10 Tips for an Effective CAPA Process

10 Tips for an Effective CAPA Process

A Corrective and Preventive Action (CAPA) process is one of the most important components of any medical device company’s Quality Management System (QMS). The objective of a CAPA process is to ensure that if a problem occurs, that it is investigated in such a way, that the corrective actions that are put in place will ensure that the problem will never occur againIt is therefore vital that the CAPA process is robust.

A Corrective and Preventive Action (CAPA) process is one of the most important components of any medical device company’s Quality Management System (QMS). The objective of a CAPA process is to ensure that if a problem occurs, that it is investigatd in such a way, that the corrective actions that are put in place will ensure that the problem will never occur againIt is therefore vital that the CAPA process is robust.

Problems that occur can be detrimental to the end user of a medical device. Unfortunately problems evidently occur in a manufacturing environment. The problem(s) must be thoroughly investigated when they occur. The true root cause(s) of the problem must be determined and eliminated. A permanent “fix” should be put in place to ensure no reoccurrence of the issue. This can only happen if there is an effective CAPA system in place.

It is vital that the CAPA system is robust.

In this blog post, I share 10 recommendations about how to create an effective CAPA process.  I have gained these insights from being responsible for CAPA systems that have successfully passed audits/inspections. I hope you find these insights helpful!

Table of Contents

Understand what a " CAPA" is.

If you are new to the medical device manufacturing industry it might be the first time you have heard of the acronym CAPA. CAPA stands for Corrective and Preventive Action.  It (CAPA) is a system/process of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of the nonconformity.

CAPAs can also be preventive in nature. These preventive CAPAs can be included in your organization’s continuous improvement process. If an organization opens preventive action CAPAs regularly it indicates that an organization has a culture of being proactive rather than reactive when dealing with it’s processes.

Get an introduction to the Quality System Regulation by taking our online course, Introduction to 21 CFR 820 (Medical Device Quality System Regulation) Online Training Course.

Know the Difference Between "Corrective Action" and "Preventive Action"

There’s an important distinction that must be understood when it comes to your CAPA processes, with the key difference being between “corrective action” and “preventive action.” Unfortunately, many do not adequately understand the difference, which leads to confusion.

Preventive action (PA)  is driven by planning, risk assessment, the analysis of data and a culture of continuous improvement. Whereas corrective action (CA) is driven by nonconformity. So, each type of action starts in a different way.

Both PA and CA require the removal of root causes from the system. So, PACA may share the same problem solving activities within these two different type of CAPA.

Familiarize yourself with the CAPA Regulations

What are the CAPA requirements that your system must adhere to? Are you working under ISO 13485:2016 or 21 CFR 820 for example. Read the sections of the regulations that relate to the CAPA requirements and UNDERSTAND them. Design your CAPA process around these regulations. 

Learn about CAPA in the medical device industry taking our instructor-led virtual, Introduction to CAPA for Medical Devices Training Course.

Create CAPA Procedures and Documentation

The regulations require you to create CAPA procedures. I also recommend considering creating other CAPA forms and work aids that can be used when working on CAPAs. Documents that could be created include:

  • A corporate CAPA policy document
  • Corrective Action Request (CAR) form
  • Forms that could be completed at each stage in the CAPA process to document the activities that were under taken at that stage
  • Problem solving procedures/work aids

Adhere to your CAPA Procedures

The CAPA procedures you create are based on the CAPA regulations. They ensure compliance with the regulations when they are followed. However, procedures won’t do your organization any good if your employees don’t follow them. Following the CAPA procedures is critical to ensure that you are not issued with a 483 or audit finding. 

To learn about what can happen when an organization does not comply with the FDA CAPA regulations take our online course, FDA cGMP Enforcement Actions Online Training Course.

Regularly review the CAPA Procedures

When practices deviate from procedure, it usually means one of two things:

  1. Your organization needs to better communicate the procedure with your staff and enforce compliance.
  2. Your procedures are outdated or incomplete.

Organizational leadership must regularly review the CAPA procedures, take new regulations, standards, and audit findings/recommendations into account. Every time you update a CAPA procedure or document, let your staff know and incorporate them into refresher training.

Making sure your employees are following the CAPA procedures takes work, but it doesn’t have to be difficult. Use a document control management system to ensure that employees understand the importance of following the CAPA  procedures and know how to do so.

Man reviewing CAPA procedures

Train Employees on the CAPA Process

Making sure that all employees read the organizations’s CAPA policies and procedures is the first step toward ensuring compliance, but it’s not enough on its own. Employees may not entirely understand how CAPAs are undertaken or know how to work on them in practice.

Your organization needs to train employees on the CAPA system you have implemented in your organization as as well as on how to perform structured problem solving activities. 

Thorough training on the organizations’s CAPA policies and procedures should happen for every new hire during the on-boarding process. Those who will work on CAPAs should receive training on structured problem solving methods.

I would recommend that hands-on, case study training is of particular importance. Examples of in-house successful CAPA projects and unsuccessful CAPA project could be reviewed during the training for example. Review of Warning Letters relating to CAPA observations should also be included in the training course. 

We can design a customized CAPA training course for your organisation. Please contact us to discuss your requirements.

But every organization will have information that employees can effectively learn through online training courses. An online training management program can save your organization time and money by allowing employees to complete training independently on their own time.

Here are just a few of the positive outcomes of employees receiving appropriate CAPA training:

  • Consistent approach on how CAPA are raised, and completed by all employees. 
  • When everyone has a deep knowledge of the organisations CAPA system the CAPA process will run smoothly.
  • Consistency in practices will have an impact positively during audit/inspection activities. It will help employees to be able to answer questions during audits/inspections with confidence.

Understand the Components of a CAPA System

The CAPA process for ISO 13485 and 21 CFR 820 can be divided in 9 unique steps. Everyone working on a CAPA should know that these are the steps involved in a CAPA process.

  1. Collect and analyze data to identify nonconforming product and other quality problems.
  2. Determine if a CAPA is required.
  3. Rasie a Corrective Action Request (CAR).
  4. Investigate cause.
  5. Identify and implement corrective and preventive action.
  6. Verify or validate effectiveness.
  7. Communicate information about quality problems, changes made, outcomes, and trends to those persons directly responsible and to the staff in general.
  8. Forward information for management review.
  9. Work with staff and management to produce continuous quality improvement.
Image of cross functional CAPA team

Use a Structured Problem Solving Method to Determine the Root Cause

Once a CA has been identified it is the responsibility of the staff member in charge of that area (or their delegate) to investigate the root cause of the problem. Depending on the size and complexity of the problem more than one person may need to investigate the problem. A problem solving team may be established.

A structured, recognizable problem solving method should be used. Although most people consider problem-solving methods a given, many organizations still use ad hoc methods for addressing problems. In other words, they latch on to the most obvious explanation for a problem and hope that they’ve addressed its root cause.  

Using an ad hoc process to determine the root cause of the problem is one of the main reasons why so many Warning Letter observations are made by the FDA against 21 CFR 820.100. They frequently find that the true root cause of the problem(s) are not discovered. Structured problem solving is a learned skill that helps you to step back and evaluate a problem, big or small, in a clearer, more structured way. It is therefore critical that organizations ensure that the relevant staff receive training on structured problem solving methods. 

We designed a number of online training courses about structured problem solving tools. These include the 5 Whys Method, Affinity Analysis and Fishbone Diagram

The reasons for using a formal method are very convincing. Here are just a few:

•Stops those working on a CAPA from jumping to conclusions. It’s always appealing to propose solutions before a problem is properly described and its root cause identified.

• Ensures appropriate root cause analysis will be performed. An inability—or unwillingness—to identify the root cause is probably the single biggest obstacle to problem solving. However, when one of the explicit steps of a structured problem-solving method is identifying the root cause, it’s much harder to ignore.

• Demystifies the problem-solving process. When each aspect of the problem-solving process is understood and agreed upon by all the team, the process gives everyone a chance to contribute. It therefore leads to a team problem solving culture.

I cannot overemphasis the importance of using a structured problem solving method when working on CAPA. To not use one will most likely leading to problems when your CAPA process is audited/inspected.

Image of the words who, when, where, how, what and why. Investigate the root cause for a capa

Was the Corrective Action Effective (Verification of Effectiveness)?

Both ISO 13485:2016 and 21 CFR 820 suggest that its not enough to identify a problem, investigate the root cause and make the required change to the system, but that the implemented corrective action must be reviewed at a later date to ensure that the change was effective. Has the change to the system prevented the problem from occurring again ? Organisations frequently struggle with this step. Before the CAPA can be closed out a relevant staff member must review the change and verify its effectiveness. This is an often overlooked step in the CAPA process but it is a critical step. 

Before the CA can be closed out a staff member must review the change and verify its effectiveness.

This verification activities must be documented. If the CA was effective and prevented the problem from occurring again without affecting the QMS then the CAPA can be “closed”. If the change to the system did not resolve the problem or caused another problem within the QMS, then the CA must be reinvestigated and a new CA developed.

Image of a man holding a thump up to indicate CAPA effectiveness

To learn about the different root cause analysis tools that can be used when working on a CAPA take our online course, Root Cause Analysis Tools & Medical Device 21 CFR 820.100 (CAPA) Online Training Course.

Conclusion

Not complying with CAPA regulations and having an ineffective system in place can have severe outcomes for your business. That’s why it’s so essential in my view that you place close attention to the 10 tips I have given you in this blog post on how to design an effective CAPA process. Good luck !

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    Dr. Fiona Masterson

    Fiona is the Managing Director and founder of The Learning Reservoir. Fiona has over 20+ years of experience in the Life Sciences, Food and Drink industries and third level education. Her Doctorate focused on the regulation of drug/device combinations products in the US and European Union. She has also published peer review publication on combination products.