計器の校正とは

改正GMP省令の第10条 製造管理、第11条 品質管理などに「計器の校正」という用語が出てくる。
しかしながら省令本文にはその用語の定義はなく、逐条解説に下記の通り記載されている。(なぜ省令本文に用語の定義を記載しなくても良いのか、甚だ疑問である。)

「計器の校正」とは、必要とされる精度を考慮し、適切な標準器又は標準試料等を用いて当該計器の示す値と真の値との関係を求めることを指すものであること。

ここで注意しなければならないことは「校正」のみでは計器の「調整」は含まれないということである。
上記の定義にある通り「校正」は「当該計器の示す値と真の値との関係」を求めるのみである。
計器の示す値から示されるべき真の値を引いた値を「器差」と呼ぶ。
もし当該計器の「器差」が許容範囲を超えている場合「調整」を実施しなければならない。
「校正」と「調整」は異なることに注意が必要だ。
厳密なことを言うと、GMP省令において「校正」は要求しているが「調整」は要求されていない。
常識的に「校正」を実施した際には、同時に「調整」も実施する。つまり、一般的に「校正」に「調整」が含まれると理解されている。

校正と検証の違い

改正QMS省令の53条には下記の要求がある。

あらかじめ定めた間隔で、又は使用の前に、計量の標準まで追跡することが可能な方法により校正又は検証がなされていること。ただし、当該標準が存在しない場合においては、校正又は検証の根拠について記録すること。

ここで「校正」と「検証」は何が違うのだろうか。 
「校正」とは基準とする計量器と比較して(被校正対象である)計量器の指示値がどの程度ずれているか確認することであり、その信頼性を表す尺度として不確かさが明示される。
「検証」とは基準とする計量器とのずれが例えばJIS規格などの規定された範囲内にあるかを確認することで、通常、合格又は不合格をいう判定がなされる。

なお、TS Z 0032:2012(ISO/IEC GUIDE99 :2007)では、次のように定義されている。

校正(calibration)

指定の条件下において、第一段階で、測定標準によって提供される測定不確かさを伴う量の値と、付随した測定不確かさを伴う当該の指示値との関係を確立し、第二段階で、この情報を用いて指示値から測定結果を得るための関係を確立する操作。

検証(verification)

与えられたアイテムが規定された要求事項を満たしているという客観的証拠の掲示
例1 対象とする任意の標準物質が、当該の量の値及び測定手順に対して、質量10mgの測定試料まで均質であることの確認
例2 測定システムが性能特性又は法的要求事項を満たしていることの確認
例3 目標測定不確かさを満たすことができることの確認

出典:経済産業省HP「計量標準FAQ(全般)

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