Regulations on the Dedication of Commercial Grade Items and Certification of Dedication Agency Article 8
Based on the acceptance criteria to establishing the acceptance program, the following acceptance methods shall be selected on the specific Critical Characteristics of the nuclear grade items.1. Special Tests and Inspections Special Tests and Inspections shall be conducted in accordance with the established acceptance criteria and procedures, and shall verify that the Dedicated Commercial Grade Item does have the Critical Characteristics required to carry out its safety functions.2. Survey or Audit of Supplier The supplier shall have a qualified Quality Assurance (QA) program and operating procedures. These requirements shall be extended as needed to include the parts of the Commercial Grade Items and/or the material manufacturer. Supplier survey or audit shall include not only QA specialist but also technical personnel in order to ensure that the supplier, the parts and/or the material manufacturer do have an appropriate and effectively implemented QA program.3. Source Verification For those Critical Characteristics or Acceptance Criteria that can not be assured by special tests and inspections, Source Verification, through on-the-scene inspections of the procedures and documentation of the Commercial Grade Item’s material fabrication process, shall be conducted to ensure that the item has been fabricated in accordance with a specified process. The requirements for Source Verification shall be stated in the procurement document.4. Acceptable Supplier/Item Performance Record Acceptable Supplier/Item Performance Record means acceptable supplier/item performance record based on the dedication requirements.Method 2 and method 4 shall not be used alone. They shall be used together with other method(s).
中文原文 核能同級品零組件檢證作業及檢證機構認可管理辦法第8條
依據允收準則訂定允收計畫時，應就核能級產品零組件之關鍵特性選擇下列適當允收方法：
一、特殊測試及檢驗：應依據允收準則之既定程序執行，並證實核能同級品零組件具有執行特定安全功能所應具備之關鍵特性。
二、供應廠商稽查或訪查：供應廠商應具備合格之品保制度及作業程序書，必要時此項要求並應延伸涵蓋商業級零組件或原料製造商。
訪查人員應具備品保及技術專業，以確保供應廠商及其商業級零組件原料製造商具有完善之品保制度並確實有效履行。
三、貨源驗證：對於無法經由特殊測試及檢驗確認之關鍵特性或允收準則，必須執行商業級零組件特定製程之材料程序及文件現場驗證，以確定商業級零組件係按一定之製程所完成。
貨源驗證之要求並應註明在採購文件中。
四、供應廠商之供貨紀錄：指供應廠商依據檢證要求所提出之供貨紀錄。
前項第二款、第四款之允收方法，應配合其他允收方法執行，不得單獨使用。
一、特殊測試及檢驗：應依據允收準則之既定程序執行，並證實核能同級品零組件具有執行特定安全功能所應具備之關鍵特性。
二、供應廠商稽查或訪查：供應廠商應具備合格之品保制度及作業程序書，必要時此項要求並應延伸涵蓋商業級零組件或原料製造商。
訪查人員應具備品保及技術專業，以確保供應廠商及其商業級零組件原料製造商具有完善之品保制度並確實有效履行。
三、貨源驗證：對於無法經由特殊測試及檢驗確認之關鍵特性或允收準則，必須執行商業級零組件特定製程之材料程序及文件現場驗證，以確定商業級零組件係按一定之製程所完成。
貨源驗證之要求並應註明在採購文件中。
四、供應廠商之供貨紀錄：指供應廠商依據檢證要求所提出之供貨紀錄。
前項第二款、第四款之允收方法，應配合其他允收方法執行，不得單獨使用。