Measuring Devices Control Procedure 測量儀器管理程序（中英版）

1、LOGOQUALITY SYSTEM PROCEDURE 質(zhì) 量 體 系 程 序Number 文件編號:PD-S3-01Department 部門:QA 質(zhì)量部 Subject 文件名稱:Measuring Devices Control Procedure測量儀器管理程序Revision版本: 3.0Effective Date生效日期:2014-11-06Page 10 of 10批準(zhǔn)：審核：作成：Change History 變更記錄Revision 版本Effective Date生效日期Originator編寫人Reasons for Change修改原因2.02013.03.21J

2、im Geng新增規(guī)定必須將校準(zhǔn)標(biāo)簽貼在器具的本體上3.0Sam MiAdd 4.5.4.3 and update 6.1 content.1.0 Purpose目的1.1 To describes the actions undertaken to ensure measuring equipment used to determine product quality is of the required accuracy. It describes identification method, checking plan, status and recording system.為確保關(guān)系

3、產(chǎn)品品質(zhì)的監(jiān)視測量設(shè)備達到足夠的精度要求，本程序介紹了對這些設(shè)備進行標(biāo)識，設(shè)定檢查計劃，以及狀態(tài)以及記錄的系統(tǒng)。2.0 Scope范圍2.1 This procedure covers all measuring tools, equipment, golden samples and standards, which requires calibration and/or verification at MMK.本程序包含了本公司所有的需要校驗或驗證的測量工具，設(shè)備，標(biāo)準(zhǔn)樣品以及標(biāo)準(zhǔn)片。3.0 Definitions定義3.1 Measuring Equipments: measuring

4、instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process. To determine a physical quantity, magnitude or dimension and then judge if the object meet the requirements.測量設(shè)備：為實現(xiàn)測量過程所必需的測量儀器、軟件、測量標(biāo)準(zhǔn)、標(biāo)準(zhǔn)物質(zhì)或輔助設(shè)備或

5、它們的組合，一般用于確定物理量、規(guī)模大小或者尺寸的大小，根據(jù)其結(jié)果判定被測對對象是否符合規(guī)定的要求。3.2 Monitoring Equipment: observing and supervising process devices. Monitoring implies observing, supervising, keeping under review (using monitoring devices).監(jiān)視儀器：用于生產(chǎn)過程狀態(tài)確認(rèn)的儀器設(shè)備；監(jiān)視指觀察、監(jiān)督、處于評審中（通過使用監(jiān)視裝置）。3 Procedure and Flow chart 程序及流程圖 4.1 Respon

6、sibility and authority 職責(zé)與權(quán)限 Lab Technician is responsible for manage the equipments calibration system.由實驗室技術(shù)員負責(zé)維護設(shè)備校驗系統(tǒng)；4.1.2 Each department is responsible for the control of monitoring and measuring devices used in their areas.各部門負責(zé)對本區(qū)域內(nèi)使用的監(jiān)視和測量設(shè)備進行控制；4.1.3 Process engineer (for production) and

7、laboratory Technician (for lab) shall carry out internal calibration of measuring equipment. And they must be trained about the related internal calibration methods.工藝工程師（生產(chǎn)線用檢測儀器）以及實驗室技術(shù)員（實驗室用檢測儀器）執(zhí)行內(nèi)部校驗，他們必須經(jīng)過相關(guān)的儀器校驗技能培訓(xùn)；4.1.4 Method of checking/calibrate is described in the relevant SOP.檢查/校驗方法件具

8、體的操作規(guī)程。4.1.5 測量儀器由質(zhì)量部門統(tǒng)一申請請購，質(zhì)量部門填寫請購申請單并詳細注明規(guī)格、型號、特殊要求，審批后由采購部門尋找相應(yīng)供應(yīng)廠商進行采購。4.1.6 Quality department validate the measuring equipments and register into TS-405.01 <Calibration devices control and checkout list> after purchase, take calibration.測量儀器采購入庫后，質(zhì)量部驗收，填寫設(shè)備驗收單，登記入計量器具管理臺帳及校驗計劃。 4.1.7 實

9、驗室保存原廠合格證或保證書、使用說明書4.2 Traceability and qualification calibration standards檢驗標(biāo)準(zhǔn)的可追溯性以及權(quán)威性4.3.1 External trace of standards: The standards of calibration must be sent out for calibration periodically, and must traceable to national/international standard.標(biāo)準(zhǔn)的外部溯源：用來內(nèi)部校驗的標(biāo)準(zhǔn)必須定期送到外部的權(quán)威機構(gòu)進行校驗，其校驗可溯源到國家或國

10、際標(biāo)準(zhǔn)；4.3.2 Special trace instruction: For special measuring equipment that external calibration lab also can not do due to lack of equipment or proper standard, calibration people may design the special calibration instruction or formula to calibrate it and describe it into document.特殊溯源：一些特殊的設(shè)備，由于缺乏

11、適當(dāng)?shù)男?zhǔn)設(shè)備或校準(zhǔn)標(biāo)準(zhǔn)，外部機構(gòu)也無法進行校驗的，校驗人員可以自行設(shè)計特定的校驗指導(dǎo)書或通用規(guī)則來實施校驗，并在文件中說明；4.3.3 The precision of standard must be 10 times or more than calibrated equipment. If the standard is a golden sample for comparison. 用來校驗的標(biāo)準(zhǔn)的精度必須為被校驗設(shè)備的10倍或以上。如果標(biāo)準(zhǔn)樣品是用來進行比對的，其至少與校驗設(shè)備的精度等級相同。4.3.4 Must be traceable to national/internati

12、onal standard.所有校驗標(biāo)準(zhǔn)必須能溯源到國家/國際標(biāo)準(zhǔn)；4.3.5 Should be stored under stated environment condition.儀器設(shè)備必須在規(guī)定的環(huán)境條件下存放。4.3 Identification and Registration of measuring equipment.監(jiān)視測量設(shè)備的標(biāo)識和登記4.3.1 Lab Technician combine all the equipments that must be calibration and build up a Calibration Master List to mana

13、ge them.實驗室技術(shù)員對所有需要校驗的設(shè)備進行整理，并建立設(shè)備檢驗清單來進行管理；Measuring equipment that are directly and indirectly related to end product should be include in < Calibration devices control and checkout list >. There are 3 kinds of calibration to be defined. Outside calibration、Inside calibration 、and exempt cal

14、ibration.所有直接或間接相關(guān)最終產(chǎn)品質(zhì)量的設(shè)備必須包含在計量器具管理臺帳及校驗計劃內(nèi)。 公司內(nèi)量具分為外校量具、內(nèi)校量具及免校量具三種.Outsie calibration 外部校驗All monitoring and measurement equipments purchased external and used to measure products and process characteristic, like caliper, dial indicator, thread gauges, micrometers, CMM etc. need to calibrated b

15、y outside intelligence organization with calibration report. Calibration cycle is normally one year,if have special requirement,will follow it.Detailed please gauge list.外部購買的用于測量產(chǎn)品和過程特性有關(guān)的通用檢測量具，如卡尺、百分表、螺紋規(guī)、千分尺、三坐標(biāo)測量機等。均由外部有資質(zhì)的機構(gòu)進行校驗，并提供檢驗報告。校驗周期一般為一年，如有特殊要求依要求執(zhí)行。具體見計量器具管理臺帳及校驗計劃。Inside calibration

16、 內(nèi)部校驗Inspeciton jigs made internal， are calibrated by qualified inspector following related drawings.Cycle time of internal calibration depending on the usage of each jig.Detailed please see gauge list 公司內(nèi)部制作測量產(chǎn)品的檢測量具，由公司內(nèi)部具有資質(zhì)的人員依據(jù)相應(yīng)的圖紙規(guī)范檢驗量具的相關(guān)尺寸。內(nèi)部校驗周期視具體的量具使用狀況而定。具體見計量器具管理臺帳及校驗計劃。No calibration

17、required if the equipment is無需校驗的設(shè)備有:- Production equipment, not measuring or testing equipment.非監(jiān)視和測量的生產(chǎn)設(shè)備.- Equipment is only for comparison. But it is necessary to check periodically.僅用來參照的設(shè)備，但其必須定期檢查. - The equipment that its measurement just for reference, it has another process to control the

18、result.為檢測設(shè)備但其檢測結(jié)果只用作參考，最終判斷由另外的過程來控制.- Environment control facilities, it makes no difference with product quality. 環(huán)境控制設(shè)備，其對產(chǎn)品質(zhì)量無影響4.3.2 Information of equipments will be stored and maintained in the computerized < Calibration devices control and checkout list >.所有校驗設(shè)備的信息在電腦的計量器具管理臺帳及校驗計劃上進行

19、存儲和管理。4.3.3 Numbering device according to the coding principle.根據(jù)編碼原則進行編號； 見附件一 Appendix 14.3.4 List of items that required calibration could be found in the Calibration Master List.設(shè)備校驗清單上顯示設(shè)備的編號.4.3.5 History and calibration due date for each equipment are maintained in the Calibration Master List

20、. The review of the equipment due for calibration will be performed in monthly basis.校驗歷史記錄以及下次校驗時間也應(yīng)在校驗清單上注明.每個月對設(shè)備的校驗情況進行審核.4.3.6 If equipment is found to be outside of permissible range and cannot be calibrate/fix internally, it should be sent out to the vendor for repair and calibration. If equi

21、pment is broken, it has to be replaced with new item. Products measured by reject instrument should be remeasured using eligible instruments, and handle as nonconformance process, keep related record also.如果設(shè)備經(jīng)過校驗超出允許的范圍,并且不能進行內(nèi)部校準(zhǔn)和維修,必須送出去進行維修并校準(zhǔn). 如果設(shè)備已經(jīng)損壞，必須立即更換新設(shè)備。若有產(chǎn)品被不合格的量具檢測過，需要對已檢測的產(chǎn)品采取相應(yīng)的措施進

22、行重新確認(rèn)，并依不合格品處理流程處理，保存相關(guān)的記錄； 4.4 External Calibration外部校驗4.4.1 Measuring equipment that cannot be calibrated internally should be sent out to accredited company for calibration. 無法進行內(nèi)部校驗的設(shè)備必須送到外部機構(gòu)進行校驗4.4.2 The standard of external calibration lab must be traceable to class II or more high class inde

23、pendent lab.外部校準(zhǔn)實驗室的標(biāo)準(zhǔn)必須能溯源到二級實驗室或更高等級的實驗室。4.4.3 Fill in the qualified label and paste it on the device，Update the calibration information in Calibration Master List.校驗后填寫內(nèi)部的合格標(biāo)簽并貼在量測儀器本體上，并更新校驗設(shè)備清單上的信息。4.4.4 All external certificates should be retained in External Calibration Cert. file for records

24、.保持所有外部校驗的報告證書，以資記錄。4.5 Internal Calibration management. 內(nèi)部校驗管理4.5.1 Select suitable measuring equipment選擇合適的測試設(shè)備4.5.1.1 All equipments be used for measuring, user must take equipment manual, specification, tolerance, environment condition, traceability, precision, accuracy for reference. And QA mak

25、e sure that it must be calibrated or not, in order to meet the product specification. 用來監(jiān)測的設(shè)備，使用者應(yīng)該取得設(shè)備手冊，規(guī)范，測量公差，保存環(huán)境，追訴標(biāo)識，精度以及參考準(zhǔn)確度。 QA工程師要確定是否進行校準(zhǔn)來判斷是否符合其產(chǎn)品規(guī)范。4.5.2 Confirm calibration period 確定校驗周期4.5.2.1 Calibration people build up the period of the equipments according to its stability, precis

26、ion, frequency of use, environment condition and manual. Calibration cycle is normally one year,if have special requirement,will follow it.Detailed please gauge list.校驗人根據(jù)設(shè)備的穩(wěn)定性、精度、使用頻率、保存環(huán)境及使用手冊來確立其校驗周期。校驗周期一般為一年，如有特殊要求依要求執(zhí)行。具體見校驗量具清單；4.5.2.2 Calibration people can adjust calibration period accordi

27、ng to calibration report.檢驗人可以根據(jù)校驗報告適當(dāng)對校驗周期進行調(diào)整。4.5.3 Calibration implementation實施校驗4.5.3.1 Calibration person who does internal calibration must get related skill training or certificate. And should be trained periodically.內(nèi)部校驗人員必須經(jīng)過相應(yīng)的技能培訓(xùn)或證書，并且培訓(xùn)要定期地進行。4.5.3.2 Should establish calibration operati

28、on procedure.建立相應(yīng)的校驗規(guī)程。4.5.3.3 Write down the calibration report after calibration finished.檢驗后填寫檢具驗收報告。4.5.3.4 All the items that are calibrated should be labelled with calibration sticker. Information such as equipment number, check date, due date and check by should be visible on the calibration

29、sticker.校驗后的設(shè)備應(yīng)在設(shè)備本體上貼上校驗合格標(biāo)簽，注明設(shè)備號碼，校驗日期，下次校驗日期等。4.5.3.5 If calibration fails, calibration people must stick the “Stop using” Label on the equipment and issue the Abnormal Notice to user. The user and relevant department should do corrective actions, and Trace the product in the passing time，and ha

30、ndle as nonconformance process, keep related record also.如果校驗失敗，校驗人貼上“停止使用”標(biāo)簽并提交異常報告給使用者。使用者以及相關(guān)的部門應(yīng)采取糾正措施，對以前使用過此量具檢驗過的產(chǎn)品進行追蹤確認(rèn)，并依不合格品處理流程處理，保存相關(guān)的記錄；4.5.3.6 If the master equipment is out of calibration. Calibration people should adjust or repair and calibrate the master equipment, then check other

31、 equipment that calibrated by this master equipment. If the result out of specification. Calibration people should adjust or repair and calibrate again. Keep the record and inform user and relevant dept.如果采用的標(biāo)準(zhǔn)設(shè)備超出規(guī)范，校驗人應(yīng)對其進行調(diào)整、修復(fù)和重新校驗，并對其校驗過的其他設(shè)備進行重新檢查。如果這些設(shè)備超出規(guī)范，檢驗人有必要對它們再次校驗。保持記錄并通知使用者和相關(guān)部門。4.5.3

32、.7 Calibration people must finish calibration within 7 working days. +/-7 days is allowed between for calibration due date.校驗人員必須在7個工作日內(nèi)完成校驗。所以校驗周期允許偏差為+/-7天。4.5.3.8 When calibration finished, Calibration Master List should be updated follow the result. 校驗完成后及時更新校驗管理清單的信息。4.5.3.9 All related records

33、, reports, documents should be kept until the equipment scraped.所有相關(guān)記錄、報告、文件應(yīng)保留至設(shè)備報廢。4.5.4 Use and Maintain for Measurement instruments 計量器具的使用和保養(yǎng)4.5.4.1 The user shall apply the measuring instruments from quality department and fill in FN-QA-026 Equipment registration/receive form使用部門到品質(zhì)部申領(lǐng)測量儀器，填寫F

34、N-QA-026量器具領(lǐng)用登記表。4.5.4.2 The user shall check the effective date and if the instruments work well before use.使用部門在使用前應(yīng)先確認(rèn)儀器在有效期內(nèi)，且正常工作。 4.5.4.3. All of the anomaly case appear of the instrument must have to verify by gauger for example including drop on the floor, impact with other metal and etc. 所有

35、測量器具出現(xiàn)的異常情況都必須經(jīng)過計量員的核實確認(rèn)方可使用，例如包括掉 落在地或與其他金屬發(fā)生碰撞等影響。4.5.4.4 The user shall use the instruments rightly and keep them in the proper place to prevent damage.使用部門正確使用儀器，保存在適當(dāng)?shù)牡胤椒乐箵p壞。4.5.4.5 The user shall check and maintain the instruments daily, and keep them clean.使用部門負責(zé)日常的保養(yǎng)檢查，保持儀器的清潔。4.5.5 Repair a

36、nd scrap for Measurement instruments 測量儀器的維修和報廢4.5.5.1 If find nonconformance in calibration or normal production, the user fill in <Equipment Maintenance Request> and send to quality department to change goods instruments.儀器校驗中或日常生產(chǎn)中發(fā)現(xiàn)儀器不良，使用部門填寫設(shè)備維修申請通知品質(zhì)部，更換合格的量具。4.5.5.2 If possible Quality

37、 departments repair or send to supplier to repair, and then calibrate. If not repairable, the instruments will be scraped and paste red label, quality department fill in FN-QA-025 <to scrap and update the control list. 如果可維修，品質(zhì)部進行簡單修理或委托外部供應(yīng)商維修，維修后經(jīng)校驗合格可以重新使用。如果不可維修，儀器進行紅色標(biāo)識，填寫FN-QA-025量具損壞報廢申請單申

38、請報廢，并更新清單。4.5.5.3 For the suspect products, Quality fills in < Nonconforming products disposal Form> to dispose. If the products have been shipped, Quality call related departments to evaluate the risk and decide the action plan, inform customers.對因儀器故障造成的可疑產(chǎn)品，品質(zhì)部填寫不合格品處理單協(xié)調(diào)處理。如產(chǎn)品已經(jīng)出貨，由品質(zhì)部召集相關(guān)

39、部門進行風(fēng)險評估，確定行動方案，必要時并通知客戶。4.6 Product Conformance產(chǎn)品一致性4.6.1 In the event of equipment is found to be outside of permissible range, suspected product shall be re-inspected and re-validated for its conformance to the product specification. The disposition of the product would be according to related no

40、nconforming products procedures.如果檢測設(shè)備超出允許范圍，受到影響的產(chǎn)品必須進行重新檢驗和確認(rèn)是否滿足產(chǎn)品規(guī)范。異常產(chǎn)品的處理可參考不合格品處理的相關(guān)程序。4.6.2 If the product is already been delivered/use has started, refer to related nonconforming products procedures.如果受影響的產(chǎn)品以及發(fā)送出去或被使用，可參考不合格品處理的相關(guān)程序。4.7 Calibration Label校驗標(biāo)簽4.8.1 qualified label 合格標(biāo)簽；分為外部校準(zhǔn)合格標(biāo)簽、內(nèi)部校準(zhǔn)合格標(biāo)簽 外部校準(zhǔn)合格標(biāo)簽管理編號Instrument NO.：校準(zhǔn)單位Calibration：校準(zhǔn)日期DATE：再次校準(zhǔn)日期DUE： 內(nèi)部校準(zhǔn)合格標(biāo)簽管理編號Instrument NO.：校準(zhǔn)人Calibration：校準(zhǔn)日期DATE：再次校準(zhǔn)日期DUE