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Templates and records · FSSC 22000 · Clause 2.5.15

FSSC 22000 equipment purchase specification and change

New or modified equipment can introduce hazards. FSSC requires it to be specified before purchase and its commissioning to be managed as a change.

In one sentence

The FSSC 22000 equipment purchase and change specification documents, before equipment is bought or modified, its hygienic design, legal and customer requirements, and manages its installation and commissioning through a change process that assesses the impact on food safety, as the additional requirements in clause 2.5.15 require.

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Where the standard requires it
FSSC 22000 · Clause 2.5.15 Clauses beginning with 2.5 are additional requirements in Part 2 of FSSC 22000 Version 6; those of ISO 22000:2018 are explained in their own templates.
Type of information
Mandatory record Specification and change record (FSSC 22000 v6, 2.5.15)
Who fills it in
Engineering or maintenance with the food safety team The food safety team approves the specification and the change
When
Before buying or modifying And at commissioning, before producing for sale
How long it is kept
Set by the organisation ISO 22000 requires documented information to be retained without setting a period. It is sensible to cover the shelf life of the product with a margin, the applicable law and the three-year certification cycle.

What the standard requires


What FSSC 22000 demands and what it leaves to your judgement

FSSC requires a purchase specification for new equipment that addresses hygienic design, legal and customer requirements and intended use, including food-contact materials.

Installing new equipment or modifying existing equipment is managed as a change: its effect on the hazard analysis and the prerequisites is assessed, it is validated if it affects a control measure, and commissioning is documented.

Preventive maintenance and infrastructure are ISO/TS 22002-1 prerequisites, covered in the ISO 22000 prerequisite programmes plan.

Structure


Fields the template should include

  • Equipment and intended use
  • Hygienic design requirements
  • Contact materials and declarations of compliance
  • Legal and customer requirements
  • Assessment of the change on hazards and prerequisites
  • Validation required
  • Commissioning: cleaning, trials, release
  • Entry into preventive maintenance

Example


Example: new packing machine at a fictitious nut plant

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field Content
Equipment Vertical form-fill-seal machine for 200 g bags
Hygienic design Stainless steel, no crevices or exposed threads above the product, tool-free dismantling
Contact Declaration of compliance for food-contact materials
Change assessment New potential metal source: the detector after the packing machine is added to the hazard analysis
Validation Detector test with the new bags
Commissioning Initial clean · 3 trial batches not sold · released on 5 May
Maintenance Preventive routines entered in the CMMS

At the audit


Mistakes auditors commonly flag

  • Equipment bought on price and capacity alone, with no hygiene requirements.
  • No declaration of compliance for contact materials.
  • Installation without reviewing the hazard analysis.
  • Production for sale before commissioning has been released.
  • The new equipment is not added to the maintenance or cleaning plan.

In Kimobox


How this record is kept in Kimobox

  1. 1Each piece of equipment has its record in the CMMS with its history, documentation and preventive routines.
  2. 2A modification or new equipment opens an action requiring the affected hazard analysis to be reviewed.
  3. 3Manufacturer documents, such as the declaration of compliance, are kept on the equipment record with their version.
  4. 4Commissioning is recorded with its trials and release.

Frequently asked questions


What people ask us before getting started

What is hygienic design?

A design that makes cleaning easy and prevents residues building up: smooth surfaces, no crevices, suitable materials and simple dismantling.

Does it apply to second-hand equipment?

Yes. Any equipment entering the process is specified and managed as a change, wherever it comes from.

What if existing equipment is only being modified?

That is also a change: its effect on food safety is assessed beforehand and the return to production is documented.

Keep your FSSC 22000 records without loose templates

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Sources


Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

  1. FSSC 22000 Version 6 — Scheme requirements (Part 2, additional requirements) Foundation FSSC · Published 31 March 2023
  2. ISO/TS 22002-1:2009 — Prerequisite programmes. Food manufacturing ISO · 2009 ed.