process variation and continuous improvements
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TRANSCRIPT
CONTINUOUS IMPROVEMENT
Tools and Techniques
Tarek Elneil Contact Information
September 12Tarek Elneil
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email: [email protected] Tel: 805-876-4356
Main Points
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What is a Process Process Components &Characteristics Process Variations and Causes Process Improvement Methodologies
04/10/2023
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.
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http://www.foodnetwork.com/recipes/paula-deen/fruit-pizza-recipe/index.html
Ingredients Directions
04/10/2023
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.
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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
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Process Variation
May 2011
Personnel (Man)
Measurement
Machine
Environmental (Mother Nature)
Material
Method
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
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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 + 1s 95% within + 2s 99.7% within + 3s
2012
1s2s3s
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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Investigating (Special Cause)
May 2011
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Nonconformance Improvement Systems
September 2012Tarek ElneilNonconformance
Improvement
SCAR CAPACustomer Complaint
s
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
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?
Problem Evaluation
It help to answer 3 questions1. 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
Nonconformance Evaluation
Safety FreqCostRevenue Env.
Start
Yes
No No No StopNoNo
Yes Yes Yes Yes
Assemble TeamInvestigate
Root Cause(s)Implement CA’s Control Phase
No
Result Acceptable?
Share
Yes
No
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?
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Nonconformance Investigation
Y
LCL UCL
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
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
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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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?
Problem AnalysisEvaluate 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?
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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The Product Components
Cartridge
Liner /Septum
Aluminum shell
Needle
Roll Grove
Plunger
DrugAluminum Cap
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Sterile Environment Barrier
Feeding
Filing
Sealing Needle Assembly
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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, Product Code AB84T, LotNo.Ax1234
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
Problem AnalysisEvaluate 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?
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 verifyO - FACT supports CAUSE BLANK- Need more dataX - FACT contradicts CAUSE A - Assumptions made; need data to verifyO - 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
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
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Uses facts to narrow the search to identify and eliminate the root cause Present
RCA Methodology
May 2011
Evidence!
Evidence!
CAUSES
CAUSES
CAUSES
Past
Why?
Why?
Why?
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
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
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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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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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!
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Solution Matrix
Develop Solution Matrix Challenge all solution ideas in the list
against criteria for viable solutions Solutions Criteria Meet Our
GoalsEffective Comply Within
ControlS1 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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Six Sigma, RCA, Problem Analysis (K.T.)
July 2012
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)
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Nonconformance Investigation Failures
July 2012
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
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Questions?