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TS 16949 Clause 7.3.6 Requirements - Last Audit NCR

D

Duke Okes

#11
#11
Marc said:
Part of the question is does 7.3.6 apply to both process and product designs? I don't have a copy of TS here and I haven't looked at a copy in a while. That's why I said I'd sorta keep out of the discussion - I'm not current. I've taken section 7 as applicable to product design as opposed to process design. It sounds like the auditor finding is a process design aspect and as was note in another post here it sounds like a metrics aspect (e.g.: tracking scrap).
Click to expand...
Yes, in TS they apply 7.3 to both product and process design.
 
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Jim Wynne

Jim Wynne

Staff member
Admin
#12
#12
Re: Clause 7.3.6 - Last Audit NCR

vitortavares said:
The auditor wrote:

"Non-compliance is considered minor given that the organization demonstrates records of these activities when the client is involved and / or more systematic at
control of consumption of raw materials and waste rates by process. However, these activities do not cover the full range of internal and external objectives set for the process."
Click to expand...
This is commentary from the auditor about the nonconformity, but it doesn't describe the nonconformity. Can you post the entire thing?
 
V

vitortavares

Involved In Discussions
#15
#15
Re: Clause 7.3.6 - Last Audit NCR

The Non Conformity Text:

"The organization does not show, in consitent way, the definition and implementation of a methodology to validate the industrial process."
 
Stijloor

Stijloor

Staff member
Super Moderator
#16
#16
Re: Clause 7.3.6 - Last Audit NCR

vitortavares said:
The Non Conformity Text:

"The organization does not show, in consistent way, the definition and implementation of a methodology to validate the industrial process."
Click to expand...
Aha! That makes sense. What methods have you defined to validate your manufacturing processes? (Keep in mind that PPAP requires validation as well and this should not create duplication of effort). Do these methods provide you and your customer with the objective evidence that the processes are performing as required? Validation includes quality and productivity measures.

There is some information available here at The Cove Forums about validation of processes.

Hope this helps.

Stijloor.
 
Last edited:
G

Golfman25

Trusted Information Resource
#17
#17
Re: Clause 7.3.6 - Last Audit NCR

vitortavares said:
The Non Conformity Text:

"The organization does not show, in consitent way, the definition and implementation of a methodology to validate the industrial process."
Click to expand...
Sounds to me like you have an auditor that is trying to impress himself. I have no clue what he is talking about. Maybe you need to ask him to speak english. Good luck, you're going to need it.
 
Jen Kirley

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#18
#18
The NC writeup is pretty cryptic, but I think I understand it.

Validating a process is examining its proper function by way of examining outcomes. It is a step beyond verifying its performance matches its definition.

A paper by Cristiv et.al. talks about Using Event Streams to Validate Process Definitions. The paper is pretty deep but some of its examples are good.

I did some looking around for material to explain the use of metrics to validate processes, and settled with the article Use project metrics to improve processes and declare success. I am not affiliated with TechRepublic.
 
P

pharmarton

#19
#19
Hi there!
I'm new in this forum, so I dont know how is working. I have a doubt about the product audits. I start to work for a company where they are pursuing to achieve the ISO TS certification asap. Im undated the procediment for internal audit, regarding to product audit, I was wonder if I can use the inspection as an audit. As I understand, the inspection is the same than an audit. isnt it??
Thank you very much in advance for your help.
pharmy
 
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