Six Sigma and Lean Tools for Validation   Jan C. Crielaard,  Principal, WW Validation  Cordis Corporation,  a Johnson and ...
Agenda <ul><li>Validation life cycle and Six Sigma methodologies  </li></ul><ul><ul><li>Concepts and Definitions </li></ul...
Agenda <ul><li>Control plans and validation metrics </li></ul><ul><ul><li>Purpose of control plans </li></ul></ul><ul><ul>...
Learning Objectives <ul><li>Provide common terminology </li></ul><ul><li>Understand GMP evolution and how it relates to Si...
Validation life cycle and Six Sigma methodologies
FDA’s Initiative GMPs for the 21st Century <ul><li>Minimize risk to the public health associated with pharmaceutical produ...
FDA’s Initiative GMPs for the 21st Century <ul><ul><li>Focus on variability reduction through process understanding </li><...
Continuous Improvement FDA <ul><li>To improve efficiency by optimizing a process and eliminating wasted efforts in product...
Six Sigma <ul><li>A systematic approach for continuous sustainable Improvements </li></ul><ul><li>Define phase: Clear prob...
DMAIC tool overview
Causal thinking y = f(x1, x2,…, xn) Cause-and-Effect Diagram
Risk Based approach <ul><li>Is a paradigm focused on testing those aspects that can affect the product quality </li></ul><...
Risk Management <ul><li>The process of measuring or assessing risk and developing strategies to manage it </li></ul><ul><l...
Risk Management
Risk Estimation <ul><li>Risk estimation is a way to quantify the risk  associated with each cause of each hazard identifie...
FTA <ul><li>Top down approach: </li></ul><ul><li>Given a potential Hazard, </li></ul><ul><li>determine the possible driver...
FTA
FMEA <ul><li>Bottom-up-approach: </li></ul><ul><li>Given a system,determine potential </li></ul><ul><li>hazards by asking ...
Impact Assessment * <ul><li>Impact assessment characteristics: </li></ul><ul><li>Bottom-up-approach </li></ul><ul><li>Spec...
System Impact Assessment* <ul><li>Criteria indicating “Direct Impact “  </li></ul><ul><li>The system has direct contact wi...
Component Criticality Assessment* <ul><li>Criteria indicating “Criticality “  </li></ul><ul><li>The component is used to d...
Component Criticality Assessment* <ul><li>Criteria indicating “Criticality “  </li></ul><ul><li>The component has direct c...
Impact Assessment Commission and  Qualify system
Risk knowledge <ul><li>Drives Design  - e.g.”Design for impact” </li></ul><ul><li>Establishes qualification requirements <...
Utilize Lean tools to assess validation system efficacy and efficiency
Overall approach  <ul><li>Principle:  Map current state ( data and facts ) </li></ul><ul><li>Purpose: </li></ul><ul><li>An...
Tools <ul><li>RACI analysis </li></ul><ul><li>Group Technology and Job Standardization </li></ul><ul><li>Value Stream Map ...
RACI Analysis <ul><li>Purpose: Identify and optimize: </li></ul><ul><li>Responsibility </li></ul><ul><li>Accountability </...
RACI Analysis <ul><li>2  Analyze / Improve </li></ul><ul><li>R and A defined for each task </li></ul><ul><li>Consistent ap...
Group Technology Analysis <ul><li>Identify similar tasks </li></ul><ul><li>Identify common groups </li></ul><ul><li>Optimi...
Group Technology Analysis <ul><li>Identify common elements based on completed validations </li></ul>
Group Technology Analysis <ul><li>Analyze data to identify groups (patterns, %) </li></ul>
Job Standardization <ul><li>Develop standard process for common groups. </li></ul><ul><li>Focus improvement initiative on ...
Job Standardization <ul><li>Develop standard process for common groups. </li></ul><ul><li>Combine groups with similar comm...
Group Technology Analysis (Compliance) <ul><li>Identify common elements based on internal and external requirements </li><...
Group Technology Analysis (Compliance) <ul><li>Improve alignment to regulatory requirements </li></ul><ul><li>Remove non v...
Value Stream Map (VSM) <ul><li>‘Walk the actual process’ (not the procedure) </li></ul><ul><li>Map the process </li></ul><...
Current state VSM
Brainstorm improvement opportunities <ul><li>‘Kaizen bursts’ </li></ul><ul><li>Green: Implement now </li></ul><ul><li>Yell...
VSM – Kaizen Bursts
Future State VSM <ul><li>New process design / lay-out </li></ul><ul><li>Targets </li></ul>
Future state VSM
Gauge RnR (Attribute) <ul><li>Can be applied to the transactional process. </li></ul><ul><li>Basic steps: </li></ul><ul><l...
Gauge RnR Identify all possible  outcomes of the transactional process
Gauge RnR  Design gauge RnR 2 people  5 scenarios  4 repeats Joe Sally Scenarios 1 2 3 4 5 1 2 3 4 5 repeats 1234 5678 .… ...
Gauge RnR <ul><li>Few examples of different scenarios  </li></ul><ul><li>(Process for handling deviations): </li></ul><ul>...
Gauge RnR <ul><ul><li>Analyze the variation in the study results to determine: </li></ul></ul><ul><ul><ul><li>Do appraiser...
Analyze data <ul><li>What about:  </li></ul><ul><li>Scenario number 1?  </li></ul><ul><li>Scenario 2?  </li></ul><ul><li>S...
Considerations for an Attribute Gage R&R Study <ul><ul><li>Clear and concise operational definitions are critical </li></u...
Control Plans and Validation Metrics
Control Plan - Purpose <ul><li>Classical: Maintain the validated state </li></ul><ul><ul><li>Change Control </li></ul></ul...
Metrics <ul><ul><li>Classical: Reported as part of the Quality System  </li></ul></ul><ul><ul><li>Metrics rolled up in Qua...
Causal thinking y = f(x1, x2,…, xn ) Causal Driver Hierarchy
Useful Metrics <ul><li>A metric is: </li></ul><ul><li>A standard or unit which can be measured </li></ul><ul><li>The dimen...
Balanced Metrics <ul><li>Leading vs.. Lagging </li></ul><ul><li>Causal Effect drivers are leading and may be used for a pr...
Balanced Metrics <ul><li>Examples: </li></ul><ul><ul><li>Leading: % engineer trained against validation procedures </li></...
Dashboard Causal driver Hierarchy Linkage / Focus Frequency of review Tactical Strategic More frequent Less frequent
Features of a Well-Dressed Dashboard # of Reviews LCL and UCL Average Benchmark Review iterations Time F M A J J A 2 4 6 8...
Interactive Exercise:  Facilitating a transactional Kaizen initiative 改善
What is Kaizen <ul><li>What is Kaizen  ? (改善 - ky’zen) </li></ul><ul><li>“ Kai” means “change” </li></ul><ul><li>“ zen” me...
What is Kaizen <ul><li>Kaizen describes an environment where functional areas and individuals  proactively  work together ...
What is Kaizen <ul><li>Most Kaizens have these common features: </li></ul><ul><li>Focus on making improvements by detectin...
The benefits to applying Kaizen <ul><li>Solutions emphasize commonsense low-cost approaches, </li></ul><ul><li>Thus, </li>...
Transactional Kaizen <ul><li>Improvement opportunities in transactional processes: </li></ul><ul><li>Simplify/streamline p...
Scope of transactional Kaizen <ul><li>Goals must be 100% achievable during the Kaizen Event </li></ul><ul><li>Results must...
Event Format <ul><li>Clear expectations </li></ul><ul><li>Start times & end times </li></ul><ul><li>Dedicated participatio...
Activity Flow Review Base  Condition Identify Waste Problem Solve Communicate Coordinate Verify  Measure Update Job Standa...
1 week Kaizen using DMAIC approach <ul><li>Day 1: Define </li></ul><ul><li>Training </li></ul><ul><li>Why are we here </li...
1 week Kaizen using DMAIC approach <ul><li>Day 5 Improve phase: </li></ul><ul><li>Implement improvements </li></ul><ul><li...
Conclusion <ul><li>Kaizen events enable resources and employees to be focused on process improvements. </li></ul>Questions?
Contact information <ul><li>Jan C. Crielaard </li></ul><ul><li>Cordis Corporation,  a Johnson and Johnson Company </li></u...
References <ul><li>A.I.A.G.  Measurement Systems Analysis: Reference Manual . A.I.A.G., 1990 (Available from A.I.A.G. (313...
References <ul><li>ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities,  Volume 5 Commissioning and Q...
References <ul><li>Siegfried Schmitt, The Manager’s Validation Handbook,  Strategic Tool for Applying Six Sigma to Validat...
References <ul><li>Mike Rother, John Shook,  Learning to See,  value –stream mapping to create value and eliminate muda, v...
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Sslean Validation 20070622

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Six Sigma and Lean Tools for Validation

Pharmaceutical Technology’s Annual Conference
July 23-25, 2007 - Philadelphia, PA

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Sslean Validation 20070622

  1. 1. Six Sigma and Lean Tools for Validation Jan C. Crielaard, Principal, WW Validation Cordis Corporation, a Johnson and Johnson Company Pharmaceutical Technology’s Annual Conference July 23-25, 2007 - Park Hyatt at the Bellevue - Philadelphia, PA
  2. 2. Agenda <ul><li>Validation life cycle and Six Sigma methodologies </li></ul><ul><ul><li>Concepts and Definitions </li></ul></ul><ul><ul><li>Basis for Process Validation </li></ul></ul><ul><li>Utilize Lean tools to assess validation system efficacy and efficiency </li></ul><ul><ul><li>RACI analysis </li></ul></ul><ul><ul><li>Group Technology and Job Standardization </li></ul></ul><ul><ul><li>Value Stream Map </li></ul></ul><ul><ul><li>Gauge RnR </li></ul></ul>
  3. 3. Agenda <ul><li>Control plans and validation metrics </li></ul><ul><ul><li>Purpose of control plans </li></ul></ul><ul><ul><li>Metrics / Quality Indicators </li></ul></ul><ul><ul><li>Dashboards </li></ul></ul><ul><li>Interactive Exercise: </li></ul><ul><ul><li>Facilitating a transactional Kaizen initiative. </li></ul></ul>
  4. 4. Learning Objectives <ul><li>Provide common terminology </li></ul><ul><li>Understand GMP evolution and how it relates to Six Sigma </li></ul><ul><li>Introduce selected Six Sigma tools and present how they can be applied to validation </li></ul><ul><li>Introduce selected LEAN tools and apply these tools to assess and improve validation systems </li></ul>
  5. 5. Validation life cycle and Six Sigma methodologies
  6. 6. FDA’s Initiative GMPs for the 21st Century <ul><li>Minimize risk to the public health associated with pharmaceutical products by: </li></ul><ul><ul><li>Encourage implementation of risk-based approaches for industry and FDA </li></ul></ul><ul><ul><li>Encourage continuous improvement </li></ul></ul>
  7. 7. FDA’s Initiative GMPs for the 21st Century <ul><ul><li>Focus on variability reduction through process understanding </li></ul></ul><ul><ul><li>Focus on detect, analyze, correct and prevent problems </li></ul></ul>
  8. 8. Continuous Improvement FDA <ul><li>To improve efficiency by optimizing a process and eliminating wasted efforts in production </li></ul><ul><li>Focus lays on reducing variability in process and product quality characteristics and are not for changing the fundamental design of a manufacturing process (FDA, page 20) </li></ul><ul><li>Achieving and maintaining a state of control for process begins at the process development phase and continuous in entire product life cycle </li></ul><ul><li>Quality should be built into the product </li></ul>
  9. 9. Six Sigma <ul><li>A systematic approach for continuous sustainable Improvements </li></ul><ul><li>Define phase: Clear problem understanding </li></ul><ul><li>Measure phase: Establish Baseline </li></ul><ul><li>Analyze phase : Identify key drivers </li></ul><ul><li>Improve phase : Manipulate key drivers for optimal solutions </li></ul><ul><li>Control phase : Strategy to maintain gains </li></ul>Measure Analyze Improve Control Define
  10. 10. DMAIC tool overview
  11. 11. Causal thinking y = f(x1, x2,…, xn) Cause-and-Effect Diagram
  12. 12. Risk Based approach <ul><li>Is a paradigm focused on testing those aspects that can affect the product quality </li></ul><ul><li>Requirements: </li></ul><ul><ul><li>A proper and true understanding of the system </li></ul></ul><ul><ul><li>The ability to identify and asses product risk inherent to the manufacturing process, Risk Management </li></ul></ul><ul><li>Traditional </li></ul><ul><li>Inputs/outputs determined at time of validation </li></ul><ul><li>Validation used to catch issues </li></ul><ul><li>All facility, utility and process equipment and components are validated </li></ul><ul><li>Risk-Based </li></ul><ul><li>Inputs/outputs transferred from design to validation </li></ul><ul><li>Validation used to confirm requirements </li></ul><ul><li>Validate equipment and components that have potential impact to product quality </li></ul>
  13. 13. Risk Management <ul><li>The process of measuring or assessing risk and developing strategies to manage it </li></ul><ul><li>Guides the setting of specification and process parameters for manufacturing, assess and mitigate the risk of changing a process or specification, and determine the extent of discrepancy investigation and corrective actions </li></ul><ul><li>Risk management is an iterative process, it should be repeated when new data becomes available </li></ul><ul><li>Controls commensurate with level of risk </li></ul>
  14. 14. Risk Management
  15. 15. Risk Estimation <ul><li>Risk estimation is a way to quantify the risk associated with each cause of each hazard identified </li></ul><ul><li>Tools: </li></ul><ul><li>Fault Tree Analysis (FTA) </li></ul><ul><li>Failure Mode Effects Analysis (FMEA) </li></ul><ul><li>Hazard Analysis and Critical Control Points (HACCP) </li></ul><ul><li>Failure Mode Criticality and Effects Analysis (FMCEA) </li></ul><ul><li>Hazard Operability Analysis (HAZOP) </li></ul><ul><li>Control HAZOP (CHAZOP) </li></ul>
  16. 16. FTA <ul><li>Top down approach: </li></ul><ul><li>Given a potential Hazard, </li></ul><ul><li>determine the possible drivers </li></ul><ul><li>of failure </li></ul><ul><li>Each failure mode may have its own failure mode </li></ul><ul><li>Continue till individual sources are identified </li></ul>Identify Hazards Identify all potential failure modes Diagram the fault tree T E A M E F F O R T
  17. 17. FTA
  18. 18. FMEA <ul><li>Bottom-up-approach: </li></ul><ul><li>Given a system,determine potential </li></ul><ul><li>hazards by asking what can go </li></ul><ul><li>Wrong </li></ul><ul><li>Focus on how and under which circumstances system will fail </li></ul><ul><li>Focus not if system will fail </li></ul>Identify component or process steps Identify what can go wrong Determine Effect for user <ul><li>Score </li></ul><ul><li>Severity </li></ul><ul><li>Occurrence </li></ul><ul><li>(Detectability) </li></ul>Evaluate the risk &identify controls and mitigation actions T E A M E F F O R T
  19. 19. Impact Assessment * <ul><li>Impact assessment characteristics: </li></ul><ul><li>Bottom-up-approach </li></ul><ul><li>Specific criteria build around families of potential failure modes </li></ul><ul><li>Criteria are common to Pharmaceutical systems </li></ul><ul><li>Assessment on system and component level </li></ul>* ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities
  20. 20. System Impact Assessment* <ul><li>Criteria indicating “Direct Impact “ </li></ul><ul><li>The system has direct contact with the product </li></ul><ul><li>The system provides an excipient, or produces an ingredient or solvent </li></ul><ul><li>The system is used in cleaning or sterilization </li></ul><ul><li>The system preserves product quality </li></ul><ul><li>The system produces data which is used to accept or reject product </li></ul><ul><li>The system is a process control system that may affect product quality and there is no system for independent verification of control system performance in place </li></ul>* ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities
  21. 21. Component Criticality Assessment* <ul><li>Criteria indicating “Criticality “ </li></ul><ul><li>The component is used to demonstrate compliance with the registered process </li></ul><ul><li>The normal operation or control of the component has a direct effect on product quality </li></ul><ul><li>Failure or alarm of the component will have a direct effect on product quality or efficacy </li></ul><ul><li>Information from this component is recorded as part of the batch record, lot release data, or other GMP-related documentation </li></ul>* ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities
  22. 22. Component Criticality Assessment* <ul><li>Criteria indicating “Criticality “ </li></ul><ul><li>The component has direct contact with product or product components </li></ul><ul><li>The component controls critical process elements that may affect product quality, without independent verification of the control systems performance </li></ul><ul><li>The component is used to create or preserve a critical status of a system </li></ul>* ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities
  23. 23. Impact Assessment Commission and Qualify system
  24. 24. Risk knowledge <ul><li>Drives Design - e.g.”Design for impact” </li></ul><ul><li>Establishes qualification requirements </li></ul><ul><li>Drives Acceptance Criteria </li></ul><ul><li>Establishes baseline for (Change Based) revalidation </li></ul>
  25. 25. Utilize Lean tools to assess validation system efficacy and efficiency
  26. 26. Overall approach <ul><li>Principle: Map current state ( data and facts ) </li></ul><ul><li>Purpose: </li></ul><ul><li>Analyze - Identify improvement opportunities based on current performance: </li></ul><ul><ul><li>Compliance </li></ul></ul><ul><ul><li>Efficiency </li></ul></ul><ul><li>Outcome: Map future state (new process, targets) </li></ul>
  27. 27. Tools <ul><li>RACI analysis </li></ul><ul><li>Group Technology and Job Standardization </li></ul><ul><li>Value Stream Map (VSM) </li></ul><ul><li>Gauge RnR (Attribute) </li></ul>
  28. 28. RACI Analysis <ul><li>Purpose: Identify and optimize: </li></ul><ul><li>Responsibility </li></ul><ul><li>Accountability </li></ul><ul><li>Consult </li></ul><ul><li>Information </li></ul>1 Map current state
  29. 29. RACI Analysis <ul><li>2 Analyze / Improve </li></ul><ul><li>R and A defined for each task </li></ul><ul><li>Consistent approach </li></ul><ul><li>Minimize duplicate roles </li></ul><ul><li>Combine C and R role where possible </li></ul><ul><li>Align A and R to organizational structure </li></ul><ul><li>Etc. </li></ul><ul><li>3 Map future state </li></ul><ul><li>Integrate in procedures </li></ul><ul><li>Typical improvement opportunities </li></ul><ul><li>Responsibilities not defined </li></ul><ul><li>More than 1 person responsible </li></ul><ul><li>Approvers that only need to be informed </li></ul>
  30. 30. Group Technology Analysis <ul><li>Identify similar tasks </li></ul><ul><li>Identify common groups </li></ul><ul><li>Optimize the validation process based on largest common groups </li></ul>
  31. 31. Group Technology Analysis <ul><li>Identify common elements based on completed validations </li></ul>
  32. 32. Group Technology Analysis <ul><li>Analyze data to identify groups (patterns, %) </li></ul>
  33. 33. Job Standardization <ul><li>Develop standard process for common groups. </li></ul><ul><li>Focus improvement initiative on occurrence: </li></ul>
  34. 34. Job Standardization <ul><li>Develop standard process for common groups. </li></ul><ul><li>Combine groups with similar common elements: </li></ul>
  35. 35. Group Technology Analysis (Compliance) <ul><li>Identify common elements based on internal and external requirements </li></ul>
  36. 36. Group Technology Analysis (Compliance) <ul><li>Improve alignment to regulatory requirements </li></ul><ul><li>Remove non value added elements / requirements from existing procedures </li></ul>
  37. 37. Value Stream Map (VSM) <ul><li>‘Walk the actual process’ (not the procedure) </li></ul><ul><li>Map the process </li></ul><ul><li>Identify and collect critical metrics </li></ul>
  38. 38. Current state VSM
  39. 39. Brainstorm improvement opportunities <ul><li>‘Kaizen bursts’ </li></ul><ul><li>Green: Implement now </li></ul><ul><li>Yellow: Get more data </li></ul><ul><li>Red: Implement later </li></ul>
  40. 40. VSM – Kaizen Bursts
  41. 41. Future State VSM <ul><li>New process design / lay-out </li></ul><ul><li>Targets </li></ul>
  42. 42. Future state VSM
  43. 43. Gauge RnR (Attribute) <ul><li>Can be applied to the transactional process. </li></ul><ul><li>Basic steps: </li></ul><ul><li>Map the process and Identify all possible outcomes of the process </li></ul><ul><li>Design gauge RnR </li></ul><ul><li>Develop different scenarios </li></ul><ul><li>Develop repeats (alternative description of scenarios) </li></ul><ul><li>Have different users evaluate the different scenario’s (blind) </li></ul><ul><li>Analyze the variation </li></ul>
  44. 44. Gauge RnR Identify all possible outcomes of the transactional process
  45. 45. Gauge RnR Design gauge RnR 2 people 5 scenarios 4 repeats Joe Sally Scenarios 1 2 3 4 5 1 2 3 4 5 repeats 1234 5678 .… .… .… …. 1234 5678 .… .… .… ….
  46. 46. Gauge RnR <ul><li>Few examples of different scenarios </li></ul><ul><li>(Process for handling deviations): </li></ul><ul><li>You are analyzing the data from a PQ, and you realize that the statistical method prescribed in the protocol is not appropriate. You can use the existing data, but you decide to use a different statistical method for the analysis. </li></ul><ul><li>You are conducting a PQ test, and you accidentally drop one of the test units on the floor and damage the unit. You decide to replace the test unit with an extra unit from the same lot. </li></ul><ul><li>Repeat: </li></ul><ul><li>You accidentally scratched the surface of a test unit. Since there are sufficient units in the lot, you decide to take a new unit from the lot and use this for testing. </li></ul>
  47. 47. Gauge RnR <ul><ul><li>Analyze the variation in the study results to determine: </li></ul></ul><ul><ul><ul><li>Do appraisers classify the same scenario in the same way each time? (% Matched Within Appraiser) </li></ul></ul></ul><ul><ul><ul><li>Did each appraiser correctly classify the scenario as compared to the standard? (% Matched Appraiser vs. Standard) </li></ul></ul></ul><ul><ul><ul><li>Do the appraisers’ classification agree with each other? (% Matched Between Appraisers) </li></ul></ul></ul>
  48. 48. Analyze data <ul><li>What about: </li></ul><ul><li>Scenario number 1? </li></ul><ul><li>Scenario 2? </li></ul><ul><li>Scenario number 5? </li></ul>2 people 5 scenarios 4 repeats Minitab: S tat> Q uality Tools>Attrib u te Agreement Analysis
  49. 49. Considerations for an Attribute Gage R&R Study <ul><ul><li>Clear and concise operational definitions are critical </li></ul></ul><ul><ul><li>Each person makes a decision (pass/fail, 1,2,3,4.., etc.) for each scenario repeatedly </li></ul></ul><ul><ul><li>The scenarios should represent the range of variation in the process </li></ul></ul><ul><ul><li>People should make random and “blind” decisions; they should not know which scenario they are reviewing when they record their results </li></ul></ul><ul><ul><li>Data must be balanced for Minitab—each person must decide each scenario the same number of times </li></ul></ul>
  50. 50. Control Plans and Validation Metrics
  51. 51. Control Plan - Purpose <ul><li>Classical: Maintain the validated state </li></ul><ul><ul><li>Change Control </li></ul></ul><ul><ul><li>APR / Periodic Review </li></ul></ul><ul><ul><li>Time based re-validation </li></ul></ul><ul><li>SixSigma: Enable effective decision making </li></ul><ul><ul><li>“ what gets measured gets managed” </li></ul></ul><ul><ul><li>Maintain performance level (set targets) </li></ul></ul><ul><ul><li>Identify improvement opportunities </li></ul></ul><ul><ul><li>Sustain gain </li></ul></ul>
  52. 52. Metrics <ul><ul><li>Classical: Reported as part of the Quality System </li></ul></ul><ul><ul><li>Metrics rolled up in Quality Management Review </li></ul></ul><ul><ul><li>SixSigma: </li></ul></ul><ul><ul><li>Based on causal thinking </li></ul></ul>
  53. 53. Causal thinking y = f(x1, x2,…, xn ) Causal Driver Hierarchy
  54. 54. Useful Metrics <ul><li>A metric is: </li></ul><ul><li>A standard or unit which can be measured </li></ul><ul><li>The dimension, capacity or amount of something </li></ul><ul><li>A means to assess performance </li></ul><ul><li>S pecific/ S ystematic (linked to business needs) </li></ul><ul><li>M easurable/ M eaningful </li></ul><ul><li>A greed-upon/ A ction </li></ul><ul><li>R elevant/ R ooted in facts </li></ul><ul><li>T angible/ T houghtful </li></ul>
  55. 55. Balanced Metrics <ul><li>Leading vs.. Lagging </li></ul><ul><li>Causal Effect drivers are leading and may be used for a proactive approach e.g analysis, decision making and corrective actions </li></ul><ul><li>Indicators measured near or at the end of process are lagging, they are useful for overall analysis but they lag the Causal effect link </li></ul><ul><li>Effectiveness vs.. Efficiency </li></ul><ul><li>Effectiveness is a metric for the result of a process </li></ul><ul><li>Efficiency expresses the capability of that process </li></ul><ul><li>Both are required to express the success of a process (optimizing one often adversely affects the other) </li></ul>
  56. 56. Balanced Metrics <ul><li>Examples: </li></ul><ul><ul><li>Leading: % engineer trained against validation procedures </li></ul></ul><ul><ul><li>Lagging: % reject protocols </li></ul></ul><ul><ul><li>Effectiveness: Validation related audit observations </li></ul></ul><ul><ul><li>Efficiency: % of validation first time right </li></ul></ul>Leading Lagging Effectiveness Efficiency Supplier Input Metrics Customer Output Process Input Output Metrics Process Metrics X X X X X X X
  57. 57. Dashboard Causal driver Hierarchy Linkage / Focus Frequency of review Tactical Strategic More frequent Less frequent
  58. 58. Features of a Well-Dressed Dashboard # of Reviews LCL and UCL Average Benchmark Review iterations Time F M A J J A 2 4 6 8 10 Good Quick reference legend i.e. “Trend down=Good” Clean Data Display: Average and control limits Trend and goal Title X and Y axis Chart legend and update frequency Description This dashboard shows the number of iterations average per month. The benchmark of 2 iterations is the goal. Explanation More then 1 review means rework. Rework is waste. Waste needs to be minimalized. Action plan Descending trend is good. Ascending is bad, requires root cause analysis and preventive action. Description, Explanation and action plan
  59. 59. Interactive Exercise: Facilitating a transactional Kaizen initiative 改善
  60. 60. What is Kaizen <ul><li>What is Kaizen ? (改善 - ky’zen) </li></ul><ul><li>“ Kai” means “change” </li></ul><ul><li>“ zen” means “good (for the better)” </li></ul><ul><li>Gradual, orderly, and continuous improvement </li></ul><ul><li>Ongoing improvement involving everyone </li></ul>Kaizen is the lean manufacturing term for continuous improvement and was originally used to describe a key element of the Toyota Production System.
  61. 61. What is Kaizen <ul><li>Kaizen describes an environment where functional areas and individuals proactively work together to improve processes . </li></ul><ul><li>Kaizen events focus resources and employees on a specific area to achieve real process improvements in a short period of time . </li></ul>
  62. 62. What is Kaizen <ul><li>Most Kaizens have these common features: </li></ul><ul><li>Focus on making improvements by detecting and eliminating waste </li></ul><ul><li>Use a problem solving approach that observes how the process operates, uncovers waste, generates ideas for how to eliminate waste, and makes improvements </li></ul><ul><li>Use measurements to describe the size of the problem and the effects of the improvement </li></ul>Tools: Six Sigma and Lean
  63. 63. The benefits to applying Kaizen <ul><li>Solutions emphasize commonsense low-cost approaches, </li></ul><ul><li>Thus, </li></ul><ul><li>Continual adjustment and improvement becomes possible and further desirable. </li></ul>Creativity before capital!
  64. 64. Transactional Kaizen <ul><li>Improvement opportunities in transactional processes: </li></ul><ul><li>Simplify/streamline processes </li></ul><ul><li>Reduce lead times </li></ul><ul><li>Eliminate mistakes/rework </li></ul>All these alternatives can be combined in a broad improvement plan.
  65. 65. Scope of transactional Kaizen <ul><li>Goals must be 100% achievable during the Kaizen Event </li></ul><ul><li>Results must be quantifiable </li></ul><ul><li>Must meet the business objectives of the organization </li></ul>
  66. 66. Event Format <ul><li>Clear expectations </li></ul><ul><li>Start times & end times </li></ul><ul><li>Dedicated participation </li></ul><ul><li>There are no bad ideas </li></ul><ul><li>Transparent roles & responsibilities </li></ul>
  67. 67. Activity Flow Review Base Condition Identify Waste Problem Solve Communicate Coordinate Verify Measure Update Job Standardization Present Out-Brief Implement Solutions
  68. 68. 1 week Kaizen using DMAIC approach <ul><li>Day 1: Define </li></ul><ul><li>Training </li></ul><ul><li>Why are we here </li></ul><ul><li>Walk the process </li></ul><ul><li>Review existing data </li></ul><ul><li>Define goals and scope </li></ul><ul><li>Day 2-3-4: Measure and Analyze phases: </li></ul><ul><li>Investigate identified problems </li></ul><ul><li>Collect additional data </li></ul><ul><li>Solve identified problems </li></ul><ul><li>Identify waste </li></ul><ul><li>Develop Performance Metrics </li></ul><ul><li>Perform Risk Assessment </li></ul><ul><li>Pilot solution (if possible) </li></ul><ul><li>Identify Validation/Regulatory Requirements. </li></ul>Measure Analyze Improve Control Define
  69. 69. 1 week Kaizen using DMAIC approach <ul><li>Day 5 Improve phase: </li></ul><ul><li>Implement improvements </li></ul><ul><li>Eliminate waste </li></ul><ul><li>Implement Performance Metrics </li></ul><ul><li>Ongoing: Control phase : </li></ul><ul><li>Verify and Measure improvements </li></ul>Measure Analyze Improve Control Define
  70. 70. Conclusion <ul><li>Kaizen events enable resources and employees to be focused on process improvements. </li></ul>Questions?
  71. 71. Contact information <ul><li>Jan C. Crielaard </li></ul><ul><li>Cordis Corporation, a Johnson and Johnson Company </li></ul><ul><li>E-mail: Jcrielaa@crdnl.jnj.com </li></ul>
  72. 72. References <ul><li>A.I.A.G. Measurement Systems Analysis: Reference Manual . A.I.A.G., 1990 (Available from A.I.A.G. (313)358-3570) </li></ul><ul><li>Wheeler, Donald J. and Lyday, Richard W. Evaluating the Measurement Process, Second Edition . Knoxville, TN: SPC Press Inc. 1989. </li></ul>
  73. 73. References <ul><li>ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities, Volume 5 Commissioning and Qualifications, first edition March 2001 www.ISPE.org </li></ul><ul><li>IVT, Technical Guide, Six Sigma and Process Validation Strategies www.ivthome.com </li></ul>
  74. 74. References <ul><li>Siegfried Schmitt, The Manager’s Validation Handbook, Strategic Tool for Applying Six Sigma to Validation Compliance, PDA, DHI Publishing, ISBN 1-930114-84-2 </li></ul><ul><li>Don Tapping and Tom Shuker, Value Stream Management for the Lean Office Productivity Press, ISBN 1-56327-246-6 </li></ul>
  75. 75. References <ul><li>Mike Rother, John Shook, Learning to See, value –stream mapping to create value and eliminate muda, version 3 The Lean Enterprise Institute, www.lean.org, ISBN 0-9667843-0-8 </li></ul><ul><li>Shigeo Shingo, Zero Quality Control: Source Inspection and the Poka-yoke System Productivity Press, ISBN 0-915299-07-0 </li></ul>

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