FDA OCRA ASQ Root Cause 06

Root Cause Analysis

ASQ – Orange Empire
Section 0701

by: Jack Dhuwalia,
MS, MBA, DTM
President,
J D Consulting
July 22, 2006
© JD Consulting, 2006

We’ll cover
• A Case Study
• Overview
• Key Ideas
• Defect (elusive)
• Jack’s Troubleshooting Concepts
• Methods - Tools
• More Case Studies
• Takeaways

© JD Consulting, 2006 4

Case Study


Slippery When Wet
• Identify and break into teams -
regroup

• Hand-outs
• Problem statement (P1)
• Situation (P2)
• Background (P3&4)

• Go for it!

What really happens
(undesirable stuff)?


Top five issues with Problem
Solving
• Experienced people not available
• Unable to identify root cause
• Solving the wrong problem
• Solutions creating more problems
• Demoralizing to employees


Key Ideas


Hidden Causes

BO
P
BO
P

Defect (elusive)


Defect Rate VS. Ease of
Discovering Cause

Jack’s Troubleshooting Concepts


Teamwork


Human Nature
• Denial
• Blind spots
• They can’t “see” the problem
• Likely to miss the cause(s)

The same mind that creates a given
problem simply cannot fix the problem.
—Jack Dhuwalia


Invite an Outside Expert

for better results!


efine problem

nvestigate

dentify potential cause(s)

ort

onfirm assumptions

Methods - Tools


Methods for Investigations,
Data Collection And Analysis
• Fish-Bone
• Flow Charts
• FMEA
• Control charts
• Pareto Charts


More Methods…

• Capability studies
• Experimentation
• DOE
• 5 W’s
• Many more…
• Analytical trouble-shooting


Fish-Bone


Fish-Bone (contd.)
Label each ""bone" of the "fish". The major
categories are:
The 4 M’s:
Methods, Machines, Materials, Manpower
The 4 P’s:
Place, Procedure, People, Policies
The 4 S’s:
Surroundings, Suppliers, Systems, Skills

Flow Chart Product ready to
package
Test "empty"
packages at the
start

Seal meets
No
specs?

Yes

Package sealing
Sterilization
operation

Take
corrective
action
Test "empty"
QC release Yes packages at the
end

Product release Seal meets
No
for sale specs?

Fig. II Modified Process Flow

FMEA

Potential Before
Causes After Mitigation
Mitigation
of
Failure

O O
D
Proce POTENTIA c D c
Potential CURRENT S S e
ss L EFFECTS c e c
# Failure PROCESS e e t
step/F OF u t u
UNCTIO Mode CONTROLS v R v e R
FAILURE r e r
N e P Mitigations e c P
r c r
ri N ri t N
e ti e
t t i
n o n
y y o
c n c
n
e e


Control Chart


Pareto Chart


Analytical Trouble Shooting
• KEPNER TREGOE® – taught in 1974
• Systematic way of analyzing and
trouble shooting
• Underlying principle: cause and effect


ATS Concepts
• Historic, demonstratable relations ship
exists between cause and effect
• Effect to be explained is always a
Deviation
• Deviation can only be recognized in
relation to a specific Should or
expectation of performance


ATS Concepts (contd.)
• Cause of a Deviation is always a
change of some kind. No change – no
Deviation
• Cause of a Deviation matches the
Deviation it produces exactly
• Action required to control an event
rests in knowing just how the cause
relates to the condition it creates


Cause and Effect


ATS Process (contd.)
1. Identify the Deviation
2. Specify the Deviation
• WHAT
• WHERE
• WHEN
• EXTENT (HOW MANY)
3. Define Boundaries
• DEVIATION IS AND IS NOT
4. Examine the Distinctions

5. Look for Changes
6. Statement of Cause
7. Testing for Cause
8. Verifying the Cause


ATS Process Questions
• Difference
• What is different
• Odd
• Unusual
• Peculiar/distinct
– About IS as compared to IS NOT



Defining the boundaries of Deviation

Deviation IS Deviation IS NOT

What

Where

When

Extent


ATS Process Questions (contd.)
• Change
– What has changed in, about, or around
the difference?


• Possible cause
– How could this change possibly cause the
trouble or what is there about this change
that could cause the trouble?


• Most probable cause (test)
– If XYZ is the cause, how does it explain
the IS and IS NOT facts?


• Verify
– Does it check-out in real life?


Process


Case Study


SWW ATS Process
• Observations
– DOE was getting “nowhere”
– Needed fresh, ATS approach
– No one really had the entire picture
– Not enough time to really understand
history, what changed, etc.
– I had to take risks – stuck my neck out


SWW ATS Process (contd.)
• Difference
– Odd/unusual that the reactor was
completely agitated/mixed so variation
could not be explained in the reactor
– Had to be before
• Action
– Flow chart
– Understand the steps
– Decided to test (2/day)


ATS (contd.) 1. Tubing
Extrusion
5. Balloon Molding

6. Balloon
2. Gamma
Bonding on
Irradiation
Catheter

7. Coating
3. Irradiation
Process (several
Testing
steps)

8. Catheter
4. Tubing Cutting
Finishing

Figure II - Process Flow Chart
© JD Consulting, 2006 for PTCA Balloon Catheter 50

• Tests – ROUND 1
1. Tubing alone (Step 4)
2. Tubing after Balloon Molding (Step 5)
3. Tubing with blown balloon (Step 5)
4. Bonded balloon (Step 6)
5. All coated at the same time


• Test results
1. The coating process: “that ain’t it!”
2. Ability to accept coating is a function of
the tubing/balloon surface (substrate)
3. Coating thickness appears to be a
function of location (see diagram)
4. Conclusion: It is not the coating
process!


• Statement of cause
1. Tubing location seem to cause variation in
coating thickness
2. Conjecture: heat history of substrate
causes variation in coating thickness


• Tests – ROUND 2
1. Tubing with blown balloon (Step 5)
2. Same as above at higher temperature
3. Same as above at lower temperature
4. All coated at the same time


SWW ATS Process Conclusion
• Results – ROUND 2
1. Higher the vertical location, thicker the
coating
2. Conclusion: Coating thickness variation
is caused by thermal history of the
balloon


SWW ATS Process Verification
• Verification
– Similar results with different balloon lots
– Conclusion: Material Lots do not cause
coating variation


SWW ATS Process Corrective
Action
• Corrective Action
– Turn the mold upside-down (see diagram)
• Verify Corrective Action
– Worked like “magic”
– Better coated balloon
– Better for the customer


More Case Studies
• Painted aircraft component
• Empowerment: Sterile packaging for
radioactive “seeds”
• Artificial Kidney Seal Rings


Key Ideas

• Cause(s) usually hidden
• Cause(s) not necessarily the “usual
suspects”
• More than one cause(s) and/or
condition

Jack’s Troubleshooting Concepts

• Team work
• Use appropriate tool(s)
• Invite an outside expert

FDA OCRA ASQ Root Cause 06

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