Failure Investigation SOP

SOP for Failure Investigation in pharmaceutical Industries

  • SOP covers below points:
    • Purpose of Failure Investigation
    • Failure Investigation Report
    • Failure Investigation Checklist
    • Failure Investigation Log
  • To define the procedure for Failure Investigation of any device or its components failing to meet performance criteria.
  • Failure Investigation are intended to determine the root cause for failure and address avoidance of recurrence.
2.0 SCOPE :
  • This procedure is applicable to investigate the failure in any activity. This SOP is not applicable to laboratory tests carried out on finished product, which is done through the SOP on out of Specification.
  • Originating Department Chemist/Supervisor or above : Reporting of failure, filling the related information of failure & investigation of failure.
  • Head Origination Department: Description / Root Cause of Investigation & comments.
  • Executive / Officer Quality Assurance : Maintain Failure Investigation Log Book, assign Investigation Report Number & Review summary of Investigation.
  • Quality Assurance Head / Designee: Review of Failure, CAPA for Failure, Impact Analysis & comments, Approval  & Final Review of Failure.
  • Impacted Department: To assess the impact with respect to their functional responsibilities.
  • Quality Assurance Head

5.1 Failure investigations are intended to determine root cause for failure and to provide adequate solutions to correct and prevent problems from recurring. 

5.2 Failure investigation report is designed to provide a record of the action taken to bring the process under control so as to meet the product to its predetermined standard. The Key objectives are –

  • To identify and describe cause of failure
  • To record subsequent actions taken to bring the operation back as per standards
  • To record the outcome of this action
  • To record recommendations for further actions when required (preventive action)
  • To provide a permanent record of the events
  • To follow-up on outstanding actions
  • To assist with identifying issues for continuous improvement of a process
  • Typical example of failure occurrence, to be reported in an failure investigation report from Good Manufacturing Practices ( GMP ), such as –
    • Product or Component mix-up
    • Product Recall
    • Incorrect printing / Overprinted batch details / deviation from SOP/ BMR, specifications which can affect the specifications of a final product.
    • Batch reconciliation of outside specified limit
    • Incorrect item or Material is used
    • Packing component that has been conditionally approved  (to be used with some modification)

5.3 Report failure occurrence immediately to the concerned department head and to Quality Assurance officer.

5.4 As per verbal request from any departmental head or his/her designee, chemist and above of Quality Assurance department will issue working copy of Failure Investigation Report and Failure Investigation Checklist and will also get acknowledgement from requesting department on format issue register.

5.5 As per Failure Investigation Report (Refer Annexure No. 01) the Quality Assurance officer along with the officer of the activity shall carry out a failure investigation.

5.6 For the process part of the investigation, as required by the respective SOP on OOS and the same shall be carried out as per Failure Investigation Checklist. (Refer Annexure No. 02).

5.7 Ensure that report is initiated for the failure occurrence, even though it may be in another area of responsibility.

5.8 Complete all the sections of failure report with as much as possible details and send the Failure Investigation Report to the Officer of Quality Assurance department so that a unique identifier can be assigned to Report.

5.9  Failure Investigation Report number as follows :

  • FIR/00/000
  • Where,
    • FIR : Failure Investigation Report
    • 00 :  Calendar year in which incident occurred
    • 000: Serial number of Report

5.10 After the investigation is over, summary of the failure and proposed corrective action shall be forwarded to Quality Assurance Head or his/her Designee for comments.

5.11 Quality Assurance Head will discuss the failure report with the impacted department and wherever required will consult  members from technical , Directors, Production Head etc to conclude.

5.12 All CAPA documents shall be collected and attached to original failure investigation form.

5.13 Failure observed in manufacturing process which could lead to finished product of non standard quality needs to be documented in the respective batch manufacturing record.

5.14 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.

5.15 Assess the failure report and decide if further actions are required and complete the Failure Investigation Report. 

5.16 Attach analytical reports to failure report.

5.17 Review and approve, or Reject the report findings those are associated with product quality (i.e. contents not as per label), customer complaint and regulatory requirements.

5.18 Quality Assurance Head shall record the disposition of the failure report and complete section considering the effect on quality of the product, customer requirement or regulatory requirement, i.e., batch approved, rejected, reworked, reprocessed etc.

5.19 If the outcome is unsatisfactory, record the reason on failure report form, and if necessary, convene a meeting with technical team and determine what action is to be taken in future.

5.20 If rework is required then rework procedure should be approved by Quality Assurance head with proper reason for rework.

5.21 When follow-up actions are required, the responsible person from the department for completing the action and target completion date must be recorded in the failure report.

5.22 Ensure that original failure report is included in the batch manufacturing record prior to approval of batch. If more than one batch is involved in single failure report, a photocopy of the failure report form must be attached to each batch in each batch manufacturing record.

5.23 After completion of corrective actions that are indicated in the report, the same shall be approved by Quality Assurance Head.

5.24 Send copy of the approved failure report to the concerned department heads.

5.25 Subject the batch(es) for stability studies, if justified.

5.26 Follow-up of any outstanding actions of a failure report must be completed within three days of the incidence.

5.27 All failure reported shall be serially logged in Failure Investigation Log Book. (Refer Annexure No. 03).

AbbreviationExpanded form
SOPStandard Operating Procedure
Q.A.Quality Assurance
Q.C.Quality Control
OOSOut of Specification
CAPACorrective Action and Preventive Action
QADQuality Assurance Department
GMPGood Manufacturing Practices

Annexure No.Title
01Format for Failure Investigation Report
02Format for Failure Investigation Checklist
03Format for Failure Investigation Log

  •  GMP Guidelines



Annex. No. 01 Format for Failure Investigation Report

Annex. No. 02 Format for Failure Investigation Checklist

Annex. No. 03 Format for Failure Investigation Log

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