Are You Mismanaging Your Management Review?

During the many quality system regulation (QSR) audits I have done with device companies, two troubling aspects have always struck me. The first one was a consistent lack of involvement of staff with executive responsibility. The second was that companies seem to merely go through the motions in their approach to management review. Occasionally, I asked the interviewee to give me some examples of problems the company has solved using the management review process. A few executives were able to cite examples of major product redesign or product recall after extensive investigations identified the problem. After all, that is the key purpose of the review: to enlist management’s help in solving problems that production line or department level employees cannot solve on their own. In addition, the review gives executive management the opportunity to fulfill its responsibility under QSR Section 820.20(c) to review quality systems at defined intervals.

Quality system regulations are substantive rules promulgated under the authority of the Federal, Food, Drug, and Cosmetic Act as Amended. They have the force of law. Management review is a specific requirement listed under Subpart B of the regulations titled Management Responsibility.

Why are these observations important for device makers? Taking management review seriously gives device company executives an additional opportunity to use group dynamics and “big picture” thinking to solve more elusive problems. The regulations require the quality organization within the company to investigate process and procedural deviations as well as product non-conformities in separate sections of the regulations. While management review is a regulatory requirement for devices made or marketed in the U.S., the International Conference on Harmonization (ICH) Q10 Draft Consensus Guide on Pharmaceutical Quality System recommends in Section 2.6 that the review be used by senior management as a means to assure appropriate governance of quality systems.

Managers and executives with little quality system experience should be advised that FDA and government attorneys use a principle of “strict liability” when interpreting the statute. This means that executives that are in a position to know about violations and have the authority to take action to resolve them may be held responsible for violations even if they did not know they occurred. This principle has been sustained by case law, and in this era of more conservative FDA enforcement, it is important to understand.

Good sources of information on management review are contained in FDA’s Compliance Program Guidance Manual, C.P. 7382.830, Inspections of Device Manufacturers, FDA’s Guide to Inspections of Quality Systems QSIT 1999, pp. 18—30, and American National Standard ANSI/AAMI/ISO 13485:2003 Medical Devices—Quality Medical Systems—Requirements for Regulatory Purposes.  

What Should The Review Encompass?

Essentially, management review should provide an objective measure of each quality system to insure its effectiveness. Typically, FDA does not provide formal guidance and nor specify metrics; therefore, you should use those processes and metrics that are the most meaningful to you and your device company. There is a good list in ISO 13485 Section 5. Section 5.6.2 of the ISO standard provides the following inputs: results of audits, customer feedback, process performance, product conformance, status of corrective and preventive actions, follow-up to previous reviews, changes that could impact quality systems, improvements, and new regulatory requirements. It is common to see frequency diagrams presented for various systems and also the use of standard scorecards in order to easily compare performance from one review period to another.

Management theory authors believe that the most successful organizations are those that are equipped and motivated to respond to challenges and problems they detect. Some call these “learning organizations.”These organizations learn lessons before their competitors or the marketplace do and act on this learning in order to give themselves a competitive advantage.

I have told clients that quality problems in well-designed devices come from only three places:

A comprehensive quality system has information about all these sources. The sources can help you identify issues if you understand them and react appropriately. Admittedly, there is a lot of information that could be presented. Also, there may be a lot of “noise”in the systems. For example, some product complaints are based on consumers’ perceptions about a product and do not really identify a problem with device quality.

If you are beginning to implement a management review process because you plan to introduce a commercial product in the near future, then I recommend that you spend some time with each quality system owner. By definition, quality systems are aspects of a company’s business that go beyond basic production processes. They include complaint investigation, preventive maintenance, and calibration. Usually, there is an appointed system owner in a given quality, production, or engineering department to help develop useful metrics and information. This overall consultation process should help you to answer the basic question: Is our system under control, or does the information suggest we have or may have quality problems?

More Questions

If you are responsible for a mature organization whose key employees have been in place and working together for a number of years and are participating in routine management reviews, then I recommend that you ask yourself and quality system owners some of the following questions. (In fact, you might prepare a 3 × 5 card with standard questions in advance.)

Regarding the last point, ask the assembled experts what they think the data mean and how they would go about confirming their hypotheses. 

Once you have answered these questions, you should consider your options, as follows: 

If you do not have this type of engagement with your quality system experts, then you are not getting the information you need. That information should answers questions such as:

At the conclusion of the discussion of each quality system metric, decide whether action is necessary. Document the decision and course of action with an assigned person and establish a time frame for completion or status report.

When most processes appear to be under control, think about introducing an initiative to reduce the most frequent defect. Ask yourself: What would it cost to reduce this defect and what would it mean to the company and product if we could eliminate or reduce the frequency of this defect?

Thoughts On Team Building

You should conduct these reviews with your staff in a very professional manner and should encourage two-way communication. Occasionally, you will have to explain that this is not an “us- versus-them” scenario and assure all present that you are concerned with the overall state of the company, as should they. This is executive management’s opportunity to show other members of the team, particularly Quality Assurance, that their contributions are valued. Make sure that all present feel their contributions and ideas are welcome. If a course of action requires a shifting of resources, then that should be a part of the decision-making process and recorded. 

Now that you have succeeded in reducing or eliminating a defect or noncompliance, reflect on how you accomplished this improvement. Write up a short statement to memorialize how you improved the process and the resources and time it took. You may want to reward and recognize the team, particularly if team members were willing to take on extra tasks or extra responsibilities. These success stories can tell you a lot about your organization and how your staff solves problems. It is likely there will be lessons learned that will make it easier the next time, provided that you take the management review process seriously.

Mark A. Lynch is a vice president with Parexel Consulting, a subsidiary of Parexel International LLC (Waltham, MA). As a member of the Strategic Consulting Services business, he helps U.S. and international clients prepare for and manage successful preapproval inspections and FDA GMP systems inspections. Previously, Lynch served 26 years with FDA in a variety of positions, including chief of the investigation and Preapproval Compliance Branch, Office of Compliance, Center for Drug Evaluation and Research (CDER). He may be reached at 301/963-0811 or at [email protected].