ISO/TS 16949 Cl 8.2.3.1 - Monitoring and Measurement of Manufacturing Processes

[lucafraca]

Good morning,
in reference to the point indicated in the Title I need a clarification. If during an SPC Study (serial production) the capacity is not achived, is it obligatory to implement a 100% selection? or I can implement a different activity?

Many thanks at all!
Luca

 

[Jim Wynne]

Re: ISOTS 16949 p.to 8.2.3.1

This is the pertinent part of 8.2.3.1:

The organization shall initiate a reaction plan from the control plan for characteristics that are either not statistically capable or are unstable. These reaction plans shall include containment of product and 100 % inspection as appropriate. A corrective action plan shall then be completed by the organization, indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable. The plans shall be reviewed with and approved by the customer when so required.

I'm not quite sure what you mean by not achieving capacity, but my assumption is that you are unable to confirm statistical stability. Your reaction plan "shall" include containment and 100% inspection as appropriate. There could be instances where 100% inspection isn't feasible, and in those cases, barring specific customer requirements, you should at least do containment and sampling inspection in order to have a reasonable level of confidence in conformance of the product.

 

[qusys]

Good morning,
in reference to the point indicated in the Title I need a clarification. If during an SPC Study (serial production) the capacity is not achived, is it obligatory to implement a 100% selection? or I can implement a different activity?

Many thanks at all!
Luca

I would add to what Jim rightly stated that you should have in place a plan ( that could be also shared with customer if needed) to face this issue.
You can also contact customer to agree with the criteria to manage the risk coming from the not achieved capacity.
I assume that you are not achieving the process capability that you reported in PPAP ( for example , I mean cpk major than 1.67 or another indicatot you agreed upon)

 

[Blaest]

Cpk would not indicate it the process is statistically capable or unstable. Cpk have no statistically value for an unstable process. Rather your Ppk would indicate if your process is capable and stable.