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Sustaining Edge Solutions, Inc. Newsletter |
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| Performance Improvement Solutions for Your Business Needs |
March 2010 |
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Greetings!
Welcome to Sustaining Edge Solutions E-
Newsletter
Our newsletters provide guidance on
operational and quality systems ISO 9001, AS9100,
ISO/TS 16949, ISO 27001, ISO 13485, ISO 14001, and
others.
This includes internal auditing techniques and
process improvement methods Six
Sigma, Lean Enterprise, and other topics of interest
to our readers.
We want your input for
2010! If
you have a topic of interest for a future newsletter,
please let us know.
Newsletter Sign-up
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Latest Information on AS9100C:2009 |
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Our readers have been asking us for the latest
information regarding the AS9100 revision since our
March 2009 newsletter update. The following is an
abridged version of Robert Parsons just
published article on this very subject.
The
AS9100C Aviation, Space and
Defense Standard (also referred
to as AS9100:2009
and AS9100 Rev C) has been published since
January 2009. You are not alone if you are confused
about the delay in being audited to this standard. Like
you, most companies seeking registration to AS9100
are in the process of trying to figure out how and when
to roll out this standard within their organization and
the following information should bring clarity to this
subject.
Question: If the standard is
published, why can't I get certified now?
Before any company can be certified to the
AS9100C standard, the aerospace industry must
complete these milestones:
- The AS9104-1 standard must be published
(expected spring 2010).
- The AS9101D standard (checklist) must be
published (expected spring 2010).
- The AS9100C/AS9101D training course for
certification body auditors (the registrar auditors)
must be developed, vetted, and made available for
use by certification bodies (expected by April 30,
2010).
- Certification body auditors must attend this
course, pass it, submit their applications to RABQSA
and get approved (expected to happen during the
summer and fall of 2010).
- The registrar must submit an application to ANAB
and then be audited before registrars can be
accredited to perform audits to AS9100C (expected to
happen early summer of 2010).
Once all of the above tasks are completed, the
registrar will be able to conduct audits to the
requirements of AS9100C.
Question:
What does that mean for your company?
In
light of the timelines described above, what this
means for companies seeking AS9100 registration is
this:
- Companies that want to upgrade during a
re-assessment or surveillance audit between now
and
mid 2010 will be audited to AS9100B.
- Companies that want to upgrade during a
re-assessment or surveillance audit between mid-
2010
and the end of 2010 may be able to be audited to
AS9100C, but that depends on the availability of
auditors that have taken the AS9100C course.
- Companies that want to upgrade during a
re-assessment or surveillance audit after January
2011
should be able to be audited to AS9100C without any
impediments.
- All audits after July 1, 2011, must be to AS9100C.
- All AS9100-registered companies must be
registered to the AS9100C standard by July 1, 2012.
Question: What should you do next?
Before your company transitions to the
AS9100C standard, you must complete the following
steps (at a minimum):
- Implement the requirements of AS9100C into your
quality management system.
- Perform a gap analysis to identify potential
problem areas.
- Conducting internal audits to this new standard,
its new requirements and ensuring your internal
auditors are trained.
- Conducting a management review of your revised
quality management system.
- Ensuring appropriate personnel are competent on
these new requirements.
- Identifying and implementing corrective actions so
that your quality system addresses and adheres to the
new requirements.
Question: Need assistance with these steps and
more?
Contact Sustaining Edge Solutions
for all your AS9100C training, documentation
development, and implementation needs.
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Tracing Products in Supply Chain |
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For reasons of safety and reliability, the importance of
being able to trace products throughout the supply
chain has strongly increased in recent years. The new
standard from the International Organization for
Standardization (ISO) 17367:2009 will help
manufacturers and distributors to track products and
to manage their traceability thanks to standardized
radio frequency tags.
Traceability is defined
as the tracking and tracing of product and information
related to it at each stage of a chain of production,
processing, distribution, and selling. The
development of radio frequency identification (RFID),
including peripheral devices and their applications, is
indispensable for increasing the safety and reliability
of products for consumers.
ISO 17367 Supply chain applications of RFID
Product tagging, defines the basic features of RFID
for use in the supply chain when applied to product
tagging. In particular it makes recommendations for:
- Encoded identification of the product;
- Additional information about the product for
inclusion on the RFID tag;
- Semantics and data syntax;
- The data protocol to be used to interface with
business applications and the RFID system;
- The air interface standards between the RFID
interrogator and RFID tag.
ISO 17367:2009 will provide higher level security of
products worldwide using RFID technology. It will
enable easy and efficient exchange of commodities in
international trade and logistics, says Craig K.
Harmon, chair of technical committee (TC)
122/working group (WG) 10.
The standard,
ISO 17367 Supply chain applications of RFID
Product tagging, is available from the ISO Website.
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Certification of Aftermarket Automotive Parts |
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Concerns regarding consumer safety and
compromised automobile crashworthiness continue
to center on the use of certain aftermarket structural
parts. NSF International recently announced the
launch of a new Automotive Parts Certification
Program to address these concerns. The one-of-a-
kind program verifies the quality and performance of
aftermarket auto parts via testing and inspections.
The certification program was developed to counter
the growing concerns that lower quality parts were
being used in the automotive repair industry.
Certification from an accredited third-party, such as
NSF International, helps ensure that an aftermarket
auto part meets rigid quality, safety, and performance
standards.
Manufacturers of parts seeking information on NSF
Internationals Automotive Parts Certification Program
can visit NSF Automotive Business Solutions.
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In the News |
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Medical Devices Industry Top Challenges
A new survey from the American Society for Quality
asking medical device manufacturers about industry
trends and challenges shows a majority (64.7%)
identify health care legislation as having a negative
effect on the industry in the year ahead. Increased
FDA oversight and compliance with regulations tops
what manufacturers feel will be the biggest challenge
in their industry in the coming year.
Respondents were also asked to identify the
hottest medical device opportunity in the next three
years:
- 31.7 percent believe neurological advancements
offer the hottest opportunity;
- 30 percent believe it is in cardiovascular;
- 25.2 percent said orthopedics.
As for economic growth in 2010, more
than half of respondents (56.9%) believe their
organization will experience more economic growth
than in 2009. A little more than 27 percent believe they
will experience about the same, and 10.3 percent
believe there will be less growth than in 2009. Read the
complete article.
Lean Talent Outpacing Six Sigma Talent
After years of steady gains, lean has now
achieved a clear and dominant standing over Six
Sigma as the leading force in corporate continuous
improvement, according to the latest study of almost
3,500 recent job postings reviewed by The Avery Point
Group. This years study showed that lean talent
demand exceeded Six Sigma by almost 35 percent,
significantly widening its lead over last years results
that only showed an 11 percent edge for lean over Six
Sigma.
In addition, this years study focused
on
how requirements for certifications played into job
specifications for lean and Six Sigma talent. This
years study found that companies that sought Six
Sigma talent were almost 50 percent more likely to
require some form of certification vs. those
companies seeking lean talent.
Toyota: Is Leanest Best?
Does lean
manufacturing make a company more prone to
errors? That is a question many business reports are
asking in light of the recent Toyota recalls. It is also a
question ASQ members ponder as Toyota's quality
systems are being called out, scrutinized, and second-
guessed. See what a few ASQ members have to say
and read about the two-part webinar ASQ is
sponsoring. Read
the article.
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ITAR and MIL-PRF-31032B - New Expanded Services |
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In addition to our current services, Sustaining Edge
Solutions is now offering International Traffic in Arms
Regulations (ITAR) and MIL-PRF-31032B consulting
services. Welcome
to the world of
import, export and defense industry compliance!
ITAR is a
set of regulations to ensure that any product that
may have a military or space application, or an item
that may have "Dual Use" is controlled, to prevent its'
unauthorized import and export.
What are
some of the benefits to a successful ITAR registration
program?
- It allows your company to compete on a
global level and work with companies that are in the
military and space supply chain;
- Addition to your sales and marketing plan.
It tells your customers that your company complies
with all regulations governing ITAR;
- It tells new and existing customers that
you can provide security for their technical data;
- It provides a mechanism for the security of
your facility, and your employees.
In today's global and competitive PCB market,
manufacturers need every strategic advantage to
capture market share. MIL-PRF-31032B is a
quality management system that was developed, in
coordination with best commercial practice, to provide
a quality management system that allows companies
to build boards that will perform to military standards.
What are the benefits to MIL-PRF-31032B
certification?
- Your company will be listed on the QML by the
Defense Supply Center-Columbus, or DSCC;
- Your customers will know that you are capable of
producing high quality printed circuit boards;
- Your certification will be a tangible marketing
tool;
- A Nationally recognized standard of
performance.
We welcome our new associate Ronald
Snartland, to our team. His
experience includes design, development and
successful registration with International Traffic and
Arms Regulations (ITAR), and Quality Management
System MIL-PRF-31032B, a military printed circuit
board specification. Ronald has over 25 years of
progressive experience in manufacturing. His
management experience includes electronic
manufacturing systems, precision machining,
operations and quality systems
management. Contact Ronald at
888-572-9642 with any questions rearding these
services.
Expanded information on these services and benefits
will be posted to our website this month!
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