Build your control plan in a design to risk objective – a new way to use Process FMEA

When building a control plan, we are always facing a threefold issue: Should we check product characteristics or process parameters? Where have we to place this check? Is our effort of control adapted; or is it undersized, oversized? Such as it is classically implemented, FMEA usually highlights the lacks and not the excess of controls, thus generating too heavy and usually too expensive a control plan. That is why we suggest to use a new FMEA to size the control plan on a just necessary level. The traditional FMEA, by the product RPN=O*S*D (Occurrence, Severity and Detection) aims at decreasing customer risks through -among othersa process of detection. Assuming that it is useless to detect a fault which never occurs or which does not bother anyone, we suggest to calculate the proper effort of control, as to obtain a level of given risk (Risk Priority Number) with the formula: D= RPN/OxS So, we hold here a new way of building control plans, in an approach of design to risk objective.