Continuous Improvement And Rca Rg Rev 2

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  • We can’t fix a problem outside of our influence such as a problem was caused by an earthquake,volcano eruption, Worker’s stick in Europe, or Transportation strike.

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  • 1. Continuous Improvement
    Eliminate the Nonconformities
    Using RCA
    June 10
    1
    Tarek Elneil
  • 2. What is Quality?
    Dictionary definition:
    degree of excellence
    superiority in kind <merchandise of quality>
    Technical definition:
    To meet or exceed customer expectation
    June 10
    2
    Tarek Elneil
  • 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
    June 10
    3
    Tarek Elneil
  • 4. Continuous Improvement Cycle
    June 10
    4
    Tarek Elneil
  • 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
    June 10
    5
    Tarek Elneil
  • 6. Measurement System
    Is an essential part of continuous improvement system
    If you can’t measure it, you can’t improve it
    Measure the vital few
    Scorecard, dashboard metrics
    Financial measures
    Performance measures
    Process cycle time
    Effectiveness of new product development
    June 10
    6
    Tarek Elneil
  • 7. CI Approach
    Active
    Strategic planning
    Validation
    FMEA
    Preventive action
    Reactive
    Corrective action
    Root cause analysis
    June 10
    7
    Tarek Elneil
  • 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
    June 10
    8
    Tarek Elneil
  • 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
    June 10
    9
    Tarek Elneil
  • 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
    June 10
    10
    Tarek Elneil
  • 11. Manufacturing Process & Continuous Improvement
    June 10
    11
    Tarek Elneil
  • 12. Process Components
    The Six M’s
    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.
    June 10
    12
    Tarek Elneil
  • 13. Customer-Supplier Chain
    External Customers
    External Supplier
    Internal Customer
    Internal Supplier
  • 14. Process Product
    Y
    LCL
    UCL
    Reject
    Accept
    Reject
    June 10
    14
    Tarek Elneil
  • 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)
    June 10
    15
    Tarek Elneil
  • 16. Sub-process Unit
    Y
    INPUT
    OUTPUT
    PROCESS
    Material
    SUPPLIER
    CUSTOMER
    X1
    Man
    X2
    Machine
    X3
    Measurement
    X4
    X5
    Method
    X6
    Environment
    June 10
    16
    Tarek Elneil
  • 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.
    June 10
    18
    Tarek Elneil
  • 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
    June 10
    19
    Tarek Elneil
  • 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
    June 10
    20
    Tarek Elneil
  • 21. Cause and Effect Principals
    June 10
    21
    Tarek Elneil
  • 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
    June 10
    22
    Tarek Elneil
  • 23. 2. Causes and Effects are Continuum
    Primary Effect
    Leaky
    Valve
    Injury
    Caused By
    Caused By
    Caused By
    Caused By
    Wet
    Surface
    Fall
    June 10
    23
    Tarek Elneil
  • 24. 3. Each Effect has at Least Two Causes
    Action
    Cause
    Effect
    Condition
    Cause
    June 10
    24
    Tarek Elneil
  • 25. 4. Effect & Causes Exists at the Same Point in Time and Space
    Action Cause
    Condition Cause
    Effect
    Space
    Oxygen
    Past -10 0 10 Future
    Present
    Time
    June 10
    25
    Tarek Elneil
  • 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
    June 10
    26
    Tarek Elneil
  • 27. Y
    LCL
    UCL
    Problem Investigation
    June 10
    Tarek Elneil
    27
  • 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
    June 10
    28
    Tarek Elneil
  • 29. Repeated Occurrence Pareto 80/20 Rule
    100%
    80%
    600%
    Costs
    40%
    20%
    0%
    Problems
    A
    B
    C
    D
    E
    F
    G
    H
    June 10
    29
    Tarek Elneil
  • 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 CA’s
    Control Phase
    June 10
    30
    Tarek Elneil
  • 31. Root Cause Analysis Methodology
    Define the problem
    Analyze the problem root causes
    Identify effective solutions
    Implement the best solutions
    June 10
    31
    Tarek Elneil
  • 32. Definition Tools
    Pareto chart
    Is, is not
    Flowchart
    June 10
    32
    Tarek Elneil
  • 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
    June 10
    33
    Tarek Elneil
  • 34. Problem Definition’s 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?
    June 10
    34
    Tarek Elneil
  • 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
    June 10
    35
    Tarek Elneil
  • 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”
    June 10
    36
    Tarek Elneil
  • 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
    June 10
    37
    Tarek Elneil
  • 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.
    June 10
    38
    Tarek Elneil
  • 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
    39
    Tarek Elneil
  • 43. What’s 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 mention the title (Analyst, Security, Manager, Technician, …etc)
    Why: this is what the investigation is all about
    June 10
    40
    Tarek Elneil
  • 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
    June 10
    41
    Tarek Elneil
  • 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
    June 10
    42
    Tarek Elneil
  • 46. Problem Analysis Tools
    5 Why’s?
    Fish Bone Diagram
    Brainstorming
    Contradiction Matrix
    June 10
    43
    Tarek Elneil
  • 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
    June 10
    44
    Tarek Elneil
  • 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
    June 10
    45
    Tarek Elneil
  • 49. Start
    Solution(s) for this causes
    Solution(s) for this causes
    June 10
    46
    Tarek Elneil
  • 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
    June 10
    47
    Tarek Elneil
  • 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
    June 10
    48
    Tarek Elneil
  • 52. Solution Matrix
    June 10
    49
    Tarek Elneil
  • 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)
    June 10
    50
    Tarek Elneil
  • 54. June 10
    Tarek Elneil
    51