How do you manage changes and risks during CAPA verification and validation?

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Corrective and preventive action (CAPA) is a systematic process of identifying, analyzing, and resolving problems that affect product quality and customer satisfaction. CAPA verification and validation are two essential steps to ensure that the implemented actions are effective and compliant with the applicable standards and regulations. However, managing changes and risks during these steps can be challenging and require careful planning and monitoring. In this article, you will learn some tips and best practices to manage changes and risks during CAPA verification and validation.

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1 Define the scope and criteria

Before you start verifying and validating your CAPA actions, you need to define the scope and criteria of your verification and validation activities. The scope should specify what aspects of the CAPA actions you will verify and validate, such as the root cause analysis, the action plan, the implementation, the results, and the documentation. The criteria should define the standards, regulations, and expectations that you will use to evaluate the effectiveness and compliance of the CAPA actions. Defining the scope and criteria will help you focus your efforts and avoid unnecessary or redundant activities.

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Scott Schneeloch

Leader | Manufacturing | Supply Chain | Cost Reduction | Continuous Improvement | Safety & Morale
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The description of the problem should be concise but contain sufficient information to ensure that the problem is easily understood when read.

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2 Plan the methods and resources

Once you have defined the scope and criteria, you need to plan the methods and resources that you will use to verify and validate your CAPA actions. The methods should be appropriate for the type and complexity of the CAPA actions, such as testing, inspection, audit, review, or simulation. The resources should include the personnel, equipment, materials, data, and time that you will need to perform the verification and validation activities. Planning the methods and resources will help you ensure that you have the necessary capabilities and availability to conduct the verification and validation effectively and efficiently.

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Scott Schneeloch

Leader | Manufacturing | Supply Chain | Cost Reduction | Continuous Improvement | Safety & Morale
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The investigation procedure must incorporate a comprehensive review and analysis of all circumstances relating to the problem.

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3 Communicate and document the changes

During the verification and validation process, you may encounter changes that affect your CAPA actions, such as new information, feedback, deviations, or errors. You need to communicate and document these changes promptly and clearly to all the relevant stakeholders, such as the CAPA team, the management, the customers, and the regulators. You also need to update your CAPA records, such as the action plan, the implementation report, the verification and validation report, and the closure report. Communicating and documenting the changes will help you maintain transparency and traceability of your CAPA actions and avoid confusion or miscommunication.

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Arleen Candari

VP, Business Development, Automation and Validation Solutions (AVS) Founder of C&A Consulting, LLC
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A proper Quality Change Control program that manages, identifies, assesses and documents any changes that occur with your GMP validated systems during a CAPA is imperative. It is not uncommon to have a CAPA that kicks off several change orders that must be managed and approved by appropriate quality personnel.

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Scott Schneeloch

Leader | Manufacturing | Supply Chain | Cost Reduction | Continuous Improvement | Safety & Morale
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All modified documents and/or other specifications should be listed, and any modifications should be communicated to affected personnel and departments. Typically, the documentation will be attached to a final printed report of this CAPA action to help facilitate verification of changes.

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4 Assess and mitigate the risks

Another challenge that you may face during the verification and validation process is the identification and management of risks that may affect your CAPA actions, such as delays, failures, non-conformities, or adverse effects. You need to assess and mitigate these risks systematically and proactively, using tools such as risk matrices, FMEA, or SWOT analysis. You also need to monitor and control the risks throughout the verification and validation process, using tools such as risk registers, dashboards, or action logs. Assessing and mitigating the risks will help you prevent or minimize the negative impacts of your CAPA actions and ensure their safety and quality.

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Scott Schneeloch

Leader | Manufacturing | Supply Chain | Cost Reduction | Continuous Improvement | Safety & Morale
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The resulting documentation should address all previously determined possible causes, as it will be used to determine the root cause of the problem. Identifying and documenting the root cause is essential for determining the appropriate corrective and/or preventive actions that must be taken.

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5 Review and approve the results

The final step of managing changes and risks during CAPA verification and validation is to review and approve the results of your verification and validation activities. You need to compare the results with the predefined criteria and evaluate whether they meet or exceed your expectations and requirements. You also need to verify whether all the changes and risks have been communicated, documented, assessed, and mitigated adequately and appropriately. You then need to obtain the approval of the authorized personnel, such as the CAPA owner, the quality manager, or the regulatory body, to confirm that your CAPA actions are effective and compliant.

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Scott Schneeloch

Leader | Manufacturing | Supply Chain | Cost Reduction | Continuous Improvement | Safety & Morale
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The implementation and completion of all changes, controls and training, etc., should be verified, and the evidence of these actions' completion should be recorded. Moreover, in verifying the effectiveness of the actions taken, a comprehensive evaluation should be done to ensure the following: the root cause of the problem has been solved; any resulting secondary situations have been corrected; proper controls have been established; adequate monitoring of the situation is in place; and any adverse effects of the actions taken are resolved. This investigation and its results should be documented.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Scott Schneeloch

Leader | Manufacturing | Supply Chain | Cost Reduction | Continuous Improvement | Safety & Morale
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For regulated companies across the globe, an effective CAPA process can be instrumental in identifying and correcting issues and preventing their recurrence in a quality system. Meeting risk-based CAPA requirements today demands a complete CAPA process - from identifying the problem through successful completion.

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How do you manage changes and risks during CAPA verification and validation?

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1 Define the scope and criteria

2 Plan the methods and resources

3 Communicate and document the changes

4 Assess and mitigate the risks

5 Review and approve the results

6 Here’s what else to consider

Corrective and Preventive Action (CAPA)

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