When a nonconformance occurs because of an error, mistake proofing methods should be used. Obtaining a process that consistently conforms to requirements requires a balanced approach using both mistake proofing and variation reduction tools. Addressing the individual failure modes will require the use of many different statistical tools.įailures or nonconformities occur because of errors made and because of excessive variation. As each failure mode is addressed, the controls established are documented.
Where potential risks exist, the FMEA can be used to document which failure modes have been addressed and which still need to be addressed.
An FMEA involves listing out the potential problems or failure modes and evaluating their risk in terms of their severity, likelihood of occurring and ease of detection. One tool that is particularly useful in organizing the overall validation effort is a failure modes and effects analysis (FMEA) or a closely related fault tree analysis (FTA). Each tool appearing in bold is further described in Section 4. This section describes the many contributions that statistical tools can make to validation. It requires that you first obtain a process that can consistently conform to requirements and then that you run studies demonstrating that this is the case. Validation requires documented evidence that a process consistently conforms to requirements. Each of these tools will be summarized and their application in validation described. Control charts, capability studies, designed experiments, tolerance analysis, robust design methods, failure modes and effects analysis, sampling plans, and mistake proofing are but a few. There are many statistical tools that can be used as part of validation.
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