change control

How to Create an Efficient Change Control Board Process

How to Create an Efficient Change Control Board Process

change control

Change in how a medical device is manufactured is often a sign of progress. Maybe the manufacturing process itself is 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 and that risks related to this change have been considered and dealt with appropriately. 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.

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Identify the Need for Change

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.
Here are some of the common reasons why medical device manufacturing processes may need to undergo changes:

  • Capacity variations
  • Requirements planning
  • Technological improvement in the device’s design or of its components
  • Manufacturing process improvement
  • Identification of a frequently failing component in produced devices

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.

Designate a Change Control Board

Once a change is requested by the change owner, 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
  • Logistics
  • Procurement
  • Financial

By bringing together representatives from all of these groups, the change control process will benefit from a variety of perspectives.

The Initial Tasks To Set

The initial tasks of this board will be to verify the change request layout and then to define the implications in the multiple key areas:

  • The required documentation to be produced
  • Defining the operational/technical/quality challenges
  • Setting a timeline for the change process and its delineate stages

The Measures for Success

It’s crucial to balance the demands of the different departments. For example, Making sure manufacturing and logistics see eye to eye against key stages in the change process. It’s also a good practice to designate a board moderator. A moderator is the one who will oversee that the process is in motion and making progress and that can include a handful of tasks. Taking charge of scheduling the board meetings, ensuring the change process remains on track and the issuing final approval on changes.

Once the change order activities have been concluded, the board is responsible to evaluate and approve that all needed deliverables have been finalized and are in compliance with the regulation. Only then the change order can be released for implementation.

Stay Proactive

Throughout the change control process, the board should be proactive rather than reactive. It’s important to look ahead to logistics and cost challenges and to deal with these issues well in advance. As the process gets underway, the timeline can and should be adjusted to avoid slippage or unexpected delays. Regular board meetings, in which members are encouraged to communicate potential problems, can help ensure the process remains on track.

Ensure Best Practices for Your Product

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 and meeting customers’ demands while also continuously meeting existing safety and quality standards.


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