Can an Auditor question Top Management decision to approve deviation?

[John Broomfield]

John, the Validation was not dodged. It did happen as per plan. To be precise, after validation when a Vehicle performance was found not meeting the target, re-design and re-validation was dodged.

Chennaiite,

Thank you for the additional evidence.

The design validation planning was ineffective.

Then the top management sanctioned release of defective product that conformed to its specification.

Were top management competent to make this design decision?

Now I'm seeing the need for value-adding corrective actions.

John

 

[Golfman25]

I fail to understand the WM/Nordstrom analogy. While we are forced to speculate somewhat as we don't have all the details, in the automotive supply chain, many design inputs, such as product characteristics and performance requirements come from a customer/OEM. If the supplier does not validate/verify that the product delivers the original customer demands and does not bother conferring with the customer about that, the organization is violating the spirit and the text of TS 16949. So, the nonconformity would be 100% justified. Because, in the automotive world, that could translate into costly automobile recalls.

If the parameter that is not being achieved is totally self driven, as an auditor I would still verify that the product specifications and it's mentions in any marketing and sales literature are revised and the information being provided to external parties is truthful.

My point is sometime stuff happens. Circumstances change. Some things can't be done. The validation process needs to account for those changes. Sometimes management has to step in and say "close enough." I would hope they document how/what/why they made the decision. You certainly take it one step further and suspect misrepresentation, lies and possible fraud. I'm not sure I would take it that far.

 

[Jen Kirley]

My point is sometime stuff happens. Circumstances change. Some things can't be done. The validation process needs to account for those changes. Sometimes management has to step in and say "close enough." I would hope they document how/what/why they made the decision. You certainly take it one step further and suspect misrepresentation, lies and possible fraud. I'm not sure I would take it that far.

Element 5.2 states "Top management shall ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction." There have been deaths and lawsuits stemming from some of management's "close enough" calls. In response to that, auditors have been told through AIAG to pay close attention to how customer requirements are met.

I am wondering, is there a customer-approved PPAP for the part in question?

 

[Reg Morrison]

I would hope they document how/what/why they made the decision.

Hope is the last one to dies, so they say. Unfortunately, for you, that is not the way the chips fall.

When the data and records show that the design validation does not confirm that all the design inputs are being satisfied and the level c suite executives use their authority to trigger volume manufacturing, they leave no traces to whom, why, for what reason the decision was made. So, we end up with a product released for manufacturing package without the proper supporting data.

The auditor in question found an instance of this and was told "top management overruled" Product Engineering (or similar). I would be astounded if the top managers generated a written communication to that effect. They know how to cover their derriere.....

 

[Chennaiite]

.....
I am wondering, is there a customer-approved PPAP for the part in question?

Not really. The discussion is about OEM and the part is a Vehicle, the characteristics is to do with Performance of the Vehicle, the Customer is Marketing (considering they represent Voice of the end users) and over and above that there is Top Management.

 

[Chennaiite]

.....
If the parameter that is not being achieved is totally self driven, as an auditor I would still verify that the product specifications and it's mentions in any marketing and sales literature are revised and the information being provided to external parties is truthful.

This sounds sensible to me. The Auditor could have done this check before raising NC.

 

[Chennaiite]

Hope is the last one to dies, so they say. Unfortunately, for you, that is not the way the chips fall.

When the data and records show that the design validation does not confirm that all the design inputs are being satisfied and the level c suite executives use their authority to trigger volume manufacturing, they leave no traces to whom, why, for what reason the decision was made. So, we end up with a product released for manufacturing package without the proper supporting data.

The auditor in question found an instance of this and was told "top management overruled" Product Engineering (or similar). I would be astounded if the top managers generated a written communication to that effect. They know how to cover their derriere.....

I am sorry. The launch of a Vehicle does not happen by a phone call or so. There is documentation of targets against actuals, there is documentation of test results, there is documentation of risk and documented approval.

 

[Golfman25]

I am sorry. The launch of a Vehicle does not happen by a phone call or so. There is documentation of targets against actuals, there is documentation of test results, there is documentation of risk and documented approval.

And that is my point. Perhaps they wanted to make a care that does 0-60 in 8 seconds. But it ends up at 8.5. Or a certain MPG. Then it becomes a business decision. Do you spend exponentially to get that last 0.5? Or go to market?

 

[Reg Morrison]

And that is my point. Perhaps they wanted to make a care that does 0-60 in 8 seconds. But it ends up at 8.5. Or a certain MPG. Then it becomes a business decision. Do you spend exponentially to get that last 0.5? Or go to market?

Based on the OP's additional disclosures, I agree with you, now.

Sometimes, the original specification for a product is overly ambitious and reality and constraints don't allow the product to satisfy all of the requirements. So, as long as nobody is being deceived and the risk management of the decisions is soundly captured and authorized by the proper personnel, it seems to me that the auditor is being unrealistic in his/her expectations and has issued an NC that would be summarily overturned by the auditor's line manager.

It is amazing how many auditors have no business acumen. The competence criteria for auditors should be significantly overhauled. Anyone who's spent 20+ years as a qc person would have a hard time understanding how business work. And we allow these people to go into business to perform quality system audits, expecting them to add value.....what can go wrong? [sarcasm alert....]

 

[Jen Kirley]

I am sorry. The launch of a Vehicle does not happen by a phone call or so. There is documentation of targets against actuals, there is documentation of test results, there is documentation of risk and documented approval.

Ah. Now I see my mistake, I did not catch at the beginning that the targets were set by marketing. Is this an accessory? I am still confused, now about vehicle launch and how marketing sets the targets. Are you the OEM? I take it the performance isn't regulated, like braking or crash tests?