ハインリッヒの法則
筆者がCAPA(是正処置・予防処置)に関するセミナーを実施する際にしばしば「どのような品質問題に関してCAPAを実施するべきか」という質問を受けることがある。
その回答は、再発防止を行わなければならない事象である。
CAPAの目的は、改善すなわち再発防止である。
したがって、医薬品や医療機器の品質に対する影響が大きいと判断される場合は、CAPAを実施するべきである。
しかしである。
ハインリッヒの法則というものがある。
これは1件の大きな事故・災害の裏には、29件の軽微な事故・災害、そしてその裏には300件のヒヤリ・ハット(事故には至らなかったもののヒヤリとした、ハッとした事例)があるとされる法則のことである。
別名1:29:300の法則とも呼ばれる。
300件もの軽微なヒヤリ・ハットを見逃すと、いずれ 29件の事故につながる。29件の事故を放置すると、1件の重大な事故につながるという法則なのである。
一つの著名な事例がある。
2004年 3月、六本木ヒルズで、6歳の男の子が回転ドアに挟まれて死亡した。
六本木ヒルズは、2003年 4月のオープン直後から、回転ドアでの事故が多発し、死亡事故までの1年の間に、報告されただけでも32 件もの事故があったということである。
これはまさしくハインリッヒの法則である。
軽微な事故が頻回したことが分かった時点で、六本木ヒルズは何らかの処置をとるべきであったのである。
それを放置したために、起こるべくして起きた事故と言えるのである。
つまり、軽微な品質問題であったとしても頻回している場合には、CAPA(改善)を実行する必要があるのである。
そのためには、統計的手法により、繰り返している軽微な品質問題に関する情報を収集しておかなければならない。
例えば、1ヶ月間に同じ軽微な苦情が3回繰り返している、軽微な逸脱が同じプロセスで3回繰り返しているなどである。
ブロークンウィンドウ理論
ハインリッヒの法則を応用した理論で「ブロークンウィンドウ理論」がある。
「ブロークンウィンドウ理論」は、ラトガース大学のケリング教授による理論である。
治安の良い住宅街で車のボンネットを開けたままに1週間放置したが、何事も起こらなかった。
しかし、フロントガラスの割れた車を同様に放置したところ、次々にガラスを割られ、金になる部品はほとんど盗まれてしまったというもの。
これは、小さな犯罪を放置すると、やがてそれが大きな犯罪につながるという犯罪心理学の理論である。
この理論をニューヨークの地下鉄でジュリアーニ市長が応用した。
地下鉄の落書きを徹底的に消したところ、重犯罪の件数が激減したのである。
小さなミスや怠慢は、それが許されると罪の意識がなくなってミスを犯すことに抵抗がなくなってしまう(習慣化)。
たとえ罪の意識があっても、ここまで許されるならもう少しと自分で勝手にこじつけてしまう心理が働く(合理化)。
上司は部下に対して、失敗を叱ってはならない。
それよりも小さなこと、些細なことを適宜注意することである。
例えば「ごみを投げてゴミ箱に入れようとしたが、床に落ちてしまったのを放置した」とか「ホッチキス止めをした書類ががたがたに綴じられていた」などである。
「机の上を整理する」「掃除をする」などは当たり前のことではあるが、案外誰も注意しないものである。
これくらいのことと思う気持ちがいつしか大きな失敗・損失につながりかねないのである。
実は筆者が専門とする品質管理・品質保証の考え方も同じである。小さな品質改善を行うと、大きなミス(欠陥によるリコール)が減少するのである。
ゆでガエル現象
カエルは、いきなり熱湯に入れると驚いて逃げ出すが、常温の水に入れて徐々に水温を上げていくと逃げ出すタイミングを失い、最後には死んでしまう…
ゆでガエル現象とはこのように、ゆっくりと進む環境変化や危機に対応する難しさや大切さを説く言葉として使用され、時には「ゆでガエルの法則」「ゆでガエル理論」という表現もされる。
ゆっくりと進む環境変化や危機に対して我々が鈍感なのは確かである。
まだ間に合うと仕事を先延ばしにしているうちに、取り返しのつかない事態に陥ったり、徐々に陳腐化しているスキルや知識に頼って、学ぶことを避けているうちに、すっかり時代に取り残されて、社内のポジションを失ったりしてしまう。
環境変化や危機に気付いたら、すぐに対処するように心がけたい。
State of Control(管理された状態)
FDAはしばしばState of Controlという用語を使用する。
ICH Q10においてもこの用語が用いられている。
上記のハインリッヒの法則、ブロークンウィンドウ理論、ゆでガエル現象などの教訓から、企業の品質管理、品質保証について”管理された状態”に保たなければならないのである。
FDA査察等において、企業が経営者のポリシーのもと、品質システムが構築され、管理された状態(State of Control)であるかどうか調査されるのである。
管理された状態である企業は、安心な企業と言える。
関連商品
[blogcard url=https://xn--2lwu4a.jp/qms-alex/ title=”QMS(手順書)ひな形 医薬品関連” ]
Aw, this was a very nice post. In concept I want to put in writing like this additionally – taking time and precise effort to make a very good article… but what can I say… I procrastinate alot and in no way appear to get one thing done.
It’s arduous to search out educated individuals on this matter, however you sound like you know what you’re speaking about! Thanks
Currently it seems like BlogEngine is the top blogging platform out there right now. (from what I’ve read) Is that what you are using on your blog?
Hi my loved one! I wish to say that this article is awesome, great written and include approximately all vital infos. I’d like to peer more posts like this.
Some truly nice stuff on this internet site, I like it.
I saw a lot of website but I think this one has something extra in it in it
I’m usually to running a blog and i really admire your content. The article has actually peaks my interest. I am going to bookmark your site and preserve checking for new information.
Wonderful work! This is the type of info that should be shared around the web. Shame on the search engines for not positioning this post higher! Come on over and visit my web site . Thanks =)
Thank you for another wonderful article. Where else could anyone get that kind of info in such an ideal way of writing? I’ve a presentation next week, and I am on the look for such information.
Hello my friend! I wish to say that this article is awesome, nice written and include approximately all vital infos. I would like to see more posts like this.
Hello There. I found your blog using msn. This is an extremely well written article. I’ll be sure to bookmark it and come back to read more of your useful info. Thanks for the post. I will definitely comeback.
We absolutely love your blog and find a lot of your post’s to be just what I’m looking for. Do you offer guest writers to write content for you? I wouldn’t mind composing a post or elaborating on many of the subjects you write about here. Again, awesome blog!
Great write-up, I am normal visitor of one¦s website, maintain up the excellent operate, and It is going to be a regular visitor for a long time.
I really appreciate this post. I have been looking all over for this! Thank goodness I found it on Bing. You have made my day! Thx again
Keep functioning ,terrific job!
Magnificent web site. Plenty of useful info here. I’m sending it to several friends ans also sharing in delicious. And of course, thanks for your effort!
Sumatra Slim Belly Tonic primarily focuses on burning and eliminating belly fat.
FlowForce Max is a 100 natural dietary supplement created to promote male health.
Tonic Greens, a natural health supplement, is designed to enhance immune function.
DentiCore is a dental and gum health formula, made with premium natural ingredients.
I truly appreciate this post. I’ve been looking all over for this! Thank goodness I found it on Bing. You’ve made my day! Thank you again!
What¦s Taking place i’m new to this, I stumbled upon this I have found It absolutely useful and it has helped me out loads. I am hoping to give a contribution & help different customers like its aided me. Good job.
Keep working ,remarkable job!
Hey there! This is kind of off topic but I need some help from an established blog. Is it tough to set up your own blog? I’m not very techincal but I can figure things out pretty quick. I’m thinking about creating my own but I’m not sure where to begin. Do you have any tips or suggestions? Cheers
Puravive is a natural weight loss supplement and is said to be quite effective in supporting healthy weight loss.
Java Burn: What is it? Java Burn is marketed as a natural weight loss product that can increase the speed and efficiency of a person’s natural metabolism, thereby supporting their weight loss efforts
It¦s really a cool and useful piece of info. I¦m happy that you simply shared this helpful info with us. Please stay us informed like this. Thanks for sharing.
I’ve read several good stuff here. Certainly worth bookmarking for revisiting. I surprise how much effort you put to create such a excellent informative web site.
It’s really a great and useful piece of info. I am glad that you shared this useful info with us. Please keep us up to date like this. Thanks for sharing.
What i don’t understood is actually how you are now not actually a lot more neatly-liked than you might be right now. You are very intelligent. You recognize therefore significantly in the case of this subject, produced me individually imagine it from numerous varied angles. Its like men and women don’t seem to be fascinated unless it’s one thing to do with Lady gaga! Your personal stuffs nice. All the time care for it up!
You have mentioned very interesting points! ps decent internet site.
Lottery Defeater is an automated, plug-and-plug lottery-winning software.
I believe you have observed some very interesting points, thankyou for the post.
I’ve recently started a web site, the info you provide on this website has helped me tremendously. Thanks for all of your time & work.
Great site. Lots of useful info here. I am sending it to a few buddies ans additionally sharing in delicious. And naturally, thanks on your effort!
Hi, Neat post. There is a problem with your site in internet explorer, would check this… IE still is the market leader and a huge portion of people will miss your wonderful writing because of this problem.
Does your website have a contact page? I’m having a tough time locating it but, I’d like to shoot you an email. I’ve got some ideas for your blog you might be interested in hearing. Either way, great website and I look forward to seeing it improve over time.
I think this is one of the most vital information for me. And i’m glad reading your article. But wanna remark on some general things, The site style is great, the articles is really great : D. Good job, cheers
Wow! This blog looks just like my old one! It’s on a entirely different topic but it has pretty much the same layout and design. Great choice of colors!
I am impressed with this website , very I am a fan.
I?¦m now not sure the place you are getting your info, but great topic. I needs to spend some time finding out more or working out more. Thank you for excellent info I used to be looking for this information for my mission.
Pretty! This was a really wonderful post. Thank you for your provided information.
I like this website very much, Its a really nice post to read and find information. “Reason is not measured by size or height, but by principle.” by Epictetus.
What Is ProDentim? ProDentim is a teeth health supplement developed to repopulate the mouth with good bacteria and improve overall dental health.
Some genuinely excellent posts on this site, regards for contribution. “For today and its blessings, I owe the world an attitude of gratitude.” by Clarence E. Hodges.
Hi there! I know this is somewhat off topic but I was wondering if you knew where I could locate a captcha plugin for my comment form? I’m using the same blog platform as yours and I’m having difficulty finding one? Thanks a lot!
Only wanna input on few general things, The website layout is perfect, the subject material is very excellent : D.
What is Java Burn? Java Burn is a unique and innovative product that enhances your morning coffee routine.
I really appreciate this post. I have been looking everywhere for this! Thank goodness I found it on Bing. You have made my day! Thank you again
I was wondering if you ever thought of changing the 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 1 or two pictures. Maybe you could space it out better?
FitSpresso: An Outline FitSpresso is a weight management formula made using five herbal ingredients.
Lottery Defeater Software is a cutting-edge application designed to analyze and optimize your chances of winning various lottery games.
What is Sugar Defender 24? Jeffrey Mitchell made the Sugar Defender 24. It is a product (Sugar Defender Diabetes) that helps your blood sugar health.
Everything is very open and very clear explanation of issues. was truly information. Your website is very useful. Thanks for sharing.
Can I just say what a relief to find someone who actually knows what theyre talking about on the internet. You definitely know how to bring an issue to light and make it important. More people need to read this and understand this side of the story. I cant believe youre not more popular because you definitely have the gift.
I have been exploring for a little bit for any high quality articles or blog posts in this sort of house . Exploring in Yahoo I finally stumbled upon this website. Studying this information So i?¦m happy to express that I’ve a very just right uncanny feeling I found out exactly what I needed. I so much surely will make sure to do not forget this website and provides it a look on a relentless basis.
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
I just wanted to compose a quick message to be able to thank you for some of the nice strategies you are placing here. My prolonged internet look up has now been rewarded with excellent know-how to exchange with my co-workers. I would assume that most of us website visitors are unquestionably blessed to live in a superb place with very many perfect people with very helpful principles. I feel quite happy to have discovered the webpages and look forward to some more brilliant times reading here. Thanks a lot once more for all the details.
I’d incessantly want to be update on new blog posts on this web site, saved to fav! .
Whats Happening i’m new to this, I stumbled upon this I’ve discovered It positively helpful and it has helped me out loads. I am hoping to give a contribution & aid different users like its helped me. Great job.
Hello 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 suggestions?
F*ckin’ amazing things here. I’m very glad to see your article. Thanks a lot and i’m looking forward to contact you. Will you please drop me a e-mail?
Woh I enjoy your articles, saved to favorites! .
I’ve read several good stuff here. Definitely worth bookmarking for revisiting. I wonder how much effort you put to make such a wonderful informative web site.
Having read this I thought it was very informative. I appreciate you taking the time and effort to put this article together. I once again find myself spending way to much time both reading and commenting. But so what, it was still worth it!
Woh I love your articles, saved to my bookmarks! .
Greetings from Ohio! I’m bored to death at work so I decided to check out your website on my iphone during lunch break. I really like the info you provide here and can’t wait to take a look when I get home. I’m surprised at how quick your blog loaded on my phone .. I’m not even using WIFI, just 3G .. Anyways, excellent blog!
I truly value your piece of work, Great post.
Valuable info. Lucky me I found your website by accident, and I’m shocked why this accident did not happened earlier! I bookmarked it.
I¦ve read several just right stuff here. Definitely price bookmarking for revisiting. I wonder how a lot attempt you set to create any such magnificent informative web site.
he blog was how do i say it… relevant, finally something that helped me. Thanks
Hi, just required you to know I he added your site to my Google bookmarks due to your layout. But seriously, I believe your internet site has 1 in the freshest theme I??ve came across. It extremely helps make reading your blog significantly easier.
I like this web site because so much useful stuff on here : D.
Lottery Defeater Software: What is it? Lottery Defeater Software is a completely automated plug-and-play lottery-winning software. The Lottery Defeater software was developed by Kenneth.
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.
Some really nice stuff on this web site, I like it.
Usually I don’t read article on blogs, however I wish to say that this write-up very pressured me to try and do it! Your writing style has been surprised me. Thank you, quite nice article.
I wish to get across my appreciation for your generosity for individuals that should have guidance on this theme. Your real commitment to getting the solution up and down has been rather productive and has really allowed ladies like me to realize their goals. Your informative information denotes a great deal to me and far more to my mates. With thanks; from everyone of us.
My brother recommended I might like this blog. He was entirely right. This post truly made my day. You cann’t imagine just how much time I had spent for this info! Thanks!
hi!,I like your writing so so much! proportion we keep up a correspondence more about your post on AOL? I need a specialist in this house to solve my problem. Maybe that’s you! Looking ahead to peer you.
I believe this site has got very fantastic written content material blog posts.
Greetings! Very helpful advice on this article! It is the little changes that make the biggest changes. Thanks a lot for sharing!
Along with every little thing that appears to be developing inside this specific area, your perspectives are very radical. Even so, I appologize, but I do not subscribe to your whole suggestion, all be it stimulating none the less. It would seem to everybody that your commentary are not totally justified and in simple fact you are generally yourself not entirely confident of your argument. In any event I did enjoy examining it.
I know this if off topic but I’m looking into starting my own blog and was wondering what all is required to get set up? I’m assuming having a blog like yours would cost a pretty penny? I’m not very web smart so I’m not 100 positive. Any recommendations or advice would be greatly appreciated. Kudos
I think this site holds some really wonderful information for everyone :D. “I like work it fascinates me. I can sit and look at it for hours.” by Jerome K. Jerome.
What Is LeanBiome? LeanBiome is a natural dietary supplement that promotes healthy weight loss.
I have not checked in here for a while because I thought it was getting boring, but the last several posts are great quality so I guess I?¦ll add you back to my daily bloglist. You deserve it my friend 🙂
Rattling wonderful information can be found on weblog.Expand blog
Very well written information. It will be supportive to anyone who employess it, as well as yours truly :). Keep up the good work – i will definitely read more posts.
What’s Happening i am new to this, I stumbled upon this I’ve found It positively useful and it has aided me out loads. I hope to contribute & assist other users like its aided me. Great job.
The other day, while I was at work, my cousin 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 apple ipad is now broken and she has 83 views. I know this is entirely off topic but I had to share it with someone!
Hello, you used to write excellent, but the last few posts have been kinda boring… I miss your great writings. Past few posts are just a little out of track! come on!
Thanks for all your efforts that you have put in this. very interesting information.
I have learn several excellent stuff here. Definitely price bookmarking for revisiting. I wonder how so much attempt you put to create any such magnificent informative website.
I don’t even know the way I finished up right here, however I thought this put up was once great. I don’t recognize who you might be however certainly you’re going to a famous blogger if you are not already 😉 Cheers!
It’s hard to find educated folks on this matter, but you sound like you already know what you’re talking about! Thanks
This really answered my drawback, thanks!
Everything is very open and very clear explanation of issues. was truly information. Your website is very useful. Thanks for sharing.
Thanks for the sensible critique. Me & my neighbor were just preparing to do some research about this. We got a grab a book from our local library but I think I learned more clear from this post. I am very glad to see such magnificent information being shared freely out there.
I really like what you guys are usually up too. This type of clever work and coverage! Keep up the excellent works guys I’ve included you guys to my blogroll.
Excellent web site. Lots of useful info here. I am sending it to a few pals ans additionally sharing in delicious. And obviously, thank you to your effort!
Thanks a lot for sharing this with all of us you really know what you are talking about! Bookmarked. Please also visit my web site =). We could have a link exchange contract between us!
Hi, just required you to know I he added your site to my Google bookmarks due to your layout. But seriously, I believe your internet site has 1 in the freshest theme I??ve came across. It extremely helps make reading your blog significantly easier.
great issues altogether, you simply won a brand new reader. What may you recommend in regards to your publish that you just made a few days in the past? Any positive?
Hey! Would you mind if I share your blog with my zynga group? There’s a lot of folks that I think would really enjoy your content. Please let me know. Cheers
Hi there! I could have sworn I’ve been to this blog before but after browsing through some of the post I realized it’s new to me. Nonetheless, I’m definitely delighted I found it and I’ll be book-marking and checking back often!
Wonderful blog you have here but I was wondering if you knew of any user discussion forums that cover the same topics discussed here? I’d really like to be a part of group where I can get feedback from other knowledgeable individuals that share the same interest. If you have any recommendations, please let me know. Cheers!
magnificent points altogether, you just received a new reader. What would you recommend in regards to your submit that you made some days ago? Any positive?
I have learn a few excellent stuff here. Certainly price bookmarking for revisiting. I wonder how much effort you place to create this type of wonderful informative site.
I love it when people come together and share opinions, great blog, keep it up.
You are my inhalation, I have few web logs and rarely run out from post :). “Analyzing humor is like dissecting a frog. Few people are interested and the frog dies of it.” by E. B. White.
Appreciate it for this post, I am a big big fan of this web site would like to go along updated.
I think this web site holds some really fantastic info for everyone :D. “Anybody who watches three games of football in a row should be declared brain dead.” by Erma Bombeck.
It is truly a great and useful piece of info. I am happy that you shared this useful information with us. Please keep us up to date like this. Thank you for sharing.
A person essentially assist to make seriously posts I would state. This is the very first time I frequented your website page and to this point? I amazed with the analysis you made to create this particular submit extraordinary. Great task!
There is noticeably a bundle to know about this. I assume you made certain nice points in features also.
I?¦ll immediately clutch your rss feed as I can’t find your email subscription link or e-newsletter service. Do you’ve any? Kindly let me recognise in order that I could subscribe. Thanks.
adidas yeezy :時尚與運動的完美融合 yeezy
It is in point of fact a great and helpful piece of information. I am glad that you just shared this helpful info with us. Please keep us informed like this. Thank you for sharing.
hi!,I love your writing so so much! percentage we be in contact extra approximately your article on AOL? I require a specialist in this house to unravel my problem. Maybe that’s you! Having a look forward to peer you.
Rattling nice style and wonderful content material, absolutely nothing else we need : D.