『CAPA』に関する誤解

医療機器企業におけるFDA査察では、CAPA(是正処置・予防処置)に関して厳格に調査される。
その理由は、事故・不具合・回収(改修)等の再発防止である。
医療機器には何某かのリスクが伴う。もしリスクのある医療機器を製造販売してはならないとなると医療の進歩は望めなくなる。
事故は起こさないに限る。しかしながらリスクを0にすることは不可能である。
愚かなことは事故を繰り返してしまうことである。
FDAは「すみやかな救済」を求めている。
苦情や有害事象・不具合報告を受けた場合、すみやかに改善を実施しなければならない。
そのためにはCAPA(是正処置・予防処置)が重要となる。

是正と修正は異なる

是正処置(CA)で重要なことは根本的原因を究明し再発を防止することである。
ここで「是正」と「修正」は異なる。
「修正」とは不具合の直接的原因を潰すことである。
一方で「是正」は不具合の根本的原因を潰すことである。
筆者がコンサルテーションを実施する中で「修正」を「是正」として間違っている例には以下の2点がある。
・設計変更
・再教育
上記の2つはいずれも修正である。
なぜならば、設計ミスの根本的原因を究明せずに設計(例:図面、仕様等)を変更したとすれば、また別の個所で同じ間違いを繰り返してしまう。
また、再教育を実施したとしても、当該本人は再発させないかも知れないが、異動があった場合、別の要員がまた同じ間違いを犯してしまうだろう。
このように是正処置で大切なことは「根本的原因を見極める」ことであり、再発防止について有効であるかどうかを十分に検討することである。

CAPAは単一の方法で処理しなければならない

筆者がコンサルテーションを実施した医療機器企業の中で、数社「簡易CAPA」と「拡大CAPA」(いずれも仮称)といった2通りのフローを作成しているケースが見受けられた。
これは明らかに間違いである。規制要件やISO-13485にはCAPAを2通りに分けるといった要求は全く記載されていない。
苦情処理やCAPAなどの「イベント管理」は単一のフローで処理しなければならない。
大切なことは、調査が進み原因究明がなされた段階で重大性が大きい場合は優先順位を上げることである。
CAPAを起票した段階で重大か軽微かを判定してフローを区別することは良くない。

CAPAのタイムフレーム

前述の通り、FDAは「タイムリーな救済」を求めている。
ISO-13485:2016においても苦情処理やCAPAに対してタイムフレーム(期限)を設けることを要求している。
しかしである。多くの医療機器企業では苦情やCAPAが何ヶ月にも渡ってオープン状態になっていることがある。
これでは「タイムリーな救済」にはならない。
当社の販売しているCAPAに関する手順書では、1ヶ月に一度進捗を確認し、クローズが遅れているCAPAに関しては当該部門から理由書を入手することとしている。
FDA査察などでは、オープン状態のCAPAについて追及されることが多いためである。
クローズが遅れているまたはクローズが困難な案件については、正当化できる理由と暫定処置を検討しておかなければならない。

CAPAにおけるリスク判定

ひとたび事故が発生するとCAPAを起票することになるが、その際に多くの企業ではリスク判定を実施している。
しかしながら、リスクの判定方法を間違っている企業が大半である。
既に起きた事象に対して、「重大性」と「発生確率」を掛け合わせているのである。
これは全くの間違いである。
リスクとはまだ起きていない問題のことであるため、発生確率を掛け合わせるのであるが、一旦発生してしまえば発生確率は1(100%)としなければならない。
例えば、航空機事故や列車事故が発生した場合、事故調査委員会が同じ事故の発生確率が極めて低いから改善策を検討しないということはあり得ない。
苦情はCAPAではリスクは重大性でのみ判定しなければならないのである。

予防処置はリスク管理のことである

予防処置とは「起こり得る不適合の原因を除去する処置」のことを言う。
ここで「起こり得る不適合」はまだ起きていない問題であることから言い換えると「リスク」である。
つまり予防処置はリスク管理なのである。
したがって、事故等が発生してから予防処置を実施するのではなく、通常業務(設計・製造・サービス・流通等)において常にリスク管理を実施してかなければならないのである。
ISO-9001:2015では、予防処置という箇条は削除され、各箇条に「リスクおよび機会」という表現で散りばめられた所以である。

https://youtu.be/jOejkKaiwBQ

Related post

Comment

  1. Oh my goodness! Incredible article dude! Many thanks,
    However I am going through difficulties with your RSS.
    I don’t understand the reason why I am unable to subscribe to it.
    Is there anybody else having the same RSS problems? Anybody who knows the answer will you kindly respond?

    Thanks!!

  2. Wow! This blog looks just like my old one! It’s on a entirely different topic
    but it has pretty much the same page layout and design. Excellent choice of colors!

  3. This paragraph will assist the internet users for setting up new web site or even a blog from
    start to end.

  4. Hello mates, how is the whole thing, and what you wish for to
    say about this paragraph, in my view its in fact amazing
    for me.

  5. Everyone loves it whenever people come together
    and share opinions. Great site, continue the good work!

  6. Yes! Finally something about Sex Dating.

  7. Have you ever considered about adding a little bit more than just your articles?
    I mean, what you say is important and everything.

    However imagine if you added some great photos or videos to give
    your posts more, “pop”! Your content is excellent but with images and clips, this blog could certainly
    be one of the most beneficial in its field.
    Great blog!

  8. I am truly delighted to read this webpage posts which includes tons of useful information, thanks for providing these
    kinds of data.

  9. Hey there! Do you know if they make any plugins to safeguard against
    hackers? I’m kinda paranoid about losing everything I’ve
    worked hard on. Any tips?

  10. I blog often and I really appreciate your information. Your article has really peaked
    my interest. I will book mark your website and keep checking for new details about once a week.
    I opted in for your Feed too.

  11. Hello! Do you know if they make any plugins to help with SEO?
    I’m trying to get my blog to rank for some targeted keywords but I’m not seeing very
    good success. If you know of any please share.

    Thanks!

  12. I am truly grateful to the owner of this site who has shared this enormous post at at this time.

  13. Can I simply say what a comfort to discover someone who genuinely knows
    what they’re talking about on the net. You definitely understand
    how to bring a problem to light and make it important.
    More and more people really need to read this
    and understand this side of your story. I can’t believe you
    aren’t more popular since you most certainly possess the gift.

  14. Whats up very cool blog!! Guy .. Excellent .. Amazing ..
    I’ll bookmark your website and take the feeds additionally?
    I am happy to seek out a lot of helpful info here within the submit, we want develop more strategies on this
    regard, thank you for sharing. . . . . .

  15. Actually when someone doesn’t be aware of then its up to other people that they
    will help, so here it happens.

  16. These are truly fantastic ideas in regarding blogging.
    You have touched some pleasant factors here.
    Any way keep up wrinting.

  17. At this time I am going away to do my breakfast, afterward having my breakfast
    coming over again to read further news.

  18. Wonderful blog! I found it while browsing on Yahoo News.

    Do you have any tips on how to get listed in Yahoo News?
    I’ve been trying for a while but I never seem to get there!
    Thank you

  19. I really like your blog.. very nice colors & theme.
    Did you make this website yourself or did you hire someone to do it for you?
    Plz answer back as I’m looking to create my own blog and would like to find out where u got this from.
    thanks a lot

  20. Just want to say your article is as surprising. The clearness in your post
    is just cool and i can assume you’re an expert on this subject.
    Well with your permission let me to grab your RSS feed to keep
    updated with forthcoming post. Thanks a million and please
    continue the enjoyable work.

  21. Great information. Lucky me I discovered your website by chance (stumbleupon).
    I have book marked it for later!

  22. Just want to say your article is as astonishing.
    The clearness in your put up is just nice and i can assume you are an expert on this subject.
    Fine with your permission allow me to seize your feed to keep
    up to date with forthcoming post. Thanks a million and please continue
    the gratifying work.

  23. Ahaa, its nice conversation on the topic of this paragraph at this place at this webpage, I have read
    all that, so at this time me also commenting here.

  24. Hey there! I know this is kinda off topic but I was wondering if you knew where I could
    get a captcha plugin for my comment form?
    I’m using the same blog platform as yours and I’m having
    problems finding one? Thanks a lot!

  25. Great post. I’m dealing with many of these issues as well..

  26. You can definitely see your enthusiasm in the work you
    write. The world hopes for more passionate
    writers like you who are not afraid to say how they believe.
    All the time go after your heart.

  27. I’ll immediately snatch your rss as I can’t find your email subscription hyperlink
    or newsletter service. Do you have any? Please permit me
    realize so that I may subscribe. Thanks.

  28. Simply wish to say your article is as astonishing.
    The clearness on your post is just nice and i can suppose you are knowledgeable on this subject.
    Fine together with your permission let me to grab your RSS feed to stay updated with imminent post.
    Thank you one million and please continue the gratifying work.

  29. I’m gone to inform my little brother, that he
    should also go to see this web site on regular basis to obtain updated
    from hottest information.

  30. Does your website have a contact page? I’m having problems locating it but, I’d like to send you an e-mail.

    I’ve got some recommendations for your blog you might be interested in hearing.

    Either way, great website and I look forward
    to seeing it improve over time.

  31. I could not refrain from commenting. Perfectly written!

  32. 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.

  33. Simply wish to say your article is as amazing. The clearness to your submit
    is simply great and i could suppose you’re an expert on this subject.
    Fine together with your permission let me to grab your feed to
    stay up to date with approaching post. Thanks one million and please
    keep up the gratifying work.

  34. I believe this is among the such a lot vital info for
    me. And i am satisfied studying your article. But should remark on few normal issues, The site taste is ideal, the articles is actually nice : D.
    Just right process, cheers

  35. Hello! Quick question that’s entirely off topic.
    Do you know how to make your site mobile friendly? My blog
    looks weird when browsing from my iphone4. I’m trying
    to find a template or plugin that might be able to fix
    this problem. If you have any suggestions, please share. With thanks!

  36. Hi there to all, the contents present at this web site are in fact remarkable for people knowledge,
    well, keep up the nice work fellows.

  37. Hello colleagues, pleasant article and nice arguments commented
    here, I am actually enjoying by these.

  38. Heya i am for the first time here. I found this board and I find It
    truly useful & it helped me out a lot. I hope to give something back and help others like you
    aided me.

  39. A person necessarily assist to make severely posts
    I’d state. This is the very first time I frequented your website page and
    to this point? I surprised with the analysis you made
    to create this actual put up extraordinary. Wonderful process!

  40. Appreciating the dedication you put into your
    website and in depth information you provide. It’s nice to come
    across a blog every once in a while that isn’t the same
    out of date rehashed information. Fantastic read!
    I’ve bookmarked your site and I’m including your RSS feeds to my Google account.

  41. Pretty! This was a really wonderful article. Thank you for providing this information.

  42. When someone writes an piece of writing he/she retains the
    plan of a user in his/her mind that how a user can understand it.

    So that’s why this article is outstdanding. Thanks!

  43. Pretty nice post. I just stumbled upon your blog
    and wished to say that I have really enjoyed surfing around your blog posts.
    After all I’ll be subscribing to your rss feed and I
    hope you write again soon!

  44. Hi! I simply wish to give you a huge thumbs
    up for the excellent info you have right here on this post.

    I will be returning to your site for more soon.

  45. Hi to every body, it’s my first go to see of this weblog; this
    website contains awesome and really excellent data in support of readers.

  46. I was pretty pleased to discover this website.
    I need to to thank you for ones time for this fantastic read!!

    I definitely appreciated every little bit of it and i also have you book marked to
    check out new information on your web site.

  47. We stumbled over here different page and thought I might check
    things out. I like what I see so now i’m following you.
    Look forward to looking at your web page again.

  48. Hi there are using WordPress for your blog
    platform? I’m new to the blog world but I’m trying to get started and set up my own.
    Do you require any coding knowledge to make your own blog?
    Any help would be greatly appreciated!

  49. Incredible story there. What occurred after? Take care!

  50. Heya i’m for the primary time here. I found this board and I find It really helpful & it helped me out much.
    I hope to give something again and help others like you helped me.

  51. After I originally left a comment I seem to have clicked the -Notify me when new comments are added- checkbox
    and from now on every time a comment is added I receive 4 emails
    with the exact same comment. Is there an easy method you can remove me from
    that service? Many thanks!

  52. Hi, I do think this is an excellent web site. I stumbledupon it 😉 I am going to come back yet again since i have book-marked it.
    Money and freedom is the best way to change, may you be rich and continue to guide others.

  53. Hi, i think that i saw you visited my weblog thus i came to “return the
    favor”.I am attempting to find things to improve my website!I suppose its ok
    to use some of your ideas!!

  54. I am really enjoying the theme/design of your blog. Do you ever run into any web browser compatibility issues? A few of my blog audience have complained about my site not working correctly in Explorer but looks great in Safari. Do you have any tips to help fix this problem?

  55. Just a smiling visitant here to share the love (:, btw outstanding style. “Individuals may form communities, but it is institutions alone that can create a nation.” by Benjamin Disraeli.

  56. I’m no longer positive the place you are getting your information, however good topic. I must spend a while learning more or working out more. Thanks for great information I was searching for this information for my mission.

  57. I love it when people come together and share opinions, great blog, keep it up.

  58. Very interesting information!Perfect just what I was searching for!

  59. You have brought up a very fantastic points, thankyou for the post.

  60. FitSpresso is a natural weight loss supplement that will help you maintain healthy body weight without having to deprive your body of your favorite food or take up exhausting workout routines.

  61. I’ve been browsing online more than 3 hours today, yet I by no means found any fascinating article like yours. It¦s lovely price sufficient for me. Personally, if all website owners and bloggers made just right content as you probably did, the net can be much more helpful than ever before.

  62. Very interesting information!Perfect just what I was searching for!

  63. As I website owner I think the content here is rattling good, thanks for your efforts.

  64. Throughout this great pattern of things you actually secure a B+ for effort. Where you actually confused everybody was in all the facts. You know, they say, the devil is in the details… And it couldn’t be much more accurate at this point. Having said that, permit me tell you precisely what did give good results. The authoring can be pretty engaging and this is most likely why I am making the effort to opine. I do not make it a regular habit of doing that. Next, despite the fact that I can easily notice the leaps in reasoning you come up with, I am definitely not sure of exactly how you seem to unite your details which in turn produce your final result. For now I shall subscribe to your position however wish in the future you actually connect the facts much better.

  65. When I originally commented I clicked the -Notify me when new comments are added- checkbox and now each time a comment is added I get four emails with the same comment. Is there any way you can remove me from that service? Thanks!

  66. I have recently started a web site, the information you offer on this website has helped me tremendously. Thank you for all of your time & work.

  67. I am only writing to make you be aware of what a fine experience my friend’s princess enjoyed browsing your blog. She picked up several details, which include what it is like to possess an awesome teaching character to make certain people easily fully grasp specific problematic subject matter. You really did more than our own desires. I appreciate you for coming up with such warm and helpful, healthy, informative and unique tips on that topic to Tanya.

  68. I got good info from your blog

  69. Lottery Defeater Software is a digital tool designed to assist individuals in improving their chances of winning in various lotteries.

  70. Sumatra Slim Belly Tonic primarily focuses on burning and eliminating belly fat.

  71. I went over this website and I think you have a lot of great information, saved to my bookmarks (:.

  72. FitSpresso: What Is It? FitSpresso is a natural weight loss aid that targets the root cause of excess body fat.

  73. Pretty component to content. I simply stumbled upon your weblog and in accession capital to claim that I acquire in fact loved account your weblog posts. Anyway I’ll be subscribing in your feeds and even I fulfillment you get entry to persistently rapidly.

  74. I found your weblog web site on google and test a number of of your early posts. Proceed to maintain up the superb operate. I simply further up your RSS feed to my MSN Information Reader. In search of forward to studying extra from you afterward!…

  75. You made some good points there. I did a search on the topic and found the majority of persons will go along with with your blog.

  76. Glad to be one of the visitors on this awe inspiring site : D.

  77. I love what you guys are usually up too. This type of clever work and reporting! Keep up the terrific works guys I’ve incorporated you guys to my blogroll.

  78. I was examining some of your articles on this internet site and I conceive this website is very informative ! Keep on putting up.

  79. The next time I read a blog, I hope that it doesnt disappoint me as much as this one. I mean, I know it was my choice to read, but I actually thought youd have something interesting to say. All I hear is a bunch of whining about something that you could fix if you werent too busy looking for attention.

  80. Hey! Do you know if they make any plugins to assist with SEO? I’m trying to get my blog to rank for some targeted keywords but I’m not seeing very good gains. If you know of any please share. Cheers!

  81. Thanks for sharing superb informations. Your site is very cool. I’m impressed by the details that you?¦ve on this web site. It reveals how nicely you perceive this subject. Bookmarked this website page, will come back for extra articles. You, my pal, ROCK! I found simply the information I already searched everywhere and just could not come across. What a great site.

  82. Your place is valueble for me. Thanks!…

  83. Real fantastic visual appeal on this web site, I’d rate it 10 10.

  84. Pretty nice post. I just stumbled upon your blog and wanted to say that I have truly enjoyed browsing your blog posts. In any case I will be subscribing to your feed and I hope you write again soon!

  85. Thanks a bunch for sharing this with all of us you really understand what you are speaking about! Bookmarked. Please additionally consult with my site =). We may have a hyperlink exchange arrangement among us!

  86. Good day! I know this is kinda off topic nevertheless I’d figured I’d ask. Would you be interested in trading links or maybe guest writing a blog article or vice-versa? My website covers a lot of the same topics as yours and I feel we could greatly benefit from each other. If you’re interested feel free to shoot me an e-mail. I look forward to hearing from you! Excellent blog by the way!

  87. Wohh precisely what I was searching for, regards for posting.

  88. I’ve been exploring for a bit for any high-quality articles or blog posts on this sort of area . Exploring in Yahoo I at last stumbled upon this site. Reading this information So i’m happy to convey that I have a very good uncanny feeling I discovered exactly what I needed. I most certainly will make sure to don’t forget this site and give it a look on a constant basis.

  89. It’s best to take part in a contest for the most effective blogs on the web. I’ll advocate this site!

  90. ProvaDent: What Is It? ProvaDent is a natural tooth health supplement by Adam Naturals.

  91. What Is Puravive? Puravive is an herbal weight loss supplement that supports healthy weight loss in individuals.

  92. What is Renew? Renew is a dietary supplement designed to support blood flow while also aiming to boost testosterone levels andprovide an explosive energy drive

  93. There’s noticeably a bundle to know about this. I assume you made sure good factors in features also.

  94. I truly enjoy reading through on this internet site, it holds wonderful articles. “When a man’s willing and eager, the gods join in.” by Aeschylus.

  95. You really make it appear so easy along with your presentation but I find this matter to be actually something which I think I’d by no means understand. It sort of feels too complex and very extensive for me. I am taking a look ahead on your next submit, I¦ll attempt to get the grasp of it!

  96. An impressive share, I just given this onto a colleague who was doing a little analysis on this. And he in fact bought me breakfast because I found it for him.. smile. So let me reword that: Thnx for the treat! But yeah Thnkx for spending the time to discuss this, I feel strongly about it and love reading more on this topic. If possible, as you become expertise, would you mind updating your blog with more details? It is highly helpful for me. Big thumb up for this blog post!

  97. I have been checking out some of your stories and i must say pretty nice stuff. I will definitely bookmark your blog.

  98. I am glad to be a visitor of this staring web site! , thankyou for this rare information! .

  99. As a Newbie, I am continuously searching online for articles that can help me. Thank you

  100. What Is Sugar Defender? Sugar Defender is a meticulously crafted natural health supplement aimed at helping individuals maintain balanced blood sugar levels. Developed by Jeffrey Mitchell, this liquid formula contains 24 scientifically backed ingredients meticulously chosen to target the root causes of blood sugar imbalances.

  101. I precisely had to appreciate you again. I am not sure what I could possibly have achieved without the entire pointers discussed by you regarding such a area. Entirely was a hard matter in my opinion, however , taking note of your expert fashion you treated the issue took me to leap with contentment. I’m just happier for your advice and thus sincerely hope you are aware of an amazing job that you are accomplishing educating some other people using your webpage. More than likely you’ve never got to know all of us.

  102. What is Gluco6? Gluco6 is a revolutionary dietary supplement designed to help individuals manage their blood sugar levels naturally.

  103. I loved as much as you’ll receive carried out right here. The sketch is attractive, your authored material stylish. nonetheless, you command get bought an shakiness over that you wish be delivering the following. unwell unquestionably come further formerly again since exactly the same nearly very often inside case you shield this hike.

  104. I like this web blog very much, Its a very nice place to read and receive information.

  105. Great write-up, I’m regular visitor of one’s blog, maintain up the nice operate, and It’s going to be a regular visitor for a long time.

  106. Superb blog! Do you have any recommendations for aspiring writers? I’m planning to start my own blog soon but I’m a little lost on everything. Would you recommend starting with a free platform like WordPress or go for a paid option? There are so many choices out there that I’m completely confused .. Any ideas? Thanks a lot!

  107. naturally like your web-site however you need to take a look at the spelling on several of your posts. A number of them are rife with spelling issues and I to find it very bothersome to inform the truth however I¦ll surely come again again.

  108. I think this website contains some real wonderful information for everyone :D. “Years wrinkle the skin, but to give up enthusiasm wrinkles the soul.” by Samuel Ullman.

  109. There is noticeably a bundle to know about this. I assume you made certain nice points in options also.

  110. Good day very nice web site!! Man .. Excellent .. Superb .. I will bookmark your site and take the feeds also?KI’m glad to search out numerous useful info right here within the post, we want work out extra strategies in this regard, thank you for sharing. . . . . .

  111. Does your website have a contact page? I’m having a tough time locating it but, I’d like to send you an e-mail. I’ve got some suggestions for your blog you might be interested in hearing. Either way, great website and I look forward to seeing it improve over time.

  112. Whats Going down i’m new to this, I stumbled upon this I’ve discovered It absolutely helpful and it has aided me out loads. I’m hoping to contribute & help different customers like its aided me. Good job.

  113. Great post. I was checking constantly this blog and I am
    impressed! Very helpful information particularly the last part 🙂 I care for such information much.
    I was looking for this particular info for a very long time.
    Thank you and good luck.

  114. Some times its a pain in the ass to read what blog owners wrote but this website is real user pleasant! .

  115. Good info. Lucky me I reach on your website by accident, I bookmarked it.

  116. Hiya! I know this is kinda off topic however I’d figured I’d ask. Would you be interested in exchanging links or maybe guest writing a blog article or vice-versa? My website goes over a lot of the same topics as yours and I feel we could greatly benefit from each other. If you happen to be interested feel free to send me an e-mail. I look forward to hearing from you! Excellent blog by the way!

  117. You are a very smart individual!

  118. I’ve recently started a website, the information you provide on this website has helped me greatly. Thank you for all of your time & work. “A creative man is motivated by the desire to achieve, not by the desire to beat others.” by Ayn Rand.

TOP