ISO 22000 guide
Effivity for ISO 22000: running PRPs, the hazard control plan and their records in one system
Clause by clause: ISO 22000:2018 requirements: every clause explained →
How Effivity, Sterling's ISO and GRC software, holds a food safety management system: the module behind each food safety task, what Sterling configures at the start, what the certification body's auditor samples, and what the software cannot do for you.
Key points
- Effivity holds an ISO 22000 food safety management system in one place: the controlled PRPs and hazard control plan, and the monitoring, verification, calibration, supplier, complaint and corrective action records that prove they work.
- The value in a food plant is timing. A CCP check entered on the line during the shift, by the operator who made it, is the record an auditor trusts; a sheet completed from memory at the end of the day is not.
- Sterling configures Effivity at the start of the engagement around your products, flows and PRPs, and it is included with the engagement, at no additional cost.
- The software stores the food safety team's decisions; it does not take them, and it does not certify. An independent, accredited certification body decides.
Why a food safety system needs one home
ISO 22000 requires a plant to run two things together. One is the management system: scope, policy, objectives, competence, internal audit, management review and improvement. The other is the operation described in clause 8: prerequisite programmes, traceability, emergency preparedness, hazard analysis, the hazard control plan with its OPRPs and CCPs, verification, and the handling of unsafe product up to withdrawal and recall. Auditors look hardest at the join between the two.
In most plants the evidence is scattered: cleaning checks on clipboards, CCP logs in a folder at the line, calibration certificates in maintenance, supplier approvals in an inbox. Each record may be sound, yet nobody can follow a deviation to its root cause and on to the review that decided what to change.
Effivity, used in 50+ countries and delivered by Sterling as Automate™, puts those records in one cloud system with owners, versions, due dates and reminders. ISO 22000 does not require software; what changes is the effort the records take and how convincing they are when an auditor traces them.
Food safety work mapped to Effivity
Each food safety task lands in an existing Effivity module, with forms set up to match your plant. The table reads from the ISO 22000 area to what Effivity holds and the record an auditor typically picks out.
| ISO 22000 area | What Effivity holds | The record the auditor samples |
|---|---|---|
| Documented information (clause 7) | PRP procedures, the plan, flow diagrams and instructions, with versions and approvals | The current approved version at the line, and who changed it last and why |
| Prerequisite programmes (8.1–8.4) | Cleaning, pest control, hygiene and maintenance checklists with schedules | A completed PRP checklist for a given day and shift, and the action raised on a failed item |
| Hazard analysis and the plan (8.5) | The hazard analysis and hazard control plan as controlled documents | The analysis behind one CCP or OPRP, its critical limit or action criterion, and the evidence of validation |
| Monitoring and correction (8.5 and 8.9) | Monitoring forms per CCP and OPRP; deviations raised as nonconformities | A CCP log for a sampled batch, and what happened to product made while a limit was exceeded |
| Measuring equipment (8.6–8.8) | Thermometers, scales and detectors with calibration records | The calibration status of the instrument used for the sampled CCP reading |
| Suppliers (clause 7 support and external providers) | Supplier selection, evaluation, approval and re-assessment in Purchase | The approval file of a raw material or packaging supplier, and its latest review |
| Complaints and communication (clause 7) | Complaints and feedback in Customer Life Cycle Management | A food safety complaint followed to its investigation and outcome |
| Traceability, withdrawal and recall (8.1–8.4 and 8.9) | The recall procedure; traceability tests and mock recalls with timing and findings | The most recent mock recall: lots traced forwards and backwards, quantities reconciled, time taken |
| Nonconformity and corrective action (clause 10) | Non-conformance/Deviation Management: correction, root cause, corrective action, effectiveness check, closure | A closed corrective action and the evidence that the cause has not recurred |
| Internal audit (clause 9) | Audit programme, plans, reports and findings in Internal Audit | The programme showing PRPs and the plan covered, and one audit report with its findings |
| Management review (clause 9) | Agenda, minutes against each input and action plans in Management Review | The last review's decisions and the status of its actions |
| Competence and awareness (clause 7) | Roles, competence evaluations, training needs and training records in HR | The hygiene and CCP monitoring training of the operator whose log was sampled |
The context, policy and objectives, risk and compliance obligation modules hold the rest of the system: issues (including climate change, added by the 2024 amendment), the food safety policy, objectives and the legal and customer requirements that apply.
What is configured at the start
Effivity arrives with pre-configured workflows, which Sterling adapts to your operation in the first weeks, alongside the gap analysis:
- Sites, lines and users. The structure mirrors your sites and lines, and the people who do the checks are users, so each record carries the right name.
- Documents moved, not copied. The existing HACCP plan, PRP procedures and work instructions go into Documented Information with owners and versions; the ones nobody follows are retired rather than migrated.
- PRP checklists and schedules. Each prerequisite programme becomes a checklist with a frequency and an owner, matched to the ISO 22002 part and legal requirements that apply to you.
- Monitoring forms. Once the hazard control plan is agreed, each CCP and OPRP gets a form with its parameter, limit or action criterion and frequency, and a failed reading is set up to open a nonconformity.
- Registers and schedules. Measuring equipment, approved suppliers, internal audits, the mock recall and management review, each with reminders.
The order matters. Monitoring forms are built after the hazard analysis, not before, because the limits must come from the analysis and its validation. The analysis itself is covered in Hazard analysis, OPRPs and CCPs: the hazard control plan, and the PRP content in Prerequisite programmes and ISO 22002-1: what a plant needs.
Records made on the line, at the time
Effivity is cloud-based with a mobile app, so checks can be entered where they happen: at the metal detector, the cooling tunnel or the goods-in bay. That addresses a common audit weakness: records completed at the end of a shift from memory.
A worked trace: one CCP deviation
On a night shift, a cooking step reads below its critical limit. The operator records the reading and the deviation opens a nonconformity owned by the shift supervisor, who records the correction: batch on hold, disposition decided by the authorised person. The food safety team adds the root cause, a probe that had drifted, and the corrective action: the probe replaced and its verification frequency increased in the equipment register. Once the next verification shows no repeat, the record is closed. An auditor who samples that batch finds each step dated and owned.
What the certification body's auditor sees
The auditor audits your food safety management system, not the software, and at Stage 2 works by sampling: a batch, a CCP, a supplier, a complaint, an operator. Your people open the records selected and explain them. For any remote part of an audit, how records are shared is agreed with the certification body in advance.
What a well-run Effivity system shows is continuity: monitoring entries spread across shifts rather than bunched before the visit, calibration current for the instruments behind sampled readings, deviations followed to disposition, a timed and reconciled mock recall, and internal audits that reached the PRPs and the plan. The detail of the audit stages is in ISO 22000 Stage 1 and Stage 2 audits: what auditors check on the floor.
How Sterling sets up Effivity for food safety
Your FSMS in one system from the gap analysis onwards.
Effivity is included with the engagement, at no additional cost, with users and access period confirmed in the proposal. Whether your team leads the work with our guidance (Design™) or we manage it for you (Drive™), our expert and experienced consultants configure the system around your lines and PRPs and complete the internal audit and management review with you before the certification body arrives. We ensure successful certification for our clients. Sterling does not certify: the certificate is issued by the independent, accredited certification body you appoint.
Book a free discovery callWhat Effivity does not do
The software does not analyse hazards, set critical limits or validate control measures; your food safety team does, and must defend its reasoning when asked. It does not replace validation studies or the physical works a PRP may need, and it does not certify. Four patterns undo the benefit:
- Paper kept alongside. A clipboard log and an Effivity form for the same check drift apart, and the auditor samples the one nobody finished.
- Forms left generic. A form without your limit and frequency invites meaningless readings.
- One person entering everything. The records then show a single name, not the operators and supervisors who did the checks.
- Closing too early. A corrective action closed before the next verification shows no evidence of effectiveness.
Effivity for ISO 22000: questions buyers ask
Can operators without office computers use Effivity?
Yes. The mobile app lets operators and supervisors record checks and deviations at the point of work. Agree early which devices your hygiene rules allow in production areas.
Can our existing HACCP plan be moved into Effivity?
Yes, as a controlled document with an owner and version. Sterling reviews it during the gap analysis first, because a plan that was copied rather than analysed needs rework before it deserves a monitoring form.
Does Effivity replace our laboratory or traceability system?
No. Laboratory results and production or warehouse systems stay where they are; Effivity holds the verification records, attachments and conclusions, and the results of traceability tests and mock recalls.
Can several plants share one system?
Yes. Effivity can be set up as a multi-site structure, so every site uses the same forms and the central food safety function reviews one body of evidence.
Will using Effivity reduce our audit days?
Plan on it not doing so. Audit time is set by the certification body under ISO 22003-1, from factors such as food chain category, HACCP studies, headcount and sites. Effivity changes how that time is spent, not its length.
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
- ISO 22000 common mistakes
- Decision guide
- ISO 22000 documentation
- Effivity for ISO 22000: the guide
- ISO 22000 for feed and animal food production
- ISO 22000 for food manufacturing
- ISO 22000 for packaging
- HACCP vs ISO 22000 vs FSSC 22000: which one, and when
- Hazard analysis, OPRPs and CCPs: 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
Services for ISO 22000
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