Non-Conformance Control- GMF3351-08_GMP102/BOP 8-02

Site conducted

Is there a procedure/policy for Control of Non-Conforming Product?

Does the procedure detail how non-conforming product is identified?

Does the procedure detail the segregation of conforming with non-conforming product?

Are product designated as Scrap clearly identified and placed in secure area?

Does the procedure define who has the authority to manage/sanction defective product?

Does the procedure define a "Rework" process?

Does the procedure define a process to contain conforming and non-conforming product ?

Is there a process for product subjected to Concession and Records maintained ?

Is there a process preventing delivery of concessed batches prior to customer acceptance ?

Is there a process for capturing Non-Conforming data ?

Does the procedure define need for raising Internal NCR's ?

Does the procedure define the control of External Non-Conforming product ?

Does the procedure detail the requirement to analyse non-conforming data ?