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Survey Results on The Structure of Medical Device Firms' Quality/Regulatory/Compliance Functions

July 2006


Medical Device Complaint Handling Practices
                    A Compliance-Alliance survey 

9. Commitment to Quality/Regulatory Compliance

When asked about commitment to quality/regulatory compliance,

  • 27% reported that their firms strive to be the best the in industry,

  • 62% reported that their firms wanted to assure product safety and efficacy, and essential quality system compliance, and

  • 7% reported wanting to minimally meet the requirements.


  • This is also an "it depends" situation. All companies should strive to be "state of the art." Best in class and world class efforts may be beyond many companies' ability to achieve. The investment is too great in terms of people, resources and capital. - Ken Imler, Arrow International

  • "Best in the business and an attractive place to work" is an attractive vision for me. - Steve Ojala, Zimmer Corporation

  • The goal for products, processes, and systems should be perfection. A company that strives to be the best in quality shows a true understanding of the reason for having a quality system. Perfection will never be reached, but moving in that direction is why we control design, manufacturing and changes, and utilize a feedback loop (CAPA). - Denise Dion, EduQuest

  • I am disappointed that any company would be in this business and strive for only meeting minimal requirements. - Tim Wells, The QualityHub

10. Performance of Quality/Regulatory/Compliance Function

When asked about how they would characterize the performance of their quality/regulatory/compliance function,

  • 17% reported that they were among the best in the industry,

  • 59% of respondents reported that they had strong performance (few to no major nonconformities),

  • 21% reported mediocre performance (some major nonconformities in some areas), and

  • 3% reported weak performance (major nonconformities).


  • The brutal facts are that only a small percentage is truly among the best. Most are in the average/competent range and a few are not effective. The problem is that many of the average/competent companies fail to recognize and accept their true status and therefore fail to make the investments (people, infrastructure, systems) required to reach and maintain "state of the art" let alone continuous improvements. - Ken Imler, Arrow International

  • If you believe your quality system needs an overhaul, take the time to look at your policies, procedures and actual practices as part of a failure investigation. Flowchart your systems and your processes. Use technical writers to write your procedures to assure they are concise and well written and not ambiguous. Make sure your flow charts for each process or subsystem flow together to form a complete quality system. The time spent in developing systems and processes that are complete, easy to follow/implement and comply with is time well spent. - Denise Dion, EduQuest

11. Measuring the Cost of Poor Quality

The majority of firms (53%) are not measuring the cost of poor quality (the cost of internal and external failures, appraisal, and preventive action).


  • The "Cost of Quality" is a metric that all good companies should utilize. How can you measure effectiveness and efficiency without it? It must include the price of conformance as well as the price of nonconformance. It can be just as important to lower the price of conformance as the price of nonconformance. - Ken Imler, Arrow International

  • The "Price of Non-Conformance" was one of the four absolutes that Phil Crosby promoted in his fundamental overview of Quality, which is still relevant today. Steve Ojala, Zimmer Corporation

  • When nothing bad is happening, how do we convince management that it is because of our good quality system? We need to show how good quality has increased our market share, decreased our inspection times, reduced our nonconformities, increased our yields, reduced costs of purchased products, etc. - Denise Dion, EduQuest

12. Use of Risk Management Principles in the Quality System

The majority of firms are using risk management principles throughout their quality system.

  • 94% design control,
  • 72% CAPA,
  • 89% complaint management,
  • 50% management review, and
  • 54% process control.


  • Risk management principles need to be utilized throughout the life cycle of the product, as it is a dynamic process, not simply a design control tool. - Steve Ojala, Zimmer Corporation

  • Using risk to help us make better decisions will assure that we spend our resources wisely. But only if quality is part of our risk decisions, not just cost/benefit issues. Denise Dion, EduQuest

  • These numbers are good, but I think they should be higher. Risk management is huge. Clearly it is not just needed for design control. The FDA stated in the QSR preamble that risk management should also be used in CAPA. It also is essential in production and process control. It is worth noting that the FDA used the word "risk" close to 50 times in the QSR preamble. - Tim Wells, The QualityHub



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