What this is
What is a Temporary Change Authorization?
What is a Temporary Change Authorization?
A Temporary Change Authorization (TCA) is a KnowQuality record that grants a short-term, time-boxed deviation from a documented standard, process or specification. It exists because some departures from standard practice — a broken piece of equipment, a material shortage, a production trial — are legitimate, provided they are risk-assessed, approved at the right level and closed on a fixed date rather than left open-ended.
How is a temporary change different from a permanent process change?
A temporary change has a built-in expiry and reverts to standard practice by default; a permanent change, raised through a Process Change Request, updates the standard itself. The TCA can point to a Permanent Change Request ID once the deviation turns out to need a lasting fix, but the two records run on opposite defaults — one assumes reversion, the other assumes it is the new normal.
Who approves a Temporary Change Authorization?
Approval sits with a named Approval Level — quality manager, site manager or group technical — chosen according to the risk the deviation carries, alongside separate Quality Approval and Production Approval decisions. A change affecting a critical control point is treated as needing to stop production rather than being approved at any level.
Scope
When is a temporary change authorization required?
This record is one step in the Change Control programme. Using it to request a permanent change, log a waiver against a customer specification, or authorise a validation trial produces records that read correctly in isolation but don't reconcile with the rest of change control later.
Use this template when
- A defined, short-term deviation from standard process is needed and an end date can be set now, before the deviation starts
- Equipment failure, a material shortage, a staffing gap, a trial or an urgent customer requirement is forcing a departure from the documented standard
- The deviation needs a documented risk assessment and a named approval level before it goes ahead, not after
- A Process Change Request already exists and needs an interim authorization to bridge the gap until the permanent change is implemented
- You are running the Change Control programme and this is the step that governs anything temporary
Do not use it for
- Product Change Request, which requests a permanent change to a product, its specification or its packaging.
- Process Change Request, which requests a permanent change to how a product is made, including equipment, settings or sequence.
- Validation Record, which records the evidence that a change works as intended before it becomes the new standard.
- Waiver and Concession Record, which accepts an out-of-specification product or batch as-is, rather than authorising an ongoing deviation in the process that made it.
- Anything outside KnowQuality, which belongs in the workspace that owns that process.
Compliance mapping
Which ISO 9001 cl.8.5.6 requirements does this satisfy?
ISO 9001 cl.8.5.6 governs the control of changes to production and service provision; the fields below map most of the record's controls back to that clause, with the surrounding planning and closure requirements coming from elsewhere in the standard.
| Clause | Requirement | Where it lands |
|---|---|---|
| ISO 9001 cl.6.3 | Changes to the quality management system, including temporary ones, are planned and their purpose and likely consequences considered before they take effect. | The deviation |
| ISO 9001 cl.8.5.6 | Changes to production or service provision are reviewed and controlled to the extent necessary to maintain conformity with requirements. | Risk assessment |
| ISO 9001 cl.8.5.6 | Documented information is retained describing the results of the review, the person(s) authorising the change, and any necessary actions arising. | Approval and closure |
| ISO 9001 cl.7.5.3 | Records of the change are identified, retrievable, and protected for as long as they remain relevant to demonstrating conformity. | Header |
| ISO 9001 cl.5.3 | Authority to approve a deviation at a given level of risk sits with a defined role, not with whoever is available to sign. | Approval and closure |
| ISO 9001 cl.8.1 | Operational processes retain their defined criteria and controls even while running under a temporary arrangement. | Duration and expiry |
| ISO 9001 cl.10.2 | Where the deviation exposes a nonconformity, its cause is addressed with corrective action rather than closed out by the expiry date alone. | Approval and closure |
What it does not cover
- An authorization with no expiry date entered, which turns a temporary deviation into a permanent one that nobody actually approved as permanent.
- CCP Affected marked Yes with Quality Approval still Approved, which lets a critical control point run on an unapproved basis dressed as a signed-off exception.
- Closure recorded weeks after the Expiry Date, which shows the deviation ran unsupervised for longer than the original approval ever covered.
- Permanent Fix Identified as Pass with no Permanent Change Request ID entered, which leaves the temporary alternative as the de facto standard with nothing tracking it.
- Extended marked Yes with no fresh Approval Level recorded, which lets the original sign-off cover a decision it never actually reviewed.
Global
Temporary Change Authorization requirements by country
ISO 9001 sets the baseline, but three contexts raise the stakes on a temporary change well beyond a generic quality record.
IATF 16949:2016 cl.8.5.6.1
Temporary change of process controls has its own named sub-clause, not a footnote to cl.8.5.6.
An approved list of back-up controls, with their authorisation and time limits, is expected to exist before a primary control fails — not be written up afterwards to match what happened.
BRCGS Food Safety Global Standard — management of change requirement
A change affecting a CCP or a food safety control triggers a full risk reassessment before authorisation, not a note added after the batch has run.
The CCP Affected field on this record is doing real certification-scheme work, not local housekeeping — an auditor will ask to see the reassessment, not just the tick.
Regulation (EC) No 852/2004, Art.5
HACCP-based procedures must remain valid for the process as actually run, including any temporary variant of it.
A temporary alternative that changes a validated parameter needs its own evidence that the hazard is still controlled — that evidence can't be borrowed from the original process's validation.
How to complete it
How to complete a temporary change authorization, step by step
Most of this record is straightforward to fill in. The judgement calls are what decide whether it holds up when someone checks it later.
A date with no consequence attached — no report, no escalation, no automatic flag — trains people to treat it as decorative. The record only does its job if 'overdue' is visible to someone other than the person who raised it.
The help text says a temporary change to a CCP is almost never acceptable. If Quality Approval can still read 'Approved' with CCP Affected set to Yes, the field is documenting a decision instead of gating one.
'Pass' here should mean a Process Change Request exists with an ID entered against it, not just that someone believes a fix is coming. Without the linked ID, the temporary alternative has no scheduled end beyond the expiry date it's already at risk of missing.
Standard Practice Restored and Restoration Verified are both optional fields. Leaving them blank on a closed record is common and defensible-looking, but it means nobody actually checked that the floor matches the paperwork.
What auditors find
Most common temporary change authorization findings
The same handful of gaps show up across most Temporary Change Authorization registers we've reviewed.
| Finding | Clause | What fixes it |
|---|---|---|
| Records sit in Open or In progress status for weeks after their Expiry Date has passed. | ISO 9001 cl.8.5.6 | Report Status against Expiry Date on a rolling basis and force a review — extend, close or escalate — the moment a record goes overdue. |
| CCP Affected is marked Yes alongside a Quality Approval of Approved with no additional controls documented. | ISO 9001 cl.8.5.6 | Add a validation rule: CCP Affected = Yes requires Additional Controls Applied to be completed and blocks a straight Approved without it. |
| Permanent Fix Identified is Pass but Permanent Change Request ID is blank. | ISO 9001 cl.10.2 | Make Permanent Change Request ID mandatory whenever Permanent Fix Identified is Pass or Partial. |
| Extended is Yes with no second Quality Approval or Approval Level recorded for the extension. | ISO 9001 cl.5.3 | Treat an extension as a new approval event: require fresh Quality Approval, Production Approval and Approval Level entries whenever Extended is set to Yes. |
| The same Reason and Site combination recurs three or more times in a quarter with no linked CAPA. | ISO 9001 cl.10.2 | Trend Reason by Site; a repeating equipment breakdown or staffing gap is a nonconformity in its own right, not a series of unrelated exceptions. |
| Restoration Verified is left blank on records already marked Closed. | ISO 9001 cl.8.5.6 | Make Restoration Verified mandatory before Status can move to Closed. |
Case in point
Case in point: the line clamp that was never really fixed
A packaging line's date-code printer failed intermittently. A Temporary Change Authorization was raised — manual date stamping as the alternative, seven-day expiry, staffing as the reason — with Permanent Fix Identified set to Partial and a Process Change Request ID promised 'once parts arrive'.
Four extensions later, the ID was still blank, Restoration Verified had never been completed, and the printer had quietly become 'the one that's always down' rather than a documented, budgeted repair. The finding at the next audit wasn't the manual stamping — it was that a four-month-old 'temporary' change had no active record proving anyone still owned closing 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-072
- Archetype
- Record
- Record ID
- TCA-2026-000
- Scoring
- Not scored
- Direction
- n/a
- Singleton
- No
- Basis
- ISO 9001 cl.8.5.6
- Links
- Links MOC
- Tags
- Change, Control
- Sections
- 5
- Fields
- 45
- Follow up fields
- 4
- Repeating sections
- 0
- Links out
- 3
Header
9 fieldsAuthorization ID*
Auto sequence. Format TCA-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
Temporary Means Temporary
Every temporary change carries an expiry date. Temporary changes that never expire are how process control quietly disappears, and they are among the most common audit findings.
Requested By*
Reason*
Equipment breakdown, material shortage, staffing, trial or urgent customer requirement.
The deviation
6 fieldsWhat Is Changing*
Standard Requirement*
Temporary Alternative*
Products Affected*
Lines Affected
Estimated Volume Affected
Risk assessment
8 fieldsFood Safety Risk*
- None4 pts
- Low3 pts
- Medium1 pt
- High0 pts
Legality Risk*
- None4 pts
- Low3 pts
- Medium1 pt
- High0 pts
Quality Risk*
- None4 pts
- Low3 pts
- Medium1 pt
- High0 pts
CCP Affected*
A temporary change to a CCP is almost never acceptable. Stop production instead.
- No3 pts
- Yes0 pts
Additional Controls Applied
Increased Monitoring Applied*
- Yes3 pts
- No0 pts
Customer Approval Required*
Customer Approval Received
Duration and expiry
6 fieldsStart Date*
Expiry Date*
Duration Days*
Permanent Fix Identified*
- Pass2 pts
- Partial1 pt
- Fail0 pts
- N/Aexcluded from denominator
Permanent Fix Detail
Permanent Change Request ID
Links to QUA-070 Request ID
Approval and closure
16 fieldsQuality Approval*
- Approved3 pts
- Conditional1 pt
- Rejected0 pts
Production Approval*
- Approved3 pts
- Conditional1 pt
- Rejected0 pts
Approval Level*
- Quality manager2 pts
- Site manager1 pt
- Group technical0 pts
Closed On Or Before Expiry
- Yes3 pts
- Late0 pts
Actual Close Date
Extended
Extensions require the same approval level as the original.
Standard Practice Restored
- Yes3 pts
- Partly1 pt
- No0 pts
Restoration Verified
- Yes3 pts
- No0 pts
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*
Production Manager*
Second Signature*
QUA-072 · record IDs look like TCA-2026-000 · Links MOC
Open in KnowellaRun it with agents
From a document you fill in to a programme that runs itself
The form captures a single decision. Keeping every open authorization visible against its expiry, and making sure a temporary fix doesn't quietly outlive its own paperwork, is where this actually gets managed.
Holds the Temporary Change Authorization register against every open deviation, flags anything approaching or past its Expiry Date, and keeps the risk assessment and approval trail attached to the record rather than scattered across email.
Surfaces the equipment history behind a recurring 'Equipment breakdown' Reason, so a temporary change that's really a maintenance backlog in disguise gets raised as one instead of re-authorised every few weeks.
Cross-checks Food Safety Risk and CCP Affected against the site's HACCP plan and control point register, so a deviation touching a critical control point gets escalated rather than approved on the form alone.
Coordinates the crew across KnowQuality, KnowMaintain and KnowSafe, rolls open and overdue authorizations into one view, and holds every write for your approval before it touches a record.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Meet KnowQuality→Glossary
Temporary Change Authorization definitions and key terms
- CCP (Critical Control Point)
- A step in a process where control is essential to prevent or eliminate a food safety hazard, or reduce it to an acceptable level. A temporary change affecting a CCP is treated in this record as close to a stop-production decision, not a routine risk to manage around.
- Concession / waiver
- Acceptance of a specific batch or product that doesn't meet specification, as it is. Distinct from a temporary change authorization, which permits an ongoing deviation in the process rather than accepting one instance of its output.
- Approval level (escalation)
- The seniority required to authorise a deviation, set according to its assessed risk. A quality manager can approve what a site manager cannot, and some risk levels require group technical sign-off regardless of urgency.
- CAPA (Corrective and Preventive Action)
- The follow-up record raised when closing this authorization reveals an outstanding action — commonly the permanent fix itself, or a control gap the deviation exposed.
- Restoration verification
- Confirming, physically, that standard practice is actually back in place once a temporary change expires — as distinct from just recording that the expiry date has passed.
FAQ
Frequently asked questions about temporary change authorization
What is the temporary change authorization template based on?+
It is built against ISO 9001 cl.8.5.6, Control of changes, with supporting requirements drawn from planning of changes (cl.6.3), documented information (cl.7.5.3) and corrective action (cl.10.2).
What sections does the temporary change authorization contain?+
Five sections: Header, The deviation, Risk assessment, Duration and expiry, and Approval and closure. Together they hold 45 fields, 30 of which are required.
How long can a temporary change stay open?+
As long as the Expiry Date allows, and no longer without a fresh Extended approval at the same Approval Level as the original. There's no built-in maximum — the control is that every extension is a deliberate, re-approved decision, not a default.
What happens if the deviation affects a critical control point?+
The help text is explicit: a temporary change to a CCP is almost never acceptable, and stopping production is the expected response instead of authorising the deviation.
Does a temporary change authorization replace a Process Change Request?+
No. It bridges the gap while a permanent fix is pending. Permanent Fix Identified and Permanent Change Request ID exist specifically to link the two records once the temporary arrangement is due to become permanent.
Can the template be changed?+
Yes. Every field, option, score and conditional rule is editable, and the links to other Change Control templates come with it. Most teams install it as it is, run it for a cycle, then adjust the approval levels and risk options to match their own site structure.
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
Process Change Request
Requests a change to how a product is made, including equipment, settings or sequence
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
- ISO 9001:2015 cl.6.3 — Planning of changes
- IATF 16949:2016 cl.8.5.6.1 — Temporary change of process controls
- BRCGS Food Safety Global Standard — Management of change
- Regulation (EC) No 852/2004, Art.5 — HACCP-based procedures
This page is general guidance, not legal advice. Confirm requirements with your jurisdiction’s regulator.