Method of designing products and processes

Abstract

A method for use in a system for prioritizing risks associated with the design and manufacture of products involves performing a failure mode detection analysis. Functions of the product and/or of the process and the effects of undesirable events related to malfunctions are characterized, and potential failure modes and causes for the effects are identified. The features of the product/process that are responsible for the undesirable effects are determined. Severity, occurrence and detectability of the undesirable events are evaluated using specific measures designed to encourage score keeping, and risk factor numbers are computed. The resultant numbers are ranked and prioritized for a set of selected functions. Risk reduction may then be performed through engineering activities directed to remedy causes associated with the malfunctioning features. Failure mode detection analysis may be updated to continue incremental and focused improvements to the product and/or process. The method permits the capture of potential failures before they reach the field and the customer.

1 . A method for addressing risk associated with a product or process, comprising the steps of:
 identifying a plurality of risks associated with the product or process;   assigning a risk factor to each of the plurality of risks, the risk factors capable of being ranked;   ranking the risk factors;   selecting a subset of the risks based on the ranking; and   addressing only those risks that have been selected.   
     
     
         2 . The method according to  claim 1 , wherein the risk factor corresponds to a function of the product or process, and wherein the addressing the risk involves attending to the function for risk reduction. 
     
     
         3 . The method according to  claim 1 , wherein the risk factor comprises a risk priority number. 
     
     
         4 . The method according to  claim 1 , wherein the ranking comprises a Pareto ranking. 
     
     
         5 . The method according to  claim 1 , wherein the subset of risks correspond to five functions. 
     
     
         6 . A method for assigning a risk factor associated with one or more aspects of a product or process, the method comprising the steps of:
 (a) identifying a function associated with the product or process, the function capable of malfunction, the malfunction having at least one associated effect;   (b) selecting one of the associated effects;   (c) for the selected associated effect, identifying at least one potential failure mode;   (d) selecting one of the at least one potential failure mode;   (e) for the selected failure mode, identifying at least one potential cause;   (f) selecting one of the at least one potential cause;   (g) for the selected cause, identifying a aspect associated with the function responsible for the malfunction; and   (h) assigning a risk factor to least one of the groups consisting of the potential cause, the potential failure mode and the potential effect.   
     
     
         7 . The method according to  claim 6 , wherein the step of assigning a risk factor comprises determining a rating selected from the group consisting of a severity rating, an occurrence rating and a detection rating. 
     
     
         8 . The method according to  claim 6 , wherein the step of assigning a risk factor comprises the further steps of determining a severity rating, an occurrence rating and a detection rating, and computing the risk factor on the basis of the determined ratings. 
     
     
         9 . The method according to  claim 6 , wherein the risk factor is computed according to an algorithm. 
     
     
         10 . The method according to  claim 9 , wherein the algorithm comprises a product of the severity rating, the occurrence rating and the detection rating. 
     
     
         11 . A method for representing a risk assessment framework associated with a product or a process having plurality of aspects, the method comprising the steps of:
 identifying a plurality of elements for representing the risk assessment;   defining attribute, phenomenon, measure, and activity categories for the elements;   assigning the elements to the categories;   ascribing value to the elements based on the aspects of the product; and   arranging the elements to form the representation of the risk assessment framework.   
     
     
         12 . The method according to  claim 11 , wherein the plurality of elements comprise fields in a data structure. 
     
     
         13 . The method according to  claim 11 , wherein the attribute category comprises a function of an aspect of the product or of the process. 
     
     
         14 . The method according to  claim 11 , wherein the attribute category comprises the name of the aspect of the product or the process. 
     
     
         15 . The method according to  claim 11 , wherein the phenomenon category comprises a potential effect of the risk of an aspect of the product or the process. 
     
     
         16 . The method according to  claim 11 , wherein the phenomenon category comprises a potential failure mode of an aspect of the product or the process. 
     
     
         17 . The method according to  claim 11 , wherein the phenomenon category comprises a potential cause for the failure mode of an aspect of the product or the process. 
     
     
         18 . The method according to  claim 11 , wherein the measure category comprises severity, occurrence and detection rating scales. 
     
     
         19 . The method according to  claim 18 , wherein the rating scale comprises a range of rating values from 1 to 
     
     
         20 . The method according to  claim 19 , wherein the range of rating values comprise full-points  1 ,  2 ,  3 ,  4 ,  5  and  6 .