How do you structure your QA (QMS) Manual? A Historical Discussion

[E Wall]

You don't know how glad I am to hear that!

Glad it wasn't my imaganings!
I most always get the edit note...if I haven't I don't realize it. But then I'm always getting interupted when at my desk...not to mention long winded so I guess I'm exceeding the 'grace' period.

Well I have some changes to get finished to my RCA program...sometimes I feel like I'm writing for 5th graders the way EVERYTHING needs to be spelled out...but anything open to interpretation seems to be challenged, so I'm updating the process...again!

hhehee, chicken hawk...I like that, I'll have to search through the avatars...wasnt' there a chicken-hawk on the Foghorn Leghorn cartoons?

 

[Marc]

I think when you go in and edit a post you've been 'working on' within the allotted time period, the timer resets for another 15 minutes or whatever time is set in the admin options when you submit the edited version.

Yup - Foghorn Leghorn (the rooster) is always being 'bothered' by the little chicken hawk.

But - back to Quality Manual issues!

 

[venkat]

Editing text

At times two persons can convey the same issues. One cant generalise that it was copied from the other.

If edit option is available after post this is possible.

I dont think this is an issue.

Let's discuss about quality, quality, quality - it can be applicable to any type of organisation.

I see very few post pertaining to US FDA approvals. What type of documentation one should prepare if a pharmaceutical company go in for US FDA approvals. The sequence of sgteps involved

Your views please

 

[Marc]

Re: Editing text

Originally posted by venkat

I see very few post pertaining to US FDA approvals. What type of documentation one should prepare if a pharmaceutical company go in for US FDA approvals. The sequence of sgteps involved

Your views please

Well, there is an FDA related forum where you might want to start a new thread on this topic. That forums is at: http://Elsmar.com/Forums/forumdisplay.php?forumid=44

You'll have to go back at least 100 days to see any posts. The forum isn't very active.

 

[tim banic]

my 2 cents worth...

Actually that would be Canadian pennies so I should really put 4 in for the exchange.

I was chatting with our registrar earlier in the week about changing our manual over to 9000:2000.

What he told me was (& I am not sure if anyone else has said this already)...look at our process, from start to finish & create main headings (Selling the product/service, then what is the next step, then the next step, forward to design/engineering, forward design to the shop floor, etc, etc, etc)

Each of these main headings is a procedure, and each step to that main heading is a point to be detailed in that procedure (be it in the procedure or reference to work instructions).

When these are complete compare it to the requirements of the standard. If you are missing any information from the standard plug it in where it belongs.

Anything that doesn't fit into one of the main heading for your business process gets placed under Management Responsibility (including Internal audits, Management Review meetings, etc.).

What the auditor told me was that "Yes it makes them work a little harder to find the information (but in MHO that is what they are being paid for), but it follows the way product/service flows through the company.

I hope this makes sense to everyone...if anyone would like to email me to discuss this more, please do (our email is hit & miss sometimes, but I will respond ASAP). I am figuring that this will take me about 1 - 2 weeks to complete (walking through the process, discussing ith staff & departments & writing the procedures).

I Would love to hear everyones opinion.

thanks tim

"...if it moves, train it...if it doesn't move, calibrate it...if it isn't written down, it never happened..."

 

[Marc]

If it works for you, do it that way. I see no problem with that methodology except how much time you want to put into it.

 

[Marc]

Also see this thread:

http://Elsmar.com/Forums/showthread.php?t=4866

 

[Greg B]

This is a Classic

DuDu,

The easiest way I have found (I have done this 4 times) is to copy sections 1 through 8.5 of the standard, VERBATIM, then use the edit/replace function to replace all references to "the organization" with your company name. You will not be able to cut and paste from the electronic version of the standard, so someone will need to manually type the manual. After you are done this go through each section and wordsmith to fit your organization. Be careful when deleting anything. This makes it virtually impossible for a registrar to give a nonconformance for the manual not fitting the standard. Let's face it, the only reason you are writing the manual in the first place is to pass your audit and possibly send to a customer. It serves no real purpose, so make it easy on yourself. The last manual I wrote took a total of 4 hours for someone to type and about another 4 of my editing.

Good luck,

Carl-

This is from waaaay back ( 12th July 2001) but when I read it I had to bring it to the attention of the current audience. If everyone did as Carl has suggested above why would we need a quality manual??? Couldn't the registrar or customer change our name to fit the 'organisation' in the standard therfore relieving us of the need to write a manual (just to waste paper)??? I have had manuals that were ....almost...verbatim from the standard but nothing like Carl's description. My new manual - in development (again) will be a story of our company, products and methodology for our customers and employees. All of our new employees and customers will recieve a copy. I hope to finish the manual in the next few weeks. It will have many process and flow charts . I was going to have only charts but decided that it needed a little more explanation.

Greg B

 

[Marc]

That was just the way you had to do it back a while in large part to satisfy auditors.

Things have seriously changed, eh?

 

[Paul Simpson]

Phew that was close!

I almost had my sanctimonious hat on! I saw the thread on "Definitive discussion on QM" come up and started reading some of the drivel about turning the standard on its head and thought it was current! Thank goodness nobody on the cove is encouraging that any more.