Corrective Action and Preventive Action Process (CAPA)

Corrective Action and Preventive Action Process

 (Quality)

 QP005

Version No.:                                    

Effective Date:                                

Review Date:                                  

Supersedes:                       

Author(s):                            

	Technical Approver	Authorized By
Name
Designation	Head of Department / DI	Director / DI	QA
Signature
Date

1.            Purpose

This procedure describes the process for recording the details of Corrective Action and Preventive Action (CA/PA).

2.            Scope

This SOP is to be followed when CA/PA’s are required, where OOS and PQI are the parent records. The CA/PA process can also be applied in stand alone cases like closure of any audit findings.

3.            Abbreviations / Definitions

OOS: Out of Specification

PQI: Product Quality Investigation

Corrective Action: Activity or activities required to remedy a problem and correct the source of that problem

Preventive Action: Activity or activities that are designed to prevent recurrence of issues requiring corrective action but also include a pro-active approach to prevent issues from arising in the first place

4.            Procedure

4.1          General

4.1.1       There are three (3) sections in the CA/PA form (refer to Appendix 1):

·         Proposed CA/PA

·         CA/PA Completion

·         CA/PA Closure

4.1.2       R&D QA will issue a unique number for every CA/PA in the format “CAPA-YY-XXX, where YY denote the year of assigning the CA/PA and XXX is a sequential number starting from 001 every year. For example, the first CA/PA drafted in 2009 will be CAPA-09-001.

4.1.3       R&D QA will maintain a log of CA/PA as per Appendix 2.

4.2          Initiation of CA/PA Form

4.2.1       R&D QA is the originator and will draft the CA/PA form in consultation with the individual/ department who will be responsible for completion of CA/PA.

4.2.2       R&D QA will complete the “Proposed CA/PA” section.

Note: If additional work/clarification is required, the R&D QA will be notified with the detail of additional work required. Once the additional work has been added, the originator will forward to ‘Assigned person’ for review and acknowledgement.

4.2.3       The assigned person will be responsible for acknowledging the CA/PA to show that they agree with the contents or for rejecting and sending back to QA if additional work is required, and they are responsible for the completion of CA/PA within the record.

4.2.4       A copy of the acknowledged CA/PA form will be retained by R&D QA and the original forwarded to “Assigned to” individual for recording CA/PA completion details.

4.2.5       Notification reminders will be sent to “Assigned to” person by R&D QA, if the form is observed to be over due for completion.

4.3          CA/PA Completion

4.3.1       The “Assigned to” person will complete the actual CA/PA taken in the “CA/PA Completion” section of the form within the agreed timeframe and forward it to R&D QA for review and closure.

4.4          CA/PA Closure

4.4.1       R&D QA will review the actual CA/PA taken and confirm the completion of activity by closing the form.

4.4.2       In case, additional work is required for completion of the CA/PA, the “Assigned to” person will be notified about the activity and R&D QA will close the form after completion and verification of the activity.

4.4.3       R&A QA will maintain the original closed CA/PA forms as per Records Retention Schedule (GRS026).

5.            Responsibilities

5.1          It is the responsibility of R&D QA to:

·         Draft CA/PA, as required

·         Confirm and close the completed CA/PA

5.2          It is the responsibility of the ‘Assigned to’ person to:

·         Acknowledge or reject the proposed CAPA

·         Complete the proposed CAPA in a timely manner

6.            References

·         Global Records Retention Policy (POL-FEM ANALYTIKA-506)

·         Out of Specification

·         Product Quality Investigations

7.            Appendices

Appendix 1:      CA/PA Form (QF015)

Appendix 2:      CA/PA Log (QF016)

8.            Revision History

SOP No.	Supersedes No. & Date	Changes made (in brief)
QP005-01	SOP/Div/xx/xx/01; 15 Feb 2015	·            Change in the SOP number due to the implementation of a new numbering system ·            Complete change in the procedure and appendices for improved QMS compliance and to meet the standards of Analytical Science Lab

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