Engineering Department Documentation Requirements - ISO 9001 Clause 7.3

J

juliov

Guest
#1
I would welcome to read your input about the following issue:

Quality Pros let me know your wise input to the following issue: Our company is registered to ISO 9k2k.

Our engineering dept has 2 engineers and a CAD/tech, both engineers are involved in product design projects, however one of the engineers is more involved with internal machine design that we will be using to manufacture our products, updates to the machinery, mechanical improvements and also does design for products in a minor scale, he is an engineer and does have design responsibilities, my question is are both engineers supposed to follow ISO 9K2K req 7.3?
His engineer partner claims that he does not have to follow 7.3 documentation requirements, what is your opinion?
I believe that he should follow all the design documentation as required by our QMS, after all he works for our company and as such should follow this req.
let me know your input
 

Jeff Frost

Inactive Registered Visitor
#2
Clause 7.3 is design and development activities related to product. You would be better looking at Clause 7.5.2 which is validation of processes for production… The bigger question may be why put your organization as risk if it is believed that these internal design and development activities related to production equipment should be controlled and records maintained. Your organization should take appropriate action.

Throughout the actual standard (I won’t quote specific clauses here) there are many references to additional documents, records, procedures, process, controls, etc that the organization may wish deploy based on their business model. In other words the standard its self is saying that it only contains the minimum management requirements for any business.

One last point to cover, you may have contractual requirements from your customer to control the design and development activities on production equipment and just saying the standard does not require it only means just that. When specified by customer contract you must do it even if not required by the standard.
 

Ted Schmitt

Quite Involved in Discussions
#3
I would welcome to read your input about the following issue:

Quality Pros let me know your wise input to the following issue: Our company is registered to ISO 9k2k.

Our engineering dept has 2 engineers and a CAD/tech, both engineers are involved in product design projects, however one of the engineers is more involved with internal machine design that we will be using to manufacture our products, updates to the machinery, mechanical improvements and also does design for products in a minor scale, he is an engineer and does have design responsibilities, my question is are both engineers supposed to follow ISO 9K2K req 7.3?
His engineer partner claims that he does not have to follow 7.3 documentation requirements, what is your opinion?
I believe that he should follow all the design documentation as required by our QMS, after all he works for our company and as such should follow this req.
let me know your input
Julio,

What does your company manufacture ? From what I understand, it´s not machinery which is what engineer #1 spends most of his time on... now... you state that engineer #1 "...and also does design for products in a minor scale..."... are these products the products defined in your scope of certification? If yes, then IMO, he should follow the documentation established in your QMS.
 

barbt

Involved In Discussions
#4
my question is are both engineers supposed to follow ISO 9K2K req 7.3?
His engineer partner claims that he does not have to follow 7.3 documentation requirements, what is your opinion?
HI,

in my opinion, the answer is pretty simple. It is the organization that is certified to ISO 9001:2000 - not an individual. Find out why he doesn't want to follow the process - does he have a better method?
 

Colin

Quite Involved in Discussions
#6
I would be quite interested in knowing why he does not want to follow the laid down processes - is it because they are too complex and onerous?

I think this also highlights one of the major problems I encounter during the training and auditing activities I am involved in. Surely the laid down methods are the way the company wants to operate, not to meet ISO 9001. There seems to be this belief that there is one way of operating the company and one way of meeting ISO 9001 - they are meant to be the same!

If we can get them the same, there is no argument when it comes to compliance:)
 

arin_23

Inactive Registered Visitor
#7
Hi Buddy !!!

I would like to answer your question in a rather simple manner, The whole design and development cycle , i.e. clause no 7.3 is done majorly in two manners:

1. The organization carries out some design and development activities with present and future market demand for a particular product and publishes abrochure or catalogue after taking the patent.

2. The customer provides some inputs regarding the intended final output he/they wants to achieve and based on that the design cycle takes place.

for #1 Following of design activity is a must.

Now for #2 we need to understand whether the customer representative is taking active part in all the design stages or not, if yes, then design can be excluded if no, then 7.3 needs to be addressed.

Again customers can either be external or internal in nature. In your case the engineer no. 1 is fulfilling the requirement of the internal customer "Production / Manufacturing" so you have to analyze how adequately the inputs are received from the internal customer before taking a final decision.

Cheers:cool:

Arindam
 

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