This is a ready-to-use form for the batch-impact assessment that lets a batch be dispositioned while a deviation’s root-cause investigation and CAPA remain open. The principle it operationalizes: what must be closed before release is the impact of the event on this specific batch; the full investigation may continue afterward. This form captures the reasoning at the point of decision, where an inspector expects to see it, rather than only in a separate deviation system. Replace every <<FILL: ...>> placeholder. A filled specimen follows. This is general guidance to adapt, not legal or regulatory advice.
When to use
Use this form when a deviation, discrepancy, or unexpected event is linked to a batch that is a candidate for disposition and the full investigation will not close before the batch must be dispositioned. It does not replace the deviation record; it is the batch-specific impact conclusion that attaches to the disposition package. Do not use it to release a batch whose impact cannot be concluded on evidence.
Field definitions
- Event summary: what happened, factually, without conclusion.
- Affected window: the bounded time, step, or unit range the event could touch, and the evidence that bounds it.
- Affected attributes: which of quality, safety, identity, strength, purity, or efficacy the event could plausibly affect.
- Batch-impact conclusion: the signed statement that the batch is or is not adversely affected, on evidence.
- Remains open: what stays in the deviation after release (root cause, CAPA), and confirmation the impact conclusion does not depend on it.
1. Event summary
<<FILL: factual description of what happened, no conclusion>>
2. Bounding the affected window
3. Affected quality attributes and alternative controls
4. Batch-impact conclusion
5. What remains open after disposition
6. Review and approval
Acceptance criteria
The assessment supports a disposition when the affected window is bounded on evidence, every plausibly affected attribute is addressed by a result or an alternative control, the conclusion is stated on evidence rather than assertion, the impact conclusion does not depend on the still-open root cause, and an independent reviewer and the disposition authority have signed.
Filled specimen
The following is completed for the metal-detector example from the batch disposition article, illustrative numbers.
1. Event summary
At end-of-shift verification the in-line metal detector failed its challenge on the smallest non-ferrous test piece. It had passed the full challenge at start of shift. The deviation was raised the same shift.
2. Bounding the affected window
3. Affected quality attributes and alternative controls
4. Batch-impact conclusion
5. What remains open after disposition
6. Review and approval
The batch was released on this signed impact assessment while the root cause and CAPA stayed open. The opposite entry, a conclusion of “metal detector issue, low risk, release” with no bounded window and no alternative control, is the one that becomes an inspection observation.
- A batch released with an open deviation whose impact on it was never assessed.
- An impact conclusion stated as assertion (“low risk”) with no bounded window and no supporting evidence.
- The batch-impact reasoning living only in a separate deviation system, invisible at the point of disposition.
- Full-investigation closure demanded before every release (unworkable), or no impact conclusion at all (dangerous), instead of the correct middle.
- Adjust the attribute rows in section 3 to your product (add container-closure and endotoxin rows for a sterile injectable; add cell-count and viability rows for a cell therapy).
- Point the tracking references to your deviation and CAPA system IDs.
- Keep the independent reviewer and disposition authority as distinct signatures from the preparer.
- Confirm the underlying disposition SOP and deviation SOP references are current.
