API Spec Q1(第七版)“设计和开发”的理解与实施

API Spec Q1(7) Design and Development and Its Implementation

结合学习标准API Spec Q1(第七版)的体会,介绍了标准API Spec Q1(第七版)中“设计和开发”条款的要求:设计和开发的外包控制,设计和开发的策划、资料收集、输入、输出、评审及确认,并且详细阐述了标准中关于这些要求的含义及意义;详细介绍了“设计和开发”的各个具体实施阶段,即策划阶段(P阶段)、实施阶段(D阶段)、检查阶段(C阶段)和纠正改进阶段(A阶段)。同时结合标准API Spec Q1(第七版)中3．1．3条款“控制细则”的定义,阐述了对标准所出现的“控制细则”的理解。

In combination with the study of new standard API Q1 （7） and understanding of ISO 9001 （2000） quality management system, this article covers in detail the requirements in Item Design and Development of API Q1 （7） which includes external packing control, plan, data collections, inputs, outputs, audits and affirmations of design and development. It also explicitly describes the connotation and meaning for all these requirements in the new standard, and each specific implemental phase, including planning-design-plan （P）, implementation-design-performance, input and output （D）, check-audit, acceptation and affirmation （C）, correction and improvement （A） . In addition, referring to the definition of Control Feature of item 3.1.3 in the new standard, this article presents understanding and analyses on detailed rules of control.