Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 1

By Marcelo Trevino, independent expert

Establishing and maintaining an airtight quality system is a prerequisite for survival in the medical device and diagnostics industry. Not only does an effective quality system help a manufacturer achieve compliance across an increasingly complex international regulatory landscape, it can also help improve the efficiency and productivity of your business processes.

While international standards and regulations are a great source of information for device makers on the processes and systems that need to be implemented, they are far from comprehensive — at best, these documents provide the absolute minimum requirements. They do not explain how to install and maintain a quality system, and that is where things can get tricky for some organizations. If you rely on these documents exclusively, you are asking for trouble during your next audit.

Problems can arise in many areas of a quality system, but two areas where manufacturers struggle are in management reviews and measurement, analysis, and improvement. The two are inextricably tied — management reviews are dependent upon effective ongoing measurement activities to analyze a system’s performance, identify potential areas for improvement, and assure that the necessary changes are being made.

This article identifies some of the common snares manufacturers fall prey to when conducting quality management reviews. It also shares strategies to help you avoid those mistakes in your organization.

Pitfall #1: Conducting quality management reviews infrequently
When it comes to quality management reviews, some medical device manufacturers (mistakenly) believe that it is sufficient to merely come up with some goals, hold a meeting once or twice a year, document the meetings, put everything in a binder, and forget about it until next time.

Unfortunately, regulators expect you to have a much more active and continuous management review process. They want to see that you are regularly checking into the effectiveness of your quality system, you have committed the necessary resources, you are meeting all the goals that you defined, you are keeping up to date with the latest regulations, and you are reacting more frequently.

If you only conduct a management review once a year, you may not have the current data a regulator or notified body expects when they show up for an audit. They will want to see recent key performance indicators and evidence of how you are adjusting based on what those KPIs show. Are you getting data from the field? Are you looking at trends from any problems or situations that have occurred? Are you coming up with new projects or objectives based on what those metrics are telling you? If you haven’t conducted a review for six or eight months, it may be difficult for you to answer these questions in an acceptable manner.

As a result, an inspector may question whether your organization is really committed to quality, as opposed to just doing the minimum to comply. You definitely don't want them to think that you are not taking them seriously, because then they will start digging more or spending more time on trivial items.

With all of the changes and all the complexity we now face with international quality requirements, it becomes hard to justify having a management review only once a year — even if the standards don't specify how often you should have them. You need to show you are ahead of the game. Conducting management reviews at least every quarter, if not more often, allows organizations to demonstrate that they are proactively overseeing their quality system and reacting as needed.

Pitfall #2: Not covering all the applicable local or international standards
Most medical device companies typically conduct integrated management reviews, where they simultaneously address the standards of all the countries into which they sell, because there is a lot of overlap between them. However, there are also a lot of differences, and regulators will not accept the fact that you conducted a general review. They will want you to show that you have looked at all of their particular requirements. Covering all these requirements as part of your management review agenda — and demonstrating that they have been addressed — can be a struggle for many manufacturers.

What if Canada has new requirements about labeling? How would you demonstrate to Canada that you actually looked at those requirements? What if Japan changed its regulations since you last held a management review meeting? How do you show them you took the changes into account?

A best practice is to document within your management review minutes that you looked at anything that is applicable to your site. That way you can show that you are aware of the latest regulations and standards, and that you concluded at the end of the meeting that everything was still on track (or you are making the necessary changes to get your quality system on track).

Pitfall #3: Failing to follow through on management review outputs
During a management review there are inputs and outputs. The inputs may consist of customer feedback, internal audit results, and CAPA metrics, among other things. After analyzing the input data, the management review determines outputs — the steps you plan take to address issues and improve your quality systems, based what the data tells you.

If all you accomplish during a management review meeting is data review and discussion, that tends to be a problem, because notified bodies and regulators want to see that the meeting is driving actions. They expect you to arrive at conclusion, form a plan, execute the plan, and use the quality system to continuously drive improvement.

It is really important to have that connection between the inputs of the review and the outputs. You need to follow up on those actions at subsequent meetings, so you don’t forget about it. Management review is a constant process of reviewing inputs and coming up with new outputs. It is a dynamic, evolving tool for your quality system.

Pitfall #4: Lacking documented rationale behind your management representative selection
Ensuring that outputs are being addressed is ultimately the responsibility of the management representative, typically a manager, a VP, or other executive appointed to oversee the management review. Standards require the designation of a management representative to ensure that quality issues will be escalated to senior levels within the organization, if necessary.

When a regulator arrives for an audit, it is unacceptable to simply say that someone is your management representative. You have to have that responsibility officially documented, whether it is on an organizational chart, a job description, or a memo from a high-level executive. The documentation must also explain who that person is and why they were appointed — not just that we decided this person is going to be management rep this month.

It is a very serious role, so you have to have that process clearly documented. Many device makers have gotten into trouble because they didn’t have documentation proving that a legitimate method for appointing management representatives was in place.

Pitfall #5: Inadequately documenting attendance and topics that were covered as part of the review
Establishing a clear agenda with all the topics to be covered is a very important element of quality management reviews. The FDA, for example, typically will not review minutes or data presented at these meetings, but they will definitely expect to see an agenda showing what was covered and who was in attendance.

Management review procedures should establish minimum topics to be addressed and quorum required to be present at each meeting. Auditors and regulators are often interested in what was covered and how much emphasis was put on analyzing trends or any areas that need attention from management.

If the organization is aware of certain problems derived from corrective and preventive actions (CAPAs), internal audits, or complaints, for instance, it is expected that enough time is allotted during this meeting to analyze information and ensure appropriate resources are allocated to drive improvements and resolve any problems. While most companies typically set aside enough time to cover these areas, they do not always provide enough information in their agenda, presentation, or meeting minutes to reflect what was discussed and the status of those topics.

Part 2 of this series examines pitfalls manufacturers face related to quality measurement, analysis, and improvement activities, including issues with nonconforming materials and products, internal audits, CAPAs, root cause analysis, and effectiveness plans.

Editor’s Note: The author is teaching an online course called Device Compliance Audit Management - Best Practices to Meet Global Regulations and Notified Body Expectations  on August 13, 2014, at 1:00 pm EDT. For more information or to register, visit the Life Science Training Institute.