Component Qualification, Process Performance Qualification, and Design Transfer

Nathan White, Co-Founder and VP of Product Design and Development

Nate has over 20 years of medical device product development experience, with diverse roles in technology innovation, R&D engineering, manufacturing engineering, program management, technical leadership, and organizational leadership. He has an extensive background in complex technologies, including minimally invasive laparoscopy, endoscopy, interventional cardiology and radiology, surgical stapling, vessel sealing, and ablation therapies. He is a named inventor on more than 30 U.S. patents. He holds a B.A. in Engineering Sciences from Dartmouth College and an M.S. in Mechanical Engineering from Stanford University, Design Division, and Biomechanics Division. Throughout his career, Nate has helped dozens of companies conceptualize, develop, and commercialize novel medical products and technologies for improved patient outcomes.

Introduction

Following Design Verification and Validation, the remaining activities are focused on readiness for human-use manufacturing.  The extent of the effort will vary depending on the commercial launch strategy and annual volumes, but it broadly includes equipment qualification, assembly processes validation, test method validation, component qualification, and qualification of the overall manufacturing process in preparation for design transfer to manufacturing.  Typically, these activities start in an earlier phase but are completed prior to production manufacturing.  This week’s article continues the overview of the NPI phase from last week by focusing on component qualification, process performance qualification, and design transfer.

Component Qualification

Component Qualification is an assessment of the components or subassemblies that are inputs to the manufacturing process and is important for ensuring the reliability and quality of the final product.  Using a risk-based approach, critical components and/or critical suppliers are identified to complete component qualification.  By thoroughly evaluating and validating the suppliers’ processes, we can analyze the capability of critical-to-function specifications and make data-driven decisions about ongoing quality controls in manufacturing. This helps maintain ongoing product quality, ensuring the device performs consistently and reliably in real-world conditions.

Component qualification typically includes:

1. IQ/OQ/PQ of the equipment and process used to manufacture the component, including the establishment of production process windows.
2. The manufacture of components at the limits of the process window as well as at nominal settings.
3. Inspection and statistical analysis of critical-to-function specifications to understand process capability.
4. Formal reports that document the established process used to produce the components and the process capability results achieved.
5. Evaluating the processes for further improvement, if appropriate.

Process Performance Qualification (PPQ)

PPQ is an industry term that refers to the “overall process” and is sometimes referred to as an “overall process validation”.  It demonstrates that the overall manufacturing process can produce devices that meet specifications during routine manufacturing, including normal variation in equipment, environmental conditions, materials, and personnel. 

PPQ typically involves:

1. Multiple lots of finished device manufacturing under typical environmental conditions and representative of routine manufacturing.
2. Independent evaluation of in-process and final inspection quality checks.
3. Inspection and statistical analysis of critical-to-function specifications of the finished device to understand process capability.
4. A formal report to document the results achieved.

Design Transfer

Design transfer is the culmination of the efforts completed throughout the NPI process, which ensures that the product design has been adequately documented and confirmed adequate for the requirements and that the production manufacturing process can capably produce devices that meet those requirements.  Meddux ensures a systematic approach to design transfer using a checklist, ensuring that all aspects of readiness for commercial manufacturing are complete and documented.  Successful design transfer is not about “throwing the design over the wall” for the operations team to catch.  It is a collaborative effort between product development, quality, and operations that sets up the product and the team for success in manufacturing.

Conclusion

During the New Product Introduction (NPI) phase, the manufacturing process is scaled appropriately and validated for production capability.  Key aspects of this process include qualifying key components and performing PPQ on the overall manufacturing process.  These elements, combined with equipment qualification, process validation, and test method validation ensure the product is ready for design transfer into manufacturing.  At Meddux, our team is experienced with initial market release of first-generation products and employs a risk-based approach to ensure ongoing quality and efficient use of resources as the product launches and volumes scale.

Key Takeaways:

• Component Qualification: Thoroughly evaluating the processes used to produce key components ensures quality on the finished device manufacturing line as volumes grow.
• Process Performance Qualification: “Turning the crank” on the manufacturing line and qualifying in-process and final inspection steps establishes the baseline for product manufacturing at launch.
• Design Transfer: A systematic review of the activities through the Verification and Validation and New Product Introduction phases ensures compliance with regulatory requirements and readiness for success in manufacturing.