Corrective and preventive action (CAPA) can be viewed differently by employees within pharmaceuticals and medical device companies. Some see CAPAs as simply an onerous task given to them to complete in order to “stay compliant,” while others look at CAPAs as simply a number based metric that needs to be reduced. However, the best view of CAPAs is as a complete system with a lifecycle made up of phases. The CAPA system should not be viewed as simply the required outcome of a deviation or event, but instead, a beginning to end system that not only provides the tools for the identification, evaluation, and investigation of a deviation, but also the tools to determine, implement, and check effectiveness of a resolution. It is clear that CAPA and its associated tools is the mechanism that enables a quality system to be “self-correcting.” Using this phase-based system will provide a systematic approach to review the Quality system data. Benefits of this approach include:
• Assurance that quality issues are resolved
• Rework and scrap numbers are reduced
• Customer complaints are reduced
• Promotion of continuous improvement
• An aligned method for problem solving
• Regulatory requirements are met
• Business needs are met
It is important that all levels of employees from senior management to floor personnel understand the phase-based system of CAPA and its importance in order for the system to be effective. Although personnel might not see the entire picture from start to finish, it is important that everyone understands each phase is part of a complete system that works together to resolve unexpected events.
Identification is the first phase of the CAPA system and sets the foundation. It should include the following elements:
• What is involved? (e.g., product, equipment, line, etc)
• What is the event? (e.g., what happened?, what should have happened?)
• Where is the event observed? (e.g., room or line number, business unit, etc)
• When did the event occur? (e.g., time, date, etc)
The Identification phase simply collects the information from the event. It should not focus on asking “who?” as this type of question can lead to placing blame rather than identifying the true root cause. The “why?” questions will be utilized during the investigation phase.
The second phase of the CAPA system is the Evaluation phase. This phase is important because it will bracket what is, and is not, affected by the event. Examples of questions to ask include:
• “Does this impact customer safety?”
• “Does this impact regulatory documents?”
• “Does this impact documentation or product design?”
• “Does this impact materials or product performance?”
• “Has this event occurred before?”
Answers to these questions and others will provide the basis of the impact assessment of the event. The impact assessment can then be used to assign a level to the event (high, medium, low) and will provide a data point to use in tracking and trending.
Once the event has been identified and evaluated, it can be investigated. Investigation is the third element in the CAPA system and is used to determine the root cause as well as identify corrective actions. A broad approach should be used to investigate all areas of potential root cause (e.g., equipment, documentation, environment, personnel, materials, or other). It is important to remember, although the goal is to determine a single root cause, some investigations may have either an unidentifiable root cause or multiple root causes. In each case, justification is needed for final conclusions. Appropriate resolutions should also be identified in response to each root cause identified.
Determination of Resolution Plans is the fourth step in the CAPA system and can be divided into three main categories:
1. Correction: a fix to a problem that already exists (e.g., equipment repair, clearance of a jam). This kind of resolution usually occurs right after the event is identified in order to correct the immediate problem. Not all events will have corrections.
2. Corrective Action: a fix to prevent the reoccurrence of a problem (e.g., SOP update, revised training, addition of controls to a system). This kind of resolution will address the root cause identified in the investigation.
3. Preventive Action: a fix to prevent the occurrence of a problem (e.g., change in line software, update to electronic controls). This kind of resolution usually involves an engineering change that will prevent the problem from ever occurring in the future.
The most effective resolution plans are usually identified with input from a cross-functional team that will provide multiple perspectives. Input will also be needed to determine the impact of the actions proposed to all affected departments.
Once Resolution Plans are identified, they must be completed in a timely manner. Implementation is the fifth phase of the CAPA system and will also require teamwork depending on the scope of the resolutions. All activities related to the Resolution Plan must be documented and supported by objective evidence. These results must also be reviewed and approved by appropriate Quality management to ensure compliance.
The last step of the CAPA system is the effectiveness check. Each corrective and preventive action should have a documented effectiveness check to ensure the action is appropriate for the root cause and prevents events in the future. Timing should be taken into consideration when determining effectiveness checks to ensure the resolution plan has been adequately completed and is functioning. Examples of effectiveness checks include:
• review of event data over time to ensure reoccurrence is avoided,
• conducting audits of affected products, materials, or equipment to ensure the issue is resolved,
• establishing a minimum acceptable level prior to implementation of the Resolution Plans and comparing these levels after implementation of the actions
A phase-based approach to CAPA is the best way to ensure that events are dealt with in a timely and quality manner. Using risk management with each of these phases will also ensure that the process is completed in an efficient manner from both the Quality and business aspects. This “complete system” approach to CAPA will provide the means to include continuous improvement in all aspects of the business.
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