo

rta-

tio

nre

gu

lati

on

s?–

Do

esa

con

trac

tex

ist

wit

ha

tran

spo

rta-

tio

nse

rvic

esp

rovi

der

?<s

ervi

cep

rovi

der

con

trac

t>–

Has

sto

rag

ese

rvic

ep

rovi

der

anIF

SLo

gis

tics

cert

ifica

tio

n?

<cer

tifi

cate

cop

y>

4.15

.8S

ecu

rity

of

tran

spo

rtve

hic

les

shal

lb

eap

pro

pri

atel

ym

ain

tain

ed.

B1.

1.1–

319

Are

load

ing

area

ssh

utt

ered

?A

reth

etr

ansp

ort

sse

aled

?

4.16

Mai

nte

nan

cean

dre

pai

r

4.16

.1A

nad

equ

ate

syst

emo

fm

ain

ten

ance

shal

lbe

inp

lace

,mai

nta

ined

and

do

cum

ente

d,c

ove

rin

gal

lcri

tica

leq

uip

men

t(i

ncl

.tra

nsp

ort

)fo

rco

mp

lian

cew

ith

pro

du

ctre

qu

ire-

men

ts.T

his

app

lies

bo

thfo

rin

tern

alan

dex

tern

alm

ain

ten

ance

acti

viti

es.

C1.

1.1–

31–

13–

Ho

wis

mai

nte

nan

ceo

rgan

ized

?<m

ain

ten

ance

pla

n>

–W

her

ear

em

ain

ten

ance

pro

ced

ure

sd

ocu

men

ted

?–

Wh

ich

equ

ipm

ents

are

sub

ject

toex

tern

alm

ain

ten

ance

?

No

mai

nte

nan

cesy

stem

exis

ts.



4.16

.2P

rod

uct

req

uir

emen

tsan

dp

reve

n-

tio

no

fco

nta

min

atio

nsh

allb

een

sure

dd

uri

ng

and

afte

rm

ain

te-

nan

cean

dre

pai

rw

ork

.Rec

ord

so

fm

ain

ten

ance

and

rep

air

wo

rkan

do

fco

rrec

tive

acti

on

sta

ken

shal

lbe

kep

t.

7.0

CC

1.1.

1–3

C1.

2.1–

21–

13

–H

ow

isit

ensu

red

that

mai

nte

nan

cean

dre

pai

rw

ork

sd

on

ot

affe

ctp

rod

uct

safe

ty?

–H

ow

are

ligh

tin

gfi

xtu

res

rep

aire

d?

–W

her

ear

ere

pai

rw

ork

sd

ocu

men

ted

?–

Are

corr

ecti

veac

tio

ns

nec

essa

ryaf

ter

rep

air

wo

rks?

–W

hat

rule

sar

ein

pla

cefo

rre

-act

ivat

ing

equ

ipm

ent

wh

enm

ain

ten

ance

isco

m-

ple

ted

?<e

xam

ple

sfo

rre

pai

rw

ork

san

dm

ain

te-

nan

ce>

Wh

ena

con

tam

ina-

tio

nri

skfo

rth

ep

rod

uct

occ

urs

du

eto

mai

nte

nan

cean

dp

rod

uct

isn

ot

seg

reg

ated

.

4.16

.3A

llm

ater

ials

use

dfo

rm

ain

ten

ance

and

rep

air

shal

lbe

fit

for

the

inte

nd

edu

se.

B2.

2.1–

4C

1.2.

14,

61,

2,4,

5–

Ho

wis

iten

sure

dth

atm

ater

ials

use

din

mai

nte

nan

ceo

rre

pai

rw

ork

are

fit

for

inte

nd

edu

se?

–W

hat

kin

ds

of

gre

ases

are

use

d?

<gre

ase

list>

Wh

enm

ater

ials

use

din

mai

nte

nan

ceo

rre

pai

rw

ork

sar

en

ot

foo

dg

rad

ean

da

safe

tyri

skfo

rth

eco

nsu

mer

ensu

es.

4.16

.4Fa

ilure

so

fp

lan

tan

deq

uip

men

t(i

ncl

.tr

ansp

ort

)co

vere

db

yth

em

ain

te-

nan

cesy

stem

shal

lbe

do

cum

ente

dan

dre

view

edw

ith

avi

ewto

adap

t-in

gth

em

ain

ten

ance

syst

em.

C1.

2.1–

21,

2,4,

5–

Are

pro

cess

ing

inte

rru

pti

on

sd

ocu

-m

ente

d?

<pro

cess

ing

inte

rru

pti

on

s>–

Are

pro

cess

ing

inte

rru

pti

on

sco

nsi

der

edin

mai

nte

nan

cep

lan

nin

g?

4.16

.5Te

mp

ora

ryre

pai

rssh

allb

eca

rrie

do

ut

soth

atp

rod

uct

req

uir

emen

tsar

en

ot

affe

cted

.Su

chw

ork

shal

lbe

do

cum

ente

dan

da

sho

rt-t

erm

dea

dlin

ese

tfo

rel

imin

atin

gth

efa

ult

.

C1.

2.1–

21,

2,4,

5–

Are

tem

po

rary

rep

airs

allo

wed

?–

Wh

ere

are

thes

ed

ocu

men

ted

?–

Ho

wfa

stm

ust

tem

po

rary

rep

airs

be

defi

nit

ely

men

ded

?–

Wh

ove

rifi

esth

is?

4.16

.6W

her

ea

com

pan

yh

ires

ath

ird

-par

tym

ain

ten

ance

and

rep

air

serv

ice

pro

vid

er,a

llth

eco

mp

any

spec

ified

req

uir

emen

tsre

gar

din

gm

ater

iala

nd

equ

ipm

ent

shal

lbe

clea

rly

defi

ned

,d

ocu

men

ted

and

mai

nta

ined

.

C1.

2.1–

21,

2,4,

5

4.17

Eq

uip

men

t

4.17

.1E

qu

ipm

ent

shal

lbe

suit

ably

des

ign

edan

dsp

ecifi

edfo

rth

ein

ten

ded

use

.Bef

ore

com

mis

sio

nin

g,

itsh

allb

eve

rifi

edth

atth

ep

rod

uct

req

uir

emen

tsar

eco

mp

lied

wit

h.

7.0

CC

1.1.

1–3

A2.

1.3

1.2.

31

–A

reeq

uip

men

tssu

itab

lyd

esig

ned

and

wer

eth

eych

ecke

db

efo

rest

art

up

?<s

tart

up

pro

toco

l>

Wh

eneq

uip

men

tco

nst

ruct

ion

can

lead

toa

pac

kag

ing

mat

eria

lco

nta

min

a-ti

on

.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.17

.2Fo

ral

leq

uip

men

tan

dto

ols

wit

hd

irec

tp

acka

gin

gm

ater

ialc

on

tact

,ce

rtifi

cate

so

fco

nfo

rmit

ysh

alle

xist

wh

ich

con

firm

com

plia

nce

wit

hcu

rren

tle

gal

req

uir

emen

ts.I

nca

sen

osp

ecifi

cle

gal

req

uir

emen

tsar

eap

plic

able

,evi

den

cesh

allb

eav

ail-

able

tod

emo

nst

rate

that

alle

qu

ip-

men

tan

dto

ols

are

suit

able

for

use

.T

his

app

lies

for

alle

qu

ipm

ent

and

too

lsin

dir

ect

con

tact

wit

hra

wm

ater

ials

,sem

i-p

roce

ssed

and

fin

ish

edp

rod

uct

s.

C1.

1.1–

35

–A

reco

nfo

rmit

yce

rtifi

cate

so

ro

ther

cert

ifica

tes

avai

lab

lefo

ral

lwra

pp

ing

mat

eria

lsw

hic

hco

me

into

dir

ect

con

tact

wit

hp

acka

gin

gm

ater

ialp

rod

uct

s?<c

on

form

ity

cert

ifica

tes>

–A

reco

nfo

rmit

yce

rtifi

cate

sav

aila

ble

for

wra

pp

ing

mat

eria

lsw

hic

hco

me

into

dir

ect

con

tact

wit

hra

wm

ater

ials

,hal

f-fi

nis

hed

or

fin

ish

edp

rod

uct

s?<c

on

form

ity

cert

ifica

tes>

–A

reco

nfo

rmit

yce

rtifi

cate

sav

aila

ble

for

con

tain

ers

and

con

veyo

rb

elts

?<c

on

form

ity

cert

ifica

tes>

Wra

pp

ing

san

dw

rap

pin

gm

ater

ials

wh

ich

com

ein

tod

irec

tco

nta

ctw

ith

pac

kag

ing

mat

eria

lar

en

ot

suit

able

for

inte

nd

edu

sean

dth

eref

ore

asa

fety

risk

exis

ts.

4.17

.3E

qu

ipm

ent

shal

lbe

des

ign

edan

dlo

cate

dso

that

clea

nin

gan

dm

ain

te-

nan

ceo

per

atio

ns

can

be

effe

ctiv

ely

per

form

ed.

C1.

1.1–

3A

2.1.

83 5

–A

reeq

uip

men

tssu

itab

lyd

esig

ned

and

wer

eth

eych

ecke

db

efo

rest

art

up

?<s

tart

up

pro

toco

l>–

Wh

atru

les

exis

tfo

rst

art

up

of

new

equ

ipm

ents

?–

Wer

en

eweq

uip

men

tsim

med

iate

lyco

nsi

der

edin

mai

nte

nan

cep

lan

?–

Do

esan

equ

ipm

ent

inst

alla

tio

np

lan

exis

t?<m

ach

iner

yin

stal

lati

on

pla

n>

Wh

eneq

uip

men

tis

inst

alle

din

aw

ayth

atcl

ean

ing

pro

ced

ure

sar

eh

ind

ered

and

thu

sco

nst

itu

tea

con

tam

i-n

atio

nso

urc

e.

4.17

.4T

he

com

pan

ysh

alle

nsu

reth

atal

lp

rod

uct

equ

ipm

ent

isin

go

od

con

dit

ion

wit

ho

ut

any

neg

ativ

ein

flu

ence

on

pac

kag

ing

mat

eria

lsa

fety

.

7.0

C

4.17

.5T

he

com

pan

ysh

alle

nsu

reth

atin

the

even

to

fch

ang

esto

pro

cess

ing

met

ho

ds

and

equ

ipm

ent,

pro

cess

char

acte

rist

ics

are

revi

ewed

ino

rder

toas

sure

that

pro

du

ctre

qu

irem

ents

are

com

plie

dw

ith

.

C1.

1.1–

34

–W

hat

hap

pen

sin

case

of

equ

ipm

ent

failu

res?

<eq

uip

men

tst

op

s>

Wh

eneq

uip

men

tst

op

sle

adto

ap

rod

uct

safe

tyis

sue

and

thes

ear

en

ot

seg

reg

ated

.

4.18

Trac

eab

ility

(in

clu

din

gG

MO

san

dal

lerg

ens)

7.0

F1



4.18

.1K

OK

ON

°6:

Atr

acea

bili

tysy

stem

shal

lb

ein

pla

cew

hic

hen

able

sth

eid

enti

fica

tio

no

fp

rod

uct

lots

and

thei

rre

lati

on

tob

atch

eso

fra

wm

ater

ials

and

wra

pp

ing

mat

eria

lsin

ten

ded

or

exp

ecte

dto

be

ind

irec

tco

nta

ctw

ith

pro

du

ced

pro

du

cts.

Th

etr

acea

bili

tysy

stem

shal

lin

corp

ora

teal

lrel

evan

tre

ceiv

ing

,co

nve

rtin

gan

dd

istr

ibu

tio

nre

cord

s.Tr

acea

bili

tysh

allb

een

sure

dan

dd

ocu

men

ted

un

tild

eliv

ery

toth

ecu

sto

mer

.

7.0

F1F

1.2.

1–2

1,2,

3,4,

5,6,

7,8

–H

ow

istr

acea

bili

tyen

sure

d?

<tra

ceab

ility

pro

ced

ure

s>W

hat

pro

du

cts

com

efr

om

wh

ich

sup

plie

r?–

Isth

ere

alis

tav

aila

ble

wit

hal

lcu

rren

tsu

pp

liers

?<s

up

plie

rlis

t>

Wh

enn

otr

acea

bili

tysy

stem

exis

tsan

dth

esy

stem

do

esn

ot

incl

ud

era

wan

dw

rap

pin

gm

ater

ials

.W

hen

trac

eab

ility

isn

ot

com

ple

teu

pto

the

sup

plie

r.

4.18

.2D

ow

nst

ream

trac

eab

ility

reco

rds

(fro

mp

rod

uct

ion

site

sto

the

cust

om

-er

s)sh

allb

eav

aila

ble

.Th

eti

me-

fram

efo

rp

rod

uci

ng

thes

ere

cord

sfo

rre

view

shal

lbe

com

plia

nt

wit

hcu

sto

mer

’sre

qu

irem

ents

.

F1.

2.1–

22,

3

4.18

.3Tr

acea

bili

tysh

allb

ein

pla

ceto

iden

-ti

fyth

ere

lati

on

ship

bet

wee

nb

atch

eso

ffi

nal

pro

du

cts

and

thei

rla

bel

s.

F1.

2.1–

22,

3

4.18

.4T

he

trac

eab

ility

syst

emsh

allb

ete

sted

on

ap

erio

dic

bas

is-

atle

ast

ann

ual

lyan

dea

chti

me

trac

eab

ility

syst

emch

ang

es.T

he

test

shal

lver

ify

up

stre

aman

dd

ow

nst

ream

trac

eab

il-it

y(f

rom

del

iver

edp

rod

uct

sto

raw

mat

eria

ls,a

nd

vice

vers

a),i

ncl

ud

ing

qu

anti

tych

ecki

ng

.Tes

tre

sult

ssh

all

be

reco

rded

.

F1.

1.1–

210

–W

hen

was

the

last

trac

eab

ility

test

inb

oth

dir

ecti

on

sd

on

e?<t

race

abili

tyte

stre

sult

s>–

Wh

atp

erce

nta

ge

of

tota

lam

ou

nt

was

trac

ed?

–H

ow

big

isa

lot?

Wh

entr

acea

bili

tysy

stem

isn

ot

test

edin

bo

thd

irec

tio

ns

soth

atn

oas

sura

nce

isg

iven

asto

its

effe

ctiv

enes

s.W

hen

test

resu

lts

are

neg

ativ

ean

dn

oco

rrec

tive

acti

on

sar

eta

ken

.

4.18

.5Tr

acea

bili

tysh

allb

een

sure

dat

all

stag

es,i

ncl

ud

ing

wo

rkin

pro

gre

ss,

po

sttr

eatm

ent

and

rew

ork

.

F1.

2.1–

24,

5–

Can

rew

ork

be

com

ple

tely

trac

ed?

<res

ult

sfr

om

rew

ork

trac

eab

ility

test

>–

Ho

wis

rew

ork

do

cum

ente

d/

Wh

enre

wo

rktr

ace-

abili

tyis

no

ten

sure

d.

4.18

.6La

bel

ing

of

sem

i-fi

nis

hed

or

fin

ish

edp

rod

uct

lots

shal

lbe

mad

eat

the

tim

ew

hen

the

go

od

sar

ed

irec

tly

pac

ked

/w

rap

ped

toen

sure

acl

ear

trac

eab

ility

of

go

od

s.W

her

eg

oo

ds

are

lab

eled

ata

late

rti

me,

the

tem

po

rari

lyst

ore

dg

oo

ds

shal

lhav

eb

een

pro

vid

edw

ith

asp

ecifi

clo

tla

bel

ing

.Th

ere

com

-m

end

edco

nve

rtin

gti

me

of

the

lab

eled

go

od

ssh

allb

eca

lcu

late

dfr

om

the

ori

gin

alp

rod

uct

ion

bat

ch.

F1.

2.1–

24,

5–

Wh

enis

lot

lab

elin

gd

on

e?–

Wh

atis

the

lot

lab

elin

gco

de?

<lo

tla

bel

ing

exam

ple

>–

Wh

enar

ela

bel

sap

plie

dto

pro

du

ctu

nit

s?–

Ho

wis

reco

mm

end

edco

nve

rtin

gti

me

calc

ula

ted

?<c

on

vert

ing

tim

eex

amp

le>

Wh

enlo

tla

bel

ing

isd

on

eat

ast

epw

her

em

ixu

ps

occ

ur

wh

ich

un

able

corr

ect

trac

eab

ility

.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

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secu

reP

Pre

quir

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ent

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er

Text

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ero

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Cse

cure

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(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

4.18

.7If

req

uir

edb

ycu

sto

mer

,id

enti

fied

sam

ple

sre

pre

sen

tati

vefo

rth

em

anu

-fa

ctu

rin

glo

tsh

allb

est

ore

dap

pro

pri

-at

ely

and

kep

tu

nti

lexp

irat

ion

of

the

reco

mm

end

edco

nve

rtin

gti

me

of

the

fin

ish

edp

rod

uct

and

ifn

eces

sary

for

ad

eter

min

edp

erio

db

eyo

nd

this

dat

e.

F1.

2.1–

27

–Is

asa

mp

leb

ank

imp

lem

ente

d?

4.19

Alle

rgen

san

dsp

ecifi

cco

nd

itio

ns

of

pro

du

ctio

n

4.19

.1W

hen

spec

ified

by

the

cust

om

er,t

he

com

pan

ysh

allm

ain

tain

aco

nti

nu

-o

usl

yu

pto

dat

elis

tin

go

fal

lraw

mat

eria

lsco

nta

inin

gal

lerg

ens

use

dat

its

pre

mis

es(e

.g.s

tarc

has

ag

lue)

,w

hic

hal

soid

enti

fies

allb

len

ds

and

form

ula

s/co

nfi

gu

rati

on

sto

wh

ich

such

raw

mat

eria

lsco

nta

inin

gal

lerg

ens

are

add

ed.

B2.

2.1–

415

–A

real

lerg

ens

iden

tifi

edin

spec

ifica

tio

ns?

–D

oes

alis

tex

ist

that

cove

rsal

lerg

ens

inu

se?

<alle

rgen

list>

Alle

rgen

sar

en

ot

iden

tifi

edan

da

cust

om

ersa

fety

issu

een

sues

.

4.19

.2T

he

man

ufa

ctu

rin

go

fp

rod

uct

sw

hic

hco

nta

inal

lerg

ens

req

uir

ing

dec

lara

tio

nsh

allb

eca

rrie

do

ut

asto

ensu

recr

oss

con

tam

inat

ion

ism

inim

ized

asfa

ras

po

ssib

le.

–Is

ap

roce

du

rein

pla

ceto

avo

idco

nta

mi-

nat

ion

of

alle

rgen

free

pro

du

cts?

–H

ow

oft

enis

effe

ctiv

enes

so

fth

ese

pro

ced

ure

sre

view

ed?

–W

her

ear

eth

ese

pro

ofs

do

cum

ente

d?

<exa

mp

les>

4.19

.3W

her

ecu

sto

mer

ssp

ecifi

cally

req

uir

eth

atp

rod

uct

sar

e“f

ree

fro

m”

cert

ain

sub

stan

ces

or

ing

red

ien

ts(e

.g.

star

ch),

or

that

cert

ain

met

ho

ds

of

trea

tmen

to

rp

rod

uct

ion

are

excl

ud

ed,v

erifi

able

pro

ced

ure

ssh

all

be

inp

lace

.

–H

asal

lerg

enst

atu

sb

een

do

cum

ente

din

spec

ifica

tio

ns?

<fin

ish

edp

rod

uct

spec

ifica

tio

ns>

Alle

rgen

sar

en

ot

dec

lare

dan

da

safe

tyri

skfo

rth

eco

nsu

mer

occ

urs

.

5M

easu

rem

ents

,An

alys

is,

Imp

rove

men

ts

5.1

Inte

rnal

aud

its



5.1.

1K

OK

ON

°7:

Eff

ecti

vein

tern

alau

dit

ssh

allb

eco

nd

uct

edac

cord

ing

toa

defi

ned

agre

edau

dit

pro

gra

man

dsh

allc

ove

rat

leas

tal

lreq

uir

emen

tso

fth

eIF

SPA

Cse

cure

Sta

nd

ard

.S

cop

ean

dfr

equ

ency

of

inte

rnal

aud

its

shal

lbe

det

erm

ined

by

haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ci-

ated

risk

s.T

his

isal

soap

plic

able

for

off

site

sto

rag

elo

cati

on

so

wn

edo

rre

nte

db

yth

eco

mp

any.

–D

oes

anu

pto

dat

ein

tern

alau

dit

pla

nex

ist?

<au

dit

pla

n>

–Is

aud

itp

lan

bas

edo

nh

azar

dan

alys

is?

<haz

ard

anal

ysis

>

No

inte

rnal

aud

its

are

per

form

ed.

5.1.

2In

tern

alau

dit

so

fac

tivi

ties

wh

ich

are

crit

ical

top

acka

gin

gm

ater

ials

afet

yan

dp

rod

uct

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

ns

shal

lbe

carr

ied

ou

tat

leas

to

nce

aye

ar.

–H

ow

oft

enar

ein

tern

alau

dit

sp

erfo

rmed

?<a

ud

itp

lan

>–

Th

efo

llow

ing

issu

esca

nb

eta

ken

into

con

sid

erat

ion

for

inte

rnal

aud

its:

·al

lpro

du

ctio

nst

eps

(pac

kag

ing

area

,la

bel

ing

,GM

P’s

,GH

P’s

,CP

’s)

·tr

acea

bili

ty,

·co

ntr

olp

lan

(an

alys

is,c

alib

rati

on

)·

do

cum

enta

tio

nm

anag

emen

t(u

pd

ates

)·

man

agem

ent

of

no

n-c

on

form

itie

s(c

om

pla

ints

,in

tern

aln

on

-co

nfo

rmit

ies,

wit

hd

raw

al,r

ecal

l)

5.1.

3T

he

aud

ito

rssh

allb

eco

mp

eten

tan

din

dep

end

ent

fro

mth

eau

dit

edd

epar

tmen

t.

–W

ho

are

the

aud

ito

rs?

<au

dit

ors

list>

–H

ow

are

aud

ito

rsq

ual

ified

for

this

job

?<c

on

tin

ued

edu

cati

on

evid

ence

>–

Hav

eau

dit

ors

any

con

nec

tio

nw

ith

aud

itar

ea?

5.1.

4A

ud

itre

sult

ssh

allb

eco

mm

un

icat

edto

the

sen

ior

man

agem

ent

and

tore

spo

nsi

ble

per

son

so

fco

nce

rned

dep

artm

ent.

Nec

essa

ryco

rrec

tive

acti

on

san

da

sch

edu

lefo

rim

ple

-m

enta

tio

nsh

allb

ed

eter

min

edan

dd

ocu

men

ted

and

com

mu

nic

ated

toev

ery

rele

van

tp

erso

n.

–H

ow

are

aud

itre

sult

sco

mm

un

icat

edto

the

per

son

sin

char

ge?

<au

dit

rep

ort

dis

trib

uti

on

>–

Isth

eco

mm

un

icat

ion

imm

edia

tean

din

tim

eto

take

mea

sure

s?–

Are

corr

ecti

veac

tio

ns

do

cum

ente

d?

<au

dit

rep

ort

>–

Isa

tim

esc

hed

ule

inp

lace

for

corr

ecti

veac

tio

ns?

<au

dit

rep

ort

>–

Fro

mw

hic

hau

dit

sw

ere

corr

ecti

veac

tio

ns

der

ived

?<a

udit

repo

rtco

ntai

ning

corr

ectiv

eac

tions

>–

Ho

war

eau

dit

resu

lts

forw

ard

edto

sen

ior

man

agem

ent?

<au

dit

rep

ort

dis

trib

uti

on

>–

Ho

war

eau

dit

resu

lts

eval

uat

ed?

No

do

cum

ente

dau

dit

resu

lts.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

5.1.

5It

shal

lbe

do

cum

ente

dh

ow

and

wh

enth

eco

rrec

tive

acti

on

sre

sult

ing

fro

mth

ein

tern

alau

dit

ssh

allb

eve

rifi

ed.

–H

ow

corr

ecti

veac

tio

nve

rifi

cati

on

reg

ula

ted

?<v

erifi

cati

on

evid

ence

>–

Wh

ove

rifi

esan

dw

hen

?

No

corr

ecti

veac

tio

ns

take

nal

tho

ug

hn

eces

sary

.

5.2

Sit

efa

cto

ryin

spec

tio

ns

5.2.

1Fa

cto

ryin

spec

tio

ns

shal

lbe

pla

nn

edan

dca

rrie

do

ut

(e.g

.pro

du

ctco

ntr

ol,

hyg

ien

e,fo

reig

nm

ater

ialh

azar

ds,

per

son

nel

hyg

ien

ean

dh

ou

seke

ep-

ing

).T

he

freq

uen

cyo

fin

spec

tio

ns

inev

ery

area

(in

clu

din

go

utd

oo

rar

eas)

and

ever

ysi

ng

leac

tivi

tysh

allb

eb

ased

on

haz

ard

anal

ysis

and

asse

ss-

men

to

fas

soci

ated

risk

san

do

nth

eh

isto

ryo

fp

revi

ou

sex

per

ien

ce.

7.0

A1

A3.

1.2

9–

Ho

wo

ften

and

wh

op

erfo

rms

site

insp

ecti

on

s?<s

ite

insp

ecti

on

sp

roto

col>

–W

hat

isre

view

edd

uri

ng

site

insp

ecti

on

s?–

For

wh

ich

area

sd

osi

tein

spec

tio

ns

exis

t?

No

site

insp

ecti

on

sar

ep

erfo

rmed

.

5.3

Pro

cess

valid

atio

nan

dco

ntr

ol

5.3.

1T

he

crit

eria

for

pro

cess

valid

atio

nan

dco

ntr

ols

hal

lbe

clea

rly

defi

ned

.6.

5A

mec

han

ism

of

chan

ge

con

tro

lwill

be

esta

blis

hed

toen

sure

chan

ges

toth

ep

acka

g-

ing

mat

eria

lsaf

ety

syst

emar

eco

mm

un

i-ca

ted

and

imp

le-

men

ted

.

5.3.

2In

circ

um

stan

ces

wh

ere

the

con

tro

lo

fp

roce

ssan

dw

ork

ing

envi

ron

men

tp

aram

eter

s(t

emp

erat

ure

,tim

e,p

ress

ure

,ch

emic

alp

rop

erti

eset

c.)

ises

sen

tial

toen

sure

the

pro

du

ctre

qu

irem

ents

,su

chp

aram

eter

ssh

all

be

mo

nit

ore

dan

dre

cord

edco

nti

nu

-o

usl

yan

d/o

rat

app

rop

riat

ein

terv

als.

–H

ow

are

tem

per

atu

res

mo

nit

ore

d?

–W

her

ear

ete

mp

erat

ure

sre

cord

ed?

<pri

nte

dm

easu

rem

ent

dat

a>

Inca

sea

leg

alit

yis

sue

occ

urs

du

eto

mis

sin

gre

cord

s.4.

12.4

.



5.3.

3A

llre

wo

rko

per

atio

ns

shal

lbe

valid

ated

,mo

nit

ore

dan

dd

ocu

-m

ente

d.T

hes

eo

per

atio

ns

shal

lno

taf

fect

the

pro

du

ctre

qu

irem

ents

.

–H

ow

isit

assu

red

that

rew

ork

sco

mp

lyto

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

tio

ns?

–W

her

eis

rew

ork

do

cum

ente

d?

<mo

del

do

cum

enta

tio

nfo

rre

wo

rk>

–W

ho

revi

ews

rew

ork

resu

lts?

–W

ho

dec

ides

rew

ork

liber

atio

n?

–H

ow

isit

ensu

red

that

rew

ork

fulfi

lsle

gal

lyre

qu

irem

ents

?

5.3.

4T

her

esh

allb

eap

pro

pri

ate

pro

ce-

du

res

for

pro

mp

tn

oti

fica

tio

n,r

eco

rd-

ing

and

mo

nit

ori

ng

of

equ

ipm

ent

mal

fun

ctio

nan

dp

roce

ssd

evia

tio

ns.

–W

hat

hap

pen

sw

hen

afa

ilure

occ

urs

?–

Wh

ath

app

ens

wh

enco

ldch

ain

isin

terr

up

ted

?<m

ach

iner

yst

and

still

pro

toco

l>

Inca

sefa

ilure

sar

en

ot

no

tice

dan

dre

sult

ina

safe

tyo

rle

gal

pro

ble

m.

5.3.

5P

roce

ssva

lidat

ion

shal

lbe

per

-fo

rmed

usi

ng

the

colle

cted

dat

ath

atis

rele

van

tfo

rp

rod

uct

safe

tyan

dth

ep

roce

sses

.If

sub

stan

tial

mo

difi

ca-

tio

ns

occ

ur,

are

valid

atio

nsh

allb

eca

rrie

do

ut.

6.4

Pre

req

uis

ite

pro

gra

mva

lidat

ion

will

be

pla

nn

edan

dim

ple

-m

ente

d.

5.4

Cal

ibra

tio

n,a

dju

stm

ent

and

chec

k-in

go

fm

easu

rin

gan

dm

on

ito

rin

gd

evic

es

5.4.

1T

he

com

pan

ysh

alli

den

tify

the

mea

suri

ng

and

mo

nit

ori

ng

dev

ices

req

uir

edto

ensu

reco

mp

lian

cew

ith

pro

du

ctre

qu

irem

ents

.Th

ese

dev

ices

shal

lbe

reco

rded

on

ad

ocu

men

tan

dcl

earl

yid

enti

fied

.

C1.

2.1–

21–

13–

Wh

atki

nd

so

fm

on

ito

rin

gd

evic

esex

ist?

<mo

nit

ori

ng

dev

ices

list>

–W

hat

isd

eman

ded

ofm

on

ito

rin

gd

evic

es?

–W

hat

mo

nit

ori

ng

dev

ice

isad

equ

ate

for

wh

ich

kin

do

fm

easu

rem

ent?

–H

ow

are

mo

nit

ori

ng

dev

ices

iden

tifi

ed?

<id

enti

fica

tio

nst

icke

rso

nm

on

ito

rin

gd

evic

es>

–D

oca

libra

ted

dev

ices

exis

t?<m

on

ito

rin

gd

evic

eslis

t>

Th

eco

mp

any

has

no

mea

suri

ng

and

mo

nit

ori

ng

dev

ices

.

5.4.

2A

llm

easu

rin

gd

evic

essh

allb

ech

ecke

d,a

dju

sted

and

calib

rate

d,

un

der

am

on

ito

rin

gsy

stem

,at

spec

ified

inte

rval

san

din

acco

rdan

cew

ith

defi

ned

reco

gn

ized

stan

d-

ard

/met

ho

ds.

Th

ere

sult

so

fth

ech

ecks

,ad

just

men

tsan

dca

libra

tio

ns

shal

lbe

do

cum

ente

d.W

her

en

eces

-sa

ry,c

orr

ecti

veac

tio

ns

on

dev

ices

and

,if

nec

essa

ry,o

np

roce

ssan

dp

rod

uct

ssh

allb

eca

rrie

do

ut.

C1.

2.1–

21–

13–

Ho

wis

mea

suri

ng

dev

ices

chec

ko

rgan

-iz

ed?

<cal

ibra

tio

np

roce

du

res>

–A

rem

easu

rin

gd

evic

esre

gu

larl

yca

li-b

rate

d?

<cal

ibra

tio

np

roto

col>

–W

ho

isre

spo

nsi

ble

for

calib

rati

on

?–

Ho

wis

calib

rati

on

do

ne?

Wh

ere

isit

do

cum

ente

d?

<cal

ibra

tio

nre

cord

s>–

Wh

atco

rrec

tive

acti

on

sar

eta

ken

wh

ena

tole

ran

ced

evia

tio

nis

fou

nd

?<c

orr

ecti

veac

tio

ns>

<cal

ibra

tio

np

roto

col>

–Is

calib

rati

on

up

tod

ate?

<cal

ibra

tio

nce

rtifi

cate

>

No

calib

rati

on

isp

erfo

rmed

.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

5.4.

3A

llm

easu

rin

gd

evic

essh

allb

eu

sed

excl

usi

vely

for

thei

rd

efin

edp

urp

ose

.W

her

eth

ere

sult

so

fm

easu

rem

ents

ind

icat

ea

mal

fun

ctio

n,t

he

dev

ice

inq

ues

tio

nsh

allb

eim

med

iate

lyre

pai

red

or

rep

lace

d.

C1.

2.1–

21–

13–

Wh

atac

tio

ns

are

take

nw

hen

mea

sure

-m

ent

resu

lts

are

un

cert

ain

?–

Ho

war

eem

bar

go

edm

easu

rin

gd

evic

esid

enti

fied

?

Wh

end

efec

tive

mea

suri

ng

dev

ices

are

no

tex

chan

ged

and

asa

fety

issu

een

sues

.(e.

g.d

efec

-ti

vem

igra

tio

nm

easu

rem

ent

dev

ice

e.g

.gas

chro

mat

o-

gra

ph

for

mig

rati

on

test

s).

5.4.

4T

he

calib

rati

on

stat

us

of

the

mea

sur-

ing

dev

ices

shal

lbe

clea

rly

iden

tifi

ed(l

abel

edat

the

mac

hin

eo

ro

na

list

of

test

dev

ices

).

C1.

2.1–

21–

13–

Ho

wis

calib

rati

on

stat

us

of

mea

suri

ng

dev

ice

iden

tifi

ed?

<mea

suri

ng

dev

ices

list>

5.5

Co

ntr

olo

fq

uan

tity

/filli

ng

qu

anti

ty

5.5.

1T

he

freq

uen

cyan

dm

eth

od

olo

gy

of

con

tro

lof

qu

anti

tysh

allb

ed

eter

-m

ined

soth

atth

ele

gal

lyre

qu

ire-

men

tsan

dcu

sto

mer

spec

ifica

tio

ns

or

oth

erle

gal

lyre

qu

ired

do

cum

enta

-ti

on

,or

ifap

pro

pri

ate,

gu

idel

ines

for

no

min

alq

uan

tity

are

met

.

–H

ow

isit

ensu

red

that

leg

alre

qu

irem

ents

for

amo

un

tco

ntr

ola

rem

et?

Leg

alre

qu

irem

ents

are

no

tm

etd

ue

tola

cko

fo

rin

suffi

cien

tam

ou

nt

mea

sure

-m

ents

bei

ng

mad

e.

5.5.

2A

pro

ced

ure

shal

lexi

stto

defi

ne

crit

eria

for

com

plia

nce

chec

kin

g.T

his

pro

ced

ure

shal

lals

o,a

mo

ng

oth

ers,

take

into

con

sid

erat

ion

the

tare

,th

ed

ensi

tyan

do

ther

crit

ical

attr

ibu

tes.

5.5.

3C

hec

kssh

allb

eim

ple

men

ted

and

reco

rded

,acc

ord

ing

toa

sam

plin

gp

lan

wh

ich

ensu

res

ap

rop

erre

pre

-se

nta

tio

no

fth

em

anu

fact

uri

ng

lot.

5.5.

4R

esu

lts

of

thes

ech

ecks

shal

lbe

com

plia

nt

wit

hd

efin

edcr

iter

iafo

ral

lp

rod

uct

sre

ady

tob

ed

eliv

ered

.



5.5.

5Fo

rp

urc

has

ed,a

lrea

dy

pre

-pac

ked

pro

du

cts

fro

mth

ird

par

ties

,th

ere

shal

lbe

evid

ence

abo

ut

the

com

pli-

ance

wit

hth

ele

gal

req

uir

emen

ts.

–H

ow

isit

ensu

red

that

pu

rch

ased

,p

re-p

acke

dp

rod

uct

sfr

om

thir

dp

arti

esco

nta

inth

eco

rrec

tp

rod

uct

amo

un

t(a

pp

licab

lefo

rre

tail

bra

nd

edp

rod

uct

san

do

ther

lab

els)

?

<dea

ler

evid

ence

>

No

evid

ence

exis

tsth

atp

urc

has

edp

rod

uct

sco

mp

lyw

ith

leg

alre

qu

irem

ents

.

5.5.

6If

app

licab

le,a

lleq

uip

men

tu

sed

for

fin

alch

ecki

ng

shal

lbe

app

rove

d.

–A

rem

easu

rin

gd

evic

esin

use

reg

ula

rly

calib

rate

d?

–W

her

eis

calib

rati

on

reco

rded

?<c

alib

rati

on

pro

toco

l>–

Are

ther

eca

libra

ted

mea

suri

ng

dev

ices

?<c

alib

rati

on

cert

ifica

te>

5.6

Pro

du

ctan

alys

is

5.6.

1T

her

esh

allb

ep

roce

du

res

ensu

rin

gth

atal

lsp

ecifi

edp

rod

uct

req

uir

e-m

ents

are

met

,in

clu

din

gle

gal

req

uir

emen

tsan

dsp

ecifi

cati

on

s.C

hem

ical

,ph

ysic

alan

dm

icro

bio

log

i-ca

lan

alys

isre

qu

ired

for

that

pu

rpo

sesh

allb

ep

erfo

rmed

inte

rnal

lyan

d/o

rsu

bco

ntr

acte

d.

–W

hic

hch

emic

al,p

hys

ical

or

mic

rob

io-

log

ical

anal

yses

are

mad

eo

rsu

bco

n-

trac

ted

?<a

nal

ysis

resu

lts>

No

resu

lts

of

anal

y-se

sar

eav

aila

ble

.

5.6.

2A

nal

yses

,wh

ich

are

rele

van

tfo

rp

acka

gin

gm

ater

ials

afet

y,sh

all

pre

fera

bly

be

per

form

edb

yla

bo

rato

-ri

esh

avin

gap

pro

pri

ate

accr

edit

edp

rog

ram

s/m

eth

od

s(I

SO

1702

5).I

fth

ean

alys

esar

ep

erfo

rmed

by

afa

cto

ryin

tern

alo

ra

lab

ora

tory

no

th

avin

gap

pro

pri

ate

accr

edit

edp

rog

ram

s/m

eth

od

s,th

ere

sult

ssh

all

be

veri

fied

on

are

gu

lar

bas

isb

yla

bo

rato

ries

accr

edit

edo

nth

ese

pro

gra

ms/

met

ho

ds

(IS

O17

025)

.

–Is

ther

ean

anal

ytic

alla

bo

rato

ryo

nsi

te?

Isit

accr

edit

edu

nd

erIS

O17

025?

<acc

red

itat

ion

evid

ence

>–

Are

inte

rnal

lab

resu

lts

veri

fied

by

anac

cred

ited

lab

?–

Wh

ich

exte

rnal

lab

ora

tori

esar

eu

sed

?A

reth

ese

accr

edit

edu

nd

erIS

O17

025?

<acc

red

itat

ion

evid

ence

>

5.6.

3P

roce

du

res

shal

lexi

stw

hic

hen

sure

the

relia

bili

tyo

fth

ein

tern

alan

alys

isre

sult

so

nth

eb

asis

of

offi

cial

reco

gn

ized

anal

ysis

met

ho

ds.

Th

issh

allb

ed

emo

nst

rate

db

yri

ng

test

so

ro

ther

pro

fici

ency

test

s.

–H

ow

isit

ensu

red

that

inte

rnal

anal

ytic

alm

eth

od

sar

eap

pro

pri

ate?

–A

reri

ng

test

sp

erfo

rmed

?<r

ing

test

per

form

ance

evid

ence

>



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

5.6.

4A

test

pla

nsh

allb

ed

raw

nu

pfo

rin

tern

alan

dex

tern

alan

alys

is,b

ased

on

haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ciat

edri

sks,

wh

ich

cove

rsra

wm

ater

ials

,sem

i-p

roce

ssed

and

fin

ish

edp

rod

uct

sas

wel

las

pro

cess

-in

geq

uip

men

tsan

dp

acka

gin

gm

ater

ials

,an

dw

her

en

eces

sary

envi

ron

men

talt

ests

.Th

ete

stre

sult

ssh

allb

ed

ocu

men

ted

.

–D

oes

anin

spec

tio

np

lan

exis

t?

–W

ho

org

aniz

esin

spec

tio

np

lan

?W

hic

hp

rod

uct

sar

een

com

pas

sed

by

insp

ecti

on

pla

n?

(raw

mat

eria

ls,h

alf-

fin

ish

edan

dfi

nis

hed

pro

du

cts,

wra

pp

ing

mat

eria

ls,e

nvi

ron

men

talt

ests

?)

–Is

insp

ecti

on

pla

nb

ased

on

haz

ard

anal

ysis

?<h

azar

dan

alys

is>

–W

her

ear

ete

stre

sult

sd

ocu

men

ted

?<t

est

resu

lts>

No

insp

ecti

on

pla

nex

ists

.

5.6.

5R

esu

lts

of

anal

ysis

shal

lbe

eval

uat

edp

rom

ptl

y.A

pp

rop

riat

eco

rrec

tive

mea

sure

ssh

allb

ein

tro

du

ced

for

any

un

sati

sfac

tory

resu

lts.

Th

ean

alyt

ical

resu

lts

shal

lbe

revi

ewed

reg

ula

rly

ino

rder

toid

enti

fytr

end

s.Tr

end

sin

di-

cati

ng

po

ten

tial

un

sati

sfac

tory

resu

lts

shal

lbe

take

nin

toco

nsi

der

atio

n.

–W

ho

revi

ews

anal

ytic

alre

sult

s?–

Ho

war

ean

alyt

ical

resu

lts

veri

fied

?–

Are

tren

ds

inve

stig

ated

?–

Are

corr

ecti

veac

tio

ns

intr

od

uce

dw

hen

resu

lts

are

un

sati

sfac

tory

?<c

orr

ecti

veac

tio

ns>

Wh

ente

stre

sult

sex

ist

that

do

no

tco

mp

lyw

ith

leg

alre

qu

irem

ents

and

no

corr

ecti

veac

tio

ns

wer

eta

ken

.

5.6.

6W

her

ein

tern

alan

alys

isis

un

der

-ta

ken

,qu

alifi

edan

dtr

ain

edp

erso

n-

nel

shal

lbe

inp

lace

,as

wel

las

app

rop

riat

eeq

uip

men

tan

dp

rem

-is

es.

–W

hic

hte

sts

are

per

form

edin

tern

ally

?–

Wha

tqua

lifica

tions

dola

bte

chni

cian

sha

ve?

<qu

alifi

cati

on

evid

ence

>–

Isan

inte

rnal

lab

avai

lab

le?

–H

ow

isp

rod

uct

con

tam

inat

ion

by

inte

rnal

lab

pre

ven

ted

?

5.6.

7Fo

rve

rifi

cati

on

of

fin

ish

edp

rod

uct

qu

alit

y,in

tern

alo

rgan

ole

pti

cte

sts

shal

lbe

carr

ied

ou

tre

gu

larl

yw

hen

spec

ified

by

the

cust

om

er.T

hes

ete

sts

shal

lbe

inac

cord

ance

wit

hsp

ecifi

cati

on

so

ro

ther

leg

ally

req

uir

-ed

do

cum

enta

tio

nan

dre

late

dto

the

imp

act

on

resp

ecti

vep

aram

eter

so

fp

rod

uct

char

acte

rist

ic.T

he

resu

lts

of

thes

ete

sts

shal

lbe

do

cum

ente

d.

–W

hen

and

ho

war

eo

rgan

ole

pti

cte

sts

per

form

ed?

<in

spec

tio

np

lan

><d

ocu

men

tati

on

of

org

ano

lep

tic

test

resu

lts>



5.6.

8B

ased

on

any

inte

rnal

or

exte

rnal

info

rmat

ion

on

pro

du

ctri

sks

wh

ich

may

hav

ean

imp

act

on

pac

kag

ing

mat

eria

lsaf

ety,

the

com

pan

ysh

all

up

dat

eit

sco

ntr

olp

lan

and

/or

take

any

app

rop

riat

em

easu

reto

con

tro

lim

pac

to

nfi

nis

hed

pro

du

cts.

For

exam

ple

,if

anal

ert

syst

emin

form

sth

ata

raw

mat

eria

lso

urc

edfr

om

asp

ecifi

cco

un

try

reg

ula

rly

has

spec

ific

rate

of

dan

ger

ou

ssu

bst

ance

,an

dif

the

com

pan

yis

use

dto

bu

yin

gth

issp

ecifi

cra

wm

ater

ial,

the

com

pan

ysh

alli

ncr

ease

the

freq

uen

cyo

fan

alys

iso

fth

isra

wm

ater

ial,

toim

pro

vem

on

ito

rin

g.

On

the

oth

erh

and

,if

resu

lts

of

anal

ysis

alw

ays

sho

wg

oo

dre

sult

s,an

dif

the

raw

mat

eria

lis

con

sid

ered

asa

low

risk

on

e,th

eco

mp

any

can

dec

ide

tod

ecre

ase

the

freq

uen

cyo

fan

alys

is.

5.7

Pro

du

ctq

uar

anti

ne

(blo

ckin

g/h

old

)an

dp

rod

uct

rele

ase

5.7.

1A

pro

ced

ure

shal

lbe

inp

lace

,bas

edo

nh

azar

dan

alys

isan

das

sess

men

to

fas

soci

ated

risk

s,fo

rth

eq

uar

an-

tin

e(b

lock

ing

/ho

ld)

and

rele

ase

of

all

raw

mat

eria

ls,s

emi-

pro

cess

edan

dfi

nis

hed

pro

du

cts

and

wra

pp

ing

mat

eria

ls.T

he

pro

ced

ure

shal

len

sure

that

on

lyp

rod

uct

san

dm

ater

ials

con

form

ing

top

rod

uct

req

uir

emen

tsar

eco

nve

rted

and

dis

pat

ched

.

7.0

B2

6.3

Inre

spo

nse

tod

evia

-ti

on

sfr

om

the

pre

req

ui-

site

pro

gra

ms

corr

ec-

tive

acti

on

sw

illb

ed

eter

min

ed.

Co

rrec

tive

acti

on

sm

ayin

clu

de,

bu

tar

en

ot

limit

edto

:–

Pro

du

cth

old

,ass

ess-

men

tan

dd

isp

osi

tio

n.

–E

nsu

rin

gth

eco

rrec

-ti

veac

tio

nis

com

-p

lete

d.

–R

oo

tca

use

iden

tifi

ca-

tio

n.

–P

reve

nti

veac

tio

ns.

–W

ho

qu

aran

tin

eso

rre

leas

esp

rod

uct

s?<j

ob

des

crip

tio

n>

–H

ow

are

qu

aran

tin

edp

rod

uct

sid

enti

fied

?

Wh

enn

op

roce

du

res

exis

tfo

rp

rod

uct

qu

aran

tin

eo

rre

leas

e.W

hen

qu

aran

tin

edp

rod

uct

sg

ou

nch

ecke

din

tofu

rth

eru

sean

da

safe

tyis

sue

occ

urs

.

5.8

Man

agem

ent

of

com

pla

ints

fro

mau

tho

riti

esan

dcu

sto

mer

s

5.8.

1A

syst

emsh

allb

ein

pla

cefo

rth

em

anag

emen

to

fp

rod

uct

com

pla

ints

.–

Ho

war

eco

mp

lain

tsh

and

led

?<c

om

pla

int

han

dlin

gp

roce

du

re>

Ifth

ere

isn

op

roce

-d

ure

for

com

pla

int

han

dlin

g.

5.8.

2A

llco

mp

lain

tssh

allb

eas

sess

edb

yco

mp

eten

tst

aff.

Wh

ere

itis

just

ified

app

rop

riat

eac

tio

ns

shal

lbe

take

nim

med

iate

ly,i

fn

eces

sary

.

–W

ho

po

nd

ers

abo

ut

com

pla

int

sig

nifi

-ca

nce

?–

Wh

od

efin

esth

eac

tio

ns

tob

eta

ken

?–

Wit

hin

wh

atti

me

fram

em

ust

acti

on

sb

eta

ken

?



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

5.8.

3C

om

pla

ints

shal

lbe

anal

yzed

wit

ha

view

toim

ple

men

tin

gp

reve

nti

veac

tio

ns

wh

ich

avo

idth

ere

curr

ence

of

the

no

n-c

on

form

ity.

–W

ho

man

ages

com

pla

int

stat

isti

cs?

<co

mp

lain

tst

atis

tics

>–

Ho

wo

ften

are

com

pla

int

stat

isti

csco

mp

iled

?–

Wh

atac

tio

ns

are

take

nto

avo

idre

cur-

ren

ce?

No

corr

ecti

veac

tio

ns

wer

eta

ken

alth

ou

gh

afa

ilure

com

esu

pm

ore

freq

uen

tly

or

isco

nsi

der

edas

seri

ou

s.

5.8.

4T

he

resu

lts

of

com

pla

int

dat

aan

alys

issh

allb

em

ade

avai

lab

leto

the

rele

van

tre

spo

nsi

ble

per

son

san

dto

the

sen

ior

man

agem

ent.

–To

wh

om

are

com

pla

int

stat

isti

csd

ata

pre

sen

ted

?<r

etai

ler

com

pla

int

stat

isti

csd

ata>

5.9

Man

agem

ent

of

inci

den

ts,p

rod

uct

wit

hd

raw

al,p

rod

uct

reca

ll

5.9.

1A

do

cum

ente

dp

roce

du

resh

allb

ed

efin

edfo

rm

anag

emen

to

fin

cid

ents

and

of

po

ten

tial

emer

gen

cysi

tua-

tio

ns

that

imp

act

pac

kag

ing

mat

eria

lsa

fety

,leg

alit

yan

dq

ual

ity.

Th

isp

roce

du

resh

allb

eim

ple

men

ted

and

mai

nta

ined

.Th

isin

clu

des

asa

min

imu

m:t

he

no

min

atio

nan

dtr

ain

ing

of

acr

isis

team

,an

aler

tco

nta

ctlis

t,so

urc

eso

fle

gal

advi

ce(i

fn

eces

sary

),co

nta

cts

avai

lab

ility

,cu

sto

mer

info

rmat

ion

,an

da

com

-m

un

icat

ion

pla

n,i

ncl

ud

ing

info

rma-

tio

nto

con

sum

ers.

7.0

F1

F1.

1.1–

21–

10–

Wh

ob

elo

ng

sto

inci

den

tm

anag

emen

tst

aff?

<ph

on

elis

t>–

Wh

ois

info

rmed

wh

enan

inci

den

to

ccu

rs?

–H

ow

are

inci

den

tsm

anag

ed?

<cri

sis

man

agem

ent

pro

ced

ure

s>–

Wh

atis

anin

cid

ent?

<in

cid

ent

man

agem

ent

pro

ced

ure

s>–

com

mu

nic

atio

np

lan

:defi

nit

ion

of

the

inte

rnal

and

exte

rnal

com

mu

nic

atio

n(i

nth

eca

seo

fin

cid

ents

,pro

du

ctw

ith

-d

raw

al,p

rod

uct

reca

ll),

Wh

ois

allo

wed

tore

po

rtw

hat

tow

ho

m?

Ifth

ere

isn

oin

cid

ent

man

agem

ent

syst

emim

ple

men

ted

.

5.9.

2K

ON

°8:

Th

ere

shal

lbe

anef

fect

ive

pro

ced

ure

for

the

wit

hd

raw

al/r

ecal

lo

fal

lpro

du

cts,

wh

ich

ensu

res

that

invo

lved

cust

om

ers

are

info

rmed

,as

soo

nas

po

ssib

le.T

his

pro

ced

ure

shal

lin

clu

de

acl

ear

assi

gn

men

to

fre

spo

nsi

bili

ties

.

7.0

F1

F1.

1.1–

21–

10–

Ho

wm

uch

isd

istr

ibu

tio

nin

volv

edw

ith

inci

den

tm

anag

emen

t?–

Wh

enan

dw

ho

info

rms

cust

om

er?

<ala

rmp

lan

>

Aw

ith

dra

wal

/rec

allm

anag

emen

tp

roce

-d

ure

isn

ot

eno

ug

hto

defi

ne

anin

cid

ent

man

agem

ent

pro

ced

ure

.

Ifth

ere

isn

op

roce

-d

ure

for

reca

ll/w

ith

-d

raw

alin

pla

ce.



5.9.

3U

pd

ated

emer

gen

cyco

nta

ctd

etai

ls(s

uch

asn

ames

and

ph

on

en

um

ber

so

fsu

pp

liers

,cu

sto

mer

san

dco

mp

e-te

nt

auth

ori

ties

)sh

allb

eav

aila

ble

.A

per

son

of

the

com

pan

y,w

ho

has

the

auth

ori

tyto

init

iate

the

inci

den

tm

anag

emen

tp

roce

ss,s

hal

lbe

per

man

entl

yav

aila

ble

.

F1.

1.1–

25

–W

hat

kin

do

fin

cid

ent

man

agem

ent

isim

ple

men

ted

?–

Who

isre

spon

sibl

efo

rco

mm

unic

atio

nw

ithcu

sto

mer

s,p

ress

/med

iaan

dau

tho

riti

es?

–Is

alis

to

fim

po

rtan

tte

lep

ho

ne

nu

mb

ers

avai

lab

le?

<ph

on

elis

t>,<

emer

gen

cyp

lan

>–

Wh

ois

info

rmed

wh

ena

cris

iso

ccu

rs?

<ala

rmp

lan

>

–W

hen

are

med

iain

volv

ed?

<in

cid

ent

man

agem

ent

pro

ced

ure

s>

No

inci

den

tm

anag

e-m

ent

isav

aila

ble

inth

eco

mp

any.

5.9.

4T

he

feas

ibili

ty,e

ffec

tive

nes

san

dti

mel

ines

so

fim

ple

men

tati

on

of

the

wit

hd

raw

alp

roce

du

resh

allb

esu

bje

ctto

reg

ula

rin

tern

alte

stin

g,

bas

edo

nh

azar

dan

alys

isan

das

sess

-m

ent

of

asso

ciat

edri

sks

bu

tca

rrie

do

ut

atle

ast

on

cea

year

.Th

issh

allb

eca

rrie

do

ut

ina

man

ner

toen

sure

the

effe

ctiv

eim

ple

men

tati

on

and

op

erat

ion

of

the

pro

ced

ure

.

F1.

1.1–

210

–H

ow

isef

fect

iven

ess

of

wit

hd

raw

alte

sted

?–

Ho

wo

ften

isef

fect

iven

ess

of

wit

hd

raw

alte

sted

?<w

ith

dra

wal

test

resu

lts>

Wh

enw

ith

dra

wal

pro

ced

ure

sar

en

ot

test

edo

rw

hen

test

resu

lts

hav

esh

ow

nth

atth

ep

roce

du

res

are

inef

fect

ive

bu

tn

oco

rrec

tive

acti

on

sw

ere

imp

lem

ente

d.

5.10

Man

agem

ent

of

no

n-c

on

form

itie

san

dn

on

con

form

ing

pro

du

cts

5.10

.1A

pro

ced

ure

shal

lexi

stfo

rth

em

anag

emen

to

fal

lno

n-c

on

form

ing

raw

mat

eria

ls,s

emi-

fin

ish

edan

dfi

nis

hed

pro

du

cts,

con

vert

ing

equ

ip-

men

tan

dw

rap

pin

gm

ater

ials

.Th

issh

alli

ncl

ud

e,as

am

inim

um

:–

iso

lati

on

/qu

aran

tin

ep

roce

du

res

–h

azar

dan

alys

isan

das

sess

men

to

fas

soci

ated

risk

s–

iden

tifi

cati

on

(e.g

.lab

elin

g)

–d

ecis

ion

abo

ut

the

furt

her

use

(e.g

.re

leas

e,re

wor

k/po

sttr

eatm

ent,

bloc

k-in

g,q

uar

anti

ne,

reje

ctio

n/d

isp

osa

l).

B2.

3.1–

28

–W

hat

pro

ced

ure

sex

ist

for

no

n-c

on

form

-in

gp

rod

uct

sm

anag

emen

t?–

Ho

war

en

on

-co

nfo

rmin

gp

rod

uct

sid

enti

fied

?–

Wh

atru

les

exis

tfo

rp

rod

uct

qu

aran

tin

ep

roce

du

res?

<qu

aran

tin

eti

cket

s>

Wh

enn

op

roce

du

res

exis

tfo

rn

on

-co

n-

form

ing

pro

du

cts

man

agem

ent.

5.10

.2T

he

resp

on

sib

iliti

esfo

rth

em

anag

e-m

ent

of

no

n-c

on

form

ing

pro

du

cts

shal

lbe

clea

rly

iden

tifi

ed.T

he

pro

ced

ure

for

the

man

agem

ent

of

no

n-c

on

form

ing

pro

du

cts

shal

lbe

un

der

sto

od

by

allr

elev

ant

emp

loy-

ees.

–W

ho

isre

spo

nsi

ble

for

pu

ttin

gn

on

-co

n-

form

ing

pro

du

cts

into

qu

aran

tin

e?<q

uar

anti

ne

tick

ets>

–W

ho

may

rele

ase

qu

aran

tin

edp

rod

uct

s?<q

uar

anti

ne

tick

ets>

–H

ow

isit

ensu

red

that

on

lyau

tho

rize

dp

erso

ns

rele

ase

qu

aran

tin

edp

rod

uct

s?<q

uar

anti

ne

tick

ets>

Wh

enem

plo

yees

do

no

tkn

ow

wh

ois

auth

ori

zed

tore

leas

eq

uar

anti

ned

pro

du

cts

or

wh

enth

ep

rod

uct

sar

ein

con

dit

ion

sto

be

rele

ased

or

wh

enp

rod

uct

sar

eq

uar

an-

tin

edan

da

safe

tyis

sue

occ

urs

.



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

5.10

.3W

her

en

on

-co

nfo

rmit

ies

are

pre

sen

t,im

med

iate

corr

ecti

on

ssh

allb

eta

ken

toen

sure

that

pro

du

ctre

qu

irem

ents

are

com

plie

dw

ith

.

B2.

3.1–

28,

9,10

–W

hat

pro

ced

ure

sar

eim

ple

men

ted

wit

hn

on

-co

nfo

rmin

gp

rod

uct

s?<q

uar

anti

ne

tick

ets>

–W

ho

dec

ides

abo

ut

no

n-c

on

form

ing

pro

du

cts?

<qu

aran

tin

eti

cket

s>

5.10

.4O

ut

of

spec

ifica

tio

nfi

nis

hed

go

od

so

rfi

nis

hed

go

od

sth

atd

on

ot

mee

to

ther

leg

alre

qu

irem

ents

are

no

tal

low

edto

be

pu

to

nth

em

arke

t.T

he

mat

eria

lhas

tob

ed

estr

oye

dap

pro

-p

riat

ely.

Exc

epti

on

ssh

allb

eag

reed

inw

riti

ng

wit

hth

eco

ntr

act

par

tner

s.

B2.

3.1–

211

,12

For

exam

ple

,evi

den

ces

can

be

pro

vid

edto

sho

wth

atp

rod

uct

sh

ave

no

tb

een

pla

ced

on

the

mar

ket

(e.g

.co

ntr

acts

wit

hex

tern

alw

aste

des

tro

yin

gse

rvic

ep

rovi

der

s).

Exc

epti

on

sca

nb

ech

ecke

dw

ith

exam

ple

s(s

itu

atio

ns

wh

ich

alre

ady

occ

urr

ed),

by

chec

kin

gth

eco

nte

nt

of

the

con

trac

t.

5.11

Co

rrec

tive

acti

on

s–

Inca

seo

fa

ren

ewal

aud

it:w

ere

the

corr

ecti

veac

tio

ns

of

the

pre

vio

us

IFS

aud

itap

plie

d?

5.11

.1A

pro

ced

ure

shal

lbe

inp

lace

for

the

reco

rdin

gan

dan

alys

iso

fth

en

on

-co

nfo

rmit

ies

wit

hth

eo

bje

ctiv

eto

avo

idre

curr

ence

sb

yp

reve

nti

veac

tio

ns

and

/or

corr

ecti

veac

tio

ns.

–W

hat

are

corr

ecti

veac

tio

ns

pro

ced

ure

s?<c

orr

ecti

veac

tio

ns

pro

ced

ure

s>N

oco

rrec

tive

acti

on

sp

roce

du

res

exis

t.

5.11

.2K

OK

ON

°9:

Co

rrec

tive

acti

on

ssh

allb

ecl

earl

yfo

rmu

late

d,d

ocu

men

ted

and

un

der

take

n,a

sso

on

asp

oss

ible

toav

oid

furt

her

occ

urr

ence

of

no

n-

con

form

ity.

Th

ere

spo

nsi

bili

ties

and

the

tim

esca

les

for

corr

ecti

veac

tio

nsh

allb

ecl

earl

yd

efin

ed.T

he

do

cu-

men

tati

on

shal

lbe

secu

rely

sto

red

,an

dea

sily

acce

ssib

le.

6,3

Inre

spo

nse

tod

evia

-ti

on

sfr

om

the

pre

req

ui-

site

pro

gra

ms

corr

ec-

tive

acti

on

sw

illb

ed

eter

min

ed.

Co

rrec

tive

acti

on

sm

ayin

clu

de,

bu

tar

en

ot

limit

edto

:–

Pro

du

cth

old

,ass

ess-

men

tan

dd

isp

osi

tio

n.

–E

nsu

rin

gth

eco

rrec

-ti

veac

tio

nis

com

-p

lete

d.

–R

oo

tca

use

iden

tifi

ca-

tio

n.

–P

reve

nti

veac

tio

ns.

–W

hic

hco

rrec

tive

acti

on

sw

ere

imp

le-

men

ted

?<m

od

elco

rrec

tive

acti

on

pro

ced

ure

s>–

Wh

ere

are

corr

ecti

veac

tio

ns

do

cu-

men

ted

?<m

od

elco

rrec

tive

acti

on

pro

ced

ure

s>

–W

ho

isre

spo

nsi

ble

for

corr

ecti

veac

tio

ns?

<mo

del

corr

ecti

veac

tio

np

roce

du

res

>–

Ho

wlo

ng

may

itta

keto

imp

lem

ent

corr

ecti

veac

tio

ns?

<mo

del

corr

ecti

veac

tio

np

roce

du

res

>

No

corr

ecti

veac

tio

ns

are

take

n.

Co

rrec

tive

acti

on

sar

en

ot

imp

lem

ente

dw

ith

ina

sho

rtti

me

span

.C

orr

ecti

veac

tio

ns

are

no

td

ocu

men

ted

No

resp

on

sib

iliti

esar

eas

sig

ned

toim

ple

men

tco

rrec

tive

acti

on

s.



5.11

.3T

he

per

form

ance

of

the

imp

lem

ente

dco

rrec

tive

acti

on

ssh

allb

ed

ocu

-m

ente

dan

dth

eef

fect

iven

ess

shal

lb

ech

ecke

d.

–W

her

ear

eco

rrec

tive

acti

on

sd

ocu

men

ted

?<m

od

elco

rrec

tive

acti

on

pro

ced

ure

s>–

Ho

war

eco

rrec

tive

acti

on

sve

rifi

ed?

<mo

del

wit

hve

rifi

edco

rrec

tive

acti

on

pro

ced

ure

s>

Co

rrec

tive

acti

on

sar

en

ot

do

cum

ente

dan

d/r

veri

fied

.

6P

acka

gin

gm

ater

iald

efen

se/F

oo

dd

efen

sean

dex

tern

alin

spec

tio

ns

6.1

Def

ense

asse

ssm

ent

6.1.

1R

esp

on

sib

iliti

esfo

rp

acka

gin

gm

ater

iald

efen

sesh

allb

ecl

earl

yd

efin

ed.T

ho

sere

spo

nsi

ble

shal

lbe

key

staf

fo

rsh

allh

ave

acce

ssto

the

top

man

agem

ent

team

.Su

ffici

ent

kno

wle

dg

ein

this

area

shal

lbe

dem

on

stra

ted

.

–W

ho

has

the

acco

un

tab

ility

for

the

pac

kag

ing

mat

eria

ldef

ense

pro

gra

m?

–W

hat

are

the

com

pet

ence

and

qu

alifi

ca-

tio

ns

dem

on

stra

ted

for

the

per

son

(s)

resp

on

sib

lefo

rth

ep

acka

gin

gm

ater

ial

def

ense

pro

gra

m?

–W

hat

isth

ep

osi

tio

no

fth

ep

erso

n(s

)re

spo

nsi

ble

for

the

pac

kag

ing

mat

eria

ld

efen

sep

rog

ram

wit

hre

spec

tto

the

man

agem

ent

team

?–

Ho

wd

om

anag

emen

tte

ams

sup

po

rtth

ep

erso

n(s

)re

spo

nsi

ble

for

the

pac

kag

ing

mat

eria

ldef

ense

pro

gra

m?

–W

her

ear

eth

ere

spo

nsi

bili

ties

clea

rly

defi

ned

?–

Was

this

com

mu

nic

ated

toth

em

emb

ers

of

the

com

pan

y?H

ow

?



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

6.1.

2A

pac

kag

ing

mat

eria

ldef

ense

haz

ard

anal

ysis

and

asse

ssm

ent

of

asso

ci-

ated

risk

ssh

allh

ave

bee

np

erfo

rmed

and

do

cum

ente

d.B

ased

on

this

asse

ssm

ent,

and

bas

edo

nth

ele

gal

req

uir

emen

ts,a

reas

crit

ical

tose

curi

tysh

allb

eid

enti

fied

.P

acka

gin

gm

ater

iald

efen

seh

azar

dan

alys

isan

das

sess

men

to

fas

soci

-at

edri

sks

shal

lbe

con

du

cted

ann

ual

lyo

ru

po

nch

ang

esth

ataf

fect

pac

kag

ing

mat

eria

lin

teg

rity

.A

nap

pro

pri

ate

aler

tsy

stem

shal

lbe

defi

ned

and

per

iod

ical

lyte

sted

for

effe

ctiv

enes

s.

–W

hat

are

the

leg

al/c

ust

om

erp

acka

gin

gm

ater

iald

efen

sere

qu

irem

ents

app

licab

leto

the

com

pan

y?–

Ho

wca

nth

eco

mp

any

dem

on

stra

teco

mp

lian

cew

ith

such

req

uir

emen

ts?

–W

hat

isth

ep

roce

ss/p

roce

du

reu

sed

top

erfo

rmth

eh

azar

dan

alyi

sis

and

asse

ss-

men

to

fas

soci

ated

risk

s?–

Isth

eh

azar

dan

alys

isin

line

wit

hle

gal

and

/or

cust

om

ern

eed

san

d/o

rex

pec

ta-

tio

ns?

–H

ow

do

the

syst

ems

assi

stth

eco

mp

any

toid

enti

fycr

itic

alo

rh

igh

risk

area

s?–

Ho

wo

ften

isa

revi

ewo

fth

ep

acka

gin

gm

ater

iald

efen

sep

rog

ram

per

form

ed?

–W

hat

crit

eria

do

esth

eco

mp

any

con

sid

erin

ord

erto

det

erm

ine

the

freq

uen

cyto

per

form

the

haz

ard

anal

ysis

,if

isn

ot

do

ne

ann

ual

ly?

–H

ow

isth

eco

mp

any

aler

ted

of

any

pac

kag

ing

mat

eria

ldef

ense

bre

ach

?–

Ho

wd

oes

the

com

pan

yev

alu

ate

the

effe

ctiv

enes

so

fth

ep

acka

gin

gm

ater

ial

def

ense

pro

gra

m?

6.1.

3If

leg

isla

tio

nm

akes

reg

istr

atio

no

ro

n-s

ite

insp

ecti

on

sn

eces

sary

,ev

iden

cesh

allb

ep

rovi

ded

.

–W

hat

are

the

leg

al/c

ust

om

erp

acka

gin

gm

ater

iald

efen

sere

qu

irem

ents

app

licab

leto

the

com

pan

y?–

Bas

edo

nle

gal

req

uir

emen

tsin

the

cou

ntr

yw

her

eth

ep

lan

tis

loca

ted

or

by

the

cou

ntr

yw

her

eth

ep

rod

uct

isco

n-

sum

ed,i

sit

req

uir

edto

app

lyfo

rfo

rmal

reg

istr

atio

n?

–If

reg

istr

atio

nis

req

uir

ed,w

ho

has

this

info

rmat

ion

?C

ou

ldth

eco

mp

any

dem

on

-st

rate

com

plia

nce

?–

Isth

ere

any

req

uir

emen

tfo

rp

erio

dic

insp

ecti

on

?If

yes,

then

:–

Wh

op

erfo

rms

it?

–A

gai

nst

wh

atst

and

ard

?



–W

hen

was

the

last

insp

ecti

on

?–

Wh

atw

asth

ere

sult

of

the

insp

ecti

on

?–

Isit

req

uir

edto

pro

vid

eev

iden

ceth

atd

evia

tio

ns

hav

eb

een

solv

ed?

(co

rrec

tive

acti

on

s)–

Wh

atar

eth

eim

plic

atio

ns

ifa

maj

or

bre

ach

isid

enti

fied

?

6.2

Sit

eS

ecu

rity

6.2.

1B

ased

on

ah

azar

dan

alys

isan

das

sess

men

to

fas

soci

ated

risk

s,id

enti

fied

area

scr

itic

alto

secu

rity

shal

lbe

adeq

uat

ely

pro

tect

edto

pre

ven

tu

nau

tho

rize

dac

cess

.A

cces

sp

oin

tssh

allb

eco

ntr

olle

d.

–B

ased

on

the

haz

ard

anal

ysis

and

asse

ss-

men

to

fas

soci

ated

risk

s,w

hat

area

sh

ave

bee

nid

enti

fied

ascr

itic

al?

–W

hat

con

tro

lmea

sure

sar

ein

pla

cein

ord

erto

con

tro

lth

een

tran

ceto

tho

sear

eas?

–H

ow

do

esth

eco

mp

any

mai

nta

inco

ntr

ol

ove

rw

ho

ente

rsto

the

pre

mis

esan

dcr

itic

alar

eas?

–W

hat

are

the

acce

ssco

ntr

ols

app

licab

leto

the

follo

win

gp

eop

le?

–Te

mp

ora

ryem

plo

yees

–C

on

trac

tors

–V

isit

ors

–E

mp

loye

es–

Car

rier

dri

vers

Un

auth

ori

zed

per

-so

ns

free

lyen

ter

pro

du

ctio

no

rst

ora

ge

area

sso

that

asa

fety

risk

occ

urs

.

6.2.

2P

roce

du

res

shal

lbe

inp

lace

top

reve

nt

tam

per

ing

and

/or

allo

wid

enti

fica

tio

no

fsi

gn

so

fta

mp

erin

g.

–D

oes

the

com

pan

yd

efin

ep

roce

du

res

toid

enti

fyta

mp

erin

go

fra

wm

ater

ials

,W

ork

sin

Pro

cess

(WIP

)an

dfi

nal

go

od

s?–

Are

ther

em

ean

sto

veri

fyif

pro

du

cts

hav

eb

een

tam

per

ed?

–A

reem

plo

yees

trai

ned

inth

eid

enti

fica

-ti

on

of

tam

per

edp

rod

uct

s?–

Do

esth

ed

esig

no

fp

acka

gin

gm

ater

ial

incl

ud

eth

eid

enti

fica

tio

no

fta

mp

erev

iden

tm

easu

res?

Isit

req

uir

edb

yla

win

the

cou

ntr

yo

fo

rig

ino

rd

esti

nat

ion

?–

Are

ther

ete

sts

tove

rify

that

mea

sure

sag

ain

stta

mp

erin

gar

ep

rop

erly

app

lied

and

wo

rkin

gp

rop

erly

?

6.3

Per

son

nel

&V

isit

or

Sec

uri

ty



IFS

PAC

secu

ren

um

ber

IFS

PAC

secu

rere

qu

irem

ent

Co

nn

ec-

tio

nw

ith

PAC

secu

reP

Pre

quir

e-m

ent

nu

mb

er

Text

/Nu

mb

ero

fco

nn

ecte

dPA

Cse

cure

PP

(Pre

req

uis

ite

Pro

gra

m)

req

uir

emen

t

Wh

atto

chec

k?W

hat

sho

uld

be

aske

d?

Exa

mp

lefo

rK

O/M

ajo

r

6.3.

1V

isit

or

po

licy

shal

lco

nta

inas

pec

tso

fp

acka

gin

gm

ater

iald

efen

sep

lan

.D

eliv

ery

and

load

ing

staf

fin

con

tact

wit

hth

ep

rod

uct

shal

lbe

iden

tifi

edan

dsh

allr

esp

ect

the

acce

ssru

les

of

the

com

pan

y.V

isit

ors

and

exte

rnal

serv

ice

pro

vid

ers

shal

lbe

iden

tifi

edin

area

sw

ith

pro

du

ctst

ora

ge

and

shal

lbe

reg

iste

red

atth

eti

me

of

acce

ss.T

hey

sho

uld

be

info

rmed

abo

ut

the

site

po

licie

san

dth

eir

acce

ssco

ntr

olle

dac

cord

ing

ly.

–D

ovi

sito

r/co

ntr

acto

rac

cess

po

licie

sin

-cl

ud

eco

ntr

ols

toav

oid

that

no

mem

ber

so

fth

eco

mp

any

are

able

tom

ove

free

lyw

ith

ou

tes

cort

sin

sid

eth

ep

rem

ises

?–

Are

visi

tors

and

con

trac

tors

info

rmed

of

the

pac

kag

ing

mat

eria

ldef

ense

rule

san

dth

eir

sco

pe

wh

ilein

sid

eco

mp

any

pre

m-

ises

?–

Do

esth

eco

mp

any

hav

ed

efin

edm

ean

sto

ensu

reth

atco

ntr

acto

rsw

ho

will

spen

da

lon

gti

me

insi

de

the

pla

nts

are

pro

per

lyid

enti

fied

,su

per

vise

dan

des

cort

edin

sid

ecr

itic

alar

eas?

–A

reth

ere

con

tro

lsto

ensu

reth

atth

eac

cess

for

tru

ckd

rive

rsw

ho

load

or

un

load

pro

du

cts/

mat

eria

lsis

rest

rict

edto

defi

ned

area

sin

sid

ean

do

uts

ide

the

bu

ild-

ing

and

com

pan

yp

rem

ises

?A

reth

ere

mea

ns

tow

atch

the

mo

vem

ents

of

no

n-e

mp

loye

eso

nce

they

ente

rco

mp

any

pre

mis

es?

(E.g

.cam

eras

or

gu

ard

sat

defi

ned

area

s?O

ther

pro

ced

ure

s?)

–If

con

trac

tors

and

visi

tors

are

pro

vid

edw

ith

acce

sske

ys,a

reth

ose

keys

pro

-g

ram

med

tolim

itth

eac

cess

tosp

ecifi

edan

dse

lect

edar

eas?

–If

esco

rts

are

req

uir

edto

gu

ide

visi

tors

and

con

trac

tors

atal

ltim

es,a

reth

ere

arra

ng

e-m

ents

toh

ave

defi

ned

gu

ides

atal

lsh

ifts

?–

Are

secu

rity

/gu

ard

saw

are

of

ho

wto

dea

lin

case

sw

her

eth

ere

are

no

esco

rts

avai

lab

leat

any

par

ticu

lar

mo

men

t?

6.3.

2A

llem

plo

yees

shal

lbe

trai

ned

inp

acka

gin

gm

ater

iald

efen

seo

nan

ann

ual

bas

iso

rw

hen

sig

nifi

can

tp

rog

ram

chan

ges

occ

ur.

Th

etr

ain

ing

sess

ion

ssh

allb

ed

ocu

men

ted

.E

mp

loye

eh

irin

gan

dem

plo

ymen

tte

rmin

atio

np

ract

ices

shal

lco

nsi

der

secu

rity

asp

ects

asp

erm

itte

db

yla

w.

–D

oes

the

ann

ual

trai

nin

gp

rog

ram

incl

ud

ep

acka

gin

gm

ater

iald

efen

se?

–H

ow

isp

acka

gin

gm

ater

iald

efen

sean

das

soci

ated

con

tro

lsex

pla

ined

ton

ewem

plo

yees

?–

Are

ther

ere

cord

sth

atd

emo

nst

rate

that

emp

loye

esre

ceiv

edp

acka

gin

gm

ater

ial

def

ense

trai

nin

g?



–Is

trai

nin

gu

pd

ated

acco

rdin

gto

chan

ges

inth

ep

acka

gin

gm

ater

iald

efen

sep

rog

ram

?–

Ho

war

eem

plo

yees

info

rmed

of

maj

or

chan

ges

inth

ep

acka

gin

gm

ater

ial

def

ense

pro

gra

m?

–D

oes

the

syst

emev

alu

ate

trai

nin

gef

fect

iven

ess?

–D

oes

trai

nin

gin

clu

de

con

tro

lso

fkn

ow

l-ed

ge

acq

uir

edfr

om

the

last

vers

ion

of

the

pac

kag

ing

mat

eria

ldef

ense

trai

nin

g?

–W

hat

con

tro

lsar

eim

ple

men

ted

atth

eti

me

of

hir

e/t

erm

inat

ion

of

anem

plo

yee

or

crea

tio

n/t

erm

inat

ion

of

ase

rvic

eb

ya

con

trac

tor?

–A

reac

cess

con

tro

lsu

pd

ated

atth

eti

me

of

term

inat

ion

of

anem

plo

yee

or

wh

enth

ew

ork

isfi

nis

hed

on

the

par

to

fa

con

trac

tor?

6.4

Ext

ern

alIn

spec

tio

ns

6.4.

1A

do

cum

ente

dp

roce

du

resh

alle

xist

for

man

agin

gex

tern

alin

spec

tio

ns

and

reg

ula

tory

visi

ts(i

fap

plic

able

).R

elev

ant

per

son

nel

shal

lbe

trai

ned

toex

ecu

teth

ep

roce

du

re.

–Is

ther

ea

do

cum

ente

dp

roce

du

reth

atd

efin

esth

ecr

iter

iato

follo

win

case

anex

tern

alo

rgan

izat

ion

req

uir

esac

cess

toth

eco

mp

any’

sp

rem

ises

?–

Are

ther

ecl

earl

yd

efin

edle

vels

of

auth

ori

tyto

pro

vid

eac

cess

toex

tern

alo

rgan

izat

ion

sat

allt

imes

?–

Do

esth

ep

roce

du

red

efin

eth

em

ean

sto

pro

ceed

ifo

rw

hen

are

gu

lato

ryb

od

yre

qu

ests

acce

ssto

the

pre

mis

es?

–A

rere

leva

nt

fun

ctio

ns

awar

eo

fth

eir

resp

on

sib

iliti

esu

nd

ersu

chco

nd

itio

ns?

–A

rele

vels

of

auth

ori

tyd

efin

edw

ith

resp

ect

toth

eki

nd

of

info

rmat

ion

that

isal

low

edto

be

pro

vid

ed?

–A

reth

ere

mea

ns

toen

sure

aco

mp

lete

reco

rdo

fac

tivi

ties

do

ne

and

det

ails

of

the

visi

t?



ANNEX 1: GLOSSARY/DEFINITIONS LIST

Definitions which are not mentioned within the glossary can be foundin relevant regulations and directives. In relation to the terms usedwithin this document and PACsecure documents, the following defini-tions apply and shall be respected.

Term Explanation

Additive Materials such as plasticizers, preservatives, slip agents, antistaticagents, processing aids, and others, added to a base material in order to achieve aspecific result.

Adhesive An adhesive substance (as glue or cement, or starch in paper industry).

Allergen (EU) Food causing an adverse reaction that is mediated by an immunological response.Defined allergens are:– Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their

hybridised strains) and products thereof– Crustaceans and products thereof– Eggs and products thereof– Fish and products thereof– Peanuts and products thereof– Soybeans and products thereof– Milk and products thereof (including lactose)– Nuts i.e. Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut

(Juglans regia), Cashew (Anacardium occidentale), Pecan nut (Carya illinoiesis(Wangenh.) K. Koch), Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera),Macadamia nut and Queensland nut (Macadamia ternifolia) and products thereof

– Celery and products thereof– Lupin and products thereof– Molluscs and products thereof– Mustard and products thereof– Sesame seeds and products thereof– Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or

10 mg/litre expressed as SO2.(Commission Directive 2007/68 EC of 27 November 2007 amending Annex III a toDirective 2000/13/EC of the European Parliament and of the Council as regardscertain food ingredients.)

Allergen (US) There are 8 major allergens recognized in the United States according to the2009 U.S. Food and Drug Administration (FDA) Model Food Code, Definitionssection, page 12.(1) “Major food allergen“ means:

(a) Milk, egg, fish (such as bass, flounder, cod, and including crustacean shell-fish such as crab, lobster, or shrimp), tree nuts (such as almonds, pecans, orwalnuts), wheat, peanuts, and soybeans

(b) A Food ingredient that contains protein derived from a food, as specified inSubparagraph (1)(a) of this definition.

(2) “Major food allergen” does not include:a) Any highly refined oil derived from a food specified in Subparagraph (1)(a) of

this definition and any ingredient derived from such highly refined oil; orb) Any ingredient that is exempt under the petition or notification process

specified in the Food Allergen Labelling and Consumer Protection Act of2004 (Public Law 108-282).

Aseptic technique Precautionary measures taken to prevent contamination.

Assessor (foraccreditation bodies)

Person assigned by an accreditation body to perform, alone or as part of an assess-ment team, an assessment of a Conformity Assessment Body.

Audit Systematic, independent and documented process for obtaining audit evidenceand evaluating it objectively to determine the extent to which the audit criteria arefulfiled.



Auditor An individual who is qualified to provide audits, such as certified auditor.Note: An employee who is qualified and independent of the audited functiontypically conducts first-party/internal audit within the organization. A totallyindependent certified auditor who is not involved in the customer-supplier relation-ship conducts third-party audits.

Biological hazards Parasites, bacteria, moulds, or viruses that have the ability to cause illness or death.

Buyer/filler A company who buys packaging materials from packaging material manufacturerand converter and fill the package with the product.

Calibration Set of operations that establish, under specified conditions, the relationshipbetween values of quantities indicated by a measuring instrument or measuringsystem, or values represented by a material measure or a reference material andthe corresponding values realised by standards.

Carrier An operator of a conveyance such as a truck, railcar, vessel, or aircraft used totransport goods.

CCP – Critical ControlPoint

A step at which control can be applied and is essential to prevent or eliminate afood safety hazard or reduce it to an acceptable level.

Chemical hazards Chemical products (e.g. agricultural chemicals, cleaning agents, food and packag-ing additives, waxes and coatings, heavy metals, inks, solvents, etc.) that have thepotential to cause illness or death especially when used in excess of regulatorylimits.

Cleaning The removal of soil, residue, dirt, grease or other objectionable matter.

Company General organisation (whereas the site is a unit of the company).

Competent employee An employee who is familiar with and capable of assessing the operation of a pieceof equipment or process.

Contact surfaces Surfaces that contact packaging product. This also includes any surface that mightdrip or drain onto a surface that contacts packaging product during the normalcourse of operations. Contact surfaces include equipment such as containers, tablesand conveyor belts used in packaging operations. It does not include forklifts, handtrucks, or pallets that are used for handling wrapped packaging products.

Contamination Introduction or occurrence of a contaminant in packaging material or environment.Contamination does include: physical, chemical, biological contamination. Contami-nation can also mean correlation of packages among themselves.

Control measure (Food safety) action or activity that can be used to prevent or eliminate a foodsafety hazard or reduce it to an acceptable level. Acceptable levels may be derivedfrom; regulatory requirements; industry standards; scientific information; customerrequirements; risk assessments.

Converter A manufacturer that takes raw materials and converts them into a usable packageor package component.

Converting time The period in which a product may be processed/converted before being consid-ered unsuitable for the purpose.

Corporate Company.

Correction Action to eliminate a detected non-conformity or deviation.

Corrective action Action to eliminate the cause of a detected non-conformity or other undesirablesituation.

CP – Control point Identified by the hazard analysis as essential in order to control the likelihood ofintroducing or proliferation of food safety hazard in the product and/or the environ-ment.A CP can be considered as an OPRP (Operational Prerequisite Program), as definedin ISO 22000.

Customer A customer is a business company or person to whom products are sold either asfinished product or as a semi-finished part of the finished product.



Deviation Non-compliance with a requirement but there is no impact on food safety related toproducts and processes. In the IFS, deviations are requirements scored with a B, Cor D and KO requirements scored with a B.

Establishment Any building or surrounding area in which packaging material and/or product ishandled manufactured, or converted, and is under the control of the same manage-ment.

Extrusion The process of forming a thermoplastic film, container, or profile by forcing thepolymer melts through a shaped orifice. The extruded plastic is immediately chilled.

Facility Buildings and other physical structures used for or in connection with the manufac-turing and converting of packaging material and product.

Factory inspection(versus Internal audits)

Factory inspection covers specific subjects and can be carried out by any appropri-ate person. That means regular visits in any areas, for any purposes, to check theconformity (hygiene, pest control, product control, fabrication, foreign materialhazards, surrounding control etc.).

FIFO “First In—First Out”: an inventory system of product rotation, where the oldestproduct is shipped first.

Flow diagram A systematic representation of the sequence of steps or operations used in theproduction or manufacture of a particular packaging material item.

Food safety Assurance that food will not cause harm to the consumer when it is preparedand/or eaten according to its intended use.

Formula Exhaustive description of quantity and quality of raw materials to be used toprocess the products, as required in customer specifications.Formula can also include technological parameters and specific “know-how” on theprocess.

FSEP Food Safety Enhancement Program. The FSEP is the Canadian Food InspectionAgency’s (CFIA) approach to encourage and support the development, implementa-tion and maintenance of Hazard Analysis Critical Control Point (HACCP) systems inall federally registered establishments of the meat, dairy, honey, maple syrup,processed fruit and vegetable, shell egg, processed egg and poultry hatcherysectors. Government and food industry developed FSEP jointly in 1991 in consulta-tion with consumer groups.(http://www.inspection.gc.ca/english/fssa/polstrat/haccp/haccpe.shtml)

Glue Any of various strong adhesive substances; especially: a hard protein chieflygelatinous substance that absorbs water to form a viscous solution with strongadhesive.

GMO An organism, with the exception of human beings, in which the genetic materialhas been modified otherwise than natural multiplication or natural recombination.

GMP – Good Manufac-turing Practices

The practices that prevent and minimize the biological, chemical and physicalcontamination of packaging material and product during receiving, manufacturing,converting, storage and transportation, to ensure food safety.

GMP regulation(EU/US)

EU: (EC) No 2023/2006 of 22 December 2006 on good manufacturing practices formaterials and articles intended to come into contact with food.

US: 21 CFR 174 - 21 CFR 190.

HACCP (risk assess-ment)

A system which identifies evaluates and controls hazards which are significant forpackaging material safety.

Hazard A biological, chemical or physical agent in, or condition of, packaging material withthe potential to cause an adverse health effect.

Hazard analysis The process of collecting and evaluating information on hazards and conditionsleading to their presence to decide which are significant for packaging materialsafety and therefore should be addressed in the HACCP plan.

Head office assessment(for accreditationbodies)

Assessment of the Conformity Assessment Body Head Office.



Hygiene Conditions and measures that are required to ensure that packaging material andproduct is safe.

Inert Material without active chemical properties.

Integrity Program Program implemented by IFS in order to:– Monitor, as preventive actions performance of auditors and certification bodies as

well as audited companies,– Manage, as corrective actions, any complaints addressed to IFS.

Internal audit General process of audit, for all the activity of the company. Conducted by or onbehalf of the company for internal purposes.Internal auditing is an independent, objective assurance and consulting activitydesigned to add value and improve an organization‘s operations. It helps anorganization accomplish its objectives by bringing a systematic, disciplinedapproach to evaluate and improve the effectiveness of risk management, control,and governance processes.

Lamination A process of plying layers of stock to a given thickness.

Lot The packaging product manufactured during a period of time or according to aspecific code.

Leak test A testing process designed to find unintended holes or voids that allow air or fluidto pass through packaging materials. For labeled products, leak test is conductedprior to labeling in order to avoid concealing any leaks.

Microorganisms Organisms too small to be seen by the naked eye that include yeasts, moulds,bacteria, and viruses.

Monitoring The act of conducting a planned sequence of observations or measurements ofcontrol parameters to assess whether a CP is under control.See also Codex Alimentarius, General principles of Food hygiene, Guidelines forthe application of the HACCP system, section 9.

MSDS – Material SafetyData Sheet

The safety data sheet information is principally intended for use by professionalusers and must enable them to take the necessary measures as regards the protec-tion of health, safety and the environment at the place of work. The safety datasheet may be supplied on paper or electronically, provided that the addressee hasthe necessary means of receiving it.

Non-conformity Non-fulfilment of a specified requirement. Non-conformity can be given in non-respect of legislation, law, packaging material safety, internal dysfunctions andcustomer issues. In the IFS, defined non-conformities are Majors and KO’s scoredwith a D.

Packaging materialdefense/Food defense(US)

Food Defense is the collective term used by the US Food and Drug Administration(FDA), United States Department of Agriculture (USDA), Department of HomelandSecurity (DHS), etc. to encompass activities associated with protecting the nation’sfood supply from deliberate or intentional acts of contamination or tampering. Thisterm encompasses other similar verbiage (i.e., bioterrorism (BT), counter-terrorism(CT), etc.),The USDA Food Safety and Inspection Service define Food Defense as “the protec-tion of food products from intentional adulteration by biological, chemical, physicalor radiological agents.”The definition also applies on packaging materials.

Pest Any animal or insect such as birds, rodents, cockroaches, flies, and larvae that maycarry pathogens and can contaminate packaging material and product.

Physical hazards Physical components (e.g. wood or glass chip, metal piece, etc.) and foreign matterthat can cause illness or injury. This includes pests and their components.

Potable air Air containing less than 1,000 viable colony-forming units of total micro-organismsper cubic meter of air. Air containing less than 200 viable colony-forming units ofbacteria and 200 viable colony-forming units of fungi in a cubic meter of air. Usersshould check with authority having local jurisdiction for limits pertaining to chemi-cal and other contaminants.



Potable water (CA) Water that meets Health Canada’s Canadian Drinking Water Guidelines.(http://www.hc-sc.gc.ca/ewh-semt/pubs/water-eau/doc_sup-appui/index_e.html)

Potable water Water suitable for human consumption without endangering health. It is immacu-late concerning smell, taste and nature.

Primary packaging Packaging coming into contact with the packed goods such as PET bottles, cups,plastic closures of packages.

Procedure Specified way to carry out an activity or process. Procedures shall be implementedand the elaboration of procedures shall be done by documents or process descrip-tion (e.g. flowchart).

Product Result of a process or activities transforming inputs into outputs. Products includeservices. In the context of this Standard a product is to be considered a packagingmaterial.

Product development The creation of products with new or different characteristics that offer new oradditional benefits to the customer. Product development may involve modificationof an existing product or its presentation, or formulation of an entirely new productthat satisfies a newly defined customer who wants a market niche. In the IFSPACsecure Standard, the requirements for chapter product development apply evenif there is just a product modification, use of new wrapping materials or modifica-tions of production processes.

Product recall Any measure aimed at achieving the return of a dangerous product that has alreadybeen supplied or made available to consumers by the producer or distributor.

Product requirements Product requirements includes: product safety, product quality, product legality,process and specification.

Product withdrawal Any measure aimed at preventing the distribution, display and offer of a productdangerous to the consumer.

Qualified employee An employee who is qualified (such as certified auditor) and independent of theaudited function conducts first-party/internal audit within the organization.

Raw material One of the parts of a mixture

Raw material specifica-tion (RMS)

A document describing detailed product features, attributes and processing factorsthat enable the user or the document (i.e. supplier) to produce or supply materialthat will fulfil its intended use.

Reviewer Person of the certification body in charge of assessing the IFS PACsecure auditsreports before a certification decision is made.The tasks of the reviewer are, at least:– To check the overall consistency of the audit reports.– To check if the audit reports are properly completed– To check if the findings are well described and if the justifications are relevant.– To check if the corrective actions proposed by the audited company have been

validated by the auditor (or by a representative of the certification body) and arerelevant.The review shall be documented.

Risk A function of the probability of an adverse health effect and the severity of thateffect consequential to (a) hazard(s) in packaging material.

Secondary packaging Packaging, e.g. films that have no contact with the food.

Senior management Executive management.

Services See definition of product.

Site A unit of the company.

Supplier QualityAssurance (SQA)Program

A program designed to ensure raw materials/other material suppliers are incompliance with product specifications and safety or quality requirements. Theprogram often includes elements such as a supplier selection and approval process;supplier auditing and product testing.



System Set of interrelated or interacting elements. System is a planned, sustainablestructured course of action. Depending on the complexity, documentation isrecommended. System includes: documentation, procedure description, con-trol/monitoring, corrective action, site plan.

Tertiary packaging Packaging/wrapping that is used to group secondary packaging together to aidhandling and transportation and prevent damage to the products, for example, thepallet and shrink wrap used to transport a number of cardboard outer containingboxes filled with packaging material.

Traceability Ability to trace and follow a material intended to be, or expected to be incorporatedinto a packaging material, through all stages of production, converting and distribu-tion.

Validation Confirmation through the provision of objective evidences that the requirements forthe specific intended use or application have been fulfiled.

Verification Confirmation through the provision of objective evidences that specified require-ments have been fulfiled.

Witness assessment(by accreditationbodies)

Assessment of the Conformity Assessment Body when it is carrying out conformityassessment services within its scope of accreditation.

Witness audit beforeapplying to IFS exami-nations

The auditor who is witnessed shall be accompanied by an observer from thecertification body during a complete audit in order to evaluate his/her competence.The observer shall not be part of the audit (as a team member).The observer shall fulfil the same requirements as for trainers or shall be an IFSPACsecure auditor, IFS Food auditor or IFS HPC auditor.This witness audit shall be a product safety audit and/or an audit under ISO/IEC17065.On the application file of the auditor (sent afterwards to the IFS offices), the certifi-cation body shall specify the name of the company, audit date and name of theperson who observed the auditor. On request, the certification body shall be able toprovide minutes of the witness audit.

Witness audit,to be performedevery 2 years,for IFS PACsecureapproved auditors

The auditor who is witnessed shall be accompanied by an observer from thecertification body during a complete IFS PACsecure, IFS Food, IFS HPC, or anotherGFSI recognized packaging material safety scheme audit, in order to evaluatehis/her competence. The observer shall not be part of the audit (as a team mem-ber).The observer shall fulfil the same requirements as for trainers or shall be an IFSPACsecure, IFS Food or IFS HPC auditor. For the observer, relevant product scope(s)approval, in relation to the products/processes of the audit, is not mandatory.The certification body shall specify the name of the observer in the participants’ listof the IFS PACsecure audit report and shall be able to provide, on request, minutesof this witness audit.

Wrapping See tertiary packaging.


International Featured Standards · IFS PACsecure ·Version 1 Part 3 119

Part 3: Requirements for AccreditationBodies, Certification Bodies andAuditors

IFS accreditation and certificationprocess

0 Introduction

IFS PACsecure certification is a product and process certification. Allbodies involved shall comply with the international rules and IFS-spe-cific requirements described in this document. Part 3 of the IFS PACse-cure Standard deals mainly with accreditation bodies, certification bod-ies and auditors.

1 Requirements for the Accreditation Bodies

1.1 General requirements

The accreditation bodies shall fulfil the requirements of the ISO/IEC17011 norm “Conformity assessment – General requirements for Accre-ditation Bodies accrediting conformity assessment bodies”, and shallhave signed the MLA (Multilateral Agreement) for Product Certificationof the EA or IAF.

As soon as it will come into force, the accreditation bodies shall alsofulfil the GFSI Requirements for the Application of ISO/IEC 17011:2004,which is complementary of the below requirements.

In order to ensure interactive communication, the accreditation bodyshall appoint an IFS contact person within their organisation.

1.2 The training of the accreditation committee(or competent person)

In general, all accreditation body personnel engaged in IFS PACsecureaccreditation activity shall have sufficient knowledge of the IFS PACse-cure scheme, related normative documents and food or packagingindustry.

Decisions on accreditation can only be made following a recommenda-tion of a competent person or accreditation committee. The person incharge, or at least one member of the accreditation committee, shall


120 Part 3 International Featured Standards · IFS PACsecure ·Version 1

have taken part in an IFS PACsecure training course organised by IFS orshall be able to demonstrate equivalent knowledge level as confirmedby IFS. In case of a committee, the trained person provides the othermembers of the accreditation committee with the necessary informa-tion.This information is based on the main points of the IFS PACsecuretraining course with the main emphasis on Part 1 (IFS PACsecure auditprotocol), Part 3 (requirements for accreditation bodies, certificationbodies and auditors), Part 4 (audit report, certificate) and the auditors’approval process for IFS.

1.3 Competences of the assessor of the accreditationbody

The assessor(s) of the accreditation bodies is responsible for the follow-ing:

– accompanying IFS PACsecure auditors during registered IFSPACsecure audits (witness assessment),

– assessing the head office of the certification body (head officeassessment) according to the ISO/IEC 17065 rules and IFS-spe-cific requirements.

In general, the assessor(s) shall meet ISO/IEC 17065 and IFS require-ments.

Witness assessors shall, at a minimum:

– Have taken part in the IFS PACsecure training course, or shallbe able to demonstrate an equivalent knowledge level as con-firmed by IFS,

– Have taken part in a HACCP course or other course related tohazard analysis and assessment of associated risks,

– Have a minimum of two (2) years of experience in the packag-ing material industry sector.

Head office assessors shall, at a minimum:

– Have specific knowledge in the IFS PACsecure scheme,

– Have specific knowledge of the related normative documents.

1.4 Frequency of the assessments of certification bodies

For initial assessment, a head office assessment (with review of at leastone full certification process) and at least one witness assessment shallbe performed.

The certification body is allowed to perform maximum 5 audits beforegetting accreditation. In this case, at least one of the audits shall be



assessed by the accreditation body (witness assessment) and all audits(including at least one full certification process) shall be reviewed by theaccreditation body during the initial headquarter assessment.

For renewal assessment, a head office assessment (with review of atleast one full certification process) and at least one witness assessmentshall be performed.

During the surveillance of the accreditation cycle:

– A minimum of one head office assessment a year,

– A minimum of one witness assessment every two (2) years

shall take place.

Remark: a flexibility of three (3) months at themaximum can be allowedfor the interval between two (2) assessments, according to the accredi-tation body rules.

During head office assessments, the following documentation shall besampled and assessed, as a minimum:

– At least 10% or two (2) IFS PACsecure auditor files, whicheveris greater,

– At least two (2) site files or 2% of delivered audits, whichever isgreater.

For consecutive witness assessments, the accreditation body shall,wherever possible, select two different certification body’s IFS PACse-cure auditors with different scopes.

1.5 Accreditation of an internationally-activecertification body

The witness assessments shall cover the typical activities (includinginternational activities and critical locations) of the certification body. Ifthe accreditation body subcontracts an assessment, the subcontractedaccreditation body shall be a signatory to the IAF MLA for Product Cer-tification. IAF GD 3 Cross Frontier Policy shall apply.

1.6 Conditions for recovering accreditation afterwithdrawal or suspension

In case the accreditation body decides to withdraw or suspend accredi-tation, certification bodies shall stop performing IFS PACsecure auditsand issuing IFS PACsecure certificates. To recover accreditation afterwithdrawal, the same conditions as for initial assessment apply. In caseof accreditation suspension, IFS and accreditation body will jointlydetermine requirements to remove suspension.



1.7 Transfer of certification

In case one certification body decides to transfer its certification activi-ties to another one, the new certification body shall verify all current IFSPACsecure certificates, in order to decide if further actions (e.g. with-drawal of recent certificates or additional IFS renewal audit) will be nec-essary.

2 Requirements for the Certification Bodies

Certification bodies intending to perform IFS PACsecure audits shallcomply with the following rules. The prescribed tender procedure forcertification bodies is supplied by IFS.

2.1 ISO/IEC 17065 IFS accreditation process

The certification body shall be accredited according to ISO/IEC 17065for the scope of IFS PACsecure by an IAF or EA recognised accreditationbody (see section 1). Certification bodies in the process of IFS accredita-tion to ISO/IEC 17065 may organise the witness assessment(s) beforehaving achieved accreditation status.They shall demonstrate that theyare actively applying for ISO/IEC 17065 accreditation.

Note: In case of withdrawal or suspension of the ISO/IEC 17065 accred-itation of the scope of IFS PACsecure for the certification body, thewhole certification process is stopped and the certification body is nolonger allowed to issue any IFS PACsecure certificates. In particular, thecertification body cannot issue IFS PACsecure certificates from the dateof withdrawal or suspension, even for the audits which have beenalready performed but which are still in the certification process (reviewof the report, certification decision, etc.).

2.2 Signing of contract with the proprietor of IFS

After having applied and then gained IFS accreditation to ISO/IEC 17065,in order to be allowed to perform IFS PACsecure audits, the certificationbody shall sign a contract with IFS in which it commits to meet all IFSrequirements. The certification body is not authorised to perform IFSPACsecure audits (except the first witness assessment(s) during theaccreditation process) before having signed this contract.



2.3 Certification decision

The person in charge of assessing the audit reports (reviewer) shall beeither an approved IFS PACsecure auditor, an IFS PACsecure trainer orshall fulfil the following rules:

– To have a food or packaging university degree and two (2) yearsprofessional experience in the food safety/packaging materialsafety and quality related professions

– To have attended (as auditor or observer) at ten (10) completeaudits (related to other packaging material safety schemes) inthe last five (5) years

– To have participated in a hygiene training course

– To have participated in IFS PACsecureTrain-the-trainer course

– To be different of the person who performed the audit.

The review shall be documented.

The decision concerning the certification can only be made followingthe recommendation of a competent person or a certification commit-tee. Furthermore, decision can only be made by a person different fromthe person who performed the audit.The competent person for the cer-tification decision or at least one of the members of the certificationcommittee shall be an IFS PACsecure auditor, an IFS PACsecure traineror an IFS PACsecure reviewer.

According to ISO/IEC 17065, the final certification decision shall bemade by the certification body and shall not be subcontracted.

2.4 Certification bodies’ responsibilities forIFS PACsecure trainers and the IFS PACsecureauditors (including freelancers)

Certification bodies have the following responsibilities:

– To facilitate witness audits (by accreditation bodies and/or byIntegrity Program).

– To ensure that at least one member of their staff is an IFS PAC-secure trainer who has taken part in an IFS PACsecure Train-the-trainer course. The trainer is responsible for the in-housetraining of all auditors, intending to become IFS PACsecureauditors or who already are IFS PACsecure auditors. Personsintending to become IFS PACsecure trainers shall meet therequirements mentioned in 2.5.Note: for a certification body which is starting IFS activities,this in-house training can be organised by IFS, on request.



– To ensure that the auditor is competent for the scope of theaudit and its execution and is able to access and to apply rele-vant laws and regulations, based on IFS and internal certifica-tion body’s requirements; the certification body shall maintainthese competences (continuous supervision by the certificationbody) and shall monitor audit execution by on-site witnessaudit. Every auditor shall be monitored by an IFS PACsecure (orIFS Food, IFS HPC or other GFSI recognized packaging materialsafety) on-site witness audit at least once every two (2) years,and the results of this witness audit shall be documented.Theobserver shall be an IFS PACsecure, IFS Food or IFS HPCapproved auditor or shall follow the same rules as for trainers(see section 2.5).

– To maintain records of auditor competences.

– To ensure that no auditor has either acted against IFS rules, forexample acting as a consultant, or has been active in and/or onbehalf of the company being audited during the previous two(2) years. That is to say, during the certification process, noother commercial and/or personal relationships are permittedbetween the auditee and the auditor.

– To ensure that no auditor shall performmore than three (3) con-secutive IFS PACsecure audits of the same production site (onlyapplies for complete audits, whatever the time between them;follow up and extension audits are not concerned by this rule).

– To ensure that an auditor is employed by only one IFS certifica-tion body for performing IFS PACsecure audits and this for aperiod of not less than 12 months. In special cases, IFS officesshall be contacted and may allow exceptions.

– To sign an audit order for each audit, this includes a statementaccepting all the above-mentioned requirements.

– To organise a 2-day training session for IFS PACsecure auditorsonce a year for the purposes of sharing experience, calibrationand updating knowledge of relevant legal requirements, etc.The IFS PACsecure trainer shall lead a part of the trainingcourse.

– To perform an on-site witness audit of an auditor during a prod-uct safety audit and/or an audit under ISO/IEC 17065 accredita-tion to ensure the auditor’s competence (see glossary) beforehe/she has applied for the IFS examinations. The certificationbody shall state the date, the name of the audited companywhere the on-site witness audit took place, and the name of theobserver in the IFS examination application file.The minutes ofthe on-site witness audit shall be provided on request to the IFSin English, French or German.The observer for the on-site wit-ness audit of an auditor applying for IFS examination shallcomply with the same requirements as the trainers (see section2.5) or shall be an IFS PACsecure, IFS Food or IFS HPC auditor.



– To include the name of the observer in the Audit Portal whenuploading the audit data, when it has scheduled specific on-site IFS witness audit(s) according to ISO/IEC 17065 on internalaudits.

The certification body is responsible for choosing an auditor with thecorresponding scope(s), language, competence(s), etc. for each IFSPACsecure audit.

2.5 Specific requirements for IFS PACsecure trainers

IFS PACsecure trainers shall have the following profile:

– Fulfil requirements for IFS PACsecure auditors as described insection 3.2 a), b), c) and d),

– Have audit experience to GFSI standards or other packagingmaterial safety schemes,

– Have knowledge of packaging legislation,

– Have taken part in a IFS PACsecure Train-the-trainer courseorganised by IFS,

– Be fluent in writing and speaking the languages they will useduring participating in training and leading training; they shallinform the IFS offices about the languages they are able to usewhen teaching.

The IFS PACsecureTrain-the-Trainer course is organised by IFS.

In order to keep his/her knowledge of IFS PACsecure up to date, eachIFS PACsecure trainer shall take part in a 2-day IFS PACsecure trainingcourse every two (2) years. These seminars are organised by IFS andshall be the basis for in-house training to all auditors.

IFS PACsecure trainers have the responsibility to:

– Train new IFS PACsecure auditors before applying to IFS PAC-secure exams,

– Lead (a part or the whole) 2-day training session for IFS PACse-cure auditors once a year, for the purposes of sharing experi-ence, calibration and updating knowledge of relevant legalrequirements, etc.

When a new version of the Standard is published, the certificationbody’s trainer shall take part in the new IFS PACsecure course organisedby IFS and carry out in-house training of all the already IFS PACsecureapproved auditors, before performing audits based on new version.Theduration of this in-house training shall be at least one day.

In case of publication of new doctrines, the trainer shall train all IFSPACsecure auditors before the doctrine comes into force.



3 Requirements for IFS PACsecure auditors

In general, the auditors shall meet the requirements of chapters 7.2 and7.3.1 of ISO 19011.

During an IFS PACsecure audit, auditors shall, according to IFS goodauditing practices, use relevant samples of products, in order to inves-tigate on-site the auditee’s production processes and documentationand to check the fulfilment of IFS requirements. In particular, auditorsshall perform, during the audit, a traceability test in the company.

IFS publishes guidelines which can provide further information on topicsto be checked and/or requested to the audited company during the audit.

3.1 Conversion of auditors to get the IFS PACsecureversion 1 auditor approval

Auditors being already qualified for PACsecure or other IFS schemesare allowed to audit against the IFS PACsecure version 1, without goingthrough the full qualification process as mentioned in 3.2 and 3.3 if theyfulfil the following requirements:

– If they are PACsecure auditors: they shall have experience inproduct/process certification (or attend a training on product/process certification organised by IFS, including verification ofacquired knowledge) and additionally attend an IFS PACsecuretraining organised by IFS.

– If they are IFS HPC auditors approved for scope 3 (Housekeep-ing properties): they shall additionally attend an IFS PACsecuretraining organised by IFS.

– If they are IFS Food approved auditors, also qualified for a pack-aging standard related to safety and quality, like GMP FEFCO,ISO 22000 scope M or BRC IoP: they shall additionally attend anIFS PACsecure training organised by IFS.

– If they are qualified for a packaging standard related to safetyand quality (e.g. BRC IoP, ISO 22000 scope M, etc.): they shallattend an IFS PACsecure training organised by IFS and, if rele-vant, additional training on product/process certification,organised by IFS.

3.2 Requirements for new IFS PACsecure auditors

3.2.1 Requirements before applying for the IFS PACsecureexaminations

Before applying for IFS examinations, auditors shall have met the fol-lowing requirements:

– They shall have signed a contract with the certification body(see ISO/IEC 17065 norm).



– They confirm to the certification body that, for a period of atleast 12 months, they will perform IFS PACsecure audits onlyfor the respective certification body.They may, however, workfor several certification bodies on other standards. In specialcases, IFS should be contacted and may allow exceptions.

– They shall have participated at the IFS PACsecure in-housecourse organised by the certification body.

– They shall have submitted all the relevant information abouttheir competence to the certification body.

– The certification body shall have observed and confirmed theprofessional qualification and competence of the auditors.

3.2.2 General requirements for auditors when applying forIFS PACsecure examinations

Candidates applying for qualification as IFS PACsecure auditors shallmeet the following requirements and provide evidence with the appli-cation documents. An outline CV is available from IFS.

a) Education in the food and packaging material sector1) A food or packaging-related university degree (bachelor’s and/or

master’s degree equivalents) and two (2) years professional expe-rience in the packaging material industry in relation to packagingmaterial production activities (quality, production, R&D, …).

or2) If the candidate started directly as an auditor after completing

his/her food or packaging related university degree then the can-didate shall have five (5) years professional audit experience inthe packaging related industry.

or3) If the candidate has a university degree but not a food or packag-

ing-related one, (bachelor’s and/or master’s degree equivalents)then the candidate shall have five (5) years professional experi-ence in the packaging material industry—in relation to packagingmaterial production activities (quality, production, R&D, …).

or4) Professional education in food or packaging processing (high

degree) and five (5) years professional experience in the packag-ing material industry—in relation to packaging material produc-tion activities (quality, production, R&D, …).

b) General audit experienceA minimum of ten (10) complete audits shall be performed by theauditor in the packaging material processing industry during the pre-vious two years. The audits shall have been carried out in differentcompanies.

c) Food/Packaging hygiene (including HACCP/risk assessment) trainingQualified training on the basis of the Codex General Principles forFood Hygiene.



d) Training in auditing techniques based on Quality Management Sys-tem or Packaging Material Safety Management SystemDuration: one week/40 hours or equivalent.

e) Specific and practical knowledge for product scopes auditors applyfor (see Annex 1 for product scopes)At least two (2) years professional experience in the packaging mate-rial industry in relation to packaging activities, for each applied prod-uct scope.orAt least ten (10) packaging safety audits and/or second party auditsincluding quality and packaging material safety investigations withtraceable origin and confirmed by the retailer or by the industry, perproduct scope.Ten (10) witness audits during IFS PACsecure audits,as observer, are also accepted to qualify the observer on the productscope. Audits shall have been carried out in different companies.

f) LanguageAuditors must be fluent in English.

g) IFS PACsecure in-house trainingIFS PACsecure in-house training materials shall be based on thematerials provided by IFS. The auditor shall have taken part in thein-house training (covering IFS, packaging-related legislation, gen-eral hygiene requirements, GMP) undertaken by an authorised IFSPACsecure trainer and organised by the certification body.The mini-mum duration shall be two (2) days.

IFS is responsible for the technical validation of the auditors’ applica-tion files before they take part in IFS examinations. If the auditor’s CVdoes not meet the above-mentioned requirements, IFS may reject theauditor’s examination application. If the auditor does not show suffi-cient evidence for the product scopes he/she is applying for, IFS mayreject the applications for the product scopes concerned.

All CV’s content shall be confirmed by a person from the accreditedcertification body who shall put his/her name and position on the bot-tom of the CV.

Note: IFS offices have the possibility to withdraw an IFS PACsecureauditor approval or not to accept him/her at the examination, if theinformation provided in the CV is false.This kind of breach will be alsoforwarded to the IFS Integrity Program.

3.3 IFS examination process (for new auditors,as specified in chapter 3.2)

Auditors who comply with the requirements mentioned in chapter 3.2can take part in an IFS PACsecure written examination. If successful, theauditor is officially authorised to perform IFS PACsecure audits. Theauditor is registered and a personal IFS PACsecure auditor certificate isissued. Starting from the day of passing the written examination, theauditor is allowed to perform IFS PACsecure audits for the product



scopes he/she was authorized for by IFS offices until the end of thesecond calendar year. The IFS PACsecure auditor certificate mentionsthe duration of validity, the name of the certification body and the audi-tors’ product scope(s).

3.4 Maintenance of auditors’ qualification (for both typesof auditors, as specified in chapters 3.1 and 3.2)

The auditor cannot perform IFS PACsecure audits anymorewhen his/herIFS PACsecure auditor certificate expires. The certification body isresponsible to maintain auditor’s IFS approval so that there are no gapsduring the auditor approval.

Auditors’ approval shall be re-assessed before end of validity of theauditor certificates. For maintaining their approval, auditors shall fulfilthe following requirements:

– have performed a minimum number of ten (10) IFS PACsecureaudits (5 audits per year),

– have been trained internally by the certification body on pack-aging-related legislation, Standard requirements, audit prac-tices, etc. (2 days per year),

– be monitored by an IFS on-site witness audit (once every twoyears).This audit can be performed at any time during the yearof end of validity of auditor’s certificate. Witness assessmentsperformed by accreditation bodies during IFS PACsecure auditsare accepted as witness audits,

– have taken part in an IFS PACsecure calibration training course(subsequent to passing the initial examination, the first manda-tory calibration training shall be successfully completed in thesecond calendar year following the date on which the initialexamination was successfully completed.Then, the re-approvalshall be managed every two (2) calendar years, based on thesame rule).

Documented evidences shall be provided to IFS offices.

Example:Date of initial written examination: 25th of October 2012Date of end of validity for IFS PACsecure auditor certificate (initialapproval): 31st of December 2014Auditor is authorised to perform IFS PACsecure audits between 25th Octo-ber 2012 and 31st December 2014.In 2014, if the auditor has performed 10 IFS PACsecure audits (5 peryear), if he/she has been trained internally, through a yearly 2 dayscourse, has been witnessed, and has taken part in the IFS PACsecurecalibration training, the new end validity date of IFS PACsecure auditorcertificate (re-approval) is: 31st December 2016.

If any of these three rules are not fulfiled, the auditor shall participateagain in the IFS PACsecure initial written examination.



3.5 Scope extension for IFS-approved auditors

Auditors may, during the validity of their IFS PACsecure auditor certifi-cate, extend their product scopes. Scopeextensionmaynot be requestedin the first 12 months after the initial IFS PACsecure auditor approval.

For extension of product scope(s), they shall provide the same evidenceas for the initial approval, based on new experience (new from the ini-tial application). At least ten (10) IFS PACsecure audits in the scope, as atrainee, can also be accepted as evidence. The auditor shall have par-ticipated in all steps of the audit (on-site audit, assessment and decisionprocesses).

The auditors can only perform IFS PACsecure audits according to thescopes stated by IFS.

3.6 Audit team

3.6.1 General rules

In general, all members of the audit team shall be IFS approved audi-tors.

In case of auditing with teams, the following general regulations apply:

– An IFS PACsecure audit team consists of IFS PACsecureapproved auditors whose product scopes comply with theactivities of the audited site.

– A lead auditor shall always be appointed.

– Co-auditor(s) shall always be approved for at least one productscope of the audit scope.Two (2) hours of the audit duration arenot shareable; this additional time shall be allocated to theteam, not to an individual auditor, for common tasks (e.g. open-ing and closing meeting, discussion about audit findings, etc.)

– The remaining time can be split as long as the auditor compe-tencies for product scopes are not disconnected during theaudit. No “crossing over” is allowed.This means that, if the leador co-auditor(s) do not have, individually, all product scopeswhich are necessary for the audit, they have to audit all parts ofthe audit related to product scope knowledge together.

It shall be clearly indicated in the audit time schedule which auditor didwhich part of the audit. Auditors without necessary scopes can onlytake part as trainees.

The minimum audit duration shall anyway be respected.



3.6.2 Specific rules for audit team and auditing 3 consecutivetimes

For audit teams an additional rule applies as regulation for consecutiveaudits. As an exceptional case, (if the certification body has no otherpossibility to combine an audit team in year 4–6, due tomissing approvalfor product scope of their auditors) the following sequence of auditorplanning is possible:

Year 1–3: Lead auditor A + co-auditor B

Year 4–6: Lead auditor B + co-auditor C

Year 7: Lead auditor A or C + co-auditor A or C.



ANNEX 1: Product scopes

1. Flexible packaging

2. Rigid plastic

3. Paper

4. Metal

5. Glass

6. Other natural materials

Multi component packagingmaterials (e.g.Tetra Pak) have tobeassignedbased on the material which is the main component of the material.Themain component of multi component packaging materials shall bementioned in the scope of the audit on the report.

Materials to be considered as “other natural materials” are, for examplewood, clay, cork, jute, textiles, banana leaves, etc.



Part 4: Reporting and IFS Audit Portal

0 Introduction

After an IFS PACsecure audit has been performed, a detailed and well-structured audit report shall be completed. The language of the reportshall be English. The IFS PACsecure audit report shall be preparedaccording to the following format.

1 Reporting

1.1 Audit overview (Annex 1)

The first part of the audit report shall contain the following generalinformation:

Audit detailsThe cover page of the audit report shall include:

– name and address of the certification body

– the logo of the certification body

– the certification body’s accreditation details

– name of the audited company or site

– date of the audit.

These first pages shall give a summary of the most important auditreport items and shall include:

– name and address of the audited site

– name and address of the company (if headquarters)

– EAN. UCC Global Location Number, if available

– COID, as defined in the IFS Portal

– audit date (in case of a follow up audit the date of the follow upaudit shall additionally be defined)

– time of the audit

– previous audit date

– the name of the certification body and the auditor who per-formed the previous audit

– details of the version of the Standard



– audit scope (mandatory detailed descriptions of processes/products)

– numbers of product scopes

– list of key personnel present at audit

– name of the lead auditor

– if applicable, additional name of the co-auditor

– if applicable, name of the auditor trainee

– result of the audit (in case of a follow up audit, to specify that afollow up audit has taken place and that the Major non-con-formity has been solved)

– company profile: some compulsory general information aboutthe company shall be provided, as follows:

· The year of construction of the plant

· The registration numbers of the company by authorities ifavailable and/or existing (and GS1 number, if available)

· The COID (IFS identification code number), in case of renewalaudit

· When the last investment was made in production, productoriented investments concerning quality and safety (con-struction changes, machines). Specify the kind of investmentmade in production area

· The name and contact data (phone/fax/e-mail) of the contactperson in case of emergency (e.g. withdrawal/recall)

· Product groups and products per group produced in thecompany

· Complete view of the company’s processes

· If the audited company also has trade products (already pro-cessed), specify the kinds products

· How many employees are there, listed according to full-timeand part-time workers (own employees, external compa-nies), shift work

· The number and names of the sub-companies (sites) of thecompany (where are they situated, if they are IFS certified),precision about names and kinds of sub-contracted part(s) ofthe process

· The site area of the plant in square meters

· State if the company fulfils the requirements about use ofIFS logo, as defined in IFS PACsecure audit protocol (Part 1)

· If the certification body has decided to decrease audit dura-tion (see rules in chapter 5.3 of audit protocol), explanationsabout the reasons for decreasing

· If the site is certified according to other schemes, specify theschemes’ names



· If there are seasonal breaks in production process, pleasespecify time frame

– further explanations regarding scoring and frequency

– below the company profile: name of the person in charge ofassessing the report (reviewer).

1.2 Audit report (Annex 2)

The audit report itself is structured as follows:

– the result of the audit with level and percentage

– observations on KO’s and Majors (in case of a follow up audit,additional explanation on which requirement the Major hasbeen solved)

– general summary table for all chapters

– an overall summary of the audit (of all chapters)

– a list of all established deviations and non-conformities foreach chapter (1 to 6)

– a description of follow up of corrective actions from the previ-ous audit

– a separate list (including explanations) of all requirementsevaluated with N/A (not applicable)

– a detailed audit report.

1.3 Action plan (Annex 3)

The certification body/the auditor describes and explains all establisheddeviations and non-conformities (KO’s, Majors) in each chapter in theaction plan, which has a specified format shown in the annex.

1.4 Minimum requirements for IFS PACsecure certificate(Annex 4)

After successful completion of the IFS PACsecure process, the certifica-tion body shall issue a certificate in English language. For the purposesof international recognition, and so as to be understandable, IFS PACse-cure certificates awarded by the certification body shall include the fol-lowing information at a minimum:

– the name and address of the certification body, including itslogo



– the logo of the accreditation body or its name and registrationnumber (requirement mentioned in the ISO/IEC Guide 65,G.12.7.); the logo of accreditation body shall be used in con-formity with accreditation body’s rules

– the name and address of the audited company

– the COID, as defined in the IFS Portal

– if the company is a subsidiary, the name of the company’sheadquarters

– audit scope (with mandatory detailed descriptions of pro-cesses/products and including for instance trade products ifapplicable). If the list of the products is too long to be specifiedon the one page certificate, the list shall be specified in an annexand the IFS certificate shall make a reference to that annex.

– name and number of product scope(s)

– level achieved

– audit score in percentage, if required by the customer or by theaudited company

– date of audit (last day of audit)

– date of follow up audit if relevant

– next audit to be performed within the time period (renewalaudit)

– certificate issue date

– certificate expiry date, i.e. 12 months after the date of issue thecertificate (the certificate validity date shall remain the sameeach year as described in the audit protocol, Part 1)

– place and date of signature

– name and signature of the certification body’s person(s) respon-sible for the certification decision as described in Part 3 of theStandard

– IFS PACsecure logo

– PACsecure logo.

2 The IFS Audit Portal and the IFS Database(www.ifs-certification.com)

Every IFS PACsecure audit shall be uploaded to the IFS Audit Portal bythe certification body (uploading of report, action plan and certificate).

There are 3 user groups which have access to the IFS Database:

– Certification bodies

– Certified companies

– Retailers and other users.



The different groups’ access rights are as follows:

Certification bodies:

– manage their certified companies and upload audit reports,action plans and certificates

– may suspend certificates in specific situations

– can manage all IFS PACsecure audit dates via the diary func-tion, enabling retailers and companies to have a good overviewof the scheduled audits. It is mandatory to upload in the diaryfunction of the Audit Portal all audits dates, at latest 2 weeksbefore the audit.

– manage their accounts

– have the possibility to compare two consecutive audit reportsand action plans, for internal auditor training and calibrationpurposes

– download the IFS logo(s).

Certified companies/suppliers:

– have access to their own audit data

– have the possibility to unlock retailers and other users for theirachieved percentage, detailed audit report and action plan

– have the possibility to compare two consecutive audit reportsand action plans, for improvement purposes

– download the IFS Logo(s)

– manage their certification bodies

– manage company personnel access (create sub-accounts) tothe audit data

– search for other certified companies

– manage their suppliers using a “favourites” option.

Access for the headquarters of certified companiesA “headquarter” access for certified companies can be set up whichallows a company headquarter to administer all of their certified sitesthrough a single access point.

Retailers and other users:

– search for certified companies

– manage their certified companies via a “favourites” option

– get information via e-mail in case of a certificate suspension oftheir favourite companies.

The user manuals for the IFSAudit Portal are available on the respectivesecured area for each user group.



Security of the DatabaseThe security system used for the database is based on internationalrecognised and mostly used security systems.The retailer and certifiedcompanies access provide general information about all certified com-panies. If no further authorisation is granted by the certified companiesboth user groups will be able to see the following information only:

– the company’s name and address

– the certification body’s name and address

– the auditor’s name (including auditor scopes)

– the scope of the audit

– the date and duration of the audit

– the level achieved at the audit

– the IFS PACsecure certificate’s date of issue and its validity.

By using their secure log-in access‚ the certified companies themselvescan give the authorisation for access to the following detailed informa-tion:

– audit report and action plan.

The retailers and other users/certified companies automatically receiveaccess to the unlocked data by the certified company after the data hasbeen unlocked. Communication to retailers and other users is via asecure Web process which guarantees that only authorised retailersand other users/certified companies can view specific data of the certi-fied companies/suppliers.



ANNEX 1

Cover page of the audit report

Logo of the certification body

IFS PACsecureVersion 1

Final Audit Report

Audited company: “Paper and Plastic Ltd”

Date of audit: 02.12./03.12.2012

Name and address of certification body

Accreditation number of the certification body



Explanations regarding the audit report

Evaluation of requirements

Result Explanation Points



KO requirementscored with a B

Almost full compliance 15 points

C (deviation) Small part of the requirement has beenimplemented

5 points

D (deviation) Requirement has not been implemented –20 points

Major When there is a substantial failure tomeet the requirements of the Standard,which includes product safety and/or thelegal requirements of the production anddestination countries. A major can alsobe given when the identified non-con-formity can lead to a serious healthhazard. A major can be given to anyrequirement which is not defined as KO.

15% of thepossible totalamount of pointsis subtracted

KO requirementscored with a D

The KO requirement has not beenimplemented

50% of thepossible totalamount of pointsis subtracted

N/A Not applicableRequirement not applicable fora company

N/A requirementswill be excludedfrom the finalscoring



Scoring and awarding of certificates

Audit result Status Action company Report form Certificate

At least 1 KOscored with D


Report givesstatus

No

>1 Majorand/or <75%of therequirementsare fulfilled


Report givesstatus

No

Max 1 Majorand ≥75% ofthe require-ments arefulfilled

Not approvedunless furtheractions takenand validatedafter follow-up audit

Send completedaction planwithin 2 weeksof receiving thepreliminarilyreport. Follow-upaudit max.6 months afterthe audit date

Report includ-ing actionplan givesstatus

Certificate atfoundationlevel, if theMajor non-conformity isfinally solvedas controlledduring thefollow-upaudit

Total score is≥75% and<95%

Approved atfoundation IFSPACsecurelevel afterreceipt of theaction plan



Yes, certifi-cate atfoundationlevel,12 monthsvalidity

Total score is≥95%

Approved athigher IFSPACsecurelevel afterreceipt of theaction plan



Yes, certifi-cate at higherlevel,12 monthsvalidity



First pages of the audit report

IFS PACsecureVersion 1, October 2012

Audit Overview

Audit details

Lead auditor:

Mr. Müller

Co-auditor:

Ms. Lehmann

Trainee:

Mr. Schubert

Date/time of current audit:

02.12.2012(09:00–18:00)

03.12.2012(08:30–17:30)

Date/time of previous audit:

07.12.2011 (09:00–18:00)08.12.2011 (08:30–17:30)

CB and auditor of previous audit:

TEST GmbH/FrankTest

Name and address of the company (or headquarter)

Perfect PackagingExample street12345WitzenhausenGermany

Name and address of the audited site

Paper and Plastic LtdMusterstraße12346 BerlinGermany

EAN Code/UCC Global Location NumberCOID

Phone:

0123456Fax:

0123456789Phone:

0123457Fax:

0123456788

Scope of audit

Production of paper and PE foilProduct scope(s): 1, 3

Audit participants

Name: Position: Openingmeeting

Documentationreview

Site assess-ment (Audit):

Closingmeeting

Mr. Quality QualityManager

X X X X

Mr. Manager GeneralManager

X X

Mr.Transport TransportManager

X X X

Final Result of Audit

As a result of the audit performed on 02.12. and 03.12.2012, “xyz” foundthat the processing activities of Paper and Plastic Ltd for the above-mentioned scope of production comply with the requirements set out inthe IFS PACsecure, Version 1, at Foundation Level, with a score of XX%.

Next audit in12 months

Company profile

Compulsory informationIn case of reduction of audit duration, explanations of the reasons:

Reviewer:



ANNEX 2


Audit Report

Result:The processing activities of company “Paper and Plastic Ltd” met therequirements of the IFS PACsecure, version 1.

The company passed with a score of XX% at:

Foundation (Higher) level…%

Date of renewal audit: between the XX/XX and the XX/XX.

Summary:

Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6

Seniormanagementresponsibility

Quality andpackagingmaterial safetymanagementsystem

Resourcemanagement

Planning andproductionprocess

Measure-ments,analysis,improvements

Packagingmaterialdefense/Food defenseand externalinspections

KO 0 0 0 0 0 0

Majors 0 0 0 0 0 0

A 0 0 0 0 0 0

B 0 0 0 0 0 0

C 0 0 0 0 0 0

D 0 0 0 0 0 0

N/A 0 0 0 0 0 0

Observations regarding KO’s and Majors:

General summary table for all chapters:

Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Total0%

20%10%

30%40%50%60%70%80%90%

100%



Overall summary of the audit:

Description of follow up of corrective actions from the previousaudit:

Chapter 1: Senior management responsibility

Summary of all Chapter 1 deviations and non-conformities found:

N° Reference IFS requirements Evaluation Explanation

1. 1.1.1

2. 1.1.2

Report of the N/A evaluations


1.

Detailed audit report


1.

2.



ANNEX 3

Action plan

Name and address of the audited company

The Corrective Action Plan must be returned to the certification bodybefore: ___________________________________________________________

Requirementnumber

IFSPACsecurerequirement

Evaluation Explanation(by theauditor)

Correctiveaction(by thecompany)

Responsibility/Date/Status ofimplementation(by thecompany)

Releaseby theauditor



ANNEX 4

CERTIFICATEHerewith the certification body

Name of the certification body

being an ISO/IEC 17065 accredited certification body for IFS certificationand having signed an agreement with the IFS owner,

confirms that the processing activities of

Name of the audited companyAddress

COID(Headquarter)

for the audit scope:(detailed descriptions of processes/products plus, if relevant, trade products)

Name and number of the product scope(s)

meet the requirements set out in the


at Foundation level/Higher Levelwith a score of XX% (if required)

Certificate – register number: ________________________________________________

Audit date: ________________________________________________(If relevant: date of follow up audit)

Date of issue of certificate: ________________________________________________

Certificate valid until: ________________________________________________

Next audit to be performed within the time period: ______________________________(specify soonest and latest audit date, according to requirements of audit protocol, Part 1)

Date and place

Name and signature ofthe responsible personat the certification body

Address of thecertification body

Logo of the accreditationbody or its name andregistration number

IFS publishes information, opinions and bulletins to its best knowledge, but cannot takeany responsibility for any mistakes, omissions or possibly misleading information in itspublications, especially in this document.

The Standard owner of the present document is:

IFS Management GmbHAmWeidendamm 1A10117 BerlinGermany

Managing Director: Stephan TrompAG Charlottenburg HRB 136333 BVAT-N°: DE278799213

Bank: Berliner SparkasseBank code number: 10050000Account number: 190029765IBAN number: DE96100500000190029765BIC-/Swift-Code: BE LA DE BE

All rights reserved. All publications are protected under international copyright laws.With-out the expressed written consent of the IFS Standard owner any kind of unauthorised useis prohibited and subject to legal action.This also applies to the reproduction with a photo-copier, the inclusion into an electronic database/software, or the reproduction on CD-Rom.

No translation may be made without official permission by the IFS Standard owner.

The IFS PACsecure is available online via:www.ifs-certification.com

Or by Mail, Fax and E-mail:IFS Management GmbHAmWeidendamm 1A10117 BerlinGermany

Phone: +49-(0)30-726250-74Fax: +49-(0)30-726250-79E-mail: [email protected]

GERMANY | BERLINIFS Management GmbHAmWeidendamm 1AD-10117 BerlinPhone: +49(0)3072625074Fax: +49(0)3072625079E-mail: [email protected]

FRANCE | PARISIFS Office ParisFCD12, rue EulerF-75008 ParisPhone: +33(0)144439916Fax: +33(0)147205353E-mail: [email protected]

ITALY | MILANIFS Office MilanFederdistribuzioneVia Albricci 8I-20122 MilanoPhone: +39(0)289075150Fax: +39(0)26551169E-mail: [email protected]

POLAND |WARSAWIFS Office Central & Eastern Europeul. Serwituty 25PL-02-233WarsawPhone: +48601957701E-mail: [email protected]

BRAZIL | DOURADOSRepesentante IFS BrasilCaroline NowakBR-79824 Dourados, MSPhone: +55(67)81514560E-mail: [email protected]

CHINA | HEFEIStarFarmRoom 2301, C building,Fortune Plaza No. 278 Suixi Road, 230041,Hefei, Anhui, ChinaPhone: +86(0)5515666069Fax: +86(0)5515681376E-mail: [email protected]

[email protected]

USA | ST. LOUISIFS Americas1610 Des Peres Road, Suite 150St. Louis, MO 63131USAPhone: +13146864610Fax: +13146864602E-mail: [email protected]

CONTACT DETAILS OF THE IFS OFFICES

CONTACT DETAILS OF THE PACKAGINGASSOCIATION OF CANADA (PAC)

THE PACKAGINGASSOCIATION | CANADA1 Concorde Gate, Suite 607Toronto ONM3C 3N6CanadaPhone: +14164907860E-mail: [email protected]

IFS PACsecureStandard for auditing quality andsafety of packaging materials

Version 1October 2012© IFS, October 2012

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