Practitioner template
Functional Risk Assessment Template
Link each important GxP function to a failure scenario, process effect, potential consequence, controls, and required evidence.
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- GxP function or requirement
- Failure scenario
- Process effect
- Potential impact
- Existing controls
- Detectability
- Risk rationale
- Mitigation or evidence needed
- Residual risk
- Owner
Completed fictional example
Fictional teaching example: This is not an executed or approved validation record.
- GxP function or requirement
- CAPA closure gate; URS-014
- Failure scenario
- Record closes before required effectiveness approval
- Process effect
- Open corrective action is represented as complete
- Potential impact
- Ineffective action may remain undetected
- Existing controls
- Server-side transition rule and role authorization
- Detectability
- Daily exception report detects closure after the event
- Risk rationale
- High consequence; preventive gate is required
- Mitigation or evidence needed
- Scripted authorized and unauthorized transitions plus exploratory interruption and API paths
- Residual risk
- Unexpected alternate integration path
- Owner
- Quality Systems Owner