Corrective and Preventative Action (CAPA) Procedure (ISO27001)
Corrective and Preventative Action (CAPA) Procedure (ISO27001)
Version 7.0
Version History
Version Date Detail Author
1.0 27/03/2013 Approved by Information Governance Jo White
Group
2.0 30/08/2013 Reviewed by Information Governance Jo White
Group. 5.2 expanded on scheduled audits
and IS reviews.
3.0 13/04/2015 Reviewed by Information Governance Jo White
Group.
4.0 09/05/2016 Reviewed by Information Governance Jo White
Group.
5.0 12/06/2017 Reviewed by Information Governance Jo White
Group.
6.0 06/08/2018 Reviewed by Information Governance Jo White
Group. Change from EDRM spreadsheet
to workflow.
7.0 08/10/2019 Reviewed by Information Governance Jo White
Group. No changes.
1 Purpose
1.1 The purpose of this procedure is to describe the CAPA (‘Corrective Action and
Preventive Action’) process for handling non-conformities.
2 Distribution
2.1 This procedure is distributed to all Employees and associated Contractors or third
parties as all individuals have a responsibility for continual improvement.
3 Responsibility
3.1 The Information Security Manager is responsible for the maintenance and distribution of
this procedure.
4.1 This procedure shall be continually monitored and shall be subject to a regular review
which shall take place annually, or when a significant change is made to the systems,
people or processes related to this procedure.
5 Process Details
5.2 CAPA
CAPA shall be used to identify, correct and eliminate the cause of potential and actual
non-conformance, minimising the risk of poor quality and providing continuous
improvement. When a discrepancy arises, through scheduled audits, information
security reviews, feedback and from other non-conformities identified through the group,
the Corrective and Preventative (CAPA) Investigation and Response Form shall be
used. This form is used to:
• Describe the discrepancy;
• Investigate the discrepancy;
• Investigate and analyse the root cause;
If scheduled internal Audits find a non-conformance, this will be discussed and agreed
with the relevant Manager or Strategic Director/Director at the conclusion of the review.
The nature of the non-conformance and associated recommendation will then be
incorporated within the Audit Services Memorandum and Action Plan issued to the
Manager or Strategic Director/Director for details on how the recommendations will be
addressed and actioned. It is the responsibility of Senior Management from the relevant
department for implementing corrective actions to address the recommendations made
and agreed by Audit Services.
Following the issue of the Audit Services memorandum and action plan it is important
that, where possible, the ‘root cause’ is identified and investigated to prevent
reoccurrence in the future. Departmental Information Governance Group (IGG)
representatives are responsible for identifying the ‘root cause’ of audit findings reported
within their respective departments and taking action to address the issue. Details of the
action taken to correct the non-conformity should be recorded within the ISO27001
Record Log in EDRM under the heading ‘Root Cause’. A standard item is included on
the IGG agenda to enable the monitoring of ‘root cause’ analysis.
It is the responsibility of Audit Services to maintain the information within the ‘ISO27001
Record Log’ workflow at the point when each Audit Services Memorandum is issued.
The monthly Audit Services’ report to the Information Governance Group will provide a
summary of the recurrent non-conformities across all Departments.
• Ensure that any remedial action is taken to deal with the immediate issue
identified. For example, the Employee’s training Records that are not up to date
are updated; and
• Then through the investigation and analysis of the root cause, understand the
cause of the deviation and if applicable, through the Change Management
Procedure request any changes to potentially prevent recurrence of a similar
problem.
This document is owned by the Information Governance Group and forms part of the
Council's ISMS Policy and as such, must be fully complied with.