CAPAの誤解

QMS省令では当然のことながら、改正GMP省令においてもCAPAの徹底した実施と管理が求められる。
しかしながら、企業の多くはCAPAを正しく理解していない。

改善について
「カイゼン」という用語は、世界で通用する有名な日本語の1つである。
1970年代に日本車が米国を席巻した。日本車は価格が安いが、故障しない。また燃費も優れている。
脅威に感じた米国の3大モータースは、日本の自動車メーカーの品質管理について徹底的に調査を行った。
その結果、たどり着いたのが「トヨタの改善方式」である。
この「カイゼン」が海を渡って米国に導入され、米国流にカスタマイズされた。
日本ではQCはボトムアップ型で実施されるが、欧米ではトップダウン型である。
CAPAは日本の「カイゼン」をトップダウン型にカスタマイズしたものなのである。
つまりCAPAは日本生まれの米国育ちである。
しかしながら、そのCAPAの実施と管理において、米国FDAなどからしばしば指摘を受けている。
本来は日本のお家芸であったにもかかわらずである。
FDAは「日本の企業はCAPAを全く理解していない」と酷評したこともあったと聞く。

修正と是正処置の違い
規制要件や国際規格(ISO-9001、ISO-13485等)では、修正と是正処置を明確に区別している。
修正(Correction)とは直接的原因を潰すことである。
一方で是正処置(Corrective Action)は、根本的原因を潰すことである。その目的は再発防止である。
例えばある装置のパイプが裂けて水が漏れたといった事故があったとしよう。修正は「パイプにテープを巻く」「パイプを交換する」などである。
しかしながら、修正だけで終えてしまうと、また再発してしまう可能性があるのである。
そこで、なぜパイプが裂けたのかという根本的原因(Root Cause)を調査しなければならない。
例えば、「パイプの材質がまずかった」「設置角度に問題があった」「過酷な使用をしてしまった」などである。
このように根本的原因を究明し解決しなければ、問題は再発するのである。
筆者はコンサルテーションを実施する中で、設計ミスがあった場合の是正処置として、しばしば設計変更(図面変更)を実施している企業を見かける。
しかしながら、設計変更(図面変更)は修正である。決して是正処置にはならない。
その理由は、設計変更(図面変更)だけでは他の個所で同様な問題が再発するからである。
是正処置としては、「なぜそのような設計をしてしまったか」といった根本的原因を調査し、再発を防止する必要があるのである。

教育訓練は是正処置ではない
やはりしばしば遭遇する間違ったCAPAでは、根本的原因が「教育不足」で是正処置が「再教育の徹底」というものがある。
しかしである。教育訓練を実施した場合、当該受講者は2度と間違いを犯さないかも知れない。しかしながら、組織が変更になり、要員が変わればまた同じ間違いを犯す可能性があるのである。
すなわち教育訓練では再発防止は不十分であり、「教育訓練を徹底する」といった是正処置などはあり得ないのである。
このような場合は必ずQMSといった仕組み(システム)を修正して、要員が変わっても間違いを犯さないようにすることが肝要である。

Related post

Comment

  1. Hi there, I want to subscribe for this web site to obtain most recent
    updates, so where can i do it please help.

  2. https://www.unotravel.co.kr/contents/board.php?bo_table=adminPhoto&wr_id=1725

  3. We’re a group of volunteers and opening a new scheme in our community.
    Your site provided us with valuable info to work on. You’ve done an impressive job and our entire community will be thankful to
    you.

  4. Hello, i read your blog occasionally and
    i own a similar one and i was just curious if you get a lot of spam
    responses? If so how do you prevent it, any plugin or anything
    you can suggest? I get so much lately it’s driving me crazy so any help
    is very much appreciated.

  5. My brother recommended I might like this blog.
    He was entirely right. This post truly made my day. You can not imagine just how much time I had spent for this information! Thanks!

  6. Fantastic blog you have here but I was curious if you knew of any community forums that cover
    the same topics talked about in this article? I’d really love to be a part of group where I can get feedback from other
    knowledgeable people that share the same interest.

    If you have any recommendations, please let me know. Kudos!

  7. Ahaa, its good discussion about this post here at this weblog, I have read all that, so at this time me also commenting at this place.

  8. Hello, the whole thing is going fine here and ofcourse every one is sharing facts, that’s in fact fine, keep up writing.

  9. Yesterday, while I was at work, my sister stole my apple ipad and
    tested to see if it can survive a twenty five foot drop, just so she can be a youtube
    sensation. My iPad is now destroyed and she has 83 views.
    I know this is completely off topic but I had to share it with someone!

  10. Inspiring story there. What occurred after? Take care!

  11. Quality articles or reviews is the main to be a focus for the
    people to visit the web site, that’s what this site is
    providing.

  12. My brother suggested I might like this blog. He was entirely
    right. This post actually made my day. You can not imagine just how much time
    I had spent for this info! Thanks!

  13. I am truly thankful to the owner of this web site who has shared this enormous post at at this place.

  14. Good day! I just wish to give you a huge thumbs up
    for your excellent information you’ve got right here on this post.
    I’ll be coming back to your blog for more soon.

  15. Hmm it appears like your site ate my first comment (it was super long) so I guess I’ll just sum
    it up what I had written and say, I’m thoroughly enjoying your
    blog. I as well am an aspiring blog blogger but I’m still new to everything.
    Do you have any points for first-time blog writers? I’d genuinely appreciate it.

  16. Good post. I learn something new and challenging on blogs I stumbleupon on a daily basis.
    It will always be useful to read articles from other authors and practice something from other websites.

  17. There’s definately a lot to know about this topic.

    I really like all of the points you’ve made.

  18. Fascinating blog! Is your theme custom made or did you download it
    from somewhere? A theme like yours with a few
    simple adjustements would really make my blog jump out. Please let me know where
    you got your design. Thank you

  19. https://zenabifair.com/bbs/board.php?bo_table=free&wr_id=511078

  20. What’s Happening i am new to this, I stumbled upon this I’ve found
    It positively helpful and it has helped me out loads.
    I hope to give a contribution & help different users like its aided me.
    Good job.

  21. My brother recommended I would possibly like this website. He
    used to be entirely right. This put up actually made my day.
    You can not believe simply how so much time I had spent for this info!
    Thank you!

  22. I don’t even know how I ended up here, but I thought this post was
    great. I do not know who you are but certainly you are
    going to a famous blogger if you aren’t already 😉 Cheers!

  23. Amazing! Its really remarkable piece of writing, I have got much clear idea concerning from this article.

  24. When someone writes an post he/she maintains the idea of a user in his/her brain that how a user can understand it.
    So that’s why this piece of writing is amazing. Thanks!

  25. Hi there everyone, it’s my first visit at this web site, and post is actually fruitful for me, keep up posting these articles
    or reviews.

  26. My brother recommended I might like this website. He was entirely right.
    This post actually made my day. You cann’t imagine simply how much time I had spent for this info!
    Thanks!

  27. This is a topic which is close to my heart… Thank you!
    Where are your contact details though?

  28. This paragraph is actually a pleasant one it assists new the web
    visitors, who are wishing in favor of blogging.

  29. Thanks for sharing your thoughts about ufo5555. Regards

  30. You need to take part in a contest for one of the greatest websites on the web.
    I most certainly will recommend this website!

  31. There’s definately a lot to find out about this subject.
    I love all the points you have made.

  32. We are a group of volunteers and starting a new scheme in our community.
    Your site provided us with valuable info to work on. You’ve done a formidable job and our whole community will be grateful to you.

  33. The other day, while I was at work, my cousin stole my iphone and tested to see if it can survive
    a 30 foot drop, just so she can be a youtube sensation. My apple ipad is now destroyed and she has
    83 views. I know this is entirely off topic but I had to share it with someone!

  34. Thanks for finally talking about > CAPAの誤解 |
    お役立ち情報 < Loved it!

  35. Spot on with this write-up, I honestly believe this amazing
    site needs far more attention. I’ll probably be back again to read through more, thanks
    for the info!

  36. I’m really enjoying the theme/design of your site. Do you ever
    run into any browser compatibility problems? A number of my blog audience have complained about
    my site not working correctly in Explorer but looks great in Chrome.
    Do you have any solutions to help fix this issue?

  37. you are in reality a excellent webmaster. The website
    loading speed is amazing. It seems that you’re doing any distinctive trick.

    Also, The contents are masterwork. you have performed
    a wonderful job on this subject!

  38. My family members always say that I am killing my time here
    at net, except I know I am getting familiarity daily by
    reading thes fastidious articles.

  39. What a information of un-ambiguity and preserveness of valuable familiarity regarding unpredicted
    emotions.

  40. Appreciating the time and energy you put into your blog and detailed
    information you present. It’s great to come across a blog every once
    in a while that isn’t the same out of date rehashed material.
    Fantastic read! I’ve bookmarked your site and I’m adding your
    RSS feeds to my Google account.

  41. When someone writes an piece of writing he/she maintains the image of
    a user in his/her mind that how a user can know it.
    Therefore that’s why this post is outstdanding.

    Thanks!

  42. Hi there, just wanted to say, I liked this blog post.
    It was helpful. Keep on posting!

  43. Hey terrific blog! Does running a blog such as this take a lot of
    work? I’ve absolutely no knowledge of programming however I was hoping
    to start my own blog soon. Anyway, if you have any ideas or tips for new blog owners please share.
    I know this is off subject but I just wanted to ask.
    Kudos!

  44. Yesterday, while I was at work, my cousin stole my iphone and tested to see if it can survive a 25 foot
    drop, just so she can be a youtube sensation. My apple ipad is now destroyed and she
    has 83 views. I know this is entirely off topic but I had to share it with
    someone!

  45. Hello there, I discovered your website by the use of Google at the same time as searching for a comparable subject, your site came up, it seems good.
    I’ve bookmarked it in my google bookmarks.
    Hello there, just became aware of your weblog through Google, and found that
    it’s truly informative. I’m going to watch out for
    brussels. I will be grateful if you continue this in future.
    Numerous people will likely be benefited from your writing.
    Cheers!

  46. Wow, that’s what I was searching for, what a data!
    present here at this blog, thanks admin of this web site.

  47. Good post. I learn something totally new and challenging on sites I stumbleupon every
    day. It’s always helpful to read articles from other authors and practice something from their websites.

  48. I got this web site from my pal who shared with me about this website and
    at the moment this time I am browsing this web page and reading very informative articles at this time.

  49. Hi! I simply would like to give you a big thumbs
    up for your great info you have here on this post.
    I am returning to your website for more soon.

  50. Hi there friends, pleasant post and fastidious urging commented at this
    place, I am actually enjoying by these.

  51. Its not my first time to pay a quick visit this web site, i am browsing this
    web page dailly and take pleasant data from here daily.

  52. WOW just what I was searching for. Came here by searching for naga169

  53. If you wish for to take a great deal from this piece of writing
    then you have to apply these strategies to your won web
    site.

  54. Great beat ! I wish to apprentice even as you amend your
    website, how could i subscribe for a weblog website?
    The account helped me a applicable deal. I were a little bit familiar of this your broadcast offered shiny clear concept

  55. It’s very trouble-free to find out any matter on net
    as compared to books, as I found this paragraph at this website.

  56. Hi! I realize this is kind of off-topic however I needed to ask.
    Does operating a well-established website such as yours take a massive amount
    work? I’m brand new to running a blog but I do write in my diary everyday.
    I’d like to start a blog so I can share my own experience and views online.

    Please let me know if you have any kind of recommendations or
    tips for new aspiring bloggers. Thankyou!

  57. Everyone loves what you guys are usually up
    too. This sort of clever work and reporting!
    Keep up the awesome works guys I’ve added you guys to our blogroll.

  58. Hey I know this is off topic but I was wondering if you knew of any widgets I could add to my blog that automatically tweet my newest twitter updates.
    I’ve been looking for a plug-in like this for quite some time and was hoping maybe you would have some
    experience with something like this. Please let
    me know if you run into anything. I truly enjoy reading your blog and
    I look forward to your new updates.

  59. If some one needs expert view on the topic of blogging and site-building after that i recommend him/her to pay a visit this
    weblog, Keep up the fastidious job.

  60. Hi this is kind of of off topic but I was wanting to know if blogs
    use WYSIWYG editors or if you have to manually code with HTML.

    I’m starting a blog soon but have no coding know-how so
    I wanted to get guidance from someone with experience.
    Any help would be greatly appreciated!

  61. Hi there would you mind stating which blog platform you’re using?
    I’m looking to start my own blog soon but I’m having a
    difficult time choosing between BlogEngine/Wordpress/B2evolution and Drupal.
    The reason I ask is because your design seems different then most
    blogs and I’m looking for something completely unique.
    P.S Apologies for being off-topic but I had to ask!

  62. Heya i am for the first time here. I came across
    this board and I find It really useful & it helped
    me out much. I hope to give something back and help others like you
    helped me.

  63. I constantly emailed this weblog post page to all my contacts,
    because if like to read it next my links will too.

  64. If you want to improve your know-how simply keep visiting this web page and be updated
    with the hottest gossip posted here.

  65. I think this is one of the most significant info for me. And i’m glad reading your article.
    But should remark on few general things, The web site style is wonderful, the articles is really great :
    D. Good job, cheers

  66. Thanks for sharing your thoughts. I really appreciate
    your efforts and I am waiting for your further post thanks once again.

  67. Great post however , I was wanting to know if you could
    write a litte more on this topic? I’d be very grateful if you could elaborate a little bit more.
    Cheers!

  68. You can definitely see your enthusiasm in the article you write.

    The arena hopes for more passionate writers such as you who are not afraid
    to say how they believe. All the time go after your heart.

  69. This is my first time pay a visit at here and i am in fact pleassant to read all at one
    place.

  70. My brother suggested I would possibly like this blog.
    He was entirely right. This submit actually made my day.
    You can not consider just how a lot time I had spent for this info!
    Thanks!

  71. Thanks for sharing your thoughts on naga169. Regards

  72. Wow, incredible blog format! How lengthy have you been blogging for?
    you made blogging glance easy. The full look of your site is excellent, let
    alone the content material!

  73. I’m really impressed with your writing skills and also with
    the layout on your weblog. Is this a paid theme or did you
    modify it yourself? Either way keep up the excellent quality writing, it’s rare to see a great blog like this one these days.

  74. hello there and thank you for your info – I’ve definitely picked up anything new from right here.
    I did however expertise a few technical points using this website, as I experienced to
    reload the website a lot of times previous to I could get it to load correctly.
    I had been wondering if your hosting is OK? Not that I’m
    complaining, but sluggish loading instances times will sometimes affect your
    placement in google and could damage your high quality score
    if advertising and marketing with Adwords. Well I’m
    adding this RSS to my email and could look out for a lot more of your respective intriguing content.
    Ensure that you update this again soon.

  75. If some one wants expert view regarding running a blog
    after that i propose him/her to pay a quick visit this weblog, Keep up the good
    work.

  76. naturally like your web-site but you have to test the spelling on several of
    your posts. A number of them are rife with spelling issues and I in finding it
    very troublesome to tell the reality however I will definitely
    come back again.

  77. I needed to thank you for this fantastic read!! I
    certainly loved every little bit of it. I have you book-marked to check out new things you post…

  78. These casinos provide actual money gaming experience
    with many other additionnal promotions.

    My web site :: here

  79. Excellent goods from you, man. I’ve understand your stuff previous to
    and you are just extremely fantastic. I really like what you’ve acquired
    here, really like what you are stating and the way in which you say it.
    You make it enjoyable and you still care for
    to keep it wise. I cant wait to read much more from you.

    This is really a wonderful website.

  80. Yes! Finally something about Hokicoy.

  81. When I initially commented I clicked the “Notify me when new comments are added”
    checkbox and now each time a comment is added I get four e-mails with the same comment.
    Is there any way you can remove me from that service?

    Bless you!

  82. I think this is one of the most significant info for me.

    And i am glad reading your article. But wanna remark
    on few general things, The site style is ideal, the articles is really excellent :
    D. Good job, cheers

  83. I was wondering if you ever considered changing the page layout of your blog?
    Its very well written; I love what youve got to say.
    But maybe you could a little more in the way of content so people could
    connect with it better. Youve got an awful lot of text
    for only having one or two pictures. Maybe you
    could space it out better?

  84. BetOnlibe additionally presents attractive bonuses and promotions, providing additional value to itts customers.

    My web-site … 슈어맨

  85. My family members every time say that I am killing my time here at web, except
    I know I am getting familiarity everyday by reading
    thes nice content.

  86. Hi, just wanted to tell you, I enjoyed this post. It was funny.
    Keep on posting!

  87. I have read so many articles on the topic of the blogger lovers however this piece of writing is truly a fastidious article,
    keep it up.

  88. http://visioncareafrica.org/bbs/board.php?bo_table=free&wr_id=192978

  89. Unfortunately, thee Oneida Casino Sportsbook doesn’t suppy new bettors sign-up bonuses when creating neew betting accounts.

    Heree is my web blog … more info

  90. SGCs supply unique odds and betting markets not seen anywhere else, together with Player Props, Futures, Totals, and more.

    Also visit my homepage … 슈어맨

TOP