Fssc 22000 v5 scheme gfsi

Introduction to FSSC 22000
Tutor: Dr.Mahendran Rajendran
Lead Max Quality and standardization llc

Introduction to FSSC 22000
FSSC
22000
V5

FSSC 22000-V5
Course Content:
 Introduction
 About FSSC 22000
 About Scheme (FSSC 22000V5)
 Part 1 –Scheme Overview
 Part 2-Requirments for organization to be audited
 Key Changes in V5
 Requirments of FSSC V5
 Additional Requirments
 Key Changes for Certified sites: what you need to know?
 Benefits of FSSC 22000
 How to achieve FSSC22000 V5 certification

This course provides an introduction to food safety
management systems (FSMS) and ISO 22000. It also
explains how to identify the key attributes of an effective
FSMS, how to describe, analyse and interpret the
fundamental requirements of ISO 22000 and helps
understand requirements of FSSC version 5.
In addition, this course will provide delegates with the skills
needed to assess and report on the effective implementation
and maintenance of a Food Safety management system in
accordance with ISO 22000, FSSC 22000 version 5.

About FSSC 22000
Food safety system certification
FSSC 22000 is a food safety management
system(FSMS):
The system defines requirements for integrated
process that work together to control and minimize
food safety hazards.
The FSSC system was designed to provide companies
in the food industry with an ISO based FSMS
certification that is recognized by the Global food
safety initiative (GFSI). Reorganization by GFSI
provides worldwide recognition and acceptance by
food manufacturers and retailers.

About FSSC 22000
Food safety system certification
FSSC 22000 is a food safety management
system(FSMS):

About FSSC 22000
Food safety system certification,,,
The FSSC 22000 system uses a management system
approach to food safety, using ISO for the
management system requirements and ISO Technical
standards or Publicly available specification(PAS)
for the prerequisite program requirements. The food
safety management system integrates nicely with
other management systems such as ISO 9001 (QMS)
and ISO14001(EMS),

About FSSC 22000
Food safety system certification,,,
The certification audit and surveillance audit also take a
management system approach, with a process based
audit instead of a checklist based audit. The audit
determine if your FSMS meets the requirements of the
standard, if it does your organization is recommended
for certification. If it does not , you will need to make
improvements to the system before achieving
certification. There is no score or grade From the audit.

About Scheme
Parts;
 PART1 SCHEMEOVERVIEW
 PART2 REQUIREMENTSFORORGANIZATIONSTOBEAUDITED
 PART3 REQUIREMENTSFORTHECERTIFICATIONPROCESS
 PART4 REQUIREMENTSFORCERTIFICATIONBODIES
 PART5 REQUIREMENTSFORACCREDITATIONBODIES
 PART6 REQUIREMENTSFORTRAININGORGANIZATIONS
The Scheme consists of six Parts and two Appendices which are
bundled in this document. Furthermore, there are seven Annexes.
All these documents also contain mandatory Scheme
requirements. Lastly, there are guidance documents on several
topics to provide additional support. All documents can be
downloaded for free from the FSSC 22000 website.

About Scheme,,,
APPENDIX 1
DEFINITIONS
This part contains all definitions that have been used
throughout all Scheme documents.
APPENDIX 2
REFERENCES
This part contains all references that have been used
throughout all Scheme documents.

About Scheme,,,
ANNEXES
There are seven Annexes which are mandatory and necessary for proper
implementation of the Scheme:
• Annex 1 CB Certificate scope statements
• Annex 2 CB Audit report template (FSSC 22000)
• Annex 3 CB Audit report template (FSSC 22000-Quality)
• Annex 4 CB Certificate templates
• Annex 5 AB Accreditation certificate scope
• Annex 6 TO Course specifications
• Annex 7 TO Training certificate templates

Part -1 Scheme Overview
The scheme;
The FSSC 22000 certification scheme (hereafter the
Scheme) outlines the requirements for the audit and
certification of food safety management systems (FSMS)
or FSMS and Quality Management Systems (QMS) of
organizations in the food supply chain. The certificate
confirms that the organization’s FSMS (FSSC 22000) or
FSMS and QMS (FSSC 22000-Quality) is in conformance
with the Scheme requirements.

Part -1 Scheme Overview,,,
The Scheme is based on the publicly available
standards/technical specifications:
 ISO 22000 requirements for any organization in the
food chain;
 ISO 9001 requirements (where FSSC 22000-Quality is
required);
 Relevant prerequisite programs (PRPs) based on
technical specifications for the sector (e.g. ISO/TS
22002-x; PAS xyz); and
 FSSC 22000 Additional Requirements as determined
by our stakeholders.

When the Foundation decides that updates or changes to
the Scheme are necessary, requirements for
communication and implementation will be published
separately.
The Scheme provides a voluntary certification model that
can be applied across the entire food supply chain.
It can cover supply chain sectors where specific
prerequisite programs (PRPs) have been developed and
accepted.

The food chain category description used by this Scheme
is defined according to ISO/TS 22003:2013 (see Chapter
3). As of February 2010, the Scheme has been
benchmarked and recognized by the Global Food Safety
Initiative (GFSI) confirming global food industry
recognition and acceptance.

PART-2 REQUIREMENTS FOR
ORGANIZATIONS TO BE AUDITED
FSSC 22000 Version 5
On June 3- 2019, FSSC 22000 published Version 5 of its
certification scheme. One big reason for the revision is
the publication of the standard ISO 22000: 2018 last
summer, which is used as a basis for the GFSI
benchmarked certification scheme. The new version
includes mainly structural changes that we will present
in this article.

PART-2 REQUIREMENTS FOR
ORGANIZATIONS TO BE AUDITED
FSSC 22000 Version 5

FSSC 22000 Version 5,,,
First, we want to give you a quick overview of the FSSC
22000 framework. The standard consists of three
components: ISO 22000, PRPs and the additional FSSC
22000 requirements. The international standard ISO
22000 forms the basis for FSSC 22000 and outlines the
requirements for the development, implementation and
maintenance of the Food Safety Management System
(FSMS) as laid down in the standard ISO 22000:2018.
This is the reason why the revision of ISO 22000 has
such a big impact on FSSC 22000.

The scheme specifies mandatory application of technical
specifications detailing the prerequisite programs
(PRPs). These PRP requirements are specified in the
ISO/TS 22002-x series, and PAS 221 standards. FSSC
22000 additional requirements are related to the topics
management of services, product labelling, food Defense
and food fraud mitigation.

In the new version 5 there is an optional quality
management module, which includes all the integrable
elements of ISO 9001 into the FSSC 22000 certification.
This way it is possible to combine a Food Safety
Management Certification with a Quality Management
Certification.

FSSC 22000 is applicable for the following branches:
food manufacturing, food packaging manufacturing,
animal feed production, farming as well as transport
and storage, catering and retail and wholesale. GFSI
benchmark is valid for food manufacturing (C), animal
feed production (D), transport and storage (G), food
packaging manufacturing (I) and bio chemicals (K).

CHANGES IN VERSION 5
ISO 22000 is a cornerstone for FSSC 22000 – therefore
it’s not surprising that all important changes in FSSC
version 5 correspond with the changes in ISO 22000.
For the sake of completeness, we will describe changes
again but you can also consult our article regarding
the changes on ISO 22000.

Reference
V5
Change Reference
V4
Part 1 Food category and sectors moved to
part 1.
1.1
2.1 and 2.2 Replacement of ISO 22000:2005 by
ISO 22000:2018
2.1 and 2.2
2.5.1 Management of services: shortened
because this is now part of ISO
22000:2018 clause 7.1.6.
Management of laboratory services
remains as an additional FSSC 22000
requirement
2.1.4.1
2.5.6 Management of allergens for C, E, FI,
G, I and K (was C, I and K)
2.1.4.6
2.5.7 Environmental monitoring for C, E,
FI, I and K (was C, I and K)
2.1.4.7
- Management of natural resources
removed.
2.1.4.9
2.5.9 New requirement Transport and
Delivery (category FI)
-

The new version adopts the so-called High-Level
Structure (HLS), the common structure for all new
management system standards. The adoption of a
common structure throughout all standards facilitates
the integration of various management systems. Users of
ISO 9001:2015, ISO 14001:2015 and ISO 45001 will
already be familiar with this structure. In practice, the
change in structure will make it easier for organizations
to combine ISO 22000 with other management system
standards.

In accordance with the changes in ISO 9001:2015 and
ISO 14001:2015, the new version of ISO 22000 is also
a risk-based standard. The standard will distinguish
between risk at the operational level l (through the
Hazard Analysis Critical Control Point approach
(HACCP)), as well at the strategic level of the
management system and its ability to reach its
specified goals as such.

The standard now consistently distinguishes two Plan-Do-
Check-Act (PDCA) cycles. The first applies to the
management system as a whole, while the second, within it,
addresses the operations described in Clause 8, which
simultaneously cover the HACCP principles. This is
illustrated in the graph above.

Additionally version 5 includes new definitions as well as
further information regarding the different categories. It
improves previous scheme requirements and enables
integrated management system audits for FSSC 22000-
Quality. Here https://www.fssc22000.com/ You can
download the standard from free of charge.

PART-2 REQUIREMENTS FOR ORGANIZATIONS
TO ACHIEVE FSSC 22000 V5

REQUIREMENTS
a) GENERAL
Organizations shall develop, implement and
maintain all the requirements outlined below and
will be audited by a licensed Certification Body in
order to receive a valid certificate.
The audit requirements for FSSC 22000 certification consist of:
1) ISO 22000:2018 food safety management system requirements;
2) sector specific prerequisite program (PRPs) requirements (ISO/TS
22002-x series or other specified PRP standard) and;
3) FSSC 22000 Additional requirements.

REQUIREMENTS
The audit requirements for FSSC 22000-Quality
certification consist of:
1) ISO 22000:2018 food safety management system
requirements;
2) 2) ISO 9001:2015 quality management system
requirements;
3) 3) sector specific prerequisite program (PRPs)
requirements (ISO/TS 22002-x series or other
specified PRP standard) and;
4) 4) FSSC 22000 Additional requirements.

REQUIREMENTS
b) ISO 22000
For both FSSC 22000 and FSSC 22000-Quality
certification, the requirements for the development,
implementation and maintenance of the Food Safety
Management System (FSMS) are laid down in the standard
ISO 22000:2018 “Food safety management systems -
Requirements for any organization in the food chain”.

REQUIREMENTS
c) ISO 9001
For FSSC 22000-Quality certification, the requirements for
the development, implementation and maintenance of the
Quality Management System (QMS) are laid down in the
standard ISO 9001:2015 “Quality management system -
Requirements”.

REQUIREMENTS
d) PREREQUISITE PROGRAMS
The Scheme specifies mandatory application of
technical specifications detailing the prerequisite
programs (PRPs) as referenced in clause 8.2 of ISO
22000:2018. These PRP requirements are specified in
the ISO/TS 22002-x series, PAS 221 standards.

FSSC 22000 ADDITIONAL REQUIREMENTS
1. MANAGEMENT OF SERVICES
In addition to clause 7.1.6 of ISO 22000:2018, the
organization shall ensure that in case external laboratory
analysis services are used for the verification and/or
validation of food safety, these shall be conducted by a
competent laboratory that has the capability to produce
precise and repeatable test results using validated test
methods and best practices (e.g. successful participation in
proficiency testing programs, regulatory approved
programs or accreditation to international standards such
as ISO 17025).

2. PRODUCT LABELLING
In addition to clause 8.5.1.3 of ISO 22000:2018, the
organization shall ensure that finished products are
labelled according to all applicable food safety (including
allergens) statutory and regulatory requirements in the
country of intended sale.

3. FOOD DEFENSE
i. THREAT ASSESSMENT
The organization shall have a documented procedure
in place to:
a) Conduct a threat assessment to identify and assess
potential threats;
b) b) Develop and implement mitigation measures for
significant threats.

3. FOOD DEFENSE
The organization shall have a documented procedure in place to:
ii. PLAN
a)The organization shall have a documented food Defense
plan specifying the mitigation measures covering the
processes and products within the FSMS scope of the
organization.
b) The food Defense plan shall be supported by the
organization’s FSMS.
c) The plan shall comply with applicable legislation and be
kept up-to-date.

3. FOOD FRAUD MITIGATION
a)The organization shall have a documented food Defense
plan specifying the mitigation measures covering the
processes and products within the FSMS scope of the
organization.
b) The food Defense plan shall be supported by the
organization’s FSMS.
c) The plan shall comply with applicable legislation and be
kept up-to-date.
a)VULNERABILITY ASSESSMENT

1. Conduct a food fraud vulnerability assessment to
identify and assess potential vulnerabilities;
2. Develop and implement mitigation measures for
significant vulnerabilities.
a)VULNERABILITY ASSESSMENT

b)PLAN
1. The organization shall have a documented food fraud
mitigation plan specifying the mitigation measures
covering the processes and products within the FSMS
scope of the organization.
2. 2. The food fraud mitigation plan shall be supported by
the organization’s FSMS.
3. The plan shall comply with the applicable legislation and
be kept up-to-date.

4. LOGO USE
a) Certified organizations, Certification Bodies and
Training Organizations shall use the FSSC 22000 logo
only for marketing activities such as organization's
printed matter, website and another promotional
material.
b) In case of using the logo the organization shall comply
with the following specifications:

4. LOGO USE,,,
Use of the logo in black and white is permitted when all other
text and images are in black and white.
c) The certified organization is not allowed to use the FSSC
22000 logo, any statement or make reference to its certified
status on:
i. a product;
ii. ii. its labelling;
iii. iii. its packaging (primary, secondary or any other form);
iv. iv. in any other manner that implies FSSC 22000 approves a
product, process or service.

5. MANAGEMENT OF ALLERGENS
(FOOD CHAIN CATEGORIES C, E, FI, G, I & K)
The organization shall have a documented allergen
management plan that includes:
 Risk assessment covering all potential sources of allergen cross-
contamination and;
 Control measures to reduce or eliminate the risk of cross-
contamination.

5. ENVIRONMENTAL MONITORING
(FOOD CHAIN CATEGORIES C, I & K)
The organization shall have in place:
 Risk-based environmental monitoring program;
 Documented procedure for the evaluation of the
effectiveness of all controls on preventing contamination
from the manufacturing environment and this shall
include, at a minimum, the evaluation of microbiological
and allergen controls present;
 Data of the monitoring activities including regular trend
analysis.

6. FORMULATION OF PRODUCTS (FOOD CHAIN
CATEGORY D)
The organization shall have in place:
procedures to manage the use of ingredients that
contain nutrients that can have adverse animal health
impact.
7. TRANSPORT AND DELIVERY (FOOD CHAIN
CATEGORY FI)
The organization shall ensure that product is
transported and delivered under conditions which
minimize the potential for contamination.

FSSC 22000 V5 – KEY CHANGES FOR
CERTIFIED SITES: WHAT YOU
NEED TO KNOW!

NEED TO KNOW!
FSSC 22000 V5 was published in June 2019 and is
mandatory for all sites from 1st January 2020
FSSC 22000 V5 Standard:
Part 1: Scheme overview
Part 2: Requirements for Organizations to be Audited
Part 3: Requirements for the Certification Process
Part 4: Requirements for Certification Bodies
Part 5: Requirements for Accreditation Bodies
Part 6: Requirements for Training Organizations
Appendix 1: Definitions
Appendix 2: References

NEED TO KNOW!
In order to get familiar as soon as possible with the
new requirements, we encourage you to visit the
FSSC 22000 website where, as always, you can
download all scheme documents for free here.
ISO 22000:2005 has now been replaced by ISO
22000:2018. You can download information on the
changes for this Standard here. All FSSC Certified
organisations will transition to ISO 22000:2018 in
2020.

CERTIFIED SITES: WHAT YOU NEED
TO KNOW!
Clauses 2.5.6, 2.5.7, 2.5.9
 Management of allergens – scope expanded to cover
more food categories (C, E, FI, G, I and K) (Clause
2.5.6)
 Environmental monitoring - scope expanded to cover
more food categories (C, E, FI, I and K) (Clause
2.5.7)
 New requirement for Transport and Delivery
(Category FI) (Clause 2.5.9) – Minimising the
potential for contamination.

TO KNOW!
Clauses 4.4 – Contract
Certified organizations have a contractual obligation to
inform the Certification Body within 3 days in case of any
of the following events which could affect the status of
their FSSC Certification:
 significant changes that may affect the compliance with the
Scheme requirements;
 serious events that impact the FSMS or FSQMS, legality
and/or the integrity of the certification which include legal
proceedings, prosecutions, situations which pose major
threats to food safety, quality or certification integrity as a
result of natural or man-made disasters (e.g. war, strike,
terrorism, crime, flood, earthquake, malicious computer
hacking, etc.);

TO KNOW!
Clauses 4.4 – Contract
 public food safety events (such as e.g. public recalls, food
safety outbreaks, incidents etc.);
 changes to organization name, address and site details;
 changes to organization (e.g. legal, commercial,
organisational status or ownership) and management;
 changes to the management system, scope of operations and
product categories covered by the certified management
system;
 any other change that renders the information on the
certificate inaccurate.

TO KNOW!
Clauses 5.4.1 – Unannounced Audits
The certified organization can voluntary choose to replace all
surveillance audits by unannounced surveillance
audits. Recertification audits may be conducted unannounced at
the request of the certified organization.

TO KNOW!
Head Office and Multi-site Audits
In the event of non-conformities raised in a head
office audit, these are assumed to have impact on
the equivalent procedures applicable to all sites.

TO KNOW!
Timeframes relating to management of non-
conformities
1. Minor non-conformity
The CB approval shall be completed within three (3)
months after the last day of the audit. Exceeding this
timeframe shall result in a suspension of the certificate.

TO KNOW!
conformities
2. Major non-conformity
The CB shall review the corrective action plan and conduct an
on-site follow-up audit to verify the implementation of the CA to
close the major nonconformity. The CB may decide to perform
a desk review if the they feel this is sufficient. Any follow-up
activity shall be completed within 28 days from the last day of
the audit..

TO KNOW!
conformities
3. Critical Non-Conformity
A separate audit shall be conducted by the CB between 6 weeks
to 6 months after the regular audit to verify the effective
implementation of the corrective actions.

Benefits of FSSC 22000 Food Safety Management
System:
 Demonstrated due diligence meeting regulatory and
customer requirements
 Enhanced company profile, reputation and brand
protection
 Increased stakeholder confidence
 Certification that is accepted by all organisations
 Significantly greater marketing opportunities leading to
higher profits
 Enhanced food safety in supply chain and increased
supply chain management
 Minimised risk and food safety related incidents
 Improved food safety performance
 Greater protection from spurious food poisoning
allegations
 Food safety culture embedded and employees empowered
 Easily integrated with other management systems.

How to Achieve FSSC 22000 V5
(Food Safety Management System)

Conduct FSSC 22000 V5
requirements Awareness
and Transition Training
Do GAP analysis to find
the new requirements
Implement the new
requirements effectively
Monitor and verify the
FSSC22000 V5 system to
Comply
Plan for Internal audit-
FSSC22000 V5
Evaluate continual
improvement
Achieve FSSC22000 V5
by CB

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Fssc 22000 v5 scheme gfsi

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