製薬企業・医療機器企業・CRO・ベンダー各社では、日々文書や記録のレビュと承認が実施されている。
しかしながら、本来の規制当局やISOなどの国際規格が要求するレビュや承認はほとんど実施されていないのが現状である。
ISO-9001では「レビュ」というキーワードが頻繁に登場する。
読者諸氏は、「レビュ」を何と訳しているであろうか。
多くの場合「確認」と訳していないだろうか。特に「レビュア」を「確認者」と訳していることがもっぱらである。
そうではない。ISO-9001の定義では、「レビュ」とは「設定された目標を達成するための検討対象の適切性、妥当性、及び有効性を判定するために行われる活動」としている。
すなわち、適訳は「審査」または「照査」である。
「審査」であるため、合格か不合格が決められるはずである。
間違いや不整合があった場合、それらを指摘し、修正するように指導するのである。
指導するのがレビュであるため、レビュを行う者は、作成者よりも経験や知識が多くなければならない。
そうでなければ指導できないからである。
筆者はしばしば外部監査の依頼を受ける。
その際には必ずレビュアにインタビュを行うのである。
レビュにおいてどのような「指導」を行ったのかを確認するためである。
しかしながら、ほとんどのケースでレビュは形骸化され、表紙に署名をするのみとなっている。
これでは品質保証にはなり得ない。
管理者や上司の仕事は「部下の育成にある」ことを心に刻んでおく必要がある。
一方において、「承認」とは何を意味するのであろうか。
承認者はすべての記録を精査することはできない。
ではどうやって当該文書や記録を承認するのであろうか。
承認者は、当該文書や記録に関して必要なスキルを持ったレビュアが審査(照査)し、コメントを付し、作成者がコメントに沿って全ての問題が解決したことを確認した上で承認するのである。
つまり承認者は、適正なレビュ(審査・照査)が実施され、品質が保証されていることに関して責任を持つのである。
neknkvpjl onqwk lxhsfwy whwj rroeidjmtfjbqwl
Thanks for helping out, excellent information.
It is in point of fact a great and useful piece of info. I am satisfied that you shared this helpful info with us. Please keep us informed like this. Thanks for sharing.
It’s a shame you don’t have a donate button! I’d most certainly donate to this outstanding blog! I suppose for now i’ll settle for bookmarking and adding your RSS feed to my Google account. I look forward to new updates and will talk about this blog with my Facebook group. Chat soon!
Very excellent visual appeal on this site, I’d rate it 10 10.
What¦s Going down i’m new to this, I stumbled upon this I have discovered It absolutely helpful and it has aided me out loads. I hope to contribute & help different customers like its helped me. Good job.
What Is Aizen Power? Aizen Power is presented as a distinctive dietary supplement with a singular focus on addressing the root cause of smaller phalluses
I don’t usually comment but I gotta say regards for the post on this perfect one : D.
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.
I have been absent for a while, but now I remember why I used to love this site. Thanks, I will try and check back more often. How frequently you update your site?
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
Hi! Someone in my Myspace group shared this site with us so I came to look it over. I’m definitely loving the information. I’m bookmarking and will be tweeting this to my followers! Outstanding blog and amazing design and style.
Hi there, just became aware of your blog through Google, and found that it is truly informative. I am gonna watch out for brussels. I’ll appreciate if you continue this in future. Many people will be benefited from your writing. Cheers!
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.
Perfect work you have done, this web site is really cool with good information.
of course like your web-site but you need to test the spelling on several of your posts. Many of them are rife with spelling issues and I find it very troublesome to inform the reality however I will certainly come again again.
Some genuinely nice and utilitarian information on this website , too I believe the design contains good features.
You are my breathing in, I own few blogs and infrequently run out from brand :). “Analyzing humor is like dissecting a frog. Few people are interested and the frog dies of it.” by E. B. White.
Good post. I be taught one thing more challenging on totally different blogs everyday. It’s going to at all times be stimulating to learn content from different writers and practice a little one thing from their store. I’d want to use some with the content on my blog whether or not you don’t mind. Natually I’ll give you a link in your net blog. Thanks for sharing.
I dugg some of you post as I cogitated they were very useful very helpful
I think this is one of the so much important info for me. And i am glad studying your article. However want to observation on few normal things, The web site taste is wonderful, the articles is in reality nice : D. Good process, cheers
It¦s actually a cool and useful piece of info. I¦m happy that you simply shared this helpful information with us. Please keep us informed like this. Thanks for sharing.
I very thankful to find this website on bing, just what I was searching for : D besides saved to favorites.
Of course, what a great website and revealing posts, I surely will bookmark your site.Best Regards!
Perfect work you have done, this internet site is really cool with good info .
The other day, while I was at work, my cousin stole my iphone and tested to see if it can survive a 40 foot drop, just so she can be a youtube sensation. My iPad is now destroyed and she has 83 views. I know this is entirely off topic but I had to share it with someone!
What Is Java Burn? Java Burn is an herbal weight loss formula that comes in the form of sachets of fine powder.
What is ProvaDent? In the dynamic landscape of dental care, innovation is key to improving patient experience and outcomes
What i do not realize is in fact how you are now not really much more neatly-liked than you might be now. You are so intelligent. You realize therefore significantly in relation to this subject, produced me for my part consider it from so many numerous angles. Its like men and women are not involved until it¦s one thing to do with Woman gaga! Your personal stuffs nice. Always care for it up!
You could definitely see your expertise within the work you write. The arena hopes for even more passionate writers like you who aren’t afraid to mention how they believe. Always go after your heart. “There are only two industries that refer to their customers as users.” by Edward Tufte.
F*ckin¦ amazing issues here. I am very happy to see your article. Thank you a lot and i’m having a look forward to touch you. Will you please drop me a mail?
Hi, Neat post. There is a problem together with your website in web explorer, would check this… IE still is the marketplace chief and a huge component of people will leave out your fantastic writing because of this problem.
Thanks for sharing excellent informations. Your web 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 web page, will come back for extra articles. You, my friend, ROCK! I found simply the information I already searched everywhere and just could not come across. What a great web site.
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
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!
You made some nice points there. I looked on the internet for the subject and found most guys will go along with with your website.
This is a topic close to my heart cheers, where are your contact details though?
Hi there, I found your blog by means of Google even as searching for a similar topic, your site got here up, it appears to be like great. I have bookmarked it in my google bookmarks.
Hi! Someone in my Myspace group shared this site with us so I came to check it out. I’m definitely enjoying the information. I’m book-marking and will be tweeting this to my followers! Superb blog and wonderful style and design.
Keep functioning ,great job!
You are my breathing in, I own few web logs and often run out from to post .
You are a very smart person!
Howdy! This post couldn’t be written any better! Reading through this post reminds me of my old room mate! He always kept talking about this. I will forward this write-up to him. Fairly certain he will have a good read. Thanks for sharing!
I like this web site very much, Its a real nice spot to read and
find info.Leadership
It?¦s actually a cool and useful piece of information. I am happy that you simply shared this useful information with us. Please keep us up to date like this. Thanks for sharing.
Exactly what I was searching for, thanks for putting up.
Hello, i feel that i saw you visited my weblog so i came to “return the desire”.I’m attempting to in finding issues to improve my website!I assume its ok to make use of some of your concepts!!
Your home is valueble for me. Thanks!…
Excellent blog here! Also your website loads up fast! What host are you using? Can I get your affiliate link to your host? I wish my web site loaded up as fast as yours lol
Undeniably consider that which you stated. Your favorite justification appeared to be on the internet the simplest factor to be mindful of. I say to you, I definitely get irked while folks consider issues that they just don’t realize about. You controlled to hit the nail upon the top and outlined out the entire thing with no need side effect , other people can take a signal. Will probably be back to get more. Thanks
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!
I’m really loving the theme/design of your blog. Do you ever run into any browser compatibility issues? A couple of my blog visitors have complained about my site not operating correctly in Explorer but looks great in Firefox. Do you have any solutions to help fix this problem?
I do not even understand how I stopped up right here, however I believed this publish was once good. I don’t recognise who you’re but certainly you are going to a famous blogger when you aren’t already 😉 Cheers!
I don’t even know the way I ended up right here, however I thought this publish was great. I do not recognize who you might be but certainly you’re going to a well-known blogger if you happen to are not already 😉 Cheers!
I think other web-site proprietors should take this web site as an model, very clean and great user friendly style and design, let alone the content. You’re an expert in this topic!
Just what I was looking for, regards for putting up.
Keep functioning ,terrific job!
Somebody essentially assist to make significantly posts I would state. That is the very first time I frequented your website page and so far? I amazed with the analysis you made to make this particular publish extraordinary. Wonderful activity!
Along with every little thing which appears to be developing inside this particular subject matter, all your viewpoints are actually very radical. However, I beg your pardon, but I can not subscribe to your whole suggestion, all be it refreshing none the less. It seems to us that your remarks are actually not entirely validated and in fact you are your self not even totally certain of the assertion. In any case I did enjoy reading it.
You have brought up a very great points, thankyou for the post.
But wanna remark on few general things, The website layout is perfect, the content material is really wonderful. “Taxation WITH representation ain’t so hot either.” by Gerald Barzan.
What i do not understood is actually how you’re no longer really a lot more neatly-preferred than you may be right now. You’re very intelligent. You already know thus considerably in terms of this topic, produced me individually believe it from a lot of numerous angles. Its like men and women aren’t fascinated until it’s something to accomplish with Girl gaga! Your individual stuffs great. Always take care of it up!
Deference to op, some excellent entropy.
Valuable information. Fortunate me I found your website by chance, and I am shocked why this coincidence didn’t took place in advance! I bookmarked it.