Hi,

Can anyone tell me if a 'concession procedure' can be called by any other name?

Can the procedure also be written within the 'non conforming product procedure, or does it have to be a procedure in it's own right?

thankyou in anticipation.

Personally, it would be covered in the Non-conforming procedure. The question as you write for allowing the use of a non-conforming item in your roduction of the final product is -Why. Some might say they you should ask the Why at least five times. If you are going to do this, a couple of things, make sure you document what you are doing and why. The following link might help. http://www.fda.gov/ora/inspect_ref/igs/med_dev_mnfct/meddev8.html
particularly,
Nonconformity Review and Disposition - 21 CFR 820.90(b)(1)

Review all records for the proper disposition of nonconforming products for assurance that use of nonconforming product has not resulted in the distribution of defective devices. The distribution and justification for concessions (allowance to use otherwise nonconforming product, often done through a Material Review Board) must be documented and based on scientific evidence. Concessions should be closely monitored and not become normal practice.

Deficiencies would include a lack of scientific evidence for justification of the concession. If a concession resulted in a change of product specifications (form, fit or function), the change should be evaluated for possible 510(k) submission. At a minimum, a risk analysis should always be considered for any changes.

Much appreciated.
Thankyou