ISO 13485 CAPA

Corrective and Preventive Action (CAPA) processes is an important part of the ISO 13485:2016 Quality Management System, and for good reason: To correct non-conformances requires doing something different than the action that caused them. Following a set problem-solving procedures ensures that critical elements and resources will not be lost and wasted along the way. But where many CAPA processes lose steam is in either over or under responding. And that is often a function of a poor set of risk filters built into the process.

CAPA is in place to help the FDA regulate medical device manufacturing facilities. Since the FDA cannot be at every facility every day, they need a system in place that supports continuous self-improvement. At a basic level CAPA requires organizations to identify the nonconformity, determine the root cause and create a plan and implement that plan into action to fix the issue. One of the challenges is correctly identifying where the nonconformity is coming from.

As of 2016, 50% of actions taken in organizations by the FDA were related to CAPA and therefore it is important for you to understand CAPA and follow the system. One of the hardest problems’ organizations have with CAPA is correctly identifying the root cause of the problem. Although identifying the root cause is achievable, a lack of a rigorous investigation into the causes makes a recurrence more likely. Experienced quality managers know you can’t fool your CAPA system. If you don’t adequately identify the root causes of a problem, the corrective measures are a waste of time.

Differences Between Corrective and Preventive Action

Both preventative and corrective action are designed to improve the quality management system, yet they have their differences as you can see by their definitions:

Corrective action: action to eliminate the cause of a detected nonconformity or other undesirable situation.

Preventive action: action to eliminate the cause of a potential non-conformity or other undesirable situation.

Corrective Action

• The root cause of the nonconformity must be identified and documented
• The effect of the nonconformity should be analyzed in order to determine its impact and the actions required to take corrective action
• The whole system needs to be assessed to ensure that the non-conformity does not occur in other areas.
• Implement the actions that will prevent the nonconformity from reoccurring
• Organizations must assess actions taken to determine its effectiveness.

Preventive Action

• Proactive actions, such as risk assessments, failure modes and effects analysis (FMEA), must be taken to identify potential nonconformities.
• The development of work instructions, documented procedures, training are examples of actions that are performed to prevent non-conformities.
• Other activities that are regularly carried out and are part of the preventive action process are audits, management reviews and inspections.

Tools for Corrective and Preventive Action (CAPA)

• Quality Improvement Fundamentals Course
• Root Cause Analysis with Corrective Action Course
• FMEA Training Course

CAPA Steps of Improvement

There are many ways to address problems within the workspace, below we will discuss common steps for improvement.

• STEP 1: Contain the problem- If you experience a problem, you should stop production and quarantine any materials, parts and inventory to prevent any additional defects or issues from expanding. Containing the problem should continue until you define the issue and feel confident it is contained.
• STEP 2: Stop Manufacturing: Production lines that may be involved with the problem need to be shut down. This way you can avoid waste that may be affected by the nonconformity.
• STEP 3: Understand the Cause- Understanding why the nonconformance occurred is the most important part of CAPA. Using a root-cause analysis can be a very helpful tool for this process.

Problems with CAPA

Although CAPA is great to have in place, there are several issues that organizations often have with CAPA.

1. There is a lack of cross functionality. CAPA is usually a process that is a part of the QMS. Although this is not a bad idea, it is seldom that an issue arises that only affects the QMS and therefore organization need to take a cross functionality approach.
2. Reactive instead of proactive- CAPA is usually only considered to be a part of the QMS and most organizations only put preference on the corrective action part. As an organization CAPA should be considered in all parts and needs to be taken seriously. Organizations also need to remember that preventative action is critical to their organization and they should be proactive rather than reactive. Being proactive can save you a lot of time and money.
3. Overuse versus underuse. CAPA is a process that should be reserved to deal with potential systemic issues. CAPA is oftentimes either overused, exhausting time and resources or underused and nonconformities are not being addressed leading to quality issues.
4. Poor Root Cause Determination- Organizations often have a challenge finding the true root cause to an issue. Finding the root cause can be challenging and therefore we recommend assembling a multifaceted team. There are many root cause techniques, strategies and trainings to improve your abilities to get to the source.
5. Poor definition of CAPA process- One of the main reasons the FDA is citing organizations regarding CAPA is because of the poor definition of the CAPA process. This can relate also relate to problem of overuse or underuse. To help you better define your process follow these 15 steps:
   1. Create CAPA request and submit for review. Identify sources of CAPA worthy issue.
   2. Review CAPA request. Determine whether or not issue requires CAPA investigation.
   3. Accept or reject CAPA request.
   4. If accepted, issue and initiate CAPA
   5. Finalize CAPA sources (i.e. products, processes).
   6. Determine CAPA cross-functional team.
   7. Identify any immediate actions and corrections required.
   8. Investigate and capture findings.
   9. Determine root cause(s).
   10. Specify corrective and/or preventive action plan.
   11. Complete action plan.
   12. Review CAPA for completeness.
   13. Approve CAPA actions.
   14. Specify steps for effectiveness verification.
   15. Verify effectiveness of CAPA.

Deciding What Problems Need to Be Fixed

Determining what problems need to be fixed can be another challenge for companies. There are also reports of countless resources which are wasted by fixing problems that probably did not need or justify the effort. Balancing these requires a blend of front-end categorizations that help all employees know when action is needed, starting with these key questions:

• How often is the problem likely to occur? (Frequency)
• How important is it likely to be? (Importance)
• Has this issue been addressed before? (Re-Occurrence)
• Are we really being open minded? (Evaluate Options)
• Did we really solve the problem? (Verification)

We will look at each of these in more detail.

What are the differences between CA/PA?

Frequency

It may be as difficult to predict the re-occurrence of a problem as the first occurrence of it. And yet, if there is at least an attempt to measure and scale a perspective can often be reached. This is particularly true if measurements exist that can compare that state of something. Poor inventory control can be a function of fluctuating customer demand, which may seem not to be controlled. But many vendors find ways to better predict the needs of a customer than they do. Starting with a simple scale of how frequently this issue is likely to occur can help determine the resources that need to be applied.

FREE ISO 9001 Corrective/Preventive Action Guide

For a limited time we are giving our CAPA Process Guide, a time-tested outline for developing or improving your corrective action/preventative action approach (CAPA). For instance, the guide helps you develop each phase of the process including:

• Record Potential or Actual Non-conformance
• Assign and Manage Request
• Investigate Root Cause
• Design Corrective Action
• Implement Corrective Action
• Follow-Up on Corrective Action to Assure Effectiveness

More About Correction, Corrective Action and Preventive Actions

Importance

As far as importance, a higher-level perspective can help decide the total impact of the problem. While not a guarantee, views from varying groups that are likely to be affected can help put the situation into perspective. The person(s) observing a potential or actual non-conformance initiates the process (often is called the “Requestor”) provides critical aid in this process in describing the problem. Having a CAPA administrator is also crucial to review and then request the appropriate people in the organization to assure the necessary action is taken in a timely manner.

CAPA influences many key processes of your QMS. When you are thinking about CAPA you need to remember that it will impact the following:

• Customer Feedback
• Complaint Handling
• Nonconforming Product
• Production & Process Controls
• Supplier Management
• Audits
• Design Controls
• Management Review

Re-Occurrence

Maintaining a “lessons learned” database of some type can at least help with those problems that seemed to recur. Providing easy and ubiquitous access and encouraging/requiring appropriate logs are necessary actions for making this database useful in the CAPA process.

Evaluate Options

Yet, there are times when new people, technologies, production and market conditions conspire to hide solutions. In this case, a more open and interrogative style of inquiry is often needed. Being good investigators with the proper methods can lead more quickly to results in these situations than past experience with its preconceived notions (that may not have detected or fixed the problem in the first place).

Verification

Finally, verifying what actions were taken and what effects they had will help ensure that the problem will not repeat (if it had for instance, temporarily righted itself). Many times, people think they have done what was asked/required only to move on a bit too quickly to the next issue without fully/correctly completing the needed actions.

In summary, no one can predict the future with 100% accuracy, and yet what CAPA teaches is that we can command our destiny to a great extent. Those who put effort into it are much less likely to repeat/experience unwanted past, or unpredictable future events.