Finding the Root Cause

Identifying the Context for

Root Cause Investigation

ASQ PALMETTO SECTION

MAY 13, 2008
 The Journey Ends (almost). . .
• Review of previous presentations on
addressing audit nonconformance's
• Refresher of CREI problem statement
format
• Every problem originates in a process
• Containment and Interim Actions
• Root Cause Analysis
 In Previous Episodes. . .
• The preparation shop makes four types of
Widget blanks for the assembly shop,
named Type A, B, C and D
• Blanks are plastic tubes of various
diameters made on two extruders
• They are temporarily stored in plastic bins
• After storage they are transported to
cutting machines where they are cut to
different lengths
 In Previous Episodes. . .
• The assembly shop puts the plastic tubes
together with other products to make a
final assembly
• They are sold to the automobile industry,
specifically Ford and GM
• The Widgets must be at the correct length
(+/- 2mm) and be free of cracks
Getting to the Process of Origin
• Where was the problem found?
• Where is the first process the problem
condition could occur?
• Go to these and any processes in between
to collect data recognizing where the
problem is actually first observed; this is
the process of origin!
• Use a process flow diagram to make this
investigation visual.
Step 3A: Containment – support
identification of Process of Origin
• Purpose: to isolate the
effects of the problem from
downstream processes and
customers; also a source of
data collection for
understanding with depth
and breadth of the problem
and identifying Process of
Origin
• Methods:
– Planning of containment
– Quarantine of product
– Evaluation
– Data collection
• Inputs:
– CREI statement
– Process flow
– Timeline
– Data to collect for Is/Is Not
Analysis
• Outputs:
– Data re: scope of problem,
(e.g. how many parts are
actually affected)
– Data for completion of Is/Is
Not Analysis
– Other opportunities
 A Root Cause is. . .

A process factor which directly defines

the reason for the problem when it is
present and is having an influence on
the process and its output.
 Root Cause Analysis
• Systematic investigation
of a process to identify
the root cause of the
gap, and take corrective
action to eliminate the
gap and keep it from
occurring again in the
future
• The Process of Origin
must be identified,
(using data), before
Root Cause Analysis
can proceed!
 Process Hierarchy
Products/Services = output of producing Processes

Producing Processes to accomplish Plans

Planning Processes apply System

to fulfill customer requirements

System Processes = Policies, Objectives & Practices

(how an organization does business)
Audit findings are typically identified at Plan & System level
 4 Levels of Root Cause
Defect/Detection Cause = Product level

Direct Process Cause = at Process of Origin

Actual Root Cause = previous process factors

contributing to Process Root Cause, (planning)

System Root Cause = management system

policy/practice contributing to Actual Root Cause
 Dig! How Deep?

• Management decides
on depth of root
cause investigation
through the
establishment of
SMART goals for
each problem solving
effort.
 Root Cause Analysis Levels
Root Cause Consideration Tools Other
Level
(Wide)
(Deep)
Defect/Detection Condition of Control What other
Product cause controls to Barrier products have
detect problem Analysis similar
controls?
Direct process Factors at Fishbone, What
Process cause, (trigger at process of (cause & processes
process of origin origin triggering effect) have similar
problem, (5Ms) trigger cause?

Actual root cause, Linkage to 5 Why with What other

Plan (led to trigger planning Hypothesis processes
cause) processes that testing affected?
trigger cause
“weakness” in Linkage of mgt. System Other affected
System mgt. policies or system to Cause mgt. policies
practices actual cause Analysis
 Failure Modes & Effects Analysis
(FMEA) – Clues for Root Cause Investigation
Process Potential Potential Potential Current
Function Failure Failure Failure Product &
Requirements Modes Effects Causes Process
Controls
Process of Technical Symptom Process Interim
origin definition of factors = root actions
problem causes
 Step 3B: Interim Action
Identifying “Product-level” Root Cause
(Defect Detection Cause)
• Purpose: to understand why
the problem condition escaped
the process/organization;
evaluation of existing process
controls for
weaknesses/deficiencies;
addressing this cause does
not prevent recurrence of the
problem
• Methods:
– Control barrier analysis
– Planning of interim actions
• Inputs:
– CREI statement
– Process flow
– FMEA
– Control plan
• Outputs:
– Defect, (detection), cause,
(why problem escaped
existing controls)
– Interim controls
– Data for Is/Is Not Analysis
– Methods for monitoring interim
controls to collect data for
problem solving effort
– Other opportunities
 Control Barrier Analysis
Process
Worksheet
Condition Control Status Capability Observations Actions

Other Opportunities:
Results of Control Barrier Analysis
• May recognize missing controls or controls not working
as planned
• Interim actions represent solutions to addressing these
concerns but should not be accepted as the
permanent solution
• When the results of this analysis uncover additional
problems, refer these to the team champion for
direction on addressing, (Other Opportunities)
• Team’s main focus at this point is to implement some
type of control to protect downstream processes from
continuing to experience the problem
• Solutions based on this level of “root cause
investigation” mainly are reactive in nature; they only
improve our ability to detect the problem condition but
don’t typically do anything about addressing the root
cause!
 Direct Process Cause
(Trigger Cause at Process of Origin)
• Must confirm process of origin in order to conduct
investigation of process-level root cause!
• Relates one or more factors of the affected
process, (process of origin), not “behaving” as
required to obtain the desired output result at that
process
• Use Cause & Effect diagram, (fishbone technique)
• Direct process causes, (trigger causes), are the
starting point for identifying actual root cause
• Some action may be required to address the direct
process/trigger cause but actions should not be
taken until actual root cause is known
 Fishbone Diagram
PROCESS:

Material Man

Gap:

Mother Method Machine

Nature
 Fishbone Process
• Involve personnel from process of origin in
brainstorming of potential causes at the process of
origin triggering the problem
• Develop a sketch/list of the process factors, (man,
material, machines, methods, mother nature), related
to the process of origin
• After brainstorming, review each identified cause to
establish:
– If the cause is actually a factor at the process of origin
– If the cause makes sense based on the operational definition
of the problem
• Prioritize remaining causes as to their possible
contribution to the problem condition
• Develop hypothesis test to evaluate each potential
cause at the process of origin
 Actual Root Cause
• Explains why trigger cause/condition exists at the
process of origin
• Typically found in previous “planning” processes
• Use 5 Why Analysis with Hypothesis testing to identify
and confirm, (collect data!)
• Many problems have multiple causes
• Usually only one over-riding cause that when addressed,
can significantly reduce the problems impact on the
organization
• Very complex problems may have interacting causes but
these are typically viewed as isolated problems that only
repeat infrequently, (often managed as Just Do It), until
resources allow necessary time to discover interaction
through data collection, analysis and experimentation
 5 Why Analysis
• Ask “Why does this
happen?” for each identified
process cause from Cause &
Effect diagram
• Differentiates between
process, (direct) cause and
underlying root cause
• Each level of causes
identified in 5 Why analysis
must also be confirmed via
testing in order to verify root
cause
• Deeper levels of 5 Why
Analysis which get into
Planning processes will
require interview-type data
collection
 Root Cause Analysis Plan
• Identify causes to be investigated
• What data supports each cause?
• Can cause be introduced and removed to
confirm presence/absence of problem?
• What tests will be performed to confirm root
cause?
• What is the statistical confidence of these
tests? (i.e. how much data is needed?)
• Results of tests recorded and analyzed with
conclusions drawn
 System Causes
• What in the system allowed this problem/cause
to occur
• Identifies why the process root causes occurred
based on current management policies/practices
• Often not readily measurable
• Data obtained through interview
• By identifying system causes, systemic
improvement can be made in order to prevent
recurrence of problem in other similar processes
• Typically addressed once process root causes of
problem are known and confirmed
 System Cause Analysis Worksheet
Operational Definition:

Process of origin cause:

Process root cause:

Which management system process is the process root cause related

to?

Who is responsible for this management system process?

What documentation/policies are available describing actions and

controls for this management system process?

Does this documentation/policy recognize the possibility for this

problem to occur?

Are there any current management system controls in place to

prevent or detect this problem?

Has this management system process been associated with previous

problems?

What other processes within the organization are driven by this

management system process?

Possible Management System Level Solutions: 1) Create new policy

2) Change existing policy 3) Reinforce/re-apply current policy
As a result of Root Cause Analysis
• Product-level cause, (related to current controls),
identified and confirmed along with appropriate
interim controls to “protect” downstream
processes/customers
• Trigger cause at process of origin identified and
confirmed
• Actual root cause, (what allowed the trigger
cause to exist at the process of origin), known
and confirmed
• System root cause identified, relating actual root
cause to management policies/practices
 A Key Outcome of Every Problem
Solving/Root Cause Investigation. . .

Expansion of Knowledge
 Next Steps, (Next Year?)
• Solution identification, (3 possible
solutions to every problem), and
evaluation/selection for each root cause
level
• Implementation of selected solutions
• Verification of the effectiveness of
implemented solutions
• Lessons learned
Your Turn for Root Cause Analysis
• For previous case study on widget
manufacture:
– CREI statement, (given)
– Process flow, (given)
– Is/Is Not analysis, (given; process of origin
known)
– Fishbone potential causes at process of origin
– Create questions for 5 Why investigation
 Widget CREI
• Concern: customer complaint from GM
re: cracked tubes, (widgets)
• Requirement: per GM drawing #123,
assembly should be free from cracks
• Evidence: GM customer complaint
• Impact: assembly leaks, (performance),
GM is requiring contained shipping, ($$$)
Widget Making Process Flow
Extrude

Store extruded
pieces

Cutting

Assembly

Final inspection

Ship to customer
 Is/Is Not Analysis
Focus Aspect Data to Where to How to Results – Results – Comments
Collect Collect Collect IS IS NOT
What? Problem # cracked Process Visual Visible Other Refer to
condition tubes flow evaluation cracks on defects requirement
tubes
Where? Geographicall Processe Process Note Cutting, Extrusion, See process
y s where flow processes customer assembly, flow
cracked where final
tubes cracked inspection
found tubes found
Where? On output Location During Concentratio Cracks at Cracks Refer to
on part containmen n diagram edge of along problem
t tube length or condition
in other
locations
When? First seen Problem Customer Review of 4/28/08, Prior to Refer to
report service customer (date of this date timeline
complaints customer
complaint
)
Who? Identified Names, Customer Interview GM, Other
problem positions, service (customer customers
contact )
info
Involved in Functions Process Interview Cutting Other Refer to
related flow operator cutting process flow
 Fishbone Diagram

PROCESS: Cutting

Material Man

Cracks on
cut edge of
tube
produced
on 3rd shift
on 4/28/08

Mother Method Machine

Nature
 Possible Questions for
5 Why Analysis
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