fda approach to auditing
Post on 06-Apr-2018
219 Views
Preview:
TRANSCRIPT
-
8/3/2019 FDA Approach to Auditing
1/38
25 Sept. 2003 Frankfurt, Germany 1
U.S. FDA Approach to
Auditing Including QSIT
Christine Nelson
Center for Devices & Radiological Health
Food & Drug Administration
-
8/3/2019 FDA Approach to Auditing
2/38
25 Sept. 2003 Frankfurt, Germany 2
FDA-Speak Terms
Inspection = Audit
I
nvestigator = Auditor
-
8/3/2019 FDA Approach to Auditing
3/38
25 Sept. 2003 Frankfurt, Germany 3
Why does FDA inspect device
manufacturers?To evaluate compliance with the
following FDA device regulations:
Quality SystemsMedical Device Reporting
Medical Device Tracking
Reports of Corrections andRemovals
Registration and Listing
-
8/3/2019 FDA Approach to Auditing
4/38
25 Sept. 2003 Frankfurt, Germany 4
Who conducts inspections for FDA?
1. FDA investigators in 20 FDA District
Offices around the U.S.
2. FDA-trained Auditors from ConformityAssessment Bodies in the European
Union (EU)
3. In the future, FDA-trained auditors fromindependent third parties accredited by
FDA
-
8/3/2019 FDA Approach to Auditing
5/38
25 Sept. 2003 Frankfurt, Germany 5
How does FDA decide who to
inspect?Registration database identifies who
manufactures devices for distribution in
the U.S. Listing database identifies what devices
they distribute
FDA prioritizes inspections by risk andgives higher risk devices/situations ahigher priority
-
8/3/2019 FDA Approach to Auditing
6/38
25 Sept. 2003 Frankfurt, Germany 6
What is high priority for inspection?
Device manufacturers that:
Make class III devices
Make implantable devices and life
supporting and life sustaining devices
Recently introduced a new device to the
market
Have had significant violations in the
past
-
8/3/2019 FDA Approach to Auditing
7/38
25 Sept. 2003 Frankfurt, Germany 7
Does FDA notify the manufacturer
of an upcoming inspection?FDA calls domestic manufacturers about
5 days before the inspection
FDA contacts foreign manufacturers 2 - 3
months in advance to schedule inspection
Manufacturer is requested to send QualitySystem Manual or equivalent for pre-
inspection review
-
8/3/2019 FDA Approach to Auditing
8/38
25 Sept. 2003 Frankfurt, Germany 8
What happens when the FDA
investigator arrives at the site?The FDA investigator will:
Ask to see the top management
Present credentials (identifies person
as an FDA investigator)
Issue notice of inspection explainingFDAs legal authority to inspect (only
in the U.S.)
-
8/3/2019 FDA Approach to Auditing
9/38
25 Sept. 2003 Frankfurt, Germany 9
What happens during the
inspection? Investigator may tour the facility to get
an idea of layout, workflow, and areas
that may need closer inspection
This helps the investigator
decide how to organizethe inspection
-
8/3/2019 FDA Approach to Auditing
10/38
25 Sept. 2003 Frankfurt, Germany 10
What happens next?
The investigator will:
Ask about size and structure of
company, who is in charge, whatproducts are manufactured there
Review registration and listing
Evaluate compliance with FDAregulations using the Quality SystemInspection Technique (QSIT)
-
8/3/2019 FDA Approach to Auditing
11/38
25 Sept. 2003 Frankfurt, Germany 11
What is QSIT?
GGUIDEUIDETOTO IINSPECTIONSNSPECTIONSOFOF
QQUALITYUALITY SSYSTEMSYSTEMS
F O O D A N D D R U G
A D M I N I S T R A T I O N
August 1999August 1999
www.fda.gov/ora/in
spect_ref/igs/qsit/q
sitguide.htm
-
8/3/2019 FDA Approach to Auditing
12/38
25 Sept. 2003 Frankfurt, Germany 12
What is QSIT?
Identifies 4 major subsystems to
evaluate and states the purpose and
importance of each subsystem
Provides flowcharts and inspectional
objectives to cover during inspection
Offers adviceProvides tables for statistical sampling
of records for review
-
8/3/2019 FDA Approach to Auditing
13/38
25 Sept. 2003 Frankfurt, Germany 13
What are the four main subsystems?
DesignControls
MaterialControls Records,
Documents, &
Change Controls
Equipment &Facility Controls
Production &Process Controls
Corrective &
Preventive
Actions
Management
-
8/3/2019 FDA Approach to Auditing
14/38
25 Sept. 2003 Frankfurt, Germany 14
What does FDA look for in the
Management Subsystem?Quality Policy established?
Management representative
appointed?
Management reviews conducted?
-
8/3/2019 FDA Approach to Auditing
15/38
25 Sept. 2003 Frankfurt, Germany 15
What does FDA look for in the
Management Subsystem?Quality audit procedures
established and quality audits
conducted?
Quality plan established?
Quality system proceduresestablished?
-
8/3/2019 FDA Approach to Auditing
16/38
25 Sept. 2003 Frankfurt, Germany 16
What does FDA look for in the
Design Control Subsystem?Design procedures and plan established?
Design inputs or requirements for device
identified?
Design outputs or specifications for
device identified?
Design verification conducted?
Design validation conducted?
-
8/3/2019 FDA Approach to Auditing
17/38
25 Sept. 2003 Frankfurt, Germany 17
What does FDA look for in the
Design Control Subsystem?Software validation completed?
Risk analysis carried out?
Design reviews conducted?
Design transfer to manufacturingcompleted successfully?
-
8/3/2019 FDA Approach to Auditing
18/38
25 Sept. 2003 Frankfurt, Germany 18
What does FDA look for in the Corrective
and Preventive Action Subsystem?
CAPA procedures established?
Sources of data analyzed to identify
nonconforming product and qualityproblems?
Statistical analysis across data
sources? Investigations conducted to identify root
cause of failures?
-
8/3/2019 FDA Approach to Auditing
19/38
25 Sept. 2003 Frankfurt, Germany 19
What does FDA look for in the Corrective
and Preventive Action Subsystem?
Nonconforming product controlled?
Appropriate corrective actions and
preventive actions carried out?
Those responsible are told about CAPA
activities?
Management review of CAPA activities?
-
8/3/2019 FDA Approach to Auditing
20/38
25 Sept. 2003 Frankfurt, Germany 20
What does FDA look for in the Production
and Process Control Subsystem?
Processes are controlled and
monitored?
Any rejects or nonconforming
product?
Equipment adjusted, calibrated andmaintained?
-
8/3/2019 FDA Approach to Auditing
21/38
25 Sept. 2003 Frankfurt, Germany 21
What does FDA look for in the Production
and Process Control Subsystem?
Manufacturing processes validated
or fully verified?
Software validated?
Production employees trained and
qualified?
-
8/3/2019 FDA Approach to Auditing
22/38
25 Sept. 2003 Frankfurt, Germany 22
What about the other subsystems?
The other three subsystems are covered
through links with the four main
subsystems:Records, documents and change control
Facility and equipment control
Material control
-
8/3/2019 FDA Approach to Auditing
23/38
25 Sept. 2003 Frankfurt, Germany 23
What happens at the end of the
inspection?The investigator will:
Meet with management to discuss the
inspection
Present the FDA 483 list of
observations of any
significant deficiencies
Discuss the deficiencies
-
8/3/2019 FDA Approach to Auditing
24/38
25 Sept. 2003 Frankfurt, Germany 24
What should the manufacturer do
after the inspection?Send a letter to FDA identifying how they
have corrected deficiencies or will correct
them
Provide documentation of any corrections
that have been completed
Provide a timetable or estimatedcompletion date for future corrections
-
8/3/2019 FDA Approach to Auditing
25/38
25 Sept. 2003 Frankfurt, Germany 25
Where should I send the letter?
Office of Compliance
Center for Devices and Radiological
Health (CDRH)Food and Drug Administration
2094 Gaither Road, HFZ-300
Rockville, Maryland 20850U.S.A.
-
8/3/2019 FDA Approach to Auditing
26/38
25 Sept. 2003 Frankfurt, Germany 26
Center for Devices & Radiological Health
Office of the
Center Director
Office of Device
Evaluation
Office ofIn Vitro Diagnostic
Device Evaluation & Safety
Office of
Compliance
Office of Surveillance
& Biometrics
Office of Science
& Technology
Office of Systems
& Management
Office of Health &
Industry Programs
Division of Small Manufacturers,
International & Consumer Assistance
-
8/3/2019 FDA Approach to Auditing
27/38
25 Sept. 2003 Frankfurt, Germany 27
Office of Compliance
Division of Enforcement A
Dental, ENT &
Ophthalmic Devices
OB/GYN, Gastro &
Urology Devices
General Hospital
Devices
General Surgery
Devices
Division of Enforcement B
Cardiovascular &
Neurological Devices
Diagnostic X-ray
Devices
Electronic Products &
Devices
Orthopedic, Physical
Medicine &
Anesthesiology Devices
-
8/3/2019 FDA Approach to Auditing
28/38
25 Sept. 2003 Frankfurt, Germany 28
What happens next?
Investigator writes an Establishment Inspection
Report or EIR
EIR is sent to the Office of Compliance, Centerfor Devices and Radiological Health (CDRH)
Inspection is classified based on inspectional
findings
Office of Compliance reviewer writes Warning
Letter for inspection classified OAI
-
8/3/2019 FDA Approach to Auditing
29/38
25 Sept. 2003 Frankfurt, Germany 29
How does FDA classify inspection
reports?NAI No action indicated
VAI Voluntary action indicated some
deficiencies identified but not serious
OAI Official action indicated
serious deficiencies identified,
and FDA must take action to
assure correction
-
8/3/2019 FDA Approach to Auditing
30/38
25 Sept. 2003 Frankfurt, Germany 30
What actions can FDA take to
addressO
AI inspections?For device manufacturers
outside the U.S.:
Warning Letter
Warning Letter +
Automatic Detention
-
8/3/2019 FDA Approach to Auditing
31/38
25 Sept. 2003 Frankfurt, Germany 31
Warning Letter
FDA sends Warning Letter
describing manufacturers violations
of FDA regulations and requesting areply within 15 days
-
8/3/2019 FDA Approach to Auditing
32/38
25 Sept. 2003 Frankfurt, Germany 32
Warning Letter + Automatic Detention
FDA sends Warning Letter describing
manufacturers violations of FDA
regulations and requesting a reply within
15 days
Manufacturers products
are put on automatic
detention to prevent
them from entering the U.S.
-
8/3/2019 FDA Approach to Auditing
33/38
25 Sept. 2003 Frankfurt, Germany 33
What will the Warning Letter say
about Automatic Detention?
Given the serious nature of these violations ofthe Act, all products manufactured at thisfacility may be detained without physical
examination upon entry into the UnitedStates. In order to prevent your devices frombeing detained without physical exam, yourfirm will need to respond to this WarningLetter (as set forth below) and correct the
violations noted in this letter. In addition, theagency usually needs to conduct a follow-upinspection to verify that the appropriatecorrections have been implemented.
-
8/3/2019 FDA Approach to Auditing
34/38
25 Sept. 2003 Frankfurt, Germany 34
How do I get my devices off
automatic detention?Submit documentation to FDA showing
that deficiencies have been corrected
FDA will inspect you to confirm that
corrections are adequate before lifting
automatic detention
-
8/3/2019 FDA Approach to Auditing
35/38
25 Sept. 2003 Frankfurt, Germany 35
Where can I get more information about
FDA inspections and regulations?
QSIT:
http://www.fda.gov/ora/inspect_ref/igs/qsit/QSI
TGUIDE.PDF
http://www.fda.gov/ora/inspect_ref/igs/qsit/qsit
guide.htm
Inspections of Medical Device Manufacturers
Compliance Program 7382.845:
http://www.fda.gov/ora/cpgm/default.htm#devi
ces More . . .
-
8/3/2019 FDA Approach to Auditing
36/38
25 Sept. 2003 Frankfurt, Germany 36
Where can I get more information about
FDA inspections and regulations?
Quality system regulation:
http://www.accessdata.fda.gov/scripts/cdrh/cf
docs/cfcfr/CFRSearch.cfm?CFRPart=820
General quality system info:
http://www.fda.gov/cdrh/devadvice/32.html
Investigations Operations Manual:
http://www.fda.gov/ora/inspect_ref/iom/default
.htm
More . . .
-
8/3/2019 FDA Approach to Auditing
37/38
25 Sept. 2003 Frankfurt, Germany 37
Where can I get more information about
FDA inspections and regulations?
Other medical device regulations:
http://www.fda.gov/cdrh/devadvice/
Division of Small Manufacturers, Internationaland Consumer Assistance - E-mail:
dsma@cdrh.fda.gov
Christine Nelson E-mail: mcn@cdrh.fda.gov
-
8/3/2019 FDA Approach to Auditing
38/38
25 Sept. 2003 Frankfurt, Germany 38
Summary
Quality System Inspection Technique (QSIT)
How FDA conducts inspections
What should a manufacturer do after aninspection
Warning Letter or Warning Letter + Automatic
Detention
Where to go for more information
top related