How can I track the effectiveness of my QMS after my medical device goes to market? We'll cover the procedures you need to establish to maintain quality control of your medical device and QMS processes.

How to Implement a World-class Medical Device QMS using the 5 Phase S.M.A.R.T Methodology

In this playlist you'll learn how to establish a world-class medical device QMS using our proven 5 phase S.M.A.R.T methodology designed to help you through each stage of your product life cycle. This is episode six of seven from this playlist brought to you by The Greenlight Guru YouTube Channel with Jon Speer.

 

Episode 6 Transcription:

Hi and welcome everyone, I’m Jon Speer, founder and VP of QA/RA at Greenlight Guru. 

Congratulations, you’ve officially released your product into the market. But your work is far from being finished.

This episode will cover the final phase of the S.M.A.R.T methodology, the Track-phase. We will focus on the QMS processes you will need to implement after your medical device has been released in the market. I’ll explain how you can track your post-market activities by assessing the performance and health of your QMS.

The previous episode covered the Release-phase where you were preparing your QMS for market release. If you haven’t watched the episodes leading up to now, do that now. And while you’re at it, subscribe to our channel so that you’re always up to date on all of our latest videos!

The activities you take to monitor the performance and health of your QMS AND your products postmarket are extremely important. So without further ado, let’s get into recommended steps to take during the Track-phase of our S.M.A.R.T methodology:

All of the product information that is gathered within your QMS becomes a valuable asset during Management Reviews. The purpose of any management review is to assess the performance of your quality management system to identify areas for improvement. 

There are several quality system procedures you will use to track the health of your QMS during this phase. One is Corrective and Preventive Action, commonly referred to as CAPA. CAPA is one process that consistently presents challenges to medical device companies. It’s important to establish sound processes to avoid experiencing such challenges. 

Another procedure is Analysis of Data. Post-market data is gathered through a range of post-market surveillance activities. Post-market surveillance activities can provide incredible valuable to your company. Plus, regulatory bodies require you to do them.

Lastly, you will utilize Internal Auditing. If you want to place your focus on quality, rather than compliance-only, then dedicating the time to conducting internal audits is essential. Make sure you have a defined, documented process for internal audits. Document the scope of regulations and note which ones apply, for example ISO, FDA, EU MDR, Health Canada, etc. This is how you build what goes into your process.

You can monitor the health of your QMS and products during this phase via the following:

  • Nonconformances. A nonconformance is an incident wherein your product has failed to meet specifications. Having robust internal procedures and a solid supplier management process can offset nonconformances, but they’re still likely to occur at some stage. You should create a procedure that defines the roles and responsibilities associated with managing nonconformances.

  • Complaint Handling. Complaints are inevitable. Despite your best efforts and cautious planning, it’s bound to happen - and that’s okay. These can present new opportunities for improvement when handled properly from a regulatory and business standpoint. Complaint management regulations are outlined in FDA 21 CFR Part 820.198 and ISO 13485 section eight dot two dot two. Both regulations stipulate the need to maintain a customer complaint file as part of your post-market surveillance activities.

  • Adverse Event Reporting / Medical Device Reporting

  • Customer Feedback. A key aspect of effective post-market surveillance is soliciting customer feedback. Most companies are good at responding to customer complaints, but not many are proactive when it comes to reaching out for unsolicited feedback. I recommend setting up a plan to gather this feedback proactively. It can help you identify problems before they become systemic.

Throughout this phase, you’ll be identifying areas of compliance concerns and opportunities for improvement, both with your QMS and products. The outcomes from this phase can lend valuable feedback that can be used in the scope of process or product changes. Now I hope you can see how the SMART methodology is a cycle designed to help you with continuous improvement. 

One common myth I hear during the Track-phase is:

Myth: “Once a product is launched and QMS is implemented, you don’t have to worry about updating your QMS unless there is an issue identified during an ISO audit or FDA inspection.” 

Reality: If issues are identified during ISO audits or FDA inspections, you will need to take appropriate actions.

The whole purpose of this phase is to identify issues and areas of concerns prior to external audits and inspections. When done properly, your tracking activities (including internal audits) will be considered world-class to any auditor or inspector.

I recommend following these 3 best practices during the Track-phase to help you maintain the health and efficacy of your world-class QMS: 

  1. Tweak and adjust your QMS for continuous improvements
  2. Make sure your QMS stays simple and right-sized
  3. Identify a handful of key performance indicators, or KPIs, and use these to help drive QMS improvement initiatives

And that concludes the five-phases of our S.M.A.R.T methodology for building a world-class medical device QMS.

But wait, there’s more! And we’ve saved the best for last. 

I’ll see you in episode seven where we’ll close out this playlist by connecting all of the key concepts to build a compelling business case for Quality.


 

Watch next:

Ep 7 thumbnail

Watch episode seven of our playlist, How to Implement a World-class Medical Device QMS using the 5 Phase S.M.A.R.T Methodology: How to Calculate the Cost Of Quality: Building the Business Case for your Medical Device QMS