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The
respondents described various reporting structures with
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41% of quality/regulatory/compliance groups reporting to a single
point of control and
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28% of quality, regulatory and compliance groups having independent reporting structures.
Comments:
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There are as many ways to do this as there are companies. The goal
is to have a structure that allows effective, efficient and timely
oversight and control. The most effective companies I have seen have
independent facility RA, QA and Compliance groups with a common
corporate oversight group that establishes and maintains consistency. -
Ken Imler, Arrow International
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I am surprised that so few organizations have a single point of control. I would
prefer to see more central control. -Tim Wells, The QualityHub
4. Top Official
There was a wide variation as to the title of the top of official
for the quality, regulatory, quality/regulatory and compliance
functions. The most common title was vice president or senior vice
president.
Comments:
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The major issue here is that the top QA, RA and compliance
person is at the same level as the top finance, marketing, R&D,
etc. executives. - Ken Imber, Arrow International
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It is important that the quality organization have similar
titles as that used in the production or manufacturing
organization. These organizations should be viewed as peers. -
Denise Dion, EduQuest
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I concur that this needs to be VP level. In fact Senior VP is
appropriate for the larger companies. - Tim Wells, The QualityHub
5.
Reporting Relationships
Most of the respondents reported that their quality, regulatory,
and compliance officials report directly to the president.
Comments:
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Quality, regulatory and compliance are senior management
responsibilities and should be recognized as such. - Steve Ojala,
Zimmer Corporation
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In my opinion, companies where quality and compliance
functions do not report to the president are often the same
companies facing compliance actions by FDA. It is essential that
quality report to the CEO/President. This assures independence as
well as access to resources. - Tim Wells, QualityHub
6.
Reporting to the Board of Directors
A majority of firms (59%) had their senior
quality/regulatory/compliance functions periodically report to the
Board of Directors.
Comments:
-
Focused quality companies provide regular updates to the Board
of Directors. - Steve Ojala, Zimmer Corporation
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Since the Board of Directors can also be held responsible for
quality system deficiencies, they should be aware through
management reviews of quality problems. - Denise Dion, EduQuest
7.
Ability to Stop Production and Order
a Product Recall
Most respondents (91%) reported that their firms allow their top
quality/regulatory personnel to stop production or order a recall.
Comments:
-
All world-class quality companies empower the quality and
regulatory functions to stop production or initiate a recall. -
Steve Ojala, Zimmer Corporation
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This is a positive trend that should be reinforced. - Denise
Dion, EduQuest
8.
Scope of the Regulatory Function
A majority of firms (67%) reported that the regulatory function
was responsible for product submissions, compliance to QSR, and
ISO13485; while 37% reported that the regulatory function was only
responsible for product registrations and licenses.
Comments:
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Depending on the size and structure of the organization, this
can be combined or separated. In either case, the functions must
communicate and coordinate their activities. - Ken Imber, Arrow
International
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Regulatory and quality are almost inseparable functions that
need to be tightly coordinated to be effective. - Steve Ojala,
Zimmer Corporation
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I am seeing more and more separation of the quality and
regulatory functions. Unless the company is quite small, I would
not recommend combining responsibilities. It spreads the manager
too thin. - Tim Wells, The QualityHub
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