In medical device manufacturing and in pharmaceutical production, strict traceability is mandated by regulation. What type of actions may draw upon this requirement?

I: Fulfillment of an unconditional guarantee

II: Replacement of failed product under warranty

III: A product recall that is needed to safeguard product users

IV: Analysis of problems leads to process improvement

It is the team sponsor’s responsibility to:

A shop floor technician has recorded the following data:

Machine 1 has an average of 12.6 inches for 10 samples.

Machine 2 has an average of 12.5 inches for 20 samples.

The samples taken from these two machines can be compared in which of the following ways, if any?

The most important reason for management to review the company’s quality system is to ensure that:

A company is considering converting a portion of its existing manufacturing space to storage in order to reduce dependence on an external warehouse. The following information reflects the results of a cost-benefit analysis.

Building construction changes$15,000

Reduced transportation$25,000 -

Manufacturing layout changes$36,000

Increased internal storage capacity$48,000

What is the total dollar benefit to be expected when the project is completed?