1. Raul Soto
Biol516

2.  System of checks and balances
to ensure product:
 Safety
 Effectiveness

3.  All domestic and foreign
manufacturers of medical devices
intended for sale in the US must
have a quality system

4. A. General provisions
B. Quality System
Requirements, including
Management responsibility,
Quality Audits, and
Personnel requirements
C. Design Controls
D. Document Controls
E. Purchasing Controls
F. Product identification and
traceability at all stages of
production
G. Controlling and defining
production and process,
including validation

5. H. Product Acceptance for
incoming, in-process, and
finished products
I. Controlling nonconforming
product
J. Instituting corrective and
preventive action when errors
occur
K. Labeling and packaging
controls
L. Handling, storage, distribution
and installation
M. Records; including the Device
Master record, Device History
record
N. Servicing
O. Statistical techniques

6. • Plan for investigators to
FO O D A N D DRUG
follow when evaluating a
Medical Device
A DM I N I STRA TI O N
GUIDE TO INSPECTIONS OF manufacturer’s compliance
QUALITY SYSTEMS with Quality Systems
regulations
August 1999

7. Corrective &
Preventive
Design Actions Production &
Controls Process Controls
Management
Material Equipment &
Controls Facility Controls
Records,
Documents, &
Change Controls

8. • QSIT instructs auditors to
focus on four (4) subsystems:
• Management
• Design control
• Corrective and Preventive
Actions
• Production and Process
Control

9.  The other subsystems are covered through links
with the four main subsystems:
 Records, Documents and Change Control
 Throughout ALL the main subsystems
 Facility and Equipment Control
 Material control
 Covered through Production and Process Control

10. A. General provisions
B. Quality System Requirements, including
Management responsibility, Quality Audits,
and Personnel requirements
C. Design Controls
D. Document Controls
E. Purchasing Controls
F. Product identification and traceability at all
stages of production
G. Controlling and defining production and
process, including validation
H. Product Acceptance for incoming, in-process,
and finished products
I. Controlling nonconforming product
J. Instituting corrective and preventive action
when errors occur
K. Labeling and packaging controls
L. Handling, storage, distribution and
installation
M. Records; including the Device Master record,
Device History record
N. Servicing
O. Statistical techniques

11.  Covers:
 Management Responsibility (820.20)
 Quality Audits (820.22)
 Training (820.25)

12.  Quality Policy must exist
 Management representative appointed as the
owner and responsible person for the Quality
System
 Management reviews of the Quality System take
place
 Quality audit procedures
 Quality system procedures
 Quality audits take place periodically

13.  Covers:
 Design Controls (820.30)
 Production and Process Changes (820.70)
 Device Master Record (820.181)
 Statistical Techniques (820.250)

14.  Design inputs or requirements for device are identified
 Design outputs or specifications for device are
identified
 Design Review, Verification and Validation
 Software validation
 Risk analysis
 Design transfer to manufacturing completed
successfully
 Device Master Record (DMR), and Design History File
(DHF)

15.  Design Review
 Are the design requirements adequate?
 Does the design meet these requirements?
 Design Verification
 Do the design outputs (specifications) meet the
design inputs (requirements)?
 Design Validation
 Do the design outputs (specifications) meet the
device’s intended use?

16.  Device design must be reviewed throughout
development to ensure all requirements are met
 Example:
 Design of a portable defibrillator must take into
account factors such as:
• Storage temperatures in an
ambulance
• Shock and vibrations on the
road
• Electromagnetic interference
from communication devices,
other medical equipment,
even the ambulance siren

17.  Compilation of records containing all
procedures and specifications for a finished
device
 Documents how to perform all specific functions
related to the production of a device
 Some examples:
 Device Design Specification
 Device and part drawings
 Manufacturing, Inspection
and Testing procedures
 Software
 Label artwork

18.  One for each device type
 Include or refer to all documents that can
demonstrate that the device has been designed
as per an approved design plan
 Also include records and results of
 Design review
 Design verification
 Design Validation
 Change control

19.  Covers:
 CAPA (820.100)
 Nonconforming product (820.90)
 Complaints (820.198)
 Servicing (820.200)
 Statistical Techniques (820.250)

20.  CAPA procedures established
 Management review of CAPA activities
 Data sources (customers, manufacturing, etc.)
analyzed to identify nonconforming product and
quality problems
 Statistical analysis across data sources
 Investigations conducted to identify root cause of
failures
 Nonconforming product controlled, segregated
 Appropriate corrective actions and preventive
actions carried out

21.  Covers:
 Purchasing Controls  Receiving, in-process, and
(820.50) finished device acceptance
(820.80)
 Identification (820.60)
 Acceptance status (820.86)
 Traceability (820.65)
 Device handling (820.140)
 Production and Process
Controls (820.70)  Device labeling (820.120)
 Inspection, measuring, and  Device storage (820.150)
test equipment (820.72)
 Device distribution (820.160)
 Process Validation (820.75)
 Device Installation (820.170)

22.  Manufacturing processes validated , controlled
and monitored
 Software validated
 Equipment is adjusted, calibrated and maintained
periodically
 What happens to rejects or nonconforming
product
 Production employees trained and qualified
 Suppliers must be certified, audited

23.  Standard Operating Procedures (SOPs)
 Standard Quality Assurance Procedures
(QAPs)
 Some examples:
 Complaint handling
 Maintenance
 Calibration
 Training
 Change Control
 Cleaning
 Safety

24.  All changes or
modifications to a device
must be documented
 Manufacturer must
provide documented
evidence of whether a
change alters the device’s
effectiveness or safety
 If there are differences in
effectiveness or safety
then the manufacturer
must file a 510(k) or PMA
supplement

25.  Company must have a Quality
System in place
 FDA audits quality systems based on
subsystems framework
 Management involvement is vital
 Design, Production, Purchasing,
Equipment, must be in state of
control
 Investigate, correct, prevent non-
conformances
 Change control
 Documentation!