Die Cutting Machine / Punching Machine – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment Details

Equipment: Die Cutting Machine / Punching Machine

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Enter deviation details here]

Date of Deviation: [Enter date]

Reported By: [Enter name]

Classification

Classification: [Enter classification]

Product/Patient Impact

Impact Description: [Enter product/patient impact]

Data Integrity Impact

Impact Description: [Enter data integrity impact]

Affected Batches/Studies

Affected Batches/Studies: [Enter affected batches/studies]

Investigation

Investigation Summary: [Enter investigation details]

Corrective and Preventive Action (CAPA)

CAPA Summary: [Enter CAPA details]

Re-Test/Requalification Decision

Decision: [Enter re-test/requalification decision]

Quality Assurance (QA) Disposition

Disposition: [Enter QA disposition]

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