ABSTRACT
COMPLAINT INVESTIGATION DURATION EXTENSION FORM
Complaint No.: Product: Code No: Batch No.(s): Name of the customer/consignee: Country: Description of the complaint:
Size/intensity: Complaint sample receipt date: Complaint receipt date: Basis for extension period: 1: 2: 3: 4:
Time period extended up to: Day Month Year
Signature QAD
cc: Complaint le
Page 1 of 1
Attachment No.: QAS-002 Revision No.: Issued on: Initiator Name:
CUSTOMER QUALITY COMPLAINT SHEET FORM – B
To : Quality assurance director From : Product manager
Attachment No.: QAS-002 Revision No.: Issued on: Initiator Name:
Complaint No.:
Product: Form: Concentration: Batch No.: Country: Name of the customer: Area/city: Description of the problem: Size/intensity of the problem: Collection date of the sample from customer: / / Receiving data of the sample by P.M.: / / Number of sample sent to quality assurance: / / Close out:
Page 1 of 1
PRODUCT COMPLAINT RECEIPT FORM
Complaint reference number: (Assigned by QA Secretary) Complaint register ref. page:
Complaint:
Product:
B. No(s):
Date received:
No. of sample received:
Investigation required
1. File samples rechecking:
2. Batch(es) documents review:
3. Reanalysis (FP, RM, PM):
QA director/QA manager
Attachment No.: QAS-002 Revision No.: Issued on: Initiator Name:
COMPLAINT CLASSIFICATION FORM
Class I : CRITICAL
Product defects that would result in serious, adverse health consequences or death
1. Active ingredient missing
2. Incorrect dosing of active ingredient that might result in serious adverse health consequences or death
3. Product decomposition that might result in serious, adverse health consequences or death
4. Changes in packaging components that might result in serious, adverse health consequences or death
5. Change in active ingredient release that might result in serious, adverse health consequences or death
6. Unexplainable changes in effectiveness that might result in serious, adverse health consequences or death
7. Misbranding mislabeling or misprints that might result in serious adverse health consequences or death
8. Counterfeit
9. Any other :
Class II: MAJOR
Product defects which will cause no adverse health consequences but will impair efficacy.
