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A robust CAPA SOP ensures proactive issue resolution and regulatory alignment, driving continuous improvement in quality processes. Thought leadership in CAPA emphasizes strategic data analysis and cross-functional collaboration for sustained operational excellence.
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Quality and Compliance are critical in life sciences industries such as pharmaceuticals and medical devices. One of the key factors in ensuring this quality and compliance is Corrective and Preventive Action(CAPA). This helps correct deviations and nonconformances and prevent future occurrence or recurrence of such deviations.
Request an Online DemoCAPA is a very detailed process requiring cross-functional expertise and collaboration. Therefore, it needs a platform that combines the different teams and a standard operating procedure or SOP to ensure its effectiveness. It ensures that all stakeholders involved in the process have a uniform understanding of the requirements, processes, and outcomes.
To follow the right procedures, every organization with a robust CAPA needs a SOP Template. This helps with approaching CAPA correctly, effectively, and efficiently.
CAPA or corrective action preventive action requires the effective identification, investigation, and resolution of issues. The template enables this by:
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The purpose of a CAPA Sop is to ensure that all deviations are:
When a deviation occurs, the tendency may be to implement a corrective action with a short-term benefit. But, if it recurs, it needs to be reported and further investigation conducted using root cause analysis.
Some of the root cause analysis tools include:
These help in determining what the real cause is. For instance, there may be a deviation due to faulty machinery. Calibrating the machine will help. However, if the issue stems from the machinist's inexperience and improper usage, there's a likelihood of the problem resurfacing. The subsequent action would involve providing training to the machinist. Nevertheless, if the lack of training results from the organization's failure to identify skill gaps accurately and deliver training accordingly, the problem is likely to reappear when a new machinist takes over. Investigating the situation further will help identify if there are any systemic issues that require a more lasting solution to prevent the problem's recurrence.
After the solution is incorporated, users must track and monitor its effectiveness to ensure it produces the desired outcomes.
Step 1: Defining the problem: In problem-solving, it is critical to identify the problem correctly. Therefore, asking the right questions to determine the true nature of the problem its history, and define it will be necessary to allow the right solution.
Some questions to be asked and answers recorded are:
Step 2: Addressing the Issue: CAPA is not always to be implemented. The gravity of the issue must be assessed and scoped out before deciding to take the CAPA route. The first step if an issue happens is to implement a correction to contain it and minimize damage.
Assessing the issues is aided by questions such as:
A unique ID must be assigned for easy tracking if the need for CAPA is indicated.
Step 3: Investigating the Issue: Once it is established that the immediate action is insufficient, an investigating team must undertake a root cause analysis. One of the tools mentioned above can be used for the team to brainstorm and assess the real cause of the issue.
Step 4: Preparing the Action Plan: When the root cause, or causes, are evident, identifying the appropriate solution becomes more straightforward. Multiple solutions may exist, and each should be assessed for its feasibility and effectiveness in implementation. Therefore, listing the action plans and justifying each based on predetermined parameters will help identify the best-fit solution.
Step 5: Implementing the Action Plan: After finalizing the corrective and preventive action plans, the subsequent step involves their execution. Precisely delineating the roles and responsibilities of the teams engaged in the implementation process, along with the specific objectives to be attained, will enhance the likelihood of their effectiveness.
Step 6: Tracking and Measuring: At the time of deciding the action plan, it will also help to establish metrics to measure success. This helps in tracking progress and mid-course correction in case of any issues.
Ensure that your CAPA SOP includes
Some of the triggers for CAPA would be:
To ensure the effectiveness of the CAPA SOP, ensure the following:
A CAPA form is a record of the issue, the processes followed to address it, and its effectiveness. Therefore, creating a form to simplify recording the details is good. Give it thought and design it before writing the procedures.
Centralizing the CAPA implementation is crucial for visibility and transparency. It will help with risk assessment, Change Management, and measuring the effectiveness of the implemented solution.
To successfully design CAPA procedures, experts in the various relevant departments must be consulted to understand their process flows. It will also be important to understand how a corrective or preventive action affects the workflows.
The current good manufacturing practice (cGMP) holds the quality department responsible for implementing the quality system in an organization. Therefore, the quality department must review and approve the final CAPA procedure draft.
CAPA form must synchronize with the CAPA procedure and be a realistic representation of the CAPA procedure outlined initially.
CAPA may be triggered based on inputs from multiple sources. These include
Customer Complaints
Feedback and complaints provide inputs for constantly improving products and processes. An investigation must be initiated to assess if it is a problem with one unit, a batch, or the product type, and action must be initiated accordingly
Nonconformance
A deviation from specifications needs to be analyzed and addressed. This is a proactive measure as the nonconformance is caught before it is despatched for delivery. Future issues must be avoided to reduce wastage and scrapping.
Production & Process Controls
Production and process controls are documented steps mandated to manufacture medical devices. This ensures conformity to specifications for making the product safe and performs as expected, including software as a medical device (SaMD) product. Any issue must be identified during production and addressed immediately. It must be evaluated for triggering CAPA.
Supplier
Ensuring the raw materials from suppliers meet the requirements is critical as input equals output. In case of any nonconformance, the CAPA procedure must be triggered.
Audits
Audits and inspections are mandated by regulatory bodies and help manufacturers with a proactive culture of quality. It helps identify potential issues and implement preventive action to eliminate product and process issues.
Management Reviews
Management reviews enable the executive leadership to evaluate the effectiveness of the quality management system and decide when CAPA is needed to set potential issues right.
Customer Complaints
Feedback and complaints provide inputs for constantly improving products and processes. An investigation must be initiated to assess if it is a problem with one unit, a batch, or the product type, and action must be initiated accordingly
Nonconformance
A deviation from specifications needs to be analyzed and addressed. This is a proactive measure as the nonconformance is caught before it is despatched for delivery. Future issues must be avoided to reduce wastage and scrapping.
Production & Process Controls
Production and process controls are documented steps mandated to manufacture medical devices. This ensures conformity to specifications for making the product safe and performs as expected, including software as a medical device (SaMD) product. Any issue must be identified during production and addressed immediately. It must be evaluated for triggering CAPA.
Supplier
Ensuring the raw materials from suppliers meet the requirements is critical as input equals output. In case of any nonconformance, the CAPA procedure must be triggered.
Audits
Audits and inspections are mandated by regulatory bodies and help manufacturers with a proactive culture of quality. It helps identify potential issues and implement preventive action to eliminate product and process issues.
Management Reviews
Management reviews enable the executive leadership to evaluate the effectiveness of the quality management system and decide when CAPA is needed to set potential issues right.
When an issue occurs, it needs to be contained and damage minimized. For instance, if there is a fire at a site, the first immediate corrective action is to put it out and save the workers and assets. This is a trigger reaction in response to the situation as it unfolds.
While this is an essential step, it may be insufficient. Therefore, the management must use data from the site to assess if the fire was a one-time event, if the cause of the fire was an unusual happening or a potential risk that had been ignored and needs CAPA to prevent future recurrence. For, the fire may have occurred only that one time. But there could be triggers such as cluttered workspace, inflammable materials kept unsafely, and other potential causes that need an investigation and a decision on whether it needs CAPA.
Since there can be more than one cause for an issue, the solutions may be multifold and involve multiple teams. The quality and safety teams, the engineering teams, the HR, and so on may have to modify processes or introduce checks and measures to mitigate risks.
Once the different action plans have been identified, they must be evaluated to choose the best fit for ease of use and effectiveness in addressing the issue. Also, there are two aspects to CAPA - the corrective and preventive actions. Both may require completely different approaches. Therefore, it will be crucial to assess what it takes to implement the solution, how equipped the company is to undertake this, and how to fill the gap.
One of the best approaches to implement the different actions is the Plan, Do, Check, and Act approach.
This requires
Did the CAPA implementation have the desired outcome? This is an important concern. Sometimes, correcting an action may give rise to other challenges downstream. Is the trade-off worth it, or should an alternative be found? This will help to verify the effectiveness of the CAPA implemented.
The quality head is critical in reviewing, verifying, and certifying the CAPA program, its implementation, and its effectiveness.
In case of a recurrence, the action must be reviewed and fine-tuned to achieve the desired results.
The corrective and preventive action plan document should be compliant with the guidelines for the organization’s corrective and preventive policy. Some of the key ingredients of a good corrective action plan and preventive action plan SOP include:
Clearly defined objectives
The criteria, steps and responsibilities of the CAPA system
An overview of the corrective and preventive action procedures covering the scope, purpose, and internal and resources
Define all key terms, including “corrective action,” “incident,” or “nonconforming product.”
A CAPA Process Flow that delineates the steps of the CAPA process and its progress in each phase
The CAPA forms that will need to be filled out at the time of identifying the need for CAPA and as the findings of the issue investigation.
The role of management review.
A process to receive inputs from various subject matter experts on the CAPA procedures document, SOPs, and work instructions.
We went live with CQ just a few weeks ago and it works great! We received excellent training and after some playing around and getting used to it we found that it is really easy to use. So far we have implemented Document and Training Management as well as CAPA and both have everything we need right out of the box. After years of cumbersome spreadsheets and databases CQ is a blessing. It makes document management quick and easy… and it’s a pleasure to use.
A corrective and preventive action plan form template helps with the correct filling out of the form with all the essential information. This improves compliance and also access to the CAPA action plan data, important to demonstrate compliance.
Some of the essential information that should be included in the form include:
The date field should cover the date when the CAPA was initiated, the target due date, and the date when the CAPA was closed.
All CAPAs must have a sequentially assigned log number. This must be displayed prominently on each page. This is especially crucial for paper-based CAPA management sytem to prevent the loss of any data.
Assign responsibility for validating the form to a designated individual to check and sign it.
Determine which of the many root cause analysis tools suits the problem and your organization and choose one accordingly. Document findings.
Once the investigation is over and an action plan frozen, it must be recorded along with the action taken and its effectiveness. It should be comprehensive and detailed.
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Some of the tools and techniques needed for verification and validation of CAPA action plan include:
Testing
Auditing
Benchmarking
Feedback
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