#408 – LEVERAGING PROCESS FAILURE MODE & EFFECTS ANALYSIS (PFMEA) – DUKE OKES

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 The primary core use of a pFMEA is to analyze a new process to identify potential failures within the process and evaluate the planned prevention & detection controls to determine the degree of risk (see Table 1). 

 Unfortunately, once the FMEA is complete the document often just sits “on the shelf” until the next major revision to the process, when it is hopefully used to analyze the planned changes. There are, however, many other potential uses for the FMEA that can leverage the information gained from the analysis. Here are five examples:  Continue reading

#402 – IMPORTANCE OF CONTEXT CHANGES IN ROOT CAUSE ANALYSIS – DUKE OKES

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One of the more valuable changes in the ISO 9001:2015 edition was the introduction of the phrase Context of the Organization. Having organizations evaluate context when designing a quality management system (QMS) meant they could better justify the degree of rigor of their processes and controls. Continue reading