Pharmaceutical Engineering: Total Quality Management II

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.