Effective prevention, reliable tests, statistical relevance and modern charlatanism
The legal importance of test results depends solely on the relevance of the documented product-specific figures for the conditions of use for the expected lifetime. Whatever is not sufficiently relevant for the foreseeable usage cannot be of any legal value. Zero-defect programmes were originated in the sixties by forensic needs to explain carefulness in a trial to a jury of lay judges. The technical importance and statistical relevance of zero-defect programmes are explained here, based upon the state of the art which has been undisputed for more than a century. Certificates of conformity to company quality systems, with ISO 9000ff, are compared with the state of the art of such organizational set-ups. The state of the art has been developed further from the description of only 20 elements of the ISO standard. The difference is described best by comparing them with the detailed demands of the Malcolm Baldrige National Quality Award (USA), and the closely related European Quality Award. These awards demand between 2.5 and 3 times more, as well as different, measures compared with ISO 9000ff. Certificates of conformity to quality management organization according to only an international standard cannot lead to any reliable legally valid demonstration of sufficient care. Ineffective procedures and useless tests constitute a vast source of unnecessary expenditure.
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