When QualityHub President Tim Wells huddled with his team at the US Food and Drug Administration (FDA) in the late 1990s to develop the agency’s Quality System Inspection Technique, they agreed that the best tack to take would be to make QSIT as efficient and user friendly as possible.
And now, nearly three decades later, the verdict is in: Mission Accomplished.
QSIT – an approach that’s been used by FDA investigators during inspections of medical device manufacturers since 1999 – will sunset on Feb. 2 when the agency’s Quality Management System Regulation comes into force. The new QMSR replaces the decades-old Quality System Regulation (QSR), which was harmonized with international quality systems standard ISO 13485:2016.
The FDA said last April that it would retire QSIT but not replace it with a “QSIT No. 2.” The agency has not revealed its QMSR inspection approach as of press time. (Related Story: “Kiss QSIT Goodbye for FDA Facility Inspections,” QualityHub, April 24, 2025.)
When drafting QSIT in the ’90s, Wells’ FDA team – for which he was leader – “knew there were many parts of the Quality Management System that should be looked at during inspections but we were driven by the need to be efficient and focused. We knew that CAPA [corrective and preventive action], management controls, design, and production were four really important areas,” he said.
“When medical device manufacturers took the QSIT inspection tool and used it themselves to audit, evaluate, calibrate, and validate their own quality systems, that made QSIT a win for the FDA, industry, and the public.” – Tim Wells
“We were concerned, however, that focusing on only four areas was risky,” said Wells, who founded QualityHub in 2004 after a distinguished career at the FDA. “We needed to make sure there was some time spent on related and important areas, as well as the ‘big four’; for example, areas such as purchasing controls, document controls, records, and more.”
Wells’ team ultimately won the FDA Award of Merit and the Vice President’s Hammer Award for creating QSIT because it saved taxpayer dollars, allowed for quicker inspections, and was extremely effective. QSIT’s development was a collaborative process supported by the FDA, the MedTech industry, and other organizations.
“We had buy-in from a very broad cross-section of stakeholders. This included a working group hosted by FDLI [the Food & Drug Law Institute] that consisted of both FDA and industry quality executives and experts,” Wells said. “We had a very collegial relationship, which was helpful when we asked for public comment” on the (then) new QSIT.
As QSIT is retired after 27 years, Wells takes a trip down memory lane, looking back at the inspection technique’s strengths while looking forward to how the FDA will inspect facilities with the advent of the QMSR. [Editor’s Note: The questions and answers below were lightly edited by QualityHub for clarity and brevity.]
QualityHub: The FDA will discontinue QSIT on Feb. 2. What was your initial reaction when you heard this?
Tim Wells: My initial reaction was disappointment, quickly followed by a reality check. I can’t believe QSIT was still being used 25 years after its creation and implementation. With so many changes in the MedTech industry, it should not surprise us when a new inspection approach is implemented.
As far as technical issues, the FDA needs to address more of the areas that ISO 13485 points out in very clear language. I am hoping the agency’s new medical device inspection approach continues to be both effective and efficient.
QH:What do you consider to be QSIT’s most significant impact on medical device quality and patient safety?
TW: Those of us who worked on QSIT can be proud of the impact QSIT has had on medical device quality and patient safety. As soon as QSIT launched, the industry quickly adopted it as an “internal” tool. We hadn’t thought much of this happening, as we at the FDA were focused on the use of QSIT by the field investigators. However, industry was not sitting back to await their QSIT inspections by FDA. Many companies started doing their own QSIT audits and they also were using third-party auditors, including QualityHub, to perform QSIT audits.
The greatest impact is the byproduct of industry using the QSIT audit tool. QSIT made the FDA more efficient and effective, but the adoption of QSIT as a self-policing tool resulted in many companies discovering areas of risk to both patients – and themselves from a regulatory perspective. I can’t put my finger on a dollar amount or the number of decreased recalls or decreased FDA-483 inspectional observations [because of the use of QSIT], but I believe strongly that both patient safety and self-policed companies improved after QSIT.
QH: You created QSIT while at the FDA, and today you lead QualityHub, advising companies on quality systems. Did your perspective on inspections change after you began working with industry?
TW: When we launched QSIT we also launched a nationwide training program for FDA investigators and compliance officers. We put in place a rule that investigators had to pass the QSIT exam before performing QSIT inspections. Several hundred field investigators nationwide were trained. We wanted to remove the randomness of FDA device inspections and focus all the inspections on those key QSIT areas. And it worked.
While my perspective on inspections never changed, I always wanted to see consistent, quality, and thorough FDA inspections. The QSIT tool has always been the same, but the users of the tool, the investigators, did change over time.
Except for for-cause inspections, where the FDA uses more experienced investigators, I believe we are seeing less consistency and depth of agency inspections. That said, I believe the FDA is doing its best to continue performing device inspections with the resources it has. Turnover at the FDA will always impact the continuity of inspections and training will always be an issue. As it stands today, the varying level of experience in FDA field forces will continue to result in uneven and very different inspections from investigator to investigator.
QH: Do you believe QSIT is still useful for industry even though the FDA will no longer use it?
TW: The QSIT approach is still very useful and can be adapted to many different areas – even areas outside of medical devices. One of the big ideas baked into QSIT is to take a “top down” approach to auditing. What this means is that the investigator/auditor begins by reviewing the procedures, policies, forms, et cetera, for any area of the quality system. They then go “down” into the records associated with those systems. This allows them to see whether they are using the procedures, tools, and other things that were put in the procedures, but also it will show whether the outputs from the procedures – a.k.a. records, or what ISO calls “objective evidence” – demonstrate a functional and compliant system.
This review of both records and procedures could find that procedures are not being followed but it also could find that despite procedures being followed, the process itself is not adequate. The trick to a good audit is to review both records/raw data and procedures without relying on one or the other as a basis for judgement.
QH: With decades of regulatory experience, do you believe FDA inspections nowadays should be more flexible and risk-based, or do investigators still need a structured roadmap like QSIT?
TW: I like the FDA approach of having both “routine” inspections as well as “for cause.” The risk-based approach allows flexibility and this area is getting bigger with the FDA and rightly so. When the agency has fewer resources, it needs to focus on the higher-risk areas, but a structured approach with a roadmap is still very much needed.
Because most FDA inspections are not for cause, they need tools for “normal” inspections. But with limited time to do the inspections, the tools need to get the investigators focused on the key areas they should cover in the inspection. With specific questions to ask – as we included in QSIT – the investigators should be able to cover the right amount of ground and be able to examine those areas that are most important.
QH: If you were designing an inspection framework from scratch in 2026, what would you do differently than you did in 1999?
TW: The design of the QSIT tool is user friendly, logical, and easy to follow. I would want any new inspection framework to follow the basic instructional approach that was used in QSIT.
Nevertheless, one of the things I would do differently is focus even more on the linkages. As a consultant we see how important the linkage is between complaints and design, for example. A complaint handling system without a direct link to the design department is risky. Complaints should be connected to product improvement. Design personnel must take all the complaint data as inputs to build better products or improve their labeling. I would emphasize the need to audit both of those systems together.
Another thing I would do is put more emphasis on management controls. I’m not talking about management review. I’m talking about all the things in the US regulations and ISO standards on management controls. This is an even bigger linkage issue because both the US and ISO trace all the gaps in the systems back to management. Management controls are not just nice to have, they are essential. The new audit tools should drive the investigator or auditor to connect the dots. (Related Story: “Successful MedTechs Use Management Controls to Oversee Quality Systems, Avoid FDA Risk. Here’s How Yours Can, Too,” QualityHub, Dec. 4, 2025.)
Lastly, I would be certain to make risk management a big underlying principle. I like to use the analogy comparing the building of a medical device to the building of a house. For your house you need footings before you pour the foundation. If you build the house on the foundation it won’t collapse because you have adequate footings. Design controls – called design and development in the QMSR – is the foundation, but risk management is the footings. (Related Story: “Risk Management & QMSR: 7 Questions Answered By FDA,” QualityHub, Jan. 15, 2026.)
When it comes to medical devices, often the problems found in recalls, complaints, and CAPAs can be tied back to inadequate risk management. In fact, you could go all the way back to conceptualization. Risk is an inherent component when companies design and make medical devices, yet too often corners are being cut or procedures and practices are not adequate to foresee risks. We need to mitigate the risks in the product’s design, and then again when problems occur after launch. The new audit approach should be heavy on the review of how risks are incorporated into the product and into quality systems.
QH: Finally, on a personal note, how do you reflect on QSIT’s legacy – and what do you hope the FDA and industry remember about QSIT’s role in medical device history?
TW: It turns out that QSIT was more than an FDA inspection tool. When medical device manufacturers took the QSIT inspection tool and used it themselves to audit, evaluate, calibrate, and validate their own quality systems, that made QSIT a win for the FDA, industry, and the public. Over the years industry has stepped up and made their products safer and they developed better quality systems.
The legacy of QSIT was a better understanding of the Quality System Regulation – not just at the FDA but in the device industry, which led to improvements in products and quality systems.
But I can’t take all the credit. There was a team of developers and writers who built QSIT, including Rob Ruff, Georgia Layloff, Denise Dion, and Norm Wong, who represented the field force at the FDA, and from CDRH [the agency’s Center for Devices and Radiological Health] we had Chris Nelson, Cory Tylka, and me as the Team Leader. We also had advisors and committees, and we had panels of quality-system-related industry personnel. Lastly, we used graphic design techniques to make the QSIT book more user friendly, understandable, and easy to follow.
