Kaizen Process Audits
Kaizen is a Japanese methodology and approach that focuses on continuous process improvement. It is translated as “change for the better” or “change for improvement.” This methodology has been used and employed by such companies as Toyota, Honda, Sony, automotive, and many technology companies. For medical device manufacturing assembly lines in the manufacture of Class III devices such as stents and catheters, Kaizen process audits are a very effective tool to decrease defects. Manufacturing defects can have a significant impact on the quality of products, leading to costly product recalls and dissatisfied customers. Quality professionals must be aware of the potential risks and be prepared to take the necessary steps to reduce the number of defects in the products they produce.
Process audits identify gaps and opportunities for improvement in a process. They identify what controls and/or lack of controls are in place. Process audits ensure deliverables are met to ensure continued successful outputs and ensure customer satisfaction. Process audits are used to verify that processes are operating within specified limits and achieving specified targets (objectives).
Kaizen is an approach to continuous improvement that has been adopted by many businesses in recent years. It is a philosophy of process improvement that encourages everyone in an organization to make small, incremental improvements and changes to their workflows, processes, and systems. Kaizen is a powerful tool for harnessing the collective talents of a company and creating an engine for improvement.