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FSSC 22000 guide

Effivity FSSC 22000 guide: the three parts of the scheme and every additional requirement in one system

How Effivity, Sterling's ISO and GRC software, holds an FSSC 22000 system: where the PRPs, the hazard control plan and each additional requirement live, what Sterling configures first, how records stay ready for the unannounced audit, and what the software cannot do.

  • Updated September 2026
  • 8-minute read
  • Part of the FSSC 22000 hub

Key points

  • Effivity for FSSC 22000 carries all three parts of the scheme in one place: the ISO 22000 management system, the ISO 22002 prerequisite programmes for your category and the eighteen additional requirements, each with owners, dates and attachments.
  • The additional requirements are where an ISO 22000 set-up falls short: food defence and food fraud assessments, the allergen risk assessment, environmental monitoring, the culture plan, equipment and food loss and waste each need a home and a review date.
  • Because one surveillance audit in every three-year cycle arrives unannounced, the records have to be current every day, not every audit month; that is the practical case for running the scheme in software.
  • Sterling configures Effivity at the start of the engagement, where it is included at no additional cost. It does not certify, and it is not the Foundation's Assurance Platform or public register.

Why FSSC 22000 asks more of the software than ISO 22000 does

FSSC 22000 is a scheme built from three normative documents, and a certification body licensed by Foundation FSSC audits all three together. An organisation that already keeps ISO 22000 in Effivity has the first part and most of the second in place. What it usually lacks is the third: a set of topics that ISO texts do not reach, each of which produces its own assessment, plan or register.

A food fraud assessment copied from a template, an allergen assessment last opened two years ago, swab results nobody trended: each passes a desk review and fails when an auditor asks who owns it and when it was last reviewed.

Effivity, used in 50+ countries, is Sterling's ISO and GRC software, and its food safety configuration is aligned with ISO 22000 and covers FSSC 22000. The scheme requires no software; what Effivity changes is that every element sits in one structure with its next review scheduled, so the system looks the same on an ordinary Tuesday as in an audit week.

Each scheme element and where it lives in Effivity

The table follows the scheme, not the ISO clause order. Forms inside each module are adapted to your site, category and products.

Scheme elementEffivity moduleWhat the licensed auditor tends to pull
ISO 22002-100 and the sector part: the PRPsDocumented Information; Quality InspectionThe PRP written to the 2025 edition, and a routine site inspection with the actions it raised
Hazard control plan, OPRPs and CCPsDocumented Information; Non-conformance/Deviation ManagementThe validation behind one limit, and product held while that limit was breached
Services, purchased materials and laboratoriesPurchaseAn approved supplier file and the laboratory's proficiency testing or ISO/IEC 17025 status
Labelling, printed materials and product designDocumented Information; Design & DevelopmentArtwork approval, the evidence behind a label claim and validated cooking instructions
Food defence and food fraud mitigationRisk & OpportunityThreat and vulnerability assessments, the people who made them and the mitigation plans
Management of allergensRisk & Opportunity; Documented InformationThe cross-contact assessment that justifies each precautionary label
Environmental monitoring and quality controlQuality InspectionSwab results trended over time, change-over checks and quantity control records
Food safety and quality culture; food loss and wastePolicy & Objectives; HRThe culture plan with targets and timelines, and the waste policy with its objectives
Equipment managementPurchase; OperationsA hygienic design specification and the commissioning evidence for a new machine
Communication to the certification bodyCommunication; Compliance ObligationThe notification route for serious events and any notice actually sent
Internal audit and management reviewInternal Audit; Management ReviewAn audit programme that reached all three components, and the review's decisions
Corrective action on any findingNon-conformance/Deviation ManagementRoot cause, action and the check that the cause has not come back

The context module holds the scope in the scheme's category language, and Customer Life Cycle Management holds complaints. What each additional requirement actually requires is set out in FSSC 22000 additional requirements explained, one by one; this guide deals only with where the evidence is kept.

What Sterling sets up in the first weeks

Configuration runs alongside the gap analysis, because several decisions that shape the system are made there. Effivity comes with pre-configured workflows; Sterling adapts them, form by form, to the site.

  • Category first. The food chain category and sub-category decide which ISO 22002 part applies and which additional requirements bite.
  • PRP inspections as checklists. Each prerequisite programme gets an inspection checklist with an owner and a frequency, written against ISO 22002-100 and your sector part rather than the retired technical specifications.
  • Assessments with review dates. Food defence, food fraud and allergen assessments are held as records with named assessors and a scheduled review.
  • A sampling plan for swabs. Where environmental monitoring applies, sampling points, organisms and frequencies are set up, and an out-of-limit result opens a nonconformity.
  • People as users. Operators, supervisors and assessors get their own logins, so each record carries the name of whoever did the work.

A register is useless until a competent team has done the assessment; those workshops are covered in Food defence and food fraud assessments.

Records that are ready on any day of the year

Under the scheme, the site is not told the date of the unannounced audit, the plan is withheld until the opening meeting and the auditor begins with an inspection of the production facilities within an hour of arriving.

Effivity is cloud-based with a mobile app, so a PRP check or a swab result is logged at the point of work rather than written up later. Dashboards and escalation show a coordinator what is overdue before an auditor does. How to prepare people and premises for that visit is the subject of The unannounced audit: how to be ready on any day.

A worked trace: one positive swab

A routine environmental swab near a filler returns a positive for an indicator organism. The result is entered against its sampling point and opens a nonconformity owned by the hygiene lead. The correction is an intensified clean and repeat swabbing; the investigation finds a worn seal where water collected. The seal is replaced through the equipment record and swabbing at that point is increased. After several clean results the record is closed, and the trend for that zone goes to the next management review. An auditor who arrives unannounced a month later can follow the whole chain from one screen.

Moving to Version 7 in the same system

Foundation FSSC published Version 7 on 1 May 2026. Version 6 audits remain possible until 30 April 2027, and upgrade audits run from 1 May 2027 to 30 April 2028. The upgrade audit is a full audit against the new version, so every changed element needs evidence, not just a revised manual.

In Effivity the upgrade is handled as a set of controlled changes. PRP documents are revised against the ISO 22002-x:2025 series and the common baseline, with the change history showing what moved and why. Revised additional requirements become updated checklists, assessments or objectives, each with an owner and a date. The full list of changes is in FSSC 22000 Version 7: what changed.

How Sterling runs FSSC 22000 in Effivity

All three components of the scheme, configured for your category from the gap analysis onwards.

Effivity comes included with the engagement, at no additional cost; the proposal states the number of users and the access period. Our expert and experienced consultants build the PRPs, the hazard control plan and the additional requirements into it with your food safety team, and run the internal audit and management review with you. We ensure successful certification for our clients. Sterling does not certify: the certificate comes from a certification body licensed by Foundation FSSC and accredited for the scheme.

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What Effivity does not do

Effivity is your system, not the scheme's. The certification body uploads its audit report and related documents to the Foundation's Assurance Platform, and the Foundation publishes certificate status on its public register; neither is run from Effivity. The software also does not assess threats, decide whether an allergen label is justified, set limits or validate them. Those remain judgements for competent people, who must explain them to the auditor. Three habits undo the benefit:

  • Assessments uploaded, not done. A downloaded food fraud template stored as an attachment is still a downloaded template.
  • Swab results left as PDFs. Results that are attached but never entered cannot be trended, and the environmental monitoring requirement is about acting on trends.
  • One site's structure copied to another. In a multi-site group, each site needs its own records under a central function, not a clone of the head office set-up.

Effivity for FSSC 22000: questions buyers ask

Does Effivity cover the FSSC 22000 additional requirements?

Yes, through configuration. Each applicable additional requirement is given a home in an existing module, as a register, assessment, checklist or objective, set up for your food chain category during the engagement.

We already run ISO 22000 in Effivity. What changes for FSSC 22000?

The management system and hazard control records carry over. Sterling then adds the additional-requirement records, rewrites the PRP inspections against the 2025 ISO 22002 editions and extends the internal audit programme to all three components.

Is Effivity the same as the FSSC Assurance Platform?

No. The Assurance Platform is where licensed certification bodies upload audit packs, and the public register shows certificate status. Effivity holds your own food safety system and its evidence.

Can operators log PRP checks and swab results on the production floor?

Yes. The mobile app records entries at the point of work.

Can a multi-site group run one FSSC 22000 system in Effivity?

Yes. Effivity can be set up as a multi-site structure, so each site records its own work on common forms and the central function reviews one body of evidence.

Will Effivity reduce the length of our certification audit?

No. The scheme sets audit duration under ISO 22003-1 plus its own component and allows no reduction below the calculated time. Effivity changes how quickly the auditor finds what is asked for, not how long the audit is.

FSSC 22000 implementation

FSSC 22000 requirements

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