QA
Quality assurance and the system as a whole
“Could we produce a named record within fifteen minutes?”
A timed retrieval exercise predicts the first day better than any document review, and takes under a day to run.
Quality · Inspection readiness
Inspection readiness
Most sites do not fail on compliance. They fail on demonstrability, and that is a rehearsal problem with a very different cost profile.
In one line
Readiness is a state, not a project — an unannounced inspection finds whatever state you were already in.
Start hereEach step links to the next rather than dead-ending.
From understanding to action
01 · Understand
Reference article
The requirement, the failure modes and the primary sources.
02 · AssessGMP Health Index
Score this domain and see where it sits against the others.
03 · PositionMaturity model
What each level looks like, and what moves you up one.
04 · If it is urgentCrisis guidance
First actions, evidence to preserve and what not to do.
One GMP problem. Multiple perspectives.Roles that genuinely see this differently — not the same text with the job title changed.
Inspection readiness from five GMP roles
QC
Laboratory, testing and analytical data
“Would laboratory records survive scrutiny at pace?”
Audit trails, sequence logs and OOS files are examined early and are where inconsistency shows first.
Manufacturing
Production, process and the floor
“Can operators explain why a step exists?”
Answers like 'because the SOP says so' indicate training that produced a record rather than understanding.
QP
Certification and batch release
“Are previous commitments closed with evidence?”
Unclosed commitments are the fastest route to a repeat finding, which is weighted far more heavily than a first.
Regulatory
Requirements, dossier and authority expectations
“Do departments tell the same story?”
Inconsistent accounts of one process suggest the written procedure is not what happens.
Related
Reading, services and tools
Where we do the work
People and training
Next step
Score it rather than estimate it
The GMP Health Index scores seven quality-system domains and maps each to a maturity level. It calculates in your browser and keeps history on your device only.