Chapter 19 Manufacturing and Quality Control

1
Chapter 19Manufacturing and Quality Control

• Design of Biomedical Devices and Systems
• By
• Paul H. King
• Richard C. Fries

2
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

3
Current Good Manufacturing Practice (CGMP)

• Assure medical devices are compatible with
  specifications for quality systems contained in
  international quality standard ISO 9001.

• 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

4
Design Controls

• Lack of Major cause of device recalls
• Intrinsic quality established during design phase
• FDA concerned that current regulations dont
  provide an appropriate level of assurance

5
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

6
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
  manufacturers quality system

7
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
• Simpler design with fewer parts
• Simple production processes
• Higher quality and reliability
• Easier to service

8
DFM Process

• Eliminate nonfunctional parts
• Reduce functional parts
• Process for a defect rate of no more than a few
  parts per million

9
Design for Assembly (DFA)

• Overall Design Concept
• Component Mounting
• Test Points
• Stress Levels and Tolerances
• Printed Circuit Boards
• Miscellaneous

10
Manufacturing Process

• Pre-production activity
• Pilot run build
• Production run
• Delivery to customer

11
Pre-Production Activity

• Selection of Suppliers
• Develop Pilot Run plan
• Develop Manufacturing Strategy
• Production plan
• Quality plan
• Test plan
• Materials plan
• Supplier plan

12
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

13
Production Run

• Produce high quality product on time, while
  continuing to fine tune the process
• 1st order manufactured
• Verification of Product cost

14
Customer Delivery

• Deliver 1st production units to customer
• Refine manufacturing process based on first build
• Monitor field unit performance to correct any
  problems