Chapter 23: Quality Management

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How do internal assessments differ from compliance inspections?

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How do internal assessments differ from compliance inspections?

Internal assessments are more frequent than compliance inspections

What department evaluates and certifies employee credentials and determines the literacy of the employee?

Human resources

Employee training takes place

after hiring and after implementing new procedures

What is a function of the quality committee or quality control?

To se priorities for quality improvements

What is the main purpose of linking Current Good Manufacturing Practices (CGMPs) to process control?

To build quality into the manufacturing process from the beginning to the end

A physician complains that she has not receivied a test report from the blood bank. The remedial action is to:

prepare a copy of the result for the physician

When a new assay is implemented, what measure is taken to determine equivalency?

Lot to lot testing of new and old lot numbers of reagent

Which of the following is not regarded as an instrument?

Which of the following might lead to unacceptable quality control results?

All of the above

Which of the following is an example of an external customer?