Develop rpn calculation for raw material supplier change

Reference no: EM133431750 , Length: 2 Pages

Assignment:

Develop the RPN calculation for the raw material supplier change (i.e., B). Assess and create a product severity, occurrence, and detection scores.

• Create an assessment of new raw material supplier and implementation into quality system. Include additional review that may be needed due to their recent history of ingredient contamination issue with potential to cause public health concerns, for another manufacturer.

• Apply general risk management process and develop a cause-and-effect assessment, as applicable for all options (two options and additional if added for contract manufacturing).

2 Page

• Calculate and present the decision path for both options and how the limited supply of raw materials and estimate of potential 40,000 I.V., production meets as best strategy for the two options and market demands of 48,000 I.V. How should the deficit of 8,000 I.V. be justified?

• Provide a comparative of both options strategies and the decision path to the best and final decision.

Reference no: EM133431750

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