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15 April 2016 SAFER, SMARTER, GREENER DNV GL © 2016

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15 April 2016 Kathleen Wybourn & Jacqueline Southee

Meeting the Requirements of FSMA with FSSC 22000

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Meet Today’s Speakers

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Kathleen Wybourn

Director Food & Beverage

DNV GL NA

Jacqueline Southee

US Liaison

FSSC 22000

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Questions are Welcome

Enter your questions in the Chat Box anytime during the presentation at the bottom right hand corner of your screen. Your questions will be answered at the end of the presentations.

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Meeting the Requirements of FSMA with FSSC 22000

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Accredited Third Party Certification Under FSMA

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FDA FSMA – Accredited Third-Party Certification

The FDA FSMA rule on the Accredited Third-Party Certification is now final. Published November 2015, establishes a voluntary program for

the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. These requirements will help ensure the competence and

independence of the accreditation bodies and third-party certification bodies participating in the program. Certification audits under GFSI should not be confused with

Accredited Third-Party Certification under FSMA. THESE AUDITS ARE COMPLETELY DIFFERENT

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Foreign entities may use certifications under FSMA for 2 purposes:

Certifications may be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food into the U.S, To prevent potentially harmful food from reaching U.S., the FDA

can also require in specific circumstances that a food offered for import be accompanied by a certification from an accredited third-party certification body, In either case domestic facilities will not be audited under

this program, This program only applies to foreign facilities and only

under very limited cases.

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Accredited Third-party certification bodies

Are required to perform unannounced facility audits and to notify the FDA upon discovering a condition that could cause or contribute to a serious risk to public health, Accredited third-party certification bodies must:

– Ensure their audit agents are competent and objective, – Verify the effectiveness of corrective actions to address

identified deficiencies in audited facilities, – Assess and correct any problems in their own performance, – Maintain and provide the FDA access to records required to be

kept under the program.

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Two Kinds of Audits that can be performed

Accredited third-party certification bodies can perform as part of the program, consultative and regulatory. In both kinds, auditors will examine compliance with applicable federal food safety requirements. – A consultative audit is conducted in preparation for a regulatory

audit and is for internal use. In addition to compliance with federal standards, a consultative audit also considers how the facility meets industry standards and practices. Only a regulatory audit can be the basis for certification.

An accredited third-party certification body could be a foreign government or other third-party entity or individual.

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DNV GL A global business assurance partner

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10,400 Food and beverage companies partner with us to ensure safety and sustainability

Position One of the world’s leading certification bodies

People 2,000 highly skilled specialized employees

2,400 Healthcare organizations trust us to help them improve quality and patient safety

Partnership with more than 70,000 customers in over 180 countries

80,000 Management system (ISO 9001, 14001, 18001, etc.) certificates issued under more than 80 accreditations

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Experience and expertise

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DNV GL has extensive competence and experience in auditing, and solid track record in tailoring assessment programs based on customer needs

We are flexible … and we work with a project management approach

Meeting the Requirements of FSMA with FSSC 22000

Jacqueline Southee. US Liaison , FSSC 22000

Current Issues for the Food Industry

• Evolving Consumer demands • Changing demographics • Complex supply chain • Emerging threats • Advancing technology • Changing Legislation

• Does GFSI meet the requirements of FSMA ?

GFSI and Private Certification

• Developed to protect private brands and ensure confidence in the production of safe food

• Global collaboration and capacity building • Guidance document

• Defines minimum safety requirements for benchmarking

• 11 recognized schemes • 100 000 Certificates worldwide

• Business to Business recognition • Global harmonization “Certified once, accepted everywhere” • Increases customer satisfaction and improves

trade • Reduces costs and facilitate exports

GFSI recognition

Food Safety Modernization Act, 2011 FSMA

• Necessary update of GMPs and old legislation • Move to be preventive rather than reactive • Months of consultation with private sector • Publication of Final Rules from Sept 2015

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

• Published Sept 2015 Implementation Sept 2016

• Preventive Controls • US-Centric but with far reaching influences

• Focus on Supply chain

Preventive Controls:

• Defines a management system approach • Flexibility with accountability • Requires HARPC • Training is a legislative requirement • Focus on the Supply Chain • Demand for the verification of suppliers • Foreign Supplier Verification

Does GFSI Certification = Compliance?

Preamble to PC Rule: “where systems mirror the requirements, existing records can be used to provide evidence of compliance” (Comment 8)

Systems could be used to provide

“…. evidence of compliance with the appropriate supplements” (Comment 382) Prior to this report, the FDA believed it premature to accept the schemes, but that once evidence of alignment was provided it is suggested that systems could be used as;

.…evidence of validation (Comment 496), …. verification of supplier (Comment 673), …. to meet the requirements of the annual audit required for FSVP (Comment 683) Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

• Shared goals of food safety through preventive controls and flexible management system approach

• FSSC 22000 comprised of 3 elements • ISO 22000 • Prerequisite Programs (PRP’s) • Additional requirements

• Gap analysis commissioned

FSSC 22000 versus FSMA

Comparison of FSSC 22000 against the P C for Human Food (Final Rule)

Key areas FDA Preventive Controls Food Safety Plan

FDA GMPs (117 Subpart B)

FSSC 22000 Scheme Equivalence

1. Overarching Policy Statement No No Yes (Exceeds) 1. Written Plan Yes No Yes (Comparable) 1. Experienced Individual in Charge Yes No Yes (Comparable in

qualifications; Exceeds in responsibility)

1. Trained Staff Yes Yes Yes (Comparable) 1. Prerequisite Programs No Yes Yes (Exceeds) 1. Raw Material/ Incoming Product

Safety Assurance No No Yes (Exceeds)

1. Supplier Verification Yes No Yes (Comparable) 1. Allergen Management Yes Yes Yes (Comparable) 1. Validation of Controls Yes No Yes (Comparable) 1. Finished Product Testing No No Yes (Exceeds) 1. Sanitation Control Yes Yes Yes (Exceeds) 1. Corrective Actions Yes No Yes (Comparable) 1. Traceability No1 No Yes (Comparable) 1. Recall Yes No Yes (Comparable) 1. Record Retention Yes No Yes (Different) 1. Food Defense No2 No Yes (Exceeds) 1. Internal Audit & Management Review No3 No Yes (Exceeds)

FSSC 22000 versus FSMA

In summary the report states of FSSC 22000; “it’s required elements exceed the rule in several areas. Where it is not exceeding, …measure comparable to the Final Rule requirements’.

“There are no elements of the FDA preventive control and cGMP requirements that are clearly just “missing” in FSSC 22000 that we could determine...”

Exceeds: FSSC 22000 vs FSMA

• Raw material/ incoming product safety assurance: Exceeds

• Finished Product Testing: Exceeds • Sanitation Control: Exceeds • Food defense: Exceeds • Internal audits and management review: Exceeds

Comparable FSSC 22000 vs FSMA

• Supplier verification: Comparable • Allergen Management: Comparable • Validation of Controls: Comparable • Corrective Actions: Comparable • Traceability: Comparable • Recall: Comparable

Different FSSC 22000 vs FSMA

• Record retention: Different • Terminology

– HACCP and operational PRPs vs Preventive Controls – Food safety team leader vs Preventive Controls Qualified

Individual – Withdrawal vs Recall

FSSC 22000 certified = FSMA compliant? • Side by side comparison • Cooperation with FDA and Industry • Share with experience and knowledge • Develop confidence of FDA, Auditors and

Inspectors

Mission of FSSC 22000

“To be the world’s leading, independent, GFSI recognized, ISO based food safety

and quality management system for the entire food supply chain.”

Global organizations using FSSC 22000

11,000+ certificates worldwide

11,000 Sites

107 Licensed CBs

Certificates in 154 countries

1500 auditors

Issued certificates (November 2015)

• Management System framework • Visibility throughout the food chain • In depth audits conducted, consistent and systematic

• Three year cycle with annual surveillance audit • Internal audit program • Training programs reviewed

• Audit ready all the time! • Consistency, Communication and Compliance

Benefits of FSSC 22000

The Entire Food Supply Chain

ISO 22000:2005 - Food safety management systems ISO/TS 22003:2013 -Requirements for bodies providing audit

Integrity Program Procedure for CB to become licensed for FSSC 22000

Scopes - checks on issued certificates

Desk reviews - checks on (surveillance) audits Auditor database screening KPI monitoring (database Audit Data Summaries)

Program for CB office audits

Witness audits - Program for announced but unscheduled audits of certified organizations

Alignment of FSSC 22000 with FSMA

• Contribute to global food safety • Extend resources of FDA • Provide supplier verification • Provide FSVP audits • Provide Risk assessment of companies • Continuous improvement by data sharing

Website www.fssc22000.com E-mail jsouthee@fssc22000.com Phone 508 932 6421 Twitter @FSSC22000 LinkedIn Group FSSC 22000

Let’s connect

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We thank you for your participation today

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Kathleen Wybourn

Director Food & Beverage

DNV GL

Jacqueline Southee

US Liaison

FSSC 22000

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Jacqueline Southee, US Liaison FSSC 22000 JSouthee@fssc22000.com Kathleen Wybourn, Director Food & Beverage, DNV GL kathleen.wybourn@dnvgl.com April Lefebvre, BDR Food & Beverage, DNV GL april.lefebvre@dnvgl.com 678- 425-8168

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CONTACT US:

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Next DNV GL & FSSC 22000 Webinar – April 29th Register now for DNV GL Food Safety Symposium – September 21st and 22nd Rosemont, IL

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