Pursuit of Excellence
- Value-Added auditing -
SAE AS9100 Auditor Workshop
July 30, 2009
Brian Hughitt, NASA Headquarters
Office of Safety and Mission Assurance
What has been done will be done again.
There is nothing new under the sun.
Is there anything of which one can say,
“Look this is something new”?
It was here already long ago.
It was here before our time.
King Solomon
1000 BC
USS THRESHER
First in her class
She was fast, quiet, and deep diving
The leading edge of US Submarine Technology
Apollo 1 Command Module
First in her class
She was much larger & far more complex
than any previous design
The leading edge of US Spacecraft Technology
Loss of the USS THRESHER
On April 10, 1963, while engaged
in a deep test dive 220 miles east
of Cape Cod, MA, the USS THRESHER
was lost at sea, settling at a depth of
8400 feet with all aboard
The crew of 112 Naval Officers and Enlisted
personnel and 7 civilians perished
Loss of the Apollo 1 Command Module
Contributing Causal Factors
- Inadequate Workmanship THRESHER
Improperly brazed pipe
joint
Apollo 1
“The board found
numerous examples in the
wiring of poor installation
and poor workmanship”.
Contributing Causal Factors
Inadequate Fabrication Processes
THRESHER
Brazed piping joints
exposed to full
submergence
pressure
Apollo 1
Teflon wire coating
could be easily
damaged or
penetrated by abrasion
Contributing Causal Factors
- Ineffective Quality Assurance USS THRESHER
Portsmouth Naval Shipyard
inspectors using newly
developed ultrasonic testing
techniques identified
numerous instances of faulty
brazed joints. Many brazed
joints on the THRESHER
were never UT’d.
Apollo 1
Kennedy Space Center
inspectors cited multiple
instances of deficient
parts, equipment, and
workmanship.
Contributing Causal Factors
Vulnerable Design
Inadequate Emergency Recovery
Unforeseen Failure Mode
THRESHER
• Reactor shutdown
• Impaired access to vital
equipment
• Compromised ballast
tank blow
Apollo 1
• Single gas atmosphere
• Flammable materials
• Inward opening hatch
BP Refinery, Texas
SL-1 Reactor, Idaho
Vacuum Chamber thought to have been a pressure vessel
Montana
Big Dig, Boston
All of these events
were terrible tragedies
All of these events
were completely avoidable
Quality System Weaknesses
The marked boxes indicate ineffective QMS elements and a failure
of quality assurance auditing to identify & correct these
shortcomings.
When Events Line Up, the
Consequences Can Be Devastating
Procedures and inspections are
often added to “correct” issues that
are symptoms, this is the often the
least effective way to manage risk.
Requirements
Design
Hazar
d
Quality Assurance
Manufacturing
Test
Operations
Mishap
Adapted from : James Reason, Managing the Risks of Organizational Accidents, 1997, p. 12
Failure to effectively respond,
failure to put cost or schedules
aside to prevent risk, lack of
communication, risk management
plans, noncompliance or fear of
raising issues are signs of a failing
quality system.
All quality professionals should
be system health monitors.
Three Rules:
1. Be attuned:
Know your internal quality system weaknesses, and
be continually working to remedy them.
2. Be attentive:
Know your external quality risks, and be continually
working to mitigate them.
3. Step back and connect the dots…
Look for intangible influences on product quality.
Become a student of quality system failures.
Removed for copyright protection
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Removed for copyright protection
20
The Two Modes of Mishap
Prevention
Become a student of quality system failures.
NASA System Safety Case Studies
http://pbma.nasa.gov/index.php?fuseaction=pbma.main&cid=584
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External Quality Risks
Zinc Whiskers on
Hot Dip Galvanized Steel Pipe
Tin Whisker on Electromagnetic Relay
Shorting Terminal to Case
“Unglamorous as the
work sounds - and
indeed is – the whole
business of
maintaining human
life in the air comes
down to thinking and
rethinking about
curious and
fiddlesome problems
of this order.”
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Paul Eddy
Destination Disaster
To improve life here,
To extend life to there,
To find life beyond.
Counterfeiting
GIDEP Counterfeit Report Submissions
Marking indicates an
Op Amp from ADI…
Device lead condition
shows parts were
used
50
R e p o rt s
40
… but contains
die for a Voltage
Reference from
PMI
30
20
10
0
1976 1978 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008
Year
Retopping
Part number indicates a
CLCC package, but this
package is a CDP…
Evidence of prior
marking for a part
with inferior
performance …
Remarking
… accompanied
by
bogus test report
27
28
Separate the vital few from the trivial many
Joseph Juran
29
… mitigate risks associated with
noncompliance. Risk considers the likelihood of
noncompliance and the consequences associated
with noncompliance, including the maturity,
complexity, criticality, and value of work
performed …
30
… attain confidence levels that are
commensurate with the severity of
consequences that would be incurred in the
event of noncompliance.
31
… periodically reevaluated and
adjusted based on changes to risk factors.
32
AS9100: 2009
A New (and needed) Focus on Risk
7.1.2 Risk Management
The organization shall establish, implement and maintain a process for
managing risk to the achievement of applicable requirements, that
includes as appropriate to the organization and the product
a)
b)
c)
d)
e)
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assignment of responsibilities for risk management,
definition of risk criteria (e.g., likelihood, consequences, risk
acceptance),
identification, assessment and communication of risks throughout
product realization,
identification, implementation and management of actions to
mitigate risks that exceed the defined risk acceptance criteria,
acceptance of risks remaining after implementation of mitigating
actions.
critical items … key characteristics … special requirements
The Stakes….
The Stakes
35
37
38
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"The society which scorns excellence in
plumbing because plumbing is a humble
activity and tolerates shoddiness in
philosophy because it is an exalted
activity will have neither good plumbing
nor good philosophy. Neither its pipes
nor its theories will hold water."
John Gardner
Back-Up slides
Counterfeit Parts Examples
National Semiconductor does
not use “ : ” in part numbers
New versus Refurbished leads
Dual Markings
Acetone Swipe
Backtop peeling away. Sand
marks evident
42
Missing Serial Number
BusinessWeek Video Clip
http://www.businessweek.com/magazine/content/0
8_41/b4103034193886.htm?chan=top+news_to
p+news+index+-+temp_top+story
Product Impact
GIDEP Counterfeit Case Summaries
44
Tools & Resources to Combat Counterfeiting
Tools & Resources (cont)