Professional Documents
Culture Documents
Handling of Out of Specification Results
Handling of Out of Specification Results
results
Handling of out of specification
results
1.0 Purpose: To provide instruction for handling
of out of specification results.
4.0 Responsibility:
– Primary: Officer – QC
– Secondary: Officer-QA / Officer-QC
5.0 Procedure
Pass / Fail
• Are methods
followed?
Phase-I
Analyst failure
(Yes / No)
• Are the test parameters
followed?
• Is sample stored appropriately?
• Is the balance used with appropriate accuracy and
calibrated?
• Is the sample Homogenous?
• Is the calibrated instruments/Glassware
used?
• Is the analyst trained and
evaluated?
Phase-I
System failure
(Yes / No)
Details:
• Item Code:
• Used For:
• Item Name:
• Date of Receipt/Manufacturing
• Control No./Batch No.:
• Quantity Received:
• Quantity Rejected:
• Supplier’s Consignment No.:
• Supplier’s Name:
• Ref. Specification:
REASON FOR REJECTION:
Enclosure:
Party COA, ---------------------- COA and Samples
Cc To: Corporate QA, Supplier through Purchase Department