83SR04C-E GJR2390200R1411 GJR2390211R45控制模塊的配置方法

您必須定義現場退貨、修理和缺陷的程序處理。由于以下原因而對最終用戶提出的信息要求該程序必須清楚記錄并提供給最終用戶。這個缺陷處理程序必須包括：

?檢測產品相關缺陷的方法，并將其報告給最初的設計師

?檢測可能影響其他元件的系統故障的方法系統或其他系統，以及與令人滿意的問題

?跟蹤所有報告異常及其臨時異常的程序解決方案和相應的糾正措施（如適用）

?本程序對最終用戶的信息要求必須清楚記錄并提供給最終用戶保留功能安全在系統生命周期內，不可避免地會發生設計變更；以確保為了保護系統安全，必須謹慎管理此類更改。

確定設備或系統更新措施的程序必須規定并記錄。這些程序是終端的責任但系統集成商必須提供足夠的指導，以便程序在變化。

產品級模塊和固件更新必須特別考慮產品級模塊的程序和固件更新。

系統更新必須包括應用程序更改和固件更改。

程序必須包括對任何此類活動進行影響分析的需要以及改變系統及其應用的措施適應要求的結果。

必須應用此處規定的其他要求，以及為以下項目規定的要求：

?范圍定義

?危害和風險分析

?系統功能和安全要求

?系統工程

?應用程序編程

?系統生產

?系統集成

?安裝和調試

這些程序的定義必須包括檢查和系統更改將采用的授權流程。修改記錄和變更管理應創建修改記錄，以提供每個請求或需要更改。變更管理程序必須考慮在授權變更之前，每項此類變更的影響。

這個變更的實施必須重復安全生命周期階段被改變了。結果變化的測試必須包括非回歸測試以及變化本身的測試。所有測試結果必須記錄。退役必須指定系統退役的程序。

這程序必須包括安全退役的要求系統和材料的安全移除或返還（如適用）。

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.