This is a ready-to-use running log for tracking every person-in-plant observation from the moment it is escalated through verified closure. Replace every <<FILL: ...>> placeholder. Update it at every visit and review it before each new campaign starts, so an open item from a prior campaign is never quietly dropped. A filled specimen follows.
Instructions
Log every observation escalated by a PIP, regardless of how minor it seems at the time. An item is not removed from this log when the CDMO reports it fixed; it moves to “closure claimed” and stays open until the verification method confirms the fix held. Retain per <<FILL: document retention period>>.
Field definitions
| Field | Format | Required | Who completes it | When |
|---|---|---|---|---|
| ID | <<FILL: sequential, e.g. PIP-OBS-001>> | Yes | PIP | At observation |
| Date/time observed | <<FILL>> | Yes | PIP | At observation |
| Observation | Free text, specific | Yes | PIP | At observation |
| Risk category | <<FILL: e.g. data integrity, aseptic technique, documentation, equipment>> | Yes | PIP | At observation |
| Escalated to | Named role | Yes | PIP | At escalation |
| CAPA / tracker reference | <<FILL: system and number>> | Yes, once assigned | CDMO or sponsor quality | At escalation |
| Owner | Named individual | Yes | CDMO or sponsor quality | At escalation |
| Due date | Date | Yes | CDMO or sponsor quality | At escalation |
| Status | <<FILL: open / closure claimed / verified closed>> | Yes | Sponsor quality | Ongoing |
| Verification method and date | Free text | Yes, before “verified closed” | Sponsor quality or PIP | At verification |
Log
| ID | Date | Observation | Risk category | Escalated to | CAPA ref | Owner | Due date | Status | Verification |
|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Filled specimen
| ID | Date | Observation | Risk category | Escalated to | CAPA ref | Owner | Due date | Status | Verification |
|---|---|---|---|---|---|---|---|---|---|
| PIP-OBS-014 | <<FILL: date>> | Environmental monitoring excursion response took 40 minutes versus the SOP’s 15-minute target during a Grade B viable count alarm | Facility / EM | CDMO floor quality representative | CAPA-2026-0077 | CDMO Shift Supervisor | <<FILL: +10 business days>> | Closure claimed | Shift retrained on excursion SOP; training records attached, but response time not yet re-tested against a live excursion |
| PIP-OBS-014 (follow-up) | <<FILL: next campaign date>> | Next EM excursion on the same suite responded in 12 minutes, within the SOP target | Facility / EM | N/A | CAPA-2026-0077 | N/A | N/A | Verified closed | Response time observed directly within target on the first real excursion after retraining; closure verified, not just claimed |
| PIP-OBS-015 | <<FILL: date>> | Line clearance checklist signed before physical clearance completed, see DEV-4471 | Documentation / batch record | CDMO Manufacturing Supervisor | CAPA-2026-0091 | CDMO Manufacturing Supervisor | <<FILL: before next changeover>> | Verified closed | Second-person verification step observed in use during the next changeover before the signature was entered |
The specimen shows the distinction the log exists to enforce: PIP-OBS-014 was not removed from the log when training records arrived. It stayed open, correctly labeled “closure claimed,” until an actual excursion tested the fix.
Common inspection findings this log prevents
- A finding marked closed on the strength of a training record alone, with no evidence the underlying behavior actually changed.
- An open item from one campaign silently absent from the next campaign’s records, with no trace of what happened to it.
- No distinction anywhere in the sponsor’s records between a CDMO’s claim of a fix and a sponsor’s own verification of it.
How to adapt this log
- Set your own risk category list to match your product and process types.
- Never delete a row on closure; change its status and add the verification entry, so the full history stays visible.
- Review all open and closure-claimed rows before every new campaign at the same site, not only at the point a new observation is made.