Part 3 Measure/Analyze: Topic: Sterility Issues Ultrasound Gel

Part 3 Measure/Analyze:

Topic: Sterility Issues Ultrasound Gel

Project: All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination: https://public4.pagefreezer.com/browse/FDA/12-02-2…

1)Create a Plan of Action to analyze the problem in your regulatory compliance issue. 

2)Your Plan of Action is simply stating the steps you will follow to analyze and determine the root cause of the problem at hand.? Your plan should state which quality tools apply most directly to your problem.

3)Some examples of commonly used tools include:? Fishbone Diagram, the 5 Whys analysis,Failure Mode and Effects Analysis (FMEA).

4) Create 3 quality tools using information about their scenario.? Include the filled-out quality tools in the Appendix of your paper.???Analyze the tools and draw conclusions

5) Use your research from the literature about similar types of problems and how they were solved to support conclusions of the root cause you found. The most probable root cause that led to the contamination of the ultrasound gels was inadequate or ineffective procedures being employed during product testing

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