83SR04C-E GJR2390200R1411 GJR2390211R45控制模块的配置方法
您必须定义现场退货、修理和缺陷的程序处理。由于以下原因而对最终用户提出的信息要求该程序必须清楚记录并提供给最终用户。这个缺陷处理程序必须包括：
•检测产品相关缺陷的方法，并将其报告给最初的设计师
•检测可能影响其他元件的系统故障的方法系统或其他系统，以及与令人满意的问题
•跟踪所有报告异常及其临时异常的程序解决方案和相应的纠正措施（如适用）
•本程序对最终用户的信息要求必须清楚记录并提供给最终用户保留功能安全在系统生命周期内，不可避免地会发生设计变更；以确保为了保护系统安全，必须谨慎管理此类更改。
确定设备或系统更新措施的程序必须规定并记录。这些程序是终端的责任但系统集成商必须提供足够的指导，以便程序在变化。
产品级模块和固件更新必须特别考虑产品级模块的程序和固件更新。
系统更新必须包括应用程序更改和固件更改。
程序必须包括对任何此类活动进行影响分析的需要以及改变系统及其应用的措施适应要求的结果。
必须应用此处规定的其他要求，以及为以下项目规定的要求：
•范围定义
•危害和风险分析
•系统功能和安全要求
•系统工程
•应用程序编程
•系统生产
•系统集成
•安装和调试
这些程序的定义必须包括检查和系统更改将采用的授权流程。修改记录和变更管理应创建修改记录，以提供每个请求或需要更改。变更管理程序必须考虑在授权变更之前，每项此类变更的影响。
这个变更的实施必须重复安全生命周期阶段被改变了。结果变化的测试必须包括非回归测试以及变化本身的测试。所有测试结果必须记录。退役必须指定系统退役的程序。
这程序必须包括安全退役的要求系统和材料的安全移除或返还（如适用）。
You must define the procedure for field returns, and repair and defect
handling. The information requirements placed on the end user because of
this procedure must be clearly documented and given to the end user. The
defect handling procedure must include:
• Method of detecting product related defects and the reporting of these to
the original designers
• Methods for detecting systematic failure that could affect other elements
of the system or other systems, and links to the satisfactory resolution of
the issues
• Procedures for tracking all reported anomalies, their temporary
solutions and resultant corrective action where applicable
• The information requirements placed on the end users by this procedure
must be clearly documented and given to the end user Preserving Functional
Safety
Design changes will inevitably occur during the system life-cycle; to make sure
that the system safety is preserved, such changes must be carefully managed.
Procedures defining the measures for updating the plant or system must be
specified and documented. These procedures are the responsibility of the end
user, but the system integrator must supply sufficient guidance so that the
procedures keep the required level of functional safety during and after the
changes.
Product Level Module and Firmware Updates
Special consideration must be given to procedures for product level module
and firmware updates.
Updates to the system must include the modification adaptation for
application changes and firmware changes.
The procedures must include the need to do an impact analysis of any such
changes, and the measures to change the system and its application as an
outcome of the adaptation requirements.
The other requirements specified here must be applied, as well as the
requirements specified for the following items:
• Scope definition
• Hazard and risk analysis
• System Functional and Safety Requirements
• System engineering
• Application programming
• System production
• System integration
• Installation and commissioning
The definition of these procedures must include the examination and
authorization process to be adopted for system changes.Modification Records and Change Management
Modification records shall be created to give traceability of each requested or
required change. The change management procedure must consider the
impact of each such change before authorizing the change. The
implementation of the change must repeat the safety lifecycle phases which
are altered by the change. The test of the resultant changes must include nonregression testing as well as test of the change itself. All test results must be
recorded.
Decommissioning The procedure for decommissioning the system must be specified. This
procedure must include the requirements for the safe decommissioning of the
system and, where applicable, the safe removal or return of materials.
