Failure Investigation

1.0 PURPOSE :
To lay down a procedure to describe the steps to be followed and the persons involved in conducting failure investigation following a market complaint or if an inprocess, intermediate or final product batch does not meet the quality specifications.

2.0 SCOPE:
This SOP is applicable for all intermediate and finished products.

3.0 RESPONSIBILITY:
General Manager-Quality Assurance

4.0 ACCOUNTABILITY:
President –Technical

5.0 DEFINITION:
Nil
6.0 PROCEDURE:
6.1 Failure investigation shall be initiated by production manager with the help of QA manager. The documentation shall be done in Failure investigation report (Annexure-I)
6.2 Failure investigation shall be carried out when a product does not meet the pre-determined specifications or any unusual observations are noted during the process of storage, handling, manufacturing or testing of the product(s).
6.3 Whenever the failure is identified in the product. The same shall be brought to the notice of QA head or his deputy.
6.4 The IPQA chemist shall quarantine any component(s)/Bulk product/Finished product which might have been affected by the failure till investigation is completed and decision is made.
6.5 The investigation shall be extended to all the batches which could have possibly been affected by the failure.
6.6 The investigation may include additional testing of the involved batches or components.
6.7 The production manager shall enter the details of failure, product involved, B. No. etc in the failure investigation report and put sign and date.
6.8 Investigation shall be carried out as per the checklist (Annexure-I) and record the details.
6.9 The failure investigations report shall be signed by the QA, production and any other department involved . The report shall be forwarded to QA head and Unit head for approval.
6.10 QA head or deputy shall take the final decision, based on the investigation findings.
6.11 The failure investigation report shall be maintained in QA-documentation cell with all the supporting data. Document control person allots number to failure investigation report which is made up as follows:
FIY/XX/XXX
1st Character is FI which is abbreviation for Failure Investigation.
2nd Second character is numerical which indicates last digit of current year.
3rd Character is “/”
4th and 5th Character are department code (Refer to QAP xxx)
6th Character is “/”
7th ,8th and 9th Characters are sequential number commencing at 001 for each department.
e.g. F13/PR/001 indicates that the Failure investigation belongs to production department whose sequential number is 001 of year 2003
Document control person enter the details in the “Failure investigation log” (Format No.QAP:000:XX)
6.12 A photocopy of investigation report shall be filed in Batch production record of affected batch(s).
6.13 Corrective actions emerged from the investigation shall be taken immediately with proper change control. if required.
6.14 The QA head or deputy shall ensure that the corrective action has been taken as per the findings
6.15 The failure investigation shall be carried out within 30 working days from the originating date.

7.0 REFERENCES :
Nil

7.1 Documentation of standard operating procedure: QAP:xxx

8.0
ENCLOSURES :
8.1 Format of Failure Investigation Repot.: QAP:008:F1
8.2 Format of Failure Investigation log QAP:008:F2

9.0
ABBREVIATION: Nil