What's new in GFSI: IFS PACsecure

What’s new in GFSI: IFS PACsecure

Q&A

Today’s Presenters

Debra Krug-Reyes• Principal in the Food Safety and

Quality Auditing GroupConAgra Foods

George Gansner• Director, Global Marketing and

Business Development; Manager -Americas

International Featured Standards (IFS)

Food Safety and Packaging:

What do CPGs Expect of Suppliers?

Debra Krug-ReyesFood Safety and Quality Auditing

ConAgra Foods, Inc.

August 14, 2014

Agenda

Current Status

Typical Expectations from CPG/Food Companies

Product Recalls

Risk-Based Preventive Programs

6

Necessary mindset

If your product touches food at some point in the downstream supply chain, you are a part of the Food Industry.

Treat Food Packaging (Human and Pet) with the same food safety rigor as food – look at potential risks from design to consumption

The Federal Food, Drug and Cosmetic Act

The FDA regulates Food Contact Materials based on the premise that they

are potential Food Additives

Section 210(s) of the Act:

A Food Additive: “Any substance the intended use of which results in or may be reasonably expected to result … in its becoming a component of food”

Any substances which then become part of a food by being transferred from the packaging are considered “Indirect Food Additives”

Conclusion: Packaging Materials are potential Food Additives

8

Typical Expectations for Packaging Supplier Approval

Supplier survey / risk assessment

Site Audit:

3rd party; GFSI or other Food Safety certification;

CPG internally developed audit

Typical assessments:

GMPs, Employee Practices, Training

HACCP/Food Safety Risk/Hazard Assessment Controls in place to eliminate identified risks– CCPs or prerequisites

Supply chain management/approval process

Raw material regulatory approvals

Chemical migration testing

9

FOOD SAFETY Continues to be Big News

10

0

100

200

300

400

500

600

700

800

900

1000

E. coli Listeria Salmonella ForeignMaterial

Packaging-Not Labeling

UndeclaredIngred/

ALLERGENS

U.S. 2011

U.S. 2012

U.S. 2013

U.S. Food Recalls – 2011-2013

11Source: Food Industry Report , Vol. 24, 25, 26 No. 4 April 2012, April 2013, April 2014

Canada Food Recalls 2011-2012

Source: Food Industry Report, Vol. 24 and 25, No. 4, April 2012 and April 2013

0

50

100

150

200

250

300

E. coli Listeria Salmonella ForeignMaterial

Packaging- NotLabeling

UndeclaredIngred/

ALLERGENS

Canada 2011

Canada 2012

12

Impact of Recall Indirect Costs

Product Reputation

LOSS OF CONSUMER CONFIDENCE in the brand, the product category, the company, the food industry

Other brands and other companies are affected

Product Recovery

Disposal Costs

Analytical Costs

Shelf-space

13

Top Food Safety Related Issues Associated with Packaging

Undeclared/Unlabeled Allergens /Misbranding Wrong food or wrong package

Mixed labeled packaging materials– Packaging Supplier or Food Plant errors(e.g., labels, cartons, film, lids, cups,…)

Human errors– multiple potential sources– Murphy’ Law

Incorrect Label Printing Copy review errors

Prior print versions re-appear

Printing changed or lost

Chemical Migration Migration into product (e.g., film, pallets, ink…)

May be “Perceived” food safety issues– odors, taste Social Media Communication (e.g., BPA)

14

People with food allergies DEPEND ON CORRECT LABELS

It’s the LAW 15

16

Reaction to MILK Reaction to PEANUTSNormal

Food Allergies can lead to serious reactions– potentially fatal

Hostess Recalls Chocolate Mini Muffins–

Mislabeled/Unlabeled Allergen

Banana Nut muffins packaged in the wrong bag-- bag was labeled as “Chocolate Chip”, walnutspresent in the muffins not listed on the label–

Unlabeled Allergen and Misbranded Product

October 1, 2010 – Consumer Reports Food Safety Alert

17

OM Wieners with Cheese in

Classic Wieners Package–

Not labeled as containing cheeseUNLABELED MILK

ALLERGEN

Fox News April 20, 2014

18

19

20

21

Pro-active packaging suppliers preventmixed labeling

Controls to prevent mislabeling:

Implement strict controls at points where human error could occur

Changeover/Line Clearance checklists

Print copy reviews

Electronic Vision Systems

Rework controls

Employee training and reinforcement

Joint Responsibility:

Controls at both the packaging supplier AND the food plant

22

Non-Label Related Issues

Less frequent

Larger amount of product implicated

Huge financial impact

23

Chemical Migration

Migration into product

Sources– film, ink, pallets, …..

Perceived or real risk?

Social Media (e.g., BPA)

News reports

24

Kellogg’s Recall 28MM Boxes of Cereal–

Cereal box liners imparted bad taste and odor to the food

Associated with nausea and vomiting in some consumers. The source was identified

as higher than normal levels of a chemical (2-Methyl Naphthalene) in the liners

June 2010 25

http://www.csmonitor.com/var/ezflow_site/storage/images/media/images/0628-kellogg/8224153-1-eng-US/0628-kellogg_full_600.jpg

http://www.csmonitor.com/var/ezflow_site/storage/images/media/images/0628-kellogg/8224153-1-eng-US/0628-kellogg_full_600.jpg

Johnson & Johnson Recalls Over 60MM Bottles of

Pain Relievers Due to Musty Odor (3 Recalls)

The odor was caused by trace amounts of a chemical (tribromoanisole(TBA)) formed as a by-product of mold growth on high-moisture

wooden pallets

In addition to causing an unpleasant odor, TBA has been associated with temporary and non-

serious gastrointestinal symptoms.

Jan - Oct 2010

26

Supplier approval programs (resin and other materials)

Letters of Guarantee/Certificate of Conformance

Chemical Migration testing

Audits of incoming materials

Consider end use of packages (e.g., direct product contact, microwave, hot fill, pH of the food,…)

Packaging supplier and customer must work closely to understand the interaction of the package with the food– consider foreseeable use

Pro-active programs prevent potential chemical migration

27

Other Considerations

CONSUMER PERCEIVEDfood safety/consumer hazards

FORESEEABLE USE of the material

28

Perceived Food Safety Risk

29

Consider foreseeable use

in the packaging risk analysis

30

Who’s Responsible for Safety

of Packaging Materials?

Joint Responsibility

Packaging Supplier and CPG Manufacturer

31

Joint Responsibilities

Sound Quality Management Systems

Risk Analysis– what “could” happen if….

Controls to prevent incidents

Secondary checks/controls

Prevent potential for human error

Use of technology (e.g., vision systems)

Learn from prior mistakes– yours and others

Remember Murphy’s Law

32

Pro-active food safety programs at packaging

suppliers and food manufacturers can prevent

potential issues

33

Prerequisites & Basics for

HACCP/Food Safety Programs

34

HACCP/ Food Safety

GMPSanitation,

Sanitary Design, Maintenance

Process Control

Microbiological Chemical &

Physical ControlSpecifications

TrainingEnvironmental

MonitoringSupplier Control

Product Traceability &

Recall

Food Safety Across the Supply Chain

HACCP/Food Safety Programs identify

potential hazards/risks and controls that can be implemented to prevent potential hazards

The HACCP approach is a proven food safety

program accepted worldwide– the ultimate goals:

Protect consumers

Prevent / Eliminate Recalls

35

GFSI– Global Food Safety Initiative

Vision: Safe Food for Consumers Everywhere

Mission: Driving continuous improvement in food safety to strengthen consumer confidence worldwide

A strong HACCP/Food Safety program including strong prerequisite programs are essential components of the Global Food Safety Initiative

36

Food Safety is everyone’s

responsibility

37

38

39

Blank area for graphicsThanks to sister CPG companies and the Food Safety Alliance for

Packaging (Technical Committee of IoPP) that contributed content to portions of this presentation.

IFS PACsecureWhat is that?

TraceGains Webinar | August 14, 2014

| 41 | www.ifs-certification.com

Introduction

The IFS PACsecure Standard - in a nutshell

For manufacturers and converters of

packaging materials

To ensure quality and safety of

packaging materials

Food and non-food materials

Meets GFSI requirements

Roll out in North America and Europe


Introduction

Origin of the Standard

Safety standards for manufacturers of

packaging material

(Packaging Association of Canada - PAC)

Prerequisite ProgramHACCP-plans and

workbooks for hazard identification


Introduction

Origin of the Standard

PACsecure: development by working group of North America’s largest packaging and food manufacturers

IFS PACsecure is GFSI Benchmarked

IFS PACsecure: Cooperation of IFS and PAC to develop the Standard andmeet GFSI requirements


Introduction

Structured as IFS Food

Part 1

(Audit protocol)

Part 2

(Requirements)

Part 3

(AB, CB & Auditors)

Part 4

(Report)

• Annex 1 – different IFS Standards

• Annex 2 – Certification process

• Annex 3 – Product scopes

• Annex 1 - Glossary

• Annex 1 – Product scopes

• Annex 1 - Report cover page

• Annex 2 - Audit report

• Annex 3 - Action plan

• Annex 4 - Certificate


Part 1: Audit protocol

The Standard applies to manufacturers of different packaging materials

Without food contact

With food contacte.g. PE foil for vegetables, tin plate cans for beverages, paper packaging for flour…

e.g. technical products

>> Scope of the audit

>> Product scopesFlex pack.

Rigid

plasticPaper Metal Glass

Other natural

mat.

>> Processing lines shall be operating during the audit



>> Scope of the audit

IFS PACsecure product scopes Examples

1. Flexible packagingBlown film extrusion of PE films for cheese

wrapping

2. Rigid plastic thermoforming of PP trays for ready meals

3. PaperPapermaking, manufacturing of corrugated

cardboard

4. Metal Drawing of two-piece alu cans for soft drinks

5. Glass Blow-blowing of glass containers

6. Other natural materialsMaterials to be considered as “other natural

materials” are, e.g. wood, clay, cork, jute, textiles,

banana leaves

Multi-componentThe main component of multi component packaging materials (e.g.

drink cartons) has to be mentioned in the scope of the audit on the

report.



>> Types of audits

Initial audit Follow up audit Renewal audit

• First audit for the

company against the

IFS PACsecure

• All requirements

shall be audited

(complete company

audit)

• Required when

Major and final

score ≥75%

• Auditor focuses on

implementation of

corrective action

related to Major

• Performed on-site,

by the same auditor

• If failure, a

complete new audit

necessary

• Any full audit after

the initial audit

• All requirements to

be audited

• Check corrective

action plan from

previous audit

• Companies are

responsible for

maintaining their

certification



>> Types of audits

Extension audit

• Between two audits, in case

of new products or processes

• CB shall decide risk based if

audit is necessary, which

requirements are applicable

• In general, extension audit

necessary when risk

assessment or product

scopes or technologies are

different



Influencing factors

Size of the site

Scope of the audit

>> Minimum audit duration: 2 days (exceptions possible)

Type of production

Number of production lines

Number of personnel

Number of non-conformities ofprevious audit

• all members shall be approved IFS PACsecure auditors

• lead auditor and co-auditor(s) shall be identified

• auditor’s profile shall comply with the activities of the audited factory

• 2 hours of the audit duration are not shareable (for common tasks, e.g.

opening and closing meeting, discussion about audit findings)

• audit time schedule shall indicate which auditor did which part of the audit



>> Audit team



>> Scoring system - deviations

Result Explanation Points

A Full compliance 20

B Almost full compliance 15

CSmall part of the requirement

has been met5

D Requirement has not been implemented - 20



>> Scoring system - Major

• May be given to any requirement (except KO)

• Meaning: substantial failure to meet the requirement (including product

safety/legal issues or if it might lead to a serious health hazard)

• Substracts 15 % of score

>> Scoring system - KO

• KO-requirements may be scored with A (20pts), B (15pts) or D (-50 %)

• “D” leads to non-certification or suspension of certificate


>> Conditions for awarding the certificate

Non conformity Status Action of the auditee Certificate

At least 1 KO scored

with DNot approved

send completed action plan

scheduling of a new initial audit, not

earlier than 6 weeks after

NO

> 1 Major

and/or

total score < 75%

Not approved

send completed action plan

scheduling of a new initial audit, not

earlier than 6 weeks after

NO

Max 1 Major and total

score is

≥ 75%

Not approved

unless further

actions taken

and validated

after follow up

send action plan within 2 weeks after

receiving preliminary report

Follow-up audit max 6 months after the

audit date

Foundation

level

(if Major NC

solved)

Total score ≥ 75% and

< 95%

Approved for

IFS PACsecure

foundation


receiving preliminary report

Foundation

level

Total score ≥ 95%

Approved for

IFS PAC secure

higher level


receiving preliminary report Higher level


Part 2: List of audit requirements

1 checklist

9 KO requirements

>> Key facts

References to the original PACsecure standard in the checklist

Example questions of auditors in the checklist

Examples for KO and Major in checklist

Additional HACCP plans and workbooks available by PAC



>> Structure of the checklist, example: trainings

No Requirement PAC

secure-

rqmnt

PAC

secure

- No

What to check?

What should be

asked?

Example for

KO/Major

3.3.4 The contents of training

and/or instruction shall be

reviewed and updated

regularly and take into

account company‘s specific

issues, packaging material

safety, packaging material

related legal requirements

and product/process

modifications.

D 1.2.1–4 4, 5 – How are training contents

reviewed?

<review test>

– When are training

contents reviewed?

– When was the latest

training content update

done?

– What was the content of

the latest update?

<audit results>

– specific issues: non-

conformities, failures

During the on-site

audit evidence was

given that

employees did not

act according to

knowledge trans-

mitted in the training

sessions and this

lead to a product

safety risk.



>> Content

• Corporate structure, Management review…

1. Senior Management Responsibility

• Documentation, Record keeping, Risk assessment…

2. Quality and Packaging MaterialSafety Management System

• Personnel hygiene, Training, Staff facilities, Working conditions…

3. Resource Management



>> Content

•Legally required documentation, Specifications, Formula/ Configurations, Purchasing, Production and storage areas, Cleaning, Waste, Foreign material, Pests, Maintenance, Traceability…

4. Planning and Production Process

•Internal audits, Calibration, Product analysis, Complaints, Corrective actions…

5. Measurements, Analysis, Improvements

•Site security, Personell and visitors…

6. Packaging Material Defense/Food Defense and External Inspections



>> 9 KO requirements – 4 of them in chapter 4 (production process)

Senior Management responsibility (1.2.4)

Personnel hygiene (3.2.1.2)

Specifcations for raw materials (4.2.1.2)

Compilance with customer agreements (4.2.2.1)

Procedures to avoid foreign material (4.12.1)

Traceability system (4.18.1)

Internal audits (5.1.1)

Procedure for withdrawal/recall (5.9.2)

Corrective actions (5.11.2)



>> Supporting documents by PAC >> example: CP determination



>> Supporting documents by PAC >> example: CP determination


Part 3: Requirements for CBs and auditors

>> Auditor requirements

IFS PACsecure

IFS Food IFS HPC scope 3

PACsecure

otherpack-stds.

poduct/process

-audit training

poduct/process

-audit training

otherpack-stds.

Key question: is the audited company capable

of supplying safe products that comply with the

agreed specifications?


Part 3: Requirements for CBs and auditors

>> Audit objectives and principles

• An audit should check the capability of a company

to use its systems and processes to realize a safe,

legal and conform product

• During the audit, the auditor uses objective

evidence on site to check whether safe, legal and

conformant products are actually produced and

delivered

• The aim is, in a given audit situation, to reach

equivalent results regardless of who the auditor is


Part 4: Reporting and IFS Audit Portal

>> Audit portal and database – where the audits are stored

• Upload

reports

• Manage

companies

• Compare

reports

• …

CBs

• Access to

own audit

data

• Unlock

retailers

• Create sub

accounts

• …

Suppliers

• Search for

suppliers

• E-mail notif.

in case of

certificate

suspension

• …

Retailers

User g roups


Update

Audit status

>> 23 sites certified, some already twice

Austria and Germany, e.g.:

Canada and USA, e.g.:


Status

News

• GFSI-recognized since December 2013

GFSI benchmark

• Working group creates training materials

• McDonald‘s Europe accepts IFS PACsecure

Rollout in Europe

• English, German, Italian and Spanish alreadyavailable

• French and Portuguese are worked on

Translation of the Standard


Conclusion

Review

• Standard for packaging material manufacturersWhat?

• Flexible & rigid plastics, paper, metal glass, othernatural materialsScope?

•Safety & quality for manufacturers

•Reduction of faults and costs

•Meet GFSI requirementsObjectives?

• Independent assessment

• Risk based

• Flexibility of implementationBenefits?


Conclusion

Benefits

• IFS PACsecure offers up to 1 year to closedeviations

• More flexible requirements

• Truly risk-based requirements

• Guideline included in the checklist

compared to

BRC IoP

• Check of compliance with customer requirements

• IFS PACsecure displays the degree of fulfillment(scoring system with percentage)

• Comparable regardless of language

• Harmonized audit report, comparable to the other IFS Standards

compared to

ISO 22000 + PAS223

IFS PACsecure, Version 1 | Neckarsulm | 11.06.2013| 68 | www.ifs-certification.com

IFS PACsecure, Version 1

Benefits

• IFS PACsecure-Anforderungen prüfen Sicherheit und Qualität von Herstellern und berücksichtigen Kundenanforderungen. So können z.B. Lieferantenaudits reduziert werden

Hohes IFS-Anforderungsniveau

• Der IFS PACsecure-Standard wird durch die GFSI geprüft – dabei werden Qualität und Belastbarkeit der Anforderungen untersucht.

GFSI-Benchmark

• Trotz vieler Gemeinsamkeiten unterscheidet sich IFS PACsecure vom BRC-IoP-Standard. IFS PACsecure fragt z.B. nach:

• Überprüfung der Mitarbeiterverantwortlichkeiten

• Hygieneregeln auch für Besucher und Dienstleiter

• Ständige Verfügbarkeit von Spezifikationen und gesetzl. geforderter Dokumente

• Erfüllung von Kundenanforderungen

• …

Unterschiede zu BRC-IoP

Thank youfor your attention

George Gansner

IFS Management

[email protected]

314-686-4610

mailto:[email protected]

Documentation — Turning Static Data Into Information

Typical

24/7 Detection& Compliance

Automation

TraceGainsDynamic

Information

AutomaticScorecarding

Difficult to search, analyze, andtake action

Instant eNotificationAlerts

No More Spreadsheets: Documents to Data

Static Data

COAsSupplier Documents

Finished Goods Quality

Machine Maint.

Receiving

Receiving Inspections Lab Results

Auto. P.O.Acknowl.

Plant Floor Feedback

Finished Goods QA

COA

ActionForm™

TraceGains Automation Solves Many Problems

GFSI

Labeling

FSMA

Audits

Q&A

Rajan Gupta

[email protected]

George Gansner

[email protected]

Debra Krug-Reyes

[email protected]

Date post:	16-Jul-2015
Category:	Food
Upload:	tracegains
View:	283 times
Download:	1 times