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Developing Technology and Equipment to Manufacture Clients Product - Can exclude 7.3?

A

armani

Involved In Discussions
#1
#1
An organization manufacturing products based on specifications / design given by client (without any further modifications suggested / imposed etc. ) -with the only contribution of developing the technology /manufacturing the equipment (for measuring / production purposes) to use for this product - can claim "exclusion of 7.3" ?
I don't know the english term for that activity - "technological design" maybe?
 
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rob73

rob73

looking for answers
#2
#2
Re: particular case of 7.3 exclusion

Have a read of this ISO guidance document. It gives advice on what can and cannot be used as an exclusion. If you are not performning any design and development work you may have grounds for exclusion, see example 2.
http://www.iso.org/iso/01_guidance_on_iso_9001_2008_sub-clause_1.2_application.pdf
It is always best to check with your certification body for confirmation though, picking it up at an audit is never a good thing.:notme:
Rob
 
H

harry

Super Moderator
#3
#3
Re: Developing technology/equipment to Manufacture Clients product - can exclude 7.3?

armani said:
An organization manufacturing products based on specifications / design given by client (without any further modifications suggested / imposed etc. ) -with the only contribution of developing the technology /manufacturing the equipment (for measuring / production purposes) to use for this product - can claim "exclusion of 7.3" ?
I don't know the english term for that activity - "technological design" maybe?
Click to expand...
The party that uses the clients specifications and design to manufacture the product can claim exclusion of 7.3 because they are just a contract manufacturer and not responsible for the design. However, the party that uses the clients specifications and design as input to manufacture or develop equipment for production purpose is clearly involved in design and development and therefore cannot claim for exclusion of 7.3.
 
A

armani

Involved In Discussions
#4
#4
Re: Developing technology/equipment to Manufacture Clients product - can exclude 7.3?

harry said:
The party that uses the clients specifications and design to manufacture the product can claim exclusion of 7.3 because they are just a contract manufacturer and not responsible for the design. However, the party that uses the clients specifications and design as input to manufacture or develop equipment for production purpose is clearly involved in design and development and therefore cannot claim for exclusion of 7.3.
Click to expand...
In process, the organization doesn't change any of client requirements, only preparing for meeting them, so why not exclusion?
 
V

vanputten

#5
#5
Re: Developing Technology and Equipment to Manufacture Clients Product - Can exclude

Do you have the authority to change a characteristic / parameter of the product? If not, you can exclude 7.3 in ISO 9001. TS 16949 includes the design of manufacturing processes. Since the question is being raised in the ISO 9001 forum, you appear to be able to exclude 7.3 because you do not define the product and do not appear to have the authority to change the product's design.

Within ISO 9001, I disagree with Harry unless the manufacturing equipment is the product.
 
H

harry

Super Moderator
#6
#6
Re: Developing Technology and Equipment to Manufacture Clients Product - Can exclude

vanputten said:
Do you have the authority to change a characteristic / parameter of the product? If not, you can exclude 7.3 in ISO 9001. TS 16949 includes the design of manufacturing processes. Since the question is being raised in the ISO 9001 forum, you appear to be able to exclude 7.3 because you do not define the product and do not appear to have the authority to change the product's design.

Within ISO 9001, I disagree with Harry unless the manufacturing equipment is the product.
Click to expand...
I am not sure if we are interpreting the situation in the same manner.

1. I use this to illustrate a clear cut situation - Party A manufactures 'a product' according to specifications and designs given by the client with no authority to change any thing - hence 7.3 can be excluded.

2. This seems to me to be the situation that the OP is referring - Party B manufactures 'measuring and production purpose' equipment with the only contribution of developing the technology /manufacturing the equipment (in the OP's language) for use in the 'client's product'. To me, the customer's design and specs forms only part of the input required to design and manufacture this secondary product, hence 7.3 cannot be excluded.
 
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A

armani

Involved In Discussions
#7
#7
Re: Developing Technology and Equipment to Manufacture Clients Product - Can exclude

harry said:
I am not sure if we are interpreting the situation in the same manner.

2. This seems to me to be the situation that the OP is referring - Party B manufactures 'measuring and production purpose' equipment with the only contribution of developing the technology /manufacturing the equipment (in the OP's language) for use in the 'client's product'. To me, the customer's design and specs forms only part of the input required to design and manufacture this secondary product, hence 7.3 cannot be excluded.
Click to expand...
Maybe I wasn't clear enough - party B manufactures "measuring and production equipment" to use them in manufacturing client's product (the same organization is manufacturing client's product, so these equipments are for helping organization in manufacturing the product).
Maybe this clarification helps.
 
somashekar

somashekar

Staff member
Super Moderator
#8
#8
Re: Developing Technology and Equipment to Manufacture Clients Product - Can exclude

armani said:
An organization manufacturing products based on specifications / design given by client (without any further modifications suggested / imposed etc. ) -with the only contribution of developing the technology /manufacturing the equipment (for measuring / production purposes) to use for this product - can claim "exclusion of 7.3" ?
I don't know the english term for that activity - "technological design" maybe?
Click to expand...
You are doing all that is required as said in 7.5.1
Why are you thinking 7.3 ?
Justify and exclude...

If you happen to make a SPM to manufacture a customer's product and your QMS scope is NOT "Design and development of SPM's", then you are not into 7.3.
You are at all liberty to use all your technical knowledge, manufacturing knowledge, jigs and fixtures knowledge, and many more in doing the planning and to carry out production and service provision under controlled conditions.
 
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S

snappy

#9
#9
Re: Developing Technology and Equipment to Manufacture Clients Product - Can exclude

armani said:
An organization manufacturing products based on specifications / design given by client (without any further modifications suggested / imposed etc. ) -with the only contribution of developing the technology /manufacturing the equipment (for measuring / production purposes) to use for this product - can claim "exclusion of 7.3" ?
I don't know the english term for that activity - "technological design" maybe?
Click to expand...
Exclude 7.3. From what you have said, you are not design responsible.
 
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