I have been discussing with a Lead Auditor the relationship between internal audit and suitability/effectiveness for a TS-16949 system.
I believe that a robust internal audit system can be the "sole" driver and reporting method to comply with suitability and effectiveness requirements. I currently use more than 1 driver but this is a hypothetical situation, so far.
The Lead Auditor says that Internal Audit can't be the sole driver for suitability and effectiveness and he/she would not accept such a condition.
I would like to read what other forum members think and how they report suitibility and effectiveness.
I don't see much difference between QS and 16949 in this requirement so I'll throw in my opinion as a lead auditor in a QS system. Internal auditing under both standards establishes that the system being reviewed is effective. In cases of corrective action it also judges the suitability. We are probably all aware that it can be effective without being suitable.
The standards both require a judgement of suitability and effectiveness of the quality system by the company's management on an executive level. Certainly, internal audits feed a considerable amount of information to help make the effectiveness judgement but can't be solely relied on for verification of suitability. Our management review of the system includes I/A, Customer service reports , Sales contact analysis, production reports, customer ratings, supplier feedback, H/R reports and many other inputs.
The internal audits touch on a lot of this as well, but the key to meeting the requirement is not to have the auditor make the judgement, but to pass along information to be used by management to make the call. Without other contributing information supporting the effectiveness of the system, how can you judge if it is also suitable?
Now, if the President is the auditor and all of the feed elements are included in the audit schedule, it probably could stand alone.
IMHO, I agree with the lead auditor.
I believe Mr. Scott hit the head on the nail. Suitability is determined by management. If evidence is present that something is not effective then (I believe) an auditor may go down the path of "un-suitable". If a process / system is effective (having positive results) I would never report it to be unsuitable.
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