This is a ready-to-use running log for tracking every issue raised with a CDMO partner against a six-rung escalation ladder, so a pattern claim at rung 3 or higher can be shown, not just asserted from memory. Replace every <<FILL: ...>> placeholder. Review open and recently closed rows at every joint quality meeting. A filled specimen follows.
Instructions
Log every issue that reaches at least rung 2, a written formal request, regardless of how minor it feels at the time; a rung 1 informal query that gets a prompt, adequate answer does not need a row. Link a new row to an existing entry whenever the issue matches a prior one’s failure mode, so the pattern is visible in the log itself rather than requiring someone to remember it. Retain per <<FILL: document retention period>>.
Field definitions
| Field | Format | Required | Who completes it | When |
|---|---|---|---|---|
| ID | <<FILL: sequential, e.g. ESC-041>> | Yes | Supply chain quality | At rung 2 entry |
| Issue | Short description | Yes | Supply chain quality | At rung 2 entry |
| Site | Named CDMO site | Yes | Supply chain quality | At rung 2 entry |
| Rung entered at | <<FILL: 1-6, per the escalation ladder>> | Yes | Supply chain quality | At entry |
| Linked to a prior entry | <<FILL: ID or "standalone">> | Yes | Supply chain quality | At entry |
| Partner’s response | <<FILL>> | Yes | Supply chain quality | At response |
| Did the response change the trend, not just close the item | <<FILL: yes/no/too early to tell>> | Yes | Supply chain quality | At next review |
| Current rung | <<FILL>> | Yes | Supply chain quality | Ongoing |
| Status | <<FILL: open / monitoring / closed>> | Yes | Supply chain quality | Ongoing |
Log
| ID | Issue | Site | Rung entered | Linked to | Partner’s response | Trend changed | Current rung | Status |
|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Filled specimen
Three linked rows from CMO Alpha showing a single late-notification incident escalate correctly into a documented pattern across two quarters.
| ID | Issue | Site | Rung entered | Linked to | Partner’s response | Trend changed | Current rung | Status |
|---|---|---|---|---|---|---|---|---|
| ESC-041 | Deviation notification arrived 9 days after confirmation, quality agreement specifies 5 business days | CMO Alpha | 2, written formal request | Standalone | Acknowledged, attributed to a single investigator’s workload during a coverage gap | Too early to tell | 2 | Monitoring |
| ESC-047 | Second late notification, 7 days, different investigator | CMO Alpha | 3, joint quality review | ESC-041 | Acknowledged as the second occurrence; committed to a written notification checklist for all investigators | No, checklist introduced but not yet observed in practice | 3 | Monitoring |
| ESC-053 | Third late notification, 8 days, same failure mode as ESC-041 and ESC-047 | CMO Alpha | 4, formal escalation to partner’s quality leadership | ESC-041, ESC-047 | Partner’s quality head committed to a process change: notification clock now starts an automated alert at confirmation, not a manual step | Yes, next two notifications arrived within the agreed window | 4, monitoring for close | Monitoring |
The log is what let ESC-053 open at rung 4 with three dated, linked entries instead of a retold impression that “this keeps happening.” Without the linkage recorded at ESC-047, the third occurrence would have looked, on its own, like a second isolated incident rather than the pattern it actually was.
Common inspection findings this log prevents
- An escalation to a partner’s quality leadership justified by a pattern claim with no record connecting the current issue to the prior ones it is supposedly part of.
- A pattern that existed but was never escalated past rung 1 or 2 because no one on the sponsor side who remembered the prior occurrences was in the room when the next one happened.
- A partner’s corrective commitment accepted at face value with no follow-up record of whether the trend actually changed afterward.