ISO 22000 Stage 1 and Stage 2 audit: what auditors check on the floor, day by day

What does Stage 1 check in a food safety system?

Initial certification always runs in two stages. ISO/IEC 17021-1, the standard certification bodies are accredited to, sets the rules, and ISO 22003-1 adds food-specific requirements. For a food plant, most certification bodies carry out Stage 1 at the site, since conditions on the floor matter as much as the files; your audit plan states where it takes place. Expect these areas.

• Scope: products, process lines, sites and shifts named precisely, with the food chain category the body has assigned and any outsourced processes identified.
• Prerequisite programmes: which PRPs you selected, the ISO 22002 part or other reference behind them, and whether the building and equipment can support them.
• Hazard analysis: product descriptions, intended use, flow diagrams confirmed on the floor, and a documented analysis of every step by a named food safety team.
• Hazard control plan: CCPs with critical limits, OPRPs with action criteria, the validation behind each control measure, and monitoring methods and frequencies.
• Legal and customer requirements: the food law, licences and specifications that apply, and how you know you meet them.
• Internal audit and management review: both completed, with reports and minutes the auditor can read.

The output is a Stage 1 report stating readiness and listing concerns that could be graded as nonconformities at Stage 2. The auditor records weaknesses but does not advise, which is what separates it from a gap analysis, Sterling's first engagement stage. How to pick the body in the first place is covered in choosing an ISO 22000 certification body.

The gap between Stage 1 and Stage 2

ISO/IEC 17021-1 requires the interval to leave enough time to resolve the concerns raised, and the certification body may revise its Stage 2 arrangements in the light of what it saw. Under FSSC 22000 the two stages may be no more than six months apart, or Stage 1 must be repeated. Use the weeks for three things.

• Close every concern with evidence, not a promise: a revised hazard analysis, a completed validation, a repaired floor drain photographed and signed off.
• Keep production running under the plan. Stage 2 samples records from this period, so monitoring sheets, verification results and calibration certificates must keep accumulating.
• Change nothing without your own change control. A new critical limit introduced in a hurry, without validation, becomes the next finding.

Stage 2 on the production floor

Stage 2 judges whether the system is implemented and effective across the whole scope. In food that cannot be done from an office: the auditor needs to see product being made. Schedule it on production days, with representative lines and higher-risk products running.

Management system clauses are audited too. Typical questions for each area are listed in our ISO 22000 audit questions guide.

How auditors sample in a food plant

No auditor reads every record. ISO/IEC 17021-1 expects conclusions drawn from samples and confirmed by interview, observation and review of documents and records.

• Products and HACCP studies: the number of HACCP studies helps set audit time under ISO 22003-1, and the auditor will usually trace at least one study end to end, from flow diagram to live monitoring.
• Shifts: if you run nights or weekends, expect a question about how the plan works then, and possibly a request to see an early or late shift.
• Records over time: dates chosen by the auditor, not by you, often around a deviation or a complaint.
• Several sites: whether sites may be sampled depends on the food chain category; the scope guide explains why many manufacturers see every site audited.

Example: a single-site plant, day by day

Audit time is calculated by the certification body using the method in ISO 22003-1, from the food chain category, the number of HACCP studies and the number of employees; see the cost guide. The table below is an example only: one auditor, one plant with two lines and three HACCP studies, a one-day Stage 1 and a two-day Stage 2. Your own plan, with the auditors' names, arrives before each stage.

Closing meeting, findings and the decision

Each nonconformity names the requirement not met, describes what was seen and cites the evidence; it is discussed with you before the closing meeting. The auditor may not suggest the cause or the solution. A major nonconformity puts the system's ability to achieve its intended results in doubt, such as a CCP operating without a validated limit; a minor one does not. The closing meeting presents the findings and the recommendation, reminds you that the audit rested on samples, and sets deadlines for your corrections and corrective action plan. How to write and close them is in our nonconformities guide.

The certification decision is taken by competent people at the certification body who took no part in the audit. They need corrections and corrective actions for any major nonconformity reviewed, accepted and verified, and plans for minor ones accepted; a major left unverified six months after the last Stage 2 day means another Stage 2. After the decision the three-year cycle begins, described in our surveillance and recertification guide.

ISO 22000 Stage 1 and Stage 2 audit: questions buyers ask