FSSC 22000 training module V4.1 Sep 2017.ppt

© - Copyright 2010 Bureau Veritas – All rights reserved
FSSC 22000 –Version-4.1
Food Safety System Certification Scheme
Sep 2017

2
Bureau Veritas – August 2017
► Introduction
► FSSC 22000
► FSSC 22000 Version-4.1
► Additional Requirements
► Bureau Veritas Certification Experience
► Questions

Introduction

4
What’s FSSC?
► Food Safety System Certification (Foundation for Food Safety
Certification)
 Non- profit association
 Facilitates the schemes
 Founded in 2004
 Legally entity owns the GFSI approved HACCP food safety systems
certification scheme (Dutch HACCP)
 Incorporates associated Certification Bodies
(no voting rights)
 The board is represented by the relevant stakeholders from all
regions
 www.fssc22000.com

5
Who is ISO?
► International Organization for Standardization
 Non-governmental
 A network of national standards institutes (148 countries)
 A bridge between public and private sectors
► An ISO Standard
 Voluntary (no legal authority)
 Purpose:
• To facilitates exchanges
• Meet a real need (market driven)
 Work of experts - achieved by consensus
 Auditable requirements
► Well-known ISO management standards:
 ISO 9000 (generic quality management)
 ISO 14000 (generic environmental management)

6
TC34 - ISO workgroup Food Products
► TC 34/ SC17 – Management Systems for Food Safety
 Secretary : Danish Standardization Association
 Chaired till 2015 by Jacob Færgemand (Bureau Veritas Certification
Denmark)
 30 participating countries: USA, Argentina, Australia, Brazil,
Netherlands, Belgium, Denmark, Switzerland, Germany, Sweden, UK,
Ireland, France, Greece, Poland, Venezuela, Japan, China,Thailand,
Vietnam, Canada,…
 14 observing countries: Hong Kong, Turkey, Indonesia, Sweden,…
 Liaison with AOCS, Codex Alimentarius, GS1, IAF, …
ISO Technical Committees

7
The ISO 22000 family
ISO Family
► ISO 22000: Food Safety Management Systems – Requirements for any organization in the food
chain
► ISO/TS 22002-1: Prerequisite Programmes on food safety. Part 1: Food manufacturing
► ISO/TS22002-2: Catering
► ISO/TS22002-3: Farming
► ISO/TS22002-4: Pacakaging
► ISO 22003: Requirements for bodies providing audit and certification of food safety management
systems (the accreditation standard)
► ISO 22004: Guidance on application of ISO 22000:2005
► ISO 22005: Traceability in the Feed and Food Chain – general principles and basic requirements
for system design and implementation

8
Who is GFSI?
► Global Food Safety Initiative (GFSI): collaboration
between some world's leading food safety experts from
retailer, manufacturer and food service companies
► Vision: “Safe Food for Consumers Everywhere”
► Aiming to harmonize approach regarding food safety
issues
► GFSI issue a guidance on food safety standards
► GFSI benchmark standards:
 Food manufacturing: IFS Food, BRC Food, SQF 2000 &
Dutch HACCP, FSSC 22000, Synergy 22000, Primus GFS
 Farming sector: SQF 1000, New Zealand GAP, GlobalGAP
► GFSI motto: “Once certified accepted everywhere!” not
really implemented each retailer demanding its own
preferred scheme

9
FSSC 22000
► Certification scheme benchmarked by the GFSI
(Global Food Safety Initiative):

10
GFSI Technical Working Groups

11
GFSI aims to…
► Less duplication
► Driving continuous improvement in the content of the standards
► Healthy competition between existing schemes, driving continuous
improvement in the delivery of the standards
► More cost efficiency in the supply chain
► Comparable audit approach and results
Websites
www.mygfsi.com
www.tcgffoodsafety.com
www.fssc22000.com

FSSC 22000 Scheme
Version-4.1

13
FSSC 22000 Scheme - Version 4.1
► First published in 2010
► Need to revise the FSSC 22000 Scheme documents:
► Update of Scheme documents
► Expected publication of GFSI Benchmarking Requirements document Version 7
► Publication of FSMA in the USA
► Has issued more than 15000 certificates world wide.
► FSSC now the largest GFSI standard in China.
FSSC Version 4.1:
► Published in December 2016. In the months after publication there were several
developments that influenced the drafting of FSSC 22000 version 4.1.
► Board of Stakeholders decided that all sites shall be audited against FSSC 22000 version
4.1 starting January 1, 2018
► Transition period discussed, Consensus reached and acceptable for all.

14
Certification Scheme
Food Safety System Certification 22000 (FSSC 22000) version 4 for the
following cluster and categories (Total 8- Clusters):
1. Cluster Farming (ISO 22000,ISO/TS 22002-3, Additional FSSC 22000
requirements):
► Category A, Farming of animals
► AI: Farming of animals for meat, milk, eggs and honey
► AII: Farming of fish and seafood
2. Cluster Auxiliary services (ISO 22000, ISO/TS 22002-4, Additional
FSSC 22000 requirements) :
► Category I, Production of food and feed packaging and packaging
material

15
3. Cluster Food and feed processing (ISO 22000,ISO/TS 22002-1,
Additional FSSC 22000 requirements):
► Category C, Food manufacturing
► CI: Processing of perishable animal products
► CII: Processing of perishable plant products
► CIII: Processing of perishable animal and plant products (mixed
products)
► CIV: Processing of ambient stable products
► DII: Production of pet food (for dogs and cats only)
Cluster (Bio)chemical
► - Category K, Production of (bio)chemicals (excluding pesticides, drugs,
► fertilizers and cleaning agents)

16
4. Cluster Food and feed processing (ISO 22000, ISO/TS 22002-6,
Additional FSSC 22000 requirements):
► Category D, Animal feed production
► DI: Production of feed
► DII: Production of pet food
5. Cluster Catering (ISO 22000, ISO/TS 22002-2, Additional FSSC
22000 requirements):
► Category E, Catering

17
6. Cluster Retail, transport and storage (ISO 22000, BSI/PAS 221,
Additional FSSC 22000 requirements:
► Category F, Distribution
► FI: Retail / Wholesale
7. Cluster Retail, transport and storage (ISO 22000, NEN/NTA 8059,
Additional FSSC 22000 requirements) :
► Category G, Provision of transport and storage services
► GI: Provision of transport and storage services for perishable food &
feed
► GII: Provision of transport and storage services for ambient stable food
& feed

18
8. Food Safety and Quality System Certification 22000 (FSSC 22000-
Quality) version 4 for the following scopes (reference to IAF ID1 sector
codes):
► 1: Agriculture and fishing (combined with ISO 22002-3)
► 3: Food products and beverages (combined with ISO 22002-1 or ISO
22002-6)
► 29: Wholesale and retail trade (combined with BSI/PAS 221)
► 30: Hotels and restaurants (combined with ISO 22002-2)
► 31: Transport and storage (combined with NEN/NTA 8059)
► 6: Wood and wood products (combined with ISO 22002-4)
► 7: Pulp, paper and paper products (combined with ISO 22002-4)
► 14: Rubber and plastic products (combined with ISO 22002-4)
► 17: Basic metals and fabricated metal products (combined with ISO
22002-4)

19
New Elements in FSSC Version-4
► 1. Unannounced audits
► 2. Food Fraud prevention and Food Defense
► 3. Auditor competence
► 4. Nonconformity grading
► 5. Audit report template
► 6. Audit and report time
► 7. Guidance documents included in Scheme documents
► 8. Scope extensions
► 9. Off-site activities
► 10. Multi-site

20
New Elements
1. Unannounced audits
► Expectation by governments
► Wish from the industry after horsemeat scandal
► GFSI Benchmarking Requirements version 7
► Some schemes already practice it
► One of the surveillance audits unannounced
► Unannounced audit (US) is full surveillance audit
► Audited site is not notified in advance
► UA takes place during operational working hours & can include night
shifts
► A defined blackout period can be agreed
► If UA is refused, certificate shall be suspended

21
New Elements
2. Food Fraud prevention & Food Defense
► Food defense
The organization shall have a documented and annually reviewed food
defense threat assessment procedure in place to identify potential threats
and prioritize food defense mitigation measures.
► Food Fraud prevention
The organization shall have a documented food fraud vulnerability
assessment procedure in place to identify potential vulnerabilities and
prioritize food fraud mitigation measures.
3. Auditor competence
► 5 FSSC audits a year
► Exemption can be granted for individual auditors on request of the CB

22
New Elements
4. Requirements for follow-up on audits
Three grading levels:
► Critical nonconformity
► Major nonconformity
► Minor nonconformity
► FSSC does no longer allow the use of OFI
5. Audit report template
► FSSC 22000 will require a mandatory audit report template for uploading
audit reports in the database.

23
New Elements
Critical Nonconformity:
► A critical nonconformity is issued where there is a critical failure to
assure food safety, legality or certification integrity
► When a critical nonconformity is issued at a certified site, the certificate
shall be immediately suspended for a maximum period of six (6) months
► A follow-up audit shall be conducted by the CB within the 6 month time
frame to verify the closure of the critical nonconformity
► The certificate shall be withdrawn when the critical nonconformity is not
effectively solved within the six months time frame
► In case of a certification audit the full certification audit shall be repeated

24
New Elements
Major Nonconformity: A major nonconformity shall be issued when the
finding affects the capability of the management system to achieve the
intended results:
When a major nonconformity is issued during an audit, the organization
must provide the CB with objective evidence of an investigation into
causative factors, exposed risks and the proposed CAP. This shall be
provided to the CB within 14 days after the audit.
Minor Nonconformity:
A minor nonconformity shall be issued when the finding does not affect the
capability of the management system to achieve the intended results:
When a minor nonconformity is issued during an audit, the organization
must provide the CB with objective evidence of an investigation into
causative factors, exposed risks and the proposed corrective action plan
(CAP). This shall be provided to the auditor within three (3) months after
the audit.

25
New Elements
6. Additional audit time
► 0.5 auditor day on-site when site has less than:
–250 employees
–3 HACCP studies
► 1.0 auditor day on-site when site has more than:
–250 employees
–3 HACCP studies
► At least 0.25 auditor day (2 working hours) shall be added to the FSSC
22000 on-site audit time for auditor audit preparation
► At least 0.5 auditor day (4 working hours) additional shall be added to
the FSSC 22000 on-site audit time for audit reporting

26
New Elements
7. Guidance documents
► The current FSSC 22000 guidance documents contain normative
requirements
► These requirements will be included in the Scheme documents.
► FSSC 22000 version 4.1 will be more transparent and easy to
understand
8. Scope extension
► Storage and distribution (NEN-NTA 8059)
► Catering (ISO/TS 22002-2)
► Retail (BSI-PAS 221)

27
New Elements
9. Off-site activities
► “Split-process” is replaced by “off-site activities”
► There is a primary manufacturing site and secondary sites for defined
process steps
► There is clearly one process involved, resulting in a finished product,
which fits within the Scheme scope
► The audit shall clearly include all relevant requirements at both the
primary and secondary sites and allow audit and findings to be identified
as site specific
► The locations are under the same overall FSMS and part of the same
legal entity
► The certificate shall show the product groups of all sites involved, but
shall clearly identify which is the primary site
► Full details of the off-site production locations shall be included in the
audit report

28
New Elements
10. Multi-site
► Certification of multi-site organizations and multi-site sampling (as
described in ISO/TS 22003 and ISO/IEC 17021) is not applicable these
food chain categories as listed in ISO 22003:2013
–CI – IV
–DI and DII
–I and K
► Multi-site shall be applicable for
–Storage and distribution
–Catering
–Retail

29
FSSC Scheme Requirements
Main Components:
► The Scheme requirements consist of separate components that shall be
audited as a single system.
► 1) ISO 22000 food safety management system requirements.
► 2) ISO 9001 quality management systems requirements – when
selected (FSSC Quality).
► 3) Sector specific pre-requisite programs (PRPs) requirements.
► 4) Additional Scheme requirements.
The following clauses provide a brief commentary on each component and
state the high level requirements to be met for each.

30
ISO 22000 & ISO 9001
ISO 22000: The requirements for the development, implementation and
maintenance of the food safety management system are laid down in the
standard ISO 22000 “Food safety management systems - Requirements
for any organization in the food chain”.
► In order to facilitate the successful implementation of a food safety
management system, the operational conditions of the food safety
management system shall be specified, documented and verified.
► ISO 9001: For FSSC 22000-Q certification, ISO 9001 is needed in
addition to the ISO 22000 management system requirements.

31
Prerequisite Programs (PRP)
► ISO 22000 requires in clause 7.2 that organizations shall select and
implement specific PRPs for basic hygiene conditions. Such information
shall include:
a) regulatory requirements;
b) recognized sector or product group codes of practices and guidelines;
c) customer requirements.
To facilitate the successful implementation of the food safety management
system, the conditions of the PRPs shall be;
a) specified,
b) documented,
c) approved and
d) verified.

32
Additional Requirements
► The additional Scheme requirements are:
1) Management of services,
2) Product labelling,
3) Food defense,
4) Food fraud prevention,
5) Logo use,
6) Management of allergens (for categories C, I and K only),
7) Environmental monitoring (for categories C, I and K only),
8) Formulation of products (for category DII only),
9) Management of natural resources (for category A only).

33
1. Management of Services-
► A. All services that may have an impact on food safety:
a) have specified requirements which are regularly reviewed,
b) are described in documents to the extent needed to conduct hazard
analysis,
c) are managed in conformance with the requirements of technical
specification for sector PRPs,
d) are assessed and approved demonstrating compliance with specified
requirements,
e) are monitored to assure continued service provider approval status.
► B) The services referred to in A) above shall include at least:
a) utilities, b) transport and storage, c) maintenance, d) cleaning and e)
outsourced services.
► C) Verification from Competent Laboratory

34
► 2. Product Labelling:
The organization shall ensure that the finished product is labelled
according to the applicable food regulations in the country of intended
sale.
INDIA- Follow FSSAI Regulations

35
► 3. Food Defense:
► Food Defense Definition : The protection of food products from intentional contamination by biological,
physical , chemical or radiological agents that are not reasonably likely to occur in the food supply.
► 1) Threat assessment: The organization shall have a documented and implemented threat assessment
procedure in place that:
► a) identifies potential threats,
► b) develops control measures, and
► c) prioritizes them against the identified threats.
To identify the threats, the organization shall assess the susceptibility of its products to potential food
defense acts.
► 2) Control measures
► The organization shall put in place appropriate control measures to reduce or eliminate the identified
threats.
► 3) Plan
► a) All policies, procedures and records are included in a food defense plan supported by
► the organization’s Food Safety Management System for all its products.
► b) The plan shall comply with applicable legislation

36
4. Food Fraud Prevention
► Food Fraud is a collective term used to encompass the deliberate and intentional substitution, addition, tampering, or
misrepresentation of food, food ingredients, or food packaging; or false or misleading statements made about a product,
for economic gain.
► Vulnerability Assessment
► 1) The organization shall have a documented and implemented vulnerability assessment procedure in place that:
► a) identifies potential vulnerabilities,
► b) develops control measures, and
► c) prioritises them against the identified vulnerabilities.
► To identify the vulnerabilities, the organization shall assess the susceptibility of its products to potential food fraud acts.
► 2)Control measures
► The organization shall put in place appropriate control measures to reduce or eliminate
► the identified vulnerabilities.
► 3) Plan
► a) All policies, procedures and records are included in a food fraud prevention plan
► supported by the organization’s Food Safety Management System for all its products.
► b) The plan shall comply with applicable legislation

37
5. Use of Logo
► 1) Certified organizations are entitled to use the FSSC 22000 logo on the
organization’s printed matter, website and other promotional material subject to
the following design specifications:
► 2. Use of the logo in black and white.
► 3. Logo is not allowed to be used on:
a) a product, b) its labelling, c) its packaging,
d) in any other manner that implies FSSC 22000 approves a product, process or
service.
Colour PMS CMYK RGB #
Green 348 U 82/25/76/7 33/132/85 218455
Grey 60% black 0/0/0/60 135/136/138 87888a

38
6.Management of Allergens (for categories C, I and K only).
1) A documented allergen management plan:
a) risk assessment addressing potential allergen cross contamination;
b) control measures to reduce or eliminate the risk of cross contamination;
c) validation and verification of effective implementation.
► 2) All finished products intentionally or potentially containing allergenic
materials are labeled according to the allergen labelling regulations in
the country of manufacture and country of destination.
7. Environmental monitoring (for categories C, I and K only):
► shall ensure that an environmental monitoring program is in place to
verify the effectiveness of cleaning and sanitation programs which shall
meet the verification requirements as described in ISO 22000.

39
8. Formulation of products (for sub-category DII, pet food for dogs
and cats only):
1) Compounded pet food for dogs and cats shall be formulated in a
manner that is consistent with the intended use of the product.
2) Formulation procedures shall be in place to manage the use of
ingredients that contain nutrients that can have adverse animal health
impact.
9. Management of natural resources (for category A only):
a) Identify the risks it exposes from animal production to both,
i) animal health, and ii) public health.
b) Assess the hazards that expose these risks derived from on-farm used
natural resources (e.g. water and soil, to include water for animals, water
for irrigation, on farm feed production for own animals).
c) Put in place appropriate control measures to protect public and animal
health.

40
VALUE-ADDED SERVICES TO COVER ALL YOUR NEEDS
Feed manufacturing Farming & fishing Manufacturing Logistics Retail Catering
 ISO/TS 22002-1
 FSSC 22000
 BRC (Food & Packaging)
 IFS
 EN 15 593
 Suppliers’ audit
 Performance evaluation
 SQF 2000
 FAMI-QS
 GMP+
 GLOBALGAP
 Integrated farming
 Organic farming
 Responsible fishing
 SQF 1000
 MSC (Marine
Stewardship Council)
 BRC Storage
& Distribution
 IFS Logistic
 GMP+
 Service certification
 BRC Storage
& Distribution
 IFS Logistic
 Supply chain
inspection
 Suppliers’ audit
 Hygiene inspection
 Supply chain
inspection
 Performance
evaluation
CHALLENGES
OUR OFFER FOR SPECIFIC SECTORS
OUR SERVICES FOR SPECIFIC SECTORS
FOOD SAFETY STANDARD: ISO 22000, HACCP (DUTCH)
MANAGEMENT SYSTEMS STANDARDS: ISO 9001, ISO 14001, OHSAS 18001, SA 8000
PRODUCT CERTIFICATION & INSPECTION
TRACEABILITY (ISO 22005, GMO, …)
INTERNATIONAL TRADE INSPECTION/TESTING
TRAINING
 Be in conformity
with the feed
safety regulation
 Focus on quality,
safety and
sustainable
agriculture/fishing
to better access the
market
 Comply with the
highest standards
of quality and safety
to meet retailer and
consumer
requirements
 Demonstrate
a commitment
to food safety
 Reinforce a
consumer confidence
while keeping
a competitive edge.
 Ensure that suppliers
are reliable in terms
of quality and safety.
 Differentiate
themselves from the
competition.
 Coping with a wide
range of challenges
including food safety
and quality, customer
satisfaction and
regulatory
requirements.

41
►Our global network of auditors
 More than 200 experienced auditors in food
 Covering the globe
 Using local language and knowing local culture
 Most are already qualified on quality & food safety schemes such as
ISO 9001, BRC Food, IFS Food, ISO 22000…
► Other useful services that we can provide
 Training
 Inspection of products
 Testing of products (in some countries)
 Product certification: Organic, Global-Gap, MSC…
BUREAU VERITAS CERTIFICATION EXPERIENCE

42

FSSC 22000 training module V4.1 Sep 2017.ppt

Recommended

Recommended

More Related Content

Similar to FSSC 22000 training module V4.1 Sep 2017.ppt

Similar to FSSC 22000 training module V4.1 Sep 2017.ppt (20)

More from MaumitaGhosh5

More from MaumitaGhosh5 (8)

Recently uploaded

Recently uploaded (20)

FSSC 22000 training module V4.1 Sep 2017.ppt