1 © 2004 Superfactory™. All Rights Reserved. Root Cause Analysis Superfactory Excellence...

1© 2004 Superfactory™. All Rights Reserved.

Root Cause AnalysisRoot Cause Analysis

Superfactory Excellence Program™Superfactory Excellence Program™www.superfactory.comwww.superfactory.com


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Course ContentCourse Content

Course ObjectivesCourse Objectives What is Root Cause?What is Root Cause? BenefitsBenefits The Problem Solving ProcessThe Problem Solving Process

Examples and ExercisesExamples and Exercises


Course ObjectivesCourse Objectives

Upon completion of this course, participants should be able to:Upon completion of this course, participants should be able to:

Understand the importance of performing root cause analysisUnderstand the importance of performing root cause analysis Identify the root cause of a problem using the problem solving processIdentify the root cause of a problem using the problem solving process Understand the application of basic quality tools in the problem solving Understand the application of basic quality tools in the problem solving

processprocess


What is a root cause?What is a root cause?

ROOT CAUSE =ROOT CAUSE = The causal or contributing factors that, if corrected, would prevent The causal or contributing factors that, if corrected, would prevent

recurrence of the identified problemrecurrence of the identified problem

The “factor” that caused a a problem or defect and should be permanently The “factor” that caused a a problem or defect and should be permanently eliminated through process improvementeliminated through process improvement

The factor that sets in motion the cause and effect chain that creates a The factor that sets in motion the cause and effect chain that creates a problem problem

The “true” reason that contributed to the creation of a problem, defect or The “true” reason that contributed to the creation of a problem, defect or nonconformancenonconformance


What is root cause analysis?What is root cause analysis?

A standard process of:A standard process of:

identifying a problemidentifying a problem containing and analyzing the problemcontaining and analyzing the problem defining the root causedefining the root cause defining and implementing the actions required to defining and implementing the actions required to

eliminate the root causeeliminate the root cause validating that the corrective action prevented validating that the corrective action prevented

recurrence of problemrecurrence of problem


BenefitsBenefits

By eliminating the root cause…By eliminating the root cause…

You save time and money!You save time and money! Problems are not repeatedProblems 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 areasProblems 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 profitsSecure long term company performance and profits

Less rework = Increased profits! $$$$


Importance of the root causeImportance of the root cause

Not knowing the root cause can lead to costly band aids.Not knowing the root cause can lead to costly band aids.

The Washington Monument was degrading The Washington Monument was degrading Why? Use of harsh chemicalsWhy? Use of harsh chemicalsWhy? To clean up after pigeonsWhy? To clean up after pigeonsWhy so many pigeons? They eat spiders and there are a lot of spiders at the Why so many pigeons? They eat spiders and there are a lot of spiders at the monumentmonumentWhy so many spiders? They eat gnats and lots of gnats at the monumentWhy so many spiders? They eat gnats and lots of gnats at the monumentWhy so many gnats? They are attracted to the light at dusk.Why so many gnats? They are attracted to the light at dusk.

Solution: Turn on the lights at a later time.Solution: Turn on the lights at a later time.


When should root cause analysis When should root cause analysis be performed?be performed?

When PROBLEMS occur !!


How does it differ from what we do How does it differ from what we do now?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!


How does it work?How does it work?

PROCESSD

PROCESSC

PROCESSB

PROCESSA

CUSTOMER

“Customer” can be Internal or External

Defect found at “Customer”…



PROCESSD

PROCESSC

PROCESSB

PROCESSA

CUSTOMER

Nothing is allowed to further escape to the customer

Contain the problem…



PROCESSD

PROCESSC

PROCESSB

PROCESSA

CUSTOMER

Nothing is allowed to further escape to the next process

Contain the root process…



PROCESSD

PROCESSC

PROCESSB

PROCESSA

CUSTOMER

Corrective action implemented so root cause of problem does

not occur again!

Prevent the problem…


But who’s to blame?But who’s to blame?

The “no blame” environment is criticalThe “no blame” environment is critical Most human errors are due to a process errorMost human errors are due to a process error A sufficiently robust process can eliminate human errorsA sufficiently robust process can eliminate human errors Placing blame does not correct a root cause situationPlacing 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?


Corrective ActionsCorrective Actions

3 types of Corrective Action:3 types of Corrective Action:

ImmediateImmediate action action

The action taken to quickly fix the impact of the problem so the “customer” is The action taken to quickly fix the impact of the problem so the “customer” is not further impactednot further impacted

Permanent root cause corrective actionPermanent root cause corrective action

The action taken to eliminate the error on the affected process or productThe action taken to eliminate the error on the affected process or product

PreventivePreventive (Systemic) root cause corrective action (Systemic) root cause corrective action

The action taken to Prevent the error from recurring on The action taken to Prevent the error from recurring on anyany process or product process or product


Examples of Corrective ActionsExamples 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!!


Examples of Corrective ActionsExamples 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!!


The Difference between The Difference between Permanent vs. Preventive Corrective ActionsPermanent vs. Preventive Corrective Actions

PermanentPermanent Trained employee on proper machine useTrained employee on proper machine use

Changed product design to make parts easier to assemble Changed product design to make parts easier to assemble manuallymanually

Specific customer document critical to project is identified with Specific customer document critical to project is identified with red folderred folder

Update all customers with latest software revision to fix problemUpdate all customers with latest software revision to fix problem

Fallen patient given full-time assistant to provide help moving Fallen patient given full-time assistant to provide help moving around hospitalaround hospital

Employee fired for ethical violationEmployee fired for ethical violation

PreventivePreventive Made training a requirement to new employees working in that Made training a requirement to new employees working in that

areaarea

Changed design guidelines to not allow for use of part in full Changed design guidelines to not allow for use of part in full scale productionscale production

All documents that are critical to project are identified with red All documents that are critical to project are identified with red foldersfolders

Check for those software bugs added to checklist and Check for those software bugs added to checklist and performed prior to release of softwareperformed prior to release of software

Process developed to identify “at risk” patients for falls who Process developed to identify “at risk” patients for falls who require assistantrequire assistant

Ethics training developed and provided to all employeesEthics training developed and provided to all employees


Problem Solving ProcessProblem 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


Step #1Step #1

Identify the ProblemIdentify the Problem

Clearly state the problem the team is to solveClearly state the problem the team is to solve Teams should refer back to problem statement to avoid getting Teams should refer back to problem statement to avoid getting

off trackoff track Use 5W2H approachUse 5W2H approach

Who? What? Why? When? Where? How? How Many?Who? What? Why? When? Where? How? How Many?

Very important!


Step #1Step #1

5W2H5W2H Who?Who? Individuals/customers associated with problem Individuals/customers associated with problem What?What? The problem statement or definition The problem statement or definition When?When? Date and time problem was identified Date and time problem was identified Where?Where? Location of complaints Location of complaints (area, facilities, customers)(area, facilities, customers)

Why?Why? Any previously known explanations Any previously known explanations How?How? How did the problem happen (root cause) and how will the problem How did the problem happen (root cause) and how will the problem

be corrected (corrective action)?be corrected (corrective action)? How Many?How Many? Size and frequency of problem Size and frequency of problem


Step #2Step #2

Identify TeamIdentify TeamWhen a problem cannot be solved quickly by an individual, use a When a problem cannot be solved quickly by an individual, use a

team!team!

Should consist of domain knowledge experts Should consist of domain knowledge experts Small group of people (4-10) with process and product knowledge, Small group of people (4-10) with process and product knowledge,

available time and authority to correct the problemavailable 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 ChampionShould have a designated Champion Membership in team is always changing!Membership in team is always changing!


Step #2Step #2

Key Ideas for Team SuccessKey Ideas for Team Success

Define roles and responsibilitiesDefine roles and responsibilities Identify external customer needsIdentify external customer needs Identify internal customer needsIdentify internal customer needs Appropriate levels of organization presentAppropriate levels of organization present Clearly defined objectives and outputsClearly defined objectives and outputs Solicit input from everyone!Solicit input from everyone! Good meeting locationGood meeting location

near work area for easy access to infonear work area for easy access to info quiet for concentration and avoiding distractions quiet for concentration and avoiding distractions


Step #2Step #2

Roles and ResponsibilitiesRoles and Responsibilities

ChampionChampion: Mentor, guide and direct teams, advocate to upper : Mentor, guide and direct teams, advocate to upper managementmanagement

LeaderLeader: day-to-day authority, calls meetings, facilitation of team, reports : day-to-day authority, calls meetings, facilitation of team, reports to Championto Champion

Record KeeperRecord Keeper: Writes and publishes minutes: Writes and publishes minutes ParticipantsParticipants: Respect all ideas, keep an open mind, know their role : Respect all ideas, keep an open mind, know their role

within teamwithin team


Step #3Step #3

Immediate ActionImmediate Action

Must isolate effects of problem from customerMust isolate effects of problem from customer Usually “Band-aid” fixesUsually “Band-aid” fixes

100% sorting of parts100% sorting of parts Re-inspection before shippingRe-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 Only temporary until corrective action is implemented (very costly, but necessary)necessary)

Must also verify that immediate action is effectiveMust also verify that immediate action is effective


Step #3Step #3

Verify Immediate ActionVerify Immediate Action

Immediate action Immediate action = activity implemented to screen, detect and/or = activity implemented to screen, detect and/or contain the problemcontain the problem

Must verify that immediate action was effectiveMust verify that immediate action was effective

Run Pilot TestsRun Pilot Tests Make sure another problem does not arise from the temporary Make sure another problem does not arise from the temporary

solutionssolutions

Ensure effective screens and detections are in place to prevent further Ensure effective screens and detections are in place to prevent further impact to customer until permanent solution is implemented.impact to customer until permanent solution is implemented.


Step #4Step #4

Root CauseRoot Cause

Brainstorm possible causes of problem with team Brainstorm possible causes of problem with team Organize causes with Cause and Effect DiagramOrganize causes with Cause and Effect Diagram “ “Pareto” the causes to identify those most likely or occurring most oftenPareto” the causes to identify those most likely or occurring most often Use 5 Why? method to further define the root cause of symptomsUse 5 Why? method to further define the root cause of symptoms

May involve additional research/analysis/investigation to get to each May involve additional research/analysis/investigation to get to each “Why?”“Why?”

Must identify the Must identify the processprocess that caused the problem that caused the problem if root cause is company-wide, elevate these process issues (outside of if root cause is company-wide, elevate these process issues (outside of

team control) to upper management to addressteam control) to upper management to address


Step #4Step #4

ToolsTools

5 Why5 Why failure mode, effect & criticality failure mode, effect & criticality

analysisanalysis fault tree analysisfault tree analysis

brainstormingbrainstorming flowchartingflowcharting cause & effect diagramscause & effect diagrams pareto chartspareto charts barrier analysisbarrier analysis change analysischange analysis


Step #4Step #4

5 Why’s5 Why’s

Ask “Why?” five timesAsk “Why?” five times Stop when the corrective actions do not changeStop when the corrective actions do not change Stop when the answers become less importantStop when the answers become less important Stop when the root cause condition is isolatedStop when the root cause condition is isolated


What is a Cause-Effect Diagram?What is a Cause-Effect Diagram?

A Cause-Effect (also called “Ishikawa” or “Fishbone”) Diagram is a A Cause-Effect (also called “Ishikawa” or “Fishbone”) Diagram is a Data Analysis/Process Management Tool used to:Data Analysis/Process Management Tool used to:

Organize and sort ideas about causes contributing to a Organize and sort ideas about causes contributing to a particular problem or issueparticular problem or issue

Gather and group ideasGather and group ideas Encourage creativityEncourage creativity Breakdown communication barriersBreakdown communication barriers Encourage “ownership” of ideasEncourage “ownership” of ideas Overcome infightingOvercome infighting


A Cause-Effect Diagram is typically generated in a group A Cause-Effect Diagram is typically generated in a group meetingmeeting

It is a graphical method for presenting and sorting ideas It is a graphical method for presenting and sorting ideas about the causes of issues or problemsabout the causes of issues or problems

Cause-Effect DiagramCause-Effect Diagram


Steps used to create a Cause-Effect Diagram:Steps used to create a Cause-Effect Diagram: Define the issue or problem clearlyDefine the issue or problem clearly Decide on the root causes of the observed issue or problemDecide on the root causes of the observed issue or problem Brainstorm each of the cause categoriesBrainstorm each of the cause categories Write ideas on the cause-effect diagram. A generic example is shown Write ideas on the cause-effect diagram. A generic example is shown

below:below:


Environment Effect

PeopleEquipment

MethodsMaterials

NOTE: Causes are not limited to the 5 listed categories, but serve as a starting point


Allow team members to specify where ideas fit into the diagramAllow team members to specify where ideas fit into the diagram Clarify the meaning of each idea using the group to refine the ideas. For Clarify the meaning of each idea using the group to refine the ideas. For

example:example:


Materials

Incorrect Quantity

Incorrect BOL

Wrong Destination

Methods

Late Dispatch

Shipping DelaySpillage

EnvironmentShippingProblems

Traffic Delays

Weather

Equipment

Wrong Equipment

Dirty EquipmentBreakdown

People

Driver

AttitudeDispatcherWrong Directions



After completing the Cause-Effect Diagram, take the following After completing the Cause-Effect Diagram, take the following actions:actions:

Rank the ideas from the most likely to the least likely cause cause Rank the ideas from the most likely to the least likely cause cause of the problem or issueof the problem or issue

Develop action plans for identifying the essential data, resources Develop action plans for identifying the essential data, resources and toolsand tools


Expected OutcomeExpected Outcome

• Individuals have become part of a problem solving teamIndividuals have become part of a problem solving team The sources of problems and other issues have been identified using The sources of problems and other issues have been identified using

a systematic processa systematic process Team members see issues from a similar perspectiveTeam members see issues from a similar perspective Ideas and solutions are documentedIdeas and solutions are documented Communication is improvedCommunication is improved Team members assume ownershipTeam members assume ownership


Step #5Step #5

Corrective Action PlanCorrective Action Plan

Must verify the solution will eliminate the problemMust verify the solution will eliminate the problem Verification before implementation whenever possibleVerification 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 actionsMake 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.


Step #5Step #5

Verification vs. ValidationVerification vs. Validation

(Before) (After)(Before) (After)

VerificationVerification Assures that at a point in time, the action taken will actually do what is Assures that at a point in time, the action taken will actually do what is

intended without causing another problemintended without causing another problem

ValidationValidation Provides measurable evidence over time that the action taken worked Provides measurable evidence over time that the action taken worked

properly, and problem has not recurredproperly, and problem has not recurred


Step #6Step #6

Complete Action PlanComplete Action Plan

Make certain all actions that are defined are completed as plannedMake certain all actions that are defined are completed as planned

If one task is still open, verification and validation is pushed backIf one task is still open, verification and validation is pushed back

If the plan is compromised, most likely the solution will not be as effectiveIf the plan is compromised, most likely the solution will not be as effective


Step #7Step #7

Follow Up PlanFollow Up Plan

What actions will be completed in the future to ensure that the root cause What actions will be completed in the future to ensure that the root cause has been eliminated by this corrective action?has been eliminated by this corrective action?

WhoWho will look at what data? will look at what data? How longHow long after the action plan will this be done? after the action plan will this be done? What criteriaWhat criteria in the data results will determine that the problem has not in the data results will determine that the problem has not

recurred?recurred?


Step #8Step #8

Validate and CelebrateValidate 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, If problem did reoccur, go back to Step #4 and re-evaluate root cause, then re-evaluate corrective action in Step #5then 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 Document savings to publicize team effort, obtain customer satisfaction and continued management support of teamsand continued management support of teams


What does a good RCA look like?What does a good RCA look like?

The Root Cause is The Root Cause is Internally Consistent , Internally Consistent , Thorough, and Thorough, and CredibleCredible



The Complete Root Cause AnalysisThe Complete Root Cause Analysis is 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 continually digging deeper by asking why, why, why at each level of

cause and effect. 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


What does a good RCA look like? What does a good RCA look like?

To be thorough a Root Cause Analysis must include: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 analysis of underlying cause and effect systems through a series of

whywhy questions 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



To be Credible a Root Cause Analysis must: To be Credible a Root Cause Analysis must: • include participation by the leadership of the organization & include participation by the leadership of the organization &

those most closely involved in the processes & systems those most closely involved in the processes & systems • be internally consistent be internally consistent


Hints about root causesHints about root causes

One problem may have more than one root causeOne problem may have more than one root cause One root cause may be contributing to many problemsOne root cause may be contributing to many problems When the root cause is not addressed, expect the problem When the root cause is not addressed, expect the problem

to reoccurto reoccur Prevention is the key!Prevention is the key!


ReviewReview

You learned:You learned: How to identify the root causeHow to identify the root cause Why it is importantWhy it is important The process for proper root cause analysisThe process for proper root cause analysis How basic quality tools can be applied to examplesHow basic quality tools can be applied to examples


ManufacturingManufacturing

Root Cause AnalysisRoot Cause AnalysisExample #1Example #1


Example #1Example #1

Identify ProblemIdentify Problem

Part polarity reversed on circuit boardPart polarity reversed on circuit board


Determine TeamDetermine Team

Team members:Team members: Team Leader – TerryTeam Leader – Terry Inspector – JaneInspector – Jane Worker – TammyWorker – Tammy Worker - JoeWorker - Joe Quality Eng – RobQuality Eng – Rob Engineer – SallyEngineer – Sally



Additional inspection added after this assembly process Additional inspection added after this assembly process step to check for reversed part defectsstep to check for reversed part defects

Last 10 lots of printed circuit boards were re-inspected to Last 10 lots of printed circuit boards were re-inspected to check for similar errors check for similar errors



Part reversed

Why?



Part reversed

Worker not sure of correct part orientation

Why?


Part is not marked properly


Part reversed


Why?


Engineering ordered it that way from vendor



Part reversed


Why?


Process didn’t account for possible manufacturing issues

Engineering ordered it that way from vendor



Part reversed



Corrective ActionCorrective Action

PermanentPermanent – Changed part to one that can only be placed in correct – Changed part to one that can only be placed in correct direction (Mistake proofed). Found other products with similar problem and direction (Mistake proofed). Found other products with similar problem and made same changes.made same changes.

PreventivePreventive - Required that any new parts selected must have - Required that any new parts selected must have

orientation marks on them.orientation marks on them.




A manager walks past the assembly line and notices a puddle of 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 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 asks the supervisor to have someone get a mop and clean up the puddle. The manager is proud of herself for “fixing” a potential puddle. The manager is proud of herself for “fixing” a potential

safety problem. safety problem.



But What is the Root Cause?But What is the Root Cause?

The supervisor looks for a root cause by asking 'why?’ The supervisor looks for a root cause by asking 'why?’



Knowing that the water is a safety hazard, the manager asks the Knowing that the water is a safety hazard, the manager asks the supervisor to have someone get a mop and clean up the puddle.supervisor to have someone get a mop and clean up the puddle.



Puddle of water on the floor

Why?




Leak in overhead pipe

Why?


Water pressure is set too high




Why?


Water pressure valve is faulty





Why?


Valve not in preventative maintenance program

Water pressure valve is faulty







Permanent – Water pressure valves placed in preventative Permanent – Water pressure valves placed in preventative maintenance program.maintenance program.

Preventive - Developed checklist form to ensure new Preventive - Developed checklist form to ensure new equipment is reviewed for possible inclusion in preventative equipment is reviewed for possible inclusion in preventative maintenance program.maintenance program.




Customers are unhappy because they are being shipped Customers are unhappy because they are being shipped products that don't meet their specifications. products that don't meet their specifications.



Inspect all finished and in-process product to ensure it meets Inspect all finished and in-process product to ensure it meets customer specifications.customer specifications.



Product doesn’t meet specifications

Why?




Manufacturing specification is different fromwhat customer and sales person agreed to

Why?


Sales person tries to expedite work by callinghead of manufacturing directly




Why?


Manufacturing schedule is not available forsales person to provide realistic delivery date




Manufacturing specification is different from what customer and sales person agreed to

Why?


Confidence in manufacturing schedule is nothigh enough to release/link with order system

Manufacturing schedule is not available forsales person to provide realistic delivery date








Why?




Parts sometimes not available therebycreating schedule changes

Why?


Expediting and priority changes consumeparts not planned for




Why?


Manufacturing schedule does not reflectrealistic assembly and test time





Why?


No ongoing review of manufacturing standards

Manufacturing schedule does not reflectrealistic assembly and test time







Permanent – Manufacturing standards reviewed and Permanent – Manufacturing standards reviewed and updated.updated.

Preventive - Regular ongoing review of actuals vs Preventive - Regular ongoing review of actuals vs standards is implemented.standards is implemented.




Department didn’t complete their project on timeDepartment didn’t complete their project on time


Determine TeamDetermine Team

Team members:Team members: Boss – JimBoss – Jim Worker – TomWorker – Tom Worker - KarenWorker - Karen Project Mgr – BobProject Mgr – Bob Admin – SallyAdmin – Sally



Additional resources applied to help get the project team Additional resources applied to help get the project team back on schedule back on schedule

No new projects started until Root Cause Analysis No new projects started until Root Cause Analysis completedcompleted



Didn’t complete project on time

Why?


Cause and EffectCause and Effect


EquipmentMaterials

PersonnelProceduresLack of worker

knowledge

Poor project mgmt skills

Poor project plan

Inadequate computer programs

Inadequate computer system

Poor documentation

Lack of resources




Resources unavailable when needed

Why?


Took too long to hire Project Manager




Why?


Lack of specifics given to Human Resources Dept





Why?


No formal process for submitting job opening

Lack of specifics given to Human Resources Dept







Permanent – Hired another worker to meet needs of next Permanent – Hired another worker to meet needs of next project teamproject team

Preventive - Developed checklist form with HR for Preventive - Developed checklist form with HR for submitting job openings in the futuresubmitting job openings in the future




High pyrogen count on finished medical catheter product High pyrogen count on finished medical catheter product using molded components. using molded components.



Immediate Action (and panic!)Immediate Action (and panic!)

Quarantine all finished and in-process productQuarantine all finished and in-process product

(over $2 million worth!)(over $2 million worth!) Analyze location of pyrogen to find common denominatorAnalyze location of pyrogen to find common denominator


Panic-Driven ActionPanic-Driven Action

Panic-driven Immediate ReactionPanic-driven Immediate Reaction(without root cause analysis)(without root cause analysis)

Pyrogen traced to molding cooling water leakPyrogen 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 systemShut down 24/7 molding operation for 2 days to clean cooling water system Implement system for weekly analysis of cooling water for pyrogensImplement system for weekly analysis of cooling water for pyrogens Threaten to fire anyone who doesn’t report a cooling water leakThreaten to fire anyone who doesn’t report a cooling water leak


Panic-Driven Action - ResultsPanic-Driven Action - Results

Results of Panic-driven Immediate ReactionResults of Panic-driven Immediate Reaction(without root cause analysis)(without root cause analysis)

Day 1 after cooling water system cleaning: water tests clean of pyrogensDay 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… All operators and technicians reporting “possible water leaks” on all presses, all molds, all shifts…

“just in case”. “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.


Logic ReturnsLogic Returns

There must be a better way! How about trying something called There must be a better way! How about trying something called “Root Cause Analysis”?“Root Cause Analysis”?



Pyrogens on molded components

Why?




Parts released from molding even though theyhad been sprayed with leaking cooling water

Why?


Disposition of contaminated parts proceduredoes not discuss water




Why?


Oil, grease, dust, human contact believed tobe primary sources of contamination





Why?


No formal evaluation of contamination sources, types, severity, and disposition action.

Oil, grease, dust, human contact believed tobe primary sources of contamination







Permanent – Disposition of contaminated parts procedure Permanent – Disposition of contaminated parts procedure re-written to include water.re-written to include water.

Preventive - Formal study of contamination sources, Preventive - Formal study of contamination sources, consequences, and disposition requirements.consequences, and disposition requirements.

1 © 2004 Superfactory™. All Rights Reserved. Root Cause Analysis Superfactory Excellence...

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