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Operational Excellence Consulting: Training Module including 68 slides covering Mistake-Proofing Process, Process Failure Mode and Effects Analysis (History, Benefits, Template, Risk Assessment ...

Operational Excellence Consulting: Training Module including 68 slides covering Mistake-Proofing Process, Process Failure Mode and Effects Analysis (History, Benefits, Template, Risk Assessment Guidelines and Detailed Step-by-Step Instructions), Human Error Modes & Prevention, Poka-Yoke Principles & Examples, Process Control Plan (Benefits, Template, Detailed Step-by-Step Instructions and Evaluation Checklist) and 6 Workshop Exercises.

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OpEx Mistake-Proofing Process Training Module OpEx Mistake-Proofing Process Training Module Presentation Transcript

  • Operational Excellence - Mistake-Proofing Workshop Instructor: Frank Adler, Ph.D. Operational Excellence Consulting February 9, 2013 – v 4.01 OPERATIONAL EXCELLENCE CONSULTING
  • Mistake-Proofing - Introduction Things can go wrong. People will make mistakes. Map Process & Building Blocks However, letting mistakes become defects that Identify Potential Failure Modes cause Customer dissatisfaction or waste and rework is avoidable. Determine Potential Effects Mistake-Proofing, is the systematic process of identifying and preventing defects from occurring Perform Root Cause Analysis in an organization’s manufacturing or business process. Prioritize Failure Opportunities It’s essence is to design both product and processes so that mistakes are impossible to Develop Mistake-Proofing Solutions make or, at the least, they are easy and early to detect and correct. Verify Mistake-Proofing Solutions Operational Excellence Consulting’s Mistake- Implement Mistake-Proofing Solutions Proofing Solution follows a 10 Step Process, combining Process Failure Mode and Effects Validate Results Analysis, Root Cause Analysis, Poka-Yoke Principles and Process Control Plans with a systematic team driven approach. Develop Process Control Plan February 9, 2013 – v 4.02 OPERATIONAL EXCELLENCE CONSULTING
  • “Mistake Proofing” Course Agenda February 9, 2013 – v 4.03 OPERATIONAL EXCELLENCE CONSULTING
  • 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. February 9, 2013 – v 4.04 OPERATIONAL EXCELLENCE CONSULTING
  • Mistake-Proofing - A Team Effort  The responsibility for Mistake-Proofing 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 consists of four to six individuals with multidiscipline and multifunctional backgrounds. In addition, all members should have ownership of the problem/process.  Mistake-Proofing should be a catalyst to stimulate the interchange of ideas between the functions effected and thus promote a team approach. February 9, 2013 – v 4.05 OPERATIONAL EXCELLENCE CONSULTING
  • Foundation of Process Thinking and Improvement Outputs Y Process Step/Activity Inputs X  Ys are the results (Critical-to-Quality or CTQ) of completing the process step  Xs are the inputs that impact the ability to achieve the Ys of that process step  Note: A Y from one process step can be a X from a later process step February 9, 2013 – v 4.06 OPERATIONAL EXCELLENCE CONSULTING
  • Mistake-Proofing - Characterize Process Inputs 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 doesnt want to control (too difficult or expensive) • humidity, temperature, ... February 9, 2013 – v 4.07 OPERATIONAL EXCELLENCE CONSULTING
  • The Human Being – Often the Biggest “Noise” Input … Lost a lot of money in Poker last night. The order really Hopefully has to go out Molly is doing today !!! well in her test today. It is Friday !!! Wonder what I should wear tonight. … in your Process. February 9, 2013 – v 4.08 OPERATIONAL EXCELLENCE CONSULTING
  • “Mistake Proofing” Course Agenda February 9, 2013 – v 4.09 OPERATIONAL EXCELLENCE CONSULTING
  • The Process Flowchart Mistake-Proofing a process should begin with a flow chart and a high-level risk assessment (based on available data) of each process step. A Process Flowchart is a graphical process description of the work flow or activities using standard symbols for each of the activities. Different types of activities are described with standard symbols. The problem areas in the process are often relatively easy to discover when assessing the flowchart. An ellipse shows the start and the end point of the process. A box describes an activity or process step. A diamond shows a decision making step. An arrow shows the direction from one activity to another. February 9, 2013 – v 4.010 OPERATIONAL EXCELLENCE CONSULTING
  • Traditional Process Flowchart February 9, 2013 – v 4.011 OPERATIONAL EXCELLENCE CONSULTING
  • Swimlane Process Flowchart … February 9, 2013 – v 4.012 OPERATIONAL EXCELLENCE CONSULTING
  • The Process Flow Chart A few more Tips:  Break the process into manageable process steps  But don’t worry too much, you can always continue doing that when starting to analyze the process step if needed  Try to keep it to max. 10 - 15 process steps  You can always split process steps later or split the process into several sub- processes and form a project team around each sub-process  Verify that the process flow chart is accurate and complete  Perform a process walkthrough and/or onsite process observation to ensure the you did not miss anything and all steps are in the correct sequence  Make sure you have all the right people on board  The process flow chart helps you to understand who is involved in the process. Pull subject matter experts in as and when needed February 9, 2013 – v 4.013 OPERATIONAL EXCELLENCE CONSULTING
  • Workshop Exercise: Coffee Brewing Process February 9, 2013 – v 4.014 OPERATIONAL EXCELLENCE CONSULTING
  • Workshop Exercise: Coffee Brewing Process Instructions to Exercise 1: Develop a Process Flow Chart for the Coffee Brewing Process.  Define the first and last step of the process you want to mistake proof  Brainstorm process steps in no particular order and write the steps on Post-It notes  Order Post-It Notes on the Flip Chart according to the actual process flow  Add any missing process steps. Try keeping it to 10 to 12 steps.  Connect process steps with arrows to visualize the process flow Resources for Exercise 1:  Flip Charts  Post-It Notes 20 Minutes  Markers February 9, 2013 – v 4.015 OPERATIONAL EXCELLENCE CONSULTING
  • “Mistake Proofing” Course Agenda February 9, 2013 – v 4.016 OPERATIONAL EXCELLENCE CONSULTING
  • The Building Blocks Controls • Procedures • Policy Information In Information Out • Data • Data • Instructions • Instructions • Drawings • Drawings • Programs • Programs Process Product In Product Out Cycle Time DPU or DPM Resources In Resources Out • Tools • Tools • Equipment • Equipment • People • People • Test Sets • Test Sets Safety • Facility • Requirements • Environmental February 9, 2013 – v 4.017 OPERATIONAL EXCELLENCE CONSULTING
  • The Building Blocks - An Example Controls Information In • Cleaning Procedure • Maintenance Procedure • Air Condition Unit • Support Block Adjustment Parameters • Board Stop Sensor • Component Teaching Adjustment • Cleaning Frequency • Optical/Vision Control System • Software Version Information Out • Camera Calibration • Fiducial Data • Air Condition Unit Values • … • PCB Dimensions (x y z) • Vision Control System Data • Temperature • Light Tower Data • Detent • Input/Output Sensor Monitoring • Angel of Squeegee • Scheduled Number of PCBs • Program Parameters • Cycle Time • Speed • … • … MPM Product In • PCB (3 Modules) without Paste Paste Printer Product Out Cycle Time • PCB (3 Modules) with Paste DPM or DPU Resources In • Operators • Paste Resources Out • Paste Dispenser • Old Paper • Stencil • Rest of old Paste • Squeegee Head • Resources In • Squeegee • … • Support Block Safety • Conveyor • Safety Sensors • Camera • … • … February 9, 2013 – v 4.018 OPERATIONAL EXCELLENCE CONSULTING
  • Workshop Exercise: Coffee Brewing Process Instructions to Exercise 2: Develop a Building Blocks Diagram for the Coffee Making Process.  Draw a Building Block Diagram on a Flip Chart  Define the “Product In” and “Product Out” of the process  Brainstorm Building Block elements in no particular order, write them on Post-It notes and stick them on the Flip Chart under the appropriate category (Information In, Resources, Controls, …) Resources for Exercise 2:  Flip Charts  Post-It Notes  Markers 20 Minutes February 9, 2013 – v 4.019 OPERATIONAL EXCELLENCE CONSULTING
  • “Mistake Proofing” Course Agenda February 9, 2013 – v 4.020 OPERATIONAL EXCELLENCE CONSULTING
  • Failure Mode and Effects Analysis - History  First used in the 1960s in the Aerospace industry during Apollo missions.  In 1974 the Navy developed MIL-STD-1629 regarding the use of FMEA.  In the late 1970s, 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. February 9, 2013 – v 4.021 OPERATIONAL EXCELLENCE CONSULTING
  • Failure Mode and Effects Analysis - Definition 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. February 9, 2013 – v 4.022 OPERATIONAL EXCELLENCE CONSULTING
  • Failure Mode and Effects Analysis - The Four Types 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 process and assembly deficiencies.  Service FMEA analyses services before they reach the customer. A Service FMEA focuses on failure modes caused by system or process deficiencies. February 9, 2013 – v 4.023 OPERATIONAL EXCELLENCE CONSULTING
  • Process Failure Mode and Effects Analysis - Outputs 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. February 9, 2013 – v 4.024 OPERATIONAL EXCELLENCE CONSULTING
  • Process Failure Mode and Effect Analysis - Benefits 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. February 9, 2013 – v 4.025 OPERATIONAL EXCELLENCE CONSULTING
  • Process Failure Mode and Effects Analysis 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. February 9, 2013 – v 4.026 OPERATIONAL EXCELLENCE CONSULTING
  • 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 February 9, 2013 – v 4.027 OPERATIONAL EXCELLENCE CONSULTING
  • 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  … February 9, 2013 – v 4.028 OPERATIONAL EXCELLENCE CONSULTING
  • Process FMEA - The Template 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. February 9, 2013 – v 4.029 OPERATIONAL EXCELLENCE CONSULTING
  • Process FMEA - The Template 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. February 9, 2013 – v 4.030 OPERATIONAL EXCELLENCE CONSULTING
  • 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 February 9, 2013 – v 4.031 OPERATIONAL EXCELLENCE CONSULTING
  • Process FMEA - The Template 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. February 9, 2013 – v 4.032 OPERATIONAL EXCELLENCE CONSULTING
  • Process FMEA - The Template 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. February 9, 2013 – v 4.033 OPERATIONAL EXCELLENCE CONSULTING
  • 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  Scatter Diagram  Why – Why Diagram  Box Plots  Fishbone Diagram  Histograms  Is – Is Not Matrix  Process Capability Studies  Affinity Diagram  SPC or Pre-Control Charts  Interrelationship Diagram  … February 9, 2013 – v 4.034 OPERATIONAL EXCELLENCE CONSULTING
  • 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, … . February 9, 2013 – v 4.035 OPERATIONAL EXCELLENCE CONSULTING
  • Root Cause Analysis Tools → The 5 Why’s Potential Failure Mode (Object & Defect)? There could be grinding marks on the door frame WHY? → The door frame had been “over-ground” WHY? → Team member did not use the grinder properly WHY? → Team member was not properly trained Potential Root Cause February 9, 2013 – v 4.036 OPERATIONAL EXCELLENCE CONSULTING
  • Root Cause Analysis Tools → Why – Why Diagram 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: Wrong Tool was used Tools are not marked Operator was No formal … untrained training exists Failure Mode: Training The door frame Current grinding Customer complaint Process was had been “over- method is not due to grinding marks not applied ground” capable on the door frame Cosmetic No written requirements cosmetic … not understood standard exists Current grinding method is too complicated February 9, 2013 – v 4.037 OPERATIONAL EXCELLENCE CONSULTING
  • How to develop a Why–Why Diagram Procedure: Step 1: Write the failure mode on a Post-It note 1 and place it at the far left of a flip chart or white board. 2 3 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, … . February 9, 2013 – v 4.038 OPERATIONAL EXCELLENCE CONSULTING
  • 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 Materials Methods = MEN Effect or Main Branch METHODS Outcome MATERIALS Trunk Potential MACHINES Failure Mode + ENVIRONMENT Minor Branch Men Machines Environment Primary Causal Factor February 9, 2013 – v 4.039 OPERATIONAL EXCELLENCE CONSULTING
  • 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 February 9, 2013 – v 4.040 OPERATIONAL EXCELLENCE CONSULTING
  • Process FMEA - The Template 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). February 9, 2013 – v 4.041 OPERATIONAL EXCELLENCE CONSULTING
  • 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: 45 Minutes  Flip Charts & Markers February 9, 2013 – v 4.042 OPERATIONAL EXCELLENCE CONSULTING
  • “Mistake Proofing” Course Agenda February 9, 2013 – v 4.043 OPERATIONAL EXCELLENCE CONSULTING
  • Process FMEA - Risk Analysis 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. February 9, 2013 – v 4.044 OPERATIONAL EXCELLENCE CONSULTING
  • 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. February 9, 2013 – v 4.045 OPERATIONAL EXCELLENCE CONSULTING
  • Process FMEA - Example for Occurrence Ranking Possible Failure Rates Rank Probability of Failure Mode Occurrence PPM*) Failure rate ppk 1 Remote: Failure is unlikely. No failures ever 1 1 out of 1.67 associated with almost identical processes. 1 000 000 2 Very Low: Only isolated failures associated 7 1 out of 1.50 with almost identical processes. 150 000 3 Low: Isolated failures associated with similar 64 1 out of 15 000 1.33 processes. 4-6 Moderate: Generally associated with 500 1 out of 2000 1.17 processes similar to previous processes which 2700 1 out of 400 1.00 have experienced occasional failures, but not in 12 500 1 out of 80 0.83 major proportions. 7-8 High: Generally associated with processes 50 000 1 out of 20 0.67 similar to previous processes that have often 125 000 1 out of 8 0.51 failed. 9-10 Very high: Failure is almost inevitable. 333 000 1 out of 3 0.33 333 000 1 out of 2 < 0.33 Please make sure that the Ranking Scheme reflects your organization’s needs. Otherwise, revise the Ranking Scheme accordingly. February 9, 2013 – v 4.046 OPERATIONAL EXCELLENCE CONSULTING
  • 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. Almost certain Reliable detection controls are known with similar processes. 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 Moderately high mode. 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. February 9, 2013 – v 4.047 OPERATIONAL EXCELLENCE CONSULTING
  • 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”. February 9, 2013 – v 4.048 OPERATIONAL EXCELLENCE CONSULTING
  • Process FMEA - Risk Priority Number Risk Priority Number (RPN): RPN ( Sev) (Occ ) ( Det ) 1 000 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. February 9, 2013 – v 4.049 OPERATIONAL EXCELLENCE CONSULTING
  • 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 45 Minutes  Markers February 9, 2013 – v 4.050 OPERATIONAL EXCELLENCE CONSULTING
  • Process FMEA - Risk Assessment Extreme cases where corrective & preventive actions must be taken include the following process ratings. Assessment Rating Causes of Failure Actions S O D 1 1 1 Ideal situation (goal) No action (N/A) 1 1 10 Assured mastery N/A 10 1 1 Failure does not reach user N/A 10 1 10 Failure reaches user Yes 1 10 1 Frequent fails, detectable, costly Yes 1 10 10 Frequent fails, reach user Yes 10 10 1 Frequent fails with major impact Yes 10 10 10 Trouble ! Yes, Yes, Yes February 9, 2013 – v 4.051 OPERATIONAL EXCELLENCE CONSULTING
  • Process FMEA - Action Planning Actions that will influence the Process FMEA risk evaluation are: Corrective & Preventive Actions S O D Redesign the process M Y Y Redesign the product M M M Improve current control N N Y Change material parts N M M Change the field environment M N N Improve reliability program N Y Y Improve employee training N M Y Implement FMEA program Y Y Y Implement SPC program N Y Y Improve quality plan N Y Y Y = Yes, M = Maybe, N = No February 9, 2013 – v 4.052 OPERATIONAL EXCELLENCE CONSULTING
  • “Mistake Proofing” Course Agenda February 9, 2013 – v 4.053 OPERATIONAL EXCELLENCE CONSULTING
  • The Human “Noise” Factor Lost a lot of money in Poker last night. The order really Hopefully has to go out Molly is doing today !!! well in her test today. It is Friday !!! Wonder what I should wear tonight. Stop trying to fix your people. Fix your Process. February 9, 2013 – v 4.054 OPERATIONAL EXCELLENCE CONSULTING
  • Human Errors - Dealing with Human Errors  Human Errors are inevitable !!! Errors can´t be avoided. People will always make mistakes.  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. February 9, 2013 – v 4.055 OPERATIONAL EXCELLENCE CONSULTING
  • Difference between Mistake and Defect “I have an extra part. I must have omitted a step!” “There must have been an error detected; the machine shut down by itself!” February 9, 2013 – v 4.056 OPERATIONAL EXCELLENCE CONSULTING
  • Quick Exercise Identify 3 Human Errors Please write down 3 Human Errors that have happened in your plant or organization over the last couple of weeks. February 9, 2013 – v 4.057 OPERATIONAL EXCELLENCE CONSULTING
  • Human Errors - The Human Work Model 3. Recognition of Work Object’s State Start 1. Work Progress Understanding 4. Recognition of the 5. Recognition of the Motion to be done Danger in the Motion on the Work Object 2. Work Object Selection 6. Motion Execution End February 9, 2013 – v 4.058 OPERATIONAL EXCELLENCE CONSULTING
  • Human Errors - The 16 Human Error Modes 1. Omission 9. Failing to sense danger 2. Excessive / insufficient repetition 10. Incorrect holding 3. Wrong order 11. Incorrect positioning 4. Early / late execution 12. Incorrect orientation 5. Execution of restricted work 13. Incorrect motion 6. Incorrect selection 14. Improper holding 7. Incorrect counting 15. Inaccurate motion 8. Misrecognition 16. Insufficient avoidance February 9, 2013 – v 4.059 OPERATIONAL EXCELLENCE CONSULTING
  • Quick Exercise Categorize the 3 Human Errors 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. February 9, 2013 – v 4.060 OPERATIONAL EXCELLENCE CONSULTING
  • The Human Work Model & The 16 Human Error Modes 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? February 9, 2013 – v 4.061 OPERATIONAL EXCELLENCE CONSULTING
  • The Human Work Model & The 16 Human Error Modes 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? February 9, 2013 – v 4.062 OPERATIONAL EXCELLENCE CONSULTING
  • The Human Work Model & The 16 Human Error Modes 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? February 9, 2013 – v 4.063 OPERATIONAL EXCELLENCE CONSULTING
  • The Human Work Model & The 16 Human Error Modes 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? February 9, 2013 – v 4.064 OPERATIONAL EXCELLENCE CONSULTING
  • The Human Work Model & The 16 Human Error Modes 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? February 9, 2013 – v 4.065 OPERATIONAL EXCELLENCE CONSULTING
  • The Human Work Model & The 16 Human Error Modes 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? February 9, 2013 – v 4.066 OPERATIONAL EXCELLENCE CONSULTING
  • The Human Work Model & Error Modes 3. Recognition of Work Object’s State Start Error Modes (8) 1. Work Progress Understanding 4. Recognition of the Error Modes (1) - (5) 5. Recognition of the Motion to be done Danger in the Motion on the Work Object Error Modes (9) Error Modes (10) - (13) 2. Work Object Selection Error Modes (6) - (7) 6. Motion Execution Error Modes (14) - (16) End February 9, 2013 – v 4.067 OPERATIONAL EXCELLENCE CONSULTING
  • Quick Exercise Categorize the 3 Human Errors Were you able to assign each of your 3 Human Errors to one of the 16 Human Error Modes? February 9, 2013 – v 4.068 OPERATIONAL EXCELLENCE CONSULTING
  • Human Work Model & Error Modes - Example 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) 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) February 9, 2013 – v 4.069 OPERATIONAL EXCELLENCE CONSULTING
  • Human Errors - Human Work Model Example 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) February 9, 2013 – v 4.070 OPERATIONAL EXCELLENCE CONSULTING
  • 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 implementation of an automatic dispenser to insure the correct amount of adhesive is applied during an assembly process or the coin dispenser in food stores preventing that customers are getting short changed. 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 a camera that will not function when there is not enough light to take a picture. Also some clothes dryers shut down when they detect an overheating situation. February 9, 2013 – v 4.071 OPERATIONAL EXCELLENCE CONSULTING
  • Six Mistake Proofing Principles 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. This would make it easier to identify the correct part for assembly. Another example would be the use of a slipping-type torque wrench to prevent over tightening. 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. Also fuses to prevent overloading circuits resulting from shorts are mitigation techniques. February 9, 2013 – v 4.072 OPERATIONAL EXCELLENCE CONSULTING
  • Five Key Mistake-Proofing Methods  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. February 9, 2013 – v 4.073 OPERATIONAL EXCELLENCE CONSULTING
  • 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. 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 February 9, 2013 – v 4.074 OPERATIONAL EXCELLENCE CONSULTING
  • Where to use Poka-Yoke Devices? 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 February 9, 2013 – v 4.075 OPERATIONAL EXCELLENCE CONSULTING
  • Characteristics of a Good Poka-Yoke Device 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. February 9, 2013 – v 4.076 OPERATIONAL EXCELLENCE CONSULTING
  • Human Errors – Seven Best Poka-Yoke Devices 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 February 9, 2013 – v 4.077 OPERATIONAL EXCELLENCE CONSULTING
  • Seven Best Poka-Yoke Devices – Guide Pins 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, … February 9, 2013 – v 4.078 OPERATIONAL EXCELLENCE CONSULTING
  • Seven Best Poka-Yoke Devices – Error Detection/Alarms 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. February 9, 2013 – v 4.079 OPERATIONAL EXCELLENCE CONSULTING
  • Seven Best Poka-Yoke Devices – Error Detection/Alarms 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. Cons: Variation in material may result in false fails and pass packages. February 9, 2013 – v 4.080 OPERATIONAL EXCELLENCE CONSULTING
  • Seven Best Poka-Yoke Devices – Limit Switches 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 February 9, 2013 – v 4.081 OPERATIONAL EXCELLENCE CONSULTING
  • Seven Best Poka-Yoke Devices – Sensors 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, … February 9, 2013 – v 4.082 OPERATIONAL EXCELLENCE CONSULTING
  • Seven Best Poka-Yoke Devices – Sensors 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, … February 9, 2013 – v 4.083 OPERATIONAL EXCELLENCE CONSULTING
  • Seven Best Poka-Yoke Devices – Vision Systems 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 Checking for Label Presence, Features Color, Orientation, & Alignment. • 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, … February 9, 2013 – v 4.084 OPERATIONAL EXCELLENCE CONSULTING
  • Seven Best Poka-Yoke Devices – Counters & Timers 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 Correct Number of Holes • excessive/insufficient repetition, incorrect counting, incorrect positioning, incorrect orientation, … February 9, 2013 – v 4.085 OPERATIONAL EXCELLENCE CONSULTING
  • Seven Best Poka-Yoke Devices – Checklists 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 by timing usage Features • Easy to develop - Easy to use - Easy for people to understand Human Error Prevention • omission, early/late execution, wrong order, misrecognition, … February 9, 2013 – v 4.086 OPERATIONAL EXCELLENCE CONSULTING
  • 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. February 9, 2013 – v 4.087 OPERATIONAL EXCELLENCE CONSULTING
  • 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. February 9, 2013 – v 4.088 OPERATIONAL EXCELLENCE CONSULTING
  • 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 February 9, 2013 – v 4.089 OPERATIONAL EXCELLENCE CONSULTING
  • 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. February 9, 2013 – v 4.090 OPERATIONAL EXCELLENCE CONSULTING
  • 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 February 9, 2013 – v 4.091 OPERATIONAL EXCELLENCE CONSULTING
  • Human Errors → Mistake-Proofing Examples 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. Human Error detection through automated defect detection devices such as sensors, limit switches, scales, …. February 9, 2013 – v 4.092 OPERATIONAL EXCELLENCE CONSULTING
  • 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, weve eliminated the risk of failure or accidents due to mismatched components.” February 9, 2013 – v 4.093 OPERATIONAL EXCELLENCE CONSULTING
  • Human Errors → Mistake-Proofing Examples Preventing missing weld nuts, with a sensor linked to a visual & audio alarm. Process will stop automatically and a corrective action is required. Consumer friendly Mistake-Proofing product design improves usability and Customer Satisfaction. … and many more. February 9, 2013 – v 4.094 OPERATIONAL EXCELLENCE CONSULTING
  • 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 February 9, 2013 – v 4.095 OPERATIONAL EXCELLENCE CONSULTING
  • “Mistake Proofing” Course Agenda February 9, 2013 – v 4.096 OPERATIONAL EXCELLENCE CONSULTING
  • 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 Process Process Customer Product & Part Process Input & Output Control Requirements Characteristics Controls Characteristics Plan February 9, 2013 – v 4.097 OPERATIONAL EXCELLENCE CONSULTING
  • Process Control Plan - Template Operational Excellence Process Control Plan Supplier: Product: Date (Orig): Key Contact: Process: E-Mail / Phone: Date (Rev): Characteristic Specification Control Limits Measurement Process Step Product Process Sample Size Sample Frequency Control Method Reaction Plan (LSL, USL &Target) (LCL & UCL) System Characteristic Characteristic February 9, 2013 – v 4.098 OPERATIONAL EXCELLENCE CONSULTING
  • Process Control Plan - Template  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). February 9, 2013 – v 4.099 OPERATIONAL EXCELLENCE CONSULTING
  • Process Control Plan - Template  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. February 9, 2013 – v 4.0100 OPERATIONAL EXCELLENCE CONSULTING
  • Out-of-Control-Action-Plans (OCAP) Start Yes Yes No No Activators Yes Yes No No Yes Yes No Checkpoints Corrective Actions End February 9, 2013 – v 4.0101 OPERATIONAL EXCELLENCE CONSULTING
  • Some Benefits of Out-of-Control-Action-Plans  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. February 9, 2013 – v 4.0102 OPERATIONAL EXCELLENCE CONSULTING
  • Process Control Plan - Check List  Process maps detail manufacturing  Reaction plan in place for out-of-spec steps, material flow and important conditions and material variables  Operating procedures identify actions,  Key product variables identified with responsibilities, maintenance schedule importance to customer, desired target and product segregation requirements value and specification range defined  Training materials describe all aspects  Key and critical process input variables of process operation and responsibili- identified with targets, statistically ties determined control limits & control  Process improvement efforts fully strategies defined documented and available for refe-  Measurement systems are capable rence with calibration requirements specified  Control plan is reviewed and updated  Sampling, inspection and testing plans quarterly and resides in the operating include how often, where and to whom area results are reported February 9, 2013 – v 4.0103 OPERATIONAL EXCELLENCE CONSULTING
  • 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 February 9, 2013 – v 4.0104 OPERATIONAL EXCELLENCE CONSULTING
  • “Mistake Proofing” Course Agenda February 9, 2013 – v 4.0105 OPERATIONAL EXCELLENCE CONSULTING
  • The End … “perfection is not attainable, but if we chase perfection we can catch excellence.” - Vince Lombardi February 9, 2013 – v 4.0106 OPERATIONAL EXCELLENCE CONSULTING