Contract Manufacturing and the Role of Quality Assurance

Last fall we highlighted the phases of our product development process and recently realized that many clients may have a hard time envisioning what the specifics of each of those phases actually entail. It is the focus of this article to shed some light on phase four of that product development process, which is the design transfer step. During this phase of the project a product quality plan and all associated work instructions are written to support the drawings, materials, customer specific requirements, and approach to device assembly. This step is critical for a successful manufacturing product launch because these documents communicate the device specific requirements and help to bridge the gap between the work that was done to bring the device to life on a small scale, as was done in the previous phases of product development, and scaling those actions up to support larger production volumes.

It is critical for all design transfer activities to be defined in a project plan; this ensures a successful commercial release because these activities directly support the design validation phase that follows. During design transfer, Keystone Manufacturing’s Engineering and Quality Assurance teams work together to establish the Device Master Record (DMR) and a Process Failure Mode Effects Analysis (FMEA), the latter of which is used to identify and later control process risks and potential failures. With these two primary documents in hand, the role of Quality Assurance spikes because the manufacture of medical devices must be aligned with the Food and Drug Administration (FDA) 21 CFR Part 820 Quality System Regulation and ISO 13485. Both of which provide guidance and regulations for good manufacturing practices for medical devices. Alignment with these standards is shown through good documentation practices including the establishment of:

1) A Manufacturing and Product Quality Plan, including but not limited to:

  • Manufacturing process flow charts
  • Essential design outputs
  • Types of inspection / testing, sampling plan and point during process when they will be performed
  • Acceptance criteria for specific inspections and tests
  • Equipment, test fixtures, and test methods that must be qualified
  • Processes that must be validated and
  • Special certifications and/or training necessary to assure manufacturing and quality activities are performed correctly

2) Supplier Qualification

  • To verify that material and service suppliers are suited for and prepared to support device manufacture
  • To ensure sufficient inventories of materials are on hand, and that inspection and certification requirements can be met

3) Training

  • To ensure production, QA and QC are equipped to perform new assembly methods, operate equipment, perform testing, and inspection.

4) Material Requisition, Planning and Inventory Control

  • Supports device manufacture and ensures traceability is maintained during all phases of production

At Keystone Manufacturing, our Quality Assurance and Manufacturing Teams ease the transition from product development to product realization, and when you partner with us you can expect long term support and commitment to making your device safe and successful.

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