This is a ready-to-use form for deciding, when a change is raised against qualified equipment, whether requalification is needed and what its scope should be. It makes the scoping decision explicit and risk-justified, which is exactly what an inspector looks for. Replace every <<FILL: ...>> placeholder, attach it to the governing change control, and route it through your normal review and approval. Field definitions and a filled specimen follow. This content is educational reference, not legal or regulatory advice.
Form header
| Field | Format | Required | Who | When |
|---|---|---|---|---|
| Form number | <<FILL: RIA-ID>> | Yes | Author | At raise |
| Change control reference | text | Yes | Author | At raise |
| Equipment ID and risk class | text | Yes | Author | At raise |
| Validated baseline reference | text | Yes | SME | At raise |
| Date raised | date | Yes | Author | At raise |
1. Description of the change
| Field | Entry |
|---|---|
| What is changing | <<FILL: component / software / location / utility / new product / parameter>> |
| Reason for the change | <<FILL>> |
| Like-for-like? | Yes / No, <<FILL: equivalence basis if Yes>> |
| Touches a critical function, control logic, or software? | Yes / No |
2. Affected qualification elements
For each IQ/OQ/PQ element the change could touch, mark whether it is affected and why.
| Qualification element | Affected? | Basis |
|---|---|---|
| IQ (installation, utilities, as-built) | Yes / No | <<FILL>> |
| OQ (control functions, alarms, set points, range) | Yes / No | <<FILL>> |
| PQ (process performance, load/recipe, worst case) | Yes / No | <<FILL>> |
| Calibration of affected instruments | Yes / No | <<FILL>> |
| Computerized-system controls (audit trail, access, data) | Yes / No | <<FILL>> |
| Cleaning validation impact | Yes / No | <<FILL>> |
3. Risk assessment
| Field | Entry |
|---|---|
| What could go wrong if the change is faulty | <<FILL>> |
| Severity to product / patient | <<FILL: high / medium / low>> |
| Detectability before product impact | <<FILL>> |
| Overall risk rating | <<FILL>> |
4. Requalification scope decision
| Field | Entry |
|---|---|
| Requalification required? | Yes / No |
| If No, justification | <<FILL: why no requalification is warranted>> |
| If Yes, scope | <<FILL: which IQ/OQ/PQ tests will be re-executed>> |
| Acceptance criteria | <<FILL: the criteria the requalification must meet>> |
| Protocol / test plan reference | <<FILL>> |
| Documentation to update | <<FILL: drawings, SOPs, register, baseline>> |
5. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| SME (technical) | <<FILL>> | ||
| QA | <<FILL>> |
QA approval of the scope decision is mandatory; the qualified-state claim is a quality decision even when the SME drives the technical content.
Field definitions
- Like-for-like: same part number or proven-equivalent spec, fit, and function, touching no critical function, control logic, or software. A “No” here, or a “Yes” to touching a critical function, points toward change control and requalification.
- Affected element: an IQ/OQ/PQ element whose original demonstration the change could invalidate. Tie scope to traceability: if you know which OQ test challenged which function, scoping is mechanical.
- Scope: the minimum testing that re-establishes confidence for what the change challenged, not a default full re-run.
Retention
Retain with the governing change control for not less than <<FILL: retention period>>. The justified scope decision is the record an inspector traces when asking why a given requalification was or was not done.
Filled specimen
The following shows the form completed for two contrasting changes on the same autoclave, to show the scoping logic. Numbers are illustrative.
Change A, RIA-2026-051 (CC-2025-204): Door gasket replaced with the same part number.
- Like-for-like: Yes (identical part number). Touches a critical function: No.
- Affected elements: IQ no; OQ no; PQ no; calibration no; computerized controls no; cleaning no.
- Risk: a failed seal would be detected by the routine leak/Bowie-Dick checks before any load is processed; severity contained by detection. Overall risk: low.
- Decision: requalification not required. Justification: genuine like-for-like with routine seal-integrity checks as the detection control. Documentation: update spare BOM. QA approved.
Change B, RIA-2026-052 (CC-2026-300): Autoclave PLC controller replaced with a new model.
- Like-for-like: No. Touches control logic and software: Yes.
- Affected elements: IQ yes (new hardware install); OQ yes (all control functions, alarms, set points); PQ yes (control logic governs lethality delivery); calibration yes; computerized controls yes (audit trail, access, data on the new controller); cleaning no.
- Risk: a controller fault could deliver an under-lethal cycle that release testing might not catch; severity high, detection moderate. Overall risk: high.
- Decision: requalification required. Scope: full OQ of all control functions and alarms, PQ heat-penetration / load re-mapping for the worst-case load, calibration of all controller-linked instruments, and re-verification of audit trail, access control, and data integrity on the new controller. Acceptance criteria per the requalification protocol RQ-STZ04-2026. Documentation: update P&ID, electrical drawings, validated baseline, and register. QA approved.
The two cases on one asset show the principle: a like-for-like seal swap needs only calibration-level confirmation and a BOM update, while a controller replacement that governs lethality needs OQ, PQ re-mapping, and computerized-system re-verification. The scope follows the risk, and both decisions are written down.
Common inspection findings this form prevents
- A controller swap, software upgrade, or relocation pushed through with no qualification-impact assessment.
- Everything re-run wastefully, or too little re-run, with no documented rationale either way.
- Like-for-like asserted with no equivalence basis, used to avoid requalifying a genuine modification.
- Documentation left describing the old configuration after the change.
How to adapt this form
- Set your form numbering and link it to your change-control system.
- Replace the qualification elements in section 2 with your own qualification structure and traceability.
- Use your established risk-rating scale in section 3.
- Make QA approval of the scope decision a hard gate; confirm the retention period against your schedule.