Quality assurance —Have we specified it the wrong way round?

There is a considerable drive in both engineering and technology to develop and improve the systems of quality assurance and quality management during the manufacturing process. This drive has led to the development of international (CEN, ISO) and European national standards (BS, ON, DIN, AFNOR) to assist engineers, metrologists and designers in the specification of products to achieve this objective. The main problem with the developments so far is that although they clearly contribute to the quality of products and their components, the quality assured may have little relevance to the function performance of the product. This paper examines as a model the functional quality assurance system that inherently exists within a human being to see if an analogy can be drawn to the differences between the human quality assurance system and what is really required in a manufacturing environment. As a result of this assessment and comparison with the human quality assurance system, proposals are made for a way forward in developing quality assurance protocols for engineering manufacture, an alternative philosophy that may lead to an approach that stems from developing a comprehensive functional specification for both manufactured parts and products. Such a new basis would meet the aims of the quality assurance community and could lead to the provision of more reliable functional product design.