【正文】 r rates of critical processes used to produce new products are fully quantified and qualified before production volumes are produced.b. Statistical data is collected and used to control and improve these processes.Performance Level for Element 5SCORE 1: ? There is no evidence of statistical data being collected to determine the capability of operations and processes used to produce new products. SCORE 2: ? Some statistical data is being collected from a few critical operations/processes. ? There is evidence that a few processes have been characterized. ? Management is being aware that the success of new product introductions depend on capable operations/processes. ? A procedure is in place to determine Cp’s and Cpk’s, or error rates of critical operations/process. ? Many such processes have been characterized and some are deemed capable. ? Some process improvement activities are underway as a result of some operations not being capable based on statistical data.SCORE 3: ? A well defined Statistical Process Control (SPC) procedure exists and is used by most major areas of the business to characterize critical operations/processes used to produce new products. ? Most critical operations/processes have been characterized and many meet the requirements of a capable process. ? Management understands the need for and provides support to assure that new products are produced with capable processes/operations.SCORE 4: ? Processes used to produce new products are well defined. ? Statistical data is used to control all critical operations/processes. ? Cp and Cpk data is known for all processes where such measurement is applicable. ? All such operations are fully qualified.SCORE 5: ? Operations which control criticaltofunction characteristics of new products are fully qualified. ? The organization has an exceptionally well defined SPC system in place with focus on reducing variation and continuous improvement. ? The capability of processes/operations contribute to the successful introduction of world class new products. ? There are no examples of customer disappointments with new products which were traced to incapable operations or processes.6 Are puter simulation and design tools used to the maximum extent practicable in the design of new products/technologies/services?Considerations:a. State of the art simulation models are used for the development of new products/services.b. Tools, such as: Computer Aided Design (CAD), Computer Aided Manufacturing (CAM) and Simulation Modeling (S/M), are used to minimize development cycle time and improve quality.Performance Level for Element 6SCORE 1: ? There is no evidence of design tools being used. SCORE 2: ? Design tools are being used in a few areas. ? These tools have been successful where applied. ? Management recognizes the need to provide more such tools. ? Computer simulation models and other design tools are used in some major areas of the business. There is evidence that where used, these tools result in reduced design/development cycle time and improved new product quality.SCORE 3: ? Design tools are used in the design/development process in most areas of the business. ? Positive results are clearly evident. ? There is support among management to extend the use of such tools.SCORE 4: ? State of the art puter simulation models are being used for all new designs. ? Significant design/development cycle time reductions have been realized through the use of tools, such as: CAD, CAM and S/M.SCORE 5: ? Computer aided design tools are linked for ease of file transfers. ? Files are automatically updated by a mon data base through an electronic network. ? The use of these sophisticated design tools results in world class new product design cycle time and a petitive edge in bringing new products to market.7 Has a system been established with the supplier for identification and verification of corrective action?Considerations:a. The system includes the use of formal corrective action requests and enables followup on supplier’s corrective actions.b. The system includes a method of preventing reoccurring defects.c. The system includes verification of formalized methods of problem solving by suppliersd. All records pertaining to supplier corrective actions are retained as quality records.Performance Level for Element 7SCORE 1: ? There is no system for supplier identification and verification of corrective action. SCORE 2: ? An informal system exists for assuring identification and verification of supplier corrective actions. ? There is evidence that a few suppliers have provided corrective actions which have been properly identified and verified to be effective. ? A basic procedure has been established, with the participation of some suppliers, for identification and verification of supplier corrective actions. ? The procedure includes the use of formal corrective action requests. ? There is evidence that some suppliers use formalized problem solving methods to determine the root causes of problems.SCORE 3: ? There is a formal system for identification and verification of supplier corrective actions. ? Evidence indicates that most supplier corrective actions are timely and adequate. ? The system provides for verification of the effectiveness of corrective actions. ? All records pertaining to supplier corrective actions are retained as quality records.SCORE 4: ? The system for identification and verification of supplier corrective actions is well designed and has proven to be effective. The system applies to all suppliers. ? There is evidence that the system is successful in reducing the number of problems with supplied products.SCORE 5: ? The organization’s system for supplier corrective action identification and verification is excep