河南省MedAccred- AC8121电子电缆和线束组件的审核标准 (9)

Performance Qualification (PQ) – establishing documented evidence through appropriate testing that the finished product produced by a specified process(es) meets all release requirements for functionality and safety.

QUALIFICATION (Of Personnel): As it relates to this checklist, Training + Certification = Qualification.

QUALIFICATION (of Materials / Processes / Equipment): As it relates to this checklist, a system to approve materials / processes / equipment to specified requirements.

RECORD: Document that provides evidence that activities have been performed or results have been achieved. All records shall be maintained and controlled under defined GDP (Good Documentation Practice).

REPAIR – the act of restoring the functional capability of a defective article in a manner that does not assure compliance of the article with applicable drawings or specifications.

REQUIREMENT: A defined need or expectation that is stated, generally implied or obligatory. Requirements can come from within customer documentation & specifications, supplier procedures, manufacturers’ data sheets, industry standards, and/or regulatory standards.

REWORK – the act of reprocessing noncomplying articles, through the use of original or equivalent processing, in a manner that assures full compliance of the article with applicable drawings or specifications.

TEST: A determination of one or more performance characteristics of a product according to a documented formal procedure.