CAPA is an area that we talk about often, mainly because it’s still such a big issue for medical device companies.With CAPAs being a key issue indicated in FDA warning letters and observations, it’s important that companies have it all together and understand how to deal with them. (See our “ultimate guide” to CAPA here).
This time, we’re looking at a step-by-step process that, if done well, should help any company to get a good result from their CAPA process.
A Step-by-step CAPA process
The key thing about the CAPA process is that there are a lot of different processes that feed into it. You need to be diligent, but also apply scrutiny to what does and doesn’t require CAPA. Remember, it should be reserved for those systemic issues - every issue is not a CAPA!
Once you have something that’s worthy of a CAPA, here are the steps:
1. Create a CAPA request and submit for review
You need to identify your sources for this CAPA and record them. For example, was the CAPA issue picked up at an audit, from a customer complaint or from a nonconformance? You need to corroborate the need or request that you are submitting. Be very clear about what the issue is and how it came to light.
2. The appropriate resources should review the request
Your sources and resources need to determine whether the CAPA should be accepted and formalized into the system. Who should be reviewing these? Usually, you’d have someone from quality, such as a quality manager, playing a critical part, but it doesn’t have to be a singular function involved. Many companies use the Management Review Board (MRB) or Quality Review Board (QRB) to review these requests as a team.
An important tip here - it might be helpful to set up some sort of frequency for these meetings, not just for CAPA but for all quality events or issues and to keep a finger on the pulse. It’s a good habit to be regularly reviewing any issues that go on.
3. Accept or reject the CAPA request
This next step is where the CAPA request will be either accepted or rejected by the board or party in charge of reviewing it. If it’s rejected, you should document the reason and rationale behind why it was rejected. This should be kept with your records. If accepted, then you move onto step #4.
4. The request is formally initiated as a CAPA
When a CAPA is initiated, you need to assign it a tracking or identification number for documentation purposes to help you keep track it throughout the process. An important part of managing a CAPA is that there should always be a clear trail and a way to monitor progress. Many companies have received warning letters or observations for failing to track CAPAs properly, especially if that failure to track meant CAPAs were left open indefinitely.
5. Finalize your CAPA sources
This includes all of your products, processes, quality events and any other source contributing to the CAPA. You need to ensure that you’ve covered everything because now you’re doing a CAPA investigation. You want to do this one time and show that you’ve been as thorough and holistic as possible.
6. Determine a CAPA cross-functional team
Your CAPA should be treated like a project. Once you’ve clearly determined the sources, products and processes involved with the CAPA, this will help you to identify the resources you really need on the team to help oversee the CAPA. For example, you might need engineering, marketing, manufacturing or regulatory as part of your team. Whatever the case may be, build your team appropriately for addressing the issues identified.
7. Identify any immediate actions or corrections required
This next step is about identifying anything that will require you to take action immediately. For example, if you identify an issue with a particular product, you may need to quarantine the product that you already have in finished goods. In an extreme case, you may need to consider issuing a recall, which is something that has to happen immediately.
The bottom line of this step is that it’s about containment. Are there any actions you must take immediately to prevent the issue from continuing or becoming more widespread?
8. Investigate and capture findings
This is where you’re going to dive into the details and conduct a thorough investigation. You’re going to look at product, process, people and the where, what, why, when and how of the issue. The idea is to leave no stone unturned as you seek to determine root cause for the problem.
You need to capture all findings as you go, as this will help you with the next step.
9. Determine a root cause
The big mistake often made here is that people will try to jump straight to this step, then end up basically regurgitating the problem rather than actually determining root cause. You just cannot reach a root cause without a proper investigation and documented findings.
If you’re not thorough, you may find yourself identifying the wrong root cause then trying to fix something that won’t actually fix the problem in the first place.
We talk about some common tools to identify root cause here.
10. Develop an action plan
This is a series of tasks or things that you’re going to do to correct the issue and/or prevent it from happening again. Remember, if you haven’t correctly identified root cause, you may come up with a whole lot of actions that are really just “busy work.”
Your effectiveness at this step is really only as good as the job you did at step #9. It is worth taking the time to get to that root cause thoroughly! Your action plan should include the steps you are going to take and have some kind of deadlines around them. It’s important that a CAPA incident is not dragged out longer than necessary and that you can demonstrate a clear process being followed.
11. Complete the action plan
At this step, you’re simply taking the actions you identified previously. You might be updating procedures, redesigning processes or even adding an inspection step. As with other parts of the process, make sure everything is well-documented and accessible to those who need it. You need to ensure that any changes being made are going to stick.
12. Review CAPA for completeness
This is where the CAPA goes back to the cross-functional team and that MRB/QRB to assess whether the CAPA has been satisfactorily completed. If it has then they move it to step #13…
13. Approve CAPA actions
This step requires those with oversight to sign off on the CAPA investigation and outcomes, to say that they feel it has been completed to a satisfactory standard.
14. Specify steps for effectiveness verification
Wait a minute - you’re not done yet! Many companies skip these last couple of steps but they are an important part of the process. How will you know that the actions you took were effective?
At this step, you need to identify some steps to take to prove that the actions taken have worked. For example, if you added an inspection step, you need to confirm that that extra inspection step is taking care of the issue as intended.
Capture all of your steps for verification at this stage, corresponding to every action you took. Remember, the overall aim of a CAPA is to correct or prevent an issue from happening again - you have to prove that the overall goal was met.
15. Verify the effectiveness of the CAPA
Managing the CAPA
Managing a CAPA with a paper-based approach is very challenging. Imagine you have a handful of CAPAs to deal with - how do you keep track of them all? It tends to be that the bigger the company, the more intense the problem.
Each CAPA may be at a different stage and, while you have a log somewhere, it gets buried and it’s hard to maintain visibility over it. From a management perspective, you’re in a challenging and time-consuming position trying to maintain oversight and ensure CAPAs are completed effectively.
This is one reason we built the postmarket workflows of Greenlight Guru. It makes it much easier for companies to not only maintain oversight but to keep the linkages between all issues visible so that you can easily see critical data.
This is a big deal - mining data can be such an issue in paper-based companies where there is no single source of truth. You need to be able to extract meaningful data to track and trend CAPA issues, and this can take hours without transparent systems. Greenlight Guru provides this with a few clicks on an analytics dashboard, helping to save time and keep companies in the loop.
Looking for an all-in-one QMS solution to advance the success of your in-market devices and integrates your quality processes with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →