QUALITY SYSTEM PROCEDURE

Document
Effective Date Revision No Page
Number
ALS/QSP/28 01.04.2019 01 Page 1 of 3
TITLE CORRECTIVE & PREVENTIVE ACTION (CAPA)

1.0 PURPOSE

This procedure defines the requirements for the Corrective and Preventive Action (CAPA) program
at. This program has a goal to collect and analyze information to identify and investigate actual and
potential product and quality problems, take appropriate and effective corrective or preventive
action and to verify or validate the effectiveness of corrective and preventive actions.

2.0 SCOPE

2.1 The corrective/preventive action program is intended to pursue continuous improvement

through quality measurement, defect prevention, employee involvement and process
control. Any corrective/preventive action taken to eliminate the existing/potential causes of
non-conformities shall be commensurate with the risks and magnitude of the problem.
Decisions concerning a regulatory action shall be made with the objective of guaranteeing
the highest standards of quality and regulatory compliance. Such decisions shall be made by
and communicated to the appropriate levels of management.

2.2 Source documents for corrective/preventive actions include customer complaints, NCRs,
internal and external audits. Quality will evaluate each of these document types to
determine if a corrective or preventive action is required to prevent recurrence of the quality
problem
3.0 RESPONSIBILITY

All process owners.

Quality Assurance and Management Representative.

4.0 PROCEDURE

The input for initiating the CAPA process may come from a variety of internal and external sources.
CAPA procedure ensures following requirements are met:
a) Determining potential nonconformities and their causes;
b) Evaluating the need for action to prevent occurrence & recurrence of nonconformities;
c) Planning and documenting action needed and implementing such action, including, as
appropriate- updating documentation;
d) Verifying that the action does not adversely affect the ability to meet applicable regulatory
requirements or the safety and performance of the medical device;
e) Reviewing the effectiveness of the corrective & preventive action taken, as appropriate.
Any employee who identifies a nonconformance may initiate the CAPA process using the CAPA form.
The request shall be forwarded to the respective Department Manager who will then schedule an
action plan.

Copyright ©: This document contains confidential information that belongs to ARTIFICIAL LEARNING SYSTEM INDIA PVT LTD cannot be fully
or partially copied without the prior written approval of the designated Directors of the organization. The content in this document is intended only for
the internal stakeholders.
 QUALITY SYSTEM PROCEDURE
Document
Effective Date Revision No Page
Number
ALS/QSP/28 01.04.2019 01 Page 2 of 3
TITLE CORRECTIVE & PREVENTIVE ACTION (CAPA)

 Once a CAPA is initiated, QA will assign it a CAPA number. The CAPA number is assigned as
CA/PA-YY-### where CA designates Corrective Actions and PA designates Preventive Actions, YY
is the 2-digit year and ### is a sequential number for CAPAs for that year. Example: 5th CAPA as a
Corrective Action of 2013 is ‘CA-13-005’; the 6th CAPA as a Preventive Action of 2013 is ‘PA-13-
006’.
 The initiator will be responsible for documenting the condition or situation, using the CAPA
form warranting a CAPA, along with a description of the deficiency or nonconformity, prior to
the initial meeting.
 The Owner of the activity is then responsible for determining and documenting the immediate
action required, the root cause of the problem and a possible corrective or preventive action
plan along with timelines.
 The Owner shall then call a review meeting with the respective Department Manager, the
Quality Assurance Manager, the Management Representative and others as needed to review
the report on the root cause of the CAPA and a possible action plan.
 The team should then review the proposed action plan for its completeness and approve/ask
for changes as needed. The outcome /follow-up items (action items and responsible personnel)
shall be documented in a CAPA review form.
 The MR will be responsible for tracking the action item list to ensure that items are completed
/implemented in a timely manner.
 The Owner is then responsible for the implementation of proposed action plan to address the
CAPA and the MR are responsible for tracking its effectiveness.
 The Owner should update the CAPA with the action taken and shall provide all supporting
documents. This is reviewed for completeness by the department Manager. After the approval
of the department Manager, it shall be submitted to the MR.
 The MR should review the CAPA and approve or disapprove the actions taken.
 The designated personnel should verify and review the effectiveness of the actions taken by
investigating whether the actions taken have solved the problem. This may entail discussions,
review of inspection records, analysis etc.
 The effectiveness shall be monitored over a time period as decided by the team and approved
by Senior Management.
 If the implemented actions are determined to be effective, the MR along with the applicable
departmental Manager will approve the CAPA for closure.

Copyright ©: This document contains confidential information that belongs to ARTIFICIAL LEARNING SYSTEM INDIA PVT LTD cannot be fully
or partially copied without the prior written approval of the designated Directors of the organization. The content in this document is intended only for
the internal stakeholders.
 QUALITY SYSTEM PROCEDURE
Document
Effective Date Revision No Page
Number
ALS/QSP/28 01.04.2019 01 Page 3 of 3
TITLE CORRECTIVE & PREVENTIVE ACTION (CAPA)

 The CAPA analysis (review of all the CAPAs in the system that is conducted periodically) will be
carried out by MR and the results will be reviewed during the Management Review Meeting.
 The analysis results and their supporting data will be documented in the CAPA report.
 The root cause of nonconformance and the CAPA results will be analyzed and documented in
the CAPA report.
 The proposed action plans should be analyzed for the completion of recommended actions and
for the follow up of the recommended actions.
 All proposed corrective / preventive actions for all CAPAs should be completed within 90 days
from the date of initiation. If a corrective / preventive action is not closed or cannot be closed
within the designated time frame, appropriate explanation should be provided during the next
Management Review Meeting.

5.0 REFERENCE

EN ISO 13485: 2016 - CL. 8.5.2 & 8.5.3 Corrective and preventive action

6.0 TEMPLATES

Corrective and Preventive Action (CAPA) Record (ALS/CAPA/R/01)

CAPA Log (ALS/CAPAL/R/02)

7.0 REVISION HISTORY

Revision Prepared By Approved By

Release Date Reason
No.
R0 17.07.2018 Initial Document QA Manager Senior Management
Updated to meet QA Manager Senior Management
R1 01.04.2019 Requirements of ISO
13485:2016

Copyright ©: This document contains confidential information that belongs to ARTIFICIAL LEARNING SYSTEM INDIA PVT LTD cannot be fully
or partially copied without the prior written approval of the designated Directors of the organization. The content in this document is intended only for
the internal stakeholders.