Pharmaceutical Engineering: Total Quality Management II

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Questions and Answers

What is the main focus of Total Quality Management (TQM)?

Reducing variation in every process of the pharmaceutical design and manufacturing enterprise (correct)
Minimizing employee efforts to cut costs
Maximizing profits by any means necessary
Ignoring customer requirements to save money

What is one of the key elements of Quality Assurance in TQM?

Increasing defects to maintain high standards
Setting the standards and running tests (correct)
Avoiding quality engineering practices
Ignoring the need for quality control

Which approach is aimed at improving process performance in Total Quality Management?

Maximizing variation in every process
Risk Management
Lean Manufacturing (correct)
Ignoring customer requirements

Who are the main targets of the outputs of Total Quality Management processes?

External and internal customers (A) Signup and view all the answers

What does Six Sigma (6σ) aim to reduce in every process of a manufacturing enterprise?

Variation (A) Signup and view all the answers

What is the ultimate goal of Total Quality Management?

To continually satisfy customer requirements at the lowest cost (D) Signup and view all the answers

What is the primary goal of Six Sigma?

To achieve a level of quality that is nearly perfect with only 3.4 defects per million opportunities (DPMO) (A) Signup and view all the answers

What is the structured approach used in Six Sigma to identify and eliminate causes of variation and improve processes?

DMAIC (Define, Measure, Analyze, Improve, Control) (A) Signup and view all the answers

What does the term 'Hidden Factories' refer to in the context of Six Sigma?

The part of the process where defective outputs are reworked or scrapped (C) Signup and view all the answers

What happens to defect costs as sigma level increases in a process?

Defect costs can be shifted to profitable generating activities (C) Signup and view all the answers

What does 'Six Sigma' symbolize in the context of statistics?

A single standard deviation from the mean (D) Signup and view all the answers

Why must the initiatives of Six Sigma be introduced by high-level management?

Because it requires experts to deploy and teach employees on the used tools of Six Sigma (C) Signup and view all the answers

What does an increase in sigma level imply in terms of process variation?

Increase in sigma level means decrease in process variation (C) Signup and view all the answers

What is the etymology of 'Six Sigma' based on?

"Sigma", a statistical term for measuring process deviation from the process mean or target (C) Signup and view all the answers

"Six Sigma" comes from which statistical concept?

"Sigma", a statistical term for measuring process deviation from the process mean or target (A) Signup and view all the answers

What does it mean if a process has Six Sigma level?

The defect rate is classified as 'extremely low' (C) Signup and view all the answers

Study Notes

Total Quality Management (TQM)

The main focus of Total Quality Management (TQM) is to achieve customer satisfaction by improving product quality and process performance.

Quality Assurance in TQM

One of the key elements of Quality Assurance in TQM is to ensure that processes are in place to prevent defects and improve overall quality.

Process Improvement in TQM

The Continuous Improvement approach is aimed at improving process performance in Total Quality Management.

Targets of TQM Outputs

The main targets of the outputs of Total Quality Management processes are customers, both internal and external.

Six Sigma (6σ)

Six Sigma aims to reduce defects in every process of a manufacturing enterprise.
The ultimate goal of Total Quality Management is to achieve near-zero defects.

Goals of Six Sigma

The primary goal of Six Sigma is to improve the quality of process outputs by identifying and eliminating defects.

Structured Approach in Six Sigma

The structured approach used in Six Sigma to identify and eliminate causes of variation and improve processes is DMAIC (Define, Measure, Analyze, Improve, Control).

'Hidden Factories'

The term 'Hidden Factories' refers to the capacity wasted due to defects and rework in a process.

Defect Costs and Sigma Level

As sigma level increases in a process, defect costs decrease.

'Six Sigma' Symbolism

The term 'Six Sigma' symbolizes a level of quality that is 99.9997% defect-free.

Introduction of Six Sigma Initiatives

The initiatives of Six Sigma must be introduced by high-level management to ensure organization-wide adoption and commitment.

Sigma Level and Process Variation

An increase in sigma level implies a reduction in process variation.

Etymology of 'Six Sigma'

The term 'Six Sigma' is based on the statistical concept of standard deviations from the mean.

Six Sigma Level

If a process has Six Sigma level, it means that the process has only 3.4 defects per million opportunities.

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Description

This quiz covers the fundamentals of Six Sigma (6σ) as part of the Pharmaceutical Engineering and Biotechnology course. Topics include recalling Total Quality Management (TQM), understanding the background, framework, methodology, and examples of Six Sigma, along with exercise questions for practice.