Product Requirements Control during Design Changes

[PRFire]

At what point do you release your revised requirement documents when making design changes?

a) before validation/verification is completed
b) after verification/validation is complete

If a) how do you manage traceability so that it's clear product on the field was built to a previous version of the product requirements document?
If b) how do you control the document that you are using for validation/verification activities?

Thank you!

 

[indubioush]

What kind of product is this? Is this a medical device?

 

[PRFire]

great question… not medical device but our QMS is 13485. RUO instruments.

 

[indubioush]

So, a medical device in development? Different companies with handle the design change process differently. In my experience, this is where a special build process comes in to play. You build one or more special units that meet the proposed new requirements, you test it to verify the change, and then you update your production build documentation, verification report, and requirements documentation to reflect the change. The special build process is intended to ensure traceability between regular production units and special units, and ensures the new, special requirements are approved prior to building the units.

Your change order that will implement the change must show the material disposition of the existing units. Traceability of the units should already be there through the lot number on the labeling. You may have both old an new units in use as long as your change order says that exiting units are okay. If not, you should get those units back from the field.

If this is an RUO instrument, have you already done design verification testing? If not, change control requirements may be different. Your customer may also have requirements on how this should be done.

 

[ChrisM]

IMHO the Requirements Document is "living". If a design review or other proposed design change results in an agreement that the Requirements have changed, the document should be updated as soon as possible after agreement has been reached. This may be before validation and verification (to the previous agreed requirements) has been completed, or it may be after

EDIT: Of course I should add that the Requirements may change as a result of input from Sales, marketing or another non-engineering source. If it is agreed that these changes are to be made to the requirements, same principle applies: change the requirements document ASAP