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)

Related post

Comment

  1. I am really impressed with your writing skills as well as with the format in your weblog.
    Is this a paid subject matter or did you modify it yourself?
    Anyway keep up the excellent high quality writing, it’s uncommon to see a nice weblog like
    this one these days..

  2. 91669 969858Flexibility means your space ought to get incremented with the improve in number of weblog users. 676931

  3. Very interesting info!Perfect just what I was searching for!

  4. I do not even know how I finished up here, however I thought this put up was good. I do not recognize who you might be however certainly you are going to a famous blogger if you are not already 😉 Cheers!

  5. you have an amazing weblog here! would you prefer to make some invite posts on my blog?

  6. My spouse and i felt so ecstatic that Albert managed to conclude his inquiry through the ideas he came across out of your web site. It’s not at all simplistic to simply possibly be giving for free tips and hints which often other people might have been making money from. And now we fully understand we have you to appreciate because of that. The most important explanations you have made, the easy website menu, the relationships you can aid to promote – it is many astonishing, and it’s really helping our son and our family believe that this concept is excellent, and that is quite important. Thank you for everything!

  7. It’s hard to find knowledgeable people on this topic, but you sound like you know what you’re talking about! Thanks

  8. I dugg some of you post as I cogitated they were handy very helpful

  9. Magnificent website. Plenty of useful information here. I am sending it to a few friends ans also sharing in delicious. And naturally, thank you in your sweat!

  10. Puravive is a weight loss supplement that targets the root cause of weight gain issues in men and women.

  11. I haven’t checked in here for a while as I thought it was getting boring, but the last few posts are good quality so I guess I will add you back to my daily bloglist. You deserve it my friend 🙂

  12. I visited a lot of website but I think this one contains something extra in it in it

  13. Hello! Would you mind if I share your blog with my twitter group? There’s a lot of folks that I think would really appreciate your content. Please let me know. Thanks

  14. I went over this internet site and I conceive you have a lot of good info , saved to favorites (:.

  15. Renew is a nutritional supplement launched in 2024 to help anyone lose weight.

  16. Thanks for ones marvelous posting! I definitely enjoyed reading it, you may be a great author.I will be sure to bookmark your blog and may come back someday. I want to encourage you continue your great writing, have a nice weekend!

  17. Hi, Neat post. There’s a problem with your web site in internet explorer, would check this… IE still is the market leader and a large portion of people will miss your great writing due to this problem.

  18. I am happy that I observed this weblog, just the right information that I was looking for! .

  19. Lottery Defeater is an automated, plug-and-plug lottery-winning software.

  20. I really like looking at and I think this website got some really utilitarian stuff on it! .

  21. Very interesting info !Perfect just what I was looking for!

  22. As I website possessor I believe the content material here is rattling wonderful , appreciate it for your efforts. You should keep it up forever! Best of luck.

  23. Thank you for sharing excellent informations. Your website is so cool. I am impressed by the details that you have on this web site. It reveals how nicely you understand this subject. Bookmarked this web page, will come back for extra articles. You, my pal, ROCK! I found just the info I already searched everywhere and just could not come across. What a great web-site.

  24. Renew: An Overview. Renew is a dietary supplement formulated to aid in the weight loss process by enhancing the body’s regenerative functions

  25. What Is LeanBiome? LeanBiome, a new weight loss solution, includes beneficial strains of gut bacteria that work fast for weight loss.

  26. Appreciating the time and energy you put into your website and in depth information you present. It’s good to come across a blog every once in a while that isn’t the same outdated rehashed information. Great read! I’ve bookmarked your site and I’m including your RSS feeds to my Google account.

  27. I like the valuable info you provide in your articles. I will bookmark your weblog and check again here regularly. I am quite certain I will learn lots of new stuff right here! Good luck for the next!

  28. What Is Sumatra Slim Belly Tonic? Sumatra Slim Belly Tonic is a weight management formula that is said to eliminate excess body fat naturally.

  29. Hello there, simply turned into aware of your blog thru Google, and located that it is really informative. I am going to be careful for brussels. I’ll appreciate if you proceed this in future. Numerous folks can be benefited from your writing. Cheers!

  30. I think other web-site proprietors should take this website as an model, very clean and wonderful user genial style and design, as well as the content. You are an expert in this topic!

  31. Thanks for helping out, excellent info. “Riches cover a multitude of woes.” by Menander.

  32. Fantastic post but I was wondering if you could write a litte more on this topic? I’d be very thankful if you could elaborate a little bit more. Cheers!

  33. Hello there, You’ve performed an incredible job. I will certainly digg it and in my opinion suggest to my friends. I am confident they will be benefited from this web site.

  34. There are definitely a whole lot of particulars like that to take into consideration. That is a nice point to carry up. I offer the thoughts above as common inspiration but clearly there are questions like the one you bring up where a very powerful factor will likely be working in honest good faith. I don?t know if best practices have emerged round things like that, but I’m certain that your job is clearly recognized as a fair game. Both boys and girls really feel the impression of only a moment’s pleasure, for the rest of their lives.

  35. I like what you guys are up also. Such intelligent work and reporting! Keep up the excellent works guys I have incorporated you guys to my blogroll. I think it’ll improve the value of my web site 🙂

  36. What Is FitSpresso? The effective weight management formula FitSpresso is designed to inherently support weight loss. It is made using a synergistic blend of ingredients chosen especially for their metabolism-boosting and fat-burning features.

  37. Hey very nice site!! Man .. Beautiful .. Amazing .. I will bookmark your blog and take the feeds also?KI’m satisfied to seek out a lot of helpful information here in the publish, we’d like work out extra strategies in this regard, thanks for sharing. . . . . .

  38. Understanding NanoDefense Pro: What is it? NanoDefense Pro is a specialized formula designed to improve nail and foot health naturally.

  39. FitSpresso: What Is It?FitSpresso is a natural weight loss aid designed for individuals dealing with stubborn weight gain. It is made using only science-backed natural ingredients.

  40. I do agree with all of the ideas you have presented in your post. They are very convincing and will definitely work. Still, the posts are very short for newbies. Could you please extend them a little from next time? Thanks for the post.

  41. I?¦m no longer positive where you’re getting your information, but good topic. I must spend a while finding out much more or working out more. Thanks for fantastic information I was searching for this information for my mission.

  42. Great post. I am facing a couple of these problems.

  43. I have been browsing online more than three hours today, yet I never found any interesting article like yours. It’s pretty worth enough for me. In my opinion, if all site owners and bloggers made good content as you did, the net will be much more useful than ever before.

  44. The very crux of your writing while appearing reasonable at first, did not work very well with me personally after some time. Somewhere throughout the paragraphs you were able to make me a believer unfortunately just for a very short while. I still have got a problem with your leaps in logic and one might do nicely to help fill in all those gaps. In the event you can accomplish that, I would surely end up being amazed.

  45. What are Ageless Knees? Ageless Knees is a knee pain relieving program. Chris Ohocinski, a State-Licensed and Nationally Certified Athletic Trainer, came up with this program.

  46. very nice put up, i definitely love this website, carry on it

  47. Only a smiling visitor here to share the love (:, btw outstanding style and design.

  48. Some really nice and useful information on this internet site, too I think the style and design contains superb features.

  49. Good write-up, I am regular visitor of one?¦s web site, maintain up the excellent operate, and It’s going to be a regular visitor for a long time.

  50. you’re actually a good webmaster. The site loading velocity is amazing. It kind of feels that you’re doing any distinctive trick. Also, The contents are masterpiece. you’ve done a great task in this subject!

  51. But a smiling visitor here to share the love (:, btw outstanding design.

  52. Hey there! Someone in my Facebook group shared this website with us so I came to check it out. I’m definitely enjoying the information. I’m book-marking and will be tweeting this to my followers! Exceptional blog and amazing design.

  53. I’d have to examine with you here. Which is not one thing I usually do! I take pleasure in reading a post that may make folks think. Additionally, thanks for permitting me to comment!

  54. I was reading some of your posts on this internet site and I believe this web site is really instructive! Retain putting up.

  55. Wow! Thank you! I constantly wanted to write on my website something like that. Can I include a fragment of your post to my site?

  56. I really appreciate this post. I have been looking all over for this! Thank goodness I found it on Bing. You’ve made my day! Thank you again

  57. I liked as much as you will receive carried out right here. The caricature is tasteful, your authored subject matter stylish. nonetheless, you command get got an shakiness over that you wish be turning in the following. ill definitely come more formerly again as precisely the similar just about a lot frequently inside of case you defend this increase.

  58. you are really a good webmaster. The site loading speed is amazing. It seems that you are doing any unique trick. Also, The contents are masterwork. you have done a fantastic job on this topic!

  59. I was suggested this website by my cousin. I’m not sure whether this post is written by him as nobody else know such detailed about my problem. You are wonderful! Thanks!

  60. I was examining some of your blog posts on this site and I believe this website is real informative ! Keep on putting up.

  61. I couldn’t resist commenting

  62. Thanks for another excellent article. Where else could anyone get that kind of information in such an ideal way of writing? I’ve a presentation next week, and I’m on the look for such info.

TOP