Planning and running the operations that make safe food
Plain-language summary
Plan, carry out and control the day-to-day processes needed to make safe product, and manage any planned or unplanned changes to them.
What the clause is really asking
This is where the system meets production. The clause requires you to plan and control the operational processes - establishing criteria, implementing controls, keeping the evidence - so that safe food is consistently made. It also covers controlling changes and reviewing the consequences of unintended changes, plus managing outsourced processes that affect food safety.
What auditors look for
Auditors watch operations against your own plans and criteria - are people following the process, are controls in place, is the evidence being captured. They examine how planned changes are controlled and how you reacted to an unintended deviation, plus how outsourced steps are kept in control.
Typical evidence
Operational plans and process criteria; production and control records; change control records; agreements and controls for outsourced processes
How to comply — recommendations
Make sure the way work is actually done matches the way it is planned, and that operators have the criteria they need at the line. Control changes through your change routine and review anything that drifted unintentionally. Where you outsource a step that affects safety, define the controls and verify them.
Common nonconformities
Actual practice differs from documented process; criteria not available at the line; outsourced process not controlled; unintended deviations not reviewed
Related clauses
ISO 22000 8.2-8.9, 6.3; ISO 9001 8.1
Qlause provides interpretive guidance only and is not a substitute for the standard. Refer to your licensed copy of the relevant standard for the authoritative text.