How can I demonstrate meeting 5.6.2.1 and 6.3.1 of ISO/TS16949 requirements?

K

Kim Yong Kil

Hello...

I wish all cuve member "happy new year"

I have two question about implementation some requirements of ISO/TS..

1) 5.6.1

" input to management review shall include an analysis of actual and
potential field-failures and their impact on quality safety or environmenmt"

What is "impact and anaysis"? Is it FMEA????
How can i this demonstred to our auditor???

2) 6.3.1

Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations

what is mean " evaluated and monitor"? also what is effective "method"??

Plaese your useful comments and helps...

Thanks
 
P

p_tww

1) 5.6.1

" input to management review shall include an analysis of actual and
potential field-failures and their impact on quality safety or environmenmt"

What is "impact and anaysis"? Is it FMEA????
How can i this demonstred to our auditor???
-----------------------
Yes impact and analysis could refer to failure modes & its affects on customer in FMEA, suggested you told auditor whether actual field failure occurred since last management review and you reviewed its cause and occurrence & current control during management review. Maybe something need be revised.
If no atual failure happened, you could mention in your management review record that management had understood failure mode & its affects which was analyzed in FMEA. AUditor maybe interview some of your top management for this understanding.




2) 6.3.1

Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations

what is mean " evaluated and monitor"? also what is effective "method"??
------------------------------------------------------

You should evaluate operation effectiveness at initial stage and reevaluated it regularly, that means monitor.
Method referred to some method of IE (Industry engineer), which was used to inprove process efficiency. such as flow analysis, man-line balance etc.

Hope help
 
P

p_tww

1) 5.6.1

" input to management review shall include an analysis of actual and
potential field-failures and their impact on quality safety or environmenmt"

What is "impact and anaysis"? Is it FMEA????
How can i this demonstred to our auditor???
-----------------------
Yes impact and analysis could refer to failure modes & its affects on customer in FMEA, suggested you told auditor whether actual field failure occurred since last management review and you reviewed its cause and occurrence & current control during management review. Maybe something need be revised.
If no atual failure happened, you could mention in your management review record that management had understood failure mode & its affects which was analyzed in FMEA. AUditor maybe interview some of your top management for this understanding.




2) 6.3.1

Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations

what is mean " evaluated and monitor"? also what is effective "method"??
------------------------------------------------------

You should evaluate operation effectiveness at initial stage and reevaluated it regularly, that means monitor.
Method referred to some method of IE (Industry engineer), which was used to inprove process efficiency. such as flow analysis, man-line balance etc.

Hope help
 
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