What this is
What counts as a process change under this record?
What counts as a process change under this record?
A process change is any alteration to how a product is made — different equipment, a changed setting, a reordered sequence, a new cleaning method, a layout change or new automation. It's distinct from a product change (QUA-069), which covers what the product itself is; the same event can trigger both if a new process also changes an attribute.
Why does this record ask about CCPs and critical limits when the product change record doesn't?
Because a process change is far more likely to move where control happens on the line — a new setting can shift a cook step's effective time, a new sequence can shift where a metal detector sits. The product change record asks about the label and recipe; this one asks about the control point.
What's the difference between a validation plan and a control plan update?
A validation plan (QUA-071) is the evidence gathered to show a new method achieves what it's meant to. A control plan update is the document change that makes the method the standard once validation confirms it works — the two are sequential, not interchangeable.
Scope
When is a process change request required?
This record covers changes to method, not the product itself, and it isn't the vehicle for validating a change works — it decides whether the change should happen and what has to be checked first.
Use this template when
- Equipment, a setting, the sequence, a cleaning method, the layout or automation is about to change, or has just been proposed
- The change could plausibly move a CCP, a critical limit, or the coverage of a metal or foreign-body detector
- A cleaning method change risks creating a hard-to-clean area that didn't exist before
- A validation plan or trial run needs to be defined and referenced before sign-off
- A linked control plan needs updating once the change is confirmed to work
Do not use it for
- Product Change Request (QUA-069), covering a change to the product itself — recipe, ingredient, supplier, pack or label
- Validation Record (QUA-071), which records the evidence a change works, once this record has approved trialling it
- Temporary Change Authorization (QUA-072), authorising a short-term deviation with an end date, not a standing change
- Equipment Specification Record (MNT-091), documenting an asset's specification rather than a proposed change to it
- Anything outside KnowQuality, such as a maintenance order for like-for-like replacement, which needs no change control
Compliance mapping
Which ISO 9001 cl.8.5.6 requirements does this satisfy?
ISO 9001 cl.8.5.6 requires organizations to review and control changes for production to the extent necessary for continuing conformity. For a process with CCPs and hygiene controls, that review has to catch a shifted critical limit before it becomes an incident.
| Clause | Requirement | Where it lands |
|---|---|---|
| ISO 9001 cl.8.5.6(a) | Review the consequences of change, including food safety impact | Impact assessment |
| ISO 9001 cl.8.5.6(b) | Verify the change meets requirements before implementation | Validation and control |
| ISO 9001 cl.8.5.6 | Authorise the change, with named approvers | Decision |
| ISO 9001 cl.8.5.1 | Traceable identification, asset affected and target date | Header |
| ISO 9001 cl.8.3.6 | Control of changes during process design and development | The change |
| ISO 9001 cl.9.1.3 | Evaluation of the change's effect after implementation | Decision |
What it does not cover
- CCP Affected marked Yes with Critical Limit Affected left blank, which leaves the question that determines the risk unanswered.
- New Hard To Clean Areas Created answered No with no description of the new layout or geometry, which gives sanitation nothing to inspect against.
- Validation Plan Defined marked Yes with no Validation ID entered anywhere on the record, which means the plan exists nowhere anyone else can find it.
- Technical Approval and Quality Approval both Yes while Decision is still Deferred pending trial, which suggests approvals came before the trial result was known.
- A Decision of Approved recorded with Trial Required Before Full Release still Yes and no trial reference anywhere, which authorises full-rate production the trial was meant to gate.
Global
Process Change Request requirements by country
A process change is judged first against the food safety management system it sits inside, not labelling law — the instruments that matter most define how a HACCP-based system treats a change to a control point.
FSMA Preventive Controls for Human Food, 21 CFR Part 117, especially the reanalysis requirement at §117.170
A significant change in facility activities requires reanalysis of the food safety plan, including whether preventive controls, critical limits and monitoring remain adequate
CCP Affected and Critical Limit Affected are effectively the reanalysis trigger the regulation requires, as two fields rather than a standalone review
Regulation (EC) No 852/2004 on the hygiene of foodstuffs, Article 5 (HACCP-based procedures)
Operators must review their HACCP procedures whenever a change is made to the product, process or any step that could affect the food safety analysis
A process change not run through this review is a gap in the HACCP system itself, not just a missed internal step
CXC 1-1969, General Principles of Food Hygiene, HACCP Annex
The HACCP system requires the hazard analysis to be reviewed whenever a change could affect it or alter the control measures
This is the baseline nearly every national scheme and customer certification builds its own change-control clause on, which is why the structure travels well across markets
How to complete it
How to complete a process change request, step by step
The mechanics of the form are straightforward. Whether it protects the site comes down to four judgement calls.
A setting or sequence change can move where control happens without anyone intending it — a faster line speed can shift a cook step's effective residence time even if the setpoint didn't change. No should follow from checking the plan, not from the change looking unrelated to food safety.
Trial Required Before Full Release records an intention. Nothing on the form ties that to evidence it happened — the record is only as strong as whatever reference gets typed into Validation ID, and a blank one under Approved is the clearest sign the trial was skipped.
This is a commonly wrong answer, because it's assessed on paper against a proposed change rather than by physically inspecting the equipment once installed. The honest answer often only becomes clear after the change is in place, later than the form asks.
The record links to a control plan but doesn't require the reference unless an update is flagged. A 'No' here is unverifiable from the record alone — no way to confirm the plan already covered the new method without reading it.
What auditors find
Most common process change request findings
What surfaces on a second look at a completed process change record.
| Finding | Clause | What fixes it |
|---|---|---|
| CCP Affected is Yes but Critical Limit Affected is unanswered | ISO 9001 cl.8.5.6(a) | Make Critical Limit Affected mandatory whenever CCP Affected is Yes, not merely conditionally shown |
| Validation Plan Defined is Yes with no Validation ID recorded | ISO 9001 cl.8.5.6(b) | Require Validation ID whenever Validation Plan Defined is Yes, matching HACCP Plan ID elsewhere in the library |
| Decision is Approved while Trial Required Before Full Release is Yes and no trial evidence is referenced | ISO 9001 cl.9.1.3 | Block Decision from Approved until a trial or Production Trial Record (QUA-100) ID is entered |
| Control Plan Update Required is No with no Control Plan Reference to verify against | ISO 9001 cl.7.5.3 | Require Control Plan Reference regardless of the answer, so a 'No' can be checked rather than trusted |
| Action Required is Yes but CAPA ID is never populated | ISO 9001 cl.10.2 | Require CAPA ID before the record can close whenever Action Required is Yes |
| Technical, Quality and Production approvals are all recorded before the Decision field itself is set | ISO 9001 cl.8.5.6 | Sequence the form so Decision cannot be Approved until all three approvals are populated |
Case in point
Case in point: a cleaning method change that created a niche nobody inspected
A site switched from manual to CIP (clean-in-place) cleaning on a filling line to cut downtime. The request recorded Cleaning Method Affected as Yes and Sanitation Schedule Update Required as Yes, both actioned within the week. New Hard To Clean Areas Created was marked No, because on paper CIP is the more hygienic method.
The CIP skid's new pipework introduced a dead-leg, a short pipe section where flow doesn't reach during the clean cycle, that hadn't existed under manual cleaning. It surfaced months later as a recurring environmental positive nobody could trace, because the record that would have flagged it had already closed with 'No' against the one question built to catch it.
The template
The template, field by field
The form exactly as it installs. Every field, option, score and conditional rule is editable, and the links to other templates come with it.
5 sections
- Reference
- QUA-070
- Archetype
- Record
- Record ID
- PRC-2026-000
- Scoring
- Risk band
- Direction
- High is bad
- Singleton
- No
- Basis
- ISO 9001 cl.8.5.6
- Links
- Links MOC, Control Plan
- Tags
- Change, Process
- Sections
- 5
- Fields
- 53
- Follow up fields
- 6
- Repeating sections
- 0
- Links out
- 7
Header
11 fieldsRequest ID*
Auto sequence. Format PRC-2026-0000.
The record's own ID. Other templates point at this value.
Status*
Drives who this goes to next.
- Planned2 pts
- In progress2 pts
- Complete3 pts
- Deferred0 pts
- Open0 pts
- Closed3 pts
- Overdue0 pts
Date and Time*
Raised By*
Site*
Site ID*
Format SITE-000.
Links to FDN-001 Site ID
Requested By*
Requesting Function*
Target Implementation Date*
Asset
Asset ID
Format AST-0000.
Links to FDN-002 Asset ID
The change
6 fieldsChange Type*
Equipment, settings, sequence, cleaning method, layout or automation.
Process Affected*
Current Method*
Proposed Method*
Reason For Change*
Reason Detail*
Impact assessment
12 fieldsCCP Affected*
- No3 pts
- Yes0 pts
Critical Limit Affected
- No3 pts
- Yes0 pts
HACCP Reassessment Required*
- No3 pts
- Yes1 pt
Cleaning Method Affected*
- No3 pts
- Yes0 pts
Sanitation Schedule Update Required
New Hard To Clean Areas Created*
Hygienic design failures introduced by process changes are a common source of environmental positives.
- No3 pts
- Yes0 pts
Allergen Risk Affected*
- No3 pts
- Yes0 pts
Foreign Body Risk Affected*
- No3 pts
- Yes0 pts
Detection Coverage Affected*
- No3 pts
- Yes0 pts
Product Attributes Affected*
- No3 pts
- Yes1 pt
Shelf Life Affected*
- No3 pts
- Yes0 pts
Yield Affected*
- No3 pts
- Yes1 pt
Validation and control
10 fieldsValidation Plan Defined*
- Yes3 pts
- No0 pts
Validation ID
Links to QUA-071 Validation ID
Trial Required Before Full Release*
- Yes3 pts
- No1 pt
Control Plan Update Required*
Control Plan Reference
Links to QUA-057 Plan ID
Capability Study Required*
Training Or Briefing Required*
- Yes3 pts
- Not needed3 pts
- No0 pts
Documents To Update
Change Involved
Anything that is not a like for like replacement needs change control.
MOC ID
Format MOC-2026-00000.
Links to FDN-020 MOC ID
Decision
14 fieldsTechnical Approval*
- Yes3 pts
- Pending1 pt
- No0 pts
Quality Approval*
- Approved3 pts
- Conditional1 pt
- Rejected0 pts
Production Approval*
- Approved3 pts
- Conditional1 pt
- Rejected0 pts
Decision*
Conditions
Post Change Review Date
Action Required*
Raise the action record, then enter its reference here.
- No2 pts
- Yes0 pts
Priority
- High0 pts
- Medium1 pt
- Low3 pts
CAPA ID
Format CAPA-2026-00000.
Links to FDN-014 CAPA ID
Action Owner
Quality Manager*
Signature*
Engineering Manager*
Second Signature*
QUA-070 · record IDs look like PRC-2026-000 · Links MOC, Control Plan
Open in KnowellaRun it with agents
From a document you fill in to a programme that runs itself
The form captures the decision. Making sure the trial, control plan and CCP reassessment it depends on happen, in the right order, is the harder part.
Holds the process change library against your HACCP plan and control plans, and flags a record moving to Approved while a required trial or capability study is still open.
Ties the change to the specific asset it affects, so an equipment change and its process change request stay linked instead of living in two systems that never talk.
Turns 'Training Or Briefing Required: Yes' into an assignment against the crew running the affected line, rather than a box ticked in isolation.
Coordinates quality, engineering and production sign-off in one thread, surfaces the ones still waiting on a trial result, and holds every write for your approval.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Meet KnowQuality→Glossary
Process Change Request definitions and key terms
- PRC
- Process Change Request — the mint code this record uses for its own ID, in the format PRC-2026-0000.
- Critical limit
- The maximum or minimum value of a parameter, such as time, temperature or pH, that must be met at a CCP to control a food safety hazard. A process change that shifts it unnoticed is a common way a HACCP plan quietly stops matching reality.
- Dead-leg
- A section of pipework where product or cleaning fluid doesn't flow, creating a niche where residue and biofilm build up. New ones are frequently introduced by process and layout changes rather than poor cleaning practice.
- Control plan
- The document setting out process parameters, monitoring methods and reaction plans for a production step. It's updated once a change is validated, not before — early updates risk documenting a method not yet confirmed to work.
- Capability study
- A statistical assessment of whether a process can consistently meet its specification limits under normal variation. Required when a change might narrow the margin between normal operation and a critical limit.
FAQ
Frequently asked questions about process change request
Does every equipment change need a process change request?+
No — swapping a worn part for an identical one from the same supplier doesn't need change control. The moment the replacement differs in make, model, setting or method, it's back in scope.
Who signs off a process change?+
Quality and engineering always, and production before implementation — three separate fields, Technical, Quality and Production, exist because a change can be sound on paper and still unworkable on the shop floor.
What happens if the change also changes the product?+
Then a Product Change Request (QUA-069) is needed alongside this one. New equipment can change both how a product is made and an attribute of the product, and the two records stay separate so each reaches the reviewer who can approve it.
Why does the form ask about detection coverage separately from foreign body risk?+
Because a layout or sequence change can move a product past a metal detector or X-ray point without changing the underlying contamination risk. Detection coverage asks whether the safety net is still in the right place, not whether the risk changed.
Is a trial always required before full release?+
No, but skipping one is the riskier choice in how the record scores. Whether it's actually needed depends on how far the new method departs from the validated baseline — a minor adjustment within an already-validated range may not need one.
What's the point of recording a Post Change Review Date if the change is already approved?+
Because approval is a judgement made before the change runs at scale, and the review date is where that judgement gets checked against what happened, yield, critical limits, complaints, rather than assumed correct.
Keep going
Related templates and programmes
Industries this is written for
Programmes this belongs to
Used together in Change Control
Management of Change
Makes sure a change to equipment, materials, people or process is assessed before it happens rather than after
Waiver and Concession Record
Records a documented decision to proceed outside the normal requirement, with the risk accepted and by whom
Interim Control Record
Records the temporary control holding a risk while the permanent fix is built, with the date it must be replaced
Equipment Specification Record
Holds the specification a new machine must meet, covering performance, safety, hygiene, energy and maintenance access
Product Change Request
Requests a change to a product, its specification or its packaging
Validation Record
Records the evidence that a change works as intended before it becomes standard
More in Change Control
Written and reviewed by
Siddarth Singh
Founder & Chief Executive Officer, Knowella
Certified Safety Professional and industrial and systems engineer with more than a decade inside food supply chain, freight and manufacturing operations. This page was written against the current text of the standards it cites, not against secondary summaries of them.
- Certified Safety Professional (CSP), Board of Certified Safety Professionals
- MBA, University of Chicago Booth School of Business
- MS and BS, The Ohio State University, Industrial and Systems Engineering
- Six Sigma Black Belt
Sources and last review. Reviewed 16 August 2026 against:
- ISO 9001:2015 cl.8.5.6 — Control of changes
- 21 CFR Part 117 §117.170 — FSMA reanalysis requirement
- Regulation (EC) No 852/2004, Article 5 — HACCP-based procedures
- Codex Alimentarius CXC 1-1969 — HACCP Annex
This page is general guidance, not legal advice. Confirm requirements with your jurisdiction’s regulator.