Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
Continuous Improvement<br />Eliminate the Nonconformities<br />Using RCA<br />June 10<br />1<br />Tarek Elneil            ...
What is Quality?<br />Dictionary definition:<br />degree of excellence<br />superiority in kind <merchandise of quality><b...
Organizational Changes That Meet Customer Expectation <br />Organization transformation from current state, to future stat...
Continuous Improvement Cycle<br />June 10<br />4<br />Tarek Elneil                                                        ...
Continuous Improvement<br />Establishing adequate processes for measurement, analysis and improvement within the QMS as re...
Measurement System<br />Is an essential part of continuous improvement system<br />If you can’t measure it, you can’t impr...
CI Approach<br />Active<br />Strategic planning<br />Validation<br />FMEA<br />Preventive action<br />Reactive<br />Correc...
CAPA the Reactive Approach<br />The concept of corrective action and preventive action has been incorrectly interpreted to...
Preventive Action <br />Action to eliminate the cause of a potential nonconformity or other undesirable situation<br />The...
Corrective Action<br />Corrective Action:<br />Action to eliminate the cause of a detected nonconformity or other undesira...
Manufacturing Process & Continuous Improvement<br />June 10<br />11<br />Tarek Elneil                                     ...
Process Components<br />The Six M’s<br />Man: Human error, technician, training.<br />Machine: Equipment, instruments, too...
Customer-Supplier Chain<br />External Customers<br />External Supplier<br />Internal Customer<br />Internal Supplier<br />
Process Product<br />Y<br />LCL<br />UCL<br />Reject<br />Accept<br />Reject<br />June 10<br />14<br />Tarek Elneil       ...
Process and Sub-processes<br />X1,1<br />X1,2<br />X1,3<br />X1,4<br />X2,1<br />X2,2<br />X2,3<br />X2,4<br />X3,1<br />X...
Sub-process Unit<br />Y<br />INPUT<br />    OUTPUT<br />PROCESS<br />Material<br />SUPPLIER<br />CUSTOMER<br />X1<br />Man...
The cost of defects when they are:<br />CUSTOMER<br />DETECTED<br />INTERNALLY<br />DETECTED<br />PREVENTED<br />100X<br /...
Cause and Effect<br />Deeply in love I fell.. Deeply in love I was... when my eyes eyed your eyes...your eyes were the cau...
Symptoms and Causes<br />Symptoms = Effects: are the signs or results of a failure but not the root cause<br />Causes leve...
Examples <br />Sep 12, 2008 Metrolinkaccident 25 fatality and 135 injuries <br />Symptom: Metrolink train collided head-on...
Cause and Effect Principals <br />June 10<br />21<br />Tarek Elneil                                                       ...
1. Causes and Effects are the Same Thing.<br />Leaky <br />Valve<br />Injury<br />Primary Effect<br />Cause<br />Caused By...
2. Causes and Effects are Continuum <br />Primary Effect<br />Leaky <br />Valve<br />Injury<br />Caused By<br />Caused By<...
3. Each Effect has at Least Two Causes<br />Action<br />Cause<br />Effect<br />Condition<br />Cause<br />June 10<br />24<b...
4. Effect & Causes Exists at the Same Point in Time and Space<br />Action Cause<br />Condition Cause<br />Effect<br />Spac...
Action & Condition Relations <br />Any effect is the result of conditions interacting with an action<br />Action Cause<br ...
Y<br />LCL<br />UCL<br />Problem Investigation<br />June 10<br />Tarek Elneil                                             ...
When to Use RCA<br />Problem that exceeded the established threshold <br />Repeated occurrence<br />One time occurrence th...
Repeated Occurrence Pareto 80/20 Rule<br />100%<br />80%<br />600%<br />Costs<br />40%<br />20%<br />0%<br />Problems<br /...
One Time Threshold<br />Start<br />No<br />Freq<br />No<br />No<br />No<br />Stop<br />No<br />No<br />Safety<br />Cost<br...
Root Cause Analysis Methodology<br />Define the problem<br />Analyze the problem root causes<br />Identify effective solut...
Definition Tools<br />Pareto chart<br />Is, is not<br />Flowchart<br />June 10<br />32<br />Tarek Elneil                  ...
Why Problem Definition is Important?<br />It focus everybody on the same problem<br />It establish the value of the proble...
Problem Definition’s Elements<br />Define the process input (X) and desired output (Y) qualitatively and quantitatively <b...
Problem Definition: What<br />The problem would be defined according to which of its aspects has the biggest impact on the...
Problem Definition: When<br />Include both chronological time and relative time<br />Example:<br />Feb 20, 2009<br />At 2:...
Problem Definition: Where<br />Start with the broad area description and step down in details until you have described exa...
Problem Significance <br />Actual vs. potential impact: In examining the problem significance we look at both actual and p...
Quantifying Problem Significance <br />It help to answer 3 questions<br />Should we continue with the investigation?<br />...
Potential loss of $1500 worth of raw materials
Twice this month
2 weeks delay in customer order </li></ul>June 10<br />39<br />Tarek Elneil                                               ...
What’s Not Problem Definition<br />Who: diverts attention from the problem, and if it is important it will be discovered d...
Look for Causes in Action & Condition<br />Focus on causes<br />Ask “what condition (input) had to be in place for the act...
Analysis<br />Action causes are momentary, they act as the catalyst for the casual relationship<br />Conditions causes exi...
Problem Analysis Tools<br />5 Why’s?<br />Fish Bone Diagram<br />Brainstorming<br />Contradiction Matrix <br />June 10<br ...
Ask “Why”<br />Action<br />Cause<br />Action<br />Cause<br />Condition<br />Cause<br />Evidence ?<br />Evidence<br />Evide...
Stop<br />Cause and effect charts can potentially extend infinitely into the past. Use stop at the end of the cause chain ...
Start<br />Solution(s) for this causes<br />Solution(s) for this causes<br />June 10<br />46<br />Tarek Elneil            ...
Solution Significance <br />The magnitude of the problem determines the amount of effort to direct toward a solution. Weig...
Solution Selection<br />Establish Solution Criteria <br />Prevent recurrence<br />Comply with requirements<br />Be within ...
Upcoming SlideShare
Loading in …5
×

Continuous Improvement And Rca Rg Rev 2

1,953 views

Published on

Published in: Business
  • Be the first to comment

Continuous Improvement And Rca Rg Rev 2

  1. 1. Continuous Improvement<br />Eliminate the Nonconformities<br />Using RCA<br />June 10<br />1<br />Tarek Elneil <br />
  2. 2. What is Quality?<br />Dictionary definition:<br />degree of excellence<br />superiority in kind <merchandise of quality><br />Technical definition:<br />To meet or exceed customer expectation<br />June 10<br />2<br />Tarek Elneil <br />
  3. 3. Organizational Changes That Meet Customer Expectation <br />Organization transformation from current state, to future state<br />Constantly meet or exceed customer expectations<br /> Superior product or service<br />Faster delivery<br />Lower price <br />June 10<br />3<br />Tarek Elneil <br />
  4. 4. Continuous Improvement Cycle<br />June 10<br />4<br />Tarek Elneil <br />
  5. 5. Continuous Improvement<br />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 <br />June 10<br />5<br />Tarek Elneil <br />
  6. 6. Measurement System<br />Is an essential part of continuous improvement system<br />If you can’t measure it, you can’t improve it<br />Measure the vital few <br />Scorecard, dashboard metrics <br />Financial measures<br />Performance measures<br />Process cycle time <br />Effectiveness of new product development<br />June 10<br />6<br />Tarek Elneil <br />
  7. 7. CI Approach<br />Active<br />Strategic planning<br />Validation<br />FMEA<br />Preventive action<br />Reactive<br />Corrective action<br />Root cause analysis<br />June 10<br />7<br />Tarek Elneil <br />
  8. 8. CAPA the Reactive Approach<br />The concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action. <br />Preventive action is taken to prevent occurrence<br />Corrective action is taken to prevent recurrence<br />June 10<br />8<br />Tarek Elneil <br />
  9. 9. Preventive Action <br />Action to eliminate the cause of a potential nonconformity or other undesirable situation<br />There can be more than one cause for nonconformity<br />June 10<br />9<br />Tarek Elneil <br />
  10. 10. Corrective Action<br />Corrective Action:<br />Action to eliminate the cause of a detected nonconformity or other undesirable situation<br />There can be more than one cause for nonconformity<br />Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence<br />Correction Action: <br />Action to eliminate a detected nonconformity <br />A correction can be made in conjunction with corrective action <br />Corrections can be, for example, rework or re-grade, fix <br />June 10<br />10<br />Tarek Elneil <br />
  11. 11. Manufacturing Process & Continuous Improvement<br />June 10<br />11<br />Tarek Elneil <br />
  12. 12. Process Components<br />The Six M’s<br />Man: Human error, technician, training.<br />Machine: Equipment, instruments, tools, calibration.<br />Material: Raw material, buffers, liquid, components.<br />Method: SOP, work instructions, test, assay, TDS.<br />Measurement: Liter, mol, vial to vial, % difference. <br />Mother Nature: Environment, temperature, pressure. <br />June 10<br />12<br />Tarek Elneil <br />
  13. 13. Customer-Supplier Chain<br />External Customers<br />External Supplier<br />Internal Customer<br />Internal Supplier<br />
  14. 14. Process Product<br />Y<br />LCL<br />UCL<br />Reject<br />Accept<br />Reject<br />June 10<br />14<br />Tarek Elneil <br />
  15. 15. Process and Sub-processes<br />X1,1<br />X1,2<br />X1,3<br />X1,4<br />X2,1<br />X2,2<br />X2,3<br />X2,4<br />X3,1<br />X3,2<br />X3,3<br />X3,4<br />X4,1<br />X4,2<br />X4,3<br />X4,4<br />Y<br />LCL<br />UCL<br />Y1<br />Y2<br />YN<br />Y4<br />Y3<br />P4<br />P3<br />P2<br />P1<br />P= Process<br />X = Drivers (input)<br />Y = Product (output)<br />June 10<br />15<br />Tarek Elneil <br />
  16. 16. Sub-process Unit<br />Y<br />INPUT<br /> OUTPUT<br />PROCESS<br />Material<br />SUPPLIER<br />CUSTOMER<br />X1<br />Man<br /> X2<br />Machine <br />X3<br />Measurement<br />X4<br />X5<br />Method<br />X6<br />Environment<br />June 10<br />16<br />Tarek Elneil <br />
  17. 17. The cost of defects when they are:<br />CUSTOMER<br />DETECTED<br />INTERNALLY<br />DETECTED<br />PREVENTED<br />100X<br />10X<br />1X<br />The 1 – 10- 100 Rule<br />
  18. 18. Cause and Effect<br />Deeply in love I fell.. Deeply in love I was... when my eyes eyed your eyes...your eyes were the cause. <br />Part 1:The Effectis what we see or experience with our senses <br />Part 2 :The CauseThe reason why a particular element of a design or process resulted in a failure mode.<br />June 10<br />18<br />Tarek Elneil <br />
  19. 19. Symptoms and Causes<br />Symptoms = Effects: are the signs or results of a failure but not the root cause<br />Causes levels:<br />First level causes: the direct lead to a problem<br />High level causes: the highest level cause is called the root cause<br />June 10<br />19<br />Tarek Elneil <br />
  20. 20. Examples <br />Sep 12, 2008 Metrolinkaccident 25 fatality and 135 injuries <br />Symptom: Metrolink train collided head-on with Union Pacific freight at combined speed of 83 mph<br />First level cause: Metrolinkengineer ran through red stop light and into a path of a Union Pacific freight train because he was text messaging.<br />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<br />June 10<br />20<br />Tarek Elneil <br />
  21. 21. Cause and Effect Principals <br />June 10<br />21<br />Tarek Elneil <br />
  22. 22. 1. Causes and Effects are the Same Thing.<br />Leaky <br />Valve<br />Injury<br />Primary Effect<br />Cause<br />Caused By<br />Caused By<br />Caused By<br />Effect<br />Cause<br />Wet <br />Surface<br />Cause<br />Effect<br />Fall<br />June 10<br />22<br />Tarek Elneil <br />
  23. 23. 2. Causes and Effects are Continuum <br />Primary Effect<br />Leaky <br />Valve<br />Injury<br />Caused By<br />Caused By<br />Caused By<br />Caused By<br />Wet <br />Surface<br />Fall<br />June 10<br />23<br />Tarek Elneil <br />
  24. 24. 3. Each Effect has at Least Two Causes<br />Action<br />Cause<br />Effect<br />Condition<br />Cause<br />June 10<br />24<br />Tarek Elneil <br />
  25. 25. 4. Effect & Causes Exists at the Same Point in Time and Space<br />Action Cause<br />Condition Cause<br />Effect<br />Space<br />Oxygen<br />Past -10 0 10 Future<br />Present <br />Time<br />June 10<br />25<br />Tarek Elneil <br />
  26. 26. Action & Condition Relations <br />Any effect is the result of conditions interacting with an action<br />Action Cause<br />Condition Cause<br />Match <br />Strike<br />Ignition <br />Source<br />Flammable <br />Material<br />Oxygen<br />June 10<br />26<br />Tarek Elneil <br />
  27. 27. Y<br />LCL<br />UCL<br />Problem Investigation<br />June 10<br />Tarek Elneil <br />27<br />
  28. 28. When to Use RCA<br />Problem that exceeded the established threshold <br />Repeated occurrence<br />One time occurrence that have high risk<br />Within your span of control<br />June 10<br />28<br />Tarek Elneil <br />
  29. 29. Repeated Occurrence Pareto 80/20 Rule<br />100%<br />80%<br />600%<br />Costs<br />40%<br />20%<br />0%<br />Problems<br />A<br />B<br />C<br />D<br />E<br />F<br />G<br />H<br />June 10<br />29<br />Tarek Elneil <br />
  30. 30. One Time Threshold<br />Start<br />No<br />Freq<br />No<br />No<br />No<br />Stop<br />No<br />No<br />Safety<br />Cost<br />Revenue<br />Envy.<br />Yes<br />Yes<br />Yes<br />Yes<br />Yes<br />Share <br />Yes<br />No<br />CAPA<br />Result Acceptable? <br />Assemble Team<br />Perform RCA<br />Implement CA’s<br />Control Phase<br />June 10<br />30<br />Tarek Elneil <br />
  31. 31. Root Cause Analysis Methodology<br />Define the problem<br />Analyze the problem root causes<br />Identify effective solutions<br />Implement the best solutions<br />June 10<br />31<br />Tarek Elneil <br />
  32. 32. Definition Tools<br />Pareto chart<br />Is, is not<br />Flowchart<br />June 10<br />32<br />Tarek Elneil <br />
  33. 33. Why Problem Definition is Important?<br />It focus everybody on the same problem<br />It establish the value of the problem<br />It communicate the problem impact on the organization<br />Problem statements it focus on facts only<br />Qualitative <br />Quantitative<br />June 10<br />33<br />Tarek Elneil <br />
  34. 34. Problem Definition’s Elements<br />Define the process input (X) and desired output (Y) qualitatively and quantitatively <br />What: Primary effect (noun verb)<br />When: Relative time of the primary effect<br />Where: Relative location in system, facility, or component<br />Significance: Why you are working on this problem?<br />June 10<br />34<br />Tarek Elneil <br />
  35. 35. Problem Definition: What<br />The problem would be defined according to which of its aspects has the biggest impact on the organization <br />Example:<br />Customer loss<br />Down time<br />Backlog <br />June 10<br />35<br />Tarek Elneil <br />
  36. 36. Problem Definition: When<br />Include both chronological time and relative time<br />Example:<br />Feb 20, 2009<br />At 2:30 PM<br />First day back to work<br />While preparing to leave for the day<br />After the completion of step xx” <br />June 10<br />36<br />Tarek Elneil <br />
  37. 37. Problem Definition: Where<br />Start with the broad area description and step down in details until you have described exactly where the problem has occurred<br />Example : <br />Camarillo facility<br />Warehouse<br />Cold storage<br />Shelf #12<br />June 10<br />37<br />Tarek Elneil <br />
  38. 38. Problem Significance <br />Actual vs. potential impact: In examining the problem significance we look at both actual and potential impact. <br />Example <br />Customer complaint of a bad kit might worth $1000, but potential losing a $50,000 contract. <br />June 10<br />38<br />Tarek Elneil <br />
  39. 39. Quantifying Problem Significance <br />It help to answer 3 questions<br />Should we continue with the investigation?<br />How much time should we spend on the investigation?<br />How much of resources (people and money) should we utilize to investigate and solve the problem?<br /><ul><li>Example of significance statement:
  40. 40. Potential loss of $1500 worth of raw materials
  41. 41. Twice this month
  42. 42. 2 weeks delay in customer order </li></ul>June 10<br />39<br />Tarek Elneil <br />
  43. 43. What’s Not Problem Definition<br />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)<br />Why: this is what the investigation is all about<br />June 10<br />40<br />Tarek Elneil <br />
  44. 44. Look for Causes in Action & Condition<br />Focus on causes<br />Ask “what condition (input) had to be in place for the action to cause the effect (output)?”<br />For each conditional cause must have an action cause<br />Action cause can have more than one condition<br />June 10<br />41<br />Tarek Elneil <br />
  45. 45. Analysis<br />Action causes are momentary, they act as the catalyst for the casual relationship<br />Conditions causes exist over time. Condition provide the best opportunities for solutions <br />June 10<br />42<br />Tarek Elneil <br />
  46. 46. Problem Analysis Tools<br />5 Why’s?<br />Fish Bone Diagram<br />Brainstorming<br />Contradiction Matrix <br />June 10<br />43<br />Tarek Elneil <br />
  47. 47. Ask “Why”<br />Action<br />Cause<br />Action<br />Cause<br />Condition<br />Cause<br />Evidence ?<br />Evidence<br />Evidence<br />Evidence<br />Evidence<br />Evidence<br />Action<br />Cause<br />Condition<br />Cause<br />Condition<br />Cause<br />Why ?<br />Why ?<br />Why?<br />Primary Effect<br />June 10<br />44<br />Tarek Elneil <br />
  48. 48. Stop<br />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 <br />Injury<br />Leaking <br />Valve<br />Fall<br />Wet Floor<br />Stop<br />June 10<br />45<br />Tarek Elneil <br />
  49. 49. Start<br />Solution(s) for this causes<br />Solution(s) for this causes<br />June 10<br />46<br />Tarek Elneil <br />
  50. 50. Solution Significance <br />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<br />If the problem is very costly and the solution or the group of solutions cost less, then it is worth implementing <br />June 10<br />47<br />Tarek Elneil <br />
  51. 51. Solution Selection<br />Establish Solution Criteria <br />Prevent recurrence<br />Comply with requirements<br />Be within control<br />Does not create other problems<br />Meet organizational goals and objectives<br />Develop solution matrix <br />Challenge all solution ideas in the list against criteria for viable solutions <br />June 10<br />48<br />Tarek Elneil <br />
  52. 52. Solution Matrix <br />June 10<br />49<br />Tarek Elneil <br />
  53. 53. The Most Effective Solutions<br />There is more control over conditional than actions causes<br />There should be far more conditions than actions in the chart, thus creating far more solution opportunities<br />Solutions for conditional causes are usually more reliable than solutions for action causes<br />Implement and control the solution(s)<br />June 10<br />50<br />Tarek Elneil <br />
  54. 54. June 10<br />Tarek Elneil <br />51<br />

×