Topic: Sterility Issues Ultrasound Gel
Project: All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination.
Describe one monitoring or listening system change to mitigate risk on the most probable root cause(s) to ensure the problem would be detected sooner (ideally, before it impacts a customer/participant/stakeholder). Some examples are a new metric or sensor or perhaps a new procedure to track defects or complaints. The next capstone on Control will delve more deeply into this topic but you need to start to think about it here.
- Fully describe 3 examples of the changes that you would implement, such as policies and procedures you have created or training you have conducted.
- Create ONE of the 3 examples to demonstrate change and improvement. Include this in an appendix.
- Create a plan of action for addressing the most probable root cause(s). Some of your actions in the plan may be corrections or corrective actions.
- Develop a communication plan to include communication internally and externally and respond to the government agencies responsible for the enforcement action.
- Describe how you would implement correction(s) and corrective action plans. What actions would you take first, second, third and so on? Start to think about how you would be sure your solutions are working.
- 6-8 pages
