Investigation and CAPA
Move investigations forward before the reviewer opens the case.
The worker assembles the evidence, reconstructs the timeline and challenges the proposed cause. The authorised investigator owns the conclusion and corrective action.
The operational problem
Most investigations wait on preparation, not on the final call.
A reviewer cannot assess root cause until records from several systems are complete, the sequence of events is clear and competing explanations have been tested.
The worker prepares that case and makes uncertainty visible. It does not turn an incomplete evidence set into a confident conclusion.
Keep the same case intact from event to effectiveness review.
The path can be adapted to the organisation’s approved investigation procedure.
Stage 01
Event
Process continuity
The record moves forward to evidence.
The worker assembles and challenges. The investigator concludes.
Important decisions are routed to named roles with the relevant evidence and unresolved questions visible.
Worker responsibility
Deliver a case the investigator can challenge and decide.
Build the evidence set
Collect relevant records and identify missing or conflicting information.
Construct the timeline
Order events, actions and observations with links to their source.
Challenge hypotheses
Compare proposed causes with available evidence and alternative explanations.
Prepare CAPA
Structure actions, owners, due dates and effectiveness criteria for review.
Accountable role
Human judgement and approval
Measure whether cases reach review sooner and need less rework.
- 01Investigation cycle time
- 02Human review minutes
- 03Evidence completeness
- 04Correction rate
- 05CAPA closure time
- 06Repeat-event rate
Choose a case set
Bring completed cases, including the difficult ones.
A representative case set reveals where evidence is lost, where judgement is needed and which measures matter.