Assure Quality and Product-Centricity Throughout NPDI

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.

Errors in medical devices can bring about harmful and sometimes fatal consequences. Preventing such errors from occuring was the impetus for the FDA’s requirement of medical device manufacturing companies to establish and document corrective and preventive action (CAPA) processes as detailed in 21 CFR 820.100.

Most medical device manufacturers have closed-loop CAPA processes in place. However, they are often poorly defined, inconsistently applied, and/or are dangerously disconnected from the product record. Here’s why having a solid closed-loop CAPA process is important:

• Inconsistent, incomplete CAPA processes leave organizations vulnerable to undesired risk and audit impacts—FDA warning letters, 483 observations, legal consequences, and customer satisfaction issues.
• A single quality issue may affect many products and stakeholder groups. Disconnected CAPA processes mean repetition of actions and reliance on tribal knowledge and ad hoc processes to identify, address, and correct issues.

How Can You Optimize Closed-Loop CAPA Processes

• Provide easy access and traceability to all teams to streamline the investigation of issues and speed resolution.
• Link quality records and CAPA processes to the affected product record, providing a unified quality and product process to identify, analyze, and resolve issues quickly and effectively.
• Ensure that issue resolution can be launched and referenced directly from the quality issue with a corrective action request (CAR). The ability to spawn engineering change orders (ECOs) at the end of the CAPA process creates a unified system approach to closing the loop on changes to design, documentation, packaging, or manufacturing processes.

Learn More:  How connected closed-loop CAPA processes help ensure safer devices