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A Compliance-Alliance
survey
9.
Commitment to Quality/Regulatory
Compliance
When asked about commitment to quality/regulatory compliance,
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27% reported that their firms strive to be the
best the in industry,
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62% reported that their firms wanted to assure
product safety and efficacy, and essential quality system
compliance, and
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7% reported wanting to minimally meet the
requirements.
Comments:
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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
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"Best in the business and an attractive place
to work" is an attractive vision for me. - Steve Ojala, Zimmer
Corporation
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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
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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,
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17% reported that they were among the best in
the industry,
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59% of respondents reported that they had
strong performance (few to no major nonconformities),
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21% reported mediocre performance (some major
nonconformities in some areas), and
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3% reported weak performance (major
nonconformities).
Comments:
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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
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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).
Comments:
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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
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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
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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.
Comments:
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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
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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
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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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