Can an Auditor question Top Management decision to approve deviation?

[Reg Morrison]

I understood the scenario differently from you. It is not a typical case of shipping suspect product. It is a case where a new product being developed was allowed to be offered in the market, despite the fact that it did not reach some of the performance/characteristics they had (originally) for the product.

For example, if I were a manufacturer of automotive xenon light bulbs and one of my performance requirements for the product was that it would have a 10,000 hours mean time between failures and, during my validation/verification cycle, I found out that product does not last more than 5,000 hours before it fails, I could:

1. go back to drawing board
2. accept a very low profit margin to minimize customer dissatisfaction
3. rush the product into the market, despite the fact that it will create customer dissatisfaction and all the risks associated with that.

The scenario leans toward a situation where top management made a decision along the lines of 3, above.

 

[Wilderness Woody]

It would be interesting to know more facts surrounding this event. How did the auditor "stumble" upon this activity in the first place? To be a valid NC, the auditor must have a sound basis for the finding such as inadequate or faulty risk analysis by top management.

 

[Golfman25]

I understood the scenario differently from you. It is not a typical case of shipping suspect product. It is a case where a new product being developed was allowed to be offered in the market, despite the fact that it did not reach some of the performance/characteristics they had (originally) for the product.

For example, if I were a manufacturer of automotive xenon light bulbs and one of my performance requirements for the product was that it would have a 10,000 hours mean time between failures and, during my validation/verification cycle, I found out that product does not last more than 5,000 hours before it fails, I could:

1. go back to drawing board
2. accept a very low profit margin to minimize customer dissatisfaction
3. rush the product into the market, despite the fact that it will create customer dissatisfaction and all the risks associated with that.

The scenario leans toward a situation where top management made a decision along the lines of 3, above.

But that is a business decision. Not the "auditor's." It's kind of like requiring Walmart to be Nordstrom.

 

[Chennaiite]

I thank all responses. For obvious reasons, without getting into the specifics I will make sure that enough details are presented to give insight.

In the first place, let me clarify that the deviation has nothing to do with violation of regulatory norms. In fact the product was certified by the Government authorized test agency. Neither does it endanger the user or even make the vehicle inoperable. It is a case of reduced vehicle performance. In an appropriately done DFMEA, the failure mode will carry Severity rating of not more than 7.

The NC statement strangely though (or perhaps not) doesn't mention a bit about the Top Management decision, rather it says the Design Verification/Validation process is ineffective. The objective evidence says, based on validation results so and so target was not met, but the product was released to market. Perhaps the Auditor meant ineffective verification of Design validation results against targets (Heaven knows) and as an Auditor one finds so many ways and means to justify his/her statement. However, by what transpired during the Audit and in closing, the fact remains that the Auditor was explained of the approval from Top Management which he had refused as a valid justification for release of product with deviation to the market. I am not trying to blame the Auditor here, but trying to find whether or not questioning Top Management decision to approve deviation is within the scope of Audit. Except in the cases of violation of regulatory requirements, are Auditors qualified enough to take such stand?

 

[somashekar]

The stamp of the top management to release the product does not absolve the design verification and validation process, if there is evidence that there is no effectiveness of that activity. All is not well even when the top management approves, and the top management very well knows it. The auditor is not questioning top management business decision, as it is not the top management that has to take corrective action. He is driving a finding to the right process for a corrective action. We are looking at the wrong side towards top management, as we find top management involvement in this decision process.

 

[Chennaiite]

Design Validation process, in short, starts with Validation plan, thereafter execution of tests as per plan, Check of test results against acceptance criteria and take actions based on check results. That sums up the PDCA of Validation process.

Now, when the results do not meet the acceptance criteria, sometimes the Management in order to find a balance between Quality, Cost and Delivery decides to go ahead without action. To my knowledge this is not uncommon in Business. Of course with due consideration of risk, many times such decisions are taken by Top Management. If such decision is cited as justification for skipping action part of PDCA, how can an Auditor contest it? The decision could be right or wrong, but are Auditors qualified enough to judge it unless otherwise there is a glaring evidence?

 

[John Broomfield]

Design Validation process, in short, starts with Validation plan, thereafter execution of tests as per plan, Check of test results against acceptance criteria and take actions based on check results. That sums up the PDCA of Validation process.

Now, when the results do not meet the acceptance criteria, sometimes the Management in order to find a balance between Quality, Cost and Delivery decides to go ahead without action. To my knowledge this is not uncommon in Business. Of course with due consideration of risk, many times such decisions are taken by Top Management. If such decision is cited as justification for skipping action part of PDCA, how can an Auditor contest it? The decision could be right or wrong, but are Auditors qualified enough to judge it unless otherwise there is a glaring evidence?

Chennaiite,

Thanks for the additional evidence of a problem with an entirely different nature to the one reported by your auditor.

It appears to be a 7.3.1 problem.

Failure of the design validation planning to result in validation criteria supported by top management. The balance of quality, cost and delivery is a risk considered when planning the design not when validating the design.

This is an exotic nonconformity that is unlikely to yield much value for the registrar's customer.

Did the top managers who dodged the validation approve the design plan?

John

 

[Chennaiite]

Chennaiite,

Thanks for the additional evidence of a problem with an entirely different nature to the one reported by your auditor.

It appears to be a 7.3.1 problem.

Failure of the design validation planning to result in validation criteria supported by top management. The balance of quality, cost and delivery is a risk considered when planning the design not when validating the design.

This is an exotic nonconformity that is unlikely to yield much value for the registrar's customer.

Did the top managers who dodged the validation approve the design plan?

John

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.

 

[Jen Kirley]

Design Validation process, in short, starts with Validation plan, thereafter execution of tests as per plan, Check of test results against acceptance criteria and take actions based on check results. That sums up the PDCA of Validation process.

Now, when the results do not meet the acceptance criteria, sometimes the Management in order to find a balance between Quality, Cost and Delivery decides to go ahead without action. To my knowledge this is not uncommon in Business. Of course with due consideration of risk, many times such decisions are taken by Top Management. If such decision is cited as justification for skipping action part of PDCA, how can an Auditor contest it? The decision could be right or wrong, but are Auditors qualified enough to judge it unless otherwise there is a glaring evidence?

When I went through the AIAG Lead Auditor class it was post-Bridgestone Tire Debacle and it was stressed that we auditors should pay attention to customer requirements and help verify the system is ensuring they are met. In this case it appears as though the auditor believed deviation was OKed by management without customer approval. That happens a lot in business, but - if I understand the situation right - it isn't supposed to happen in automotive.

 

[Reg Morrison]

But that is a business decision. Not the "auditor's." It's kind of like requiring Walmart to be Nordstrom.

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.