Understanding 22000

Food Safety Management Systems

 The 22000 Standards,
ISO and FSSC 22000
Many standards already exist worldwide...
ISO 22000 and FSSC 22000 have global
acceptance
FSSC 22000 is a GFSI Benchmarked standard
 What is ISO & FSSC 22000?
ISO 22000
Applies to all stages of the supply chain
Is aligned with ISO 9001 to enhance compatibility with
existing management system
FSSC 22000
Applies to Food Manufacturers
Contains the requirements of ISO 22000 and the ISO/TS
22002-1, or ISO/TS 22002-4.
ISO/TS 22002-1 contains specific requirements for
prerequisite programs (PRPs). The ISO/TS 22002-4 contains
PRP requirements for Food Packaging Manufacturers
 FSSC 22000 Requirements for Auditee
Organizations
The Audit Requirements for FSSC 22000
Certification consists 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. FSCC 22000 Additional requirements.
 What is ISO 22000?
A set of requirements for a Food Safety
Management System (FSMS)
It was developed to fill the need for a
worldwide Food Safety Standard
 What is ISO 22000:2018?
Sections 4 - 10 Contain the requirements
ISO 22000:2018 Standard
• Section 1: Scope
• Section 2: Normative Reference
• Section 3: Terms & Definitions
• Section 4: Context of the organization
• Section 5: Leadership
• Section 6: Planning
• Section 7: Support
• Section 8: Operation
• Section 9: Performance evaluation
• Section 10: Improvement
 Prerequisite Programs
The scheme specific 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, NEN/NTA 8059 and/or the
BSI/PAS 221 standards.
 FSSC 22000 Explanation
• FSSC 22000 is a company-level certification
based on a scheme developed by the
Foundation for Food Safety Certification. The
standard helps organizations ensure the
supply of safe food and beverages. In addition
to the requirements set forth in this
certification, FSSC 22000 fully incorporates ISO
22000 and pre-requisite programs
 Background to FSSC 22000 V5
• Version 5 is a revised version of FSSC. The
latest version of FSSC 22000 was released on
June 3 2019. Version 5 is a revised version of
FSSC 22000 v 4.1, formally launched in July
2017.
FSSC 22000 V4.1 to FSSC 22000 V5
The main reasons for changes in the new version
of FSSC 22000 V5 are :
• Publication of the new ISO 22000:2018
standard
• Inclusion of the Board of Stakeholders list of
decisions
• Compliance with GFSI requirements
• Continual improvement process
Key Changes to the Version 5 Requirements

The key changes incorporated into the FSSC

22000 version 5 can essentially be divided
into:
• Changes due to HLS of ISO 22000
• Changes that are specific to ISO 22000
• Changes that are specific to FSSC 22000
 Key Changes induced by HLS (High Level
Structure)
• As a result of HLS, the structure and clauses of the
Standard are largely changed compared to the
previous version.
• New Clauses for systematic determination and
monitoring of the business context (external and
internal issues) (Ref. 4.1) and Needs and
expectations of interested parties (Ref. 4.2). This is
to identify and understand the factors that can
(potentially) affect the ability of Management
System to reach the intended results.
 Key Changes induced by HLS (High Level
Structure)
• Strengthened emphasis on Leadership and
Management commitment (Ref. 5.1), including to
actively engage and take accountability for the
effectiveness of the management system.
• Risks management (Ref. 6.1.1 to 6.1.3) to
determine, consider and, where necessary, take
action to address any risks that may impact (either
positively or negatively) the ability of management
system to deliver its intended results.
 Key Changes induced by HLS (High Level
Structure)
5.1 Top Management shall demonstrate
leadership and commitment by:
a) Ensuring that the Food safety policy and
objectives of the food safety management
system (FSMS) are established.
b) Ensuring the implementation of FSMS.
c) Ensuring that resources for the FSMS are
available.
 Key Changes induced by HLS (High Level
Structure)
d) Communicating the importance of effective food
safety management.
e) Ensuring that FSMS is evaluated and maintained.
f) Directing and supporting persons to contribute to
the FSMS’ effectiveness.
g) Prompting continual improvement.
h) Supporting other relevant managements roles to,
i) Demonstrate their food safety leadership.
 Key Changes induced by HLS (High Level
Structure)
• Strengthened focus on objectives as drivers
for improvements (6.2.1/6.2.2) & performance
evaluation (9.1.1/9.1.2).
• Extended requirements related to
Communications (7.4); More prescriptive in
respect of the mechanics of communication,
including determination of what, when and
how to communicate.
 Key Changes induced by HLS (High Level
Structure)
• Less strict requirements for a Food Safety
Manual (7.5.1). It is still required to have
documented information.
• Documented information shall be controlled
to ensure It is adequately protected (ref.
7.5.3). The explicit requirement to have a
documented procedure has been removed.
 Key Changes induced by HLS (High Level
Structure)
• The HLS does not refer to Preventive action as
a term of clause. However, the concept of
preventive action is considered to be covered
through the risk based thinking throughout
the standard and implicitly embedded in
relevant clauses (e.g. through chapter 4, 6, 8
and 9).
• Documented information is now the term
used as replacement of Documents & Records.
 Two Stage PDCA implementation
• The standard clarifies the Plan-Do-Check-
Act cycle, by having two separate cycles
in the standard working together; one
covering the management system and
the other; covering the principles of
HACCP.
Two Stage PDCA implementation
Other Specific Key Changes
Changes affecting systematic on Hazard
analysis, CCP’s and oPRP’s
 FSSC 22000 v5 changes - Additional
requirements
• 2.5.1 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
undertaken for the verification and/or validation
of food safety, this shall be conducted by a
competent laboratory that has the capability to
produce precise and repeatable test results
using validated test methods and…….
 FSSC 22000 v5 changes - Additional
requirements
best practices (e.g. successful participation in
proficiency testing programs, regulatory
approved programs or accreditation to
international standards such as ISO 17025).
- ISO 22000:2018 now covers suppliers
qualification and monitoring including
relevant services in 7.1.6, so that the previous
additional requirements have been removed.
 FSSC 22000 v5 changes - Additional
requirements
• 2.5.2 Product Labeling (version 5)
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 an regulatory
requirements in the country of intended sale.
2.1.4.2 Product Labeling (version 4.1)
The organization shall ensure that the finished product
is labeled according to the applicable food regulations
in the country of intended sale.
 FSSC 22000 v5 changes - Additional
requirements
• 2.5.6 Management of allergens (for categories C, E, F, G, I
and K, Version 5) (Extended to Cat. E, F and G)
The organization shall have a documented allergen
management plan that includes :
a) Risk assessment covering all potential sources of allergen
cross-contamination and;
b) Control measures to reduce or eliminate the risk of cross-
contamination.
> Validation and verification requirements removed from
this section (to be covered by the FSMS). Labeling moved to
relevant additional clause in this section.
 FSSC 22000 v5 changes - Additional
requirements
• 2.5.7 Environmental monitoring (for categories C, I and K)
The organization shall have in place :
a) Risk-based environmental monitoring program;
b) 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;
c) Data of the monitoring activities including trend
analysis.
 FSSC 22000 v5 changes - Additional
requirements
• Formulation of products (for Category D)
(Extended to entire Category D)
The organization shall have in place
procedures to manage the use of
ingredients that contain nutrients that
can have adverse health impact.
 FSSC 22000 v5 changes - Additional
requirements
(New Requirement)
• 2.5.9 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.