Department | Quality Management | Document no | QMS-175 | ||
Title: Corrective and Preventive Action | |||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
A. PURPOSE
To define the process for control of non-conformance/deficiencies or quality problems that require corrective and preventive action (CAPA).
B. SCOPE
The process applies to identified product, process or system non-conformities. Issues may be identified during manufacture, product reviews, recurrent deviations, customer complaints, and internal or external audits. The procedure applies to all GMP manufacturing sites.
This procedure does not apply to non-conformities identified by third-party suppliers. Corrective actions that have been identified through change control will be managed using the change control system.
C. RESPONSIBILITY
1. Quality Assurance / Compliance Manager (or delegate)
– Approves or rejects proposed CAPA
– Review documented root cause and CAPA plan for approval.
2. Quality Assurance Associate
– Allocates CAPA number
– Facilitate the preparation and implementation of CAPA plans
– Track all CAPAs to completion.
– Initiates follow–up verification of completed CAPA for effectiveness check.
– File and maintain all CAPA documentation
3. Quality Assurance Associate (auditor)
– Performs follow-up verification of completed CAPA.
4. Department Manager (or delegate)
– Participate in review or respond to CAPA when requested
– Perform risk assessment if required
– Investigate potential causes of non-conformance.
– Assist in the implementation of the CAPA.
5. Personnel
– Report problems or non-conformance to QA on the CAPA form
D. SAFETY AND PROCESS SPECIFIC INFORMATION (if applicable)
1. Safety
– All safety requirements for relevant areas at any GMP facility must be followed at all times.
E. DEFINITIONS
1. Corrective Action
To prevent a recurrence, action is taken to eliminate the root cause(s) and symptom(s) of an existing undesirable deviation or non-conformity.
2. Nonconformity
A deviation that may cause a product, process, environment or system not to meet specified requirements.
3. Remedial Action
Action is taken immediately to resolve a problem.
4. Preventative Action
An action is taken to eliminate a potential non-conformance and / or re-occurrence.
5. Objective Evidence
Verifiable qualitative or quantitative information, observations, records or statements of fact pertaining to the quality of the product, process or system.
6. Root Cause
A fundamental deficiency that results in a nonconformance that must be corrected to prevent the recurrence of the same or similar nonconformance.
F. PROCEDURE – CAPA IDENTIFIED INTERNALLY
1. Requesting a CAPA
1.1. Any staff member may report a potential or actual problem or nonconformance by completing Section 1 of the CAPA form (Appendix 1). Issues may be identified through
– Internal audits
– Product quality complaints or adverse events
– Recall of product
– Product reviews
– Repeat deviations indicating a systemic problem
– Manufacturing concerns
1.2. If an internal audit finding is complex and cannot be closed within 30 calendar days, a CAPA must be opened to track the resolution.
1.3. Submit the completed form to the QA Associate for review.
1.4. If the problem relates to a defective item, submit the item with the CAPA form (Appendix 1).
2. Quality Assurance Review
2.1. The QA Associate liaises with the QA Manager (or delegate), who will determine if the CAPA is appropriate and accept or reject the CAPA.
2.2. The QA Manager (or delegate) will document the rationale for any rejections on the CAPA form.
2.3. The QA Manager will notify the originator if a request has been rejected, providing the rationale.
2.4. The QA Associate files the rejected CAPA.
2.5. If the CAPA is approved, the QA Manager documents any immediate action required with a completion date on the CAPA form (Appendix 1).
2.6. The QA Manager determines the responsible department and notifies the Manager. This is documented on the CAPA form.
2.7. The QA Associate takes a copy of the CAPA form and enters details in the CAPA tracker.
2.8. The QA Associate will notify the originator of the CAPA regarding the outcome of their request and who will be responsible for completion.
3. Responsible Department Action
3.1. The responsible department manager (or delegate) must implement any immediate action within the timeframe stipulated on the CAPA form.
3.2. The department manager determines the root cause (QMS-140 Root Cause Analysis Investigation Procedure) and performs a risk assessment.
3.3. A corrective action plan is developed in consultation with QA to eliminate the root cause and prevent recurrence. The plan must include a date for completion.
4. CAPA implementation
4.1. The responsible department manager implements the CAPA plan within the prescribed timeframe.
4.2. Any changes to procedures or processes must be documented and recorded on the CAPA form.
4.3. Communication and training of the changes are performed and documented.
4.4. The responsible department manager (or delegate) collates all objective evidence of completion and attaches it to the CAPA form.
4.5. The CAPA form is signed and dated before being forwarded to the QA Associate.
5. CAPA Follow-up Verification
5.1. The QA Associate assesses the documentation and ensures the objective evidence is complete
5.2. The QA Associate verifies that the corrective or preventative action is effective.
5.3. If the actions are determined to be ineffective, the responsible department manager is notified, and a new plan is devised.
5.4. Once verification of effectiveness is complete, the CAPA form is signed to show completion.
5.5. The QA Associate notifies the responsible department manager and the originator.
5.6. The CAPA tracker is updated to reflect the status of the CAPA as closed.
5.7. All documentation is filed in QA records.
6. CAPA Awareness
6.1. The nature and status of CAPA are reported to site management through the monthly Site Quality Council meetings.
H. PROCEDURE – CAPA IDENTIFIED THROUGH EXTERNAL AUDIT
1. Tracking CAPA
1.1 The QA Associates prepare a tracking spreadsheet for all non-conformances identified in the formal audit report issued by the regulator.
1.2 The QA Manager (or delegate) convenes a meeting of all managers responsible for closure of non-conformance within 3 working days of receipt of the report.
1.3 Action plans are developed for each nonconformance and will include:
– Person responsible
– Date for completion
– Objective evidence required
The QA Manager will convene weekly meetings to ensure all non-conformances are closed within predetermined timeframes.
I. REVISION HISTORY
Date | Replaces | Writer | Role | Change | Reason for change |