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TUV Middle East

Member of TÜV NORD Group

Requirements/Challenges of Auditing ISO/FSSC 22000

Benzily Alexander
PURPOSE:

• Discuss who and what is FSSC 22000


• Review the benefits of the FSSC 22000 standard
• Review the basic elements of the scheme
• Describe what is involved in each of the elements of the scheme
• Discuss how does the FSSC 22000 standard differentiate from other GFSI
standards
• Challenges in auditing ISO 22000/FSSC 22000 schemes.

2 TUV ME │ Exchange of Experience


CURRENT CLIMATE

• Food safety systems today are not preventing food-borne illness and death
• Businesses face catastrophic consequences from media-hyped adverse
events
• We depend more on imported food products in our global supply chains
• Current regulatory framework and inspection cannot secure the food supply
chain on its own
• Retailers and manufacturers, in response to consumer demand, are driving a
change to a safer, more secure, and sustainable food supply chain

3 TUV ME │ Exchange of Experience


PUBLIC & PRIVATE SECTOR RESPONSES

• Codex Alimentarius Commission


• HACCP
• Government Initiatives
• Private Sector Schemes
• GFSI Benchmarking
• International Standards System Framework

4 TUV ME │ Exchange of Experience


CURRENT TRENDS

• Mandated compliance by both retailers and manufacturers around the globe


will continue to grow.
• Benchmarking of audit schemes is a good first step
• Further convergence between food safety standards will happen, like in other
industries.
• GFSI (Global Food Safety Initiative) recognized as a benchmark process for
food safety management schemes.
• Further inclusion and recognition of 3rd party certification programs in
regulation

5 TUV ME │ Exchange of Experience


Standard Owner for FSSC 22000

• The Foundation for Food Safety Certification was founded in 2004


• Non profit organization
• Foundation facilitates and owns the schemes and manages its copyright
• Maintains the license agreements with accredited CBs

• Incorporates:
 68 associated Certification Bodies for FSSC 22000
 The actual responsibility and authority for the content of the scheme resides
with Board of Stakeholders

6 TUV ME │ Exchange of Experience


STRUCTURE OF THE FOUNDATION

7 TUV ME │ Exchange of Experience


BACKGROUND , OBJECTIVES & BENEFITS OF FSSC
22000?

• Need for international harmonization of food safety standards


• Need for supply chain approach
• Use of existing, independent, international standards
• ISO-22000, PAS 220 (ISO TS 22002/1) and ISO-22003
• ISO 17021 accreditation (system & process approach)
• Scope: food manufacturing (including slaughtering and pet food)
• Stakeholder approval & commitment (industry, retailers)
• In depth and rigorous food safety audits
• Independent scheme management
• Transparency
• Non profit approach
• Owned by the Foundation for Food Safety Certification

8 TUV ME │ Exchange of Experience


BENEFITS OF FSSC 22000
• FSSC 22000 is a food safety management certification, which enables
manufacturers to focus their food safety efforts on scientific and technical
advances, and their audit resources on continuous improvement.
• FSSC 22000 is owned and governed by a non profit foundation.
• FSSC 22000 is governed by a Board of Stakeholders representing a range of
relevant international sectors with an independent chair. This provides FSSC
22000 with an independence from any specific stakeholder and ensures
international commitment.
• FSSC 22000 is based on the international family of ISO 22000 standards:
• it has global recognition and worldwide credibility; provides a common
language, improving communication and food safety across the supply chain;
• it provides a systematic management protocol for pre requisite programs
(PRPs), with control focused on what is really necessary;
• it provides confidence to other stakeholders of an organization's ability to
identify and control food safety hazards;
• it provides sufficient flexibility to take specific and varied customer
requirements into account.
• FSSC 22000 is recognized by GFSI and accepted by ABs worldwide.
9 TUV ME │ Exchange of Experience
WHY WAS THE FSSC 22000 CERTIFICATION SCHEME
DEVELOPED?

• FSSC 22000 was developed to facilitate broader acceptance of ISO 22000,


and recognition by the Global Food Safety Initiative (GFSI).
• ISO 22000 alone is not recognized by the GFSI.
• FSSC 22000 provides the certification scheme, the audit protocol, and the
owner organization required to meet the GFSI benchmarking requirements.
• FSSC 22000 is the name chosen for the sum of ISO 22000, the sector
specific PRPs like ISO/TS 22002-1 and the additional requirements.

10 TUV ME │ Exchange of Experience


WHAT IS FSSC 22000?

• FSSC 22000 is a Food Safety System Certification based on ISO 22000 and
ISO/TS 22002-1 (ISO/TS 22002-4 for Packaging)
• ISO/TS 22002-1 gives the requirements for Prerequisite Programs for food
manufacturers & ISO/TS 22002-4 gives the requirements for Prerequisite
Programs for food manufacturers.
• This document was added to ISO 22000 to create a system that could be
benchmarked by the Global Food Safety Initiative (GFSI)
• Some large retailers require suppliers to have a GFSI benchmarked scheme
• It provides a single, internationally recognized food safety management
system
• Scheme operated by the Foundation for Food Safety Certification based in the
Netherlands

11 TUV ME │ Exchange of Experience


ELEMENTS OF FSSC

• ISO 22000:2005
• ISO 22003:2013
• ISO 22002-1 – Food Manufacture
• ISO 22002-3 – Farming
• ISO 22002-4 – Food Packaging Mat

12 TUV ME │ Exchange of Experience


CONTENTS OF THE FSSC SCHEME

• Features of the scheme.


• Scope, content, references, terms & definitions.
• Requirements for the food safety management system
• Food safety management system, PRP’s, additional, guidance
• Requirements for providing certification
• Approval by the Foundation, accreditation, audit process
• Harmonization, providing information
• Requirements for providing accreditation
• Accreditation process, providing information
• Regulation for the board of stakeholders

13 TUV ME │ Exchange of Experience


BENEFICIARIES OF THE FSSC SCHEME

• FSSC 22000 is designed for manufacturers who supply their products (i.e.
national brands or private label) to major food retailers or their ingredients to
food manufacturers
• Food manufacturers that process or manufacture:
 Animal products (meat, poultry, eggs, dairy & fish products) [ISO C]
 Perishable vegetal products [ISO D]
 Products with a long shelf life [ISO E]
 Food ingredients such as additives, vitamins and bio-cultures [ISO L]
 Food packaging material manufacturing [ISO M]
• For details see FSSC 22000 guidance document on certification scopes
[www.fssc22000.com/en/page.php]
• Manufacturers already certified against ISO 22000 will only need an additional
review against the ISO/TS 22002-1

14 TUV ME │ Exchange of Experience


ADDITIONAL REQUIREMENTS OF FSSC SCHEME

To meet the needs of the key stakeholders and to ensure an adequate control of
food safety, additional specifications are required by the FSSC 22000 scheme.
These include elaborations of the clauses in ISO 22000, technical specifications
for sector PRPs and the additional requirements as laid down in Scheme
Documents Part 1, Appendix IA:

• Specifications for services


• Supervision of personnel in application food safety principles.
• Reference to specific regulatory requirements
• Management of inputs
• Management of natural resources such as water and soil regarding animal
production
• Food defense, bio vigilance and bioterrorism

15 TUV ME │ Exchange of Experience


ISO 22000:2005-FOOD SAFETY MANAGEMENT SYSTEM

• ISO 22000 is a Food Safety Management System (FSMS) that uses a


management system approach and HACCP requirements.
• Published August 2005.
• Published in response to the proliferation of private food safety standards
• The goal of ISO 22000 is to provide one internationally recognized standard
that can be applied to any organization in the food chain.
• Its structure complements the quality management system requirements
defined by ISO 9001:2008
• Provides an internationally recognized certification program for food safety
management systems
1. 18

16 TUV ME │ Exchange of Experience


WHAT IS ISO 22000:2005?

ISO 22000 combines generally recognized key elements to ensure food safety
along the food chain:

• Interactive Communication
• HACCP Principles
• System Management
• Prerequisite programs

17 TUV ME │ Exchange of Experience


ISO 22000:2005

• Section.1 – Scope
• Section.2 – Normative References
• Section.3 – Terms and Definitions
• Section.4 – Food Safety Management System
• Section.5 – Management Responsibility
• Section.6 – Resource Management
• Section.7 – Planning and realization of Safe Products
• Section.8 – Validation, Verification and Improvement of the Food Safety
Management System

18 TUV ME │ Exchange of Experience


FOOD SAFETY MANAGEMENT SYSTEM

19 TUV ME │ Exchange of Experience


ISO/TS 22002-1:2009

• Food industry driven and developed and supported by key manufacturers and
trade associations.
• Harmonizes prerequisite programs best practice for food manufacturing.
• Meets the PRP expectations and requirements of food manufacturing
stakeholders, including food retailers and foodservice providers.
• Is fully auditable enabling organizations to demonstrate compliance with
industry best practice.
• ISO/TS 22002-1 enhanced initiatives to harmonize global food safety
standards.
• Provides detail on PRP's to meet ISO 22000:2005 requirement 7.2.3
1

20 TUV ME │ Exchange of Experience


REQUIREMENT OF ISO 22002-1:2009
Requirements for:
• 4. Construction and layout of buildings
• 5. Layout of premises and workspace
• 6. Utilities - air, water and energy
• 7. Waste disposal
• 8. Equipment suitability , cleaning and maintenance
• 9. Management of purchased materials
• 10. Measures for prevention of cross contamination
• 11. Cleaning and sanitizing
• 12. Pest control
• 13. Personnel hygiene and employee facilities
• 14. Rework
• 15. Product recall procedures
• 16. Warehousing
• 17. Product information/consumer awareness
• 18. Food defense, bio vigilance and bioterrorism
21 TUV ME │ Exchange of Experience
HOW IS FSSC 22000 DIFFERENT FROM OTHER GFSI
STANDARDS?

• Independent , international standards


• Management system certification
• Focused on food safety
• Independent scheme management
• Non profit
• Transparency
• Supply chain approach
• Integrity program
• Scope of audit is system based, not product based
• Program is ISO based and does not have scheme specific requirements that
other programs have

22 TUV ME │ Exchange of Experience


FSSC 22000 FOOD CHAIN CATEGORIES

• C Processing 1 (Perishable animal products) including all activities after


farming, e.g. slaughtering meat, poultry, eggs, dairy and fish products
• D Processing 2 (Perishable vegetal products) fresh fruits and fresh juices;
preserved fruits; fresh vegetables; preserved vegetables
• E Processing 3 (Products with long shelf life at ambient temperature) canned
products; biscuits; snacks; oil; drinking water; beverages; pasta; flour; sugar;
salt
• L (Bio)chemical manufacturing additives; vitamins; pesticides; drugs;
fertilizers; cleaning agents; bio cultures
• M Packaging material manufacturing packaging material

*these food chain categories have changed with the release of ISO 22003:2013

23 TUV ME │ Exchange of Experience


MOST COMMON PROBLEMS WHEN AUDITING
ISO 22000/FSSC 22000

• Lack of Risk Assessments & Hazard Analysis using probability and severity
method.
• Confusion of Hazards , CCP’s , OPRP’s , PRP’s
• Confusion of Control & Monitoring
• Lack of Pre-Requisite Programs
• Poor CCP , OPRP & PRP’s Identification
• Lack of Validation and FSMS Verification Planning
• Logical approach is not used in selection and assessment of control
measures.
• Lack of product identification and traceability system in place.

24 TUV ME │ Exchange of Experience


Thank You

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