Does a FMEA need to fall into the ISO Documentation?

S

Shawn97701 - 2009

#1
I am buliding our Quality system and I am not sure if I need to put the FMEA worksheet into an ISO document... or assign it a number? Reference only?:confused:
 
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Stijloor

Staff member
Super Moderator
#2
I am building our Quality system and I am not sure if I need to put the FMEA worksheet into an ISO document... or assign it a number? Reference only?:confused:
Hello Shawn,

There's no such thing as "ISO Documentation." Yes, there are documented procedures and certain records required by the Standard, but the rest is up to you. I would like to call them "business (or quality) system documents." And if you need to include FMEA process related documents, you add them too. People building a quality system get too wrapped up in what to call "ISO" and what to call whatever... Not necessary. Don't waste your time.

Take a good look at what you must have. In addition, take a look at what would make sense for your business and your customers. Control this in a manner that's convenient to manage. Voila, you're good to go. Please explore the various threads and attachments here in The Cove.

We're always ready for more questions. :yes:

Stijloor.
 
D

darkafar

#3
Hi Shawn:

If you use the FMEA form recommended by the FMEA Manual, the FMEA Number and FMEA Date blank can be used for traceability, so I don’t think you need to assign it another number, after all, traceability is all what form number is about.
 

Helmut Jilling

Auditor / Consultant
#4
I am buliding our Quality system and I am not sure if I need to put the FMEA worksheet into an ISO document... or assign it a number? Reference only?:confused:

The FMEA's need to be controlled documents. The method you choose is up to you. Revision dates are required for all controlled documents, but form numbers are nt a requirement. That is up to you.
 
M

M Greenaway

#5
There seems to be a lot of questions floating around recently asking if specific documents need to be controlled within an ISO9001 system.

The question is somewhat nonsensical, simply ask yourself do we need to ensure this information, whatever it is, is kept up to date and everyone has the latest copy - if that is important then 'control' the document, if it is not then I would question why you have the document anyway.

Do people need accuracte and current information to do there jobs, yes they do - forget ISO9001 just think common sense and your ISO9001 cert will follow.
 

Colin

Quite Involved in Discussions
#6
There seems to be a lot of questions floating around recently asking if specific documents need to be controlled within an ISO9001 system.

The question is somewhat nonsensical, simply ask yourself do we need to ensure this information, whatever it is, is kept up to date and everyone has the latest copy - if that is important then 'control' the document, if it is not then I would question why you have the document anyway.

Do people need accurate and current information to do there jobs, yes they do - forget ISO9001 just think common sense and your ISO9001 cert will follow.
Great answer! I too have noticed a number of posts regarding 'quality records' & 'ISO documents'. Lets get away from doing things for 'quality' and 'ISO' and remember why we have our QMS - to assure conformity and satisfy customers.
 
W

Willem

#7
The question is somewhat nonsensical, simply ask yourself do we need to ensure this information, whatever it is, is kept up to date and everyone has the latest copy - if that is important then 'control' the document, if it is not then I would question why you have the document anyway.

Do people need accuracte and current information to do there jobs, yes they do - forget ISO9001 just think common sense and your ISO9001 cert will follow.
I agree. We don't have a "Quality Manual" we have a "Business Manual". What ever forms are necessary to be able to get to the final quality product is recorded in the manual, from support forms to WIP Job Cards. There are so many unnecessary forms going around in organizations. At the end of the day you must be able to answer to the auditor about each and every form.
The more infomation in a Quality/Business manual the more answers you must be able to give, the more you can get a hiding on
 
Last edited by a moderator:

Colin

Quite Involved in Discussions
#8
At the end of the day you must be able to answer to the auditor about each and every form.
Never mind the auditor, do what is right for you and your organisation first and foremost. If you do that, the auditor can look after him/herself. This system is for you, not them. By the way, I speak as someone who also does auditing!
 
W

Willem

#9
Never mind the auditor, do what is right for you and your organisation first and foremost. If you do that, the auditor can look after him/herself. This system is for you, not them. By the way, I speak as someone who also does auditing!
Colpart
I agree forget the auditor but some auditors can be very dificult. I specifically talk about auditors from customers and not a auditor as a supplier. Our company work with a lot mines in South Africa. Some of them try to be very dificult and try to change your system the ay hey think it should be.
 

Colin

Quite Involved in Discussions
#10
Colpart
I agree forget the auditor but some auditors can be very difficult. I specifically talk about auditors from customers and not a auditor as a supplier. Our company work with a lot mines in South Africa. Some of them try to be very difficult and try to change your system the way hey think it should be.
I agree that this is a problem, especially when it is a 2nd party audit and they make 'threatening' noises about what they want to see in your system.

Still, it is good sport to have discussions with them and use the immortal phrase 'show me where it states that in the standard'.:D
 
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