WI-09 Corrective and Preventive Action (CAPA)
Work Instruction for Corrective and Preventive Action (CAPA)
1. Introduction
1.1. Purpose
This Work Instruction provides the tasks required to be performed as part of the CAPA Item lifecycle.
A CAPA process is a systematic approach to identifying, investigating, and addressing issues that arise during the design, manufacture, and use of medical devices. The goal of a CAPA process is to prevent or correct problems that could affect the safety, effectiveness, or quality of a medical device.
1.2. Scope
This Work Instruction covers the complete CAPA lifecycle. Records for each CAPA will be held based on the records and retention policy.
1.3. Records and evidence
Records for each CAPA will be held based on the records and retention policy. CAPAs are used to generate the following artifacts:
Change management file
Change request verification report
Test Plan
1.4. Definitions and Acronyms
CAPA: Corrective and Preventive Action
Corrective Action: Action taken to eliminate the causes of non-conformities or other undesirable situations, to prevent a recurrence
Preventative Action: Action taken to prevent the occurrence of such non-conformities, generally as a result of a risk analysis.
1.5. Responsibilities
As listed in 2.1 in the procedure description, each task in the CAPA item’s lifecycle will be completed by a member that is part of one of the following approval steps. When anyone of these members can perform the task, Anyone is listed.
Item Assignee: The person responsible for the CAPA. This organization member is responsible for managing/completing the CAPA lifecycle activities. This Item Assignee can change from time to time.
Product Manager: The person accountable for the CAPA. This organization member leads the product development, defines requirements, and ensures that the product meets customer demands. The Product Manager is accountable for the requirement being correct.
Quality Manager: The person that verifies the CAPA is correctly documented. The Quality Manager is consulted to approve that the CAPA is correctly documented.
R&D Lead: The person that verifies the CAPA is executable. The R&D Lead is consulted to approve that the CAPA is actionable.
2. Procedure description
2.1. Step 1: Log into Jira
Anyone
Log into your Jira organization, e.g., your-company.atlassian.net.
2.2. Step 2: Create
Anyone
Make sure to set the Introduced in version to the version that will include the described changes.
Draft the template, adding information as needed. The only required field is the Summary, marked by a red asterisk (*).
2.3. Step 3: Navigate to the issue page
Anyone
Using the popover shown by Jira or through other means, navigate to the Jira page of the CAPA.
2.4. Step 4: Change status to In Progress
Anyone
Select the Status button
2.5. Step 5: Identify the non-conformity
Item Assignee
The first step in the CAPA process is to identify the non-conformity(s) (i.e., Anomaly or Complaint) and document the issue that needs to be addressed. Once identified, the CAPA should be entered into the Anomaly or Complaint Resolved by fields.
2.6. Step 6: Perform Root Cause Analysis
Item Assignee
Investigate the issue: Once the issue has been identified, it is important to investigate it thoroughly to understand the root cause of the problem. This may involve reviewing relevant documentation, conducting interviews with individuals involved in the issue, and gathering additional information as needed.
During RCA, ensure that proper subject matter experts (e.g., Cloud R&D, AI Validation) are part of the analysis.
Put the findings into the Root Cause Analysis field.
Fill in the Affected items
2.7. Step 7: Plan Corrective Action
Item Assignee
The next step is to determine a corrective action that will address the problem. This may involve changing the design or manufacturing process, implementing new training or procedures, or taking other steps to prevent the issue from occurring again.
Put the findings in the Corrective Action field.
2.8. Step 8: Plan Preventive Action
Item Assignee
Determine the preventive actions to prevent the recurrence of a nonconformance that has been identified and addressed through corrective action.
Put the findings in the Preventive Action field.
2.9. Step 9: Implement Corrective and Preventive Action
Item Assignee
Once a corrective action has been determined, it is important to implement it promptly and effectively. This may involve changing the design or manufacturing process, implementing new training or procedures, or taking other steps to prevent the issue from occurring again.
2.10. Step 10: Monitor the effectiveness of the corrective action
Item Assignee
After the corrective action has been implemented, it is important to monitor its effectiveness to ensure that it is addressing the issue in an effective manner. This may involve collecting data, conducting inspections or audits, or taking other steps to ensure that the corrective action is working as intended.
2.11. Step 11: Change status to Resolved
Item Assignee
Make sure that all corrective actions have been implemented, and the monitoring ensures that all actions are addressing the issues before proceeding to resolve and review the ticket.
Select the Status button.
2.12. Step 12: Review as Owner
Item Assignee
Read through the CAPA, verify the RCA, corrective and preventive action was performed correctly, that it is completely fixed by the suggested changes, and that those changes are implemented.
Find the Approvals widget.
2.13. Step 13: Review as R&D Lead
R&D Lead
Read through the CAPA, review the RCA, corrective and preventive action was performed correctly, that it is completely fixed by the suggested changes, and that those changes are implemented.
Find the Approvals widget.
2.14. Step 14: Review as Quality Manager
Quality Manager
Read through the CAPA, review the RCA, corrective and preventive action was performed correctly, that it is completely fixed by the suggested changes, and that those changes are implemented.
Find the Traceability widget.
Ensure the Traceability widget shows a related Test Case that tests for the implemented corrective and preventive actions.
Find the Approvals widget.
2.15. Step 15: Review as Product Manager
Quality Manager
Read through the CAPA, review the RCA, corrective and preventive action was performed correctly, that it is completely fixed by the suggested changes, and that those changes are implemented.
Find the Approvals widget.
2.16. Step 16: Transition to a controlled state
Ketryx
Only Ketryx can move a CAPA to a controlled and effective state by transitioning its status to Closed. Ketryx moves the CAPA to a Closed state after all approval rules have been passed, i.e., all required steps have approved the CAPA.
Ketryx automatically adds a comment to the Jira issue, with a link to the effective controlled record in Ketryx.
2.17. Step 17: Change status to Reopened
Anyone
If a CAPA needs to be reopened:
Select the status button.
Go back to Step 3.
3. Procedure flow diagram
4. Item schema
Description (rich text)
Root cause analysis (rich text): Description of the root cause following an investigation.
Corrective actions (rich text): Actions to correct the existing product nonconformity or quality problems.
Preventive actions (rich text): Actions to prevent the recurrence of the problem.
Reporter type: Source of this issue.
Internal
External
Affected items (-> Requirement, Software Item Spec, Hardware Item Spec, Test Case, Risk, Configuration Item, CAPA, Anomaly, Change Request): Items affected by this change or issue.
New items (-> Requirement, Software Item Spec, Hardware Item Spec, Test Case, Risk, Configuration Item, CAPA, Anomaly, Change Request): Items resulting from this change.
5. Traceability to other configuration items
The following relations can be defined from a CAPA to other configuration items:
CAPA affects CAPA, Change Request, Anomaly, Configuration Item, Risks, Hardware Item Spec, Requirement, Software Item Spec
CAPA results in CAPA, Software Item Spec, Change Request, Anomaly, Requirement, Risks, Hardware Item Spec, Configuration item
The following relations can be defined from other configuration items to a CAPA:
CAPA is implemented by Task
CAPA is affected by CAPA, Change Request, Anomaly
CAPA is tested by Test Case
CAPA results from Change Request, CAPA
CAPA resolves Anomaly, Complaint
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