Quality System Process Changes

Continuing with the Quality Management discussion that I started in my last blog, let’s talk about how changes may occur within a predefined process.

Perhaps your company has a software development process that it has been using for some time. Someone at your company thinks that the process is too burdensome and would like “streamline” it by removing some required tests. Careful considerations need to be made before such a change is undertaken.

For example, if your software were considered a medical device, this change could impact your company’s ability to meet the medical device regulations. Could this change impact the ability of your software to perform as intended?  If your company has a quality system change process in place, this type of change would need to be reviewed for the impact of the change and approved by designated personnel prior to implementation.

While change is necessary in some circumstances, it is best to understand its impact on quality of the product and also the regulatory implications of the change.

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