仪校程序文件

Class : Equipment Calibration
類　別　： 儀器調校

Doc No : ECG20001
文件編號

Title : Calibration Control Procedure
題 目 ： 調校監管程式


1. Purpose
目的

2. Scope
範圍

3. Reference Documents
參考文件

4. Definitions
定義

5. Forms and Records
表格及記錄

6. Responsibilities
責任

7. General Requirements
一般要求

8. General Procedures
一般程式

9. Attachment
附件

1. Purpose 目的

1.1 This document shall define the quality system of the Quality Assurance (Q.A.) Calibration including the requirements and procedures to carry out calibration of all applicable test and measuring equipments, and manufacturing equipments carried out by in-house Calibration Group and external Calibration laboratories.(except Chemical Laboratory Equipment)
本文件旨在訂定品質保證(QA)調校品質系統，包括檢查、量度及生産機器的調校要求和程式，而有關事項由公司調校及外部調校實驗室進行（化學品實驗室除外）。

2. Scope 範圍

2.1 This document shall be applicable to all tests and measuring equipments, and manufacturing equipments used to ensure products manufactured by XXX Limited conform to prescribed technical requirement.
本文件適用於XXX有限公司所有檢查、量度及生産機器，以確保品質有限公司的産品符合預定的技術要求。

3. Reference Documents 參考文件

3.1 QSG10001 Quality Systems Manual
品質系統守則

3.2 ECG20002 Measurement System Analysis (MSA) Procedure
工作指引－量度系統分析及評估

3.3 PCG20003 Environmental Condition and Plant Facilities Monitoring Procedure
環境及廠房設施監管程式

3.4 PCG20015 Environment condition and Plant Facilities Mornitoring Procedure in QPL Chang An
長安品質有限公司環境及廠房設施監管程式

3.5 DCG30006 Work Instruction – Record Retention
工作指引－檔案儲存

3.6 ECG30001 Work Instruction - Calibration Control
工作指引－調校監管

3.7 QSG20007 Material Review Board
物料檢討委員會(MRB)程式

3.8 ECXxxxxx A series of WI's applicable to the calibration of individual categories of equipment
適用於調校各類機器／儀器的一系列工作指引

3.9 MIL-STD-45662A Calibration System Requirements
調校系統要求

3.10 Equipment Operation Manual 儀器操作手冊

4. Definitions 定義

4.1 Calibration The comparison of a measurement standard of instrument of known accuracy with another standard of instrument to detect, correlate, eliminate by adjustment, and report any variation in the accuracy of the item being compared.
調校 把一部己知其準確度的儀器的量度標準與另一儀器的標準作比較，來檢查、連系、更正並消除及報告比較專案的誤差。

4.2 Calibration Interval The number of work days, work weeks, months etc. between two scheduled calibrations.
調校周期 兩個調校之間的工作天、工作星期、工作月份等。

4.3 Calibration Master List A list of all measuring / test equipment to be calibrated at stated intervals.The list shall include the date of PM, MSA, the number of calibration report, GR&R, and BIAS,and calibration reference document. This list shall be originated and updated by Q.A. Calibration.
調校列表 一份列有所有量度／測試儀器在特定時間進行調校的列表。列表還須包括PM,MSA的日期和調校報告，GR&R，BIAS的編號及調校的參考文件。此列表須由品質保證部調校組發出及更新。

4.4 Calibration Recall A system for indicating in advance the date for each measuring and test equipment device and each measurement standard is next due to be calibrated.
調校提示 一個預先