process variation and continuous improvements

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CONTINUOUS IMPROVEMENT Tools and Techniques

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Page 1: Process variation and continuous improvements

CONTINUOUS IMPROVEMENT

Tools and Techniques

Page 2: Process variation and continuous improvements

Tarek Elneil Contact Information

September 12Tarek Elneil

2

email: [email protected] Tel: 805-876-4356

Page 3: Process variation and continuous improvements

Main Points

September 12Tarek Elneil

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What is a Process Process Components &Characteristics Process Variations and Causes Process Improvement Methodologies

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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

Page 5: Process variation and continuous improvements

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.

5

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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Tarek Elneil

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Process Variation

May 2011

Personnel (Man)

Measurement

Machine

Environmental (Mother Nature)

Material

Method

Page 7: Process variation and continuous improvements

Types of Process Variation

Tarek Elneil

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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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Tarek Elneil

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

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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

September 2012

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Tarek Elneil

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Investigating (Special Cause)

May 2011

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Nonconformance Improvement Systems

September 2012Tarek ElneilNonconformance

Improvement

SCAR CAPACustomer Complaint

s

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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

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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?

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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

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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

Page 16: Process variation and continuous improvements

Risk Assessment

September 2012Tarek Elneil

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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

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Nonconformance Investigation

September 2012Tarek Elneil

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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

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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

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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?

September 2012

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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?

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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?

Page 23: Process variation and continuous improvements

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

May 2011

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Page 24: Process variation and continuous improvements

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

25 Tarek Elneil

Page 26: Process variation and continuous improvements

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

September 12

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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

Page 28: Process variation and continuous improvements

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?

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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

Page 30: Process variation and continuous improvements

What is Root Cause Analysis (RCA)?

September 2012Tarek Elneil

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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?

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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

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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

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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

September 2012Tarek Elneil

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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

May 2011

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Page 36: Process variation and continuous improvements

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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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

September 2012Tarek Elneil

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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

Page 40: Process variation and continuous improvements

Tarek Elneil40 September 2012

Questions?