Quality Progress - October 2017 - 24

F E AT U R E

ISO 9001:2015
TA B L E 7

Supports
Safety operator
bar
cage in
rollover

Potential
cause of
failure

Fails to
support the
operator
cage in a
rollover

User
injury

4 Improve
welds

Current
controls

Recommended
actions

1. X-ray inspection
weld 3 36
of welds
3 Visual
inspections
2. Robotic welding
process

Actions taken

1. Add X-ray inspections
as part of the measurement requirements
4 2 2 16
2. Implement robotic
welding process

SEV = severity
OCC = occurrence
DET = detection
RPN = risk priority number
FMEA = failure mode and effects analysis

criticality and occurrence action
requirements listed in Table 4 have
also been satisfied. With a criticality/severity of four and probability
of occurrence as two, the risk is
now considered to be ALARP.
It should be apparent from the
example that the power of FMEA
comes from individuals working on teams being proactive in
reducing or ultimately eliminating
risk. The FMEA process can be
used to address ISO 9001:2015,
Clause 8.2-Requirements for
products and services (uFMEA),
Clause 8.3-Design and development of products and services
(dFMEA), and Clause 8.5-Production and service provision
(pFMEA).
The information derived from
FMEA can be used to drive
inspection activities, supplier qualification, corrective and preventive
action complaints, nonconformance criticality and many other
activities. 
REFERENCES
1. International Organization for
Standardization (ISO), ISO 9001:2015-
Quality management systems.
2. ISO, ISO 9004:2009-Managing
for the sustained success of an
organization-a quality management
approach.

24 QP

October 2017 ❘ qualityprogress.com

BIBLIOGRAPHY
Breneman, Jim E., USAF Weibull Handbook,
United Technologies Corp. and Pratt
& Whitney Aircraft Group Government
Products Division, 1983.

RPN

Potential
effects
of failure

SEV
OCC
DET

Potential
failure
mode

DET
RPN

Function

OCC

Item

SEV

Example of FMEA-revised

Durivage, Mark A., The Certified
Pharmaceutical GMP Professional
Handbook, second edition, ASQ Quality
Press, 2016.

Jim Breneman retired as an ACE mentor and manager
of engineering technical excellence at Pratt & Whitney, a
division of United Technologies. Breneman, an ASQ senior
member, is also an SAE fellow in reliability, and a member
of American Statistical Association and the Society of
Reliability Engineers. He holds a master's degree in applied
mathematics from North Carolina State University in Raleigh.

Dan Burrows has more than 25 years of experience in
reliability, quality, Six Sigma and continuous improvement in
aerospace, electronics, electro-mechanics, heavy equipment
and production systems. He is a senior ASQ member and is
an ASQ-certified engineer, Six Sigma Black Belt and manager
of quality/organizational excellence. Burrows is also chairelect and regional councilor of the ASQ Reliability and Risk
Division, and a member of the Society of Reliability Engineers
and the Institute of Electrical and Electronics Engineers Reliability Society. He holds
an MBA from Dallas Baptist University.

Mark Durivage is managing principal consultant at Quality
Systems Compliance LLC in Lambertville, MI. He earned
his master's degree in quality management from Eastern
Michigan University in Ypsilanti. He is an ASQ fellow and
holds several ASQ certifications, including quality auditor,
biomedical auditor, hazard analysis and critical control point
auditor, pharmaceutical good manufacturing practices
professional, Six Sigma Black Belt and manager of quality/
organizational excellence. Durivage also authored and edited several ASQ Quality
Press books.


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Table of Contents for the Digital Edition of Quality Progress - October 2017

Seen and Heard
Progress Report
Mr. Pareto Head
Expert Answers
Career Coach
In Focus
The Results Are In
Visual Aid
Experimental Learning
Statistics Spotlight
Standard Issues
Marketplace
Footnotes
Try This Today
STANDARDS AND AUDITING GUIDE
Quality Progress - October 2017 - intro
Quality Progress - October 2017 - cover1
Quality Progress - October 2017 - cover2
Quality Progress - October 2017 - 1
Quality Progress - October 2017 - 2
Quality Progress - October 2017 - 3
Quality Progress - October 2017 - 4
Quality Progress - October 2017 - 5
Quality Progress - October 2017 - Seen and Heard
Quality Progress - October 2017 - 7
Quality Progress - October 2017 - Progress Report
Quality Progress - October 2017 - Mr. Pareto Head
Quality Progress - October 2017 - 10
Quality Progress - October 2017 - 11
Quality Progress - October 2017 - Expert Answers
Quality Progress - October 2017 - 13
Quality Progress - October 2017 - Career Coach
Quality Progress - October 2017 - 15
Quality Progress - October 2017 - 16
Quality Progress - October 2017 - 17
Quality Progress - October 2017 - In Focus
Quality Progress - October 2017 - 19
Quality Progress - October 2017 - 20
Quality Progress - October 2017 - 21
Quality Progress - October 2017 - 22
Quality Progress - October 2017 - 23
Quality Progress - October 2017 - 24
Quality Progress - October 2017 - 25
Quality Progress - October 2017 - The Results Are In
Quality Progress - October 2017 - 27
Quality Progress - October 2017 - 28
Quality Progress - October 2017 - 29
Quality Progress - October 2017 - 30
Quality Progress - October 2017 - 31
Quality Progress - October 2017 - 32
Quality Progress - October 2017 - 33
Quality Progress - October 2017 - Visual Aid
Quality Progress - October 2017 - 35
Quality Progress - October 2017 - 36
Quality Progress - October 2017 - 37
Quality Progress - October 2017 - 38
Quality Progress - October 2017 - 39
Quality Progress - October 2017 - Experimental Learning
Quality Progress - October 2017 - 41
Quality Progress - October 2017 - 42
Quality Progress - October 2017 - 43
Quality Progress - October 2017 - 44
Quality Progress - October 2017 - 45
Quality Progress - October 2017 - 46
Quality Progress - October 2017 - 47
Quality Progress - October 2017 - Statistics Spotlight
Quality Progress - October 2017 - 49
Quality Progress - October 2017 - Standard Issues
Quality Progress - October 2017 - 51
Quality Progress - October 2017 - 52
Quality Progress - October 2017 - 53
Quality Progress - October 2017 - 54
Quality Progress - October 2017 - 55
Quality Progress - October 2017 - STANDARDS AND AUDITING GUIDE
Quality Progress - October 2017 - 57
Quality Progress - October 2017 - Marketplace
Quality Progress - October 2017 - 59
Quality Progress - October 2017 - Footnotes
Quality Progress - October 2017 - 61
Quality Progress - October 2017 - 62
Quality Progress - October 2017 - 63
Quality Progress - October 2017 - Try This Today
Quality Progress - October 2017 - cover3
Quality Progress - October 2017 - cover4
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