ISO 22000 guide
ISO 22000 implementation plan: phases, owners, deliverables and decision points
Clause by clause: ISO 22000:2018 requirements: every clause explained →
How to run an ISO 22000 project in a food plant: the eight phases from project set-up to certification, who owns each deliverable, where management decides, an estimated week-by-week plan, and the things that stall food safety projects.
Key points
- An ISO 22000 project runs in eight phases, from project set-up to the certification body's audit. Each phase has one accountable owner, a named deliverable and a decision point where the sponsor agrees the next phase can start.
- The critical path in a food plant is rarely the paperwork. It is PRP works that need capital approval, validation studies that take weeks, and an operating period long enough to produce records worth auditing.
- The food safety team leader needs real authority over hold, release and line changes. A team that can only advise will produce a hazard control plan nobody on the floor follows.
- Sterling supports the project at one of two levels, Design™ (guided) or Drive™ (managed). You choose one; they are alternatives, not steps in sequence.
How an ISO 22000 project is organised
Running an ISO 22000 implementation well comes down to three things: a sequence of phases that respects the order food safety work has to happen in, a clear owner for every deliverable, and decision points where management confirms the plant is ready to move on.
The order matters because the standard's operational requirements depend on one another. You cannot finish a hazard analysis until the flow diagrams have been checked on the floor, you cannot rely on a control measure until it has been validated, and you cannot show an auditor that the system works until monitoring, verification and traceability records have built up over real production. The plan below assumes the scope and gap analysis are agreed; our ISO 22000 gap analysis guide covers that first stage, and the ISO 22000 timeline guide covers overall duration in more depth.
Who owns what: the project roles
Six roles carry the project. In a small business one person may hold two; what must not happen is for every role to collapse into the quality manager.
- Sponsor. A member of top management who approves budgets for works, releases people from production and chairs each decision point.
- Food safety team leader. Runs the food safety team, owns the hazard analysis and the hazard control plan, and reports to management on how the system performs. This person needs the authority to stop a line or hold product, not only to recommend it.
- Food safety team. A multidisciplinary group from production, quality, maintenance, hygiene and purchasing, bringing the process knowledge the hazard analysis depends on.
- Process owners. Line managers and supervisors who run the PRPs, complete monitoring records at the time of the activity and handle deviations on their shifts.
- Maintenance and engineering. Own the infrastructure side of the PRPs: layout, segregation, pest proofing, water, equipment design and calibration of monitoring devices.
- Internal auditors. Trained people, independent of the areas they audit, who test the PRPs and the hazard control plan before the certification body does. Our ISO 22000 internal audit guide explains how they work.
The eight phases, with deliverables and decision points
1. Project set-up and the food safety team
Confirm the scope, appoint the food safety team and its leader, agree the project plan and set up the system in software from day one. The decision point: does the team have the time and authority it needs?
2. PRP upgrades
Assess the prerequisite programmes against the applicable ISO 22002 part and legal requirements, then separate what needs a procedure from what needs works. Drains, changing areas and allergen segregation are engineering jobs with lead times. The decision point is capital approval, and it should come early; the prerequisite programmes guide covers the content.
3. Hazard analysis and hazard control plan
Build product descriptions and flow diagrams, verify the diagrams on the floor, analyse hazards step by step, select control measures and categorise them as OPRPs or CCPs. The deliverable is a hazard control plan with critical limits and action criteria. The decision point is the team's sign-off that the analysis reflects the plant as it actually runs. The method itself is set out in our hazard control plan guide.
4. Validation and verification planning
Plan how each control measure will be shown to work before it is relied on, through scientific evidence, testing or challenge studies, and set the verification schedule: swabs, product tests, calibration and record reviews. The decision point is whether any validation result forces a change to the plan.
5. Documentation and records
Put in place the documented information the standard requires, and the forms that people on the line will actually fill in. Keep it lean; our documentation guide sets out what is required and what is optional.
6. Operating period
Run production under the system. Monitoring, verification, calibration, traceability and deviation records accumulate; a mock recall is run and timed. The decision point is whether the records show a pattern across products, shifts and lines.
7. Internal audit and management review
Audit the PRPs and the hazard control plan across the whole scope, correct what is found, then hold a management review that takes decisions. The decision point is the sponsor's confirmation that the plant is ready for the certification body.
8. Certification
The accredited certification body conducts its Stage 1 readiness review and then the Stage 2 audit, and decides. Sterling does not certify. The certification process guide covers this stage step by step.
A Gantt-style view of the plan
The table shows a typical single-site manufacturer with an existing HACCP plan and PRPs that need some works. The week ranges are an estimate, not a commitment; overlapping ranges indicate phases that run in parallel. A plant needing major works or new validation studies will take longer.
| Phase | Weeks (estimate) | Deliverables | Owner |
|---|---|---|---|
| 1. Project set-up and food safety team | Weeks 1 to 2 | Team appointment, project plan, scope statement, software set-up | Sponsor |
| 2. PRP upgrades | Weeks 2 to 14 | PRP assessment, works list with approvals, PRP procedures and monitoring forms | Maintenance and process owners |
| 3. Hazard analysis and hazard control plan | Weeks 3 to 10 | Product descriptions, verified flow diagrams, hazard analysis, plan with OPRPs and CCPs | Food safety team leader |
| 4. Validation and verification planning | Weeks 8 to 14 | Validation evidence for each control measure, verification schedule, calibration programme | Food safety team |
| 5. Documentation and records | Weeks 4 to 14 | Controlled documents, record formats, traceability and recall procedure | Food safety team leader |
| 6. Operating period | Weeks 14 to 24 | Monitoring and verification records, mock recall report, deviation handling | Process owners |
| 7. Internal audit and management review | Weeks 22 to 26 | Audit reports, corrective actions closed, management review record | Internal auditors and sponsor |
| 8. Certification | Weeks 26 onwards | Stage 1 and Stage 2 reports, closure of any findings, certification decision | Sponsor, with the certification body |
Book the certification body while phase 6 is under way. Its lead time is outside your control.
Design™ or Drive™: choosing the level of support
The phases are the same whichever route you take; what changes is who carries the work. With Design™, your food safety team leads each phase and Sterling provides structure, templates, workshops, coaching and review at every decision point. It suits plants with an experienced quality function. With Drive™, Sterling consultants take on the agreed consulting and documentation work alongside your process owners, including drafting the hazard analysis with the team and running the internal audit. It suits plants with a deadline and a thin team. Either way, the knowledge must end up with your people; the auditor interviews them.
How Sterling runs ISO 22000 projects
One plan, clear owners, and evidence building from the first workshop.
Since 2003, with 8,100+ client engagements in 60+ countries, every Sterling ISO 22000 engagement follows Sterling OS™ at the level you choose, Design™ or Drive™, with the project milestones, PRP actions and records held in Effivity, included with the engagement at no additional cost. We plan the works, the validation and the operating period together, so the audit date is realistic from the start. We ensure successful certification for our clients. The certificate is issued by the independent, accredited certification body you choose.
Book a free discovery callWhat stalls food safety projects
- Capital works approved late. A PRP gap that needs a new wash area or physical segregation will not close with a procedure. If approval waits for the hazard analysis, the works land in the operating period and the audit date slips.
- A HACCP team without authority. When the food safety team leader cannot hold product or change a line without escalation, deviations are handled informally and the records show it. Give the role its authority in writing at set-up.
- Seasonal lines missed. A product made for three months of the year may sit outside the operating period entirely, leaving no monitoring records for its CCPs. Map the production calendar at the start and plan the operating period, or the scope, around it.
ISO 22000 implementation plan: questions buyers ask
Who should be the food safety team leader?
Someone with process knowledge, food safety competence and the standing to be heard by production. Often the quality or technical manager, sometimes a trained production manager. Authority matters more than job title.
Can phases run at the same time?
Yes, and they should. PRP works, the hazard analysis and documentation usually overlap. What cannot overlap is the operating period with major changes to the plan, because records made under a plan that then changes carry little weight.
How much time does the food safety team need to give the project?
It depends on the route, the number of products and flows, and the state of the PRPs. Expect regular workshops during the hazard analysis and lighter involvement afterwards. The project plan should state the hours per member so production can release them.
What if validation shows a control measure does not work?
That is the purpose of validation. The team changes the control measure, its limits or the step, and updates the plan before the operating period relies on it.
Does the plan change if we are aiming for FSSC 22000?
The phases stay the same, with additional scheme requirements and sector PRPs built into phases 2 and 5. Our HACCP, ISO 22000 and FSSC 22000 comparison explains when each is the right choice.
More ISO 22000 guides
Every guide in the ISO 22000 series is written for one question and links back to the hub for the whole picture.
- ISO 22000 certification cost: what moves the price
- ISO 22000 certification process, step by step
- Effivity for ISO 22000: the guide
- ISO 22000 gap analysis
- HACCP vs ISO 22000 vs FSSC 22000: which one, and when
- Hazard analysis, OPRPs and CCPs: the hazard control plan
- ISO 22000 certification in India
- ISO 22000 for food ingredients, additives and supplements
- Integrating ISO 22000 with ISO 9001 and ISO 14001
- ISO 22000 internal audit: PRPs and the hazard control plan
- Prerequisite programmes and ISO 22002-1: what a plant needs
- ISO 22000 requirements explained, clause by clause
Keep exploring
Explore more about ISO 22000
Watch a video on how to implement ISO 22000 here.
Watch a video on ISO 22000 requirements here.
ISO 22000 resources
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