Medical device manufacturing is a highly regulated activity. Some manufacturers may be dealing with one regulator or they may be working with multiple regulators. In this blog post and subsequent webinar, Seabrook will talk in the context of FDA, 21 CFR 820. FDA: CFR 21 820.100 corrective and preventative action states “each manufacturer shall establish and maintain procedures for implementing corrective and preventive action”.
FDA 2015 Quality Subsystem Observations tell us that CAPA accounts for 32% of observations. CAPA is as problematic as physically manufacturing the product. The three areas generating the highest numbers of CAPA non compliance issues are 820.90 – Nonconforming product, 820.100 – Corrective and preventative action, 820.198 – Complaint files. In all three the number has risen from 2014 to 2015.
When managing CAPA specifically, organizations face several challenges with disparate quality systems. These include:
- Time to Closure: Without a centralized system for quality, completing a corrective or preventative action can be arduous and long process.
- Time and Effort: Organizations face difficulty with aligning and executing on deliverables for preventing a root cause from reoccurring in the future. Deliverables may include changing work instructions, educating employees, communicating root causes to the broader enterprise, or an engineering change order. These deliverables touch many areas across the engineering process and broader value chain, such as design, control plans, production processes, equipment, facilities, materials, and more.
- Rework and Repeat Actions: Companies with disparate quality systems tend to have higher rework rates and more repeat efforts in regard to the identification of a specific root cause. Reasons for this include incomplete investigations due to lapses in manual processes, poor documentation and communication of previous root cause analysis efforts, and inconsistent processes between plants, facilities, and business units.
- Increased Risk: Without a centralized system for communicating and collaborating on corrective and preventative actions, root causes have a greater chance of both not getting resolved and not being communicated to the broader enterprise. The lack of visibility with manual processes increases risk at the point of the root cause, as well as in all dependent processes across the value chain.
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