SOP For Failure Investigation

1. OBJECTIVE :

The purpose of this SOP is to lay down the procedure for ( Failure Investigation ) investigation failure of any activity to meet its predetermined specification, limits or acceptance criteria

2. SCOPE : 

This SOP is applicable to process failures as well as non process failures (e.g. operator related). This SOP is not applicable to failure in laboratory tests carried out on finished product, which is done through the SOP on Investigation of out of Specification results. This SOP is applicable.

3. RESPONSIBILITY:
   1. Preparation: Officer QA is responsible to prepare the SOP.
   2. Review:  Executive QA is responsible to review the SOP.
   3. Approval: Head QA is responsible to approve the SOP.

4. PROCEDURE: 
   1. Whenever a failure is identified in product or process or system, the particular activity, or reviewer of the activity operation needs to be brought to the notice of immediate supervisor and QA Head. 

[E.g. Failure may be observed in in-process test results, environment monitoring data, wash water analysis results, availability of sub standard utility, OOS Investigation (not due to analytical error / non-assignable cause)  etc.].

4. QA along with the supervisor of the activity shall carry out a failure investigation as per (F/QA000/01). 
5. For the process part of the investigation, as required by the OOS SOP, the same shall be carried out as per (F/QA000/02). 
6. Investigation: 
   1. A procedure is written down for conducting an investigation.
   2. The procedure should include the objective for the action that will be taken, the strategy to be followed and the responsibilities assigned to personnel involved in the case.
   3. To perform a fact based investigation for determining the root cause during the investigation is essential.
   4. The investigation shall be adequate with the significance and risk of the situation shall include:
      1. 4.4.4.1.A description of the situation including its impact on product quality, safety, efficacy and purity. 
      2. 4.4.4.2.A review of all processes and/or system that interact with or may have contributed the cause.
   5. Based on the information available, identify the probable cause for the non-conformance by using the investigational tools defined in SOP for CAPA (SOP/QA000). 
7. After investigation, summary of the failure and proposed corrective action shall be forwarded to Head-QA for comments.
8. Head-QA may initiate CAPA as per SOP (QA000) in order to avoid the recurrence of the failure of similar or related types.
9. All CAPA documents shall be collected and attached to original failure investigation form for trail and records.
10. Failure observed in manufacturing process which could lead to finished product of non standard quality needs to be documented in the respective batch record.
11. Any out of specification results observed in the laboratory which may have resulted due to failure in the manufacturing process as per the investigation, shall lead to rejection of the batch.
12. For any non process failure observed in a campaign manufacturing, the impact of the same shall be evaluated by QA on the batches produced prior to the reporting of failure.
13. ALL failure reported shall be serially logged as per the format provide in (F/QA000/03).
14. Quality Assurance Head should Quarantine the finished product that might have been affected by the failure.
15. Investigation should be extended to all the batches / products, which could have possibly been affected by the failure.  
16. Quality Assurance Head shall hold the release of the batch(s) containing rework of the subjected batch(s). Such batches should be quarantined and should not be released for sale, till investigation is complete and a decision is made.
17. All corrective actions planned in the investigation report shall be monitored by Quality Assurance for completion of the activities.
18. After completion of corrective actions that are indicated in the report, the same shall be approved by Head – Q.A.
19. A copy of the approved report shall be forwarded to concerned persons.
20. Follow the above steps also for investigation of Out of Trend results (OOT).
21. Failure Investigation numbering system consist of combination of twelve digits of alphabetical and numerical number i.e. XXX / YYY/ ZZZZ where 

first three characters (XXX) denote FIR (Failure Investigation Report), 

forth character ( “/ ” ) denotes “Slash”, 

5^th, 6^th, 7^th, characters (YYY ) denote sequential number starting from 001 to 099, 

8^th character ( “/ ” ) denotes “ Slash” ), 

9^th, 10^th, 11^th, 12^th, characters (ZZZZ ) denote current calendar year. For e.g. first failure Investigation raised during current calendar year 2022 shall be as FIR / 001 / 2022. 

5. TRAINING: 

Trainer — Head – Quality Assurance 

Trainees — All Departmental / Sectional Heads 

6. DISTRIBUTION:

Controlled Copy No. 1  : Head of Department – Quality Assurance 

Controlled Copy No. 2  : Head of Department – Production

Controlled Copy No. 3  : Head of Department – Quality Control 

Controlled Copy No. 4  : Head of Department – Warehouse / Store 

Original Copy   :  Head – Quality Assurance

7. ANNEXURE(S):

Annexure I             :  Failure Investigation Report 

Annexure II             :  Batch Failure investigation Checklist 

Annexure III             :  Failure Investigation Log   

8. REFERENCE(S):

SOP of Out of Specification  

SOP of Corrective Action and Preventive Action 

9. REVISION HISTORY:

Sr. No.	Revision No.	Change Control No.	Details of Revision	Reason(s) for Revision
01	00	———–	New SOP	New SOP