QMS for Life Sciences
Elsmar Cove Forum Sponsor

Design Responsible

#1
My company has decided that we should of never been registered to QS/ISO9001, because we don't what to be held to the requirements of Design Control 4.4 The reasoning for changing our scope of our registration is we receive tooling designed by our parent compnay in Japan and we haven't been able to get them to develop dFMEA's. Our design engineers don't feel that they should be held responsible for developing dFMEA's because they weren't involved in the tooling design and when we receive the tooling it's somewhat after the fact. I believe that we should perform subcontractor development on our parent company for failure to provide dFMEA's. The company believes that we are not design reponsible but I point them to the definition of design responsible in the QS9000 Standard in that we are responsible for making design changes once the tooling is received from our parent company and that our customers expect us to control design changes prior to and after we go into mass production. Our customer base includes two Japanese automotive manufacturers and one Big 3. I don't see anyway out of being held to the requirements of 4.4 and we should re-evaluate our internal procedure and provide training to ensure that we meet the standard. I would appreciate any and all responses to this posting.
 
N
#2
As you say, you are responsible for a design as soon as you make one or make changes on an existing one. The best way to solve this problem is to talk with your parent company about making DFMEA:s and maybe changing their rutines.
It is your company's responsibility to make sure that suppliers to you follow the QS requirements.

------------------
 
A

Al Dyer

#3
Just a idle thought (I'm watching Detroit beat New York) considering that if you are QS-9000 registered, you are directly (tier I)supplying the automotive industry (big 3)

Do you have the authority to establish new customer specifications for product delivered to the customer?

Do you have the authority to change existing customer product specifications for the product you deliver to the customer?

If the answer is no, you are not design responsible.

See the first note under QS-9000 third edition element 4.4 and then review the TS-16949 definition of Design-responsible suppliers. (page 34 A.18)

As usual it is best to contact your customer representative.
 
Top Bottom