Quality Progress - September 2017 - 56

Standard Issues
to the customer was reinforced in the 2016 standard revision because the industry continues to see a high level
of escapes to the customer. An organization is required
to show effective controls to prevent the delivery of nonconforming products and services to the customer and
robust corrective actions when escapes are encountered.
Risk-based thinking versus risk management understanding. Risk management always has been required
by the 9100 standard. The first release of 9100 in 1999
required a contract or order to be reviewed to ensure
that any risk associated with the new technology or short
delivery time scales was evaluated.
The 9100:2009 series of standards further required
formalized product risk management processes to be
applied to product realization activities. Organizations
are required to plan, implement and control a process for
risk management. Risk management includes requirements for assigning responsibilities, defining risk criteria,
identifying and assessing risk, mitigation actions and
acceptance. These requirements have been carried
forward to 9100:2016, subclause 8.1.1-Operational risk
management.
In the 9100:2016 series of standards, the risk-based
thinking concept has been expanded throughout
the QMS, as emphasized by the addition of "actions
to address risk and opportunities" to ISO 9001:2015,
subclause 6.1. Risk-based thinking promotes proactive
thinking throughout the QMS. The requirements in ISO
9001:2015, subclause 6.1, specify that an organization shall
plan actions to address risks. Formal risk management
methods or a documented risk management process is
not required, except as denoted in subclause 8.1.1.
The intent of risk management and risk-based thinking
is to:
+ Change an organization's culture and mindset to be
proactive.
+ Focus on priorities and what adds value to an
organization.
+ Ensure alignment of resources to issues and risks.
+ Ensure greater knowledge of risks and improved
preparedness.
+ Increase the probability of reaching objectives while
reducing the probability of negative results.
Product safety applicability. Product safety, as it
relates to an end user's experience with the product,
has always been implicit in the 9100 series of standards.
Some lower-tiered supply chain organizations might
think product safety doesn't apply to them because
those organizations don't know how their customers use
their supplied products.

56 QP

September 2017 ❘ qualityprogress.com

Organizations must
assess their risks
associated with
counterfeit or suspect
counterfeit parts and
implement appropriate
controls.

If an organization doesn't
know how its products are
used, it should find out
from its customers so it can
understand the potential
product safety implications.
Based on an organization's
knowledge of the parts it produces, how can the product
be manufactured to meet
engineering and product conformity requirements?
Remember that product
safety is related to the operation of the product. It is not
about Occupational Safety and
Health Administration-related
personnel safety. Product
safety risk assessments should
proactively identify risks that
potentially affect product
safety and address them
before they generate adverse
effects.
Guidance for implementing
product safety requirements
can be found in the note of
subclause 8.1.3. Possible implementation activities include:
+ Assessing hazards and managing associated risks (see
subclause 8.1.1).
+ Managing safety critical
items.
+ Analyzing and reporting
occurred events affecting
safety.
+ Communicating these events
and training employees.3

"Counterfeit part" doesn't
apply only to electronic
parts. IAQG's definition of
"counterfeit part" is:
"An unauthorized copy, imitation, substitute, or modified
part (for example, material,
part, component), which is
knowingly misrepresented
as a specified genuine part
of an original or authorized
manufacturer.
Note: Examples of a counterfeit part can include, but
are not limited to, the false
identification of marking or
labeling, grade, serial number,
date code, documentation or
performance characteristics."4
Organizations must assess
their risks associated with
counterfeit or suspect counterfeit parts and implement
appropriate controls. The note
in subclause 8.1.4 suggests, for
example:
+ Training appropriate
employees in the awareness and prevention of
counterfeit parts, including
procurement, receiving
inspection, inspection and
design personnel.
+ Applying a parts obsolescence monitoring program
for the service life of the
product.
+ Implementing controls for
acquiring externally provided products from original
or authorized manufacturers, authorized distributors
or other approved sources.
+ Requiring that parts and
components are traceable to
their original or authorized
manufacturers.
+ Verifying and testing methods to detect counterfeit
parts.

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

Seen and Heard
Progress Report
Mr. Pareto Head
Career Coach
Expert Answers
Field Notes
Data Disruption
The Deal With Big Data
Better Intelligence
A Study in Measurement
Innovation Imperative
Statistics Spotlight
Standard Issues
ASQ's 2017 Quality Resource Guide
Marketplace
Footnotes
Back to Basics
Quality Progress - September 2017 - Intro
Quality Progress - September 2017 - cover1
Quality Progress - September 2017 - cover2
Quality Progress - September 2017 - 1
Quality Progress - September 2017 - 2
Quality Progress - September 2017 - 3
Quality Progress - September 2017 - 4
Quality Progress - September 2017 - 5
Quality Progress - September 2017 - Seen and Heard
Quality Progress - September 2017 - 7
Quality Progress - September 2017 - Progress Report
Quality Progress - September 2017 - 9
Quality Progress - September 2017 - Mr. Pareto Head
Quality Progress - September 2017 - 11
Quality Progress - September 2017 - Career Coach
Quality Progress - September 2017 - 13
Quality Progress - September 2017 - 14
Quality Progress - September 2017 - Expert Answers
Quality Progress - September 2017 - Field Notes
Quality Progress - September 2017 - 17
Quality Progress - September 2017 - 18
Quality Progress - September 2017 - 19
Quality Progress - September 2017 - Data Disruption
Quality Progress - September 2017 - 21
Quality Progress - September 2017 - 22
Quality Progress - September 2017 - 23
Quality Progress - September 2017 - 24
Quality Progress - September 2017 - 25
Quality Progress - September 2017 - The Deal With Big Data
Quality Progress - September 2017 - 27
Quality Progress - September 2017 - 28
Quality Progress - September 2017 - 29
Quality Progress - September 2017 - 30
Quality Progress - September 2017 - 31
Quality Progress - September 2017 - 32
Quality Progress - September 2017 - 33
Quality Progress - September 2017 - Better Intelligence
Quality Progress - September 2017 - 35
Quality Progress - September 2017 - 36
Quality Progress - September 2017 - 37
Quality Progress - September 2017 - 38
Quality Progress - September 2017 - 39
Quality Progress - September 2017 - 40
Quality Progress - September 2017 - 41
Quality Progress - September 2017 - A Study in Measurement
Quality Progress - September 2017 - 43
Quality Progress - September 2017 - 44
Quality Progress - September 2017 - 45
Quality Progress - September 2017 - 46
Quality Progress - September 2017 - 47
Quality Progress - September 2017 - Innovation Imperative
Quality Progress - September 2017 - 49
Quality Progress - September 2017 - 50
Quality Progress - September 2017 - Statistics Spotlight
Quality Progress - September 2017 - 52
Quality Progress - September 2017 - 53
Quality Progress - September 2017 - Standard Issues
Quality Progress - September 2017 - 55
Quality Progress - September 2017 - 56
Quality Progress - September 2017 - 57
Quality Progress - September 2017 - ASQ's 2017 Quality Resource Guide
Quality Progress - September 2017 - 59
Quality Progress - September 2017 - 60
Quality Progress - September 2017 - 61
Quality Progress - September 2017 - 62
Quality Progress - September 2017 - 63
Quality Progress - September 2017 - 64
Quality Progress - September 2017 - 65
Quality Progress - September 2017 - 66
Quality Progress - September 2017 - 67
Quality Progress - September 2017 - Marketplace
Quality Progress - September 2017 - 69
Quality Progress - September 2017 - Footnotes
Quality Progress - September 2017 - 71
Quality Progress - September 2017 - Back to Basics
Quality Progress - September 2017 - cover3
Quality Progress - September 2017 - cover4
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