1. CONTINUOUS
IMPROVEMENT
Tools and Techniques

2. Tarek Elneil Contact Information
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 email: telneil@msn.com
 Tel: 805-876-4356

3. Main Points
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 What is a Process
 Process Components &Characteristics
 Process Variations and Causes
 Process Improvement Methodologies

4. Fruit Pizza Recipe
 Pizza Dough:
 1 package store bought sugar cookie dough
 Toppings:
 8 ounces softened cream cheese
 1 cup confectioners' sugar
 1 large peach, sliced
 1 large green apple, sliced
 1 large orange, sectioned
 1/2 pint fresh strawberries, sliced
 6 ounces fresh blueberries
 6 ounces fresh raspberries
 1/2 cup white chocolate chips, melted
 1/2 cup chocolate syrup
 Preheat oven to 350 degrees F.
 Flatten cookie dough onto a 6-inch
pizza pan. Bake until firm to
touch, about 11 to 15 minutes.
 Cool. In a medium bowl, blend cream
cheese and sugar.
 Spread the baked cookie with the
cream cheese mixture and decorate
with sliced fruit.
 In a small bowl, combine melted
white chocolate with chocolate syrup.
Top the pizza with remaining berries
and chocolate mixture. Slice and
serve immediately.
5/20/2013
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http://www.foodnetwork.com/recipes/paula-deen/fruit-pizza-recipe/index.html
Ingredients Directions

5. Process Structure
 Pizza Dough:
 1 package store bought sugar cookie dough
 Toppings:
 8 ounces softened cream cheese
 1 cup confectioners' sugar
 1 large peach, sliced
 1 large green apple, sliced
 1 large orange, sectioned
 1/2 pint fresh strawberries, sliced
 6 ounces fresh blueberries
 6 ounces fresh raspberries
 1/2 cup white chocolate chips, melted
 1/2 cup chocolate syrup
 Preheat oven to 350 degrees F.
 Flatten cookie dough onto a 6-inch
pizza pan. Bake until firm to
touch, about 11 to 15 minutes.
 Cool. In a medium bowl, blend cream
cheese and sugar.
 Spread the baked cookie with the
cream cheese mixture and decorate
with sliced fruit.
 In a small bowl, combine melted
white chocolate with chocolate syrup.
Top the pizza with remaining berries
and chocolate mixture. Slice and
serve immediately.
5/20/2013
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http://www.foodnetwork.com/recipes/paula-deen/fruit-pizza-recipe/index.html
Input : Bill Of Material (BOM) Output : Master Batch Record
Machine
Measurement
Environment
Material
Chef
Method

6. Process Variation
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Measurement
Machine
Environmental
(Mother Nature)
Material
Method

7. Types of Process Variation
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 Variations in process input cause the variations in
the process output (Products)
 There are three basic kinds of variation:
 Common cause variation: is variation inherent to the
process. It is due to the interface of the different
components of the process input
 Structural variation: is variation due to differences
among parallel parts of the process
 Special (Assignable) cause variation: is variation due to
sources outside the process, due to changes in the
process input

8. Common Variation
 Not all parts are
created equal
 Any population under
control follows the
Normal Curve
characteristics:
 Probability of the
population variation
from the Mean
 68 % within + 1
 within + 2
 within + 3
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2
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9. Process Improvements
 Reduce the process
common cause
variation throughout
incremental
improvements steps to
identify, and eliminate
the causes of defects
(errors) and minimizing
process variability
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10. Investigating (Special Cause)
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11. Nonconformance Improvement Systems
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Nonconformance
Improvement
SCAR CAPA
Customer
Complaints

12. Major Steps of Quality Investigation
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 Define the problem
 Evaluate the failure
 Failure risk assessment
 Investigate failure causes
 Select and implement effective solutions
 Ensure the solution effectiveness

13. Problem Definition’s Elements
Define the process input (X) and desired output (Y)
qualitatively and quantitatively
 What: Primary Effect
 What object (or group of objects) has the failure?
 What failure type does it have?
 What do we see, hear, feel, taste, or smell that tells us there
is a failure?
 When: Relative Time of the Primary Effect
 Where: Relative Location in System, Facility, or Component
 Significance: Why you are working on this problem?

14. Problem Evaluation
It help to answer 3 questions
1. Should we continue with the investigation?
2. How much time should we spend on the
investigation?
3. How much resources (people and money) should we
utilize to investigate and solve the problem?
 Example of significance statement:
 Potential loss of $1500 worth of Raw Materials
 Twice this month
 2 weeks delay in customer order

15. Nonconformance Evaluation
Safety FreqCostRevenue Env.
Start
Yes
No No No StopNoNo
Yes Yes Yes Yes
Assemble Team
Investigate
Root Cause(s)
Implement CA’s Control Phase
No
Result Acceptable?
Share
Yes
No

16. Risk Assessment
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Risk assessment attempts to answer the following
fundamental questions:
 what can happen and why (by risk identification)?
 what are the consequences?
 what is the probability of their future occurrence?
 are there any factors that mitigate the consequence
of the risk or that reduce the probability of the risk?

17. Nonconformance Investigation
Y
LCL UCL
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18. Nonconformance Investigation
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 Nonconformance should be investigated when
 Identified Cause have exceeded the expected
frequency limits
 Special (Assignable )Cause has unexpectedly occurred
Which have significant impact on the
product, safety, cost or any established criteria

19. Nonconformance Investigation
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 Kepner Trego: investigate the changes that
probably caused the failure.
 Root Cause Analysis: investigate the actions and
condition that caused the failure

20. Kepner Trego Methodology
 Problem analysis: Corrective Action
 Things were OK; they’re not now. What’s changed?
 Something distinguishes what is a problem and what is not.
 Who was involved? Who was not?
 Why was it important? Why is it unimportant?
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21. Problem Analysis - When
Is Is Not
 When was the deviation
observed first (clock and
calendar time)?
 How many objects have the
deviation?
 What is the size of a single
deviation?
 How many deviations are
on each object?
 When else could the
deviation have been
observed first, but was not?
 How many objects could have
the deviation, but don’t?
 What other size could a
deviation be, but isn’t?
 How many deviations could
there be on each object, but
are not?

22. Problem Analysis
Evaluate Possible Causes
 Examine possible causes against the IS and IS NOT
specification
 explain both the IS and IS NOT information?
 What assumptions have to be made?
 Determine the most probable cause
 Which possible cause best explains the IS and IS NOT
information?
 Which possible cause has the fewest, simplest, and most
reasonable assumptions?

23. Real Case Study
 On 10/6 the MQ (Manufacturing Quality) light test
audit rejected a segment of 12,422 units for a bad
seal during the second light test audit in the CPM line.
 What: Light Test Audit
 When: 10/6
 Where: CPM line
 Significance: 12,422 units were rejected
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24. The Product Components
Cartridge
Liner /Septum
Aluminum shell
Needle
Roll Grove
Plunger
DrugAluminum Cap
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25. Sterile Environment
Barrier
Feeding
Filing
Sealing Needle
Assembly
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26. Kepner Trego Investigation
 Is
 It was in CPM (Cartridge
Processing Machine) Line
 Product A4D
 Failed Light Test
 Leaking Cap
 A1st and A2nd Shift
 Is Not
 Line 1,2 or 3
 Product B1C
 Sterility
 Labeling
 B1 and B2 Shift
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VIS-Seal
Deficiencies, Pr
oduct Code
AB84T, LotNo.A
x1234
ENVIRONMENT
MEASURES
METHODS MATERIALS
MACHINE PEOPLE
N/A
Carpujects in disarray at accumulation
area
Poor lighting for inspection
tests
Distractive environment for
personnel
N/A Batch records consistent
Consecutive inspections by same
personnel
MQ Audit AQL correct
QES not set correctly for alert
limits
SOPs clear?
Capper parts worn
out
Bad plungers
Bad seal caps
Bad glass vials
Capper not spinning at correct
rpm
Lack of procedural understanding
Human error
Personnel error
Training current
Lack of Quality oversight
Plungers not set correctly
Capper pivots arms
defective
Worn capper parts
Cap seal set up not
correct
Seal crimper not set
correctly
N/A
N/A
N/A
N/A
N/A

28. Problem Analysis
Evaluate Possible Causes
 Test possible causes against the facts, use Contradiction Matrix to
sort out the facts and the causes
 The facts from the IS and IS NOT
 The causes from the Fishbone diagram
 Determine the most probable cause
 Which possible cause best explains the IS and IS NOT
information?
 Which possible cause has the fewest, simplest, and most
reasonable assumptions?

29. Contradiction Matrix
Why
 To determine relationships between facts
obtained in the Define Phase and the likely
causes of a problem obtained during the
Measure Phase of a problem solving effort.
 Allows us to focus on the most likely causes of
the problem.
 Effective tool for sorting the few likely causes
from many possible causes.
What
 A matrix that compares the likely
causes, obtained during a brainstorming
session, in the left column with the facts of a
problem in the upper row.
How
 Complete the IS/IS NOT and Distinction &
Changes Matrices along with a timeline of
process changes.
 Prepare a Cause & Effect diagram during the
Measure Phase of the problem solving process.
 Conduct a Change Point Analysis (CPA) of
existing process output data, and note any
significant changes.
 Construct the Contradiction Matrix and fill in all
cells where know information exists. Leave cells
blank where unknown information exists. Place
an “A” in cells where assumptions for a
contradiction can be made.
 Strike any rows where an obvious contradiction
exists.
X - FACT contradicts CAUSE A - Assumptions made; need data to verify
O - FACT supports CAUSE BLANK- Need more data
X - FACT contradicts CAUSE A - Assumptions made; need data to verify
O - FACT supports CAUSE BLANK- Need more data
FACTS
CAUSES
#1 #2 #3 #4 #5
A X X X
B O O O O
C X X
D O A

30. What is Root Cause Analysis (RCA)?
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 Root Cause is the fundamental breakdown or failure
of a process which, when resolved, prevents a
recurrence of the nonconformance
 Root Cause Analysis is a systematic approach to
investigate, identify and eliminate the true root
causes of the process failure

31. Uses facts to narrow the search to
identify and eliminate the root cause
Present
RCA Methodology
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Evidence!
Evidence!
CAUSES
CAUSES
CAUSES
Past
Why?
Why?
Why?

32. How to Use RCA
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 Investigate an incident or series of incidents
 Attempt to understand the underlying causes of the
incident(s)
 Generate effective corrective actions to prevent or
mitigate incident(s) reoccurrence

33. Root Cause Analysis Principals
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 Symptoms = Effects: are the signs or results of a
failure but not the root cause
 Causes levels:
 First level causes: the direct lead to a problem
 High level causes: is called the root cause
 Cause and Effect Roles
 Causes and Effects are the same thing
 Causes and Effects are part of an infinite continuum of
causes
 Each effect has at least two causes; Action and Condition
 effect & causes exists at the same point in time and space

34. Solution Criteria
 Solution Selection Criteria
 Prevent recurrence
 Comply with requirements
 Be within the span of
control, or sphere of
influence
 Does not create other
problems
 Meet organizational goals
and objectives
 Will save money in the
long run (cost less to
implement than the
problem reoccurrence)
Span
of
Control
Outside of Influence
Sphere of Influence
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35. Corrective Actions
 Recommended
 Evaluate the feasibility for using an automatic visual system to
identify and remove the non-conformed units
 Reduce the MQ Audit segment size
 Review the component specifications which are critical to
manufacturing
 A vendor qualifications program should be evaluated
 Implemented
 Management was satisfied with the Supplier corrective
actions, and decided no more corrective actions are required
 No effectiveness check is needed because there is no corrective
action
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36. Previous Failure Investigation
Corrective Actions
 A CAD (Communication Awareness Discussion)
session was conducted with all CPM line personnel
for failing to identify a possible unit closure defect.
 Personnel were reminded of the need to pay more
attention to detail!
May 2011
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37. Solution Matrix
 Develop Solution Matrix
 Challenge all solution ideas in the list against criteria
for viable solutions
Solutions Criteria Meet Our
Goals
Effective Comply Within
Control
S1 Y N N N
S2 Y Y Y Y
S3 N Y Y Y
S4 Y Y Y N
S5 N N N N
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38. Six Sigma, RCA, Problem Analysis (K.T.)
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Function Six Sigma RCA Problem Analysis
Use •Proactive : Reduce
process variation
•Reactive: Identify,
reduce or eliminate
root causes
•Reactive
Phases •Define
•Measure
•Analyze
•Improve
•Control
•Problem Definition
•Risk Assessment
•Analyze
•Corrective Action
•Effectiveness
•Problem Definition
•Identify possible
causes
•Evaluate possible
causes (Hypothesis)
• Confirm true cause
Definition
Tools
Input Output, Pareto
Chart , Flowchart
What, When, Where,
Significance
Is, Is Not Analysis
Analysis Tools Fishbone Diagram,
FMEA, 5 “Whys”
Identify the Causes
Actions and Conditions
Contradiction Matrix
Solution
Selection
Selection Matrix,
Force Field Analysis,
Brainstorming
Eliminate root cause
conditions
Decision Analysis
(DA)

39. Nonconformance Investigation Failures
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Any organization has two choices to treat their nonconformance. They can
choose between treating the symptom, or eliminating the root causes.
Approach Treating Symptom Eliminating Root Causes
Cause Errors are often a result of worker
carelessness
Errors are the result of defects in the
system. People are only part of the
process
Corrective Actions train and motivate workers to be
more careful
need to find out why this is
happening, and implement mistake
proofs so it won’t happen again
Justification don’t have the time or resources to
really get to the bottom of this
problem
failure to eliminate the root causes
will results in the reappearance of
the same problem but in different
forms

40. September 2012Tarek Elneil40
Questions?