As each failure mode is addressed, the controls established are documented. Addressing the individual failure modes will require the use of many different statistical tools.
Failures or nonconformities occur because of errors made and because of excessive variation.
Finally, in the event of potential errors, challenge tests should be performed to demonstrate that mistake proofing methods designed to detect or prevent such errors are working.For measurable characteristics like wire length, fill volume, and seal strength, the goal is to optimize the average and reduce the variation. Stable processes produce a consistent level of performance. It involves collecting samples over a period of time.Optimization of the average may mean to center the process as in the case of fill volumes, to maximize the average as is the case with seal strengths, or to minimize the average as is the case with harmful emissions. The average and standard deviation of each time period is estimated and these estimates plotted in the form of a control chart.Products (HOME) Books Software Courses Consulting Expertise Acceptance Sampling Process Validation CAPAs and Trending of Quality Data FMEA Measurement Systems Analysis Spec Setting, Tolerance Analysis and Robust Design General Statistics Statistical Process Control Design of Experiments Six Sigma Store What's New Technical Library FAQ By entering your e-mail address and clicking the Subscribe button, you will automatically be added to our mailing list.You will receive an e-mail when new versions of our software or books are available as well as other significant announcements. There are many statistical tools that can be used as part of validation.Reducing variation and proper targeting of a process requires identifying the key input variables and establishing controls on these inputs to ensure that the outputs conform to requirements.