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7/30/2019 Root Cause Examples (I) http://slidepdf.com/reader/full/root-cause-examples-i 1/56 1 © 2004 Superfactory™. All Rights Reserved.  Manufacturing Root Cause Analysis Example #1

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7/30/2019 Root Cause Examples (I)

http://slidepdf.com/reader/full/root-cause-examples-i 1/56

1© 2004 Superfactory™. All Rights Reserved. 

Manufacturing

Root Cause AnalysisExample #1

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2© 2004 Superfactory™. All Rights Reserved. 

Example #1

Identify Problem 

Part polarity reversed on circuit board

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3© 2004 Superfactory™. All Rights Reserved. 

Immediate Action

Additional inspection added after this assembly processstep to check for reversed part defects

Last 10 lots of printed circuit boards were re-inspected to

check for similar errors

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4© 2004 Superfactory™. All Rights Reserved. 

Root Cause

Part reversed

Why?

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5© 2004 Superfactory™. All Rights Reserved. 

Root Cause

Part reversed

Worker not sure of correct part orientation

Why?

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6© 2004 Superfactory™. All Rights Reserved. 

Part is not marked properly

Root Cause

Part reversed

Worker not sure of correct part orientation

Why?

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Engineering ordered it that way from vendor 

Part is not marked properly

Root Cause

Part reversed

Worker not sure of correct part orientation

Why?

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8© 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

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9© 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 problemand made same changes.

Preventive  - Required that any new parts selected must have

orientation marks on them. 

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10© 2004 Superfactory™. All Rights Reserved. 

Root Cause AnalysisExample #2

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11© 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, sheasks the supervisor to have someone get a mop and clean up thepuddle. The manager is proud of herself for “fixing” a potential

safety problem.

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12© 2004 Superfactory™. All Rights Reserved. 

Example #2

But What is the Root Cause? 

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

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13© 2004 Superfactory™. All Rights Reserved. 

Immediate Action

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

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14© 2004 Superfactory™. All Rights Reserved. 

Root Cause

Puddle of water on the floor 

Why?

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15© 2004 Superfactory™. All Rights Reserved. 

Root Cause

Puddle of water on the floor 

Leak in overhead pipe

Why?

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16© 2004 Superfactory™. All Rights Reserved. 

Water pressure is set too high

Root Cause

Puddle of water on the floor 

Leak in overhead pipe

Why?

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17© 2004 Superfactory™. All Rights Reserved. 

Water pressure valve is faulty

Water pressure is set too high

Root Cause

Puddle of water on the floor 

Leak in overhead pipe

Why?

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18© 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

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19© 2004 Superfactory™. All Rights Reserved. 

Corrective Action

Permanent – Water pressure valves placed in preventativemaintenance program.

Preventive - Developed checklist form to ensure new

equipment is reviewed for possible inclusion in preventativemaintenance program.

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20© 2004 Superfactory™. All Rights Reserved. 

Example #3

Root Cause AnalysisExample #3

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21© 2004 Superfactory™. All Rights Reserved. 

Example #3

Identify Problem 

Customers are unhappy because they are being shipped

products that don't meet their specifications.

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22© 2004 Superfactory™. All Rights Reserved. 

Immediate Action

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

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23© 2004 Superfactory™. All Rights Reserved. 

Root Cause

Product doesn’t meet specifications 

Why?

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24© 2004 Superfactory™. All Rights Reserved. 

Root Cause

Product doesn’t meet specifications

Manufacturing specification is different from

what customer and sales person agreed to

Why?

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25© 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?

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26© 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?

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27© 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

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28© 2004 Superfactory™. All Rights Reserved. 

Root Cause

Confidence in manufacturing schedule is not

high enough to release/link with order system

Why?

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29© 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?

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30© 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?

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31© 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?

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32© 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

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33© 2004 Superfactory™. All Rights Reserved. 

Corrective Action

Permanent – Manufacturing standards reviewed andupdated.

Preventive - Regular ongoing review of actuals vs

standards is implemented.

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34© 2004 Superfactory™. All Rights Reserved. 

Root Cause AnalysisExample #4

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35© 2004 Superfactory™. All Rights Reserved. 

Example #4

Identify Problem 

Department didn’t complete their project on time 

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36© 2004 Superfactory™. All Rights Reserved. 

Immediate Action

Additional resources applied to help get the project teamback on schedule

No new projects started until Root Cause Analysiscompleted

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37© 2004 Superfactory™. All Rights Reserved. 

Root Cause

Didn’t complete project on time 

Why?

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38© 2004 Superfactory™. All Rights Reserved. 

Cause and Effect

Didn’t complete

project on time

EquipmentMaterials

PersonnelProceduresLack of worker 

knowledge

Poor project

mgmt skills

Poor project plan

Inadequate

computer 

programs

Inadequate

computer system

Poor 

documentation

Lack of resources

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39© 2004 Superfactory™. All Rights Reserved. 

Cause and Effect

Didn’t complete

project on time

EquipmentMaterials

PersonnelProceduresLack of worker 

knowledge

Poor project

mgmt skills

Poor project plan

Inadequate

computer 

programs

Inadequate

computer system

Poor 

documentation

Lack of resources

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40© 2004 Superfactory™. All Rights Reserved. 

Root Cause

Didn’t complete project on time 

Resources unavailable when needed

Why?

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41© 2004 Superfactory™. All Rights Reserved. 

Took too long to hire Project Manager 

Root Cause

Didn’t complete project on time 

Resources unavailable when needed

Why?

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42© 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?

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43© 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

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44© 2004 Superfactory™. All Rights Reserved. 

Corrective Action

Permanent – Hired another worker to meet needs of nextproject team

Preventive - Developed checklist form with HR forsubmitting job openings in the future

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45© 2004 Superfactory™. All Rights Reserved. 

Example #5

Root Cause AnalysisExample #5

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46© 2004 Superfactory™. All Rights Reserved. 

Example #5

Identify Problem 

High pyrogen count on finished medical catheter product using

molded components.

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47© 2004 Superfactory™. All Rights Reserved. 

Immediate Action

Immediate Action (and panic!) 

Quarantine all finished and in-process product

(over $2 million worth!)

Analyze location of pyrogen to find common denominator

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48© 2004 Superfactory™. All Rights Reserved. 

Panic-Driven Action

Panic-driven Immediate Reaction(without root cause analysis) 

Pyrogen traced to molding cooling water leak 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 Implement system for weekly analysis of cooling water for pyrogens Threaten to fire anyone who doesn’t report a cooling water leak 

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49© 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 2: cooling water is saturated with pyrogens. Uh oh.

All operators and technicians reporting “possible water leaks” onall presses, all molds, all shifts… “just in case”.

Molding operation shuts down. Operations manager nearly fired.

 “Help” flying in from corporate offices and other molding plants.  Hourly conference calls to give status updates to executives.

 

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50© 2004 Superfactory™. All Rights Reserved. 

Logic Returns

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

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51© 2004 Superfactory™. All Rights Reserved. 

Root Cause

Pyrogens on molded components

Why?

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52© 2004 Superfactory™. All Rights Reserved. 

Root Cause

Pyrogens on molded components

Parts released from molding even though they

had been sprayed with leaking cooling water 

Why?

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53© 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?

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54© 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?

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55© 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 

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Corrective Action

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

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