Log – Deviation
Deviations are the system’s early warning – a process that drifted, a limit missed, a step skipped. This log captures them all in one place so patterns become visible and nothing gets quietly forgotten.
Instructions: Log every deviation when it’s found – process, CCP, specification, or procedural. Record what happened, what was done immediately, and the final disposition. QA reviews the log regularly; trends feed into corrective action and management review.
Record details
- Site:
- Year:
Acceptance criteria
Anything outside these criteria is a deviation – act, record, and tell QA.
- Every deviation investigated with root cause identified
- Product disposition recorded for each
Log
| Date | Deviation no. | Description | Immediate action | Investigation / root cause | Product disposition | Closed (date) | QA sign |
|---|---|---|---|---|---|---|---|
| [Date] | [Deviation no.] | [Description] | [Immediate action] | [Investigation / root cause] | [Product disposition] | [Closed (date)] | [QA sign] |
| [Date] | [Deviation no.] | [Description] | [Immediate action] | [Investigation / root cause] | [Product disposition] | [Closed (date)] | [QA sign] |
| [Date] | [Deviation no.] | [Description] | [Immediate action] | [Investigation / root cause] | [Product disposition] | [Closed (date)] | [QA sign] |
| [Date] | [Deviation no.] | [Description] | [Immediate action] | [Investigation / root cause] | [Product disposition] | [Closed (date)] | [QA sign] |
| [Date] | [Deviation no.] | [Description] | [Immediate action] | [Investigation / root cause] | [Product disposition] | [Closed (date)] | [QA sign] |
| [Date] | [Deviation no.] | [Description] | [Immediate action] | [Investigation / root cause] | [Product disposition] | [Closed (date)] | [QA sign] |
| [Date] | [Deviation no.] | [Description] | [Immediate action] | [Investigation / root cause] | [Product disposition] | [Closed (date)] | [QA sign] |
| [Date] | [Deviation no.] | [Description] | [Immediate action] | [Investigation / root cause] | [Product disposition] | [Closed (date)] | [QA sign] |
| [Date] | [Deviation no.] | [Description] | [Immediate action] | [Investigation / root cause] | [Product disposition] | [Closed (date)] | [QA sign] |
| [Date] | [Deviation no.] | [Description] | [Immediate action] | [Investigation / root cause] | [Product disposition] | [Closed (date)] | [QA sign] |
Notes and corrective action
A deviation log with three entries a year isn’t a sign of excellence – it’s a sign nobody’s reporting. Healthy systems log the small stuff; that’s what keeps the big stuff from happening.
- [Describe any deviation, action taken, and product disposition.]
Review
| Reviewed by (name / signature) | Date | Comments |
|---|---|---|
| [Name / Signature] | [YYYY-MM-DD] | [Comments] |