本年度に改正が予定されているGMP省令では、第四条(予定)の「上級経営陣の責任」において
「製造所ごとに、製品品質及び医薬品品質システムの問題等に係る情報を、すべての職員から適時に上げるための情報伝達の仕組みを、構築、維持すること。」という要求が盛り込まれる予定だ。
「情報伝達(コミュニケーション)」は品質方針などが製造業者、製造所全体に行きわたっていることと、製造現場の情報が経営層にまで届いていることの双方がある。
経営者はいつも従業員に向けて“法令を遵守する”ということを訴え続けることが重要である。
経営者のそういった姿勢があってこそ、何か問題が起きたとき、品質不良にかかわる事項が発見されたとき、迅速な対応を可能にし、従業員の中にも法令遵守意識が生まれる。
一方で、昨今のGMP調査では、品質システムが適正であるかを調査することに主眼が置かれている。
当該品質システムが個々の製品に落とし込まれて、仕組みが適正に運用されていることが重要である。
品質情報の把握・評価・対策に不備があることで製品回収につながることもある。
現場の担当者が品質上の異変に気づくこともある。それが経営者にも伝達され、組織内で共有できることが重要である。
組織として共有することで必要な対策を迅速にとることが可能になる。
組織にとって情報共有が重要であることは言うまでもない。
しかしである。
本当に報告しやすい文化を醸成しているであろうか。
人は必ず間違うし忘れる。しかしミスを上司に報告すれば叱られてしまう。
そこで小さなウソをつく。その小さなウソを隠すためにちょっと大きなウソをつく。それを隠すためにもっと大きなウソをつく。
発覚した時には対処し得ないくらいの大問題となってしまうことが世の常である。
ISO 9001のような国際規格や、データインテグリティの要件では、このコミュニケーションの重要性がうたわれている。
ミスをしたことを報告した人ほど褒められなければならない。
なぜならば改善の機会を提供したからである。
人は必ずミスを犯すのであるから、仕組み(システム:QMS)を改善してミスを発見、予防できるようなプロセスに改善しなければならない。
まずは経営者は「報告しやすい文化」を醸成することだ。
Hey very cool site!! Man .. Excellent .. Amazing .. I will bookmark your website and take the feeds also…I’m happy to find numerous useful info here in the post, we need work out more techniques in this regard, thanks for sharing. . . . . .
After I initially commented I clicked the -Notify me when new comments are added- checkbox and now every time a comment is added I get 4 emails with the same comment. Is there any approach you’ll be able to remove me from that service? Thanks!
I’m still learning from you, while I’m trying to reach my goals. I definitely enjoy reading all that is posted on your blog.Keep the posts coming. I enjoyed it!
I am continually invstigating online for ideas that can benefit me. Thx!
I’m really enjoying the design and layout of your website. It’s a very easy on the eyes which makes it much more pleasant for me to come here and visit more often. Did you hire out a designer to create your theme? Exceptional work!
Good web site! I really love how it is simple on my eyes and the data are well written. I’m wondering how I might be notified whenever a new post has been made. I have subscribed to your RSS which must do the trick! Have a great day!
Rattling superb visual appeal on this web site, I’d value it 10 10.
I went over this site and I believe you have a lot of wonderful information, saved to favorites (:.
Hello! 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. Anyways, I’m definitely happy I found it and I’ll be book-marking and checking back frequently!
Admiring the persistence you put into your blog and detailed information you offer. It’s awesome to come across a blog every once in a while that isn’t the same out of date rehashed material. Wonderful read! I’ve bookmarked your site and I’m including your RSS feeds to my Google account.
This web site is my intake, rattling great layout and perfect content.
FitSpresso: What Is It? FitSpresso is a natural weight loss aid that targets the root cause of excess body fat.
Thank you for the auspicious writeup. It in fact was a amusement account it. Look advanced to more added agreeable from you! By the way, how could we communicate?
Some really choice posts on this site, saved to fav.
I’m still learning from you, but I’m improving myself. I certainly love reading all that is written on your blog.Keep the information coming. I loved it!
I have recently started a blog, the information you offer on this site has helped me greatly. Thanks for all of your time & work.
What Is ZenCortex? ZenCortex is an ear health booster that protects ears from potential damage and improves your hearing health.
hey there and thank you for your info – I’ve certainly picked up anything new from right here. I did however expertise a few technical points using this site, since I experienced to reload the website a lot of times previous to I could get it to load properly. I had been wondering if your web hosting is OK? Not that I am complaining, but sluggish loading instances times will sometimes affect your placement in google and can damage your high-quality score if ads and marketing with Adwords. Anyway I’m adding this RSS to my e-mail and can look out for much more of your respective fascinating content. Make sure you update this again soon..
Howdy would you mind letting me know which web host you’re using? I’ve loaded your blog in 3 different internet browsers and I must say this blog loads a lot faster then most. Can you recommend a good web hosting provider at a honest price? Cheers, I appreciate it!
Great post, you have pointed out some superb details , I too conceive this s a very excellent website.
I like what you guys tend to be up too. This type of clever work and reporting! Keep up the wonderful works guys I’ve included you guys to our blogroll.
Heya i am for the first time here. I came across this board and I find It really useful & it helped me out a lot. I hope to give something back and help others like you aided me.
What Is ProDentim? ProDentim is a teeth health supplement developed to repopulate the mouth with good bacteria and improve overall dental health.
Saved as a favorite, I really like your blog!
great post, very informative. I wonder why the other specialists of this sector don’t notice this. You should continue your writing. I am confident, you have a huge readers’ base already!
This is a very good tips especially to those new to blogosphere, brief and accurate information… Thanks for sharing this one. A must read article.
Hi there, I discovered your blog by way of Google at the same time as looking for a similar matter, your site came up, it appears great. I have bookmarked it in my google bookmarks.
Some really fantastic blog posts on this site, thankyou for contribution.
I precisely wished to thank you so much once again. I am not sure the things I would’ve tried without the ways provided by you over such subject. It had become a daunting dilemma in my opinion, however , taking note of a new expert technique you handled it forced me to leap over joy. I’m happier for the guidance and hope you comprehend what a great job your are doing instructing many people with the aid of a site. I’m certain you’ve never come across any of us.
Real fantastic info can be found on website. “The quality of an organization can never exceed the quality of the minds that make it up.” by Harold R. McAlindon.
What Is Puravive? Puravive is an herbal weight loss supplement that supports healthy weight loss in individuals.
I don’t usually comment but I gotta admit thankyou for the post on this perfect one : D.
Howdy, i read your blog occasionally and i own a similar one and i was just curious if you get a lot of spam comments? If so how do you stop it, any plugin or anything you can recommend? I get so much lately it’s driving me insane so any assistance is very much appreciated.
I want to show appreciation to the writer just for rescuing me from such a circumstance. After checking throughout the the web and getting advice which are not productive, I figured my life was well over. Living minus the answers to the problems you have sorted out through your write-up is a critical case, and those which could have negatively damaged my entire career if I had not discovered your site. Your own personal training and kindness in handling all the stuff was very useful. I don’t know what I would’ve done if I had not encountered such a point like this. I’m able to now look forward to my future. Thanks for your time so much for your reliable and effective guide. I will not think twice to recommend your web page to any individual who will need tips about this area.
I have been exploring for a little for any high quality articles or blog posts in this kind of area . Exploring in Yahoo I finally stumbled upon this web site. Reading this info So i am glad to express that I’ve an incredibly excellent uncanny feeling I came upon just what I needed. I so much undoubtedly will make sure to do not forget this site and give it a glance regularly.
This is very interesting, You’re a very skilled blogger. I have joined your rss feed and look forward to seeking more of your excellent post. Also, I’ve shared your website in my social networks!
Very interesting subject, thanks for posting. “The great aim of education is not knowledge but action.” by Herbert Spencer.
I appreciate, cause I found just what I was looking for. You’ve ended my four day long hunt! God Bless you man. Have a nice day. Bye
I would like to thnkx for the efforts you have put in writing this blog. I am hoping the same high-grade blog post from you in the upcoming as well. In fact your creative writing abilities has inspired me to get my own blog now. Really the blogging is spreading its wings quickly. Your write up is a good example of it.
fantastic points altogether, you just gained a brand new reader. What would you recommend about your post that you made some days ago? Any positive?
Good – I should certainly pronounce, impressed with your website. I had no trouble navigating through all tabs and related info ended up being truly easy 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 something, web site theme . a tones way for your customer to communicate. Nice task.
You are a very bright person!
Sweet website , super design, real clean and employ friendly.
Good V I should certainly pronounce, impressed with your website. I had no trouble navigating through all tabs as well as related info ended up being truly simple to do to access. I recently found what I hoped for before you know it in the least. Reasonably unusual. Is likely to appreciate it for those who add forums or anything, web site theme . a tones way for your customer to communicate. Excellent task..
You can certainly see your skills in the paintings you write. The sector hopes for even more passionate writers like you who aren’t afraid to say how they believe. At all times go after your heart.
I love your writing style truly enjoying this website .
Tonic Greens: An Overview Introducing Tonic Greens, an innovative immune support supplement meticulously crafted with potent antioxidants, essential minerals, and vital vitamins.
Thanx for the effort, keep up the good work Great work, I am going to start a small Blog Engine course work using your site I hope you enjoy blogging with the popular BlogEngine.net.Thethoughts you express are really awesome. Hope you will right some more posts.
You are my intake, I possess few web logs and sometimes run out from to post .
Great post, you have pointed out some excellent details , I likewise think this s a very good website.
Deference to author, some great selective information.
You made some first rate points there. I seemed on the internet for the difficulty and found most people will go along with with your website.
Thank you for the good writeup. It in fact was a amusement account it. Look advanced to more added agreeable from you! However, how can we communicate?
Excellent read, I just passed this onto a colleague who was doing some research on that. And he just bought me lunch since I found it for him smile Thus let me rephrase that: Thank you for lunch! “Feeling passionate about something is like getting a peak at your soul smiling back at you.” by Amanda Medinger.
Dead composed subject material, appreciate it for selective information.
I always was interested in this subject and still am, thanks for posting.
Hiya, I’m really glad I have found this info. Today bloggers publish only about gossips and net and this is actually annoying. A good site with interesting content, this is what I need. Thank you for keeping this website, I will be visiting it. Do you do newsletters? Can not find it.
As I website possessor I believe the content matter here is rattling wonderful , appreciate it for your efforts. You should keep it up forever! Good Luck.
Woah! I’m really enjoying the template/theme of this blog. It’s simple, yet effective. A lot of times it’s challenging to get that “perfect balance” between usability and visual appearance. I must say you have done a superb job with this. Also, the blog loads super quick for me on Safari. Superb Blog!
I wanted to thank you for this great read!! I definitely enjoying every little bit of it I have you bookmarked to check out new stuff you post…
Simply a smiling visitant here to share the love (:, btw outstanding style. “Everything should be made as simple as possible, but not one bit simpler.” by Albert Einstein.
Very great visual appeal on this internet site, I’d rate it 10 10.
Hello just wanted to give you a brief heads up and let you know a few of the images aren’t loading correctly. I’m not sure why but I think its a linking issue. I’ve tried it in two different internet browsers and both show the same results.
Hi my friend! I wish to say that this article is awesome, nice written and come with almost all important infos. I’d like to look more posts like this.
Hi! Do you know if they make any plugins to assist with Search Engine Optimization? I’m trying to get my site to rank
for some targeted keywords but I’m not seeing very good success.
If you know of any please share. Thank you! I saw similar blog here:
Eco bij
It’s really a cool and useful piece of information. I am glad that you simply shared this helpful information with us. Please stay us informed like this. Thank you for sharing.