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  • Aasutosh Purohit replied to the topic What it an NCMR in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

    Any item, part or product with one or more characteristics which depart from the requirements of the specification, safety, legality, regularity & quality or other approved product description. Nonconformity refers to a failure to comply with the requirement.A requirement is a need, expectation, or obligation; it can be stated or implied by an organization, its customer, or other interested parties. There are many types of requirement .some of these include the quality requirement, customer requirement, management requirement, product requirement and legal requirement .whenever any organization fails to meet one of this requirement, nonconformity occurs.

    Purpose of NCMR:
    1. Strong controls of non – conforming materials reduce the risk of receiving a product that is not compliant or that does not meet quality expectation.

    2. It is the policy to ensure the procedure is in place to identify: segregate and dispose of Non-Conforming Material Report related to safety, legality or quality in a systematic manner and to establish corrective action with the goal of preventing future reoccurrence.
    3. The purpose of this procedure is to describe how Non -confirming material, components, partial assemblies & final product are controlled.