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For most organizations, having a purpose-built risk management tool is just a dream (and/or completely unnecessary). In most cases you would then have to use a spreadsheet software such as MS Excel or Google Sheets or similar to document your risk analysis, evaluation and control. With the use of formulas and some other functions of Excel you can save a lot of time and reduce the risk of error. In the video below I will show you some of the tweaks that I always do with the spreadsheet I am working with for risk analysis.
Automate risk evaluation
In the video below you will see how you can automate your risk evaluation. Saves a lot of time!
Remember that when implementing this functionality in MS Excel spreadsheets, you may be required to validate the spreadsheet.
If you want to try the function out for yourself, you can download a free hazard traceability matrix template that includes the formatting described in the video.
Let me know how it works in the comment field or by contacting me!
Get instant access to our online Risk Management course on ISO 14971:2019 right here. In 10 hours, you can learn more about how to estimate risk and perform risk management. This course is taken by both competent authorities, notified bodies and medical device manufacturers and distributors.
Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.
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