SOP Corrective and
Preventive Action (CAPA)
| 8.5.1 |
(All) |
| 8.5.2 |
(All) |
| 8.5.3 |
(All) |
Summary
This SOP describes how CAPAs are implemented and tracked.
| Process Owner |
<enter role of process owner> |
| Key Performance Indicators |
<enter KPIs to be tracked for the Management
Review> |
Process Steps
Various events may lead to creation of CAPA. Examples include:
- Product or QMS non-conformities
- Customer complaints
- Internal bug reports, e.g. by developers
- Audit findings
- Post-market surveillance findings, including trends
- Management review findings, including trends
These inputs may be received from any person inside or outside the
company. The QMO is responsible for creating the CAPA and tracking its
resolution.
CAPAs are tracked in the CAPA list.
| Non-conformity, complaint, etc. |
CAPA created |
If immediate action is necessary (e.g. field safety corrective action
or a notification to authorities according to SOP Vigilance), the QMO
consults the Person Responsible for Regulatory Compliance. Immediate
action is carried out without undue delay (see ISO 13485 para.
8.5.2).
In any case, the QMO discusses the next steps with the person closest
to the issue, e.g. for software bugs, the Head of Software
Development.
| QMO |
| Medical Device Safety Officer / Person Responsible for Regulatory
Compliance (optional) |
| CAPA |
CAPA, updated with action |
3. Root Cause Analysis
The QMO coordinates a root cause analysis with the person closest to
the issue. The preferred method for this is Five Whys. The result is
added to the CAPA list.
| QMO |
| Other people in company (optional) |
| CAPA |
CAPA, updated with root cause |
4. Implementation of Action
The QMO coordinates defining and implementing corrective and
preventive action. Additionally, the QMO takes into account adverse
negative implications and verifies that the actions do not adversely
affect the ability to meet applicable regulatory requirements or the
safety and performance of the medical device. Outcomes are documented in
the CAPA list.
| QMO |
| Other people in company (optional) |
| CAPA |
CAPA, updated with action plan |
5. Verification and
Check of Effectiveness
The QMO conducts the verification and effectiveness review of the
implemented action. These are defined as below. Thereafter, the QMO
closes the CAPA.
- Verification: Documenting proof of implementation of actions
taken.
- Effectiveness: Review of the effectiveness of actions taken.
| CAPA |
CAPA, updated with verification, effectiveness review, closed
date |
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