Lean Six Sigma Mistake-Proofing Process Training Module

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The Mistake-Proofing Process Training Module v5.0 includes:

1. MS PowerPoint Presentation including 128 slides covering in detail an Introduction to Process Risk Analysis & Mistake-Proofing, Process Variables Mapping, Cause & Effect Matrix, Process Failure Mode and Effects Analysis, Human Work Model, Sixteen Human Error Modes, Six Mistake-Proofing Principles, Five Mistake-Proofing Methods, Seven Types of Poka-Yoke Devices, Poka-Yoke Examples, Process Control Plan, and 6 Workshop Exercises.

2. MS Word Process FMEA Severity, Occurrence, and Detection Risk Assessment Guidelines

3. MS Excel Process Variables Map Template, Cause & Effect Matrix Template, Process Failure Modes and Effects Analysis Template, and Process Control Plan Template

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Lean Six Sigma Mistake-Proofing Process Training Module

  1. 1. 1 April 9, 2016 – v 5.0 Lean Six Sigma Mistake-Proofing Process by Operational Excellence Consulting LLC
  2. 2. 2 April 9, 2016 – v 5.0 Process Risk Analysis & Mistake-Proofing - Overview  Things can go wrong. People will make mistakes.  However, letting mistakes become defects that cause Customer dissatisfaction or waste and rework is avoidable.  Process Risk Analysis & Mistake-Proofing, is the systematic process of identifying and preventing defects from occurring in an organization’s manufacturing or business process.  It’s essence is to design both product and processes so that mistakes are impossible to make or, at the least, they are easy and early to detect and correct.
  3. 3. 3 April 9, 2016 – v 5.0 Process Risk Analysis & Mistake-Proofing - Overview Our Process Risk Analysis & Mistake-Proofing Solution follows a proven 10 Step Process, combining Process Failure Mode and Effects Analysis, Root Cause Analysis, Poka-Yoke Principles and Process Control Plans with an effective team driven approach. Perform Risk Analysis Develop Mistake-Proofing Solutions Implement Mistake-Proofing Solutions Establish Process Control Plan List Current Process ControlsDevelop a Process Variables Map Develop a Cause & Effects Matrix Determine Potential Root Causes Determine Potential Failure Modes Determine Potential Effects
  4. 4. 4 April 9, 2016 – v 5.0 “Process Risk Analysis & Mistake Proofing” Agenda 1. Introduction to Mistake-Proofing (≈ 30 min) 2. Process Mapping & Exercise (≈ 90 min) 3. Cause & Effect Matrix & Exercise (≈ 60 min) 4. Process FMEA & Exercise (≈ 60 min) 5. Risk Analysis & Exercise (≈ 30 min) 6. Human Errors and Poka-Yoke & Exercise (≈ 60 min) 7. Process Control Plan & Exercise (≈ 60 min)
  5. 5. 5 April 9, 2016 – v 5.0 Getting 99.9% “right” may not be “good enough” Getting it right 99.9% of the time means …  268,500 defective tires shipped per year.  22,000 checks deducted from the wrong account every hour.  19,000 babies dropped at birth per year.  12 babies given to wrong parents each day.  2 unsafe landings at O’Hare airport per day.
  6. 6. 6 April 9, 2016 – v 5.0  The responsibility for performing a Process Risk Analysis & Mistake-Proofing of a process must be assigned to an individual.  However, the responsible individual is expected to directly and actively involve representatives from all affected areas.  The team should reflect the needs and requirements that the problem and culture of the organization requires.  It normally consists of four to six individuals with multidiscipline and multifunctional backgrounds. In addition, all members should have ownership of the problem/process. Process Risk Analysis & Mistake-Proofing - A Team Effort  Mistake-Proofing should be a catalyst to stimulate the interchange of ideas between the functions effected and thus promote a team approach.
  7. 7. 7 April 9, 2016 – v 5.0  Y's are the attributes or characteristics of the results (Critical-to-Quality or CTQ) of completing the process step  X's are the are the attributes or characteristics of the inputs that impact the ability to achieve the outputs and their Y's of that process or process step  The output or Y of a process or process step is a function of the process inputs or Xs  To eliminate or reduce variation in the output or Y of a process or process step one needs to eliminate or reduce the variation in the process inputs or Xs  Note: An output or Y from one process step can be an input or X from a later process step Process or Process Step Input's & X’s Output's & Y’s Foundation of Process Thinking and Improvement
  8. 8. 8 April 9, 2016 – v 5.0 Process inputs can be categorized using the 6Ms  Manpower  Machine  Materials  Methods  Measurement  Mother Nature Process Inputs & The 6Ms
  9. 9. 9 April 9, 2016 – v 5.0 Process inputs can be classified as one of three types:  Controllable (C) – can be adjusted or controlled during the process • speeds, pressure, ...  Standard Operating Procedures (SOP) – common sense items; activities that are always done just because it makes sense • set-up, cleaning, maintenance, ...  Noise (N) – things one cannot control – things one doesn't want to control (too difficult or expensive) • humidity, temperature, ... Characterize Process Inputs
  10. 10. 10 April 9, 2016 – v 5.0 The Human Being – Often the Biggest “Noise” Input … The order really has to go out today !!! Lost a lot of money in Poker last night. Hopefully Molly is doing well in her test today. It is Friday !!! Wonder what I should wear tonight. … in your Process.
  11. 11. 11 April 9, 2016 – v 5.0 “Process Risk Analysis & Mistake Proofing” Agenda 1. Introduction to Mistake-Proofing (≈ 30 min) 2. Process Mapping & Exercise (≈ 90 min) 3. Cause & Effect Matrix & Exercise (≈ 60 min) 4. Process FMEA & Exercise (≈ 60 min) 5. Risk Analysis & Exercise (≈ 30 min) 6. Human Errors and Poka-Yoke & Exercise (≈ 60 min) 7. Process Control Plan & Exercise (≈ 60 min)
  12. 12. 12 April 9, 2016 – v 5.0 Process Variables Mapping → Basics • Process Variables Maps should include: – All value-added and non-value-added process steps – Major activities and/or tasks in each process step – Process Inputs and Xs for each process step – Process Outputs and Ys for each process step – Data Collection Points if applicable • The Process Variables Map documents the process as it is actually performed, not necessarily as it is supposed to be performed • Key deliverable from the Process Variables Map is a complete list of all the Process Inputs and Xs within the project scope, from which all future work will be performed
  13. 13. 13 April 9, 2016 – v 5.0 Process Variables Mapping → Preparation • Team Effort – Process Owners / Leaders, Workers, Supervisors, Technicians / Engineers / Developers, Upstream and Downstream Representatives (Suppliers and Customers) • Inputs to Mapping – Brainstorming and operator knowledge / experience – Operator manuals / standard work instructions – Customer specifications – 6Ms - Machine (Equipment), Methods (Procedures), Measurement, Materials (Information), Manpower (Personnel), Mother Nature (Environment) • Excel Template – Process Variables Map – Template.xls
  14. 14. 14 April 9, 2016 – v 5.0 Process Variables Mapping → Step-by-Step Approach 1. Identify the process or sub-process, with its external inputs and customer outputs (High Level Process Map) 2. Identify all process steps in the process or sub-process graphically 3. List outputs and their Ys for each process step (before listing the inputs) 4. List all inputs and their Xs for each process step and classify them as controlled or uncontrolled 5. Optional: Add process specifications for the identified Xs and Ys
  15. 15. 15 April 9, 2016 – v 5.0 Process Variables Map → Step 1: High Level Process Map High Level Process Map  Define the process or sub-process in simple terms (one box!)  List the 5 – 10 key process steps or activities performed as part of this process  Identify the Outputs, their Ys (measurable attributes of the outputs), and the Customer Requirements  Briefly list the general types of external inputs → Use the 6 Ms as input categories BIG Project Ys Xs or INPUTS Ys or OUTPUTS INPUTS Coffee Machine Quantity of Coffee (in ml) Think 6 M's Coffee Maker (Operator) Taste of Coffee (Scale 1 - 10) Man Coffee Powder Machine Water Material Coffee Filter Method Power Outlet Measure Coffee Cup Mother Earth 1. Prepare Coffee Machine 2. Add Coffee Filter & Coffee Powder 3. Add Water 4. Turn on Coffee Machine 5. Pour Coffee into Coffee Cup Coffee Making Process
  16. 16. 16 April 9, 2016 – v 5.0 Process Variables Map → Step 2: Identify Process Steps Identify Process Steps  Include all value-added and non value-added process steps and key activities or tasks  Hint: Process Step Names are verbs or gerunds Answering Phone 1. Greeting customer 2. Getting customer Information 3. Getting order information 4. Time needed Completing Order Form 1. Completing and entering order information into production system Making & Packaging Pizza 1. Preparing & making pizza 2. Packaging pizza Delivering Pizza 1. Transporting pizza to customer’s location Pizza Delivery Process
  17. 17. 17 April 9, 2016 – v 5.0 Process Variables Map → Step 3: List the Outputs & Ys List the outputs and Ys for each process step. Include both process and product outputs. Ys 1. Time to answer 2. Accuracy of customer info 3. Order / quantity 4. Delivery time 1. Accuracy of order information 2. Accuracy of pricing info 3. Speed to complete form Answering Phone 1. Greeting customer 2. Getting customer information 3. Getting order information Time needed Completing Order Form 1. Completing and entering order information into production system Ys 1. Temperature of the pizza 2. Time to complete 1. Time to deliver 2. Correct quantity 3. Correct order 4. Pizza Temperature 5. Pizza Condition Making & Packaging Pizza 1. Preparing & making pizza 2. Packaging pizza Delivering Pizza 1. Transport pizza to customer’s location
  18. 18. 18 April 9, 2016 – v 5.0 Process Variables Map → Step 4: List and Classify Xs  List all Xs for each Inputs (usually specific attributes of the input which could be a source of variation)  Classify Xs – Controlled (C): These are inputs that you adjust or control while the process is running (Examples: Speed, feed rate, pressure, temperature, experience level of worker, data system size) – Uncontrolled (U): Noise variables. These are things you cannot, or do not currently, control (Examples: Ambient temperature, humidity, order quantity, training hours of worker) • Could be due to the expense or difficulty controlling them This step is where the team should spend most of its time
  19. 19. 19 April 9, 2016 – v 5.0 Ys 1. Time to answer 2. Accuracy of customer info 3. Order / quantity 4. Delivery time 1. Accuracy of order information 2. Accuracy of pricing info 3. Speed to complete form Process Variables Map → Step 4: List and Classify Xs Information from customer C Greeting script C Answering procedure C Telephone system U Number of calls U Order information clarity C Order form layout C Number of phones U Computer program U Pricing options C Xs Type Answering Phone 1. Greeting customer 2. Getting customer information 3. Getting order information Time needed Completing Order Form 1. Completing and entering order information into production system …
  20. 20. 20 April 9, 2016 – v 5.0 Process Variables Map → Step 5: Add Specifications  Document any known operating specification or requirements for each X and Y if applicable
  21. 21. 21 April 9, 2016 – v 5.0 Process Variables Mapping → Next Steps  Identify “Easy Opportunities” and “Quick Fixes”  Review current process controls  Assess effectiveness of current process controls  Generate action plan with clear responsibilities and time lines  Identify opportunities to improve or develop process controls  Identify critical process inputs or Xs for the Process FMEA  …
  22. 22. 22 April 9, 2016 – v 5.0 The Coffee Making Process
  23. 23. 23 April 9, 2016 – v 5.0 Workshop Exercise: Coffee Brewing Process Instructions to Exercise 1: Develop a Process Variables Map for the Coffee Making Process. 1. Review the High Level Process Map 2. Review (& modify) the identified process steps in the process 3. List outputs and their Ys for each process step 4. List all inputs and their Xs for each process step and classify them as controlled or uncontrolled 5. Optional: Add process specifications for the identified Xs and Ys Resources for Exercise 2:  Flip Charts  Post-It Notes  Markers 30 Minutes
  24. 24. 24 April 9, 2016 – v 5.0 “Process Risk Analysis & Mistake Proofing” Agenda 1. Introduction to Mistake-Proofing (≈ 30 min) 2. Process Mapping & Exercise (≈ 90 min) 3. Cause & Effect Matrix & Exercise (≈ 60 min) 4. Process FMEA & Exercise (≈ 60 min) 5. Risk Analysis & Exercise (≈ 30 min) 6. Human Errors and Poka-Yoke & Exercise (≈ 60 min) 7. Process Control Plan & Exercise (≈ 60 min)
  25. 25. 25 April 9, 2016 – v 5.0 Cause & Effect Matrix → Basics  This is a simple matrix to quantify and emphasize the importance of customer requirements  Relates the Xs to the Ys (Customer Requirements) using the process map as the primary source of information  Process Ys are weighted as to their importance to the customer  Process Xs are scored as to their relationship to Process Ys
  26. 26. 26 April 9, 2016 – v 5.0 Cause & Effect Matrix → Results  Pareto of Process Xs to be evaluated further using the Process FMEA  Funnels the complete list of inputs and Xs generated in the Process Variables Map  Identify Ys that would be prioritized for Measurement Systems Analysis and initial Process Capability Studies (Six Sigma tools)  Continues the review and assessment of the Process Control Plan
  27. 27. 27 April 9, 2016 – v 5.0 Cause & Effect Matrix → Steps- by-Step Approach 1. Identify key customer requirements (Ys) from Process Variables Map 2. Rank order and assign priority factor to each Y (usually using a 1 to 10 scale) 3. Identify all process steps and Xs from the Process Variables Map 4. Evaluate correlation of each X to each Y • Low score: changes in the X have small effect on the Y • Moderate score: changes in the X can have some affect the Y • High score: changes in the X can greatly affect the Y 5. Cross multiply correlation values with priority factors for Ys and sum for each X
  28. 28. 28 April 9, 2016 – v 5.0 Importance to Customer >> (weighting value) Process Step X ProjectY1 ProjectY2 ProjectY3 ProjectY4 Total 1 Process Step 1 X 1 0 2 Process Step 1 X 2 0 3 Process Step 1 X 3 0 4 Process Step 1 X 4 0 5 Process Step 1 X 5 0 6 Process Step 1 X 6 0 7 Process Step 1 X 7 0 8 Process Step 1 X 8 0 Cause & Effect Matrix → Step 1: List the Ys 1. List the Process Ys These Ys are your high level Ys from your High Level Process Map. Most processes will have fewer than 3 or 4.
  29. 29. 29 April 9, 2016 – v 5.0 Importance to Customer >> (weighting value) Process Step X ProjectY1 ProjectY2 ProjectY3 ProjectY4 Total 1 Process Step 1 X 1 0 2 Process Step 1 X 2 0 3 Process Step 1 X 3 0 4 Process Step 1 X 4 0 5 Process Step 1 X 5 0 6 Process Step 1 X 6 0 7 Process Step 1 X 7 0 8 Process Step 1 X 8 0 Cause & Effect Matrix → Step 2: Weight the Ys 2. Weight Ys as to Customer importance. The weighting is normally from 1 to 10 with 10 being the most important or a distribution of 100 points across the identified Ys.
  30. 30. 30 April 9, 2016 – v 5.0 Importance to Customer >> (weighting value) Process Step X ProjectY1 ProjectY2 ProjectY3 ProjectY4 Total 1 Process Step 1 X 1 0 2 Process Step 1 X 2 0 3 Process Step 1 X 3 0 4 Process Step 1 X 4 0 5 Process Step 1 X 5 0 6 Process Step 1 X 6 0 7 Process Step 1 X 7 0 8 Process Step 1 X 8 0 Cause & Effect Matrix → Step 3: List Steps and Xs 3. List Process Xs by Process Step 3. Be sure to include each process and all process Xs for each step
  31. 31. 31 April 9, 2016 – v 5.0 Importance to Customer >> (weighting value) Process Step X ProjectY1 ProjectY2 ProjectY3 ProjectY4 Total 1 Process Step 1 X 1 0 2 Process Step 1 X 2 0 3 Process Step 1 X 3 0 4 Process Step 1 X 4 0 5 Process Step 1 X 5 0 6 Process Step 1 X 6 0 7 Process Step 1 X 7 0 8 Process Step 1 X 8 0 Cause & Effect Matrix → Step 4: Relate Xs to Ys 4. Relate or correlate Xs to Ys based upon team members experience
  32. 32. 32 April 9, 2016 – v 5.0 Relating Xs to Customer Requirements (Ys)  The team is ready to relate the Ys to the Xs  Correlational scores: No more than 4 levels  0, 1, 3 and 9 are typical values  Assignment of the scoring takes the most time  Independent scoring can help speed up process by having each team member first fill out the matrix silently  The most common scoring values are: 0 = No relationship / impact 1 = The X only remotely affects the Y 3 = The X has a moderate effect on the Y 9 = The X has a direct and strong effect on the Y  Some practitioners combine the 0 and 1 scores
  33. 33. 33 April 9, 2016 – v 5.0 Importance to Customer (weighting) 10 9 7 1 2 3 Numberof cracks Numberof pinholes Surface Defects Total Process Step X 1 Slip Prep Raw material vendor 3 0 0 2 Slip Prep Solid returns % 3 0 0 3 Slip Prep Liquid returns % 3 0 0 4 Slip Prep Operator experience 1 1 0 5 Slip Prep Slip rheological properties 9 0 0 6 Slip Prep Slip stirring speed 9 9 0 7 Slip Prep Deflocculant concentration 9 0 0 8 Slip Prep Composition formula 3 0 0 9 Slip Prep Operator 9 9 9 10 Mold Casting Type of plaster 9 0 0 11 Mold Casting Cast parameters 9 0 3 12 Mold Casting # of thickness pieces 9 3 3 13 Mold Casting # of finishing pieces 9 1 3 14 Mold Casting Tool type 9 1 9 15 Mold Casting Temperature 9 9 9 16 Mold Casting Humidity 9 1 1 17 Mold Casting Operator training 3 3 3 18 Mold Casting Work procedure detail 3 1 1 19 Mold Casting Installation 3 1 3 20 Mold Casting Drying time 9 3 1 4. Relate Xs to Ys Cause & Effect Matrix → Step 4: Relate Xs to Ys This is a subjective estimate of how influential the Xs are on the Ys
  34. 34. 34 April 9, 2016 – v 5.0 Importance to Customer >> (weighting value) Process Step X ProjectY1 ProjectY2 ProjectY3 ProjectY4 Total 1 Process Step 1 X 1 0 2 Process Step 1 X 2 0 3 Process Step 1 X 3 0 4 Process Step 1 X 4 0 5 Process Step 1 X 5 0 6 Process Step 1 X 6 0 7 Process Step 1 X 7 0 8 Process Step 1 X 8 0 Cause & Effect Matrix → Step 5: Prioritize the Xs Sum of Weighting values x Correlation scores across all Ys 5. Cross- multiply, sort & prioritize
  35. 35. 35 April 9, 2016 – v 5.0 10 4 8 Process Step Key Process Input Xs Paperwork errors Visitduration Unbilled expenses Total Verify patient / payer info Patient forms Amount of needed info 9 9 9 198 Update chart Care giver Time on job 9 9 9 198 Update chart Environment Time during shift 9 3 9 174 Update chart Environment Number of forms to update 9 3 9 174 Verify patient / payer info Reviewer Knowledge of requirements 9 1 9 166 Verify patient / payer info Environment Federal requirements 9 0 9 162 Verify patient / payer info Environment State requirements 9 0 9 162 Verify patient / payer info Environment Hospital requirements 9 0 9 162 Update chart Diagnosis information Quantity of items 9 0 9 162 Update chart Diagnosis information Code clarity 9 0 9 162 Complete billing info Billing clerk Knowledge of requirements 9 0 9 162 Complete billing info Billing clerk Knowledge of codes 9 0 9 162 Complete billing info Chart Code accuracy 9 0 9 162 Complete billing info Chart Completeness of patient info 9 0 9 162 Complete billing info Payer Requirement clarity 9 0 9 162 Rating of Importance to Customer >> Cause & Effect Matrix → Example
  36. 36. 36 April 9, 2016 – v 5.0 Too many Inputs & Xs? Narrow the Focus!  Phase 1 • Place the Ys across the top of the matrix and weight • Place ONLY the process steps down the side of the matrix • Score the relationship of the process steps to the Ys • Prioritize the process steps  Phase 2 • Start a new C&E Matrix with the Xs from only the top process steps from Phase 1 above • Score the relationship of the Xs to the Ys → Focuses the efforts and gives the team a feeling that they’re working on the important process steps first → Gives you a running start at the FMEA and preliminary Control Plan Analysis
  37. 37. 37 April 9, 2016 – v 5.0 Cause & Effect Matrix → Next Steps  Process FMEA • Transfer the highest ranked Xs to Process FMEA • Consider what it means if many of your highly ranked Xs are classified as Uncontrolled  Capability Review • Check Capability Summary for those Xs ranked high in the C&E matrix • If key process capabilities are not known, create a plan to study measurement systems and collect baseline data  Process Control Plan Review • Consider existing process controls for all highly ranked Xs and Ys from the C&E Matrix • Document short- and long-term Process Control Plan opportunities • Identify and implement “Low hanging fruit” and “Quick wins”
  38. 38. 38 April 9, 2016 – v 5.0 Cause & Effect Matrix → Initial Control Plan Evaluation  Key Question: Have you identified any obvious gaps in your existing process controls that will have to be addressed for this process to be successful?  Standard Operating Procedures • Do they exist? • Are they up-to-date and comprehended? • Do “operators” know where to find them? • Is “operator” certification necessary and done? • Is there a process audit timetable?  Controlled Inputs and Xs • How is monitoring done? • When are Xs verified? • Are specifications and optimum target values known? • Are target values consistent?
  39. 39. 39 April 9, 2016 – v 5.0 Workshop Exercise: Coffee Brewing Process Instructions to Exercise 2: Develop a Cause & Effect Matrix for the Coffee Making Process. 1. Rank order and assign priority factor to each Y 2. List all process steps and Xs from the Process Variables Map 3. Evaluate correlation of each X to each Y (low – moderate – high) 4. Cross multiply correlation values with priority factors for Ys and sum for each X 5. Identify and review TOP 10 – 15 Xs and inputs Resources for Exercise 2:  Flip Charts  Post-It Notes  Markers 30 Minutes
  40. 40. 40 April 9, 2016 – v 5.0 “Process Risk Analysis & Mistake Proofing” Agenda 1. Introduction to Mistake-Proofing (≈ 30 min) 2. Process Mapping & Exercise (≈ 90 min) 3. Cause & Effect Matrix & Exercise (≈ 60 min) 4. Process FMEA & Exercise (≈ 60 min) 5. Risk Analysis & Exercise (≈ 30 min) 6. Human Errors and Poka-Yoke & Exercise (≈ 60 min) 7. Process Control Plan & Exercise (≈ 60 min)
  41. 41. 41 April 9, 2016 – v 5.0  First used in the 1960's in the Aerospace industry during Apollo missions.  In 1974 the Navy developed MIL-STD-1629 regarding the use of FMEA.  In the late 1970's, automotive applications driven by liability costs, began to incorporate FMEA into the management of their processes  Now used across many industries as a method to improve quality and reliability and to manage risk. Failure Mode and Effects Analysis → History
  42. 42. 42 April 9, 2016 – v 5.0 Failure Mode and Effects Analysis or FMEA is a systematic methodology used to analyze the reliability of processes or products, i.e. latent process or product component failures and their effects on the overall process/product performance and/or safety. Failure Mode and Effects Analysis → Definition
  43. 43. 43 April 9, 2016 – v 5.0 The Four Types of FMEAs  System FMEA is used to analyze systems and sub-systems in early concept and design stage. A System FMEA focuses on potential failure modes between the functions of the system caused by system deficiencies. It includes the interactions between systems and elements of the system.  Design FMEA analyses products before they are released to manufacturing. A Design FMEA focuses on failure modes caused by design deficiencies.  Process FMEA analyses manufacturing and assembly processes. A Process FMEA focuses on failure modes caused by manufacturing, service or transactional process deficiencies.  Service FMEA analyses services before they reach the customer. A Service FMEA focuses on failure modes caused by system or process deficiencies. Failure Mode and Effects Analysis → The Four Types
  44. 44. 44 April 9, 2016 – v 5.0 Outputs of a Process FMEA A Process FMEA can be described as a systematic group of activities intended to:  recognize and evaluate the potential failure of a (new) product/ process and its effects,  develop a ranked list of potential failure modes, thus establishing a priority system for corrective action and improvement consideration,  identify actions which could eliminate or reduce the chance of the potential failure occurring, and  document the result of the process. Process Failure Mode and Effects Analysis → Outputs
  45. 45. 45 April 9, 2016 – v 5.0 Benefit of a Process FMEA The benefits of the Process FMEA are:  assists in the analysis of the manufacturing or business process, and  identifies process deficiencies and offers a corrective action plan,  identifies the critical and/or significant characteristics and helps in developing process control plans,  establishes a priority of corrective actions,  documents the rationale for changes. Process Failure Mode and Effect Analysis → Benefits
  46. 46. 46 April 9, 2016 – v 5.0 Important Note before we get started:  When conducting a Process FMEA, it is assumed that the design is the best it can be. If this assumption is not made, the FMEA team will perform the Design and Process FMEA simultaneously and will move in a circular pattern not accomplishing its task.  The only way to address the Design FMEA in the Process FMEA of conducting the Process FMEA is when the root cause of the failure modes in the process are caused by design specifications. Process Failure Mode and Effects Analysis
  47. 47. 47 April 9, 2016 – v 5.0 Process FMEA → The Template PROCESS FMEA Process Name: FMEA Team: Ranking Guidelines: [attached as copy] FMEA Worksheet Document No: Process Responsible: Severity of failure effect: 1 = Minor/No effect 10 = Very high/Hazardous File Location: FMEA Responsible: Occurrence of failure cause: 1 = Remote/Unlikely 10 = Very high/Almost inevitable Date (Orig.): Other Areas Involved/Effected: Detection of failure cause: 1 = Very high/Almost certainly 10 = Very low/Unlikely Date (Rev.): Risk Priority Number (RPN) = Severity * Occurrence * Detection Page of Process Description and Potential Potential Severity Potential Occurrence Current Process Detection RPN Recommended Responsible Completion Status Action Results Process Purpose Failure Mode Effect(s) of Failure of effect Cause(s) of Failure of cause Control(s) of cause (S*O*D) Action(s) Person Date Action Taken [S] [O] [D] RPN Process FMEA Body Improvement Plan
  48. 48. 48 April 9, 2016 – v 5.0 Process FMEA → The Template PROCESS FMEA Process Name: FMEA Team: Ranking Guidelines: [attached as copy] FMEA Worksheet Document No: Process Responsible: Severity of failure effect: 1 = Minor/No effect 10 = Very high/Hazardous File Location: FMEA Responsible: Occurrence of failure cause: 1 = Remote/Unlikely 10 = Very high/Almost inevitable Date (Orig.): Other Areas Involved/Effected: Detection of failure cause: 1 = Very high/Almost certainly 10 = Very low/Unlikely Date (Rev.): Risk Priority Number (RPN) = Severity * Occurrence * Detection Page of Process Description and Potential Potential Severity Potential Occurrence Current Process Detection RPN Recommended Responsible Completion Status Action Results Process Purpose Failure Mode Effect(s) of Failure of effect Cause(s) of Failure of cause Control(s) of cause (S*O*D) Action(s) Person Date Action Taken [S] [O] [D] RPN  The Process FMEA should be part of your Quality Management System. Manage it like you manage every other document.  Every Process FMEA should have an owner. It is the owner’s responsibility to understand and consider if process changes will impact the performance of other processes  The Process FMEA should be a living document. Make sure it is updated by the owner as needed and review it periodically as you review any other QMS document  …
  49. 49. 49 April 9, 2016 – v 5.0 Column: Process Step Description and Purpose Enter a simple description of the process step or activity being analyzed and indicate as concisely as possible its purpose. – What is the purpose, objective, function, goal of the process step? – What is the process step supposed to do ? Where the process step involves numerous operations (e.g. assembling) with different potential modes of failure, it may be desirable to list the operations as separate process steps. Process FMEA → The Template
  50. 50. 50 April 9, 2016 – v 5.0 Column: Potential Failure Mode Potential Failure Mode is defined as the manner in which the process step could potentially fail to meet the process step requirements and/or design intent. It is a description of the non-conformance at that specific operation. – How could this process step fail to complete its intended function? – Why could this part be rejected after this process step? – What does the customer find unacceptable? – How would the part not conform to specifications after this process step? Typical failure modes could be, but are not limited to: – bent, burred, cracked, deformed, short circuited, dirty, handling damage, improper set-up, tool worn, misprinted, or missing. Process FMEA → The Template
  51. 51. 51 April 9, 2016 – v 5.0 Process FMEA → Potential Failure Modes Process Step Description:  “Inserting the Coffee Filter” Process Step Success Criteria:  Filter Present – Right Filter – Right Position – … Potential Failure Modes:  No Filter – Too many Filters  Filter too small – Filter too large – Wrong Type  Filter misaligned – Filter not opened
  52. 52. 52 April 9, 2016 – v 5.0 Column: Potential Effect(s) of a Failure Mode Potential Effects of Failure are defined as the effects of the failure mode on the customer(s). It describes the effects of the failure in terms of what the customer might notice or experience. – What does the customer experience as a result of the failure mode described? – What happens or what is (are) the ramification(s) of this problem or failure? Typical potential effects could be, but are not limited to: – noise, inoperative, poor signal strength, or rough. If the “customer” is one of the next process steps: – cannot mount, cannot face, or does not fit. Process FMEA → The Template
  53. 53. 53 April 9, 2016 – v 5.0 Column: Potential Cause(s) of a Failure Mode Potential Cause of Failure is defined as why the failure could occur, described in terms of something that can be corrected or can be controlled. Only specific errors or malfunctions should be listed; ambiguous phrases (e.g. operator error, machine malfunction) should not be used. List, to the extent possible, every conceivable failure cause assignable to each potential failure mode. – Why would this failure mode occur? – What circumstances could cause the failure mode? Typical potential causes could be, but are not limited to: – improper heat treat (time, temperature), part missing or misaligned, improper torque (under, over), inadequate control procedure, human error like omission or wrong selection, lack or improper operating instruction. Process FMEA → The Template
  54. 54. 54 April 9, 2016 – v 5.0 Root Cause Analysis (RCA) Tools  Thorough probing to root causes will lead to broad, fundamental issues, involving management policies, product design, process capabilities or process control, technology constraints, standard operating procedures, work instruc- tions, training, … .  Root Cause Analysis Tool Box:  The 5 Why’s  Why – Why Diagram  Fishbone Diagram  Is – Is Not Matrix  Affinity Diagram  Interrelationship Diagram  Scatter Diagram  Box Plots  Histograms  Process Capability Studies  SPC or Pre-Control Charts  …
  55. 55. 55 April 9, 2016 – v 5.0 How to apply the 5 Why’s Description: The 5 Why’s Analysis helps to identify the root cause of a problem in a graphical and systematic manner. It encourages the team to reach an answer that is fundamental and actionable. Procedure: Step 1: Write the Failure Mode in the upper left corner of a flip chart or white board. Step 2: Ask “Why?” this problem could occur. Write the potential cause underneath the original Failure Mode. Step 3: The potential cause identified in Step 2 now becomes a new Failure Mode. Repeat Step 2 and ask “Why?”, e.g. “Why would this failure occur?", again. Step 4: Continue Step 2 and Step 3 until you reach an answer that is fundamental and actionable, e.g. standard operating procedure, work instruction, system issues, training needs, … .
  56. 56. 56 April 9, 2016 – v 5.0 Potential Root Cause Root Cause Analysis Tools → The 5 Why’s Potential Failure Mode (Object & Defect)? WHY? → The door frame had been “over-ground” WHY? → Team member did not use the grinder properly There could be grinding marks on the door frame WHY? → Team member was not properly trained
  57. 57. 57 April 9, 2016 – v 5.0 Root Cause Analysis Tools → Why – Why Diagram Failure Mode: Customer complaint due to grinding marks on the door frame The door frame had been “over- ground” Wrong Tool was used Operator was untrained Current grinding method is not capable Cosmetic requirements not understood Current grinding method is too complicated Description: The Why-Why Diagram helps to identify possible causes of a problem or failure mode in a graphical and systematic manner. The tools helps the team to recognize the broad network of possible causes and the relationship among them. Example: No written cosmetic standard exists No formal training exists Training Process was not applied Tools are not marked … …
  58. 58. 58 April 9, 2016 – v 5.0 How to develop a Why–Why Diagram Procedure: Step 1: Write the failure mode on a Post-It note and place it at the far left of a flip chart or white board. Step 2: Ask “Why?” this failure mode does or could occur. Write all these possible causes on Post-It notes (one for each) and place them in a column right to the initial failure mode. Connect the failure mode with the possible causes. Step 3: Each of the possible causes now becomes a new failure mode. Repeat Step 2 and ask “Why?”, e.g. “Why does this situation could cause the problem?”, again. Connect the new failure mode with the associated possible causes. Step 4: Continue Step 2 and Step 3 with each new failure mode until you reach answers that are fundamental and actionable, e.g. standard operating procedure, work instruction, system issues, training needs, … . 1 2 3
  59. 59. 59 April 9, 2016 – v 5.0 Root Cause Analysis Tools → Fishbone Diagram The Fishbone Diagram (Cause-and-Effect or Ishikawa Diagram) is a systematic way of looking at the causes of a problem and how they are related using pre-defined categories, e.g. 4Ms & 1 E. 4M’s & 1E = MEN METHODS MATERIALS MACHINES + ENVIRONMENT Effect or Outcome Machines Materials Methods Environment Trunk Primary Causal Factor Main Branch Minor Branch Men Potential Failure Mode
  60. 60. 60 April 9, 2016 – v 5.0 How to develop a Fishbone Diagram  Step 1: Define the failure mode to be analyzed  Step 2: Draw a horizontal trunk line (the backbone of the fish) and to the right end of this write the failure mode (= fish’s head)  Step 3: Draw the main branches and write the selected categories at the end of each main branch  Step 4: Brainstorm for all possible causes for each of the selected categories  Step 5: Group the possible causes under each of the categories and draw a minor branch for each cause  Step 6: Check that the diagram is complete and logical
  61. 61. 61 April 9, 2016 – v 5.0 Column: Current Controls Current Process Controls are descriptions of the controls that either prevent to the extent possible the failure mode from occurring or detect the failure mode should it occur. The focus is on the effectiveness of the control method/technique to catch the problem before it reaches the customer. Typical process controls could be, but are not limited to: – Standard Operating Procedures (“SOPs”) & Work Instructions – Checklists – Error-proofing systems and devices (e.g. Poka-Yoke) – Color coding or tags – Examining safety margins (e.g. Process Capability Studies) – Statistical Process Control (SPC) or Pre-Control – Post-process evaluation (sample based inspection AQL). Process FMEA → The Template
  62. 62. 62 April 9, 2016 – v 5.0 Workshop Exercise: Coffee Brewing Process Instructions to Exercise 3: Define Potential Failure Modes, Effects and Possible Causes for 2-3 Process Steps of the Coffee Making Process.  Create a Process FMEA Template on a Flip Chart  Select a process step to be analyzed  Identify all potential Failure Mode for the selected process step.  For each of the identified Failure Modes, determine the potential Effects and possible Causes.  Identify the current Controls for each identified Cause or Failure Modes.  Repeat the last 4 activities above for 1 or 2 additional process steps. Resources for Exercise 3:  Flip Charts & Markers45 Minutes
  63. 63. 63 April 9, 2016 – v 5.0 “Process Risk Analysis & Mistake Proofing” Agenda 1. Introduction to Mistake-Proofing (≈ 30 min) 2. Process Mapping & Exercise (≈ 90 min) 3. Cause & Effect Matrix & Exercise (≈ 60 min) 4. Process FMEA & Exercise (≈ 60 min) 5. Risk Analysis & Exercise (≈ 30 min) 6. Human Errors and Poka-Yoke & Exercise (≈ 60 min) 7. Process Control Plan & Exercise (≈ 60 min)
  64. 64. 64 April 9, 2016 – v 5.0 Risk Analysis 1. Severity (Sev): Severity is an assessment of the seriousness of the effect of the potential failure mode to the customer. 2. Occurrence (Occ): Occurrence is how frequently the specific failure cause/mechanism is projected to occur. 3. Detection (Det): Detection is an assessment of the likelihood that a failure mode will stay undetected by the proposed process controls and thus will leave the manufacturing or assembly process. Process FMEA → Risk Analysis
  65. 65. 65 April 9, 2016 – v 5.0 Process FMEA → Example for Severity Ranking Rank Severity of the Effect of a Failure Mode 1 Minor: Unreasonable to expect that the minor nature of this failure would cause any real effect on the product and/or service. Customer will probably not even notice the failure. 2-3 Low: Low severity ranking due to nature of failure causing only a slight customer annoyance. Customer probably will notice a slight deterioration of the product and/or service, a slight in convenience in the next process, or minor rework action. 4-6 Moderate: Moderate ranking because failure causes some dissatisfaction. Customer is made uncomfortable or is annoyed by the failure. May cause the use of unscheduled repairs and/or damage of equipment. 7-8 High: High degree of customer dissatisfaction due to the nature of the failure such as an inoperable product or inoperative convenience. Does not involve safety issues or government regulations. May cause disruptions to subsequent processes and/or services. 9-10 Very high: Very high severity is when the failure affects safety and involves non- compliance with government regulations. Please make sure that the Ranking Scheme reflects your organization’s needs. Otherwise, revise the Ranking Scheme accordingly.
  66. 66. 66 April 9, 2016 – v 5.0 Process FMEA → Example for Occurrence Ranking Rank Probability of Failure Mode Occurrence Possible Failure Rates PPM*) Failure rate ppk 1 Remote: Failure is unlikely. No failures ever associated with almost identical processes.  1 1 out of 1 000 000  1.67 2 Very Low: Only isolated failures associated with almost identical processes.  7 1 out of 150 000  1.50 3 Low: Isolated failures associated with similar processes.  64 1 out of 15 000  1.33 4-6 Moderate: Generally associated with processes similar to previous processes which have experienced occasional failures, but not in major proportions.  500  2700  12 500 1 out of 2000 1 out of 400 1 out of 80  1.17  1.00  0.83 7-8 High: Generally associated with processes similar to previous processes that have often failed.  50 000  125 000 1 out of 20 1 out of 8  0.67  0.51 9-10 Very high: Failure is almost inevitable.  333 000  333 000 1 out of 3  1 out of 2  0.33 < 0.33 Please make sure that the Ranking Scheme reflects your organization’s needs. Otherwise, revise the Ranking Scheme accordingly.
  67. 67. 67 April 9, 2016 – v 5.0 Process FMEA → Example for Detection Ranking Rank Probability of Failure Mode or Possible Cause Detection Detection 1 Current control(s) almost certain to detect the failure mode. Reliable detection controls are known with similar processes. Almost certain 2 Very high likelihood current control(s) will detect failure mode. Very high 3 High likelihood current control(s) will detect failure mode. High 4 Moderately high likelihood current control(s) will detect failure mode. Moderately high 5 Moderate likelihood current control(s) will detect failure mode. Moderate 6 Low likelihood current control(s) will detect failure mode. Low 7 Very low likelihood current control(s) will detect failure mode. Very low 8 Remote likelihood current control(s) will detect failure mode. Remote 9 Very remote likelihood current control(s) will detect failure mode. Very remote 10 No known control(s) available to detect failure mode . Almost impossible Please make sure that the Ranking Scheme reflects your organization’s needs. Otherwise, revise the Ranking Scheme accordingly.
  68. 68. 68 April 9, 2016 – v 5.0 Process FMEA → General Comments to Risk Analysis Achieving agreement across the FMEA Team about the “correct” risk ranking is not always easy or possible. Below some team decision rules an organization may consider to not waste valuable time on non-value add discussions.  If the disagreement is an adjacent category, average out the difference. For example, if one member says 4 and someone else says 6, the ranking in this case should be 5.  If the disagreement jumps one category, then consensus must be reached. Even with one person holding out, total consensus must be reached. No average, no majority. Everyone in that team must have ownership of the ranking. They may not agree 100 %, but they need to be able to “live with it”.
  69. 69. 69 April 9, 2016 – v 5.0 Risk Priority Number (RPN): For higher RPN’s the team must undertake efforts to reduce this calculated risk through corrective action(s). In general practice, regardless of the resultant RPN, special attention should be given when severity is high. 0001)()()(  DetOccSevRPN Process FMEA → Risk Priority Number - RPN
  70. 70. 70 April 9, 2016 – v 5.0 Workshop Exercise: Coffee Brewing Process Instructions to Exercise 4: Perform a Risk Assessment (Sev, Occ, Det & RPN) for 3 Process Steps of the Coffee Making Process.  Perform a Severity Assessment on all potential Failure Effects identified in the last exercise  Perform an Occurrence Assessment on all potential Root Causes identified in the last exercise  Perform a Detection Assessment on all current Process Controls identified in the last exercise  Calculate the RPN for every Failure Effect – Root Cause – Process Controls combination Resources for Exercise 4:  Flip Charts  Markers45 Minutes
  71. 71. 71 April 9, 2016 – v 5.0 Extreme cases where corrective & preventive actions must be taken include the following process ratings. Assessment Rating Causes of Failure Actions OS D 11 1 Ideal situation (goal) No action (N/A) 11 10 Assured mastery N/A 110 1 Failure does not reach user N/A 110 10 Failure reaches user Yes 101 1 Frequent fails, detectable, costly Yes 101 10 Frequent fails, reach user Yes 1010 1 Frequent fails with major impact Yes 1010 10 Trouble ! Yes, Yes, Yes Process FMEA → Risk Assessment
  72. 72. 72 April 9, 2016 – v 5.0 Actions that will influence the Process FMEA risk evaluation are: Corrective & Preventive Actions OS D Redesign the process YM Y Redesign the product MM M Improve current control NN Y Change material parts MN M Change the field environment NM N Improve reliability program YN Y Improve employee training MN Y Implement FMEA program YY Y Implement SPC program YN Y Improve quality plan YN Y Y = Yes, M = Maybe, N = No Process FMEA → Action Planning
  73. 73. 73 April 9, 2016 – v 5.0 “Process Risk Analysis & Mistake Proofing” Agenda 1. Introduction to Mistake-Proofing (≈ 30 min) 2. Process Mapping & Exercise (≈ 90 min) 3. Cause & Effects Matrix & Exercise (≈ 60 min) 4. Process FMEA & Exercise (≈ 60 min) 5. Risk Analysis & Exercise (≈ 30 min) 6. Human Errors and Poka-Yoke & Exercise (≈ 60 min) 7. Process Control Plan & Exercise (≈ 60 min)
  74. 74. 74 April 9, 2016 – v 5.0 The Human “Noise” Factor The order really has to go out today !!! Lost a lot of money in Poker last night. Hopefully Molly is doing well in her test today. It is Friday !!! Wonder what I should wear tonight. Stop trying to fix your people. Fix your Process.
  75. 75. 75 April 9, 2016 – v 5.0  Human Errors are inevitable !!! Errors can´t be avoided. People will always make mistakes. Human Errors → Dealing with Human Errors  Human Errors can be eliminated !!! Any kind of mistake people make can be reduced or even eliminated. People make fewer mistakes if they are supported by a production system based on the principle that human errors can be prevented.  An organizations must establish a mistake-proofing mindset that promotes the belief that it is unacceptable to allow for even a small number of product or service defects caused by human errors.
  76. 76. 76 April 9, 2016 – v 5.0 Difference between Mistake and Defect “There must have been an error detected; the machine shut down by itself!” “I have an extra part. I must have omitted a step!” "The causes of defects lie in worker mistakes, and defects are the results of neglecting those mistakes. It follows that mistakes will not turn into defects if they are discovered and eliminated beforehand.” Dr. Shigeo Shingo
  77. 77. 77 April 9, 2016 – v 5.0 Please write down 3 Human Errors that have happened in your plant or organization over the last couple of weeks. Quick Exercise Identify 3 Human Errors
  78. 78. 78 April 9, 2016 – v 5.0 1. Work Progress Understanding Start End 2. Work Object Selection 3. Recognition of Work Object’s State 4. Recognition of the Motion to be done on the Work Object 6. Motion Execution 5. Recognition of the Danger in the Motion Human Errors → The Human Work Model
  79. 79. 79 April 9, 2016 – v 5.0 1. Omission 2. Excessive / insufficient repetition 3. Wrong order 4. Early / late execution 5. Execution of restricted work 6. Incorrect selection 7. Incorrect counting 8. Misrecognition 9. Failing to sense danger 10. Incorrect holding 11. Incorrect positioning 12. Incorrect orientation 13. Incorrect motion 14. Improper holding 15. Inaccurate motion 16. Insufficient avoidance Human Errors → The 16 Human Error Modes
  80. 80. 80 April 9, 2016 – v 5.0 Please try to assign each of the 3 Human Errors you wrote down earlier to one of the 16 Human Error Modes we will now discuss in more detail. Quick Exercise Categorize the 3 Human Errors
  81. 81. 81 April 9, 2016 – v 5.0 1. Failures in “Understanding the Work Progress” 1. Omission → What part of the process is prone to be omitted? 2. Excessive / Insufficient Repetition → What part of the process is prone to be excessively repeated? 3. Wrong Order or Sequence → In what wrong sequence can the process be executed? 4. Early / Late Execution → What execution can be early or late? 5. Execution of Restricted Work → What tasks could be executed by unauthorized personnel? The Human Work Model & The 16 Human Error Modes
  82. 82. 82 April 9, 2016 – v 5.0 2. Failures in “Selecting the Work Object” 6. Incorrect Selection (or Identification) → What object of the process is prone to be incorrectly selected or identified? 7. Incorrect Counting (or Calculating) → What objects of the process can be counted, measured or calculated incorrectly? The Human Work Model & The 16 Human Error Modes
  83. 83. 83 April 9, 2016 – v 5.0 3. Failures in “Recognizing the State of the Work Object” 8. Misrecognition (or Misunderstanding or Misreading) → What misunderstanding or misreading is prone to occur? → What information, risk or failure/error is prone to be overlooked? → What miscommunication is prone to occur? → What incorrect decision is prone to occur? The Human Work Model & The 16 Human Error Modes
  84. 84. 84 April 9, 2016 – v 5.0 4. Failure in “Recognizing Correct Motion to be Done on Work Object” 10. Incorrect Holding → What object of the process are prone to mishandling? 11. Incorrect Orientation → What orientation error is prone to occur? 12. Incorrect Positioning → What positioning setting error is prone to occur? 13. Incorrect Motion → What motion or movement error is prone to occur? The Human Work Model & The 16 Human Error Modes
  85. 85. 85 April 9, 2016 – v 5.0 5. Failure in “Recognizing the Danger in the Motion” 9. Failure to Sense Danger → What information, risk or failure/error is prone to be overlooked? The Human Work Model & The 16 Human Error Modes
  86. 86. 86 April 9, 2016 – v 5.0 6. Failure to “Execute Correct Motion on Work Object” 14. Improper Holding → What object of the process are prone to mishandling? 15. Inaccurate Motion → What motion or movement error is prone to occur? 16. Insufficient Avoidance → What can be unintentionally touched, stuck or splashed? → What movement can cause harm? The Human Work Model & The 16 Human Error Modes
  87. 87. 87 April 9, 2016 – v 5.0 1. Work Progress Understanding Error Modes (1) - (5) Start End 2. Work Object Selection Error Modes (6) - (7) 3. Recognition of Work Object’s State Error Modes (8) 4. Recognition of the Motion to be done on the Work Object Error Modes (10) - (13) 6. Motion Execution Error Modes (14) - (16) 5. Recognition of the Danger in the Motion Error Modes (9) The Human Work Model & Error Modes
  88. 88. 88 April 9, 2016 – v 5.0 Were you able to assign each of your 3 Human Errors to one of the 16 Human Error Modes? Quick Exercise Categorize the 3 Human Errors
  89. 89. 89 April 9, 2016 – v 5.0 A worker reads a work-order sheet, selects an appropriate part, and assembles it onto a corresponding sub-assembly product. Decomposition in Work Segments: i. reading the work-order sheet ii. getting a part to be assembled from parts boxes iii. assembling the part onto the sub-assembly product Human Error Modes: i. Reading the work-order sheet 1. Forgetting to read the sheet (mode 1: omission) 2. Reading the wrong sheet (mode 6: incorrect selection) 3. Misreading the sheet (mode 8: misrecognition) Human Work Model & Error Modes → Example ii. Getting a part to be assembled from parts boxes 1. Forgetting to get the part (mode 1: omission) 2. Selecting the wrong part (mode 6: incorrect selection) 3. Dropping the part (mode 14: improper holding)
  90. 90. 90 April 9, 2016 – v 5.0 iii. Assembling the part onto the sub-assembly product 1. Forgetting to assemble the part (mode 1: omission) 2. Assembling onto the wrong sub-assembly product (mode 6: incorrect selection) 3. Holding a damageable part of the sub-assembly product (mode 10: incorrect holding) 4. Assembling the part in the wrong position (mode 11: incorrect positioning) 5. Assembling the part the wrong way around (mode 12: incorrect orientation) 6. Inaccurately assembling the part (mode 15: inaccurate motion) Human Errors → Human Work Model Example
  91. 91. 91 April 9, 2016 – v 5.0 Human Errors → Six Mistake Proofing Principles 1. Elimination seeks to eliminate an error-prone process step by redesigning the product or process so that the task or part is no longer necessary. Example: An example of elimination is the use of ambient- light sensors to turn outside lighting on and off. 2. Prevention modifies the product or process so that it is impossible to make a mistake or that a mistake becomes a defect. Example: An example would be the change from a rectangular to a round manhole.
  92. 92. 92 April 9, 2016 – v 5.0 Human Errors → Six Mistake Proofing Principles 3. Replacement substitutes a more reliable process to improve repeatability. This includes use of robotics or automation that prevents a manual assembly error. Example: An example would be the coin dispenser in food stores preventing that customers are getting short changed. 4. Facilitation is the most used principle and employs techniques and combining steps to make a process step easier to perform or less error- prone. This includes visual controls including color coding, marking or labeling parts; checklists that list all tasks that need to be performed; exaggerated asymmetry to facilitate correct orientation of parts. Example: An example would be to color code parts that are similar in shape or the use of a slipping-type torque wrench to prevent over tightening.
  93. 93. 93 April 9, 2016 – v 5.0 Human Errors → Six Mistake Proofing Principles 5. Detection involves identifying a mistake before further processing occurs so that the operator can quickly correct the defect. Example: Examples would include a weld counter to ensure the correct number of welds or a software modification that will not allow incorrect entries. 6. Mitigation seeks to minimize the effects of the mistake. This includes mechanisms that reduce the impact of a error and defect; products designed with low-cost, simple rework procedures when an error is discovered; extra design margin or redundancy in products to compensate for the effects of errors. Example: An example would be a smoke or heat detector detecting a hazardous situation.
  94. 94. 94 April 9, 2016 – v 5.0  Variation Control Use of special jigs, fixtures, or assembly tools that reduce the variation of how parts are manufactured or assembled  Workplace Organization Error prevention by proper organization of the workplace or work station; e.g. implementation of a 5S Visual Workplace Program  Identification Errors are prevented by use of clearly written, visual and easily available materials, work instructions and tools  Process Checks Performance of specific in-process checks to prevent errors  Poka - Yoke Devices Ensures mistake and errors cannot become defects by automatically detecting error conditions and immediately rejecting the part or shutting down the process. Poka- Yoke devices work best when a specific step must be taken to re-start the process once a mistake or error has been detected. Five Key Mistake-Proofing Methods
  95. 95. 95 April 9, 2016 – v 5.0 Poka (= inadvertent error) - Yoke (= avoid) devices help us avoid defects, even when inadvertent errors are made. Poka - Yoke helps build Quality into Processes and Products Human Errors → Poka-Yoke Mistake Proofing Poka-yoke (poh-kah yoh-keh) was coined in Japan during the 1960s by Shigeo Shingo who was one of the industrial engineers at Toyota.
  96. 96. 96 April 9, 2016 – v 5.0 Requirements: • The outcome of the process or routine must be known in advance so as to have a standard for comparison • There must be an ability to create a break between cause and effect in the process so as to provide an opportunity to insert a Poka-Yoke Poka-Yoke devices work best in environments or processes: • requiring substantial operator skill • where training or turnover cost is high • with frequent interruptions and distractions • with a consistent set of mixed products • with similarly positioned or configured parts, controls or tools • requiring replacement or orientation of parts in order to prevent mispositioning Where to use Poka-Yoke Devices?
  97. 97. 97 April 9, 2016 – v 5.0 Good Poka-Yoke devices, regardless of their implementation, share many common characteristics:  they are simple and cheap. If they are too complicated or expensive, their use will not be cost-effective.  they are part of the process, implementing what Shingo calls "100%" inspection.  they are placed close to where the mistakes occur, providing quick feedback to the workers so that the mistakes can be corrected. Characteristics of a Good Poka-Yoke Device
  98. 98. 98 April 9, 2016 – v 5.0 1. Guide “Pins” of Different Size & Shape 2. Error Detection and Alarms 3. Limit Switches 4. Sensors 5. Vision Systems 6. Counters and Timers 7. Checklists Human Errors → Seven Best Poka-Yoke Devices
  99. 99. 99 April 9, 2016 – v 5.0 1. Guide Pins Guide pins of different sizes and/or shapes and placed in the proper locations ensure that parts are being assembled correctly by providing the operator feedback when a mistake has been made. Guide pins can also be used in jigs to ensure proper positioning of the part. Applications • Proper alignment of a work piece • Proper orientation of a work piece Features • Easy to develop & implement • May be the result of DFA and DFM activities (Product Quality Planning) Human Error Prevention • wrong order, incorrect selection, incorrect positioning, incorrect orientation, … Seven Best Poka-Yoke Devices → Guide Pins
  100. 100. 100 April 9, 2016 – v 5.0 2. Error Detection & Alarms In general, an error detection device can provide a visual alarm such as a flashing light or an audible alarm such as a horn or siren. These devices signal that a problem is either about to occur or has just happened. With a warning effect, the response is not automatic; someone has to take action. Application • The signal must be triggered by something in the process, usually a sensor. Features • For audible warnings, there are sirens, horns, bells, and even voice synthesizers. • For visual alarms, there are lights that flash, rotate, strobe, or just light up. Warning: If you do use warnings, the audible or visual signal must stand out from background noise and lights. If audible alarms are used, be careful not to exceed noise standards. Be careful of “alarm silence buttons.” It is easy to silence the alarm and then forget to take action. Operators need thorough training on how to react to warnings. Seven Best Poka-Yoke Devices → Error Detection/Alarms
  101. 101. 101 April 9, 2016 – v 5.0 Problem Statement: How to ensure that everything makes it in the box? Solution: Use of a scale connected with a visual & audio alarms when the weight of a package falls outside pre-defined specification limits. Seven Best Poka-Yoke Devices → Error Detection/Alarms Cons: Variation in material may result in false fails and pass packages.
  102. 102. 102 April 9, 2016 – v 5.0 3. Limit Switches Limit switches are electro-mechanical devices that are activated or deactivated when an object comes in contact with them. They are used to detect the presence or absence of an object. Applications • Proper positioning of safety devices • Detection presence or absence of an object • Positioning of a work piece Features • Requires physical contact Human Error Prevention • Omission, excessive/insufficient repetition, incorrect selection, incorrect counting, incorrect positioning, incorrect orientation Seven Best Poka-Yoke Devices → Limit Switches
  103. 103. 103 April 9, 2016 – v 5.0 4.1 Proximity Sensors Proximity sensors emit a high-frequency magnetic field and detect an upset in the field when an object enters it. They can be used to detect the presence or absence of an object. Applications • Sensing of tank or bin level • Confirmation of part or object passes by • Detection presence or absence of object • Positioning of work piece Features • Non-contact - Work in harsh environments - Small sensors are available for installation in tight areas - Fast response speed Human Error Prevention • Omission, excessive/insufficient repetition, incorrect selection, incorrect counting, incorrect positioning, incorrect orientation, … Seven Best Poka-Yoke Devices → Sensors
  104. 104. 104 April 9, 2016 – v 5.0 4.2 Laser Displacement Sensors Laser displacement sensors focus a semiconductor laser beam on a target and use the reflectance of the beam off the target to determine the presence of a target and distance to it. Applications • Measuring distance • Detection of presence or absence of a feature • Confirmation of part or object passes by • Positioning of work piece Features • Non-contact - Works in harsh environments - Some devices can achieve measurement precision down to .004 mils (0.1µm). Human Error Prevention • Omission, incorrect selection, incorrect counting, failing to sense danger, … Seven Best Poka-Yoke Devices → Sensors
  105. 105. 105 April 9, 2016 – v 5.0 5. Vision Systems Vision systems use cameras to look at a surface and then compare the surface viewed to a “standard” or reference surface stored in the computer. They can be used to detect the presence or absence of an object, the presence of defects, or to make distance measurements. Applications • Missing or incorrect parts in an automated assembly line • Poor quality surfaces or components • Correct orientation of parts or labels • Ensure correct relative position • Color detection Features • Non-contact - Need to have sufficient light - Flexible (can be reprogrammed for a variety of applications) - Compact systems are now available. Human Error Prevention • Omission, incorrect selection, incorrect positioning, incorrect orientation, misrecognition, … Seven Best Poka-Yoke Devices → Vision Systems Checking for Label Presence, Color, Orientation, & Alignment.
  106. 106. 106 April 9, 2016 – v 5.0 6. Counters & Timers Counters (optical or electro-mechanical) look at the occurrence of events. They are usually triggered by some type of sensor. Counters can be programmed to shut down the process if a set number of events do not occur or if too many events do occur. Timers can shut down the process if processing time or activity time does not meet or exceeds a preset level. Applications • Ensuring the proper number of events occurred • Preventing failure of equipment or a component by timing usage Features • Flexible - Easy to use - Easy for people to understand Human Error Prevention • excessive/insufficient repetition, incorrect counting, incorrect positioning, incorrect orientation, … Seven Best Poka-Yoke Devices → Counters & Timers Correct Number of Holes
  107. 107. 107 April 9, 2016 – v 5.0 7. Checklists A checklist is a type of informational job aid used to reduce failure by compensating for potential limits of human memory and attention. It helps to ensure consistency and completeness in carrying out a task. Applications • Shift Start-up • Product Changeover • Equipment Set-up Features • Easy to develop - Easy to use - Easy for people to understand Human Error Prevention • omission, early/late execution, wrong order, misrecognition, … Seven Best Poka-Yoke Devices → Checklists
  108. 108. 108 April 9, 2016 – v 5.0 Human Errors → Mistake-Proofing Examples SIM cards only fit one way. The right way. Expose your team to (simple) everyday Mistake-Proofing devices and examples and make them think about how they could use these concepts in their own process and work area.
  109. 109. 109 April 9, 2016 – v 5.0 Human Errors → Mistake-Proofing Examples Never forget your cell phone again. «Pick to Light»: on an assembly line, if the above light is green means that you must take the piece. If the light above the rack is red means that you must not take that piece.
  110. 110. 110 April 9, 2016 – v 5.0 Human Errors → Mistake-Proofing Examples Some of you may not remember. I still do and have lost (and found) a few of them. Does it fit. Error detection and defect prevention. → Limit Switches
  111. 111. 111 April 9, 2016 – v 5.0 Human Errors → Mistake-Proofing Examples It only fits one way by using guide pins and asymmetric product design. Good Product Quality Planning. → Guide “Pin” Human Error prevention through a visual workplace.
  112. 112. 112 April 9, 2016 – v 5.0 Human Errors → Mistake-Proofing Examples An oil change facility puts the dip stick on the fender protector. Removing the fender protector will cause the dip stick to clatter on the floor unless it has been reinserted. → Workplace Organization After a patient died from receiving a medication that was not properly diluted, all of that medication was diluted before being stored. → Pre-Kitting
  113. 113. 113 April 9, 2016 – v 5.0 Human Errors → Mistake-Proofing Examples Human Error detection through automated defect detection devices such as sensors, limit switches, scales, … . Getting the torque on bolts right is very tricky business for many companies. Huck fasteners mistake-proof this problem using a hybrid: half “pop-rivet,” half bolt. The tension on the bolt is created in a linear fashion and the “nut” is clamped in place and the excess bolt length is cut off.
  114. 114. 114 April 9, 2016 – v 5.0 Human Errors → Mistake-Proofing Examples Well Designed garage door openers have two safety features: (1) a contact safety reverse feature, which opens the door if it hits a person or object, and (2) an infrared beam across the doorway that causes the door to reverse automatically if a person or pet who passes through the beam. A company called Metric Blue offers metric bolts tinted blue. Why blue? So that when you have mixed metric and inch-series parts and fasteners it is easier to determine which standard you are working with. Company literature says, “by differentiating the metric fasteners (and tools) through our "blue" coating, we've eliminated the risk of failure or accidents due to mismatched components.”
  115. 115. 115 April 9, 2016 – v 5.0 Human Errors → Mistake-Proofing Examples Consumer friendly Mistake-Proofing product design improves usability and Customer Satisfaction. … and many more. Preventing missing weld nuts, with a sensor linked to a visual & audio alarm. Process will stop automatically and a corrective action is required.
  116. 116. 116 April 9, 2016 – v 5.0 Workshop Exercise: Coffee Brewing Process Instructions to Exercise 5: Develop improved Process Controls using Mistake-Proofing Principles and Poke-Yoke Devices where possible.  Brainstorm and develop as many mistake-proofing methods and Poke-Yoke devices to the process steps with the highest RPN and highest Detection ranking as time allows Resources for Exercise 5:  Flip Charts  Post-It Notes  Markers 30 Minutes
  117. 117. 117 April 9, 2016 – v 5.0 “Process Risk Analysis & Mistake Proofing” Agenda 1. Introduction to Mistake-Proofing (≈ 30 min) 2. Process Mapping & Exercise (≈ 90 min) 3. Cause & Effect Matrix & Exercise (≈ 60 min) 4. Process FMEA & Exercise (≈ 60 min) 5. Risk Analysis & Exercise (≈ 30 min) 6. Human Errors and Poka-Yoke & Exercise (≈ 60 min) 7. Process Control Plan & Exercise (≈ 60 min)
  118. 118. 118 April 9, 2016 – v 5.0 Process Control Plan → Objective A Control Plan is a written statement of an organization’s quality planning actions for a specific process, product, or service. The Objective of an effective Process Control Plan is to  operate processes consistently on target with minimum variation, which results in minimum waste and rework  assure that product and process improvements that have been identified and implemented become institutionalized  provide for adequate training in all standard operating procedures, work instructions and tools Customer Requirements Product & Part Characteristics Process Input & Output Characteristics Process Controls Process Control Plan
  119. 119. 119 April 9, 2016 – v 5.0 Process Control Plan → Template Supplier: Product: Key Contact: Process: E-Mail / Phone: Product Characteristic Process Characteristic Characteristic Process Step Specification (LSL, USL &Target) Date (Orig): Date (Rev): Control Method Reaction Plan Control Limits (LCL & UCL) Measurement System Sample Size Sample Frequency Operational Excellence Process Control Plan
  120. 120. 120 April 9, 2016 – v 5.0  Process: Name of the process to be controlled  Process Step: The process steps of the process to be controlled  Characteristic (Product/Process): Name of the characteristic of a process step or a product, which will actually be controlled.  Specification: Actual specification, which has been set for the characteristic to be controlled. This may be verified e.g. in standards, drawings, requirements or product requirement documents.  Control Limits: Control limits are specified for characteristics that are quantifiable and selected for trend analysis (x-bar/R, x/mR, p charts). When the process exceeds these limits, corrective actions are required.  Measurement System: Method used to evaluate or measure the characteristic. This may include e.g. gages, tools, jigs and test equipment or work methods. An analysis of the repeatability and the reproducibility of the measurement system must first be carried out (e.g. Gage R&R Study). Process Control Plan → Template
  121. 121. 121 April 9, 2016 – v 5.0  Sample Size: Sample size specifies how many parts are evaluated at any given time. The sample size will be “100 %” and the frequency “continuous” in case of 100% inspection.  Sample Frequency: Sample frequency specifies the how often a sample will be taken, e.g. once per shift or every hour.  Control Method: Brief description of how the information/data will be collected, analysed/controlled and reported. More detailed information may be included in a named work instruction.  Reaction Plan: Necessary corrective actions to avoid producing non- conforming products or operating out-of-control. Corrective actions should normally be in the responsibility of the person closest to the process, e.g. the machine operator. This is to secure, that immediate corrective actions will take place and the risk of non-conforming products will be minimized. More detailed information may be included in a named work instruction. Process Control Plan → Template
  122. 122. 122 April 9, 2016 – v 5.0 Start Checkpoints Activators Corrective ActionsNo No No Yes Yes Yes Yes Yes Yes End No No Out-of-Control-Action-Plans (OCAP)
  123. 123. 123 April 9, 2016 – v 5.0  The OCAP is a systematic and ideal problem-solving tool for process problems because it reacts to out-of-control situations in real time.  OCAPs standardize the best problem-solving approaches from the most skilled and successful problem solvers (experts/operators).  The OCAP also allows (and requires) off-line analysis of the terminators to continually improve OCAP efficiency. Some Benefits of Out-of-Control-Action-Plans
  124. 124. 124 April 9, 2016 – v 5.0  Process maps detail manufacturing steps, material flow and important variables  Key product variables identified with importance to customer, desired target value and specification range defined  Key and critical process input variables identified with targets, statistically determined control limits & control strategies defined  Measurement systems are capable with calibration requirements specified  Sampling, inspection and testing plans include how often, where and to whom results are reported  Reaction plan in place for out-of-spec conditions and material  Operating procedures identify actions, responsibilities, maintenance schedule and product segregation requirements  Training materials describe all aspects of process operation and responsibili- ties  Process improvement efforts fully documented and available for refe- rence  Control plan is reviewed and updated quarterly and resides in the operating area Process Control Plan → Check List
  125. 125. 125 April 9, 2016 – v 5.0 Workshop Exercise: Coffee Brewing Process Instructions to Exercise 6: Develop a Process Control Plan for the Coffee Making Process.  Create a Process Control Plan Template on a Flip Chart  Develop a Process Control Plan for all 3 process steps analyzed in the Process FMEA Resources for Exercise 6:  Flip Charts  Post-It Notes  Markers 45 Minutes
  126. 126. 126 April 9, 2016 – v 5.0 “Process Risk Analysis & Mistake Proofing” Agenda 1. Introduction to Mistake-Proofing (≈ 30 min) 2. Process Mapping & Exercise (≈ 90 min) 3. Cause & Effect Matrix & Exercise (≈ 60 min) 4. Process FMEA & Exercise (≈ 60 min) 5. Risk Analysis & Exercise (≈ 30 min) 6. Human Errors and Poka-Yoke & Exercise (≈ 60 min) 7. Process Control Plan & Exercise (≈ 60 min)
  127. 127. 127 April 9, 2016 – v 5.0 The End … “Perfection is not attainable, but if we chase perfection we can catch excellence.” - Vince Lombardi
  128. 128. 128 April 9, 2016 – v 5.0 Terms & Conditions After you have downloaded the training material to your own computer, you can change any part of the course material and remove all logos and references to Operational Excellence Consulting. You can share the material with your colleagues and re-use it as you need. The main restriction is that you cannot distribute, sell, rent or license the material as though it is your own. These training course materials are for your — and your organization's — usage only. Thank you.

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