1. Continuous Improvement
Eliminate the Nonconformities
Using RCA
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2. What is Quality?
Dictionary definition:
degree of excellence
superiority in kind
Technical definition:
To meet or exceed customer expectation
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3. Organizational Changes That Meet Customer Expectation
Organization transformation from current state, to future state
Constantly meet or exceed customer expectations
Superior product or service
Faster delivery
Lower price
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4. Continuous Improvement Cycle
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5. Continuous Improvement
Establishing adequate processes for measurement, analysis and improvement within the QMS as related to correction and/or corrective action for nonconformities or preventive action for potential nonconformities of systems, processes or products
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6. Measurement System
Is an essential part of continuous improvement system
If you cant measure it, you cant improve it
Measure the vital few
Scorecard, dashboard metrics
Financial measures
Performance measures
Process cycle time
Effectiveness of new product development
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7. CI Approach
Active
Strategic planning
Validation
FMEA
Preventive action
Reactive
Corrective action
Root cause analysis
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8. CAPA the Reactive Approach
The concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action.
Preventive action is taken to prevent occurrence
Corrective action is taken to prevent recurrence
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9. Preventive Action
Action to eliminate the cause of a potential nonconformity or other undesirable situation
There can be more than one cause for nonconformity
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10. Corrective Action
Corrective Action:
Action to eliminate the cause of a detected nonconformity or other undesirable situation
There can be more than one cause for nonconformity
Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence
Correction Action:
Action to eliminate a detected nonconformity
A correction can be made in conjunction with corrective action
Corrections can be, for example, rework or re-grade, fix
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11. Manufacturing Process & Continuous Improvement
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12. Process Components
The Six Ms
Man: Human error, technician, training.
Machine: Equipment, instruments, tools, calibration.
Material: Raw material, buffers, liquid, components.
Method: SOP, work instructions, test, assay, TDS.
Measurement: Liter, mol, vial to vial, % difference.
Mother Nature: Environment, temperature, pressure.
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13. Customer-Supplier Chain
External Customers
External Supplier
Internal Customer
Internal Supplier
14. Process Product
Y
LCL
UCL
Reject
Accept
Reject
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15. Process and Sub-processes
X1,1
X1,2
X1,3
X1,4
X2,1
X2,2
X2,3
X2,4
X3,1
X3,2
X3,3
X3,4
X4,1
X4,2
X4,3
X4,4
Y
LCL
UCL
Y1
Y2
YN
Y4
Y3
P4
P3
P2
P1
P= Process
X = Drivers (input)
Y = Product (output)
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16. Sub-process Unit
Y
INPUT
OUTPUT
PROCESS
Material
SUPPLIER
CUSTOMER
X1
Man
X2
Machine
X3
Measurement
X4
X5
Method
X6
Environment
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17. The cost of defects when they are:
CUSTOMER
DETECTED
INTERNALLY
DETECTED
PREVENTED
100X
10X
1X
The 1 10- 100 Rule
18. Cause and Effect
Deeply in love I fell.. Deeply in love I was... when my eyes eyed your eyes...your eyes were the cause.
Part 1:The Effectis what we see or experience with our senses
Part 2 :The CauseThe reason why a particular element of a design or process resulted in a failure mode.
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19. Symptoms and Causes
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: the highest level cause is called the root cause
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20. Examples
Sep 12, 2008 Metrolinkaccident 25 fatality and 135 injuries
Symptom: Metrolink train collided head-on with Union Pacific freight at combined speed of 83 mph
First level cause: Metrolinkengineer ran through red stop light and into a path of a Union Pacific freight train because he was text messaging.
High level cause: Metrolink founders made a decision two decades ago to agree to share tracks with two giant freight lines, and refused to install an automatic breaking system
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21. Cause and Effect Principals
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22. 1. Causes and Effects are the Same Thing.
Leaky
Valve
Injury
Primary Effect
Cause
Caused By
Caused By
Caused By
Effect
Cause
Wet
Surface
Cause
Effect
Fall
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23. 2. Causes and Effects are Continuum
Primary Effect
Leaky
Valve
Injury
Caused By
Caused By
Caused By
Caused By
Wet
Surface
Fall
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24. 3. Each Effect has at Least Two Causes
Action
Cause
Effect
Condition
Cause
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25. 4. Effect & Causes Exists at the Same Point in Time and Space
Action Cause
Condition Cause
Effect
Space
Oxygen
Past-10010Future
Present
Time
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26. Action & Condition Relations
Any effect is the result of conditions interacting with an action
Action Cause
Condition Cause
Match
Strike
Ignition
Source
Flammable
Material
Oxygen
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27. Y
LCL
UCL
Problem Investigation
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28. When to Use RCA
Problem that exceeded the established threshold
Repeated occurrence
One time occurrence that have high risk
Within your span of control
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29. Repeated Occurrence Pareto 80/20 Rule
100%
80%
600%
Costs
40%
20%
0%
Problems
A
B
C
D
E
F
G
H
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30. One Time Threshold
Start
No
Freq
No
No
No
Stop
No
No
Safety
Cost
Revenue
Envy.
Yes
Yes
Yes
Yes
Yes
Share
Yes
No
CAPA
Result Acceptable?
Assemble Team
Perform RCA
Implement CAs
Control Phase
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31. Root Cause Analysis Methodology
Define the problem
Analyze the problem root causes
Identify effective solutions
Implement the best solutions
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32. Definition Tools
Pareto chart
Is, is not
Flowchart
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33. Why Problem Definition is Important?
It focus everybody on the same problem
It establish the value of the problem
It communicate the problem impact on the organization
Problem statements it focus on facts only
Qualitative
Quantitative
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34. Problem Definitions Elements
Define the process input (X) and desired output (Y) qualitatively and quantitatively
What: Primary effect (noun verb)
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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35. Problem Definition: What
The problem would be defined according to which of its aspects has the biggest impact on the organization
Example:
Customer loss
Down time
Backlog
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36. Problem Definition: When
Include both chronological time and relative time
Example:
Feb 20, 2009
At 2:30 PM
First day back to work
While preparing to leave for the day
After the completion of step xx
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37. Problem Definition: Where
Start with the broad area description and step down in details until you have described exactly where the problem has occurred
Example :
Camarillo facility
Warehouse
Cold storage
Shelf #12
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38. Problem Significance
Actual vs. potential impact: In examining the problem significance we look at both actual and potential impact.
Example
Customer complaint of a bad kit might worth $1000, but potential losing a $50,000 contract.
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39. Quantifying Problem Significance
It help to answer 3 questions
Should we continue with the investigation?
How much time should we spend on the investigation?
How much of resources (people and money) should we utilize to investigate and solve the problem?

Example of significance statement:

40. Potential loss of $1500 worth of raw materials 41. Twice this month 42. 2 weeks delay in customer order June 10
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43. Whats Not Problem Definition
Who: diverts attention from the problem, and if it is important it will be discovered during the investigation. If it is necessary to mention who then mentionthe title (Analyst, Security, Manager, Technician, etc)
Why: this is what the investigation is all about
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44. Look for Causes in Action & Condition
Focus on causes
Ask what condition (input) had to be in place for the action to cause the effect (output)?
For each conditional cause must have an action cause
Action cause can have more than one condition
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45. Analysis
Action causes are momentary, they act as the catalyst for the casual relationship
Conditions causes exist over time. Condition provide the best opportunities for solutions
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46. Problem Analysis Tools
5 Whys?
Fish Bone Diagram
Brainstorming
Contradiction Matrix
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47. Ask Why
Action
Cause
Action
Cause
Condition
Cause
Evidence ?
Evidence
Evidence
Evidence
Evidence
Evidence
Action
Cause
Condition
Cause
Condition
Cause
Why ?
Why ?
Why?
Primary Effect
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48. Stop
Cause and effect charts can potentially extend infinitely into the past. Use stop at the end of the cause chain if there is no value in pursuing causes further
Injury
Leaking
Valve
Fall
Wet Floor
Stop
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49. Start
Solution(s) for this causes
Solution(s) for this causes
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50. Solution Significance
The magnitude of the problem determines the amount of effort to direct toward a solution. Weight the cost of the problem and efforts verses the cost and efforts of the solution
If the problem is very costly and the solution or the group of solutions cost less, then it is worth implementing
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51. Solution Selection
Establish Solution Criteria
Prevent recurrence
Comply with requirements
Be within control
Does not create other problems
Meet organizational goals and objectives
Develop solution matrix
Challenge all solution ideas in the list against criteria for viable solutions
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52. Solution Matrix
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53. The Most Effective Solutions
There is more control over conditional than actions causes
There should be far more conditions than actions in the chart, thus creating far more solution opportunities
Solutions for conditional causes are usually more reliable than solutions for action causes
Implement and control the solution(s)
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