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A Compliance-Alliance survey
Demographics
Two hundred and fifty eight (258) professionals in medical device firms
completed the survey. Respondents represented firms of various sizes that
manufacture medical devices in class I, II and III. With the exception of
the number of personnel employed in specific functions, there were no
significant differences among the answers based on the size of the firm. For
a breakdown of the number of personnel employed in various functions, see
Appendix 1.
1.
Organization
of Quality/Regulatory/Compliance Function
Approximately half of the firms organized their
quality/regulatory/compliance function locally by manufacturing site, while
the other half had corporate oversight for these functions.
Comments:
Corporate must
have oversight responsibilities and direct responsibility for QA and RA.
Corporate is the umbrella over all other systems and facilities. - Ken
Imler, Arrow International In large firms,
any given manufacturing site quality system should have a definite
mechanism for assuring the site complies with corporate quality policies.
FDA will hold headquarters management accountable/responsible for site
failures. Corporate management reviews should include assessments of site
quality functions. - Denise Dion, EduQuest
2.
Responsibilities
There was variation among the responses about who was the responsible party
for each function. The most common responses indicate that
Quality has
responsibility for CAPA management, document control, equipment
calibration, external audits, final inspection, incoming inspection of raw
material, in process inspection, internal quality audits, management
representative, product and GMP audits, product complaint management,
product releases, process validation, risk management, sterilization,
supplier program management, and supplier qualification. Regulatory has
responsibility for adverse event reporting, annual product releases,
facility registration and licenses, production registration and
certification, product regulatory submissions, and recalls. Compliance/other
groups have responsibility for business code of conduct, environmental
program management, health and safety program management, preventive
maintenance, and training.
Comments:
In addition to
the items others have listed, my experience has been that the most
effective QA and RA groups have a major role in establishing, maintaining
and continuously improving metrics, monitoring and reporting of quality
data. The key areas are NCMR, CAPA, complaints/MDR/field actions, change
management, risk management, and management responsibility. This does not
exclude other areas; these are the primary areas. - Ken Imber, Arrow
International Having separate
functions for quality, regulatory and compliance is normal. The management
representative should have a mechanism to be informed of all quality
issues, no matter what department he/she is part of. It is also important
to assure quality remains independent of production (or R&D in design
only) facilities. - Denise Dion, EduQuest
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