Change in how a medical device is manufactured is often a sign of progress. The manufacturing process itself can improve by becoming more efficient, or the design of the device is being tweaked to improve its functionality or durability. But, any change also comes with regulation. Change control is a formal process imposed by the FDA and international regulators to ensure that devices produced after any changes meet the same quality and safety standards as before. Change control is a significant process that introduces several challenges. So, let’s look at some best practices for how to establish a change control board process for medical device production.
The first step in any change control board process is to identify why a change is being made. Changes may be proposed by either the device designer or the manufacturer. Some common reasons why medical device manufacturing processes need to undergo changes are variations in capacity requirements planning, technological improvement in the device’s design or one or more of its components, or materials. There can also be a need for analysis and identification of a failiar in an already produced device. Whatever the reason, it’s essential that the device designer and manufacturer are on the same page. This ensures that the change control board process will be collaborative and that both parties are working towards the same end-goal.
Once a change is laid out, the next key step is to form a board that will take charge of the change control process. The board should include personnel from across the product life stages, including manufacturing engineers, project managers, sales managers, logistics staff, procurement managers, and financial staff. By bringing together representatives from all of these groups, the change control process will benefit from a variety of perspectives. It’s imperitive to designate a board moderator. This moderator can take charge of scheduling board meetings, ensuring the change process remains on track, and issue final approval on changes.
The initial tasks of this board should be to define the final outcome and aims of the change control process, both in terms of the documentation produced and the manufacturing goals. The board also needs to set a timeline for the change process and to delineate stages, balancing the demands of manufacturing and logistics against key stages in the change process. Members of the board can also take responsibility for evaluating the costs of the desired change and the impact of the process on ongoing manufacturing.
Carrying out changes to the manufacturing process for a medical device is a major task that shouldn’t be undertaken lightly. But, the burden of change isn’t so great that it should hinder progress, either. At Quasar, we rely on these best practices for conducting change control board processes to ensure that the medical devices we produce are constantly improving while also continuously meeting existing safety and quality standards.
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