RCA Intro and Tools
RCA Intro and Tools
RCA Intro and Tools
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
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?
10
First Assumption of Root Cause is Quick,
but often Incorrect
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
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
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
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
HOW MANY? How many were there? How much does it cost
Which?
Step 2 Define Problem or Issue20
Problem Definition and CAPA Rationale
Who?
What?
When?
What?
What?
2 Containment actions
Standardization 1)
Process 1 pt lesson
Instructions Training 2)
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
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
Date to answer:
2 Containment actions
Standardization 1)
Process 1 pt lesson
Instructions Training 2)
31
Exercise
Group discussion:
Containment
It is necessary to contain the problem before
finding the root causes
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
Venue for
brainstorming of
potential causes See the relationship
between causes which might
lead to Potential Causes
Detailed enough to
Remove non-related
create common
A title of CAPA information for the
understanding what
potential root causes
the problem is
• 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”
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
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
In structured Problem-Solving,
small pieces help solve the Puzzle!
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
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
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
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
No evaluation
▪ Evaluate ideas after
We thought about this 2 years ago!
brainstorming
53
Root Cause Analysis - Process
54
ROOT CAUSE PROBLEM SOLVING
Exercise
Date to answer:
2 Containment actions
Standardization 1)
Process 1 pt lesson
Instructions Training 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
Focus
Haze
1 Why is
that?
2
Why is
Helpful Tips: 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.
Local focus
“Ask the question on causes
‘Why’ five times”
Why?
1. Why did X happen?
Wider focus
Because of W. on causes
Problem:
Use the assigned case
Breakout Session
Completed Why Why Analysis
69
ROOT CAUSE PROBLEM SOLVING
Exercise
Date to answer:
2 Containment actions
Standardization 1)
Process 1 pt lesson
Instructions Training 2)
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
Who is my supplier?
Step 3 Conduct Analysis / Investigation
76
Creating a flow chart
VSM / Fishbone /
FMEA
Flow Chart Why-Why
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
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FMEA
FMEA - Failure Modes and Effects Analysis
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
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
9 Be illegal
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
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
VSM / Fishbone /
FMEA
Flow Chart Why-Why
Investigation – Fishbone
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.”
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)
– Process
missing process understanding
rushing to Actions
focusing on Initial response which is usually the Symptom
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
104
ROOT CAUSE PROBLEM SOLVING
Exercise