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The key takeaways from the document are that root cause analysis is a systematic process used to identify underlying factors that caused an undesirable event. It involves defining the problem, investigating causes, determining root causes, developing corrective actions, and preventing future occurrences.

The five main steps in the root cause analysis process outlined in the document are: 1) organize team, 2) define problem or issue, 3) conduct analysis/investigation, 4) determine root cause(s), and 5) correct and prevent.

Tools mentioned as being used in the root cause analysis process include cause and effect diagrams, 5 whys, fishbone diagrams, and other tools for problem analysis, investigation, and defining the problem.

Root Cause Analysis

WWSP 0310 (Rev 0)

QUALITY
ONE SYSTEM
Course Information
How this course is intended to be used:
 An overview of the Root Cause Analysis and how to apply tools
 Upon completion of this module, you will be able to identify the key tools
activities within Root Causes Analysis
 This course is intended to be process-focused in relation to the Enterprise
Standard DS-STA-1033 linking to WWSP-00310

COURSE OVERVIEW
• Background
• Problem & Investigation
• Root Cause Analysis
• Class Room Workshop
• Correct and Prevent and Document
Practice Question
When should Root Cause Analysis be performed?
A. Product or Process did not conform to a specific
requirement
B. Significant or consequential events
C. Repetitive human errors, equipment and/or process failures
are occurring during a specific process
D. Performance is generally below desired standard
E. All of these answers are correct
Define the Problem

“A problem well defined is


a problem half solved”
(anonymous)
4
Thinking Approach
Processes Tools Used
Large Vague problem
1. Understand the situation
Clarify the Problem
Problem Investigation
Breakdown the Problem 5W / 2H / 1C
Cause Investigation
Cause & Effect Analysis Problem Analysis

2. Root Cause Investigation Cause and Effect (Fishbone)


True
Why - Why Training
Training
focus Causes Is/Is not focus
 etc….
Why?
3. Correct and Prevent Why?
Why?
Why?
4. Document

Why did it happen?


Complete Problem Definition
Define the problem.
 Early determinations to the problem/issue drive the approach to the more detailed
investigation
 Clear articulation of the problem is absolutely critical to assist in the next steps of
bounding, severity, and correction activities

 Problem statement should clearly and  5W:


factually describe the current  What was affected
condition.
 Where did the problem take place
 Be measurable
 When was the problem discovered
 Be fact-based (focus on what is
wrong)  Who discovered the problem
 Be objective and free from opinion  Which it was effect of the problem
 Focus on the effect to the
performance of the product,  2H:
device, or system/process  How much was affected
 Reference the specification or  How often has the problem occurred
requirement that is not being met
 1C:
 It may be necessary to review current
and historical sources  What is the consequence
Investigation Process / Conduct Analysis
•What is an Investigation?
 An Investigation is a formal documented process to determine the most probable
cause of a nonconformance.
• Develop Investigation Strategy
• Conduct Investigation
• Assessment of non-conformance

Conduct Data Analysis – View objectively


 Patterns
 Trends
 Variability
 Assessment
 Complaints

• For detailed Investigation process refer to WWSP 000243


What is Root Cause
& Root Cause Analysis

8
What is Root Cause(s)
Root The source or reason for a product nonconformance or
Cause other undesirable problem or situation which, if
eliminated, would prevent recurrence.

Root The process of looking for the problems that can be fixed
Cause when best practices and knowledge are applied.
Analysis
An analysis conducted to determine assignable cause(s)
or root cause(s) of an event or issue associated with a
deficiency in a product, process, or quality system that
fails to meet established specifications or requirements.
Why Use Root Cause Analysis?

• Helps identify the problem or challenge


• Resolution of fundamental issue(s)
• Eliminates short term solutions
• Conserves Resources
• Preventive measures
• Facilitates Discussion (leading to solutions)

10
First Assumption of Root Cause is Quick,
but often Incorrect

For example, a normal response is:


• Equipment Failure
• Human Error

Initial response is usually the symptom, not the root cause


of the problem.
This is why Root Cause Analysis is a very useful and
productive tool.

• Focus on Systemic issues, systems and processes


• Focus is not on individuals
Root Cause Analysis (Basics)
Symptom of the problems
WEEDS (VISIBLE)
Above the surface (obvious)
May not always be the Root
Cause

Primary Cause(s) below the surface


THE ROOTS (NOT VISIBLE)

FOCUS AREA
The word root, in root cause analysis, refer to underlying cause(s).
Root Cause Analysis
Root Cause Analysis is an integral part of conducting an investigation. It allows the
Investigator to determine the underlying cause of a problem and break the
investigation into manageable pieces.

WHAT?
ROOT
an undesirable condition or
CAUSE
HOW? nonconformance happened,
ANALYSIS
thus preventing recurrence
HELPS

INVESTIGATION
IDENTIFY WHY?

Improved Quality
Root Eliminate Risk
Costs Contained
Cause
Found? Achieve Confidence Results Met

Does Not Return


Good Indicators of a “Comprehensive” Root Cause Analysis
 Permanent solutions identified
 Recurring failures prevented
 Descriptive logical problem solution. Can apply to nonconformities of all sizes
Examples of US FDA CAPA observations

Failure to document CAPA as required by … Many CAPA Reports failed to identify:

 Cause of non-conformances

 Action(s) needed to correct and prevent recurrence of nonconforming product and other
quality problems

 Action(s) taken to verify or validate CAPA action and ensure that such action is effective and
does not adversely affect the finished device

 Method(s) taken to implement necessary CAPA

 Action(s) taken to ensure that information related to quality problems or nonconforming


product is disseminated to the responsible parties

14
FDA wants to see evidence for how you ...

1. Analyze
2. Investigate
3. Identify Actions
4. Verify/Validate
5. Implement
6. Effectiveness check
7. Communicate …All done in a
8. Management Review “timely” manner
15
Root Cause Analysis - Process

Step 1 Organize Team

Step 2 Define Problem or Issue

Step 3 Conduct Analysis / Investigation

Step 4 Determine Root Cause(s)

Step 5 Correct and Prevent

16
Investigation – Team Formation

Purpose
Create right team to investigate root cause of the problem
Description
Team formation create the team – which should include:
Key stakeholder
Area owner
BB/MBB
Technical person
User

Step 1 Organize Team 17


Problem Definition
Define the problem
The Project’s purpose and scope are defined
Background information on the process and customer is collected

Component of Problem Definition:


Detailed explanation: Concise and easy enough to understand the
problem or potential problem
Evidences: Documentation of information and dates analysis to show
that it is a real problem

Step 2 Define Problem or Issue18


Getting an accurate understanding of the problem
is the first priority

WHAT happened? Situation before, during and after the problem

WHERE detected? Location of the detection (in house and/or at customer)

WHEN did it happen? Date, time, frequency

WHO detected? Name, function (customer, we)

WHICH is requirement ? Effect of the problem

HOW detected? Reason for detection (provide measurement)

HOW MANY? How many were there? How much does it cost

Use the 5W+2H framework to understand problem

Step 2 Define Problem or Issue19


What make a complete problem definition?

Focus your problem by


asking who, what, when,
What? where, and which. How?
What is the nature of the
problem?
What happens?
What type of problem is it?
Where? What do we know about it? How much?
Where does the problem
occur?
Physical location?
Step in the process?

When does the problem


When? occur?
Day, time of day, shift,
month, season, annual
cycle?
When doesn’t it occur?
When is the problem
greatest?
Who?
Who is involved?
Which customers?
Which suppliers?
Who else is involved?

Which?
Step 2 Define Problem or Issue20
Problem Definition and CAPA Rationale
Who?
What?

When?

What?

What?

Step 2 Define Problem or Issue21


Simple Problem Solving Tracking Sheet
Simple Problem Tracking Sheet Date:

1 Problem definition 3 Direct causes 4 Root causes

Step 2 Define Problem or Issue


Date to answer:

2 Containment actions

Date to answer: Date to answer: Date to answer:

6 Final results versus objectives 5 Actions Responsible Date Result

Standardization 1)
Process 1 pt lesson

Instructions Training 2)

Verification: Measurement and audit show that


the problem is : 3)
Solved
Not solved
2

Step 2 Define Problem or Issue22


Before investing time and effort in determining the root causes,
containment actions are taken

Plant Customers
1. Delivery to customers is ▪ Customers receive
secured requested deliveries on
2. If possible, problem is time
bypassed while root Customer
cause is resolved never knows
3. Team installs new and problem
improved procedures existed

Step 2 Define Problem or Issue23


Containment

Step 2 Define Problem or Issue24


Exercise
Group Breakout-Interactive Session

Purpose
• To apply learning from RCA training to the real life CAPA Case

Deliverables
• Completion of Problem Statement

Process
• Break into 5 groups
• Investigate the problem using 5W 2H
• Define the problem statement
• Report out to the group, 5 minutes per group

Step 2 Define Problem or Issue25


Warm-up problem: My flash light does not work! WHY?
Exercise
Warm-up problem: My flash light does not work! WHY?
Exercise
ROOT CAUSE PROBLEM SOLVING
Exercise

Early determinations to the


problem/issue drive the approach to
the more detailed investigation
 Be measurable
 Be fact-based (focus on what is wrong)
 Be objective and free from opinion
 Focus on the effect to the performance
of the product, device, or
system/process
 Reference the specification or
requirement that is not being met

Step 2 Define Problem or Issue


Exercise

In your groups apply


containment action of the
problems:
 Immediate act to the situation,
limit effect of issue
 Stop problem

Before investing time and effort in determining


the root causes, containment actions are taken

Step 2 Define Problem or Issue


Exercise
Simple Problem Solving Tracking Sheet

Simple Problem Tracking Sheet Date:

1 Problem definition 3 Direct causes 4 Root causes

Date to answer:

2 Containment actions

Date to answer: Date to answer: Date to answer:

6 Final results versus objectives 5 Actions Responsible Date Result

Standardization 1)
Process 1 pt lesson

Instructions Training 2)

Verification: Measurement and audit show that


the problem is : 3)
Solved
Not solved
2

31
Exercise
Group discussion:
Containment
It is necessary to contain the problem before
finding the root causes

Step 2 Define Problem or Issue32


Case Study & Grouping
No CAPA subject Coordinator Team Member

1 Pouch Leakage of JB Srivishnu Krisada (TH), Chun Hui (DB), Matthew (CH), Suit Yan (MY),
Active Fresh 200 ml (10) Apichai (TH), In Bong, Su Jeong, Min jeong, Yoon Kyung,

2 Tube Leakage of NGNA Natthachai Maytawin, Zhi Yu (DB), Zhi Min (CH), Simon (DB), Alan
Liquid 100 ml (10) (MY), Mum (TH), Dong Min, Keong Keun, Dong Hun

3 Label defects from Ahmad Suhaimi Time (TH), Raj (SG), Belle (SG), Aranyapuk (TH), JaeUen,
Pemara (12) Joon Seok, Yuna Kim, So Yeon, Sung Eun, Hyun Seok,
Jeong wook,

4 Rebuild the QS in HK BQ Raymond Chan Poi Khun (MY), Andy (IN), Rena (AU), Lino (JP), Eva (TW),
(11) Show (TW), Harrison, Sophia, Ha Seong, Sang Joon,

5 MPS OOS (pH, Viscosity) Tom Wongphoom, Wanakorn, Shaun (CH), James (elsker),
(11) Catherine (CH), Jennifer (CH), Andy (CH), Jing (DB), Toh
Theng (MY), Meow Fun (MY)

6 Tube Leakage of NGNA Sang Bum Hyo Jung, Tae Kyoung, Peter, Jina, Sang Bum, Seul Ji, Eun
Liquid 100 ml (local KR (12) Ju, Edmond, Hwa Lee, Young Pi, Sang Hoon,
team)
TOOLS OVERVIEW

34
Examples of Root Cause Analysis
DATA GATHERING TOOLS Root Cause Analysis TOOLS
Control Plans Barrier Analysis Tree Diagrams

Scatter Diagram Parameter Diagram Fishbone


Process Maps
Interrelationship Digraph Risk Tree Analysis
Pie Charts
Histograms Design FMEA
Process Capability Change Analysis Process FMEA
DMAIC
5 Why’s
Control Charts
Flowcharts Pareto Charts Affinity Diagrams
Is / Is Not
Force Field Analysis DOE
Events & Causal Analysis
Run Charts
Brainstorming

Refer to Appendix 1 of WWSP-00310 for guidance of which tool to use


as it relates to your investigation
Why Use Cause-and-Effect Diagrams

Venue for
brainstorming of
potential causes See the relationship
between causes which might
lead to Potential Causes

As a place for keep tracking of all


potential causes have been investigated

Step 3 Conduct Analysis / Investigation


Focus Problem Statement  a fish head

Can broad problem statement make Actually, what is


big improvement? the problem?

Too much at once?

Step 3 Conduct Analysis / Investigation


38
Focus Problem Statement  a fish head

Why do we need How do we


What is problem
problem develop problem
statement?
statement? statement?

A short version for


team member or
A short form of Start from Problem
communication to
Problem Definition Definition
related people to the
problem

Detailed enough to
Remove non-related
create common
A title of CAPA information for the
understanding what
potential root causes
the problem is

Short enough to fit the


A fish head
fish head

Step 3 Conduct Analysis / Investigation


39
Cause-and-Effect Activity

Put as many as you can,


no right or wrong

Logical & Scientific


4-6 M concept Problem / Effect
Use Post-it

Step 3 Conduct Analysis / Investigation


40
Cause and Effect (Fishbone) Diagram
A structured brain storming event is a good way of filling the fishbone with possible causes

The categories Machines / Methods / Name Your


Materials
Place Process
of causes Cause Here
(bones of the fish)

• aka the 6 Ms
• “Ishikawa
diagram” Backbone
Problem
• Should be flexible Statement here
• Name only those /Root Cause /
that contribute to EFFECT
the problem

Root
Sub-Causes Cause
Mother Nature
Measurements Man / People
/ Policies
The categories
of causes • Brainstorm a list of causes / sub-causes and write them on
(inputs to the bones) the appropriate cause category “bone”

NOTE: Causes are not limited to the 6 listed categories,


but serve as a starting point

IF the primary Root Cause (or most probable root cause) CANNOT be identified THEN Identify a
most probable root cause(s) (in order of greatest to least probability).
FISHBONE CONSTRUCTION (Tool)
1. Draw a fishbone diagram

2. List the problem/issue to be studied in the head of the fish

3. Label each bone of the fish. The major categories typically used are:
1. The 6 M’s: Methods, Machines, Materials, Manpower, Measurement, Management
2. The 4 P’s: Place, Procedure, People, Policies
3. The 4 S’s: Surroundings, Suppliers, Systems, Skills

4. Repeat this procedure with each factor under the category to produce sub-factors.
Continue asking, “Why is this happening?” and put additional segments each factor and
subsequently under each sub-factor.

5. Continue until you no longer get useful information as you ask, “Why is that happening?”

6. Analyze the results of the fishbone after team members agree that an adequate amount of
detail has been provided under each major category. Do this by looking for those items
that appear in more than one category. These become the ‘most likely causes”.

7. For those items identified as the “most likely causes”, the team should reach consensus on
listing those items in priority order with the first item being the most probable” cause
Step 3 Conduct Analysis / Investigation
Step 3 Conduct Analysis / Investigation
Break those down into smaller pieces

… one small piece at a time!

In structured Problem-Solving,
small pieces help solve the Puzzle!

Step 3 Conduct Analysis / Investigation


ROOT CAUSE PROBLEM SOLVING
Exercise
Warm-up problem: Flash light
Instructions

▪ Apply Fish bone methodology to identify the main


causes of two problems at hand:
– My flash light does not work!?

▪ The management team have asked your team to


identify the root cause of the two problems above
using brainstorm methodology

▪ Fill your findings in the template provided, prepare


to syndicate your findings and prioritize your
hypothesis for further investigation

▪ Write a standard usage instruction using the


template provided

10 minutes
Exercise

Machine Man

Effect

Method Material

1 Also known as “Ishikawa diagram” and “Cause and Effect diagram” Step 3 Conduct Analysis / Investigation 4
Risks of FISHBONE

 Tendency to identify multiple root causes

 Different people using Fishbone may have different outcome of


same problem

 Relying too much on problem description (must have clearly


documented problem statement)

Step 3 Conduct Analysis / Investigation


Exercise
Group Breakout-Interactive Session
Purpose
• To apply learning from RCA training to the real life CAPA Case

Deliverables
• Completion of Problem Statement, Rationale for CAPA, Containment
• Identify Cause

Process
• Break into same 5 groups
• Investigate the problem using Cause –Effect Analysis (Fish Bone)
• Develop root cause verification plan
• Report out to the group, 30 minutes per group

Step 3 Conduct Analysis / Investigation


49
Case Study & Grouping
No CAPA subject Coordinator Team Member

1 Pouch Leakage of JB Srivishnu Krisada (TH), Chun Hui (DB), Matthew (CH), Suit Yan (MY),
Active Fresh 200 ml (10) Apichai (TH), In Bong, Su Jeong, Min jeong, Yoon Kyung,

2 Tube Leakage of NGNA Natthachai Maytawin, Zhi Yu (DB), Zhi Min (CH), Simon (DB), Alan
Liquid 100 ml (10) (MY), Mum (TH), Dong Min, Keong Keun, Dong Hun

3 Label defects from Ahmad Suhaimi Time (TH), Raj (SG), Belle (SG), Aranyapuk (TH), JaeUen,
Pemara (12) Joon Seok, Yuna Kim, So Yeon, Sung Eun, Hyun Seok,
Jeong wook,

4 Rebuild the QS in HK BQ Raymond Chan Poi Khun (MY), Andy (IN), Rena (AU), Lino (JP), Eva (TW),
(11) Show (TW), Harrison, Sophia, Ha Seong, Sang Joon,

5 MPS OOS (pH, Viscosity) Tom Wongphoom, Wanakorn, Shaun (CH), James (elsker),
(11) Catherine (CH), Jennifer (CH), Andy (CH), Jing (DB), Toh
Theng (MY), Meow Fun (MY)

6 Tube Leakage of NGNA Sang Bum Hyo Jung, Tae Kyoung, Peter, Jina, Sang Bum, Seul Ji, Eun
Liquid 100 ml (local KR (12) Ju, Edmond, Hwa Lee, Young Pi, Sang Hoon,
team)
Practice Case Study Exercise
Problem:
Customer complaint of ‘opened tube seal’ of Neutrogena Fragrance free cleanser 100ml
(Formula #832-92)

On September 17th, Customer & Logistic Service team got informed about “Opened Tube Seal
of Liquid NGNA 100 ml” found at Watson.
By 100% visual inspection for 6 batches of product in warehouse , we could narrow down the
scope of this issue to only 2 batches
• Batch # 210614T177 (complaint batch) , It is sold out 76 dz. There is 663 dz in Thailand
warehouse.
• Batch # 200614R177, filled on same date and same line (Line F), before complaint batch. It is
already sold out 436 dz in Thailand and 74 dz in Malaysia. There is 116 dz in Malaysia
warehouse.
A full detailed investigation is required to be completed.

Breakout Session
Completed Fishbone

 Form teams for investigating


 You have 20 minutes
 Will debrief as a large group afterwards
GROUND RULES for RCA

5
Ground Rules are….. Avoid Idea Killers
Everyone participates
Full attention required Respect one another (Turn off
Phones, close up laptops)
Think “outside the box”
▪ Consider different approaches Manager XYZ won’t support this idea

Suggest concrete ideas


▪ Formulate concrete and “doable”
It won’t work anyway
ideas
▪ No idea is a poor idea That is too complicated
Don’t stomp on an idea
▪ Build on someone’s idea to We are already better than most
make it better plants, why bother?
It’s too risky
Think about solutions, not
only problems
This is a known issue and fixable

No evaluation
▪ Evaluate ideas after
We thought about this 2 years ago!
brainstorming
53
Root Cause Analysis - Process

Step 1 Organize Team

Step 2 Define Problem or Issue

Step 3 Conduct Analysis / Investigation

Step 4 Determine Root Cause(s)

Step 5 Correct and Prevent

54
ROOT CAUSE PROBLEM SOLVING
Exercise

Identify direct causes that could


lead to a problem
 Expand your thinking of what
are the potential causes of the
problem

Step 3 Conduct Analysis / Investigation


Exercise

Simple Problem Tracking Sheet Date:

1 Problem definition 3 Direct causes 4 Root causes

Date to answer:

2 Containment actions

Date to answer: Date to answer: Date to answer:

6 Final results versus objectives 5 Actions Responsible Date Result

Standardization 1)
Process 1 pt lesson

Instructions Training 2)

Verification: Measurement and audit show that


the problem is : 3)
Solved
Not solved
2

59
Why - Why (TOOL)
Tool to identify the root cause of a problem
• Determine the relationships between different root causes of a
problem
• One of the simplest tools, easy to complete without statistical
analysis

CONSTRUCTION:
By simply asking 5x “Why?” the layers of symptoms which can lead to the root
cause of a root problem can be peeled away. Very often the answer to one “why”
will lead to another “why” question which will lead to another. This allows
consideration of all symptoms and causes of the problem establishing what went
wrong simply by asking the question “why” continuously during the brainstorming
session.
Website LINK: http://www.velaction.com/5-whys

Step 4 Determine Root Cause(s)


Why-Why
Root Cause Analysis Worksheet
Define the Problem:

Why did the process fail?

to locate the problem (why made?)


Why is
that?

to establish physical phenomena


(why not detected?)
Why is
Helpful Tips: that?

to establish the mechanics of the


• Why’s should focus on what went
wrong in the process, not people phenomena (what are the reasons?)
Why is
• If your last answer is something that?
you cannot control, go back up to
previous answer
to identify a cause effect
Why is
that?

to identify a cause effect (establish


systemic cause)
Why Why (Tool)

The parts are out of specs


Why?`
The wrong tool has been used
The part are out of specs
Why? Why?
The standard tool has burnt out
The right tool was not available
Why? Why?
The temperature of the oil was too
We don't have a second one
Why? high Why?
According to management, return on
Why? There is no temperature standard
Why? investment is too low to purchase
another one
Why?
Due to global competition, the
product market price is too low

Focus
Haze

5 Why’s are efficient if focus is maintained


all along the process

62 Step 4 Determine Root Cause(s)


Why-Why
Root Cause Analysis Worksheet
Define the Problem:

Why did the process fail?

1 Why is
that?

2
Why is
Helpful Tips: that?

• Why’s should focus on what went


wrong in the process, not people
3
Why is
• If your last answer is something that?
you cannot control, go back up to
previous answer
4
Why is
that?

5
Why-Why – keep asking why…

Simple technique used to analyse the causes of problems that should be seen
as a easy and quick alternative to Cause and Effect Analysis
– Mechanism: repeatedly asking ‘why?’ until the answer is ‘because that’s the
way it is’. At this point, it is likely that you have identified a root cause of the
problem.

Step 4 Determine Root Cause(s) 64


Why Why & Mile-Deep Thinking
Problem Problem Problem Problem Problem Problem Problem Problem Problem Problem Problem Problem Problem Etc.
A B C D E F G H I J K L M

Local focus
“Ask the question on causes
‘Why’ five times”
Why?
1. Why did X happen?
Wider focus
Because of W. on causes

2. Why did W happen? Why?


Because of V. Wider focus
on causes

3. Why did V happen?


Because of U. Why?
Wider focus
on causes

4. Why did U happen?


Because of T. Why?
Wider focus
on causes
5. Why did T happen?
Because of S.
Why?
Wider focus
on causes

Step 4 Determine Root Cause(s) 65


Root Cause Analysis
Caretakers of the Washington Monument
determined that the exterior was deteriorating.
Asking “why” five times, they determined:

– Why? Using harsh chemicals


– Why? To clean pigeon droppings
– Why so many pigeons? They eat spiders and
there are a lot of spiders at monument

– Why so many spiders? They eat mosquito’s


and there are lots of mosquito’s at the
monument
– Why so many mosquito’s? They are
attracted to the light at dusk!

Solution: Turn on the lights at a later time!

Step 4 Determine Root Cause(s)


66
Risks of Why-Why

 Tendency to stop at symptoms


 Inability to go beyond the current knowledge
 Tendency to isolate a single root cause
 Different people using 5 WHYs may have different outcome of
same problem

Step 4 Determine Root Cause(s)


Practice Case Study Exercise

Problem:
Use the assigned case

Breakout Session
Completed Why Why Analysis

 Connect teams for investigating


 You have 20 minutes
 Will debrief as a large group afterwards
Root Cause Analysis - Process

Step 1 Organize Team

Step 2 Define Problem or Issue

Step 3 Conduct Analysis / Investigation

Step 4 Determine Root Cause(s)

Step 5 Correct and Prevent

69
ROOT CAUSE PROBLEM SOLVING
Exercise

identify test plan


• Deeply review theory
• Clarify the scientific rational
that causes of the problem

Step 4 Determine Root Cause(s)


Exercise

Simple Problem Tracking Sheet Date:

1 Problem definition 3 Direct causes 4 Root causes

Date to answer:

2 Containment actions

Date to answer: Date to answer: Date to answer:

6 Final results versus objectives 5 Actions Responsible Date Result

Standardization 1)
Process 1 pt lesson

Instructions Training 2)

Verification: Measurement and audit show that


the problem is : 3)
Solved
Not solved
2

Step 4 Determine Root Cause(s) 71


DAY 1 WRAP UP

Key take away

 NC Trigger
 INV Process
 Problem Statement
 Root Cause Analysis
DAY 2 Tools & Application
Day 2 : Root Cause Analysis & NC/CAPA Tool Kit
Deliverable: Application of RCA Tools; Define CAPA
9:00 AM 9:15 AM 15 mins Day 1 Re-Cap & Deliverables for Day 2 Duran Duran & Su-Lyn
11:45
9:15 AM 1.5 hrs Alternative Tools Karl Zhu Group 2
AM
11:45 12:00 RCA Case Study Exercise - Workshop / Practical
1 hr Thanya
AM PM session
12:00
1:00 PM 1 hr LUNCH Duran
PM
1:00 PM 1:45 PM 45 mins CAPA Process & Definition Khim Khim
CAPA Process & Definition (Workshop & Practice
1:45 PM 2:30 PM 45 mins Khim
Session)
Khim / Suit
2:30 PM 4:00 PM 1.5hrs INV & CAPA Toolkit (Lecture) Group 1
Yan
4:00 PM 5:00 PM 1 hr INV & CAPA Toolkit (practice using the checklist) Khim
Duran & Su-
5:00 PM 5:30 PM 30 mins Day 2 Wrap Up Su-Lyn
Lyn
DAY 2 Recap
Investigation – Fishbone / 5 Whys, Funneling Down and FMEA

Purpose
– Identify potential root causes to the defect
– Evaluate risk of each root cause and identify appropriate action to
address root causes

Description
– Use appropriate root cause analysis tool
(fishbone, Why - Why) to identify potential root causes
– Funneling down by eliminating non-relevant causes to the defect
– Use FMEA framework to evaluate risk of each root cause and identify
appropriate action to address root causes

74
Root cause finding – Other tools

VSM / SIPOC Fishbone /


FMEA
/ Flow Chart Why-Why

Step 3 Conduct Analysis / Investigation


75
VSM / Flow chart
Does it impact to
• Objectives other areas (or
– Understand the complete process products)?

– Identify the critical stages of a process


– know
Do you Locate
whereproblem
exactly areas
your problem is?

Who are my customers?

Who is my supplier?
Step 3 Conduct Analysis / Investigation
76
Creating a flow chart

1. Start with End to End Boundary

2. Walk thru entire process and map them


base on actual

Step 3 Conduct Analysis / Investigation


77
Example of Flow chart

Title: Black particle


contamination in Dehyton CB
which was supplied by Cognis

Step 3 Conduct Analysis / Investigation


78
79
Step 3 Conduct Analysis / Investigation
Root cause finding – Other tools

VSM / Fishbone /
FMEA
Flow Chart Why-Why

Step 3 Conduct Analysis / Investigation


80
FMEA
FMEA is normally used as Risk Assessment BUT for our
CAPA analysis we will use FMEA as a funneling process

Step 3 Conduct Analysis / Investigation


81
Funneling down to probable root causes
Brainstorming

Cause
Cause A
B
Rejected by
Hypothesis test Result from
Cause Experiment
C
SPC shows stable process
with acceptable variation FMEA –
Potential Causes

Vital few
Step 3 Conduct Analysis / Investigation
82
FMEA
FMEA - Failure Modes and Effects Analysis

- FMEA is a risk analysis tool. It is a procedure for analysis


of potential failure modes within a production system for
classification by severity or determination of the effect of
failures on the system.

- Failure modes are any errors or defects in a process,


design, or item, especially those that affect the customer,
and can be potential or actual.

- Effects analysis refers to studying the consequences of


those failures.

Step 3 Conduct Analysis / Investigation


83
How to Conduct an FMEA
1. Identify potential failure modes, ways in which the product, service,
or process might fail.
2. Identify potential effect of each failure (consequences of that failure)
and rate its severity.
3. Identify causes of the effects and rate their likelihood of occurrence.
4. Rate your ability to detect each failure mode.
5. Multiply the three numbers together to determine the risk of each
failure mode (RPN = Risk Priority Number).
6. Identify ways to reduce or eliminate risk associated with high RPNs
and put them in place before start-up.
7. Re-assess risk after taking action and take further action, if needed.
An FMEA is a living document and should be updated as the
process/product design changes over its lifecycle.

Step 3 Conduct Analysis / Investigation


84
FMEA: Failure Modes and Effects Analysis
Date ___________ (original)
Project: _____________________
Team
: _____________________ ___________ (revised)

Occurrence

Occurrence
Detection
Detection
“After”

Severity

Severity
Item or Potential Potential Responsibility

RPN
RPN
Process Failure Effect (s) Potential Current Recommended and
Step Mode of Failure Cause(s) Controls Action Target Date Action Taken

Cause & Effect Risk: Countermeasure


Analysis of Severity Identification
Potential Occurrence,
Failures Detect-ability Impact Assessment

How To:
1. Identification of failure “modes” that result in defects
2. Prioritize them: Risk Priority Number = Severity X Occurrence X Detect-ability
3. Analyze Cause and Effect for priority risks
4. Develop Mistake Proof Countermeasures
5. Assess Impact of Countermeasures by recalculating the RPN afterwards

Step 3 Conduct Analysis / Investigation


85
Example of a Severity Rating
Scale
• Severity = likely impact of the failure
Rating Criteria: A failure could…

Bad 10 Injure a customer or employee

9 Be illegal

8 Render the product or service unfit for use

7 Cause extreme customer dissatisfaction

6 Result in partial malfunction

5 Cause a loss of performance likely to result in a complaint

4 Cause minor performance loss

3 Cause a minor nuisance; can be overcome with no loss

2 Be unnoticed; minor effect on performance


Good
1 Be unnoticed and not affect the performance

86Step 3 Conduct Analysis / Investigation


Example of an Occurrence Rating
Scale
Rating Time Period Probability
10 More than once per day 30%
Bad
9 Once every 3–4 days 30%

8 Once per week 5%

7 Once per month 1%

6 Once every 3 months .03%

5 Once every 6 months 1 per 10,000

4 Once per year 6 per 100,000

3 Once every 1 – 3 years 6 per million

2 Once every 3 –6 years 3 per 10 million


Good
1 Once every 6 –100 years 2 per billion
Step 3 Conduct Analysis / Investigation
87
Example of a Detection Rating
Rating
Scale
Definition
10 Defect caused by failure is not detectable
Bad 9 Occasional units are checked for defects

8 Units are systematically sampled and inspected

7 All units are manually inspected

6 Manual inspection with mistake-proofing modifications

5 Process is monitored (SPC) and manually inspected

4 SPC used with an immediate reaction to out of control


conditions

3 SPC as above with 100% inspection surrounding out of


control conditions
Good 2 All units are automatically inspected

1 Defect is obvious and can be kept from affecting customer

88Step 3 Conduct Analysis / Investigation


Risk Priority Number
 Risk Priority Number = RPN =
• Severity x Occurrence x Detection

 Risk increases with


1) The severity of the failure,
2) The occurrence of the cause,
3) The inability to detect the failure.

Step 3 Conduct Analysis / Investigation


89
Investigation – FMEA

Step 3 Conduct Analysis / Investigation


90
The 5 Why method will help you confirming the
EXAMPLE
real root causes
Ask “Why?” until you get to the bottom of the problem
1. Why has the
machine stopped?
2. Why did the
overload fuse
blow? 3. Why wasn’t there
enough oil?
4. Why doesn’t the
oil pump work
properly? 5. Why has the
shaft worn?

▪ The overload fuse


has blown
▪ There was not
enough oil on the ▪ The oil pump doesn’t
shaft pump enough oil
▪ Because the shaft
has worn
▪ Because the oil
strainer is blocked
with metal swarf

Step 3 Conduct Analysis / Investigation


91
Investigation – Funneling Down
• Brainstorming with all SMEs from Engineering, Maintenance and
production team by using elimination technique and it was agreed upon
that following probable root causes are not related to the scratch polybag
problems:
– Scratch occurred from supplier, as checking the defects polybag, it is low risk
to happen at supplier because the supplier machine did not have shape edge
along the flow and bag feeder should find the defect during feeding the
polybag to the bagger
– Polybag design not match to machine, If the polybag design not machine with
the specification, the validation should not be passed.
– Polybag defect and defective product cannot causing bagger to perform poorly
because the polybag material have low mass to impact bagger machine to
perform poorly and the mechanical part already design to prevent this issue
– Lack of bagger adjustment experience, as checking with operator and packer
team, both shift are experience person and during that day, key operator
controlled the machine by themselves

Step 3 Conduct Analysis / Investigation


92
IS and IS NOT Sheet (Tool)
IS IS NOT
Who is affected by the problem?
Who

Who first observed the problem? Who is not affected by the problem?
(internal/external?) Who did not find the problem?
To whom was the problem reported?
What type of problem is it?
What has the problem? What does not have the problem?
What

What is happening? What could be happening but is not?


Do we have physical evidence of the What could be the problem but is not? Is/Is Not Analysis is
problem in our possession? a method of
Why is this a problem?
narrowing down or
Why

Is the process where the problem Why is it not a problem?


occurred stable? focusing by
successively asking
Where

Where could the problem be located but is not?


Where was the problem observed? both 'What is it' and
Where else could the problem be located but is
Where does the problem occur?
not? 'What is it not'.
When was the problem first
Much/ When

When could the problem have been noticed but


noticed?
was not?
When has it been noticed since?
Quantity of problem?
Many
How

How many could have the problem but don’t?


How Much is the problem causing in
How big could the problem be but is not?
dollars, people, & Time?

What is the trend (continuous,


random, cyclical)?
Often
How

Has the problem occurred What could the trend be but is not?
previously? (If so attach previous
PSWs & CIFs)

Problem Description - Combine the relevant information, this will be your Problem
Description
Find Possible Cause

IS IS NOT Differences Changes Possible Explain all?


Causes
What
Where
When
Extent

We are going to fill this together after reading the case


ATS (Analytic Troubleshooting)
Confidential |
Examples of Tools
Root cause finding – Other tools

VSM / Fishbone /
FMEA
Flow Chart Why-Why

Step 3 Conduct Analysis / Investigation


96
Exercise
Tools Application

Investigation – VSM, Process Flow

Investigation – Fishbone

Investigation – Why Why

Investigation – FMEA …..

Confidential |
No Root Cause
OR
 Poor Root Cause Analysis?
What If No Root Cause?
• When root cause cannot be determined, the reason for
not being able to determine “shall be justified,
documented and approved by the Quality Unit.”

• Helps ensure that the use of “Undetermined” is


appropriately applied, and a strong rationale for such is
included within the investigation.

BENEFIT:
• Applying this diligence will reduce the risk
• Helps avoid prematurely concluding an investigation
Poor Root Cause Reasons
– No set criteria about what makes an acceptable
 corrective action plan (Satisfied when we don’t receive any more defective
parts and stop here)

– Continue to accept bad answers


 even if say we will not, but reality continue to accept

– Process
 missing process understanding
 rushing to Actions
 focusing on Initial response which is usually the Symptom

– People (internal and external)


 missing the Root Cause Analysis culture
 missing training & understanding
Case Study & Grouping
No CAPA subject Coordinator Team Member

1 Pouch Leakage of JB Srivishnu Krisada (TH), Chun Hui (DB), Matthew (CH), Suit Yan (MY),
Active Fresh 200 ml (10) Apichai (TH), In Bong, Su Jeong, Min jeong, Yoon Kyung,

2 Tube Leakage of NGNA Natthachai Maytawin, Zhi Yu (DB), Zhi Min (CH), Simon (DB), Alan
Liquid 100 ml (10) (MY), Mum (TH), Dong Min, Keong Keun, Dong Hun

3 Label defects from Ahmad Suhaimi Time (TH), Raj (SG), Belle (SG), Aranyapuk (TH), JaeUen,
Pemara (12) Joon Seok, Yuna Kim, So Yeon, Sung Eun, Hyun Seok,
Jeong wook,

4 Rebuild the QS in HK BQ Raymond Chan Poi Khun (MY), Andy (IN), Rena (AU), Lino (JP), Eva (TW),
(11) Show (TW), Harrison, Sophia, Ha Seong, Sang Joon,

5 MPS OOS (pH, Viscosity) Tom Wongphoom, Wanakorn, Shaun (CH), James (elsker),
(11) Catherine (CH), Jennifer (CH), Andy (CH), Jing (DB), Toh
Theng (MY), Meow Fun (MY)

6 Tube Leakage of NGNA Sang Bum Hyo Jung, Tae Kyoung, Peter, Jina, Sang Bum, Seul Ji, Eun
Liquid 100 ml (local KR (12) Ju, Edmond, Hwa Lee, Young Pi, Sang Hoon,
team)
CORRECT AND PREVENT
Corrective Action / Preventive Action Plan

• This step involves identifying possible solutions,


selecting the appropriate solution(s), and developing
corrective action and preventive action plans

• Determine how you will measure effectiveness and


document that in your effectiveness check plan

There may be more than one root cause. Additional Corrective


Actions for any other causes should be implemented

Refer to WWSP 000243 and WWSP027


Root Cause Analysis - Process

Step 1 Organize Team

Step 2 Define Problem or Issue

Step 3 Conduct Analysis / Investigation

Step 4 Determine Root Cause(s)

Step 5 Correct and Prevent

104
ROOT CAUSE PROBLEM SOLVING
Exercise

identify test plan


• Deeply review theory
• Clarify the scientific rational
that causes of the problem

Step 5 Correct and Prevent


Conclusion
 The importance of Root Cause Analysis

 Consequences of inadequate Root Cause Analysis and Investigation

 Application of Root Cause Analysis tools

 The systematic approach to planning, executing, and documenting failure


investigations, Root Cause and problem solving
QUESTIONS

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