Transcript QMS at FDA - ASQ East Bay Section

Page
QualityTitle
Management
@
Mo Samimi, Ph.D. CMQ/OE
Presented at the ASQ Biomedical Division
Northern California Discussion Group.
May 2011
A short personal history
Finished Ph.D. in Food Science in ’84, and
worked as a Post-Doc for 2 years
Worked in the Food Industry for 7 years
Consulting for 9 years
Joined FDA in 2003
– QSM in SAN-DO Lab for ISO-17025
accreditation.
– Joined the QMS group in the Office of the
ACRA in 2009.
Looking from the outside
Looking from the inside
FDA ORG Chart
FDA Organization Charts
Centers & Offices
–Office of the Commissioner
–Center for Biologics Evaluation and Research (CBER)
–Center for Devices and Radiological Health (CDRH)
–Center for Drug Evaluation and Research (CDER)
–Center for Food Safety and Applied Nutrition (CFSAN)
–Center for Tobacco Products (CTP) (New)
–Center for Veterinary Medicine (CVM)
–National Center for Toxicological Research (NCTR)
–Office of Regulatory Affairs (ORA)
How do you implement QMS?
How do you implement QMS in a
bureaucratic –and compartmentedorganization?
How do you align QMS with the FDA’s
mission and vision?
How does a large organization, such as
the FDA, accomplish it’s mission?
Alignment in
purpose for all its
functional units.
FDA Mission
FDA is charged with protecting the public health by
ensuring the safety, effectiveness, and security of human
and veterinary drugs, biological products, and medical
devices; ensuring the safety of foods, cosmetics, and
radiation-emitting products; and regulating tobacco
products.
Specifically, FDA is responsible for advancing the public health by:
Helping to speed innovations that make foods safer and make
medicines and devices safer and more effective;
Ensuring the public has accurate, science-based information they
need to use medicines, devices, and foods to improve their health;
Regulating the manufacture, marketing, and distribution of tobacco
products and reducing tobacco use by minors; and,
Addressing the Nation’s counterterrorism capability and ensuring the
security of the supply of foods and medical products.
FDA Vision
FDA is dedicated to world-class excellence
as a science-based regulatory agency with
a public health mission. We aim to provide
effective and innovative leadership — both
domestically and internationally — to
protect health, prevent illness, prolong life,
and promote wellness.
HHS Mission
The mission of HHS is to enhance the health
and well-being of Americans by providing
effective health and human services and by
fostering sound, sustained advances in the
sciences needed to promote medicine, public
health, and social services.
ORA Mission and Vission
ORA Mission:
ORA Vision:
Protecting consumers and enhancing public
health by maximizing compliance of FDA
regulated products and minimizing risk
associated with those products.
All food is safe; all medical products are safe
and effective; and the public health is
protected and advanced.
What QMS hopes to achieve
Employees
Management
Supervisors
Mandate and Funding
(Congress)
Staff Manual Guide (SMG) 2020
Similar to the International Standards (ISO,
etc.), SMG defines the requirements, and
establishes guidelines, to allow each Center
or Office, to set up their own QMS.
SMG2020 Page
QMS at FDA today
Strategic Priorities
FDA Strategic Priorities
QM Plan
FOREWORD
Quality is defined as a measure of a product's
or service's ability to satisfy the customer's
stated or implied needs (Staff Manual Guide
(SMG) 2020). Quality Systems (also called
Quality Management Systems) are formalized
business practices that define management
responsibilities for organizational structure,
processes, procedures, and resources needed
to fulfill product/service requirements, customer
satisfaction, and continual improvement (SMG
2020). There are many quality process
improvement models that take this approach,
including the plan– do–check–act cycle included
in SMG 2020. Quality Systems are typically
documented and managed by means of Quality
Management Plans (QMPs).
CDRH – Direct Reports
CFSAN QA Newsletter
CFSAN Lab QM
ORA-Timeline1
ORA-Timeline2
ORA-Timeline3
ORA-Timeline4
ORA Quality Policy
ORA QM
ORA Core QMS Procedures
ORA-QMS.001 Document Control & Management
ORA-QMS.002 Record Control
ORA-QMS.003 Management Review
ORA-QMS.004 Audits
ORA-QMS.005 Control of Non-Conforming
Processes, Services or Products
ORA-QMS.006 Continual Improvement Procedure
ORA-QMS.007 Corrective Action Procedures
ORA-QMS.008 Preventive Action Procedure
ORA-QMS.009 Complaints and Other Feedback
Current State of QMS @ ORA
All ORA units have at least one QSM
All units of ORA have implemented the core
procedures.
At least one round of management review is
conducted in each business unit.
All QSMs will be ASQ certified (CMQ/OE) by the
mid FY 2012.
Audits performed on all units for basic quality
functions (e.g. doc control, records
management, etc.)
Application of QMS at FDA
Documented QMS reviews by the Management.
Records of non-conformances for trending and
process improvement
Addressing internal/external* complaints, and
starting corrective actions when needed.
Opening proper communications channels
between different “pyramids” within the FDA.
Making sure the Management takes ownership
of quality issues.
Inventory Approximate Numbers
(not including medical gas)
USA
2,000 human drug manufacturing sites
1,100 human drug CGMP inspections/yr
200 pre-market approval inspections
International
3,500 human drug manufacturing sites
200 human drug quality inspections/yr
FDA’s Foreign Inspection
Accomplishments
1400
1200
213
1000
800
600
400
200
96
153
148
350
132
125
270
267
153
329
262
499
491
2007
2008
264
259
277
687
374
370
342
2004
2005
2006
0
2003
2009
Other
Foods
Devices
Drugs
Why QMS is important to the FDA?
Thank you!
Links and info
– www.fda.gov
– [email protected]
– 510-846-7973 and 510-287-2709