FDA OCRA ASQ Root Cause 06

© JD Consulting, 2006

Root Cause Analysis

ASQ – Orange Empire Section 0701

by: Jack Dhuwalia,

MS, MBA, DTM

President,

J D Consulting

July 22, 2006

© JD Consulting, 2006 4

We’ll cover

• A Case Study

• Overview

• Key Ideas

• Defect (elusive)

• Jack’s Troubleshooting Concepts

• Methods - Tools

• More Case Studies

• Takeaways


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

Bailing Water


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


for better results!

Invite an Outside Expert


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

Product release

for sale

QC release

Sterilization

Fig. II Modified Process Flow

Take

corrective

action

Package sealing

operation

Test "empty"

packages at the

start

Seal meets

specs?

Test "empty"

packages at the

end

Seal meets

specs?

Yes

Yes

No

No


FMEA

#

Proce

ss

step/FUNCTIO

N

Potential

Failure

Mode

POTENTIA

L EFFECTS

OF

FAILURE

Potential

Causes

of

Failure

CURRENT

PROCESS

CONTROLS

Before

MitigationAfter Mitigation

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R

P

N

Mitigations

O

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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.)

Figure II - Process Flow Chart

for PTCA Balloon Catheter

1. Tubing

Extrusion

6. Balloon

Bonding on

Catheter

5. Balloon Molding

4. Tubing Cutting

3. Irradiation

Testing

2. Gamma

Irradiation

7. Coating

Process (several

steps)

8. Catheter

Finishing



• 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

© JD Consulting, 2006

Root Cause Analysis

ASQ – Orange Empire Section 0701

by: Jack Dhuwalia,

MS, MBA, DTM

President,

J D Consulting

July 22, 2006

Documents

FDA OCRA ASQ Root Cause 06