A 7–10 page paper is required to complete this course. Considered a best practice case study. A major quality or compliance incident was identified and successfully resolved. issue can be linked to a regulation that has been violated, or a major quality system gap or breach.
The attached two pdf files are the outline and background of the paper I completed.Topic Zhejiang Huahai Pharmaceutical https://www.fda.gov/inspections-compliance-enforce…
Problem statement is clear and concise. Regulations violated are included
Magnitude of problem both in terms of impact to patients or customers and to the organization are defined. Size and consequences of the issue/event are
quantified as much as possible.
Identify at least two quality systems tools and apply them by filling them out correctly to determine the reason this problem occurred. Include the completed
tools as a figure or in an appendix. Provide a conclusion you drew from each tool used. State the root cause(s) of the problem.
analyze solution(s) implemented by the organization, if that information is available. If solutions are not provided in the literature, propose the ideal set of solutions that should be implemented to fully address the main reason of the issue/event.
Based on the actions taken by the organization, do you think the problem re-occur? Why or why not?
If you proposed solutions to implement, will they be enough to prevent the problem from happening again?
Why or why not?
Ideally, the problem should be caught before impacting patients. What measures could be put in place to catch the problem before it leaves the facility? How will the
solution(s) be monitored for effectiveness? If you have information about what an organization has done to monitor the situation, so they catch it sooner, is it
enough or not? If you don’t assess if the organization can do enough to ensure the issue will be detected earlier.
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