Potential risks of food safety in purchasing activities

Japan Quality Assurance Organization

( Member of IQNet )

11. Nov. 2015

Shigenobu Yamashita

IQNet Association Public presentation

2015 version

Part1：IQNet

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Before the presentation.... Introduction of IQNet

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IQNet – The International Certification

Network

IQNet is the largest global network of its kind:

Founded in 1989 as EQNet Head Office in Berne, Switzerland Network of 36 Partner Certification Bodies Over 200 subsidiaries worldwide More than 360,000 management systems certificates Around one-quarter of all Management System

certifications worldwide are issued through IQNet partners

Membership criteria The IQNet member bodies are the signatories of the IQNet Multilateral Agreement (MLA) and shall: a) be management system certification bodies which are accredited

against ISO/IEC 17021 for QMS and EMS

b) have the potential (e.g. the capabilities, resources, established

services) and will to contribute to the purpose and strategy of IQNet

c) apply the rules of the Association

d) co-operate within the Association on a technical basis in order to

develop and implement measures aiming at improving the quality of

their certification and the coherence of the Association,

e) agree to periodically undergo surveillance of their compliance with

the criteria of membership according to the rules and conditions of

the Association,

f) ………… . 4

IQNet Vision and Mission

Purpose of IQNet (Vision)

IQNet, through its worldwide partner network,

being the leading local and global provider of value adding assessment and certification services.

IQNet partners focus on minimizing risks and improving sustainable organizational performance for the benefit of our customers and related interested parties.

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JQA Business Outline

Part2：JQA

JAPAN QUALITY ASSURANCE ORGANIZATION

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Next, introduction of the organization for which I am working.

Overview

Company Name Japan Quality Assurance Organization (JQA)

President & CEO Noriaki KOBAYASHI

Head Office 1-25, Kandasudacho, Chiyoda-ku, Tokyo, Japan

Established October 28, 1957

Revenue from Business Operation 14.2 billion yen (Fiscal Year 2013)

Fiscal Year From April 1 to March 31 of the following year

Employees 820 (as of April 1, 2014)

Offices 15 offices throughout Japan

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History 1957 Established as “Japan Machinery and Metals Inspection Institute (JMI)”

1958 Started inspection in the fields of electronics and machinery Under such a situation, I was born in the weight of 3,060 grams on September 4, 1958 .

1962 Started overseas safety conformity testing based on the standards of UL (USA) and CSA (Canada) under the MOU contracts

1963 Started calibration of measuring instruments

1990 Started certification based on ISO 9000 series (Quality)

1993 Changed name to “JQA” 1995 Started the S-JQA mark certification of product safety

2004 Registered as a Designated Operational Entity for CDM by UN

2005 Started JIS Mark certification under the Industrial Standardization Law

2007 The 50th anniversary of establishment

2011 Changed the corporate status to a general incorporated foundation with the laws concerning the reform of public-interest corporations

2013 Established JQA Asia (Thailand) Co., Ltd. in Bangkok, Thailand.

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Offices

• Head Office • Safety & EMC Center /Measurement & Calibration Center • KANTO Machinery Testing Lab.

Aichi • ISO CHUBU Office • CHUBU Testing Center • SHIKATSU Branch • NAGOYA Construction Materials Testing Lab.

Osaka • ISO KANSAI Office • KANSAI Testing Center • KITA-KANSAI Testing Center • SAITO EMC Branch

Fukuoka • ISO KYUSHU Office • KYUSHU Testing Lab.

Iwate ISO TOHOKU Office

Yamanashi TSURU EMC Site

Tokyo

Office in Bangkok, Thailand：

JQA Asia (Thailand) Co., Ltd.

Operating Certification Services

for Management Systems.

15 Offices are located in Japan, operating various services.

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By the way, I am living around this area.

Chiba

Testing and Certification of Electrical and Electronic Products

Certification Services for Management Systems

Testing and Inspection of Construction Materials and Machinery

Calibration and Verification of Measuring Instruments

Certification Services for Environmental Concerns

JIS Mark Certification

Evaluation and Certification of Functional Safety

Testing and Inspection related to Information Security

Business Segments

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Revenue (as of March 31, 2014)

© JQA 2014

Certification Services for Management

Systems \7,538,727

Testing & Certification of Electrical and Electronic Products \2,472,759

Calibration & Verification of Measuring Instruments \2,518,117

Testing & Inspection of Construction Materials and Machinery \1,135,620

JIS Mark Certification \425,523

Certification Services for Environmental Concerns

\124,558

Others \11,872

Total: 14,227 million yen

(UNIT : 1,000 YEN)

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Organization Chart (as of July 11, 2014) Chairman

President &CEO

Ikusaburo KASHIMA

Noriaki KOBAYASHI

Board Director

Hiroshi TOUGE

Shigeyuki KONDO

Yasuhiro FUKUI

Fumio NAKAMOTO

Yoshikazu MORIHIRO

Corporate Auditor

Yasushi TANAKA

Administration

Safety and EMC Ctr.

KITA-KANSAI Testing Ctr.

Product Safety Sector

Measurement and Calibration Ctr.

Measurement and Calibration Sector

CHUBU Testing Ctr.

KYUSHU Testing Office

Machinery Sector KANSAI Testing Ctr.

KANTO Machinery Testing Lab.

JIS Certification Dept.

Global Environment Dept.

Management systems Headquarter ISO TOHOKU Office

ISO KYUSHU Office

Planning & Promotion Ctr.

Assessment Ctr.

ISO KANSAI Office

ISO CHUBU Office

Senior Executive Board Directoｒ

Tadayuki YANO

Certification Scheme Development & Promotion Dept.

Toshinori HIRATA

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Business Segments Certification Services for Management Systems

We, as a certification body boasting both comprehensive strength and expertise, offer our certification services of management systems based on various standards and criteria.

Main Activities Assessment and Registration in accordance with;

Quality Environment Information Security IT Service Business Continuity

Medical Devices Food Safety Occupational

Health & Safety Automotive Aerospace Telecommunication

Energy

Privacy Protection

Road Traffic Safety

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Potential risks of food safety in purchasing activities

Shigenobu Yamashita

Japan Quality Assurance

Organization 11 Nov. 2015

Part3： Potential risks of food safety in purchasing activities

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Finally, today’s main theme.

1. Introduction-1

ISO22000：2005 states in its introduction that “Food safety is related to the presence of food-borne hazards in food at the point of consumption (intake by consumer). As the introduction of food safety hazards can occur at any stage of the food chain, adequate control throughout the food chain is essential.”

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1.Introduction -2

These explains that: Even though one food manufacturer fully perform the hygiene

control of its manufacturing facilities and processes, if there are any critical defects with regard to the raw materials provided or the services purchased (distribution/storage, cleaning of facility, pest control, operation of staff canteen, etc.) - especially in case of unexpected defects, those defects may bring a significant effect on food safety to its end products, slipping through the control measures of the organization.

Therefore, it is essential to control throughout the food chain in

order to prevent such situation.

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1.Introduction-3

• FSSC Part1 Appendix １A ADDITIONAL

REQUIREMENTS ( １．Specifications for services )

provides the requirements on purchasing of services,

and requires the establishment of highly effective

system.

• On the other hand, in ISO22002-１ 9．Management

of purchased materials, many cases which evaluate

suppliers by a convenient means, targeting

wholesalers and trading companies, in order to cover

a wide variety of purchased goods are observed.

• Today, I would like to consider what kind of risks exist

in this matter.

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• ISO9001:2008 CL. 7.4 Purchasing

• ISO22002-1: 2009 CL. 9 Management of purchased materials

• FSSC22000 Part1: Ver.3 Appendix 1A CL. 5 Management of inputs

• ISO22000: 2005 CL. 7.3.3.1 Raw materials, ingredients and product-contact materials

2. Provisions on raw materials / purchasing activities-1

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2. Provisions on raw materials / purchasing activities -2

• ISO9001: 2008

7.4.1 Purchasing process

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established.

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2. Provisions on raw materials / purchasing activities-3

• ISO/TS 22002-1：2009

9.2 Selection and management of suppliers

There shall be defined process for the selection, approval and monitoring of suppliers. The process used shall be justified by hazard assessment, including the potential risk to the final product, and shall include:

a) assessment of the supplier’s ability to

meet quality and food safety expectations,

requirements and specifications;

b) description of how suppliers are assessed;

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2. Provisions on raw materials / purchasing activities-4

• ISO/TS 22002-1：2009

9 Management of purchased materials

9.1 General requirements

Purchasing of materials which impact food safety shall be controlled to ensure that the suppliers used have the capability to meet the specified requirements. The conformance of incoming materials to specified purchase requirements shall be verified.

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2. Provisions on raw materials / purchasing activities-5

• ISO22000: 2005

7.3.3.1 Raw materials, ingredients and

product-contact materials

All raw materials, ingredients and product-contact materials shall be described in documents to the extent needed to conduct the hazard analysis (see 7.7), including the following a)～h) as appropriate:

The organization shall be kept up-to-date including when required, in accordance with 7.7

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2. Provisions on raw materials / purchasing activities-6

a) biological, chemical and physical characteristics:

b) composition of formulated ingredients,

including additives and processing aids;

c) origin;

d) method of production;

e) packaging and delivery method;

f) storage conditions and shelf life;

g) preparation and/or handling before use or

processing;

h) food safety-related acceptance criteria or

specifications of purchased materials and

ingredients appropriate to their intended uses.

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3. Accidents caused by raw materials -1

Examples of the past accidents caused by raw materials:

• Detection of agrochemicals which should have not been used

Procured deficient raw materials from outside of its own field (a public tender) in order to satisfy the number of contracts.

• Mixing of unexpected allergen

Erroneous write-in when creating raw material specifications by suppliers, cross contamination in suppliers' sites, lack of investigation in raw materials by suppliers, etc.

• Violation of product labeling

Lack of communications on the changes such as raw materials, additives used, etc.

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• Complaints on foreign objects Increase of parasites due to the change of fishing area and/or

season. Occurrence of natural poison such as shellfish poison • Bioterrorism Intentional mixing of foreign objects caused by dissatisfaction

with employment condition and treatment. Food contamination by the infusion of drugs.

These cases cannot be protected by measures such as the agreement on specifications and the verifications of purchased goods.

Such cases are restrained implicitly by the effectiveness of supplier's management system, information gathering /offering and so forth, as well as corporate attitude of suppliers.

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3. Accidents caused by raw materials -2

The following issues are frequently pointed out in FSMS audits.

1) Deficiency in raw material specifications. Insufficient information gathering. 2) Misprint (typo) of documents /record. Omission of entry and verification. 3) Failure to update FSMS documents in case of changes in

processes 4) Insufficient execution of corrective actions against the

nonconforming purchased goods.

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3. Accidents caused by raw materials -3

The same is true with suppliers, and it causes the followings.

1) Deficiency in raw material specifications. Insufficient information gathering. ⇒ Provision of incorrect specifications (raw materials, process) of the supplied goods. 2) Misprint (typo) of documents /record. Omission of entry and verification. ⇒ Erroneous write-in of raw material specifications (additives, allergen, etc.) 3) Failure to update FSMS documents in case of changes in

processes ⇒ Failure to update purchased goods information and raw material

specifications. 4) Insufficient execution of corrective actions against the nonconforming purchased goods. ⇒ Provision of raw materials which may not be safe.

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3. Accidents caused by raw materials -4

Expected abilities to prevent the following accidents.

1) Deficiency in raw material specifications. Insufficient information gathering.

⇒ Knowledge of the supplier’s own raw materials . Ability of verification.

2) Misprint (typo) of documents /record. Omission of entry and verification. ⇒ Ability of control by management system 3) Failure to update FSMS documents in case of changes in

processes ⇒ Quality of evaluating sub-suppliers who provide raw materials

to suppliers. 4) Insufficient execution of corrective actions against the nonconforming purchased goods. ⇒ Appropriateness of verification when accepting purchased

goods by suppliers.

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3. Accidents caused by raw materials -5

4.Abilities expected for suppliers-1

• Collect exact information on the raw materials to be used in the products they supply, manufacturing processes of the purchased products, and the relevant hazard, as well as completely evaluating the effect on the product they supply.

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4. Abilities expected for suppliers-2

• Ensure collecting necessary information within its organization (sub-supplier, purchased goods, composition of raw materials of its own products, its own manufacturing processes, etc.), including changes in the products they supply, as well as providing those information timely and exactly.

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4. Abilities expected for suppliers-3

• By steadily conducting the reliable management system, collect necessary internal information exactly, document those information, undergo verification /approval, and ensure management of those documents as submitted to external organizations.

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4. Abilities expected for suppliers-4

• In the case of purchasing goods from non-manufacturers such as trading company and evaluating such company as sub-supplier, such trading company should be competent enough to communicate the customer requirements to their suppliers, monitor conformity, and detect changes, as well as having adequate product knowledge. In addition, ability to steadily conduct its own management system is also required.

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5. Items which improve effectiveness of supplier evaluation-1

It is essential to set the above-mentioned “Items which evaluate the abilities expected to suppliers”

For example, in case of evaluating trading company as supplier:

• Competence of organization as an intermediary agent with regard to the purchased (delivered) goods .(Product knowledge, trading volume, information gathering/offering, etc.)

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5. Items which improve effectiveness of supplier evaluation-2

• Ability to prepare and verify the specifications of the purchased (delivered) goods.

• Ability to manage the documents obtained from, and submitted to, external organizations

• Visit to the factories of purchased goods, appropriateness of audit frequency

• Competence of auditors who visit the factories of the (trading company’s ) suppliers, and their awareness for food safety.

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Thank You

Shigenobu Yamashita

Japan Quality Assurance

Organization 11 Nov. 2015

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