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Beyond Compliance
Webinar & Podcast Series for Process Manufacturers
Understand SPC Fundamentals
Michael Parent
Michael Parent Consulting Services
Lean and Six Sigma Master Black Belt, MBA
// About SafetyChain
✔Improve Yield
✔Maximize Productivity
✔Ensure Compliance
Plant Management Platform
Casual but Professional Format
✔Ask questions! (Q&A at end)
✔Only panelists are displayed
✔Recording link will be shared
✔Audio issues: use call-in number
Before We Get Started
BEYOND COMPLIANCE
Helpful tips
BEYOND COMPLIANCE
Meet the Speaker - Michael Parent
● Bachelor of Science in Industrial and Operations
Engineering from the University of Michigan
● MBA from William and Mary, in Williamsburg Virginia
● Named a 40 under 40 “Rising Star” by The American
Society for Quality
● Author of The Lean Innovation Cycle: A Multi-Disciplinary
Framework for Designing Value with Lean and Human-
Centered Design (Routledge, 2022).
Michael Parent, MBA
Lean and Six Sigma Master Black Belt
Principal of Michael Parent Consulting Services
BEYOND COMPLIANCE
Objectives
● Define Statistical Process Control (SPC)
○ Understand the math (statistics) behind it
● Apply SPC to process capability
● Understand how to apply control charts to Root Cause Analysis (RCA)
● Improving a system with control charts
Session Overview
What Best Describes How You're Currently Using SPC?
BEYOND COMPLIANCE
What is Statistical Process Control (SPC)
• A way to use data to improve and control systems and processes
• Improving Quality, Reducing defects
• Helps answer Operational Questions:
• Is a hospital ER capable of seeing patients within 1 hr of arrival?
• For every million products we produce, how many are defective?
• What’s the cost?
• By How much does my product vary from unit to unit?
BEYOND COMPLIANCE
1986: Motorola Creates Six Sigma
- a formal methodology to
improve quality by reducing
variation in products and
processes.
Six Sigma is actually a
measurement of Process
Capability.
History of SPC
1920: While at Bell Labs, Walter
Shewart invents control charts as
a way to detect whether or not
sources of variation come from
the process or from external
factors. What is referred to today
as Common Cause vs. Special
Cause variation.
1950s: W. Edwards Deming travels to
Japan as a management consultant.
His efforts greatly affect the
Japanese Economy and instill his 14
quality principles into the culture of
Japanese Manufacturing.
1948-1975: Taiichi Ohno of
Toyota formalizes a system for
in-process quality and
ongoing improvement. The
Toyota Production System will
later be brought to the US
under the umbrella term "Lean"
BEYOND COMPLIANCE
Real Life Examples - Variability is Everywhere
BEYOND COMPLIANCE
Real Life Examples - Variability is Everywhere
BEYOND COMPLIANCE
Real Life Examples Variability is Everywhere
BEYOND COMPLIANCE
The Bell Curve
BEYOND COMPLIANCE
The Bell Curve…continued
Less Disperse
BEYOND COMPLIANCE
Process Capability
Too High
Target
Too Low
BEYOND COMPLIANCE
Measuring Process Capability
• DPMO: How many defects were created per million products?
• σ Level: How many σs fall within limits?
• Cpk & Ppk: A Capability index score.
• Yield %: Within Spec divided by total Produced.
BEYOND COMPLIANCE
Process Capability Example
V
en
t
BEYOND COMPLIANCE
Process Capability Example
Bead Vent:
12 mm
Bead Vent:
7 mm
BEYOND COMPLIANCE
Process Capability Example
Not Centered
Not Capable
Large Outliers
BEYOND COMPLIANCE
Vendor Relationships
Pizza Company contracts vendor. Contract specifies
packs of pepperoni must have 13 slices, +/- 2 slices
BEYOND COMPLIANCE
Intro to Control Charts
BEYOND COMPLIANCE
Special Cause vs. Common Cause
• All processes vary
• There are two sources of variation
• Common Cause: regular variation within the process creating the output
• Factors external to the process affecting the output
• Control charts help us identify and discriminate between the two
BEYOND COMPLIANCE
Special Cause vs. Common Cause
BEYOND COMPLIANCE
Other Control Chart Uses
● Weight per unit (Defects)
● Time between batches (Productivity)
● Defects per 5,000 units (Defects)
● Cold Chain Temperature (Quality Control)
Opinion: What Are the Best Uses of SPC?
BEYOND COMPLIANCE
● What if your data is Pass/Fail?
● Use subgroups to calculate a (P)roportion of defects per group.
● Example:
• 24 turtles
• 3 defects
• P = 0.125 (1/8th)
Types of Control Charts – P Chart
BEYOND COMPLIANCE
Types of Control Charts – P Chart
● Subgroup Size affects our confidence to detect a signal.
● We can become more sensitive to changes in the
process with the more data we observe
BEYOND COMPLIANCE
• In Excel, Control charts are time consuming to create
• In Excel, Control charts are time consuming to update
• Can Become Difficult to Read
Control Charts without Charts
How Many
Signals?
Where?
BEYOND COMPLIANCE
Control Charts without Charts
=Countif(“HIGH”)
We can create signals
without building charts.
● Saves Time
● Get Clear Signals
● Easy to count
signals and perform
calculations
BEYOND COMPLIANCE
Solving Special Cause
● Special cause alerts us to something other than the process.
● It invites us to identify the root cause.
● We use Root Cause Analysis (RCA) tools.
BEYOND COMPLIANCE
Why was my water bill higher than normal?
• I used more water this month
Why?
• A pipe had a small leak
Why?
• The fitting was not tightly sealed
Why?
• The rubber gasket had cracked
Why?
• It was old and worn away
RCA #1 – 5-Whys
COUNTERMEASURES:
1. Replace the rubber gasket
2. Determine how old the gasket was and how it failed.
3. Set up PM plan for all gaskets.
4. Inspect all gaskets in house.
5. Buy spare gaskets.
BEYOND COMPLIANCE
RCA #2 – Fault Tree Analysis (FTA)
BEYOND COMPLIANCE
Systems Improvement #1 – Shift the Mean
● We can increase capability by
shifting the average of our process.
● This is a systems based
improvement. There will be no
smoking gun on “what went wrong”.
BEYOND COMPLIANCE
Systems Improvement #2 – Decrease Variation
● We can increase capability by
decreasing variation in our process.
● This is a systems based
improvement. There will be no
smoking gun on “what went wrong”.
BEYOND COMPLIANCE
Process Capability Example
New Tooling = Systems-
based solution
Shifted
Mean
Decreased
Variation
BEYOND COMPLIANCE
Prioritizing Systems Solutions
Which target is easiest to
improve to get to the
desired state?
General Rule: Improve
Variation First
BEYOND COMPLIANCE
Conclusion
● SPC is an effective technique for understanding and quantifying
current process capability
● By understanding and improving process capability companies can
reduce defects and waste
● Process Control Charts are particularly useful to understand changes
over time and diagnose the root cause of issues
● In particular, common cause and special cause issues require
different approaches toward improvement
Q&A
BEYOND COMPLIANCE
BEYOND COMPLIANCE
Contact the Speaker
● Website: www.sixsigma-consulting.com
● Twitter: @Lean_Innovator
● Linkedin: https://www.linkedin.com/in/parent-michael/
● Book: https://www.amazon.com/Lean-Innovation-
Cycle-Multi-Disciplinary-Human-Centered-
ebook/dp/B09SVQJ98G
● Udemy: https://www.udemy.com/user/michael-
16068/
Michael Parent, MBA
Lean and Six Sigma Master Black Belt
Principal of Michael Parent Consulting Services
More Resources at www.safetychain.com
White Papers & Surveys
Webinars & Videos
Product & Partner Info
Solution Consultation
Friday, April 29, 2022, 9am PT | 12pm ET
Building Accessible Food Safety Training for a Diverse Workforce
safetychain.com/resources/webinars-events/
BEYOND COMPLIANCE

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Understand SPC Fundamentals

  • 1. Beyond Compliance Webinar & Podcast Series for Process Manufacturers Understand SPC Fundamentals Michael Parent Michael Parent Consulting Services Lean and Six Sigma Master Black Belt, MBA
  • 2. // About SafetyChain ✔Improve Yield ✔Maximize Productivity ✔Ensure Compliance Plant Management Platform
  • 3. Casual but Professional Format ✔Ask questions! (Q&A at end) ✔Only panelists are displayed ✔Recording link will be shared ✔Audio issues: use call-in number Before We Get Started BEYOND COMPLIANCE Helpful tips
  • 4. BEYOND COMPLIANCE Meet the Speaker - Michael Parent ● Bachelor of Science in Industrial and Operations Engineering from the University of Michigan ● MBA from William and Mary, in Williamsburg Virginia ● Named a 40 under 40 “Rising Star” by The American Society for Quality ● Author of The Lean Innovation Cycle: A Multi-Disciplinary Framework for Designing Value with Lean and Human- Centered Design (Routledge, 2022). Michael Parent, MBA Lean and Six Sigma Master Black Belt Principal of Michael Parent Consulting Services
  • 5. BEYOND COMPLIANCE Objectives ● Define Statistical Process Control (SPC) ○ Understand the math (statistics) behind it ● Apply SPC to process capability ● Understand how to apply control charts to Root Cause Analysis (RCA) ● Improving a system with control charts Session Overview
  • 6. What Best Describes How You're Currently Using SPC?
  • 7. BEYOND COMPLIANCE What is Statistical Process Control (SPC) • A way to use data to improve and control systems and processes • Improving Quality, Reducing defects • Helps answer Operational Questions: • Is a hospital ER capable of seeing patients within 1 hr of arrival? • For every million products we produce, how many are defective? • What’s the cost? • By How much does my product vary from unit to unit?
  • 8. BEYOND COMPLIANCE 1986: Motorola Creates Six Sigma - a formal methodology to improve quality by reducing variation in products and processes. Six Sigma is actually a measurement of Process Capability. History of SPC 1920: While at Bell Labs, Walter Shewart invents control charts as a way to detect whether or not sources of variation come from the process or from external factors. What is referred to today as Common Cause vs. Special Cause variation. 1950s: W. Edwards Deming travels to Japan as a management consultant. His efforts greatly affect the Japanese Economy and instill his 14 quality principles into the culture of Japanese Manufacturing. 1948-1975: Taiichi Ohno of Toyota formalizes a system for in-process quality and ongoing improvement. The Toyota Production System will later be brought to the US under the umbrella term "Lean"
  • 9. BEYOND COMPLIANCE Real Life Examples - Variability is Everywhere
  • 10. BEYOND COMPLIANCE Real Life Examples - Variability is Everywhere
  • 11. BEYOND COMPLIANCE Real Life Examples Variability is Everywhere
  • 13. BEYOND COMPLIANCE The Bell Curve…continued Less Disperse
  • 15. BEYOND COMPLIANCE Measuring Process Capability • DPMO: How many defects were created per million products? • σ Level: How many σs fall within limits? • Cpk & Ppk: A Capability index score. • Yield %: Within Spec divided by total Produced.
  • 17. BEYOND COMPLIANCE Process Capability Example Bead Vent: 12 mm Bead Vent: 7 mm
  • 18. BEYOND COMPLIANCE Process Capability Example Not Centered Not Capable Large Outliers
  • 19. BEYOND COMPLIANCE Vendor Relationships Pizza Company contracts vendor. Contract specifies packs of pepperoni must have 13 slices, +/- 2 slices
  • 20. BEYOND COMPLIANCE Intro to Control Charts
  • 21. BEYOND COMPLIANCE Special Cause vs. Common Cause • All processes vary • There are two sources of variation • Common Cause: regular variation within the process creating the output • Factors external to the process affecting the output • Control charts help us identify and discriminate between the two
  • 23. BEYOND COMPLIANCE Other Control Chart Uses ● Weight per unit (Defects) ● Time between batches (Productivity) ● Defects per 5,000 units (Defects) ● Cold Chain Temperature (Quality Control)
  • 24. Opinion: What Are the Best Uses of SPC?
  • 25. BEYOND COMPLIANCE ● What if your data is Pass/Fail? ● Use subgroups to calculate a (P)roportion of defects per group. ● Example: • 24 turtles • 3 defects • P = 0.125 (1/8th) Types of Control Charts – P Chart
  • 26. BEYOND COMPLIANCE Types of Control Charts – P Chart ● Subgroup Size affects our confidence to detect a signal. ● We can become more sensitive to changes in the process with the more data we observe
  • 27. BEYOND COMPLIANCE • In Excel, Control charts are time consuming to create • In Excel, Control charts are time consuming to update • Can Become Difficult to Read Control Charts without Charts How Many Signals? Where?
  • 28. BEYOND COMPLIANCE Control Charts without Charts =Countif(“HIGH”) We can create signals without building charts. ● Saves Time ● Get Clear Signals ● Easy to count signals and perform calculations
  • 29. BEYOND COMPLIANCE Solving Special Cause ● Special cause alerts us to something other than the process. ● It invites us to identify the root cause. ● We use Root Cause Analysis (RCA) tools.
  • 30. BEYOND COMPLIANCE Why was my water bill higher than normal? • I used more water this month Why? • A pipe had a small leak Why? • The fitting was not tightly sealed Why? • The rubber gasket had cracked Why? • It was old and worn away RCA #1 – 5-Whys COUNTERMEASURES: 1. Replace the rubber gasket 2. Determine how old the gasket was and how it failed. 3. Set up PM plan for all gaskets. 4. Inspect all gaskets in house. 5. Buy spare gaskets.
  • 31. BEYOND COMPLIANCE RCA #2 – Fault Tree Analysis (FTA)
  • 32. BEYOND COMPLIANCE Systems Improvement #1 – Shift the Mean ● We can increase capability by shifting the average of our process. ● This is a systems based improvement. There will be no smoking gun on “what went wrong”.
  • 33. BEYOND COMPLIANCE Systems Improvement #2 – Decrease Variation ● We can increase capability by decreasing variation in our process. ● This is a systems based improvement. There will be no smoking gun on “what went wrong”.
  • 34. BEYOND COMPLIANCE Process Capability Example New Tooling = Systems- based solution Shifted Mean Decreased Variation
  • 35. BEYOND COMPLIANCE Prioritizing Systems Solutions Which target is easiest to improve to get to the desired state? General Rule: Improve Variation First
  • 36. BEYOND COMPLIANCE Conclusion ● SPC is an effective technique for understanding and quantifying current process capability ● By understanding and improving process capability companies can reduce defects and waste ● Process Control Charts are particularly useful to understand changes over time and diagnose the root cause of issues ● In particular, common cause and special cause issues require different approaches toward improvement
  • 38. BEYOND COMPLIANCE Contact the Speaker ● Website: www.sixsigma-consulting.com ● Twitter: @Lean_Innovator ● Linkedin: https://www.linkedin.com/in/parent-michael/ ● Book: https://www.amazon.com/Lean-Innovation- Cycle-Multi-Disciplinary-Human-Centered- ebook/dp/B09SVQJ98G ● Udemy: https://www.udemy.com/user/michael- 16068/ Michael Parent, MBA Lean and Six Sigma Master Black Belt Principal of Michael Parent Consulting Services
  • 39. More Resources at www.safetychain.com White Papers & Surveys Webinars & Videos Product & Partner Info Solution Consultation Friday, April 29, 2022, 9am PT | 12pm ET Building Accessible Food Safety Training for a Diverse Workforce safetychain.com/resources/webinars-events/ BEYOND COMPLIANCE

Editor's Notes

  1. Map analogy- to get anywhere you have to start with where you are