This paper I wrote needs to be edited per the professor’s remarks. Only the sect

This paper I wrote needs to be edited per the professor’s remarks. Only the sections missing need to be included as he will not check the whole paper. The Paper is about Medtronic, a leading medical device company that develops and manufactures various products for clinical therapies
His remarks are as followed
“The paper had a good summary of the company, product, and events. The risk assessment only had 2 hazardous situation and the risk was not estimated based on the class criteria. The analysis in the risk column was good, but just add in low/medium/high based on our class criteria. Review your email for the classes risk critieria so you have the right severity / occurrence / and risk classifications. The FMEA only had 2 failure modes and was not fully developed. Recommend having 10 failure modes that are fully developed. For the FMEA, use a 5 x 5 x 5 or a 10 x 10 x 10 scale. Include a discussion about how you would use rpn to prioritize and select the most important failure modes. The paper had some discussion regarding production and post – production data and was missing the updated risk / benefit analysis. It is alway good to review the assignment and the rubric to be sure you complete all the element in the assignment.”
1) use process maps and HACCP tools.
2) or use Fault Tree Analysis (FTA)
3) which analysis tool is most appropriate to use, given a hazardous product issue.
4)Evaluates the Benefit and Risk. Provides analysis based class material and student’s experience.
5) proposes and discusses how the analysis of FSE could be used to monitor production and post-production information.
6)Identified the 2- 3 FSE to evaluate. • 5 failure modes and causes (at least 1 cause per failure mode) for each FSE (minimum of 10) • Selected controls for each failure mode and cause. •
References to use for class material points
https://www.ich.org/page/quality-guidelines
https://citeseerx.ist.psu.edu/viewdoc/download?doi…
https://www.fda.gov/food/hazard-analysis-critical-…

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