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NonConformance Reports for non ISO facilities

A

aaron850

#11
What exceptions to quality clauses would they have taken if they understood the contract requirements?

What is your role in all this? Do you work for the parent organization?
We could have taken exception to certain SPAPP requirements on the PO. Doing this would help us avoid a rejected source inspection.

I work at our corporate facility. I was sent to China to train our staff there on SPC and CPK. As I started to pull on the string and really understand the CAPA's and listen in our management teleconferences, the tone was less about trying to fix the problems and more about not having to answer the CAPA's because the managing site wasn't ISO.

I figured I'd put this up for discussion to a diverse group on the forums.

Right now, internally, its a debate between our QA director and the site manager. The director has been in quality for 20+ years, while the site manager has never really embraced any sort of QMS system.
 
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S

Sardokar

#12
Regardless of ISO certification status , Are those problems affecting your business ?

Yes : Find root cause of problem , fix it and prevent future problems

dont talk about ISO , talk about Quality Management ... (ISO after all is a QMS )

Managers refusing to fix problems by investigating root causes and taking measures to fix them are people that are bad managers

Escalate this problem to top management , but Make sure you dont mention the term"ISO" in the report : Speak about problems that affect quality and customer satisfaction

and then let us see how that problematic site manager can get out of it ... will he pretend that customer satisfaction is also out of his site's scope of work ?

just my :2cents:
 

Big Jim

Super Moderator
#13
We could have taken exception to certain SPAPP requirements on the PO. Doing this would help us avoid a rejected source inspection.

I work at our corporate facility. I was sent to China to train our staff there on SPC and CPK. As I started to pull on the string and really understand the CAPA's and listen in our management teleconferences, the tone was less about trying to fix the problems and more about not having to answer the CAPA's because the managing site wasn't ISO.

I figured I'd put this up for discussion to a diverse group on the forums.

Right now, internally, its a debate between our QA director and the site manager. The director has been in quality for 20+ years, while the site manager has never really embraced any sort of QMS system.
And therein lies your problem. He is not a team player. He doesn't care about overall company performance. Until that is corrected, you will not make any progress. This stuff starts at the top. Who above him is permitting this?
 
#14
This is my first post.

I am a manufacturing engineer working for a small company (350 emp) that has made the jump to ISO9001 certification within the past 5 years.

We have 6 sites and only 2 of our sites are ISO 9001 certified.

My question is, can NCR's and CAPA's be written against our NON-ISO certified facilities?

Example: One of our sites has poor contract review, yet our Quality director writes and issues CAPA's to that facility for not adhering to ISO standards and working to company work instructions.
Regardless of the status of certification, do these sites operate a Quality Management System? If not, I'd question why the QM is bothering, since the personnel may not have the competency to be able to deal with the NCRs etc in a systematic manner! Does the QM have any authority over these sites? It seems to me that there's some organizational issues here which might need some fundamental 'sorting' before we have to be concerned over what CAPA etc procedures say...
 
A

aaron850

#15
And therein lies your problem. He is not a team player. He doesn't care about overall company performance. Until that is corrected, you will not make any progress. This stuff starts at the top. Who above him is permitting this?
President/CEO

Regardless of the status of certification, do these sites operate a Quality Management System? If not, I'd question why the QM is bothering, since the personnel may not have the competency to be able to deal with the NCRs etc in a systematic manner! Does the QM have any authority over these sites? It seems to me that there's some organizational issues here which might need some fundamental 'sorting' before we have to be concerned over what CAPA etc procedures say...
I agree with what you are saying, thanks for the insight.
We are transitioning sites to a standard QMS one by one by personnel size, not by $'s managed.
Either way, this site is the next one to be integrated with the corporate QMS.
 
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