Transcript Chapter 19 Manufacturing and Quality Control

Chapter 19
Manufacturing and
Quality Control
Design of Biomedical Devices and
Systems
By
Paul H. King
Richard C. Fries
GMP: History
 Good
Manufacturing Practices - Series of
requirements that prescribed the facilities,
methods, and controls to be used in
manufacturing, packaging, and storage of
medical devices
 Medical Device Amendments of 1976
 Unchanged since 1978
Current Good Manufacturing
Practice (CGMP)
•Assure medical devices are compatible with specifications for
quality systems contained in international quality standard ISO
9001.

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Quality system
requirements: design,
purchasing, and
servicing controls
Clarify record keeping
requirements for device
failure and complaint
investigations

Clarify requirements for
qualifying, verifying, and
validating processes
and specification
changes
 Clarify requirements for
evaluating quality data
and correcting quality
problems
Design Controls
 Lack
of = Major cause of device recalls
 Intrinsic quality established during design
phase
 FDA concerned that current regulations
don’t provide an appropriate level of
assurance
Purchasing controls

Unacceptable components = recalls due to
device failures
 Unacceptable components due to failure of
manufacturer to adequately define and establish
requirements
 Purchasing of components, finished devices,
packaging, labeling, and manufacturing
materials must be conducted with same level of
planning, control, and verification as internal
activities
Servicing Controls
 Maintenance
and repair data provide
insight into adequacy of the performance
of the device
 Use to evaluate and monitor adequacy of
device design, quality system, and
manufacturing process
 Use as part of overall device experience
data in manufacturer’s quality system
Design for Manufacturability (DFM)
 Assures
that a design can be repeatedly
manufactured while satisfying the
requirements for quality, reliability,
performance, availability, and price.
 Less costly due to

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Simpler design with fewer parts
Simple production processes
Higher quality and reliability
Easier to service
DFM Process
 Eliminate
nonfunctional parts
 Reduce functional parts
 Process for a defect rate of no more than
a few parts per million
Design for Assembly (DFA)
 Overall
Design Concept
 Component Mounting
 Test Points
 Stress Levels and Tolerances
 Printed Circuit Boards
 Miscellaneous
Manufacturing Process
 Pre-production
 Pilot
activity
run build
 Production run
 Delivery to customer
Pre-Production Activity
 Selection
of Suppliers
 Develop Pilot Run plan
 Develop Manufacturing Strategy
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Production plan
Quality plan
Test plan
Materials plan
Supplier plan
Pilot Run Build

Validate manufacturing process against objectives set
forth in manufacturing strategy and product
specification
 Standard cost
 Product quality
 Documentation
 Tooling
 Training
 Process control
 Validates supplier plan and contracts
 Internal failure analysis and corrective action
Production Run
 Produce
high quality product on time,
while continuing to fine tune the process
 1st order manufactured
 Verification of Product cost
Customer Delivery
1st production units to customer
 Refine manufacturing process based on
first build
 Monitor field unit performance to correct
any problems
 Deliver