CAPA

Corrective Action
• Corrective action is aiming to correct an existing non-conformity and to avoid reoccurrence of the same non-conformity.
• Corrective action may arise e.g. from manufacturing deviations, OOS investigations, complaints, audit findings, recalls.
• A systematic investigation should be performed to determine the reason(s) for the non-conformities and to agree upon appropriate corrective action.
• Agreed corrective actions should be closely followed-up and monitored until their completion.
• In the frame of the management review, management should be notified about the costs and impact of failure including the respective corrective actions.

Preventive Action
• Preventive action is aiming to avoid the initial occurrence of a non-conformity by proactively implementing improvements.
• Preventive action may result i.e. from trending of in process data, of analytical data, of audit findings, trending of root causes for non-conformities or complaints, from product quality reviews(annual product reviews), quality risk analyses, etc.
• Similar to corrective actions, agreed preventive actions should be closely followed-up and monitored until their completion. Effectiveness of preventive actions should be reviewed regularly, i.e. as part of the product quality review (annual product review).
• Information regarding preventive actions including costs and cost savings should be regularly subject to management review in support of maintaining and improving the effectiveness of the Quality Management System.

CAPA Process
1. Identification: Define the problem
2. Impact / Risk Assessment: Initial assessment of the impact and the magnitude of the problem.
3. Immediate Action: Protect the customer from the problem.
4. Root Cause Investigation: Identify the root cause of the problem by using a systematic approach.
5. Conclusion and Quality Decision: Final thorough conclusion on the impact and magnitude of the problem, decision regarding the use of the product, etc.
6. Action Plan: Define corrective and preventive actions.
7. Implementation and Follow-up: Implement corrective and preventive actions and verify their effectiveness (global approach).

1. Identification
To enable an efficient root cause investigation, the problem has to be clearly defined.
• Collect all available information, ask questions: Who, when, what, why, how
• Summarize the problem in a detailed and concise description.

2. Impact / Risk Assessment
The problem must be evaluated to determine the need for immediate, corrective and preventive actions and the level of action required, based on the impact and risk of the problem.
The evaluation should include:
• Potential Impact of the problem.
• Risk to its customers and/or the company (i.e. risk to the patient related to the quality, efficacy or safety of the product; risk for the reputation of the company; risk of adverse regulatory actions; financial risk)
• Immediate action that may be required

3. Immediate Action
Immediate action is necessary, when the quality, efficacy or safety may be compromised by the problem.

4. Root Cause Investigation
A systematic approach should be applied to ensure that no potential root cause is lost through focusing only on a few assumed root causes. Tools can be applied to facilitate the investigation.

5. Conclusion and Quality Decision
• Summarize the identified root cause(s).
• Summarize the impact and the risk for the customer and/or company.
• Document the quality decision, i.e.
– No impact of the deviation on the product quality, efficacy or safety – product can be released.
– Product is rejected due to major impact of the failure on product quality.
– Product is recalled.

6. Action Plan
• Based on the result of the root cause analysis, all tasks required to correct the problem and prevent a reoccurrence are identified and included in an action plan.
• The plan assigns responsibilities and due dates for implementation.
• Enough detail must be included regarding the required action and হthe expected outcome.
• Pay attention on correct order of activities.

7. Implementation and Follow-up
• The Action Plan is executed and all tasks are completed.
• The actions that were taken are documented.
• The appropriateness and effectiveness of the actions taken is
evaluated:
– Have all recommended changes been completed and verified?
– Have all objectives been met?
– Has training been performed to ensure that all affected employees understand the changes that have been made?
– Was an assessment made that the actions taken have not had an adverse effect on other properties or aspects of a product or process.
• Closure of CAPA after successful implementation.

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