Biomedical Engineering Reference
In-Depth Information
LEVEL 3
Attachments No.: QAS-028-II
Issued on:
Revision No.: 6
Attachment II
trend analysis
INSPECTION REPORT/CORRECTIVE ACTION
To:
From: QA manager
Date:
Plant:
Area:
NUMBER OF
DEVIATON
FOR THE
MONTH
TOTAL
DEVIATION
YTD
TOTAL
OBSERVATION
YTD
S.
No
OBSERVATION/
DEVIATION
TYPE OF
DEVIATION
DEVIATION
BY
01
GENERAL GMP VIOLATION
Unattended operations
Not wearing mask
Door kept open during
processing
Dust/dirt in the area
Improper clothing
Dirty gowning
Broken apparatus
Unclean equipment
Cages dirty/pallets dirty
Material not on the pallet
Cages unlocked
Insects in production area
Long hair
Long nails
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