Deviation to CAPA Linkage Form (Free)

Form – Deviation / CAPA Linkage

Deviations get logged; CAPAs get raised – but the link between them is where things fall through the cracks. This form ensures every significant deviation either has a CAR or has a documented reason why not.

Fill this in as you go, not from memory at the end of the shift – records reconstructed later are where the errors creep in. Replace [bracketed] guidance with your site’s detail.

1. Document control

1. Deviation reference

• Deviation no.: | Date: [YYYY-MM-DD]
• Detected by: [Name] | Method of detection:
• Summary:
• Immediate action and disposition:
• Logged by: [Name]

2. CAPA decision

Not every deviation needs a full CAR – a one-off with an obvious cause and no product impact can be justified. But ‘not every’ is not ‘none’, and the justification must be written down. When in doubt, raise the CAR: an unnecessary CAR costs an hour, a missed systemic problem costs far more.

• CAR required? [Y – CAR no.: / N – justification]
• Trend review: similar deviations in last [6 months]? [Y/N – refs]
• If no CAR: rationale and approver: [Name / signature / date]
• Risk of recurrence without CAR: [low / medium / high – justify]
• If CAR: linkage verified by QA: [Name / date]

3. Trend summary

• Deviation trend code:
• Similar deviations last quarter: [count]
• Trend chart / data reference:
• QA review date: [YYYY-MM-DD]
• Escalation to management review? [Y/N]
• Reviewed by: [Name / signature / date]

Approval and control

Keep completed forms for Retain with the deviation record. at [defined location] – and make sure someone besides you knows where that is.