A deviation is any departure from an approved instruction, procedure or standard. Inspectors look for deviations raised promptly, classified with a rationale, investigated to a root cause and closed before batch release — with the impact on other batches considered.
What the template covers
- Identification — when, where, product, batch and process step.
- Description against the approved instruction or limit.
- Immediate action and containment.
- Classification with rationale (minor, major, critical).
- Impact assessment across product quality, other batches, validation, stability, regulatory filing and data integrity.
- Root cause, CAPA reference, QA decision and approvals.
Tips
- Quote the instruction and the actual value — it makes classification and impact obvious.
- Record containment even when it seems trivial.
- Do not close the deviation until its CAPA is raised and the batch decision is made.