SI #7 8.4.2.1 Type and extent of control_supplemental

maggylu168

Starting to get Involved
#1
IATF added the below requirements in this clause. I am not quite sure about the meaning. Could someone guide me when and how to have such kind of controls? Why IATF added this new requirement through SI? Explicating through examples will be appreciated.

Where characteristics or components "pass through" the organization's quality management system without validation or controls, the organization shall ensure that the appropriate controls are in place at the point of manufacture.
 
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Sebastian

Trusted Information Resource
#2
Construction of front suspension top mount includes bearing.
Internal diameter of inner ring is (shall be) one of special characteristics, as it fits to piston rod of shock absorber.
Bearing is manufactured by external supplier therefore control over this characteristic is not covered by organizational control plan.
Organization is not going to perform receiving inspection through measurement of certain product characteristics of bearings received from supplier.
So part of organizational control process over external sources shall be activity, which shall ensure that e.g.:
- this characteristic was selected by supplier as special one,
- control over this characteristic is included in supplier control plan,
- capability is analyzed and monitored for this characteristic,
- alternative to measurement, methods of receiving inspection selected by organization include this characteristic, e.g. supplier certificate attached to each delivery presenting measurement results,
- one of focus points of organizational 2nd party audits performed in bearing supplier premises is control of this characteristic.

Alternative way is.
Organization includes this characteristic as one of final inspection items, then it seems that it does not applies, but..
Let see results of risk analysis for this component/supplier and watch future claim if there is no case related to this characteristic.
Because after all, organizational inspection does not ensure quality of received components.
Supplier (manufacturer) control does.
 

maggylu168

Starting to get Involved
#3
Construction of front suspension top mount includes bearing.
Internal diameter of inner ring is (shall be) one of special characteristics, as it fits to piston rod of shock absorber.
Bearing is manufactured by external supplier therefore control over this characteristic is not covered by organizational control plan.
Organization is not going to perform receiving inspection through measurement of certain product characteristics of bearings received from supplier.
So part of organizational control process over external sources shall be activity, which shall ensure that e.g.:
- this characteristic was selected by supplier as special one,
- control over this characteristic is included in supplier control plan,
- capability is analyzed and monitored for this characteristic,
- alternative to measurement, methods of receiving inspection selected by organization include this characteristic, e.g. supplier certificate attached to each delivery presenting measurement results,
- one of focus points of organizational 2nd party audits performed in bearing supplier premises is control of this characteristic.

Alternative way is.
Organization includes this characteristic as one of final inspection items, then it seems that it does not applies, but..
Let see results of risk analysis for this component/supplier and watch future claim if there is no case related to this characteristic.
Because after all, organizational inspection does not ensure quality of received components.
Supplier (manufacturer) control does.
Thank you, Sebastian, for your clear explanation. It looks like such characteristics is connecting between customers' manufacturing process and organizations' components. As a second-tier supplier in automotive chain, it's not easier to know the customers' further assembly unless they want to share or identify this kind of characteristics. How come the clause asks organizations to define and control them? Usually the validation should be done and qualified during APQP process at customers' side; all organization can do is control the component itself on dimensions and functions.
BTW, what is so-called "pass through"? Does it mean no inspecting or testing? I am curious if this is talking about products like fireworks or airbags?
 

Sebastian

Trusted Information Resource
#4
"Pass through" means, that organization has no intention to alter properties of product characteristic originated from its supplier process, during own manufacturing process until delivery to customer. I gave example of bearing inner diameter.
Cascading knowledge, related to manufactured product purpose, within supply chain is a one of biggest problem in automotive industry. Even within one organization it is hard, but all say about "lessons learned" and "protection of know how".
 
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