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Public Health Quality Management Systems in Pharmaceutical Products Paper

Public Health Quality Management Systems in Pharmaceutical Products Paper

Description

Consider appropriate elements of this course into your process and proposal including literature research. In a 6-8 page paper, detail the QMS elements and the integration of the risk management process including the rationale that support your decisions.

Consider, at minimum:

Description of industry, product use, type of products, size, etc. Description of specific product / process problems to be addressed by your proposal. Description of the impact to customer / patient and business.(industry must be in Healthcare)

  • QMS integration (identify the QMS elements that you will focus on for the integration and why these element were selected based on the issues identified) – minimum of 3 elements.
  • Integration of the risk management process, tools, methods, etc. into each QMS element (discuss how risk management tools will be used and integrated into each QMS element).
  • Top Management buy-in and involvement (what is their role and responsibility?)
  • Implementation, training, and sustainability (how will you implement the process and ensure the sustainability of the process? resources, timing,)
  • Metrics and monitoring of effectiveness (what type of metrics will be tracked to ensure that the process is effective and expected outcomes in 2yrs and 5 yrs.)
  • You might have 2 pages summarizing your company and risk assessment…and the balance on the QMS…and your proposal to management.
  • For your paper you don’t need to include your complete risk assessment in your paper. You could reference your analysis and summarize the key findings but you don’t need to make your risky business + the FMEA the start of you paper. If you look at the points in the rubric….most of the paper should be about linking the top failures to the 3 QMS elements and your proposal for improving those processes by implementing risk management tools.
  • Describe how risk management integrates into the Quality Management System.
  • Analyze how risk management is applied in each element of the Quality Management System.
  • Conduct FMEA using template https://docs.google.com/spreadsheets/d/1k0eOhmLUvh…

Summarize your process, proposal, and rationale in a 10 minute (maximum time) video presentation. Be prepared to answer questions and defend your choices.

Things that can be used in the paper discussed in class have learned about the requirements for completing a risk assessment and the risk management process requirements.

  • Fault Tree Analysis
  • Hazard Analysis Critical Control Point (HACCP)

References to use for the Course MRSC 435, Risk Management and Decision Making

https://www.ich.org/page/quality-guidelines

https://asq.org/quality-resources/fmea

https://www.fda.gov/food/hazard-analysis-critical-…

https://asq.org/quality-resources/iso-9000

https://www.fda.gov/media/84831/download

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