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Many organizations misinterpret CAPA's role, often placing too much emphasis on tracking and managing the reaction to a non-conformance (corrective action) and not placing an equal, if not greater, amount of weight toward risk mitigation and assessment (preventive action).
From developing a clear understanding of what should trigger a CAPA, determining your corrective or preventive action, to determining root cause, there are a number standards and myths greenlight.guru is trying to shed light on.
Here are four myths to get you started. To find out the other four myths (and to get a sneak peak into how greenlight.guru is now helping manufacturers solve these), you’ll have to head over to booth #628 at The MedTech Conference and talk to myself, Jon Speer, founder and VP of QA/RA at greenlight.guru (quality management software exclusively for medical device companies) or another member of our team.
1. Everything is a CAPA
This is a common mistake with companies. They have an issue or discover something in audit and go straight to creating a CAPA. Soon, they find themselves with so many CAPAs on the books that it’s difficult to get anything done.
This loses the entire point of why CAPA exists and how it can be of value to companies. CAPA should be a tool that you can use to make real improvements, not a burdensome checkbox activity that you try to race through.
For medical device companies in this camp, being a bit more discriminating about what determines a CAPA is a necessary exercise, which leads nicely into our next myth…
2. We should measure the time it takes to close a CAPA
This might be a slightly controversial point to hold as a myth. There’s often a management review process and KPIs leading into those reviews. Usually there will be CAPA metrics and one of those is often time to close the CAPA. It’s understandable why companies think speed might be a good metric, but what seems to happen quite often is that an arbitrary time of “within 90 days” is set as the target for the management review.
Tracking and trending in a CAPA is also challenging, particularly where timing is concerned. This is where detailed reporting is important - you should know where they are in the process, what is left to do and who is involved. How big is the CAPA? One may be completely different to another in terms of complexity, so an arbitrary time goal doesn’t make sense.
Sometimes companies assign risk levels to identify the complexity of the CAPA. Having good traceability through the phases will also give some idea - CAPA should have a plan just like any project.
3. CAPAs do not have to link to other quality management systems or processes
If you go through an FDA inspection or an ISO audit, your CAPA processes will be looked at and probably close to the beginning of the inspection. An inspector will want to trace any complaints through your entire system. Did you initiate a CAPA for this? If not, why not?
CAPA becomes a foundational piece for the health of your QMS. Historically, we haven’t had good tools to manage this, but this is one of the things we’re solving at greenlight.guru. You need that visibility through one whole system rather than papers spread from filing cabinets to desks.
4. CAPA does not tie back to design controls or risk management
So much of what we’re doing in our systems revolve around our medical devices and ability to develop safe and effective products. This means you should always be looping back into your Design History File and design control or risk management practices.
Design controls are the mechanism to ensure you’re creating a safe, effective product. Some changes identified in CAPA may warrant a design change or an update in verification and validation.
Risk management is related because you should always have up-to-date files that demonstrate you're on top of any risk issues. Almost every time you go through a CAPA, there’ll be updates needed for design controls and risk.
Avoid these common myths and remember, CAPA should be something of value to your company that actually serves you. How will you ensure that your CAPAs are effective and a source of learning?
The greenlight.guru team looks forward to talking more with The MedTech Conference attendees about the common issues medical device companies face every day. Come to booth #628 to hear more about how a great eQMS can help get products to market faster, reduce your risk and help improve your CAPA process.