Can an Auditor question Top Management decision to approve deviation?

[Chennaiite]

Here's a real situation where an external Auditor of ISO/TS has raised a non-conformance basically by not accepting the decision taken by the Top Management. The Top Management, while fully in cognizance of a Product not meeting a particular target, decided to go for its launch in the market. Being a OEM, the product targets are generally set by the Marketing team and agreed or traded off by Product Development team. Therefore, can an Auditor question the decision taken by the Top Management to approve deviation?

 

[dgriffith]

Perhaps the auditor was an unhappy customer, and upon discovering why the product wasn't all it should have been, exacted some 'satisfaction'.

 

[Helmut Jilling]

Here's a real situation where an external Auditor of ISO/TS has raised a non-conformance basically by not accepting the decision taken by the Top Management. The Top Management, while fully in cognizance of a Product not meeting a particular target, decided to go for its launch in the market. Being a OEM, the product targets are generally set by the Marketing team and agreed or traded off by Product Development team. Therefore, can an Auditor question the decision taken by the Top Management to approve deviation?

If there is a customer involved, the customer usually has to agree with the deviation. If there is no customer, if they are the OEM, they own the design. I think it would be fair to say many cars and products have launched where the product did not meet all requirements, at the initial launch.

 

[maaquilino]

Here's a real situation where an external Auditor of ISO/TS has raised a non-conformance basically by not accepting the decision taken by the Top Management. The Top Management, while fully in cognizance of a Product not meeting a particular target, decided to go for its launch in the market. Being a OEM, the product targets are generally set by the Marketing team and agreed or traded off by Product Development team. Therefore, can an Auditor question the decision taken by the Top Management to approve deviation?

When I audited and found a justification for something, such as a deviation or for not closing a fairly significant bug before launch, there were times the justification wasn't very clear or didn't adequately justify why the decision was made, so yes it got questioned. If the auditor raised a non-conformance, what was the rationale for it? They have to 'justify' their non-conformances, so they should have said why it was a non-conformance, either in the closing meeting or in their final report. If you can share that info, I might be able to answer your question better.

 

[TWA - not the airline]

Here's how we do it: If during the development phase it is found that the product does not meet the spec (i.e. design output does not match the requirements set in design input) then our procedure says we cannot market that product. If top management just decides to ignore this then it is a deviation. If marketing or top management change the requirements and rev up the respective documents then everything is fine as long as it does not collide with regulatory or safety requirements.

 

[Mikishots]

Here's a real situation where an external Auditor of ISO/TS has raised a non-conformance basically by not accepting the decision taken by the Top Management. The Top Management, while fully in cognizance of a Product not meeting a particular target, decided to go for its launch in the market. Being a OEM, the product targets are generally set by the Marketing team and agreed or traded off by Product Development team. Therefore, can an Auditor question the decision taken by the Top Management to approve deviation?

Sure they could. But I would be interested as to which part of the Standard they would raise that non-conformance against. What exactly was this missed target (you don't say). Was it a quality requirement?

 

[Ajit Basrur]

Here's a real situation where an external Auditor of ISO/TS has raised a non-conformance basically by not accepting the decision taken by the Top Management. The Top Management, while fully in cognizance of a Product not meeting a particular target, decided to go for its launch in the market. Being a OEM, the product targets are generally set by the Marketing team and agreed or traded off by Product Development team. Therefore, can an Auditor question the decision taken by the Top Management to approve deviation?

You may mentioned "not meeting target" which is not clear if it violated any quality / regualtory requirement. Since you also mention about "launch", I assume the auditor would have considered as a "high risk".

Could you pls give more details on the issue ?

 

[BigMatt]

Was the auditor's problem with the decision itself or the way it was made? I would assume that there is an internally documented deviation process. If that process was not correctly followed in this instance, I could see a finding being raised.

 

[Reg Morrison]

Therefore, can an Auditor question the decision taken by the Top Management to approve deviation?

Hallelujah...Yes, we can....

Finally some evidence of an auditor with enough courage to burst top management's dictatorial tendencies. Obviously, I am making a number of assumptions here, but all too often top management will disregard performance requirements, safety issues, validation and verification decisions, etc. and use their "authority" to shove/rush an underdeveloped product into the market, simply for financial reasons. Pressed by corporate to improve their bottom line, some misguided "managers" will make decisions against all the data, putting the organization, it's employees, it's customers and it's future at risk.

I am extremely impressed and surprised that your external auditor was brave enough to call your top management's bad decision. It is a very rare occurrence. Most external auditors spend their time with document control clerks, calibration supervisors and don't have the guts, knowledge or competence to interact with and challenge "top management".

Tell us more....

 

[John Broomfield]

Here's a real situation where an external Auditor of ISO/TS has raised a non-conformance basically by not accepting the decision taken by the Top Management. The Top Management, while fully in cognizance of a Product not meeting a particular target, decided to go for its launch in the market. Being a OEM, the product targets are generally set by the Marketing team and agreed or traded off by Product Development team. Therefore, can an Auditor question the decision taken by the Top Management to approve deviation?

Chennaiite,

This is another time when it useful to differentiate between the release of a defective product (in that it could injure the customer) or a nonconforming product (in that it may disappoint the customer or designer).

Auditor is right to issue a corrective action request if the management system allowed release of defective product.

Top management has authority to issue a waiver to ship nonconforming product but not to unilaterally breach a contract or to endanger customers with defective products.

John