1 © 2004 Superfactory™. All Rights Reserved. Root Cause Analysis Superfactory Excellence Program™ www.superfactory.com.

2 © 2004 Superfactory™. All Rights Reserved. Disclaimer and Approved use Disclaimer The files in the Superfactory Excellence Program by Superfactory Ventures LLC (“Superfactory”) are intended for use in training individuals within an organization. The handouts, tools, and presentations may be customized for each application. THE FILES AND PRESENTATIONS ARE DISTRIBUTED ON AN "AS IS" BASIS WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED. Copyright All files in the Superfactory Excellence Program have been created by Superfactory and there are no known copyright issues. Please contact Superfactory immediately if copyright issues become apparent. Approved Use Each copy of the Superfactory Excellence Program can be used throughout a single Customer location, such as a manufacturing plant. Multiple copies may reside on computers within that location, or on the intranet for that location. Contact Superfactory for authorization to use the Superfactory Excellence Program at multiple locations. The presentations and files may be customized to satisfy the customer’s application. The presentations and files, or portions or modifications thereof, may not be re-sold or re- distributed without express written permission from Superfactory. Current contact information can be found at: www.superfactory.com

3 © 2004 Superfactory™. All Rights Reserved. Course Content Course Objectives Course Objectives What is Root Cause? What is Root Cause? Benefits Benefits The Problem Solving Process The Problem Solving Process Examples and Exercises Examples and Exercises

4 © 2004 Superfactory™. All Rights Reserved. Course Objectives Upon completion of this course, participants should be able to: Understand the importance of performing root cause analysis Understand the importance of performing root cause analysis Identify the root cause of a problem using the problem solving process Identify the root cause of a problem using the problem solving process Understand the application of basic quality tools in the problem solving process Understand the application of basic quality tools in the problem solving process

5 © 2004 Superfactory™. All Rights Reserved. What is a root cause? ROOT CAUSE = The causal or contributing factors that, if corrected, would prevent recurrence of the identified problem The causal or contributing factors that, if corrected, would prevent recurrence of the identified problem The “factor” that caused a a problem or defect and should be permanently eliminated through process improvement The “factor” that caused a a problem or defect and should be permanently eliminated through process improvement The factor that sets in motion the cause and effect chain that creates a problem The factor that sets in motion the cause and effect chain that creates a problem The “true” reason that contributed to the creation of a problem, defect or nonconformance The “true” reason that contributed to the creation of a problem, defect or nonconformance

6 © 2004 Superfactory™. All Rights Reserved. What is root cause analysis? A standard process of: A standard process of:  identifying a problem  containing and analyzing the problem  defining the root cause  defining and implementing the actions required to eliminate the root cause  validating that the corrective action prevented recurrence of problem

7 © 2004 Superfactory™. All Rights Reserved. Benefits By eliminating the root cause… You save time and money! Problems are not repeated Problems are not repeated Reduce rework, retest, re-inspect, poor quality costs, etc… Reduce rework, retest, re-inspect, poor quality costs, etc… Problems are prevented in other areas Problems are prevented in other areas Communication improves between groups and Communication improves between groups and Process cycle times improve (no rework loops) Process cycle times improve (no rework loops) Secure long term company performance and profits Secure long term company performance and profits Less rework = Increased profits! $$

8 © 2004 Superfactory™. All Rights Reserved. Importance of the root cause Not knowing the root cause can lead to costly band aids. The Washington Monument was degrading Why? Use of harsh chemicals Why? To clean up after pigeons Why so many pigeons? They eat spiders and there are a lot of spiders at the monument Why so many spiders? They eat gnats and lots of gnats at the monument Why so many gnats? They are attracted to the light at dusk. Solution: Turn on the lights at a later time. The Washington Monument was degrading Why? Use of harsh chemicals Why? To clean up after pigeons Why so many pigeons? They eat spiders and there are a lot of spiders at the monument Why so many spiders? They eat gnats and lots of gnats at the monument Why so many gnats? They are attracted to the light at dusk. Solution: Turn on the lights at a later time.

10 © 2004 Superfactory™. All Rights Reserved. How does it differ from what we do now? Firefighting! Immediate Containment Action Implemented Problem Identified Immediate Containment Action Implemented Defined Root Cause Analysis Process Solutions validated with data Solutions are applied across company and never return! USUAL APPROACH PREFERRED APPROACH Problem Identified Problem reoccurs elsewhere! Find someone to blame!

14 © 2004 Superfactory™. All Rights Reserved. How does it work? PROCESS D PROCESS C PROCESS B PROCESS A CUSTOMER Corrective action implemented so root cause of problem does not occur again! Prevent the problem…

15 © 2004 Superfactory™. All Rights Reserved. But who’s to blame? The “no blame” environment is critical The “no blame” environment is critical Most human errors are due to a process error Most human errors are due to a process error A sufficiently robust process can eliminate human errors A sufficiently robust process can eliminate human errors Placing blame does not correct a root cause situation Placing blame does not correct a root cause situation Is training appropriate and adequate? Is training appropriate and adequate? Is documentation available, correct, and clear? Is documentation available, correct, and clear? Are the right skillsets present? Are the right skillsets present?

16 © 2004 Superfactory™. All Rights Reserved. Corrective Actions 3 types of Corrective Action: Immediate action Immediate action The action taken to quickly fix the impact of the problem so the “customer” is not further impacted The action taken to quickly fix the impact of the problem so the “customer” is not further impacted Permanent root cause corrective action Permanent root cause corrective action The action taken to eliminate the error on the affected process or product The action taken to eliminate the error on the affected process or product Preventive (Systemic) root cause corrective action Preventive (Systemic) root cause corrective action The action taken to Prevent the error from recurring on any process or product The action taken to Prevent the error from recurring on any process or product

17 © 2004 Superfactory™. All Rights Reserved. Examples of Corrective Actions Immediate (step #3) Permanent (step #5) Preventive (step #5) All current batch of paperwork re-inspected by another worker for same type of problem Form changed to mandate completion of certain fields Similar forms with same fields used all over in company are changed to “mandatory” If preventive not addressed, problem will return!!

18 © 2004 Superfactory™. All Rights Reserved. Examples of Corrective Actions Immediate (step #3) Permanent (step #5) Preventive (step #5) Part removed and replaced in product, retested Product redesigned to account for part variability Design process changed to require variation analysis testing on similar supplier parts If preventive not addressed, problem will return!!

19 © 2004 Superfactory™. All Rights Reserved. The Difference between Permanent vs. Preventive Corrective Actions Permanent Trained employee on proper machine use Trained employee on proper machine use Changed product design to make parts easier to assemble manually Changed product design to make parts easier to assemble manually Specific customer document critical to project is identified with red folder Specific customer document critical to project is identified with red folder Update all customers with latest software revision to fix problem Update all customers with latest software revision to fix problem Fallen patient given full-time assistant to provide help moving around hospital Fallen patient given full-time assistant to provide help moving around hospital Employee fired for ethical violation Employee fired for ethical violation Preventive Made training a requirement to new employees working in that area Made training a requirement to new employees working in that area Changed design guidelines to not allow for use of part in full scale production Changed design guidelines to not allow for use of part in full scale production All documents that are critical to project are identified with red folders All documents that are critical to project are identified with red folders Check for those software bugs added to checklist and performed prior to release of software Check for those software bugs added to checklist and performed prior to release of software Process developed to identify “at risk” patients for falls who require assistant Process developed to identify “at risk” patients for falls who require assistant Ethics training developed and provided to all employees Ethics training developed and provided to all employees

20 © 2004 Superfactory™. All Rights Reserved. Problem Solving Process Validate Follow Up Plan Complete Plan Action Plan Root Cause Immediate Action Identify Team Identify Problem Problem Solving Process 1 2 3 4 5 6 7 8

21 © 2004 Superfactory™. All Rights Reserved. Step #1 Identify the Problem Clearly state the problem the team is to solve Clearly state the problem the team is to solve Teams should refer back to problem statement to avoid getting off track Teams should refer back to problem statement to avoid getting off track Use 5W2H approach Use 5W2H approach Who? What? Why? When? Where? How? How Many? Who? What? Why? When? Where? How? How Many? Very important!

22 © 2004 Superfactory™. All Rights Reserved. Step #1 5W2H Who? Individuals/customers associated with problem Who? Individuals/customers associated with problem What? The problem statement or definition What? The problem statement or definition When? Date and time problem was identified When? Date and time problem was identified Where? Location of complaints (area, facilities, customers) Where? Location of complaints (area, facilities, customers) Why? Any previously known explanations Why? Any previously known explanations How? How did the problem happen (root cause) and how will the problem be corrected (corrective action)? How? How did the problem happen (root cause) and how will the problem be corrected (corrective action)? How Many? Size and frequency of problem How Many? Size and frequency of problem

23 © 2004 Superfactory™. All Rights Reserved. Step #2 Identify Team When a problem cannot be solved quickly by an individual, use a team! Should consist of domain knowledge experts Should consist of domain knowledge experts Small group of people (4-10) with process and product knowledge, available time and authority to correct the problem Small group of people (4-10) with process and product knowledge, available time and authority to correct the problem Must be empowered to “change the rules” Must be empowered to “change the rules” Should have a designated Champion Should have a designated Champion Membership in team is always changing! Membership in team is always changing!

24 © 2004 Superfactory™. All Rights Reserved. Step #2 Key Ideas for Team Success Define roles and responsibilities Define roles and responsibilities Identify external customer needs Identify external customer needs Identify internal customer needs Identify internal customer needs Appropriate levels of organization present Appropriate levels of organization present Clearly defined objectives and outputs Clearly defined objectives and outputs Solicit input from everyone! Solicit input from everyone! Good meeting location Good meeting location near work area for easy access to info near work area for easy access to info quiet for concentration and avoiding distractions quiet for concentration and avoiding distractions

25 © 2004 Superfactory™. All Rights Reserved. Step #2 Roles and Responsibilities Champion: Mentor, guide and direct teams, advocate to upper management Champion: Mentor, guide and direct teams, advocate to upper management Leader: day-to-day authority, calls meetings, facilitation of team, reports to Champion Leader: day-to-day authority, calls meetings, facilitation of team, reports to Champion Record Keeper: Writes and publishes minutes Record Keeper: Writes and publishes minutes Participants: Respect all ideas, keep an open mind, know their role within team Participants: Respect all ideas, keep an open mind, know their role within team

26 © 2004 Superfactory™. All Rights Reserved. Step #3 Immediate Action Must isolate effects of problem from customer Must isolate effects of problem from customer Usually “Band-aid” fixes Usually “Band-aid” fixes 100% sorting of parts 100% sorting of parts Re-inspection before shipping Re-inspection before shipping Rework Rework Recall parts/documents from customer or from storage Recall parts/documents from customer or from storage Only temporary until corrective action is implemented (very costly, but necessary) Only temporary until corrective action is implemented (very costly, but necessary) Must also verify that immediate action is effective Must also verify that immediate action is effective

27 © 2004 Superfactory™. All Rights Reserved. Step #3 Verify Immediate Action Immediate action = activity implemented to screen, detect and/or contain the problem Immediate action = activity implemented to screen, detect and/or contain the problem Must verify that immediate action was effective Must verify that immediate action was effective Run Pilot Tests Run Pilot Tests Make sure another problem does not arise from the temporary solutions Make sure another problem does not arise from the temporary solutions Ensure effective screens and detections are in place to prevent further impact to customer until permanent solution is implemented. Ensure effective screens and detections are in place to prevent further impact to customer until permanent solution is implemented.

28 © 2004 Superfactory™. All Rights Reserved. Step #4 Root Cause Brainstorm possible causes of problem with team Brainstorm possible causes of problem with team Organize causes with Cause and Effect Diagram Organize causes with Cause and Effect Diagram “Pareto” the causes to identify those most likely or occurring most often “Pareto” the causes to identify those most likely or occurring most often Use 5 Why? method to further define the root cause of symptoms Use 5 Why? method to further define the root cause of symptoms May involve additional research/analysis/investigation to get to each “Why?” May involve additional research/analysis/investigation to get to each “Why?” Must identify the process that caused the problem Must identify the process that caused the problem if root cause is company-wide, elevate these process issues (outside of team control) to upper management to address if root cause is company-wide, elevate these process issues (outside of team control) to upper management to address

29 © 2004 Superfactory™. All Rights Reserved. Step #4 Tools 5 Why 5 Why failure mode, effect & criticality analysis failure mode, effect & criticality analysis fault tree analysis fault tree analysis brainstorming brainstorming flowcharting flowcharting cause & effect diagrams cause & effect diagrams pareto charts pareto charts barrier analysis barrier analysis change analysis change analysis

30 © 2004 Superfactory™. All Rights Reserved. Step #4 5 Why’s Ask “Why?” five times Ask “Why?” five times Stop when the corrective actions do not change Stop when the corrective actions do not change Stop when the answers become less important Stop when the answers become less important Stop when the root cause condition is isolated Stop when the root cause condition is isolated

31 © 2004 Superfactory™. All Rights Reserved. What is a Cause-Effect Diagram? A Cause-Effect (also called “Ishikawa” or “Fishbone”) Diagram is a Data Analysis/Process Management Tool used to: A Cause-Effect (also called “Ishikawa” or “Fishbone”) Diagram is a Data Analysis/Process Management Tool used to: Organize and sort ideas about causes contributing to a particular problem or issue Organize and sort ideas about causes contributing to a particular problem or issue Gather and group ideas Gather and group ideas Encourage creativity Encourage creativity Breakdown communication barriers Breakdown communication barriers Encourage “ownership” of ideas Encourage “ownership” of ideas Overcome infighting Overcome infighting

32 © 2004 Superfactory™. All Rights Reserved. A Cause-Effect Diagram is typically generated in a group meeting A Cause-Effect Diagram is typically generated in a group meeting It is a graphical method for presenting and sorting ideas about the causes of issues or problems It is a graphical method for presenting and sorting ideas about the causes of issues or problems Cause-Effect Diagram

33 © 2004 Superfactory™. All Rights Reserved. Steps used to create a Cause-Effect Diagram: Steps used to create a Cause-Effect Diagram: Define the issue or problem clearly Define the issue or problem clearly Decide on the root causes of the observed issue or problem Decide on the root causes of the observed issue or problem Brainstorm each of the cause categories Brainstorm each of the cause categories Write ideas on the cause-effect diagram. A generic example is shown below: Write ideas on the cause-effect diagram. A generic example is shown below: Cause-Effect Diagram Environment Effect PeopleEquipment MethodsMaterials NOTE: Causes are not limited to the 5 listed categories, but serve as a starting point

34 © 2004 Superfactory™. All Rights Reserved. Allow team members to specify where ideas fit into the diagram Allow team members to specify where ideas fit into the diagram Clarify the meaning of each idea using the group to refine the ideas. For example: Clarify the meaning of each idea using the group to refine the ideas. For example: Cause-Effect Diagram Materials Incorrect Quantity Incorrect BOL Wrong Destination Methods Late Dispatch Shipping Delay Spillage Environment Shipping Problems Traffic Delays Weather Equipment Wrong Equipment Dirty Equipment Breakdown People Driver Attitude Dispatcher Wrong Directions

35 © 2004 Superfactory™. All Rights Reserved. Cause-Effect Diagram After completing the Cause-Effect Diagram, take the following actions: After completing the Cause-Effect Diagram, take the following actions: Rank the ideas from the most likely to the least likely cause cause of the problem or issue Rank the ideas from the most likely to the least likely cause cause of the problem or issue Develop action plans for identifying the essential data, resources and tools Develop action plans for identifying the essential data, resources and tools

36 © 2004 Superfactory™. All Rights Reserved. Expected Outcome Individuals have become part of a problem solving team Individuals have become part of a problem solving team The sources of problems and other issues have been identified using a systematic process The sources of problems and other issues have been identified using a systematic process Team members see issues from a similar perspective Team members see issues from a similar perspective Ideas and solutions are documented Ideas and solutions are documented Communication is improved Communication is improved Team members assume ownership Team members assume ownership

37 © 2004 Superfactory™. All Rights Reserved. Step #5 Corrective Action Plan Must verify the solution will eliminate the problem Must verify the solution will eliminate the problem Verification before implementation whenever possible Verification before implementation whenever possible Define exactly… Define exactly… What actions will be taken to eliminate the problem? What actions will be taken to eliminate the problem? Who is responsible? Who is responsible? When will it be completed? When will it be completed? Make certain customer is happy with actions Make certain customer is happy with actions Define how the effectiveness of the corrective action will be measured. Define how the effectiveness of the corrective action will be measured.

38 © 2004 Superfactory™. All Rights Reserved. Step #5 Verification vs. Validation (Before) (After) Verification Verification Assures that at a point in time, the action taken will actually do what is intended without causing another problem Assures that at a point in time, the action taken will actually do what is intended without causing another problem Validation Validation Provides measurable evidence over time that the action taken worked properly, and problem has not recurred Provides measurable evidence over time that the action taken worked properly, and problem has not recurred

39 © 2004 Superfactory™. All Rights Reserved. Step #6 Complete Action Plan Make certain all actions that are defined are completed as planned Make certain all actions that are defined are completed as planned If one task is still open, verification and validation is pushed back If one task is still open, verification and validation is pushed back If the plan is compromised, most likely the solution will not be as effective If the plan is compromised, most likely the solution will not be as effective

40 © 2004 Superfactory™. All Rights Reserved. Step #7 Follow Up Plan What actions will be completed in the future to ensure that the root cause has been eliminated by this corrective action? What actions will be completed in the future to ensure that the root cause has been eliminated by this corrective action? Who will look at what data? Who will look at what data? How long after the action plan will this be done? How long after the action plan will this be done? What criteria in the data results will determine that the problem has not recurred? What criteria in the data results will determine that the problem has not recurred?

41 © 2004 Superfactory™. All Rights Reserved. Step #8 Validate and Celebrate What were the results of the follow up? What were the results of the follow up? If problem did reoccur, go back to Step #4 and re-evaluate root cause, then re-evaluate corrective action in Step #5 If problem did reoccur, go back to Step #4 and re-evaluate root cause, then re-evaluate corrective action in Step #5 If problem did not reoccur, celebrate team success! If problem did not reoccur, celebrate team success! Document savings to publicize team effort, obtain customer satisfaction and continued management support of teams Document savings to publicize team effort, obtain customer satisfaction and continued management support of teams

42 © 2004 Superfactory™. All Rights Reserved. What does a good RCA look like? The Root Cause is The Root Cause is Internally Consistent, Internally Consistent, Thorough, and Thorough, and Credible Credible

43 © 2004 Superfactory™. All Rights Reserved. What does a good RCA look like? The Complete Root Cause Analysis is inter-disciplinary, involving experts from the frontline services inter-disciplinary, involving experts from the frontline services involving of those who are the most familiar with the situation involving of those who are the most familiar with the situation continually digging deeper by asking why, why, why at each level of cause and effect. continually digging deeper by asking why, why, why at each level of cause and effect. a process that identifies changes that need to be made to systems a process that identifies changes that need to be made to systems a process that is as impartial as possible a process that is as impartial as possible

44 © 2004 Superfactory™. All Rights Reserved. What does a good RCA look like? To be thorough a Root Cause Analysis must include: determination of human & other factors determination of human & other factors determination of related processes and systems determination of related processes and systems analysis of underlying cause and effect systems through a series of why questions analysis of underlying cause and effect systems through a series of why questions identification of risks & their potential contributions identification of risks & their potential contributions determination of potential improvement in processes or systems determination of potential improvement in processes or systems

45 © 2004 Superfactory™. All Rights Reserved. What does a good RCA look like? To be Credible a Root Cause Analysis must: include participation by the leadership of the organization & those most closely involved in the processes & systems include participation by the leadership of the organization & those most closely involved in the processes & systems be internally consistent be internally consistent

46 © 2004 Superfactory™. All Rights Reserved. Hints about root causes One problem may have more than one root cause One problem may have more than one root cause One root cause may be contributing to many problems One root cause may be contributing to many problems When the root cause is not addressed, expect the problem to reoccur When the root cause is not addressed, expect the problem to reoccur Prevention is the key! Prevention is the key!

47 © 2004 Superfactory™. All Rights Reserved. Review You learned: You learned: How to identify the root cause How to identify the root cause Why it is important Why it is important The process for proper root cause analysis The process for proper root cause analysis How basic quality tools can be applied to examples How basic quality tools can be applied to examples

50 © 2004 Superfactory™. All Rights Reserved. Determine Team Team members: Team members: Team Leader – Terry Team Leader – Terry Inspector – Jane Inspector – Jane Worker – Tammy Worker – Tammy Worker - Joe Worker - Joe Quality Eng – Rob Quality Eng – Rob Engineer – Sally Engineer – Sally

51 © 2004 Superfactory™. All Rights Reserved. Immediate Action Additional inspection added after this assembly process step to check for reversed part defects Additional inspection added after this assembly process step to check for reversed part defects Last 10 lots of printed circuit boards were re-inspected to check for similar errors Last 10 lots of printed circuit boards were re-inspected to check for similar errors

56 © 2004 Superfactory™. All Rights Reserved. Process didn’t account for possible manufacturing issues Engineering ordered it that way from vendor Part is not marked properly Root Cause Part reversed Worker not sure of correct part orientation

57 © 2004 Superfactory™. All Rights Reserved. Corrective Action Permanent – Changed part to one that can only be placed in correct direction (Mistake proofed). Found other products with similar problem and made same changes. Permanent – Changed part to one that can only be placed in correct direction (Mistake proofed). Found other products with similar problem and made same changes. Preventive - Required that any new parts selected must have orientation marks on them. Preventive - Required that any new parts selected must have orientation marks on them.

59 © 2004 Superfactory™. All Rights Reserved. Example #2 Identify Problem A manager walks past the assembly line and notices a puddle of water on the floor. Knowing that the water is a safety hazard, she asks the supervisor to have someone get a mop and clean up the puddle. The manager is proud of herself for “fixing” a potential safety problem.

66 © 2004 Superfactory™. All Rights Reserved. Valve not in preventative maintenance program Water pressure valve is faulty Water pressure is set too high Root Cause Puddle of water on the floor Leak in overhead pipe

67 © 2004 Superfactory™. All Rights Reserved. Corrective Action Permanent – Water pressure valves placed in preventative maintenance program. Permanent – Water pressure valves placed in preventative maintenance program. Preventive - Developed checklist form to ensure new equipment is reviewed for possible inclusion in preventative maintenance program. Preventive - Developed checklist form to ensure new equipment is reviewed for possible inclusion in preventative maintenance program.

73 © 2004 Superfactory™. All Rights Reserved. Sales person tries to expedite work by calling head of manufacturing directly Root Cause Product doesn’t meet specifications Manufacturing specification is different from what customer and sales person agreed to Why?

74 © 2004 Superfactory™. All Rights Reserved. Manufacturing schedule is not available for sales person to provide realistic delivery date Sales person tries to expedite work by calling head of manufacturing directly Root Cause Product doesn’t meet specifications Manufacturing specification is different from what customer and sales person agreed to Why?

75 © 2004 Superfactory™. All Rights Reserved. Confidence in manufacturing schedule is not high enough to release/link with order system Manufacturing schedule is not available for sales person to provide realistic delivery date Sales person tries to expedite work by calling head of manufacturing directly Root Cause Product doesn’t meet specifications Manufacturing specification is different from what customer and sales person agreed to

77 © 2004 Superfactory™. All Rights Reserved. Root Cause Confidence in manufacturing schedule is not high enough to release/link with order system Parts sometimes not available thereby creating schedule changes Why?

78 © 2004 Superfactory™. All Rights Reserved. Expediting and priority changes consume parts not planned for Root Cause Confidence in manufacturing schedule is not high enough to release/link with order system Parts sometimes not available thereby creating schedule changes Why?

79 © 2004 Superfactory™. All Rights Reserved. Manufacturing schedule does not reflect realistic assembly and test time Expediting and priority changes consume parts not planned for Root Cause Confidence in manufacturing schedule is not high enough to release/link with order system Parts sometimes not available thereby creating schedule changes Why?

80 © 2004 Superfactory™. All Rights Reserved. No ongoing review of manufacturing standards Manufacturing schedule does not reflect realistic assembly and test time Expediting and priority changes consume parts not planned for Root Cause Confidence in manufacturing schedule is not high enough to release/link with order system Parts sometimes not available thereby creating schedule changes

81 © 2004 Superfactory™. All Rights Reserved. Corrective Action Permanent – Manufacturing standards reviewed and updated. Permanent – Manufacturing standards reviewed and updated. Preventive - Regular ongoing review of actuals vs standards is implemented. Preventive - Regular ongoing review of actuals vs standards is implemented.

84 © 2004 Superfactory™. All Rights Reserved. Determine Team Team members: Team members: Boss – Jim Boss – Jim Worker – Tom Worker – Tom Worker - Karen Worker - Karen Project Mgr – Bob Project Mgr – Bob Admin – Sally Admin – Sally

85 © 2004 Superfactory™. All Rights Reserved. Immediate Action Additional resources applied to help get the project team back on schedule Additional resources applied to help get the project team back on schedule No new projects started until Root Cause Analysis completed No new projects started until Root Cause Analysis completed

87 © 2004 Superfactory™. All Rights Reserved. Cause and Effect Didn’t complete project on time EquipmentMaterials PersonnelProcedures Lack of worker knowledge Poor project mgmt skills Poor project plan Inadequate computer programs Inadequate computer system Poor documentation Lack of resources

88 © 2004 Superfactory™. All Rights Reserved. Cause and Effect Didn’t complete project on time EquipmentMaterials PersonnelProcedures Lack of worker knowledge Poor project mgmt skills Poor project plan Inadequate computer programs Inadequate computer system Poor documentation Lack of resources

91 © 2004 Superfactory™. All Rights Reserved. Lack of specifics given to Human Resources Dept Took too long to hire Project Manager Root Cause Didn’t complete project on time Resources unavailable when needed Why?

92 © 2004 Superfactory™. All Rights Reserved. No formal process for submitting job opening Lack of specifics given to Human Resources Dept Took too long to hire Project Manager Root Cause Didn’t complete project on time Resources unavailable when needed

93 © 2004 Superfactory™. All Rights Reserved. Corrective Action Permanent – Hired another worker to meet needs of next project team Permanent – Hired another worker to meet needs of next project team Preventive - Developed checklist form with HR for submitting job openings in the future Preventive - Developed checklist form with HR for submitting job openings in the future

96 © 2004 Superfactory™. All Rights Reserved. Immediate Action Immediate Action (and panic!) Quarantine all finished and in-process product Quarantine all finished and in-process product (over $2 million worth!) Analyze location of pyrogen to find common denominator Analyze location of pyrogen to find common denominator

97 © 2004 Superfactory™. All Rights Reserved. Panic-Driven Action Panic-driven Immediate Reaction (without root cause analysis) Pyrogen traced to molding cooling water leak Pyrogen traced to molding cooling water leak Holy cow!… cooling water system hasn’t been cleaned in 15 years! Holy cow!… cooling water system hasn’t been cleaned in 15 years! Shut down 24/7 molding operation for 2 days to clean cooling water system Shut down 24/7 molding operation for 2 days to clean cooling water system Implement system for weekly analysis of cooling water for pyrogens Implement system for weekly analysis of cooling water for pyrogens Threaten to fire anyone who doesn’t report a cooling water leak Threaten to fire anyone who doesn’t report a cooling water leak

98 © 2004 Superfactory™. All Rights Reserved. Panic-Driven Action - Results Results of Panic-driven Immediate Reaction (without root cause analysis) Day 1 after cooling water system cleaning: water tests clean of pyrogens Day 1 after cooling water system cleaning: water tests clean of pyrogens Day 2: cooling water is saturated with pyrogens. Uh oh. Day 2: cooling water is saturated with pyrogens. Uh oh. All operators and technicians reporting “possible water leaks” on all presses, all molds, all shifts… “just in case”. All operators and technicians reporting “possible water leaks” on all presses, all molds, all shifts… “just in case”. Molding operation shuts down. Operations manager nearly fired. Molding operation shuts down. Operations manager nearly fired. “Help” flying in from corporate offices and other molding plants. “Help” flying in from corporate offices and other molding plants. Hourly conference calls to give status updates to executives. Hourly conference calls to give status updates to executives.

102 © 2004 Superfactory™. All Rights Reserved. Disposition of contaminated parts procedure does not discuss water Root Cause Pyrogens on molded components Parts released from molding even though they had been sprayed with leaking cooling water Why?

103 © 2004 Superfactory™. All Rights Reserved. Oil, grease, dust, human contact believed to be primary sources of contamination Disposition of contaminated parts procedure does not discuss water Root Cause Pyrogens on molded components Parts released from molding even though they had been sprayed with leaking cooling water Why?

104 © 2004 Superfactory™. All Rights Reserved. No formal evaluation of contamination sources, types, severity, and disposition action. Oil, grease, dust, human contact believed to be primary sources of contamination Disposition of contaminated parts procedure does not discuss water Root Cause Pyrogens on molded components Parts released from molding even though they had been sprayed with leaking cooling water

105 © 2004 Superfactory™. All Rights Reserved. Corrective Action Permanent – Disposition of contaminated parts procedure re-written to include water. Permanent – Disposition of contaminated parts procedure re-written to include water. Preventive - Formal study of contamination sources, consequences, and disposition requirements. Preventive - Formal study of contamination sources, consequences, and disposition requirements.

1 © 2004 Superfactory™. All Rights Reserved. Root Cause Analysis Superfactory Excellence Program™ www.superfactory.com.

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