Hammer Mill – Deviation Impact Assessment

Deviation Impact Assessment

Equipment Details

Equipment: Hammer Mill

Area: Production/Milling

Criticality: Major

Product Impact: Direct

Deviation Details

Description of Deviation:

Classification

Classification of Deviation:

Major
Minor
Critical

Product/Patient Impact

Impact Assessment:

Data Integrity Impact

Data Integrity Assessment:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Summary:

Corrective and Preventive Actions (CAPA)

CAPA Plan:

Re-test/Requalification Decision

Decision:

QA Disposition

Disposition by QA:

See also  Hammer Mill – Qualification Execution Checklist

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