💊 Pharma & Life Sciences · Flowchart
GxP Deviation and CAPA Workflow
How a pharmaceutical plant handles a manufacturing deviation: report, impact assessment, root cause, CAPA and batch disposition.
Drawing diagram…
What this diagram shows
- Quality assurance decides if the batch is affected
- Every critical deviation gets a root cause investigation
- CAPA effectiveness is checked before closure
Prompt used
GxP deviation and CAPA workflow: an operator reports a deviation in the quality management system. QA classifies it as minor, major or critical and assesses product impact. Major and critical deviations get a root cause investigation (5 Whys, fishbone). Corrective and preventive actions (CAPA) are raised, implemented and checked for effectiveness. QA decides batch disposition: release, rework or reject, then closes the record.
Mermaid code
flowchart TD
A[Operator reports deviation in QMS] --> B[QA classifies severity]
B -->|Minor| C[Document and correct] --> H
B -->|Major or Critical| D[Impact assessment on batch]
D --> E[Root cause investigation]
E --> F[Raise CAPA]
F --> G[Implement actions]
G --> H{Batch disposition}
H -->|Release| I[Batch released]
H -->|Rework| J[Rework under protocol] --> H
H -->|Reject| K[Batch destroyed]
I --> L[CAPA effectiveness check]
K --> L
L --> M[Close deviation]Related templates
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