What is Process Performance and Product Conformity - ISO/TS16949:2002 Clause 5.6.2.c

[A Navajo - 2012]

Hi,
Could someone help to clarify and provide example for the following requirement in ISO/TS16949:2002.
Clause 5.6.2.c requires Inputs to management review to include :
Process Performance and Product Conformity.
In my organization (Semiconductor Assembly & Packaging) we provided Process Cpk Trend for Process Performance and PPM levels and Lot Rejection Rates for Product Conformity.

However, during the recent Certification audit, the Auditors intepretated this as overall QMS Process Performance instead of Production Process Performance. Is this a correct (auditor's intepretation)? If this is a correct intepretation, than how does one intepret clause 5.1.1 Process Efficiency, where the standard states that.....management shall review the product realization processes and the support processes to assure their effectiveness and efficiency.
Pls help to clarify and provide some examples in relation to Manufacturing environment.
Thank You
Navajo

 

[Marc]

This should be in the TS forum - Moved.

 

[Howard Atkins]

Hi,
Could someone help to clarify and provide example for the following requirement in ISO/TS16949:2002.
Clause 5.6.2.c requires Inputs to management review to include :
Process Performance and Product Conformity.
In my organization (Semiconductor Assembly & Packaging) we provided Process Cpk Trend for Process Performance and PPM levels and Lot Rejection Rates for Product Conformity.

However, during the recent Certification audit, the Auditors intepretated this as overall QMS Process Performance instead of Production Process Performance. Is this a correct (auditor's intepretation)? If this is a correct intepretation, than how does one intepret clause 5.1.1 Process Efficiency, where the standard states that.....management shall review the product realization processes and the support processes to assure their effectiveness and efficiency.
Pls help to clarify and provide some examples in relation to Manufacturing environment.
Thank You
Navajo

All defined processes should be monitored and measured 8.2.3 and analysed 8.4.
You should have defined how you monitor the processes, example- purchasing- suppliers quality rating, delivery times etc.
These are summarized and reported to the MR to enable the management to decide on the need for improvement.
5.1.1 this is having a finger on the pulse of the production and being kept in the loop, Daily/weekly/Monthly (delete not applicable) operational reports of production levels etc.

 

[A Navajo - 2012]

Howard, Thanks for the quick resposne.
Now i am more confused.

Yes, we have have all processes identifed and measured...however clause 5.6.2.c specially referes to the inputs to MR ofn process performaces. In this context my interpertation is of Production related process and not the whole QMS Procesess. The entire QMS processes would be more applicable if referenced under Clause 5.1.1. But clause 5.6.2.C does not address QMS, it simply states Process Performaces and Product Conformity.

So, What does Process Performance means when referenced in 5.6.2.C?
Regards
Navajo

 

[Howard Atkins]

Howard, Thanks for the quick resposne.
Now i am more confused.

Yes, we have have all processes identifed and measured...however clause 5.6.2.c specially referes to the inputs to MR ofn process performaces. In this context my interpertation is of Production related process and not the whole QMS Procesess. The entire QMS processes would be more applicable if referenced under Clause 5.1.1. But clause 5.6.2.C does not address QMS, it simply states Process Performaces and Product Conformity.

So, What does Process Performance means when referenced in 5.6.2.C?
Regards
Navajo

The clause 5.6.2c does not say manufacturing process whereas 5.1.1 says "product realization process and the support processes" that as I see it refers to the process in chapter 7- product realization.
The place for a discussion on all QMS processes is the MR and thus this is the reason it is input.
Does this make sense?

 

[Helmut Jilling]

The clause 5.6.2c does not say manufacturing process ...

The place for a discussion on all QMS processes is the MR and thus this is the reason it is input.

Absolutley agree. You don't need to parse the standard too precisely. The review meeting with top managment is to review all the processes of your system. This is the proper forum to evaluate wether the criteria (4.1.c) and the measureables (4.1.e) demonstrtate that the objectives and targets (5.4.1) have been achieved.