8 运行
8.5生产服务提供
8.5.6.1.1过程控制的临时更改 【SI-11：2024-07】 组织应识别过程控制手段，包括检验、测量、试验和防错装置，形成文件化的清单并予以保持，清单包含主要过程控制和经批准的备用或替代方法。过程控制的列表应包括主要过程控制和已批准的备份或替代方法，如果存在备份或替代方法。
组织应有一个形成文件的过程，对替代控制方法的使用进行管理。组织应基于风险分析（例如FMEA ）和严重程度，在本过程中包含要在生产中实施替代控制方法之前获得的内部批准。
在发运采用替代方法检验或试验的产品之前，如有要求，组织应获得顾客批准。组织应保持一份控制计划中提及的经批准替代过程控制方法的清单并定期评审。
每个替代过程控制方法应有标准的工作指导书。组织应至少每日评审替代过程控制手段的运行，以验证标准作业的实施，旨在尽早返回到控制计划规定的标准过程。方法范例包括但不限于：
a） 以质量为关注的每日审核（如：分层过程审核，如
适用）；
b） 每日领导会议
基于严重程度，并在确认防错装置或过程的所有特征得以有效恢复的基础上，在规定时期内对重新启动验证形成文件。
在使用替代过程控制装置或过程期间，组织应实现生产的所有产品的可追溯性（如：验证并保留每个班次的首件和末件）。 8 Operation
8. 5 Production and service provision
8. 5.6 .1 .1 Temporary change of process controls The organization shall identify，document，and maintain a list of the process controls，including inspection，measuring，test，and error-proofing devices，that includes the primary process control and the approved back-up or alternate methods. The list of process controls shall include the primary process controls and the approved back-up or alternate methods, if back-up or alternate methods exist.
The organization shall document the process that manages the
use of alternate control methods. The organization shall include in this process，based on risk analysis（such as FMEA），severity，and the internal approvals to be obtained prior to production implementation of the alternate control method.
Before shipping product that was inspected or tested using the alternate method，if required，the organization shall obtain approval from the customer(s）. The organization shall maintain and periodically review a list of approved alternate process control methods that are referenced in the control plan.
Standard work instructions shall be available for each alternate process control method. The organization shall review the operation of alternate process controls on a daily basis，at a minimum，to verify implementation of standard work with the goal to return to the standard process as defined by the control plan as soon as possible. Example methods include but are not limited to the following:
a） Daily quality focused audits（e.g., layered process audits，as applicable）；
8.5.6.1.1 过程控制的临时更改 【SI-11：2024-07】-IATF16949条款解读
