Calibration Determination
An effective calibration program must firstidentify which items must be calibrated. The following items must becalibrated: items used to make a release (quality) decision, items used to setcritical process settings, items used to monitor critical process(environmental) conditions, and items used to make measurements supportingequipment product, process, design verification/validation/qualificationactivities.
一個(gè)有效的校準(zhǔn)程序必須首先確定哪些測(cè)量項(xiàng)目必須校準(zhǔn)。以下測(cè)量項(xiàng)目必須進(jìn)行校準(zhǔn)：用于做出放行(質(zhì)量)決定的測(cè)量項(xiàng)目，用于設(shè)置關(guān)鍵工藝參數(shù)的項(xiàng)目，用于監(jiān)測(cè)關(guān)鍵工藝(環(huán)境)條件的項(xiàng)目，以及用于測(cè)量支持設(shè)備、工藝、設(shè)計(jì)驗(yàn)證/驗(yàn)證/確認(rèn)活動(dòng)的儀器。
Items used to make a release (quality)decision or used to approve materials, components, subassemblies, assemblies,and finished goods at incoming, in-process, or final inspection must becalibrated to ensure compliance with predetermined specifications.
用于做出放行(質(zhì)量)決定或用于在入庫、中控或最終檢驗(yàn)中進(jìn)行物料、組分、組件、和成品批準(zhǔn)的測(cè)量項(xiàng)目必須進(jìn)行校準(zhǔn)，以確保符合預(yù)定的標(biāo)準(zhǔn)。
Items used to set critical process settingsmust be calibrated. Items that set critical process settings, such astemperature, pressure, time, etc., are examples of items typically used tocontrol a process to ensure process outputs meet predetermined specifications.
用于設(shè)置關(guān)鍵工藝參數(shù)的項(xiàng)目必須進(jìn)行校準(zhǔn)。設(shè)置關(guān)鍵工藝參數(shù)的項(xiàng)目，如溫度、壓力、時(shí)間等，是典型的用于控制工藝的項(xiàng)目，以確保工藝輸出滿足預(yù)定的標(biāo)準(zhǔn)。
Items used to monitor critical process(environmental) conditions must be calibrated. Items used to monitor criticalprocess conditions such as pressure differential, temperature, and humidity areexamples of items typically used to monitor critical process conditions toensure process outputs meet predetermined specifications.
用于監(jiān)測(cè)關(guān)鍵工藝(環(huán)境)條件的項(xiàng)目必須進(jìn)行校準(zhǔn)。用于監(jiān)測(cè)關(guān)鍵工藝條件(如壓差、溫度和濕度)的項(xiàng)目是常見的關(guān)鍵工藝條件監(jiān)測(cè)項(xiàng)目以確保工藝輸出符合預(yù)定標(biāo)準(zhǔn)。
Items used to make measurements supportequipment product, process, design verification/validation/qualificationactivities include those that are used to approve materials, components,subassemblies, assemblies, and finished goods, set critical process settings,and monitor critical process (environmental) conditions.
用于測(cè)量支持設(shè)備、工藝、設(shè)計(jì)確認(rèn)/驗(yàn)證/確認(rèn)活動(dòng)的項(xiàng)目，包括用于物料、組分、組件、和成品批準(zhǔn)、設(shè)置關(guān)鍵工藝參數(shù)和監(jiān)測(cè)關(guān)鍵工藝(環(huán)境)條件的項(xiàng)目。
Reference Only Calibration Not Required
用于參考目的不需要校準(zhǔn)
Instruments that are not used to get exactmeasurements but are used only to obtain status information do not requirecalibration. Table 2 provides some examples of when calibration may and may notbe required.
不用于獲得精確測(cè)量而僅用于獲取狀態(tài)信息的儀器不需要校準(zhǔn)。表2提供了一些可能需要和可能不需要校準(zhǔn)的示例。
|
Calibration Not Required |
Calibration Required |
|
不需要校準(zhǔn) |
需要校準(zhǔn) |
|
Calipers that are verified against a traceable standard before each use |
Calipers that are not verified against a traceable standard before each use |
|
每次使用前根據(jù)可追溯標(biāo)準(zhǔn)進(jìn)行確認(rèn)的卡尺 |
每次使用前沒有根據(jù)可追溯標(biāo)準(zhǔn)進(jìn)行確認(rèn)的卡尺 |
|
Voltmeter used for basic maintenance activities |
Voltmeter used to take measurements used for qualification, validation, verification, and inspection activities |
|
用于基本維護(hù)活動(dòng)的電壓表 |
用于確認(rèn)、驗(yàn)證、確證和檢驗(yàn)活動(dòng)的電壓表 |
|
Weight scale used for the purposes of determining postage (not a quality measurement) |
Weight scale used to determine pass/fail quality criteria |
|
用以確定郵費(fèi)的重量秤(非質(zhì)量量度) |
用于確定符合/不符合質(zhì)量標(biāo)準(zhǔn)的重量秤 |
|
Pressure gauge used to show the amount of nitrogen gas in a cylinder |
Pressure gauge where a process requires a specific pressure for proper operation |
|
用于顯示鋼瓶中氮?dú)鈹?shù)量的壓力表 |
一種工藝需要特定壓力才能正常操作的壓力表 |
|
Tape measure used to measure the length of pipe for a water system |
Tape measure used to measure a fabricated part to determine pass/fail quality criteria |
|
用于測(cè)量供水系統(tǒng)中管道長(zhǎng)度的卷尺 |
用于測(cè)量制造部件，以確定符合或不符合質(zhì)量標(biāo)準(zhǔn)的卷尺 |
Table2: Calibration not required/calibration required examples.
表2:不需要校準(zhǔn)/需要校準(zhǔn)示例。
Another simple test that I like to use todetermine if calibration is required is to apply this simple test: If the itemwas covered (not visible), can the process be set up, monitored, and operated correctly?If the answer is no to any of these questions, the item must be calibrated;otherwise, calibration is not required.
另一個(gè)我喜歡用來確定是否需要校準(zhǔn)的簡(jiǎn)單測(cè)試：如果沒有該項(xiàng)目，過程是否可以被正確設(shè)置、監(jiān)測(cè)和操作？如果這些問題的答案都是否定的，就必須對(duì)儀器進(jìn)行校準(zhǔn)；否則，不需要校準(zhǔn)。
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