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FSSC 22000 v5 – Key changes DNV GL - Business Assurance, 3 June 2019 Summary

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Why these changes? Background to FSSC 22000 v5  FSSC 22000 v4.1 was published July 2017, v5 3 June 2019. The main reasons for the changes in the new version (v5) of FSSC 22000 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

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 FSSC 22000 v5: Overview

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Key changes to the requirements The key changes incorporated into the FSSC 22000 version 5 can essentially be divided into:

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01

Changes due to HLS of the ISO 22000

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Changes that are specific to ISO 22000

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Changes that are specific to FSSC 22000

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Key changes induced by the HLS

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 As a result of the 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 to identify and understand factors that can (potentially) affect the ability of Management System to reach the intended results.  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. 5

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Key changes induced by the HLS  5.1 Top Management shall demonstrate leadership and commitment by: a) Ensuring that the food safety policy and the objectives of the food safety management system (FSMS) are established b) Ensuring the implementation of the FSMS c) Ensuring that the resources for the FSMS are available d) Communicating the importance of effective food safety management e) Ensuring that the FSMS is evaluated and maintained f) Directing and supporting persons to contribute to the FSMS’ effectiveness. g) Promoting continual improvement; h) supporting other relevant management roles to i) demonstrate their food safety leadership

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Key changes induced by the HLS  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.  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.

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Note also the following related to the HLS  The HLS does not refer to Preventive action as a term or 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 and Records.

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In addition there are other key changes (see next slides)


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ISO 22000 – two stage PDCA implementation

* Including control of externally provided processes, products and services.

Organizational planning and control PLAN (FSMS)

The PDCA cycle

 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.

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4. 5. 6. 7.

DO (FSMS)

Context of the organization Leadership Planning Support*

8. Operation

CHECK (FSMS) 9. Performance evaluation

ACT (FSMS)

10. Improvement

Operational planning and control PRPs Traceability system Emergency preparedness & response

Hazard analysis

Validation of control measures

Hazard control plan (HACCP/oPRP plan)

Verification planning

PLAN (food safety)

Updating of preliminary information and documents specifying the PRPs and the hazard control plan

Verification activities

ACT (food safety)

CHECK (food safety)

Analysis of results of verification activities

Implementation of the PLAN (food safety) Control of monitoring and measuring Control of products & process nonconformities

DO (food safety)


Other specific key changes Step

Step

What has changed?

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Scope

7.4.1

General

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Definitions

7.5.1

General

3.21

Food safety

8.3

3.33

Outsource

3.39

Risk

8.9.4.2

Evaluation for release

5.2.2

Communicating the food safety policy

8.9.4.3

Disposition of nonconforming products

6.2.1

Food safety objectives

7.1.6

Control of externally-provided processes, products or services

7.2

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What has changed?

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Competence

8.8.1

8.5.1.5.3 9.3.2

Traceability system Verification

Description of processes and process environment Management review input


Changes affecting systematics on hazard analysis, CCP’s and oPRP’s Step

3.8

Control measure

3.11

Critical control point CCP

3.12

Critical limit

3.30

Operational prerequisite programme

8.1 8.5.2.4.1

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What has changed?

Operational planning and control Reworded and clarified

8.5.4.1

HACCP Plan vs Hazard Control Plan

8.5.4.2

Determination of critical limits and action criteria

8.5.4.3

Monitoring systems at CCPs and for oPRPs

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FSSC 22000 v5 changes Additional requirements – What is new?

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Additional requirements

(Modifications in yellow)

2.5.1 Management of services

2.5.2 Product labelling (v5)

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 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

 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.

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2.1.4.2 Product labelling (v 4.1)  The organization shall ensure that the finished product is labelled according to the applicable food regulations in the country of intended sale.

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Management of allergens extended to E,F,G category 2.5.6 Management of allergens (for categories C, E, F, G, I and K, v5)

 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). Labelling moved to relevant additional clause in this section.

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Environmental monitoring (for categories C, I and K) 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 regular trend analysis.

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(Modified)


Formulation of products (extended for entire category D) 2.5.8 Formulation of products (for 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.

New!

2.5.9

Transport and delivery (food chain category FI)

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.

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FSSC 22000 v5 key changes  

Short presentation of key changes in FSSC 22000 v5, released June 3 2019

FSSC 22000 v5 key changes  

Short presentation of key changes in FSSC 22000 v5, released June 3 2019

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