Deviation Impact Assessment

Equipment: Terminal Sterilization Load Carts/Racks

Area: Production

Criticality: Major

Product Impact: Direct

Deviation Details

[Insert detailed description of the deviation]

Classification

[Insert classification of the deviation]

Product/Patient Impact

[Insert assessment of product/patient impact]

Data Integrity Impact

[Insert assessment of data integrity impact]

Affected Batches/Studies

[List affected batches or studies]

Investigation

[Insert summary of investigation conducted]

Corrective and Preventive Actions (CAPA)

[Insert details of CAPA taken]

Re-test/Requalification Decision

[Insert decision regarding re-test or requalification]

QA Disposition

[Insert QA disposition]