Common Change Management Challenges Lack of visibility Perhaps your team will go through the change management process and elect to install an overmolded elastometer to improve the physicians ability to grip the device, and this is an example of a design change. A physician could recommend that a medical instrument be easier to grip to prevent it slipping during use. Post-market design changes can also occur based on feedback or complaints from end users, or ongoing research into a product after launch. This could trigger a change wherein your team elects to qualify a new supplier for that component. Repeat quality issues with a partner supplying a critical component for your device could introduce business risk associated with that supplier. Let’s say a CAPA investigation reveals that devices are being damaged in transit due to a combination of the packaging design and failure to account for extreme temperature conditions during shipping - this could trigger a change to the devices packaging design or updated requirements when handling the devices during shipment. While these are all somewhat predictable triggers, there will also be unexpected situations during the post-market surveillance that may prompt the need for change. Or maybe you have identified opportunities for improvements to your products and processes to focus on “true quality” initiatives. Use Cases of ChangeĬhanges could also be driven by new regulations that will require updates to specific processes and procedures. You might find yourself needing to do additional validation on a device, or maybe you are changing suppliers, which requires changes to associated documents and procedures. A change can involve modifications to records and procedures in your design controls, or your device master record (DMR). New products, processes, or controlled documents all require change management practices be put in place. New or modified controlled documents, such as templates, work orders, forms, etc., as well as any subsequent revisions made to those documents New or modified processes for how you conduct business as you right-size and grow your QMS New or modified products, as well as any subsequent change to those products Many events can trigger a change throughout the lifecycle of a product or organizations, including: Change can come about for a number of reasons, and we refer to these as triggers for change. Greenlight Guru Change Management SoftwareĬhange management refers to the way a company manages modifications to products and processes within their medical device business. Documenting Decisions and Supporting Evidence
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