Pharmaceutical CDMO · oral solids and liquids · 1 GMP site in Centre-Val de Loire · 290 employeesThis War Map shows how we turn an operational review into an implementation plan. The dates show a possible sequence; the scope and schedule of a real engagement are agreed with you.
Findings
Where work gets held up, who has to step in, and what it costs in this example.
Release queue
About 68 batches wait for certification at any time. Release takes 19 working days on average, against 10 in most quality agreements.
Records go back and forth
Each batch record returns to production 2.4 times on average for documentation corrections before QA can finish its review.
Deviations age
About 38 new deviations a month. 41% close after the 30-day target, and an open deviation blocks certification of the batches it touches.
Client obligations buried in PDFs
35 quality agreements set notification and release rules. Nobody can list them without opening each file.
Illustrative time allocation for 12 interview roles
- Record corrections and re-review
- 27%
- Searching records and chasing status
- 21%
- Improvement and client work
- 20%
- Investigations and impact assessments
- 17%
- Required QA checks and sign-offs
- 15%
These scenario percentages total 100%. They describe the 12 interview roles only, without extrapolating to all 290 employees.
48% of the time goes to correcting and re-reviewing records and to searching and chasing status. Investigations and impact assessments take 17%, required checks and sign-offs 15%. 20% remains for improvement work and clients.
SOP vs. Reality
The written flow has five steps. In practice the record shuttles between QA and production until every entry is complete, while QC and deviation status are checked in two other systems. Certification itself is quick once the file is clean; most of the 19 days are waiting and rework.
The analysis itself is careful. The time goes into rebuilding facts that already exist in records and logbooks, and into finding out whether the same problem happened before. Every week a deviation stays open, the batches it touches stay out of the certification queue.
The board decides well when the impact list is complete. Building that list depends on the author's memory and on reading PDF agreements one at a time. A missed notification clause surfaces months later, in a client audit.
Every document the client wants already exists in an approved form. The work is finding the right batch, the effective version and the client's own list, then getting QA to look at the pack. The QA check is required; the searching around it is avoidable.
Work that needs attention
Risk Register
Strategy Session · 30 min
A real engagement is scoped in the Strategy Session and may begin with a War Map or a bounded Feasibility Sprint.