Learn how to use a systematic and structured approach to design and implement corrective and preventive actions (CAPAs) for SOP deviations and exceptions.

Actually I disagree with the "continuous update of a CAPA to reflect any changes or improvements". Reviewing and updating all SOPs to reflect changes in the system should be an integral part of the Quality System. This should be performed on at least a bi-annual basis. Once a CAPA is Closed and an Improvement has been noted; the Improvement(s) should be documented separately from the CAPA, implemented and monitored. The Improvements should be a part of the Management Review Meeting and made available to the users and stakeholders.

How do you design and implement corrective and preventive actions (CAPAs) for SOP deviations and exceptions?

Standard operating procedures (SOPs) are essential for ensuring quality, consistency, and compliance in any organization. However, sometimes deviations and exceptions may occur, which can compromise the effectiveness and reliability of the SOPs. Deviations are unplanned or unintentional departures from the SOPs, while exceptions are planned or authorized changes to the SOPs. Both deviations and exceptions require corrective and preventive actions (CAPAs) to address the root causes, prevent recurrence, and improve the SOPs. In this article, you will learn how to design and implement CAPAs for SOP deviations and exceptions using a systematic and structured approach.

1 Identify and document

The first step in designing and implementing CAPAs is to identify and document the deviation or exception. You need to record the details of what, when, where, how, and why the deviation or exception occurred, as well as who was involved and what was the impact. You also need to classify the deviation or exception according to its severity, frequency, and risk. This will help you prioritize and assign the CAPAs accordingly. You should use a standardized form or template to document the deviation or exception and ensure that it is reviewed and approved by the appropriate authority.

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Sara Webster

Director Quality |Regulatory
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At this point you should identify if there is an immediate impact to any current product or process in the field that may put the consumer at risk; and determine how to mitigate this. This is crucial before starting the Root Cause portion of the CAPA.

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2 Analyze and determine

The second step in designing and implementing CAPAs is to analyze and determine the root cause and the corrective action for the deviation or exception. You need to use a suitable method or tool, such as the 5 Whys, fishbone diagram, or Pareto chart, to identify the underlying factors and sources of the deviation or exception. You also need to evaluate the effectiveness and feasibility of the potential corrective actions, such as retraining, rework, revision, or recall. You should select the most appropriate and proportionate corrective action that can eliminate or minimize the root cause and prevent recurrence.

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3 Plan and execute

The third step in designing and implementing CAPAs is to plan and execute the corrective action for the deviation or exception. You need to define the scope, objectives, responsibilities, resources, timeline, and measures of the corrective action. You also need to communicate and coordinate with the relevant stakeholders, such as the process owners, operators, customers, suppliers, or regulators, to ensure alignment and support. You should follow the SOPs or work instructions for executing the corrective action and document the results and outcomes.

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Arleen Candari

VP, Business Development, AVS Life Sciences Founder of C&A Consulting, LLC
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In my experience with a major CAPA I've managed, during the Plan and Execute stage it's imperative the proper players are identified and engaged long before execution of the corrective/preventive actions. Depending on the scope of the deviation or exception, often times your Global Partners and CMOs can be affected as well.

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4 Verify and evaluate

The fourth step in designing and implementing CAPAs is to verify and evaluate the effectiveness and sustainability of the corrective action for the deviation or exception. You need to monitor and measure the performance indicators, such as quality, productivity, customer satisfaction, or compliance, to determine if the corrective action has achieved the desired results and resolved the issue. You also need to conduct audits, inspections, or reviews to verify if the corrective action has been implemented correctly and consistently. You should document the findings and feedback and report them to the appropriate authority.

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5 Prevent and improve

The fifth step in designing and implementing CAPAs is to prevent and improve the SOPs based on the lessons learned from the deviation or exception. You need to identify and implement the preventive actions, such as updating, standardizing, simplifying, or optimizing the SOPs, to avoid or reduce the likelihood of similar deviations or exceptions in the future. You also need to share and disseminate the best practices, recommendations, or suggestions for improving the SOPs across the organization. You should document the changes and improvements and ensure that they are reviewed and approved by the appropriate authority.

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6 Maintain and monitor

The final step in designing and implementing CAPAs is to maintain and monitor the SOPs and the CAPAs on a regular basis. You need to ensure that the SOPs and the CAPAs are compliant with the applicable regulations, standards, or guidelines. You also need to ensure that the SOPs and the CAPAs are accessible, available, and understandable for all the users and stakeholders. You should conduct periodic training, refresher, or awareness sessions for enhancing the knowledge and skills of the users and stakeholders. You should also review and update the SOPs and the CAPAs as needed to reflect any changes or improvements.

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Sara Webster

Director Quality |Regulatory
Report contribution
Actually I disagree with the "continuous update of a CAPA to reflect any changes or improvements". Reviewing and updating all SOPs to reflect changes in the system should be an integral part of the Quality System. This should be performed on at least a bi-annual basis. Once a CAPA is Closed and an Improvement has been noted; the Improvement(s) should be documented separately from the CAPA, implemented and monitored. The Improvements should be a part of the Management Review Meeting and made available to the users and stakeholders.

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7 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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How do you design and implement corrective and preventive actions (CAPAs) for SOP deviations and exceptions?

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1 Identify and document

2 Analyze and determine

3 Plan and execute

4 Verify and evaluate

5 Prevent and improve

6 Maintain and monitor

7 Here’s what else to consider

SOP Development

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