root cause analysis

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Successful Corrective Action Through Effective Problem Solving IT470a Six Sigma Green Belt-I Summer 2009 Reference Material #2 Ken White

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Page 1: Root Cause Analysis

Successful Corrective Action Through Effective

Problem Solving

IT470a Six Sigma Green Belt-ISummer 2009

Reference Material #2

Ken White

Page 2: Root Cause Analysis

K White 2/12/2009 2

Course Objectives

• Understand the basic structure of the C/PA Process

• Understand how to define a problem to allow a solution

• Review of basic root cause analysis tools

• Understand the importance of tracking and completing C/PA Steps

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#1 - Describe the Problem

#2 - Determine the Root Cause

#3 – Determine C/PA Steps

#4 - Verification

#5 - Conclusion

Date Issued: KNAM Quality CPA Number: (Sector ID/Originator Initials/No. assigned)

Corrective Action Preventive Action

Section A: Incident Summary

1. Title:

2. Failure of KNAM Requirements:

QPE (List reference)

QCMS (list section)

OTHER (describe)

3. Description of the nonconformity:

Date of incident:

Describe the issue:

Who identified the issue?

Where was the issue identified?

What are the consequences?

Location:

Other circumstances that potentially contributed to the issue

4. Root Cause (5 “WHYS”):

Section B: Plant identified CPA or Corporate driven Activities Describe the actions to be taken, assigned responsibilities and target completion dates 1. Action Steps: “PLAN – DO”

What Who Target Completion Date Date completed

“CHECK – ACT” 2. Verification: Details must include description of evidence reviewed such as type of data, observation, titles and data range of records reviewed 3. Conclusion:

Effective Not Effective If not effective, explain: Verification Completed By:

Date:

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Problem Description

If we do not define the problem correctly, we will never be able to solve the problem --- PERMANENTLY

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Symptoms• Any circumstance, event or condition

that accompanies something and indicates its evidence or occurrence; a sign

Examples of symptoms:– Procedures are not followed– Operator error– Incomplete information

• Ensure you break through symptoms by asking “WHYS”

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Problem Description• Must be clearly defined• Define in terms of WHAT, WHERE,

WHEN, WHO, HOW MUCH, and the CONSEQUENCES

Example:

At 9:07 p.m., mixer operator found 2”x 4” metal piece in mix tank #5. The cook process was stopped immediately – batch #1-8 were put on hold.

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1. What was affected? Be specific about product type, lot numbers,

location, customers 2. Where did the problem take place?

Be specific about where the problem was found, department, equipment, customer

3. When was the problem discovered? Be specific to times, shifts, end of production

run, monthly period clean 4. Who discovered the problem?

Internal or external persons, position, customer

1. How much was affected? Think in terms of pounds, units, dollars, number

of customers 2. How often has this problem occurred?

Is this the first time or has the same or similar issue happened in the past

1. What is the consequence of this situation? Late or short shipments, delayed start-up,

downtime, product loss, loss of customer

The 4W/ 2H/ 1C FORMULA

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Problem DescriptionCommon mistakes• Defining the problem and the solution at

the same time– The lot tags were not found on the pallet

and the supervisor has shown the operator the correct location for placement.

• Defining a symptom as the problem– The operator was confused on how to place

the label on the pallet.

• Defining the problem without data to support definition. – The case operator works slowly.

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Problem Description

Avoid mistakes• State WHAT is wrong, not WHY it’s

wrong• Define the “gap” between what is

expected and what is actually happening

• As new information/data becomes available review and update the problem description as necessary.

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Step #2Determining the Root Cause

What is a root cause?The single, verifiable reason for the problem, which if corrected – prevents its recurrence.

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Problem Solving Tools Brainstorming The act of defining a problem

or idea and coming up with anything related to the topic – no matter how remote a suggestion may sound.

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BrainstormingHow to Facilitate• Assign a scribe – set a time limit• Ask each member to contribute an idea or

suggestion• Allow no positive or negative comments about

the suggestions, at this point• Record all possible causes or sources of a

problem• Evaluate the responses as a group discussion

– Look for answers that are repeated or similar– Group like-concepts together– Eliminate responses that definitely do not fit

• Decide which cause to attack first, by voting

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Problem Solving Tools5 Whys• Helps to identify the relationship

between causes• Forces you to “drill down” the

symptoms

Problem Cause

Cause

Cause

Why? Why?

Why?

Why?

Why?

Cause

ROOToot

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5-WhysHow to facilitate

• Write down the specific problem• Ask “Why the problem happens” and write the answer

down below the problem• If the answer you just provided doesn't identify the root

cause of the problem that you wrote down in step 1, ask Why again and write that answer down

• Loop back to previous step until the team is in agreement that the problem's root cause is identified.– May take fewer or more times than five Whys.

• Please note that the 5 WHYs make take the group down multiple paths – and that’s OK.

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Problem Solving Tools

• 5 Why’s• Check Sheet• Pareto Chart• Time Line• Fishbone

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Problem Solving Tools

Check Sheets

• For Collecting data and is Useful when data is needed to determine frequency, patterns, defects by type or location

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Check SheetOperators Name(s) Sandy Bauer, Eddie Banks, Steve Larsen

For week of: January 21 - 25, 2003

How Many times did it happen Total

IIII IIII IIII IIII II 22IIII IIII IIII I 16IIII IIII III 13IIII IIII IIII IIII IIII II 27IIII IIII II 12IIII IIII II 12IIII IIII I 11IIII II 7Wrong label

No sealContainer missingCodes missingCan't read printer

Packaging Issue

Wrap was looseNo labelsBubbles

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Pareto Chart

27

22

16

13 12 1211

7

0

5

10

15

20

25

30

No Seal Loose Wrap No Labels Bubbled No container Missing CodeDates

Unreadableprint

Wrong Label

Packaging Defects

Count

Working on top ½ of your causes may help 2/3 of the problems go away!

65%

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Problem Solving Tools

Develop a Time Line• Provides a clear picture for

understanding the incident and how it evolved

• Record known changes– Must be specific with verifiable

facts

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Time Line ExamplePackage Defects (rejects) have suddenly increased

Jan. 1st March 1st

Average Line Speed 500 packages per minute Average Line Speed 600 packages per minute

Feb. 1st

Reject Rate 3% Reject Rate 10%

1/2Running 1 shift with

experienced employees

1/4Hired 30 new employees

1/5Trained new employees

1/10 Started 2nd

shift operation

1/2016 hour

equipment PM

completed

2/3 Implemented

new packaging material

2/5 Increased line speed

2/1010 more new employees

more training

View Check Sheet

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Problem Solving ToolsCause and Effect Diagram• Also referred to as “fishbone”

diagram• Useful for organizing large

amounts of information about a problem

• Most effective when done as a team with individuals who are knowledgeable of the overall process

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C & E Diagram• As a group, identify what the major

categories of causes are to the process. – Most common:

- People - Materials - Equipment - Environment - Methods - Measurement

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C & E Diagram

Problem Product placed on hold due to

uneven distribution of fruit topping. This caused uncontrollable weights and below standard appearance of finished product

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C & E Diagram

UNEVEN FRUIT APPLICATION ON

PRODUCT

ENVIRONMENT

METHODSPEOPLE

MATERIALS

EQUIPMENT

Temporary Position

Excessive downtime

Scale errors

Room Temperature

Temperature

Tote size

Excessive waste

Poor Inspections

Overloading hopper

Tote size

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Prioritizing Activities

EASY DIFFICULT

HIGH

LOW

DIFFICULTY

IMPACT

1 32

2 41

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Step #3C/PA Steps

Well defined steps…

Can be the difference between a successful resolution or one that falls short of preventing recurrence

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C/PA Steps

The process:• Formalize and capture the activities

that need to take place• Clearly identify:

– WHO is going to do WHAT by WHEN

• Use an Action Register to track activities

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C/PA Steps• Monitor the status of the activities

– Continually update action register (adding new tasks, completion dates)

– Add as a standard agenda item in department meetings, management review

• Maintain action register as part of the C/PA Program

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Step #4Verification

Verification needs to be supported by evidence :

– Type of data• What was reviewed (charts, observation, records)

– Observations

– Titles and data range– Records reviewed– Who was interviewed– Summary of overall findings

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Step #5Conclusion

• Confirms the solution - has fixed the problem so it doesn’t come back

• Confirms that the system change is effective

• Process• People

• May need additional long-term monitoring– Incorporate as an internal audit check point

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Questions

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Additional ResourcesReferences• Correct! Prevent! Improve! – ASQ (American

Society of Quality) publication • The Root Cause Handbook – Max

Ammerman• The Basics of FMEA (Failure Mode and Effect

Analysis) – McDermott, Mikulak, Beauregard. Focus is on machinery and safety

Courses• Problem Solving and Decision Making

Problem Solving and Decision-Making: A Course in Critical Thinking Skills