The Heart of QMS: Navigating CAPA and Quality Assurance in the MedTech Industry
The following is a clean verbatim transcript from an episode of The Elendi Files.
Host Teddy, General Manager of ElendiLabs, sits down with Jan, Chief Manager of Regulatory Affairs and Quality Devices at Essence Consulting Services, to discuss the critical role of CAPA (Corrective and Preventive Action) in maintaining a robust Quality Management System (QMS) for medical device manufacturers.
1. Introduction to Essence Consulting Services and Global QMS Expertise
Teddy: Welcome to The Elendi Files, where we navigate the complexities of the global regulatory landscape and Quality Management Systems of the MedTech industry. Our goal is to make global medical product regulations and industry know-how accessible to everyone, whether you are a manufacturer, intermediary, regulatory specialist, or CEO of a startup. Today, I am thrilled to be joined by Jan from Essence Consulting Services, a firm that helps manufacturers with audits, inspection readiness, and the integration of regulatory requirements into real QMS processes. Jan, could you give us a brief introduction of yourself and your specialization?
Jan: Thank you, Teddy, for having me. I am a Quality Assurance and project management expert with almost 13 years of international experience in medical devices and 27 years of total work experience. I have worked across EU and US markets and lived in several countries across Europe and South America. I specialize in "rescue projects," meaning that if a company has a backlog of non-conformities or problems dealing with CAPAs, I am called in to help them out with my expertise. I hold an executive MBA from the University of Applied Sciences in Switzerland and studied MedTech in Bern. Today, I am an entrepreneur helping companies across a wide range of services.
2. Defining CAPA: The Proactive and Reactive Loops of Quality
Teddy: You have a lot of hands-on experience in dealing with rescue cases. Can you tell us a bit more about what exactly CAPA is and its essence?
Jan: CAPA is really the foundation—the heart—of your Quality Management System. Anything that does not go as planned must find some consideration into CAPA. It stands for Corrective and Preventive Action, and it consists of two loops. The preventive action loop is proactive; its purpose is to prevent errors before they happen. If companies invested more in prevention today, they would greatly benefit later down the road. However, I often observe that companies lack the understanding of preventing errors and instead fall into a corrective action loop. Corrective action comes in after a problem has already occurred. In that case, you must determine the magnitude of the problem through a systematic structure to determine why it happened and prevent it from happening again.
3. Distinguishing "Corrections" from "Corrective Actions"
Teddy: You mentioned correction and corrective action. Are there any differences between a correction and a corrective action?
Jan: Yes. A correction is dealt with when you discover a defective product in a production cycle that is an isolated problem. You already know the root cause, so you repair the device, validate it, and bring it back into the production cycle. There is no further investigation required.
Teddy: So a correction seems more like a solution or a fix on the spot?
Jan: Exactly. Correction is not meant to be part of the CAPA system because if you included every minor correction, it would clog the system and consume too many resources.
Teddy: Is there a well-defined definition for corrective actions?
Jan: The FDA defines corrective action as an action to eliminate the cause of a detected non-conformity or other undesirable situation. Unlike a correction, corrective action requires a root cause analysis and specific steps to ensure that the error never recurs.
Teddy: Is there a similar definition for preventive action?
Jan: According to the FDA, preventive action is any action to eliminate the cause of a potential non-conformity or other undesirable situation. A preventive action is taken to prevent the occurrence of a nonconformity and to eliminate the cause of a potential nonconformity.
4. Global Regulatory Alignment: ISO 13485 and the FDA
Teddy: How do we find the requirements for CAPAs? Are they all from the FDA or other sources?
Jan: It is interesting because, in February 2024, the FDA changed its law to proclaim that ISO 13485 will now be at the heart of FDA law. They now accept the requirements from ISO 13485, which facilitates our work as auditors. Specifically, Chapters 8.5.2 and 8.5.3 of ISO 13485 speak about corrective and preventive action. This global focus on one common source is a good thing for companies.
5. The Challenges of "Reactive Mode" and Short-Term Productivity
Teddy: What are the obstacles to introducing CAPA? Why are some people not valuing its importance enough?
Jan: Many MedTech companies grow very quickly. For example, during the pandemic, I worked with a company producing ventilators that were in high demand. When you are concentrating on producing as many units as possible to meet market demand, quality must step up to accompany that development. I often see companies in a "reactive mode," putting out fires and calling in consultants only when they have massive backlogs.
Teddy: I get that many companies focus on short-term money-making, but a robust CAPA system is a long-term investment. What are the potential benefits of having a stable, robust system?
Jan: The benefits are really what the company makes of it. You will identify discrepancies, non-conformances, and adverse trends using statistical methods. It allows you to prioritize quality problems so you can deal with high-risk issues first. While it seems resource-intensive in the beginning, it pays off over time because it is a structured approach that clears out issues in your organization.
6. The CAPA Workflow: Internal and External Loops
Teddy: How do we execute a robust CAPA system? Are there subsystems or feedback mechanisms?
Jan: We talk about an internal loop and an external loop. The internal loop deals with in-house audit findings, test reports, and quality records generated inside the organization. The external loop focuses on customer complaints, external audit findings (like the FDA), and issues with suppliers.
Teddy: I understand there is a workflow for the CAPA process. Is there a high-level structure?
Jan: Yes, here is a high-level overview:
- Initiation: Anyone in the organization can report a problem to the CAPA manager.
- Verification: The manager verifies if a CAPA is already open for that specific problem.
- Draft Request: Details are recorded, including who observed it, the consequences, and whether containment or immediate action is necessary.
- CAPA Review Board Approval: I strongly support involving management in a review board to approve the request.
- Root Cause Analysis: We use tools like the Fishbone (Ishikawa) diagram or the "5 Whys" method. I love the 5 Whys because it is easy and almost always leads to the correct root cause by stripping away layers of a problem.
- CAPA Plan: Appropriate actions are determined (Correction, Corrective, or Preventive) and approved by the CAPA Review Board (CRB).
- Implementation: The defined actions are executed.
- Verification of Effectiveness (VoE): You determine the criteria to prove the problem has been completely resolved.
- Implementation Review by CRB: If the problem does not reappear over a certain time, the CAPA is closed. If it does reappear, a new CAPA is opened because an error was committed in the process.
7. Case Study: A Swiss MedTech Rescue Mission
Teddy: Do you have any interesting case studies to share?
Jan: A few years ago, I was called to a medical device manufacturer in Switzerland for a rescue mission. They had a high number of backlogs consisting of non-conformities and CAPAs that had accumulated over a long period. They were desperate for a quick resolution. Most of the problems were occurring in production. By using observation and interviews with subject matter experts, we identified the root causes of their recurring problems within just a few days. We meticulously documented the root cause, created a provisional CAPA Review Board with management, and implemented corrective and preventive actions. The backlog was reduced to nothing within a few weeks, and we left them with a shaped process so they could handle future issues on their own. It was a very rewarding experience.
Teddy: Thank you so much, Jan, for sharing your hands-on experience and perspective with us today. We will be featuring Essence Consulting Services as a vetted specialist firm on our platform. Thanks again for joining us, and we'll see you on the platform. If you haven't checked our website, please head to elendilabs.com and be sure to connect with us on LinkedIn.
