Quality should never be considered something that ceases upon initial compliance to regulations or even upon delivery of products to market. Continuous improvement is key to improve processes and products. Establishing practices that ensure devices are safe and effective requires a multidisciplinary approach spanning design, development, production, installation, and servicing of all finished devices. Product-centric QMS provides the BOM foundation necessary to manage quality and training records in context with the product record throughout the entire NPDI process.
For an organization to deliver high-quality products that 1) meet regulatory and market demands and 2) lead in innovation—quality, operations, and related teams must be able to:
- Seamlessly advance their respective objectives in a shared environment
- Maintain constant traceability, control, and visibility of the product record
- Quickly understand and address the impacts that actions in one area may have on another
It’s important to remember that quality issues can arise during any and all phases of a product’s lifecycle. Successful organizations maintain persistent connection between the product record and quality at all times to prevent issues from arising in the first place or accelerate resolution if they do.