Example of the Risk Template

John Predmore

John Predmore

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I attached a sample of the Risk Template we use. I deleted company-specific details, but I think you can see how this spreadsheet may be used. My full FMEA has one matrix for each of 7 QMS process areas. I deleted all FMEA worksheets except one in this file, leaving Product Delivery Process as representative of all manufacturing companies, and the common failure modes are generically worded. The summary worksheet shows how much improvement we have shown in our QMS Risk profile, as measured by RPN scores, since the original assessment in March 2019. We have done a re-assessment every 6 months (detail deleted from this example). The Risk Yardstick is a baseline for all users to employ a common definition of how severe or how frequent is a 3, or any other score 1-9.
 

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  • QMS-Process Risk Assessment Example.xlsx
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