东莞市MedAccred AC8121电子电缆和线束组件的审核标准 (8)

MEASURING EQUIPMENT: It is a measuring instrument, a calibrated source, a measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process.

PURGE: Process to ensure expired, age-sensitive or nonconforming materials are not used.

PROCEDURE: A procedure is a defined and documented way to carry out an activity or process. Documentation should be under formal revision control, reviewed on a regular cycle, and properly communicated to production. Electronic procedures under 21CFR Part 11 compliance are acceptable. For the purposes of this checklist, could encompass a procedure, work instruction, etc. which is a revision controlled document.

PROCESS VALIDATION: Confirmation by examination and provision of objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Validation consists of the following:

Validation Protocol – a written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results,

Installation Qualification (IQ) - establishing documented evidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.

Operational Qualification (OQ) – establishing documented evidence that the process is effective and reproducible.