Deviation handling is the most-read part of a quality system, because it shows an inspector how the site behaves when something goes wrong.
The question that decides the investigation is what else shares the same cause.
The requirement, the failure modes and the primary sources.
02 · AssessScore this domain and see where it sits against the others.
03 · PositionThe five levels, and the domains modelled so far.
04 · If it is urgentFirst actions, evidence to preserve and what not to do.
Quality assurance and the system as a whole
“Is the cause confirmed, and is impact assessed beyond this batch?”
Impact should cover other batches sharing equipment, materials, personnel or time window. That second half is the part most often skipped.
Laboratory, testing and analytical data
“Does the laboratory data support the conclusion?”
Where the event involves a result, the analytical record needs to be examined in its original form rather than as a summary.
Production, process and the floor
“Why did the process permit this?”
Ambiguous instruction, layout, workload, or a control depending on vigilance rather than design. Open deviations also gate release, making closure a throughput constraint.
Certification and batch release
“Can the affected batch be certified, and on what basis?”
The assessment and its rationale must be documented; a certified batch with an open significant deviation and no recorded reasoning is a serious finding.
Requirements, dossier and authority expectations
“What does our cycle time say about control?”
Investigation cycle time is read as a proxy for whether the quality system is under control, and the data is in your own registers.
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.