The process from Stage 1 – 5 has resulted in a validated product design that meets all regulatory requirements and market demands for performance and reliability. However, that does not mean we can launch the product and manufacture exact copies of the prototype design. For example, over time, fixtures and tools wear, and this wear induces variance.
This variance causes typically significant performance and reliability issues, and each product has its manufacturing challenges. A robust process validation process has a considerable positive impact on solving and preventing manufacturing issues. Performing process validation ensures reliable, dependable, and effective manufacturing processes are in place to manufacture the product. Typically, broken down into three steps:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Process Qualification (PQ)
An IQ is performed to ensure the equipment, and ancillary systems, are installed correctly and adhere to the manufacture’s specifications. An OQ is performed to determine the limit conditions of critical process parameters and relies on process development or engineering studies to establish process tolerances. A PQ is performed under nominal process conditions (with sufficient replicated production runs) to prove repeatability. Ultimately, a process verification is a confirmation that the process outcome meets established requirements.
An adequately validated process helps to mitigate risk and eliminate waste when it comes to performing in-process quality inspections. Utilizing Process Failure Mode Effects Analysis is utilized to determine the potential impact a process step may have on the performance of the device and its failure modes. Process validations are reviewed and approved by a cross-functional team that includes at a minimum: Design Engineering Team, Quality Engineering Team, Process Owner, and Technical Reviewer.
Favorable results in the development stage precede large-scale production and commercialization. Here, the business launches its promotional campaign for the new product. The market research conducted during the conception stage influences the timing and location of the product launch.
- Installation Qualification Protocol and Report (IQ)
- Operational Qualification Protocol and Report (OQ)
- Process Qualification Protocol and Report (PQ)
- Test Method Validation (TMV)
- Tool Verification (VER)
- Program Verification
- End Item Specifications
- Raw Material and Component Specifications
- Inspection Procedures
- Process Failure Mode Effects Analysis
- Manufacturing Procedures