多功能谷物实验室质量管理体系的实施过程

R. Ferguson, R. Henry, P. Inkerman
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引用次数: 1

摘要

本研究的目的是设计、记录和实施质量管理体系(QMS),以纳入实验室的研究和开发(R&D)和日常分析活动。此外,质量管理体系必须易于和有效地维护:(a)提供文件证据,以验证系统符合可认证的标准,(b)符合实验室的目的,(c)适应现行的政府政策和标准,(d)通过对所实施的程序和方法的文件化和验证,促进实验室的积极成果。最初,开发了一个矩阵,记录了标准的要求和为满足这些要求而采取的必要步骤。矩阵提供了对系统开发进程的检查机制。此外,它后来在《质量手册》中用作查找系统其他地方记录的完整程序的参考工具。构建和监视系统所需的文档包括一系列手册以及提供质量管理体系工作的可审计证据的表格。自20世纪初以来,质量管理(QM)以一种或另一种形式存在。然而,问题仍然存在:这是一件好事还是只是一个麻烦?许多老式系统之所以失败,是因为它们是由非用户设计的,监管严格,限制性强,通常被认为是一种强加。现在认为重要的是培养使用系统的人对系统的所有权意识。如果要获得组织的最大利益,系统的设计必须量身定制,以最适合设施运营的目的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The process for implementation of a Quality Management System within a multi‐functional cereal laboratory
The intent of this study was to design, document and implement a Quality Management System (QMS) into a laboratory that incorporated both research and development (R&D) and routine analytical activities. In addition, it was necessary for the QMS to be easily and efficiently maintained to: (a) provide documented evidence that would validate the system's compliance with a certifiable standard, (b) fit the purpose of the laboratory, (c) accommodate prevailing government policies and standards, and (d) promote positive outcomes for the laboratory through documentation and verification of the procedures and methodologies implemented. Initially, a matrix was developed that documented the standards' requirements and the necessary steps to be made to meet those requirements. The matrix provided a check mechanism on the progression of the system's development. In addition, it was later utilised in the Quality Manual as a reference tool for the location of full procedures documented elsewhere in the system. The necessary documentation to build and monitor the system consisted of a series of manuals along with forms that provided auditable evidence of the workings of the QMS. Quality Management (QM), in one form or another, has been in existence since the early 1900's. However, the question still remains: is it a good thing or just a bugbear? Many of the older style systems failed because they were designed by non-users, fiercely regulatory, restrictive and generally deemed to be an imposition. It is now considered important to foster a sense of ownership of the system by the people who use the system. The system's design must be tailored to best fit the purpose of the operations of the facility if maximum benefits to the organisation are to be gained.
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