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  • Ricki Chase


If you work in the medical device arena and have products in the US, then you are likely familiar with the FDA’s Quality System Inspection Technique or QSIT. QSIT is the method taught to FDA investigators which they are expected to follow when inspecting a medical device firm. It was developed with good intent to focus investigators on the critical elements of the quality system while allowing inspections to be completed quickly. Further, the publication of the inspection technique made it completely transparent to the industry the specific types of questions that would be asked and what the investigators would be reviewing.

If you are not familiar with QSIT, it is based on 21 CFR Part 820, Quality System Requirement (QSR), and identifies four key quality system elements: Design Control, Corrective and Preventive Action (CAPA), Production and Process Control (P&PC) and Management Control, with the other elements of the QSR being identified as satellite systems. QSIT instructs the investigator to inspect the firm as either a full or abbreviated inspection based on several factors. A full inspection is expected to last four days and cover each of the four subsystems. The abbreviated inspection is expected to last two days and cover two of the four subsystems.

QSIT was doomed from the start. When it was first launched, FDA investigators were told you always inspect CAPA and add one other subsystem for an abbreviated inspection. It did not take long to see that human nature coupled with the ongoing struggle of FDA to retain investigators resulted in poor decision making. FDA investigators quickly discovered that inspecting CAPA and management made for the quickest entrance and exit from a firm.

Most investigators have little appreciation for the impact of various aspects of the regulation. Specifically, FDA-483 Observations noting lack of management controls and oversight rarely result in Warning Letters on their own. They must be almost completely absent or egregious in their deficiencies and coupled with stronger observations related to CAPA, Design or P&PC. The fact is lack of management oversight is hard to punish if there is nothing else going wrong. The QSIT approach did allow FDA to come closer to meeting their statutory obligations for biannual inspections of device firms by keeping them short and plentiful.

Within a few years, the FDA’s management got wise to this approach and changed the inspection requirement to CAPA plus either Design Control or P&PC, meaning that management controls were only evaluated when a full inspection was required. You would think that this would solve the matter. Once again, Agency shortcomings skewed inspections in another direction, P&PC. It was noticeable that P&PC was the subsystem of choice leaving Design Control swinging in the wind. I have a lot to say about FDA’s inspection of Design Control…but saving that for later.

During my time at ORA, I believe with the objective in mind to complete more, timely inspections with fewer resources, the programs governing how inspections were performed and reported became dumbed down. Instead of hiring investigators with critical thinking skills and an understanding of risk, and teaching them the application to medical device inspections, ORA simply handed them a book of questions to ask and then armed them with a “pick your observation” program to make it easier to communicate the answers (eNSpect program for writing Establishment Inspection Reports and Inspectional Observations).

With the pseudo harmonization of the QSR with ISO 13485 resulting in the new Quality Management System Requirement (QMSR), the shift should be toward evaluation of risk and risk management across the quality system. FDA has stated that a new inspectional technique to address the move to QMSR will need to be developed. I am hopeful that the QSIT concept is not even remotely a model for this new approach.

FDA investigators should be trained to thoroughly evaluate the requirements of ISO 13485 and the nuances that will remain as part of FDA’s QMSR. Proper training will need to include the ability to evaluate the facility, products, personnel, firm and quality system performance history, design, and production before making the decision of where to focus the investigator’s resources during the inspection. Ideally, the FDA will train investigators on the principles of risk and the application of risk management such that they can adequately evaluate the firm’s quality system, identifying any gaps which would potentially impact patient safety or outcomes.

In my experience, investigators are still limiting their inspections to asking if a firm has risk management (often limited to the context of design). When risk management is presented, few investigators know what they are looking for or in what context to make that information valuable. This approach does not help to identify opportunities for improvement or prevention.

Moving away from QSIT and into a risk-based inspection model, not just in deciding which firms are inspected when, but what specifically should be evaluated at each inspection, can help FDA identify potential gaps earlier and put firms on notice that improvements are expected before adverse outcomes are realized. In the absence of QSIT, questions remain regarding how FDA will manage investigator resources without a program which seeks to set time limits around the hours spent on inspection.

The medical device community will need to adjust as well. The QSIT program has been around for over twenty years. It is routine for management to ask and for the investigator to tell what level of inspection is to be conducted, and frequently that is communicated at the pre-announcement of the inspection. I expect pre-announcing inspections will remain, but hopefully under the QMSR, QSIT will go away, and inspections will be performed more organically based on the totality of intelligence available to the investigator. This means the firm may no longer be able to anticipate that the inspection will only focus on CAPA and P&PC or CAPA and Design. It is possible, and recommended, that the inspection follow the signals and not be limited by an arbitrary inspection program.

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