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Positive recall is a term used in quality systems, most notably ISO9000.It is part of receiving inspection procedures. [1] It defines the concept that if a producer or manufacturer receives a product or process that requires inspection and it wishes to postpone the inspection process, it must have a system in place that will ensure that the postponed inspection process will take place at some ...
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FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
A design specification (or product design specification) is a document which details exactly what criteria a product or a process should comply with. [1] If the product or its design are being created on behalf of a customer , the specification should reflect the requirements of the customer or client. [ 2 ]