制度化一个已定义过程

将过程制度化为一个已定义过程。 

（Institutionalize a Defined Process：The process is institutionalized as a defined process.）

"GP2.1 建立组织级方针：建立和维护一个组织级方针，来计划和执行确认过程。

（Establish an Organizational Policy：Establish and maintain an organizational policy for planning and performing the validation process.）"       

                               

"GP2.2 计划过程：建立和维护执行确认过程的计划。

(Plan the Process:Establish and maintain the plan for performing the validation process. )"

"GP2.3 提供资源：提供适当的资源，来执行确认过程、开发工作产品并提供过程的服务。

（Provide Resources: Provide adequate resources for performing the validation process, developing the work products, and providing the services of the process.）  "                                   

 

"GP2.4 分配职责：分配职责和职权，来执行过程、开发工作产品并提供确认过程的服务。

（Assign Responsibility:Assign responsibility and authority for performing the process, developing the work products, and providing the services of the validation process.)  "                                      

"GP2.5 培训人员：需要时，培训人员来执行或支持确认过程。

（Train People: Train the people performing or supporting the validation process as needed.）

"GP2.6 管理配置：将确认过程所产生的工作产品，进行适当等级的配置管理。

（Manage Configurations: Place designated work products of the validation process under appropriate levels of configuration management.)  "            

                         

"GP2.7 标识和使相关人员参与：标识确认过程的相关人员，并使其参与确认的实际活动。

（Identify and Involve Relevant Stakeholders: Identify and involve the relevant stakeholders of the validation process as planned.） "      

                                   

"GP2.8 监督和控制过程：按计划监督和控制项目的确认过程的执行过程并采取适当的纠正行动。

（Monitor and Control the Process: Monitor and control the validation process against the plan for performing the process and take appropriate corrective action.）  "                                        

"GP2.9 客观地评价符合性：根据过程描述、标准和规程，客观地评价确认过程的符合性，并处理不符合性。

（Objectively Evaluate Adherence: Objectively evaluate adherence of the validation process against its process description, standards, and procedures, and address noncompliance.）  "                                       

"GP2.10 高层管理者参与评审：高层管理者参与评审确认过程的活动、状态和结果，并解决问题。

（Review Status with Higher Level Management:Review the activities, status, and results of the validation process with higher level management and resolve issues.）  "     

                                

"GP3.1 建立已定义过程：建立和维护确认过程的描述。

（Establish a Defined Process: Establish and maintain the description of a defined validation process.）

"GP3.2 收集改进信息：收集策划和实施确认过程的工作产品、度量、测量结果和改进信息，以支持未来的使用和组织的过程和过程资产的改进。

（Collect Improvement Information:Collect work products, measures, measurement results, and improvement information derived from planning and performing the validation process to support the future use and improvement of the organization’s processes and process assets.）