Applying Lean Sigma Into Validation

Applying Lean Sigma into Validation Thomas J Cornish PMP

Introduction / Agenda ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

What is Six Sigma? Terminology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Benefits of Six Sigma and Lean Sigma—Business Gains ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Basic Statistics ,[object Object],[object Object],[object Object],[object Object],Mean

Basic Statistics NORMAL DISTRIBUTION Approximately 99.7% of the data (or virtually all) are between +/- 3 standard deviations from the mean when data is normally distributed. Mean -1s +1s 99.7% -2s +2s -3s +3s

Process Capability LSL USL Poor Process Capability! Off Center, Spread Too Wide LSL USL Fair Process Capability! Off Center, Tight Spread LSL USL Fair Process Capability! Centered, Spread Too Wide LSL USL THE MISSION: Excellent Process Capability! Centered, Tight Spread Centering and Spread are critical components of Process Capability!

Process Capability Process Capability Statistics The formula: USL - X Cpk-upper = 3  Cpk-overall = X – LSL min {Cpk-up, Cpk-lo} Cpk-lower = 3  *Note: we are working with continuous data only when computing a Cpk

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],It is envisioned that the other process improvement techniques will be integrated with our use of the Six Sigma approach Why Six Sigma ? Control Define Improve Measure Analyze

Deviation and Six Sigma Methods ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

What is Lean Sigma? ,[object Object],[object Object],[object Object],[object Object]

Lean Sigma Customer focus Culture Values and Mindset Capability Lean Sigma

What is the difference between Lean Sigma and Six Sigma? ,[object Object],[object Object],[object Object],[object Object]

What is the difference between Lean Sigma and Six Sigma? ,[object Object],[object Object],[object Object]

Process Terminology ,[object Object],[object Object],[object Object],[object Object],[object Object]

Process Terminology ,[object Object],[object Object]

Examples of where Lean Sigma can be used ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Applying Lean Sigma ,[object Object],[object Object],[object Object],[object Object],[object Object]

Applying Lean Sigma ,[object Object],[object Object],[object Object],[object Object]

Where to begin? ,[object Object],[object Object]

Define ,[object Object],[object Object],[object Object]

Measure ,[object Object],[object Object]

Analyze ,[object Object],[object Object],[object Object]

Improve ,[object Object],[object Object],[object Object],[object Object]

Control ,[object Object],[object Object]

Where to use in Validation? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Where to use in Validation? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Example of using Lean Sigma into Validation ,[object Object],[object Object],[object Object]

Example of using Lean Sigma into Validation ,[object Object],[object Object],[object Object],[object Object]

Critical Lean Sigma Metrics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Critical Lean Sigma Metrics ,[object Object],[object Object],[object Object],[object Object]

Reference Material ,[object Object],[object Object],[object Object]

Case Study ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Applying Lean Sigma Into Validation

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