品質システムとは

医療機器におけるISO 13485やQMS省令では、品質システムの構築が求められてきた。
一方で、2021年8月1日に施行される改正GMP省令においても医薬品品質システムの構築が要求されることとなった。
品質システム(QS:Quality System)は、品質管理システム(QMS:Quality Management System)とも呼ばれる。
品質システムの基本は、PDCAサイクルである。
PDCAサイクルがあるということは、今日よりも明日、明日よりも明後日、品質が向上していくといった“仕組み”つまり“システム”が存在するということである。
品質システムにおいては、品質を管理し向上させる“仕組み”と、品質を保証する“仕組み”を文書(SOP)により構築することになる。
また、品質リスクマネジメントも同様にPDCAサイクルを持ち、品質システムと表裏一体をなすものである。
品質システムと品質リスクマネジメントを組合せることによって、製品の品質を管理し、製品の品質を保証し、製品のリスクを受容可能なまでに低減させることになる。

ISO 9001における品質マネジメントシステム

品質マネジメント規格であるISO 9001:2015では、PDCAモデルを下記の図で示している。


【計画(Plan)】

計画プロセスでは、経営者が品質方針を作成し、また年度毎に品質目標をたてさせる。
品質目標では、達成可能な目標であることと、具体的な数値とともにその達成基準が明確になっていなければならない。例えば、顧客苦情を3ポイント減少させる、逸脱を5ポイント下げる、顧客満足度を10ポイント増加させるなどである。
また、経営者は適切なリソース(人、モノ、金)をあてがわなければならない。口頭で指示するだけでリソースを準備しなければ、品質改善が実行できないからである。例えば、要員を雇用する、教育訓練を実施する、コンサルタン トを雇うなどである。

【支援及び運用(Do)】

支援及び運用プロセス(製品実現プロセス)では、QMSに従って、研究・開発・設計・製造・流通・サービス等を実施する。
その目的は、ユーザニーズ(要求)に合致した製品を市場に出荷し、顧客満足度を得ることである。
そのためには要員の力量(Competence)が大切である。

【パフォーマンス評価(Check)】

パフォーマンス評価プロセスでは、製品およびプロセスの状況を監視、測定を行う。
製品には原材料、中間品、半製品、完成品、サービスなどが含まれる。
製品は、受入検査、中間検査、最終検査などを通じて、設計品質を満たしているかどうかが測定される。
また、製造するにあたって、温度・湿度、パーティクル(塵埃)、差圧、トルクなどのプロセスパラメータを測定する。
また内部監査を実施し、潜在している問題点(つまりリスク)を自ら発見することである。なお内部監査は「Self Inspection」(自主的な査察)と呼ばれている。Self Inspectionは、日本の省令等では「自己点検」と訳されているが、この用語は適切ではない。
Self Inspectionでは、企業自らの内部監査等によって、日々リスクを発見し、是正・予防することが重要である。
つまり当局査察で指摘されるのを待って改善するのではなく、企業自らが積極的に改善活動を実施するのである。
是正措置・予防措置や内部監査の結果は、マネージメントプロセスにフィードバックし、マネジメント(経営者)が、マネジメントレビュなどによって改善指示を出したり、次年度の品質目標をたてることになる。
さらに、定期的に経営者はマネジメントレビュを実施し、品質改善に関する適切な指示を出さなければならない。

【改善 Action】

改善プロセスでは、顧客苦情などの収集を行い、再発防止に向けた是正措置・予防措置を行う。
是正措置で重要なことは、問題の根本的原因を調査し、それを解消することにより、再発を防止することである。是正と修正は異なることに注意が必要である。
改善は1度きりであってはならない。継続的な改善を通じて、規制要件及び顧客要求事項を満たさなければならない。


FDAによる品質システム査察

医薬品企業・医療機器企業がグローバル化を促進する中、FDAをはじめ海外の規制当局の査察を受ける機会が多くなった。
一方で規制当局は、サプライチェーンがグローバル化していることに伴い、海外査察の回数を増やしている。
しかしながら、査察にかけることができるリソースは限られているため、効率的な査察手法が必要である。
従来の査察では、査察官から指摘された事項を是正しておけば、容認されてきた。
しかしである。わずか数日の査察(FDA査察の場合、日本においては4日間または5日間)で査察官が発見することができる問題点・リスクは数が限られている。
したがって、査察官が発見したエラー(リスク)に対して是正を行えば自国民の安全が守られるということにはならない。
そこでFDAなどの査察では、エラー(リスク)を発見する査察手法から、当該企業が経営者のガバナンス(統治)のもと『品質システム(Quality System)』を確立しているかどうかを調査するといった手法に切り替えている。
FDAでは、医療機器企業に対する査察はQSR(品質システム規則)に従って、品質システム査察をQSIT(Quality System Inspection Technic)に従い実施している。
また医薬品企業においては、製造所の活動を以下の6つに分類し、「システム査察」と呼ばれる体系的な査察を行っている。

  1. 品質システム(Quality System)
  2. 施設および施設管理システム(Facilities and Equipment system)
  3. 原材料システム(Materials system)
  4. 製造システム(Production system)
  5. 包装および表示システム(Packaging and Labeling system)
  6. 試験室管理システム(Laboratory control system)

システム査察には、フル査察と簡略査察がある。
フル査察では、6つのシステムのうち最低4つのシステムが選択され、そのうち品質システムは必須である。
フル査察になるケースは、その企業のGMP状況が不明の時、大きな変更があった場合、重大な苦情、品質問題が発生した場合等に行われる。
簡略査察では、6つのシステムのうち最低2つのシステムが選択され、フル査察と同様、品質システムは必須である。

FDA等の査察では、企業自らが品質システム(QS)を確立しており、査察が実施されていなくとも査察官と同様の目線(レベル)で指摘・改善活動が実施されていること(Self Inspection)を確認するのである。
そのためには優秀な監査要員の確保が最重要である。
品質システム(QS)が確立されている企業は、査察官にとって「安心」できる企業であるといえる。

お役立ち動画


Related post

Comment

  1. I do not even know how I ended up here, but I thought this put up
    was good. I do not understand who you’re however definitely
    you’re going to a famous blogger should you aren’t already.
    Cheers!

  2. best allergy medication for itching exact allergy pills allergy med comparison chart

  3. I like the efforts you have put in this, regards for all the great content.

  4. 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.

  5. Thanks a lot for sharing this with all of us you really know what you are talking about! Bookmarked. Kindly also visit my web site =). We could have a link exchange arrangement between us!

  6. Greetings! I’ve been following your blog for a long time now and finally got the bravery to go ahead and give you a shout out from Houston Tx! Just wanted to say keep up the excellent job!

  7. Howdy! Quick question that’s completely off topic. Do you know how to make your site mobile friendly? My web site looks weird when viewing from my iphone. I’m trying to find a template or plugin that might be able to correct this issue. If you have any suggestions, please share. Appreciate it!

  8. hello!,I like your writing very a lot! proportion we communicate extra about your article on AOL? I require an expert in this house to unravel my problem. May be that’s you! Looking ahead to see you.

  9. I have been exploring for a little for any high quality articles or blog posts on this kind of space . Exploring in Yahoo I eventually stumbled upon this web site. Reading this info So i am glad to express that I’ve a very excellent uncanny feeling I found out exactly what I needed. I most indubitably will make sure to don¦t disregard this web site and provides it a glance on a continuing basis.

  10. Have you ever thought about adding a little bit more than just your articles? I mean, what you say is valuable and everything. But think about if you added some great images or video clips to give your posts more, “pop”! Your content is excellent but with pics and videos, this blog could certainly be one of the most beneficial in its field. Amazing blog!

  11. 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.

  12. What is a Sugar Defender? Sugar Shield could be an affront affectability enhancement product that effectively supports stable blood sugar levels.

  13. Hmm is anyone else encountering problems with the pictures on this blog loading? I’m trying to figure out if its a problem on my end or if it’s the blog. Any responses would be greatly appreciated.

  14. Somebody necessarily assist to make seriously articles I would state. That is the very first time I frequented your website page and thus far? I amazed with the research you made to create this actual post extraordinary. Great activity!

  15. Great wordpress blog here.. It’s hard to find quality writing like yours these days. I really appreciate people like you! take care

  16. I was just seeking this info for a while. After 6 hours of continuous Googleing, finally I got it in your site. I wonder what is the lack of Google strategy that don’t rank this kind of informative web sites in top of the list. Usually the top web sites are full of garbage.

  17. I have been reading out many of your stories and i can state nice stuff. I will definitely bookmark your website.

  18. I¦ve recently started a blog, the info you offer on this web site has helped me greatly. Thanks for all of your time & work.

  19. Fitspresso stands out among the crowded health supplement market as an exceptional product.

  20. It’s really a nice and useful piece of information. I’m glad that you shared this helpful info with us. Please keep us informed like this. Thank you for sharing.

  21. After all, what a great site and informative posts, I will upload inbound link – bookmark this web site? Regards, Reader.

  22. Hi! Would you mind if I share your blog with my myspace group? There’s a lot of folks that I think would really appreciate your content. Please let me know. Thank you

  23. Great write-up, I am regular visitor of one’s website, maintain up the nice operate, and It is going to be a regular visitor for a lengthy time.

  24. Hello.This post was extremely fascinating, particularly because I was looking for thoughts on this topic last Sunday.

  25. Awesome blog! Do you have any tips and hints for aspiring writers? I’m hoping to start my own blog soon but I’m a little lost on everything. Would you advise starting with a free platform like WordPress or go for a paid option? There are so many options out there that I’m completely overwhelmed .. Any tips? Bless you!

  26. You have brought up a very fantastic details, regards for the post.

  27. Good – I should definitely pronounce, impressed with your web site. I had no trouble navigating through all the tabs and related info ended up being truly simple to do to access. I recently found what I hoped for before you know it at all. Reasonably unusual. Is likely to appreciate it for those who add forums or anything, website theme . a tones way for your customer to communicate. Excellent task..

  28. I truly enjoy looking at on this website , it has got fantastic blog posts. “Those who complain most are most to be complained of.” by Matthew Henry.

  29. Puravive is a natural weight loss supplement and is said to be quite effective in supporting healthy weight loss.

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

  31. What Is Sugar Defender? Sugar Defender is a new blood sugar-balancing formula that has been formulated using eight clinically proven ingredients that work together to balance sugar levels.

  32. I?¦ll right away grab your rss as I can’t in finding your e-mail subscription link or newsletter service. Do you have any? Kindly permit me recognize in order that I may subscribe. Thanks.

  33. you are in reality a just right webmaster. The website loading speed is amazing. It seems that you are doing any distinctive trick. In addition, The contents are masterpiece. you have performed a excellent process on this topic!

  34. With havin so much written content do you ever run into any issues of plagorism or copyright violation? My site has a lot of exclusive content I’ve either authored myself or outsourced but it looks like a lot of it is popping it up all over the internet without my authorization. Do you know any techniques to help protect against content from being stolen? I’d genuinely appreciate it.

  35. It’s really a great and useful piece of info. I’m glad that you shared this helpful information with us. Please keep us informed like this. Thanks for sharing.

  36. Hmm it seems like your site ate my first comment (it was extremely 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 tips for inexperienced blog writers? I’d definitely appreciate it.

  37. A large percentage of of whatever you articulate is supprisingly accurate and it makes me ponder the reason why I had not looked at this in this light previously. This piece truly did turn the light on for me as far as this specific issue goes. But at this time there is one factor I am not too comfortable with so whilst I attempt to reconcile that with the actual main idea of your point, permit me see just what all the rest of the readers have to point out.Nicely done.

  38. I really enjoy looking at on this internet site, it has superb articles.

  39. Thanks a lot for sharing this with all of us you actually recognise what you’re speaking approximately! Bookmarked. Please also consult with my site =). We could have a hyperlink trade agreement between us!

  40. obviously like your web-site but you need to take a look at the spelling on quite a few of your posts. Several of them are rife with spelling issues and I to find it very troublesome to inform the reality on the other hand I¦ll certainly come back again.

  41. I enjoy the efforts you have put in this, regards for all the great blog posts.

  42. you are really a good webmaster. The web site loading speed is incredible. It seems that you are doing any unique trick. Furthermore, The contents are masterpiece. you have done a excellent job on this topic!

  43. Java Burn is the world’s first and only 100 safe and proprietary formula designed to boost the speed and efficiency of your metabolism by mixing with the natural ingredients in coffee.

  44. Hiya! I know this is kinda off topic nevertheless I’d figured I’d ask. Would you be interested in exchanging links or maybe guest authoring a blog post or vice-versa? My blog covers a lot of the same subjects as yours and I believe we could greatly benefit from each other. If you might be interested feel free to send me an e-mail. I look forward to hearing from you! Awesome blog by the way!

  45. I don’t even know how I ended up right here, but I believed this publish used to be good. I do not understand who you are but certainly you’re going to a well-known blogger for those who aren’t already 😉 Cheers!

  46. Thank you for sharing excellent informations. Your website is so cool. I’m impressed by the details that you have on this web site. It reveals how nicely you perceive this subject. Bookmarked this web page, will come back for extra articles. You, my friend, ROCK! I found just the info I already searched everywhere and just couldn’t come across. What a perfect web site.

  47. Very interesting info !Perfect just what I was searching for! “The whole point of getting things done is knowing what to leave undone.” by Lady Reading.

  48. Pretty section of content. I just stumbled upon your web site and in accession capital to assert that I acquire in fact enjoyed account your blog posts. Anyway I’ll be subscribing to your feeds and even I achievement you access consistently rapidly.

  49. You really make it seem so easy with your presentation but I find this topic to be actually something that I think I would never understand. It seems too complex and extremely broad for me. I am looking forward for your next post, I’ll try to get the hang of it!

  50. I love your blog.. very nice colors & theme. Did you create this website yourself? Plz reply back as I’m looking to create my own blog and would like to know wheere u got this from. thanks

  51. You made some decent points there. I regarded on the web for the difficulty and located most people will associate with with your website.

  52. Good day! I could have sworn I’ve been to this site before but after browsing through some of the post I realized it’s new to me. Nonetheless, I’m definitely happy I found it and I’ll be bookmarking and checking back often!

  53. You really make it appear really easy with your presentation but I in finding this matter to be really one thing that I believe I might by no means understand. It sort of feels too complex and very wide for me. I’m having a look ahead in your subsequent submit, I will try to get the dangle of it!

  54. I’m still learning from you, as I’m trying to achieve my goals. I certainly enjoy reading everything that is written on your website.Keep the stories coming. I loved it!

  55. I beloved as much as you will receive performed right here. The caricature is attractive, your authored material stylish. nonetheless, you command get got an impatience over that you want be handing over the following. sick definitely come further beforehand once more since precisely the same nearly a lot ceaselessly inside of case you shield this increase.

  56. Tonic Greens: An Overview. Introducing Tonic Greens, an innovative immune support supplement

  57. FitSpresso is a natural weight loss supplement crafted from organic ingredients, offering a safe and side effect-free solution for reducing body weight.

  58. Pretty nice post. I simply stumbled upon your blog and wanted to mention that I have truly enjoyed browsing your weblog posts. After all I will be subscribing for your feed and I hope you write again soon!

  59. Dead composed written content, Really enjoyed reading.

  60. Pretty! This was a really wonderful post. Thank you for your provided information.

  61. What is Gluco6 Supplement? Gluco6 is a blend of doctor-formulated ingredients promising to help users develop healthy blood sugar ranges.

  62. Wow, awesome weblog format! How lengthy have you ever been blogging for? you make running a blog glance easy. The whole look of your website is excellent, let alone the content material!

  63. I’ve been absent for a while, but now I remember why I used to love this web site. Thank you, I’ll try and check back more frequently. How frequently you update your site?

  64. I am no longer sure the place you are getting your information, but good topic. I needs to spend a while learning much more or understanding more. Thanks for wonderful info I used to be searching for this info for my mission.

  65. I have been exploring for a bit for any high-quality articles or blog posts on this kind of area . Exploring in Yahoo I at last stumbled upon this site. Reading this info So i’m happy to convey that I’ve an incredibly good uncanny feeling I discovered exactly what I needed. I most certainly will make sure to do not forget this website and give it a glance regularly.

  66. Hello.This post was really remarkable, especially since I was searching for thoughts on this matter last Wednesday.

  67. Amazing blog! Do you have any tips and hints 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 totally overwhelmed .. Any tips? Many thanks!

  68. It’s hard to search out knowledgeable individuals on this subject, however you sound like you understand what you’re speaking about! Thanks

  69. An attention-grabbing dialogue is value comment. I think that it is best to write extra on this topic, it might not be a taboo topic but usually individuals are not enough to talk on such topics. To the next. Cheers

  70. This website online is mostly a stroll-through for all the information you wanted about this and didn’t know who to ask. Glimpse here, and you’ll definitely discover it.

  71. I’ve been exploring for a little for any high-quality articles or blog posts on this kind of area . Exploring in Yahoo I at last stumbled upon this website. Reading this info So i am happy to convey that I have an incredibly good uncanny feeling I discovered exactly what I needed. I most certainly will make sure to do not forget this website and give it a look regularly.

  72. I like this site very much, Its a real nice position to read and receive information. “Young men think old men are fools but old men know young men are fools.” by George Chapman.

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

  74. I must show some appreciation to the writer just for rescuing me from this particular predicament. Just after searching throughout the internet and obtaining solutions that were not beneficial, I figured my life was gone. Existing without the answers to the difficulties you have fixed through your write-up is a crucial case, and the kind which could have badly damaged my entire career if I had not discovered your web blog. The know-how and kindness in controlling almost everything was valuable. I am not sure what I would’ve done if I had not come upon such a subject like this. I can now relish my future. Thanks a lot so much for your impressive and results-oriented help. I won’t be reluctant to refer the website to any individual who should get assistance on this matter.

  75. 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 from this post. I’m very glad to see such excellent information being shared freely out there.

  76. I really 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

  77. I like this weblog its a master peace ! Glad I observed this on google .

TOP