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Our newsletters provide guidance on ISO 9001,
AS9100, ISO 13485, ISO/TS 16949, TL 9000, ISO
14001,
ISO 27001, ISO 20000, and related ISO
standards, as well as, Six Sigma.
If you have any questions about the articles
appearing in this issue, or you want to suggest
topics for future issues, please let us
know.
ISO/TS 16949:2009
The third edition of the automotive quality
standard, ISO/TS 16949:2009, has been
published to include the text of ISO
9001:2008. ISO/TS 16949:2009 replaces ISO/TS
16949:2002 and can be ordered at this AIAG
web page.
ISO/TS 16949:2009 can be ordered in hard copy
or electronic format at an AIAG member price of
$30 or a non-member price of $90. You are
allowed to print two copies of the e-standard
PDF file before storing it on your hard
drive.
ISO/TS 16949:2009 was developed by the
International Automotive Task Force (IATF).
Along with the embedded ISO 9001:2008 text,
it defines the quality management system
requirements for the design and development,
production and, when relevant, installation
and service of automotive-related products.
ISO/TS 16949:2009 is applicable to sites
where customer-specified parts, for
production and/or service, are manufactured.
Transition
The IATF provided the following transition
information to Certification Bodies:
1. No New Requirements
ISO/TS 16949:2009 introduces no new or
changed requirements. The incorporated ISO
9001:2008 standard is based on clarifications
or amendments to ISO 9001:2000 and those
intended to improve consistency with ISO
14001:2004.
2. Application
Certification Bodies and Organizations are
expected to understand and apply the
amendments in ISO/TS 16949:2009. Application
of the clarifications related to ISO
9001:2008 requirements is effective no later
than 120 days after the release of ISO/TS
16949:2009.
3. Certification Status to ISO/TS
16949:2002
The certification status to ISO/TS 16949:2002
remains in effect for the certification life.
Certification to ISO/TS 2009 will be
recognized with the effective date of the
release of ISO/TS 16949:2009. Certification
to ISO/TS 16949:2009 is not an upgrade and
its term is the same as the current ISO/TS
16949:2002 certificate.
4. Certificates Issued to ISO/TS
16949:2009
IATF recognized certificates to ISO/TS
16949:2009 may be issued upon request by an
organization (client) after official
publication and after a regularly scheduled
surveillance audit, but are not required
until the next recertification audit.
Key Differences
ISO/TS 16949 incorporates text from the ISO
9001 standard within boxed sections. The text
unique to ISO/TS 16949 is included outside
the boxed ISO 9001 sections.
Most of the differences in ISO/TS 16949:2009
compared to ISO/TS 16949:2002 are due to
including the ISO 9001:2008 standard to
replace the old ISO 9001:2000 text. You can
see these ISO 9001:2008 changes at this
Whittington & Associates web
page.
The changes in the unique ISO/TS 16949:2009
text are described at this Whittington &
Associates web
page. Deleted ISO/TS
16949:2002 text is indicated with
strikethroughs. The new ISO/TS 16949:2009
text is underlined and highlighted in yellow.
Most of the differences in ISO/TS 16949:2009,
beyond those in the boxed ISO 9001:2008 text,
were to:
1. Change from "product quality" to
"conformity to product requirements" in
multiple places for consistency with the same
change made in ISO 9001:2008.
2. Change from "regulatory" requirements to
"statutory and regulatory" requirements in
multiple places for consistency with the same
change made in ISO 9001:2008.
3. Modify the titles for clauses 6.2.2 and
7.6 to match the changed titles in ISO
9001:2008.
4. Replace "ISO 9001:2000" with "ISO
9001:2008" and "ISO 9000:2000" with "ISO
9000:2005".
5. Add new references in the Bibliography
section and remove the withdrawn standards.
TL 9000 R5.0 Handbook
The QuEST Forum has issued Release 5.0 of the
TL 9000 Requirements Handbook, the latest
edition of the global quality standard used
by the telecommunications industry.
The R5.0 Handbook has an effective date of
November 15, 2009 to ensure adequate time for
organizations to complete their training and
seamlessly upgrade to the new release. The
new standard can be used after November 15,
2009 and must be used after November 15,
2010.
Release 5.0 includes clarifications,
additional adders, and notes. Three specific
areas emphasized in the revision are:
risk management,
supplier management, and
design for manufacturability.
The updated handbook also includes the new
ISO 9001:2008 text. To see the changes in TL
9000 Requirements Handbook R5.0 versus R4.0,
go to this TL
9000 Changes web page.
The QuEST Forum publishes the TL 9000
Requirements and Measurements Handbooks as
the definitive guides to implementing the TL
9000 quality management system and
performance measurements to assess progress
and evaluate results of its implementation.
The TL 9000 Measurements Handbook remains at
Release 4.0 and is a comprehensive guide to
measurements processing, usage,
responsibilities, and requirements. It
identifies performance measurements in the
key areas of hardware, software, common,
outage, and service quality.
A hard copy of the Requirements R5.0 Handbook
can be purchased for $95 regular price and
$50 discounted price. Soft copies can only be
ordered as part of a site license, with the
lowest fee being $500 for 1 to 9 users.
The Outline for the Requirements 5.0 Handbook
is shown below. The number of specific TL
9000 adders (92) are indicated in parentheses
at each requirements section.
Foreword
A note from the QuEST Forum Executive Board.
Preface
Explanation of QuEST Forum's goal in creating
and using TL 9000.
Acknowledgements
A list of the companies and people who
participated in the development of Release
5.0 of the Requirements Handbook.
Table of Contents
List of Figures
List of Tables
Section 1: Introduction
Lists the goals of TL 9000, states the
purpose of TL 9000, benefits of
implementation, relationship to ISO 9001 and
other requirements, speaks about customer
communication, explains how the TL 9000
handbooks are developed and maintained, and
defines the effective date of use.
Section 2: Structure
Defines the structure of the handbook and
terminology used.
Section 3: TL 9000 administration
Defines the scope of registration including
options and required documentation, migration
path from other standards, how registrations
can be publicized, how registrars are
qualified, how accreditation bodies are
recognized, responsibilities of registrars,
and training information.
Section 4: Quality management system (1)
Lists general requirements and documentation
requirements for TL 9000, including the
quality manual, control of documents, and
control of records.
Section 5: Management responsibility (7)
Topics include management commitment;
customer focus, including customer
relationship development and customer
communication methods; quality policy;
planning, including quality objectives, long
and short term quality planning, customer
input, and supplier input; responsibility,
authority and communication; and management
review.
Section 6: Resource management (9)
Defines requirements for provision of
resources; human resources, including
competence, awareness and training for
employees; infrastructure, and work
environment.
Section 7: Product realization (60)
Extensive information about planning of
product realization, including life-cycle
model; customer-related processes for
determination of product requirements, review
requirements, communication; design and
development planning, project planning, test
planning, risk management planning,
integration planning, estimation, migration
planning, design and development inputs,
outputs, review, verification, and control of
design and development changes; purchasing
processing; production and service provision
including emergency service, installation,
software patching, tool changes,
traceability, electrostatic discharge
protection, packaging and labeling, and
software virus protection; and control of
monitoring and measuring devices including
equipment verification.
Section 8: Measurement, analysis and
improvement (15)
Requirements for monitoring and measurement;
and control of non-conforming product.
Glossary
Definitions of 36 terms used in the handbook.
ISO 9000:2005 Defined Terms
A list of ISO terms with references to their
definitions
Bibliography and End References
List of 11 references used in the development
of TL 9000 Quality Management System Release
5.0.
4-Day Lead Auditor
Being trained as an ISO 9001:2008 Lead
Auditor just got easier. Our 5-day course has
been both improved and shortened into a new
4-day version.
The 5-day ISO 9001:2008 Lead Auditor course
was certified by the RABQSA through the
Training Course Certification (TCC) program.
The TCC program emphasizes content more than
competency. It ensures that the necessary
course subjects are covered in satisfactory
depth. As a result, the 5-day course required
40 class hours and long days. Students
complained it was too much to cover in too little
time.
Our new 4-day ISO 9001:2008 Lead Auditor
course is certified by the RABQSA through its
Training Provider and Examiner Certification
Scheme (TPECS) program. The TPECS program is
more focused on competency and allows more
flexibility on content and duration. It is
designed to reflect innovative learning and
assessment practices, as well as, to
demonstrate that students achieve the level
of knowledge competence needed for RABQSA
personnel certification.
Students successfully completing our new
4-day Lead Auditor course receive a
Certificate of Attainment for each of these
RABQSA knowledge competency units:
QM - Quality Management Systems
AU - Management Systems Auditing
TL - Leading Management Systems Audit Teams
Due to the modular nature of the new course,
students can enroll for the first two days to
complete the Requirements portion (QM), add
one more day to be trained as an Internal
Auditor (AU), or go all four days to be
trained as a Lead Auditor (TL).
Exams are given at the end of each competency
unit. Certificates of Attainment are provided
to students who are deemed "Competent" for
each competency unit. Certificates of
Attendance are provided to students that do
not pass a competency exam. Students will be
given an opportunity to retake an exam.
The 2-day QM course is ISO 9001:2008
Requirements with a fee of $895. You can
see the course description and enroll at this web
page. The class hours are:
Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 4:00 PM
The 3-day QM+AU course is ISO 9001:2008
Internal Auditor with a fee of $1195. You
can see the course description and enroll at
this web
page. The class hours are:
Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 4:00 PM
Day 3: 8:00 AM - 5:30 PM
The 4-day QM+AU+TL course is ISO 9001:2008
Lead Auditor with a fee of $1695. You can
see the course description and enroll at this web
page. The class hours are:
Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 4:00 PM
Day 3: 8:00 AM - 5:30 PM
Day 4: 8:00 AM - 3:30 PM
This modular structure means someone can
attend the 3-day Internal Auditor course and
return later to pick up the fourth day (TL)
to complete the Lead Auditor course. In the
past, students would attend a 3-day Internal
Auditor course and return later to take the
5-day Lead Auditor course. What would take
eight days can now be completed in only four
days.
Discounts
If you pay at least 60 days in advance, you
will receive a $100 fee discount for the
Internal Auditor and Lead Auditor courses.
The early bird discount is $75 for the
Requirements course. If you enroll three
students,
the fourth student is free, which equates to
25% off each enrollment.
Contact
If you have any questions after viewing the
course descriptions, please call us at
770-517-7944 or send an e-mail to
Larry@WhittingtonAssociates.com.
Root Cause Analysis
Does your organization know how to perform
effective root cause analysis? If not, you
should arrange for us to teach our Root Cause
Analysis course at your site. It is offered
in 2-day and 3-day versions.
ROOT CAUSE ANALYSIS
Our 3-day course consisting of lectures,
practices, and role plays that will provide
attendees with an in-depth understanding of
how to analyze a system in order to identify
the root causes of problems. The following
topics are covered:
The difference between problem solving
and root cause analysis
Why effective root cause analysis is more
important in today's world
Some common problem solving models and
their weaknesses
Five steps for performing the root cause
analysis part of problem solving
What each step accomplishes and some
tools available for carrying it out
COURSE OBJECTIVES:
This program is designed to:
Enhance problem solving effectiveness
through a model for more deeply analyzing problem
situations
Clarify the difference between analytical
and creative thinking, and when each is most
useful
Promote the ability to provide
problem-solving support in situations where
one is not an expert in
the process or technology involved
Expand the range of tools available for
analysis of problem situations
WHO SHOULD ATTEND:
Quality and process engineers, technicians or
others responsible for troubleshooting
technical problems, corrective action
coordinators, or managers; supervisors, team
leaders, and process owners; anyone who wants
to improve their ability to solve recurring
problems.
PRE-REQUISITES:
None, although familiarity with standard
problem solving models (e.g., PDCA, 8-D, ISO
9001 corrective action) and the seven QC
tools (flowcharts, cause & effect diagrams,
Pareto charts, check sheets, run charts,
histograms, scatter diagrams) would be
useful.
LEARNING OUTCOMES:
Participants will learn how to:
Differentiate between problem solving and
root cause analysis
Implement five steps for carrying out
effective root cause analysis
Select from and apply a variety of tools
that support root cause analysis
Support and critique root cause analysis
carried out by others
COURSE OUTLINE
TYPICAL PROBLEMS WITH RCA
Why most problem solving models don't get
to the root cause
How analytical and creative thinking must
be integrated
Difference between content and process
thinking
STEP 1 - PROBLEM DEFINITION
How to ensure that the right problem is
being worked on
Tools for priority setting (Pareto,
performance matrix, radar chart)
Developing a clear and sufficient problem
statement (includes practice)
STEP 2 - UNDERSTANDING THE PROCESS
How every problem is a process failure
How a SIPOC diagram can set boundaries
and define interrelationships
Using flowcharts to drill down into the
right part of the process (includes practice)
STEP 3 - IDENTIFYING POSSIBLE CAUSES
Why this step is critical to effective
root cause determination
Three ways to identify possible causes
Three options for selecting or
eliminating causes
STEP 4 - DATA COLLECTION
How this step avoids shotgun problem
solving by identifying the most likely
cause(s)
Population versus sampling; options for
sampling
Check sheets, graphs and tables for
discrete data collection
Surveys, interviews and field observation
for opinions or less precise data
STEP 5 - DATA ANALYSIS
Tools for discrete data analysis (run
charts, histograms, Pareto diagram, modified
scatter diagram, pivot tables)
Tools for softer type data (affinity
diagram, relationship digraph)
Technical versus organization problems,
and analytical versus creative problems
Statistical tools for data analysis (z,
t, & F tests; ANOVA, chi-square) and use of
MS Excel
CONSULTING CASE STUDY PRACTICE
CASE STUDY PRACTICE
INCIDENTS/EVENTS AND HUMAN ERROR
CASE STUDY PRACTICE
THE REST OF THE PROBLEM SOLVING PROCESS
Identifying and selecting solutions
The importance of project management and
consideration of change management issues
Some models for understanding resistance
and planning change
The 3-day RCA course is $4500, plus $50 per
student, plus instructor travel expenses. Our
2-day RCA course is $3000, plus $50 per
student, plus instructor travel expenses. The
2-day course version excludes one of the case
studies, as well as, the facilitating and
statistical modules.
If interested in scheduling a class, please
send an email note to
(Larry@WhittingtonAssociates.com).
More CMMI Classes
We have expanded the class schedule for our
Introduction to CMMI - Development Model to
include:
Milwaukee, WI on September 3-5, 2009
Anchorage, AL on September 3-5, 2009
Columbus, OH on September 8-10, 2009
Raleigh, NC on September 15-17, 2009
Orlando, FL on September 29 - October 1,
2009
Montgomery, AL on October 13-15, 2009
Nashville, TN on October 20-22, 2009
Omaha, NE on October 27-29, 2009
Colorado Springs, CO on November 3-5, 2009
Provo, UT on November 17-19, 2009
Tucson, AZ on November 30 - December 2, 2009
Honolulu, HI on December 7-9, 2009
Albuquerque, NM on December 7-9, 2009
San Antonio, TX on December 15-17, 2009
The 3-day SEI-licensed course introduces the
participant to Capability Maturity Model
Integration (CMMI) fundamental concepts. The
CMMI for Development (CMMI_DEV) model, which
includes the Integrated Product and Process
Development (IPPD), is a tool that helps
organizations improve their ability to
develop and maintain quality products and
services. CMMI-DEV is an integration of best
practices from proven improvement models.
The course is taught by SEI-authorized
instructors and delivered through PI-21, an
SEI-authorized partner. Our instructors have
real-world experience in using models to
guide organizational process improvement
efforts. We bring those experiences to every
course. We teach through examples, lesson
learned, and "food for thought".
The course is composed of lectures, class
exercises, and evening reading assignments.
It provides ample opportunity for participant
questions and discussions. Emphasis is placed
on understanding the process areas and how to
apply the CMMI models to real-world process
improvement programs.
There is no prerequisite for this course.
However, its successful completion is a
prerequisite forCMMI-SVC and CMMI-ACQ
supplemental courses and SCAMPI Team
Training, as well as, Intermediate Concepts
of CMMI, SCAMPI Lead Appraiser Training, and
CMMI Instructor Training.
Successful completion requires active
participation and attendance throughout the
full three days and will result in
certificates of completion and the
participants' names being included in the SEI
database..
The course fee of $1300 per student is
reduced to $1000 for early enrollment. This
fee includes a course notebook (including
copy of slides) and CMMI - Guidelines for
Process Integration and Product Improvement,
Second Edition.
Bob Parsons with NQA recently published an
article in the NQA Update Newsletter
explaining the delay in releasing the AS9101D
checklist, and therefore, the delay in
AS9100C certifications. An edited version of
his article, along with information from the
NQA website, appears below.
The AS9100 Revision C standard was released
in January 2009, but to date, no
organizations have been registered to it.
This holdup is due to the delay in releasing
the accompanying AS9101D checklist standard.
The new checklist will replace the AS9101C
checklist used by 3rd party auditors. The
current checklist breaks down the AS9100B
standard into question form and encourages
the auditor to verify the conformity of a
process to the applicable aerospace
requirements. The new AS9101D checklist will
require the auditor to verify the "effectiveness" of a process, not just
conformity.
This simple concept change actually
represents a monumental shift in the way an
auditor is required to document the results
of an aerospace audit. The rewrite for the
new AS9101D checklist is extensive and it
will have a totally different look when
compared to the current checklist, therefore,
feedback within the aerospace community has
been significant and the AS9101D release date
has yet to be determined.
Since the AS9100C standard is tied to the
AS9101D checklist, the consensus within the
aerospace industry is that it will not be
before 1st quarter of 2010, at the earliest,
before any organization can be registered to
the requirements of the AS9100C standard.
Since ISO 9001:2000 expires in November 2010,
the timeline for organizations to upgrade
their certifications to AS9100C (and ISO
9001:2008), may only be a few months. As a
result, the International Aerospace Quality
Group (IAQG) issued Resolution 55 that allows
organizations meeting the requirements of
both AS9100B and ISO 9001:2008 to have both
standards included on their certificate of
registration.
Rather than wait for AS9100C to incorporate
ISO 9001:2008, you can maintain your current
AS9100B certification and transition to ISO
9001:2008 now.
Whittington & Associates provides training, consulting and auditing services for
management systems based on
ISO 9001, ISO/TS16949, ISO/TS 29001, TL 9000, AS9100, ASS9110, AS9120, ISO 13485,
ISO 27001, ISO 20000, and ISO 14001.