Clause 8 – Operation
In clause 8, we reach the core of the standard and we can find most of the content related to the Codex Hazard Analysis and Critical Control Points (HACCP) principles and steps. In fact, only Step 1 (Assemble the HACCP team) and Step 12 (Establishing documentation and record keeping) are totally addressed outside clause 8 (clauses 5.3 and 7.5, respectively). Internal audits, which are a verification procedure (Step 11), is covered in clause 9.2.
Clause 8.1 – Operational Planning and Control
This clause has several differences when compared with the equivalent 7.1 of the 2005 version. It is more precise about an organization’s responsibility regarding processes that are needed to meet requirements (plan, implement, control, maintain, and update) and provides examples on how to do it (establishing criteria, implementing control of the processes, and demonstrating that processes have been carried out as planned). It also introduces the necessity to implement actions in the risk and opportunities assessment.
Clause 8.2 – Prerequisite Programs
Prerequisite programs (PRPs) are a key aspect of any food safety system. There are some differences when compared with the 2005 version:
1. The word update was added in “establish, implement, maintain, and update PRP(s)”
2. When selecting and/or implementing PRP(s) organizations:
The wording is very important; the standard includes the terms “shall,” indicating a mandatory requirement and “should,” indicating a recommendation. This signifies that the ONLY prerequisites organizations must implement (mandatory) are the ones presented in the standard (clause 8.2.4) since ISO/TS 22002 series prerequisites are not compulsory.
When clause 8.2.4 of the standard is compared with ISO/TS 22002-1 (Prerequisites for Food Manufacturing), something stands out immediately: food defense, biovigilance, and bioterrorism. This is mandatory if organizations follow ISO/TS 22002-1 but not if you set your prerequisites according to ISO 22000:2018.