API Q1 Quality Manual / ISO 29001 - 7.3 - The need for "Control Features"

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R

radica

#12
Hi to everyone!
I have a problem with term "control feature", I realy don`t know what exactly this term mean. My company will have on-site API audit 22-26 February and our Quality Manual is OK. Now I need to correct our Procedures and I don`t know how. I must add all requests from API Spec Q1. Please help!!! :(((
 

Confussed

Involved In Discussions
#13
Hello

Control feature.
I can provide the info in great detail just drop me a line.

Edit note: Email address removed. You can contact this person through the forum PM system (see the person's Profile).
 
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N

need help

#14
I need help adjusting my API Quality Program Manual to API Q1 8th Edition from the 7th....Can anyone suggest someone who can help re-write it?

Thanks so much for any help!!
 

Confussed

Involved In Discussions
#15
Yes

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N

need help

#16
Dear Confussed -

How can you help me with my manual? I can use anything you got!
Thanks again!!
Need Help:)
 
V

Valve Nerd

#18
Re: API Q1 Quality Manual / ISO 29001 - 7.3

Mani,

It's been a year but I'll take you up on your offer since we put the audit on hold until now.

My company is an OEM, but this manual is for a QA facility located overseas. At that plant they do mostly inspection and testing. They oversee all of our outsourced work and check everything. So all they would do regarding design and development is check that the drawings are correct and verify the new design passes testing.

So My question is which part of 7.3 do I need to put in my QA book? Could I just insert 7.3.1 Design and Development Controls Planning Features as shown in Rosie's Q1 sample posted in this thread: API Q1 Quality Manual Example - Trying to convert an existing ISO 9001 QMS

...or do I need to put in the whole section and get into the details at the audit site?
 
V

Valve Nerd

#19
Yes, it is supplemental in Q1 but I am applying for other API certificates which require me to at least have Design and Dev controls in place; even though this is just as QA facility.

It seems to me my QA team would do their normal inspection and testing and file away the new drawings, which is what they do already. So how do I put that in the manual? Or do I just put all of 7.3 in and during the audit explain that the role of QA/QC on this site is just receipt inspection and testing.
 
C

claire_deen

#20
Hi there,

I just wanted to write to you all here as I will definitely be needing your help. I am doing my masters and need to update an existing QMS manual to become compliant with API Q1 ed 8. I am worrying about where to even start!

Does anyone have an example manual? It isn't to copy it but just to see and understand what to do! Any help is appreciated from you guys. I think the company I'm doing this for has also mentioned that they don't do design for their customers so would that just be an exclusion you could explain in the manual?

I have a lot of reading to do and hope to be able to return any help when I know what I'm doing!!!

Claire
 
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