Predictive indicator model

#The field of art to which this invention relates is business methods, more specifically, methods of statistically predicting risk in manufacturing processes.

#Statistical analysis as a way of controlling the quality of the product produced by a manufacturing process is well known in the art. Data is collected and various process parameters are measured for conformance with standards. The conformance of the parameters to a range is typically related to a measure of the quality of the product. Variations of the parameters from the accepted range are indicative of a process that is out of control, possibly resulting in products that do not conform to specifications.

#One example of a quality assurance process is the six-sigma process. The six-sigma process is a problem solving methodology using statistical tools. The six-sigma process is utilized by many businesses to solve quality and business problems.

#FIG. 1 is a flow diagram of how the predictive indicator tool is utilized or the method of the present invention.

#FIG. 2 is an illustration of a predictive indicator tool for a medical device or diagnostic manufacturing process.

#The Predictive Indicator Tool (PI Tool) method of the present invention, is a novel method of predicting areas in manufacturing processes with a higher risk of potential non-conformances based upon answering and scoring questions related to product design, regulatory risk, and the manufacturing process variables associated with the products produced in the process.

#The method facilitates a more predictive process than GMPs and statistical control systems of identifying potential risks, thus providing a means to identify and prioritize quality improvement efforts and preventive actions. The purpose of the novel method of the present invention is to identify through scoring processes the potential risk, based upon answering questions related to the product's design, regulatory risk and associated performance of the manufacturing process that produced the product. In this method, the scores are then used to prioritize quality improvement efforts.

#The predictive indicator tool was developed using conventional, known Six Sigma statistical tools and techniques. Using these Six Sigma tools and techniques, a series of twelve scored questions was generated to serve as a predictive indicator of risk. The following is a discussion and listing of the conventionally known tools and techniques, including acronyms, which are utilized in the predictive indicator tool of the present invention.