Transcript Root Cause Corrective Action

Dataplate Training
Introduction to Root
Cause Corrective Action
and the 5 Why Process
Konrad Burgoyne
www.dataplate.co.uk
Introduction
 Aim - To understand the concepts of cause analysis and to be
able to apply those concepts to prevent or eliminate errors and
defects
 Reason - This is a requirement of the aerospace industry
 Incentive – RCCA is a fundamental and valued skill used within
many areas of business.
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What is Root Cause Corrective Action?
An effective process for finding the
causes of an event and facilitating
effective corrective actions to
prevent recurrence.
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RCCA for Non Conformances
A requirement of the aerospace industry for many
years.
A process of determining the causes that led to a
nonconformance or event.
An effective method for implementing corrective
actions to prevent recurrence.
Requirements are not new, but they may not have
been aggressively enforced in the past.
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Event
An all inclusive term for any of the following:
Product Failure
Non Conformance
Audit finding
Special Cause (SPC)
Accident
Customer complaint
Failure Mode (FMEA)
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The Traditional Approach to an Event
Event
(Problem)
•
•
•
•
•
•
•
•
Containment
Establish Team
Identify Problem
Gather & Analyze Data
Find the Root Cause
Determine Corrective Action
Implement Corrective Action
Review Corrective Action
Fix it
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Traditional Problem Solving
Don't Mess
With It!
Yes
Did
You Mess
With It?
No
Does
It Work?
No
Yes
No
Does
Anyone Know
You Messed
With It?
Yes
You Could
Be In
Trouble!
Will
You Be
Blamed For It
Anyway?
No
No
Yes
Can You
Transfer Blame
To Someone
Else?
Yes
Uh - Oh !
Hide It Or
Throw
Away The
Evidence!
Can
It Be Fixed
Before Your
Boss Finds
Out?
Yes
No
L
PROBLEM!
J NO
PROBLEM !
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The Requirement - AS9100
8.5.2 Corrective Action: The organization shall take action to eliminate the cause of
nonconformities in order to prevent recurrence. Corrective actions shall be
appropriate to the effects of the nonconformities encountered.
A documented procedure shall be established to define requirements for:
a) reviewing nonconformities (including customer complaints),
b) determining the causes of nonconformities,
c) evaluating the need for action to ensure that nonconformities do not occur,
d) determining and implementing action needed,
e) records of the results of action taken,
f) reviewing corrective action taken,
g) flow down of the corrective action requirement to a supplier, when it is
determined that the supplier is responsible for root cause, and
h) specific actions where timely and/or effective corrective actions are not
achieved.
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The RCCA Approach to an Event
Event
(Problem)
•
•
•
•
•
•
•
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Containment
Establish Team
Identify Problem
Gather & Analyze Data
Find Root Cause
Determine Corrective Action
Implement Corrective Action
Review Corrective Action
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Containment
Immediate Corrective Action
Put out the fire
STOP producing bad product
Evaluate product impact
Inform customer if shipped product impact is
suspected – A legal requirement.
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Establish Teams
Natural Team
Assignment of wrong personnel a common problem.
Common to assign to Quality – did quality make the error?
Who owns the problem?
Who has a stake in the outcome and the solution to the problem?
Who are the vested owners of both the problem and the solution?
Who knows the process – have data and experience?
Who will have to implement and live with the corrective action?
Without the full buy-in and support of the stakeholders, long-term solutions are
not likely.
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Establish Teams
Qualified Team
The Natural team plus other individuals who can provide necessary resources to
understand the problem further.
Those who can provide additional information
Those who have technical expertise – Subject Matter Experts (SME)
Those who may need to act as advisors
Those providing management support
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Remember
Take action:
To a degree appropriate to the magnitude of
the problem.
Proportionate with the risks encountered.
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Identify Problem
• You must understand the problem.
• Is there more than one problem?
• You must know what you don’t
know, to be able to find out.
• Keep it simple
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The Problem
Must be clearly and appropriately defined.
 The nonconformance identified may not be the real
problem – only a symptom of the problem.
Asking questions is helpful.
 What is the scope of the problem?
 How many problems are there?
 What is affected by the problem?
 What is the impact on the company?
 How often does the problem occur?
Addressing appropriate questions will assist in
clarifying and defining the problem(s).
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Caution
If you cannot say it
simply, you do not
understand the
problem!
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Gather & Analyse Data
Performed by Team Members
Look for:
 Location.
 Names of Personnel.
 Date and Time.
 Operational Conditions.
 Environmental Conditions.
 Communications.
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





Sequence of Events.
Equipment.
Physical Evidence.
Recent Changes.
Training.
Other Events.
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Gather & Analyse Data
Problem identified – begin data collection.
May need to be collected several times.
The preliminary collection phase occurs now
and will guide the analysis process.
Initial data gathering starts at the scene.
 Data has a shelf life.
 Waiting makes it difficult to obtain good information.
 Go to the scene.
 Note those present, what is in place, when the event
occurred, and where the event happened.
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Remember
Take action:
To a degree appropriate to the magnitude of
the problem.
Proportionate with the risks encountered.
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Find The Root Cause
The Cause Chain
Direct>Contributing>Root
•
The direct cause is the cause that immediately
caused the problem
• Causes in-between are contributing causes
• A root cause is the last cause in the cause chain
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Find The Root Cause
An Important Thing to Remember About
“Root Cause.”
 It’s not always the most significant cause in the
chain ...
 Just focus on the fact that it is the
LAST
cause in the chain ...
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The 5-Why Process
The ‘5 why’ is one method that can be used to
find:  the cause chain.
 A natural logical progression for thinking
through a problem.
 The direct cause.
 The root cause.
 The contributing causes.
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Why?
State the
Problem as an
Event Question
starting with:
Why . . . ?
• An event question is short, concise, and focused on ONE
problem.
• It is a question starting with Why . . . ?
• It is the first “Why” in the process.
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Common Initial Considerations
Operator error (most common).
Honest mistake.
Second shift did it.
We didn’t include the requirement in our
internal procedure.
We didn’t know it was a requirement.
Not familiar with the specification.
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Caution : Operator Error
Yes, it does happen, but . . .
Used as “root cause” much too often.
Used as an easy way out.
Ask: If the operator was replaced, could the next person
make the same mistake? If so, then you have not
determined the Root Cause!
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Is it really Operator Error?
You must ask these five questions:
• Proper Instructions?
• Proper Tools?
• Proper Training?
• Clear Expectations / Goals?
• Is the process Complex or Unusual?
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How many whys?
Do not believe that the 5 Why process restricts
you to asking why 5 times
A root cause may be found with 3 Whys or it
may take 7 Whys
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How many whys?
Times asked why
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Remember
Take action:
To a degree appropriate to the magnitude of
the problem.
Proportionate with the risks encountered.
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No Big Secret
Simple Question
Simple Answer
Simple Question
Simple Answer
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Simple Question
Simple Answer
Simple Answer
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Don’t fall into the trap
CAUTION
Cause chain under
construction.
No corrective
actions allowed!
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The cause chain
Event
Direct
Cause
Contr.
Cause
Root
Cause
How many root causes are
you allowed?
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The cause chain
Event
Problem
#1
Direct
Cause
CC
CC
Root
Cause
Problem
#2
Direct
Cause
CC
CC
Root
Cause
Two or more, if you have
multiple branches.
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Fishbone Diagram
A fishbone diagram is a graphic methodology to identify “Whys.” To make a
Fishbone Diagram, start with your problem or event and brainstorm ideas
about why that problem/event is happening. Each one of these ideas (or
causes) becomes a “bone” that shoots off the main one. Then, brainstorm
ideas that might have caused those “bones.” Eventually, it will look like a
skeleton of a fish.
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5 Why Example
The Problem
Nadcap Audit 54345 NCR5
For job 6 (OEM Prime, job no. B140898), drawing DX667-039 required "stress relieve at 525 +/-5°C for
30min to KPS425”
It was found that the data card, DC2488, required 538 +/-13.9°C for 20 - 25min. Although this is in line
with the requirement of KPS425, there was no customer or delegated approval on the data card to
show that this deviation from the drawing was acceptable.
It was determined by OEM Prime that a Drawing Clarification Form should have been raised in the first
instance. Drawing Clarification Forms were not formalised or understood throughout the company
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5 Why Example
The “Drawing Clarification Form” was known as a “query form” and came into use in September 2013. There is no identified formal process
or procedure in place in obtaining clarification from the OEM Prime.
Why is there no formal process for implementing the Drawing Clarification Form (Query form)?
This form was a new form that was sent to a specific engineer in January 2014 for project G053XX016-103, G053XX038-103 and
G053XX048-101 queries.
Why was this form not put in general use for OEM Prime queries?
There was no other information or instruction flowed down from OEM Prime in relation to this form
Why was there no other information requested?
It was understood that this form was an informal document specific to project G053XX
Why was this form understood to be an informal document?
It was created with no process or instruction document and showed no document ID number and it is not referenced in the OEM Prime
Q700 Requirements for Suppliers document?
Root cause: Inadequate control of documentation
Containment:
The Drawing Clarification Form has now been completed for drawing DX667-039 and sent to OEM Prime (See attached)
Corrective Action
Quality Alert OEM11 has been raised and distributed throughout. (See attached)
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5 Why Example
Quality Alert – OEM11– Control of Documents
Aim – The aim of this quality alert is to put in place corrective action and initiate preventative action for similar situations.
Reason – Control of Documents is a requirement of AS9100
Incentive – A well understood standardised quality system will improve efficiency, productivity and profitability throughout the business.
Issue
A recent Nadcap audit NCR response led to a discovery of a document (issued by a customer) used without a formal process or written
procedure.
Action
With immediate effect, all users of documents both internally generated and externally provided shall ensure there is a formal process to
follow that is referenced in the Quality Management System (QMS).
In the event a document is identified having no formal process please refer to P-Q-2-11 Document Control & Control of Records Procedure
for the process to follow.
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Caution
Complex problems, especially those where an entire
process has been brought into question require a
more thorough analysis.
Requirements
& Design
Equipment
& Maintenance
Process Planning
& Materials
Production Operations
& Quality Assurance
Root Cause Analysis (RCA) is a systematic approach to determining all the
contributors to a problem before attempting to implement a corrective action plan.
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Corrective Action
A set of planned activities
(actions) implemented for the
sole purpose of permanently
resolving the problem.
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Types of Corrective Action
Specific corrective action changes only
the direct cause or the effect. Action(s)
taken to correct the direct cause and/or
the effect.
Sustaining corrective action changes
contributing and root causes. Actions
taken to prevent recurrence of the event
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Sustaining Corrective Action
Sustaining corrective actions focus on
changing root cause(s) and contributing
cause(s).
If
you have only identified one cause,
you probably won’t get a 100% effective
fix.
Remember – today’s contributing cause
is tomorrow's root cause.
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Corrective Action – What, Who & When
The three W’s
What, Who, When.
What is the corrective action?
Who is responsible for doing it?
When is it going to be done?
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Corrective Action
Establish the most effective corrective action
to put in place.
Must correct the root cause
Must correct contributing causes
Must be workable
Must have a effectivity date
Must be sustainable
Must not be the cause of other unforeseen nonconformances
Must be reviewed
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Remember
Take action:
To a degree appropriate to the magnitude of
the problem.
Proportionate with the risks encountered.
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Corrective Action - Review
The corrective action can have a working review
to ensure it is effective
Adjustments to the corrective action can be made
and documented
A formal review is required to document
effectivity
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Summary
EVENT
Containment
Form Team
Identify Problem
Gather & Verify Data
Determine Causes
Direct
Root
Contributing
Determine Corrective Actions
(Specific & Preventive)
Mistake Proofing
Implement & Follow up
No
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Solution
Acceptable?
Yes!
Done
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Documentation
EVENT
Containment
Form Team
Identify Problem
Minutes Team
Meetings
Gather & Verify Data
Document Causes
Determine Causes
Document
Corrective
Action
Direct
Root
Contributing
Determine Corrective Actions
(Specific & Preventive)
Document
Follow-up
Mistake Proofing
Implement & Follow up
No
Solution
Acceptable?
Yes!
Done
Write Final
Report
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Remember
Take action:
To a degree appropriate to the magnitude of
the problem.
Proportionate with the risks encountered.
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Questions?
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