- Objective :
To lay down the procedure of for identification, evaluation, implementation,effectiveness monitoring, closure and documentation of Corrective Actions and Preventive Actions (CAPA).
This SOP is applicable for all Corrective Actions and Preventive Actions (CAPA) initiated for following GxP systems, processes and records, but not limited to…
- Deviations, Event & incident investigation
- Out-of-Specification (OOS) Results
- Out-of-Trend (OOT) Results
- Change Control & Planned modification
- Market complaints
- Stability failures
- Product recalls
- Annual Product Quality Review
- Risk Management Assessments
- Regulatory Recommendations
- Internal / External Audit Observations
- Management Reviews and other sources of quality data/trends.
Concerned Dept., Concerned Dept. Head, QA Person, QA Head, Quality Head
4. Definitions :
- Corrective Action: Action to eliminate cause of non conformity, defect or other undesirable situation, in order to prevent recurrence.
- Preventive Action: Action taken to eliminate the cause of a potential nonconformity, defect or other undesirable situation, in order to prevent occurrence.
- Effectiveness Monitoring: Process for post implementation of CAPA outcome to conform the adequacy & sustainability of the steps taken to correct & prevent deficiency.
- Root cause analysis: To identify the true cause(s) of failure or deviation, to implement corrective actions to immediately eliminate failures or deviations and implement preventive actions to prevent re-occurrence.
- Action Plan: Committed strategies to address corrective actions and /or preventive action. Plan(s) required overcoming and preventing identified nonconformities.
5. Procedure :
- On receipt of approved documents (e.g. documents as mentioned under scope),
- QA supervisor shall list down the recommendation or suggestive Corrective Action or Preventive Action and update the CAPA register (As per given format)
- CAPA can be initiated by any Dept. which shall be raised & approved by QA Dept.
- QA Dept. shall make entry into CAPA register by giving following nomenclature.
Where CAPA : prefix of Corrective Action & Preventive Action
XXX : Dept. Code (For ex. QC. PRD, QA, WH, ENG etc.), which is allotted by respective company/location vise.
NNN : Sequential No. starts from 001 ,002 & so on … from 1st January of each year
YY : Stands for last two digits of current year (ex. 19 for 2019)
Note: CAPA/PRD-002/19 indicates Second no. of CAPA initiated in year 2019 of Production Dept.
6.Issuance of CAPA Form :
- Based on the CAPA register entries, CAPA Request Form shall be filled up by QA designee and issued to concerned department (As per given format)
- Apart from details as per CAPA Register, details shall be filled in CAPA Request Form.
- After filling the details, CAPA Request Form shall be forwarded to concerned department for the implementation of the recommendation.
- QA shall issue original CAPA Form to the Head of concerned department.
7.Execution of CAPA by Concerned Department :
- Concerned department head is responsible to complete the CAPA as per requirement and within defined time schedule.
- Upon completion of the recommended activity, concerned department shall fill up the details of action taken along with supporting data, if any, after verification from department head or designee.
- The person performing the assigned Corrective and preventive action shall sign in the performed by column and the respective person of the concerned department verifying the above action shall sign in the verified by column.
- After completion of above activity, the duly filled and signed CAPA Request Form shall be submitted to QA department for evaluation along with supporting data / documents.
- If extension of target completion date is required, then justification note shall be prepared and approval of Quality Head shall be taken.
- In case of CAPA where collection of extensive data or consultation with some external agency is required, then the target completion date may be extended with a justified reason after approval by Quality Head.
- The justification for extension shall be prepared by the concerned department head and send the same to Quality Head for approval along with CAPA Form.
- Extension can be taken maximum two times for timely closure of CAPA. (May vary as per different company’s procedures)
- After two extensions in target completion date, Management Notification shall be raised.
8.Evaluation and Closure of CAPA by QA Department:
- Any supporting data attached with the CAPA form shall be evaluated by QA designee.
- On the basis of evaluation, CAPA register shall be updated for the status. During evaluation, if any shortcomings are found then it shall be returned to concerned department with extended target completion date and reasons after authorization.
- After evaluation, QA person shall sign in evaluated by column.
- If all recommended activities have been performed satisfactorily, QA designee shall update the status of CAPA as “Closed” in CAPA register and in CAPA Form.
- The Corrective Actions to be implemented as described in the Corrective Action Request Form shall be discussed and if required circulated to concerned departments on monthly basis.
- Effectiveness of the CAPA shall be evaluated through quarterly review of repetitive events, market complaints, OOS, OOT, Change Control, Planned modification and other quality system documents.
- After closing of CAPA if some event occurs, new separate CAPA needs to be raised which shall be different than the earlier CAPA.
CAPA : Corrective Action & Preventive Action
OOS : Out of Specification
OOT: Out of trend
QA : Quality Assurance Dept.: Department
CAPA Request Form
|To Be Filled By QA Department|
|Department:||Issued By (Name): |
Sign & Date:
|CAPA No. :|
|Extended Target Completion Date:|
CAPA Recommended As Per:
|Product Name / Material Name|
|Document Name (Type)||Document No.|
|Ref. Batch No. / Effective Date||Any Other (Specify) :|
|Details of Recommendations: |
Remarks By Responsible Person:
|Product Name / Matrix |
|Page No. / Step No.|
|Supporting Data |
Remarks By Evaluator:
|Evaluated By |
|Action Performed By||Verified By|
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