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Whittington Newsletter )
QMS, EMS, Information Security, Services Management, and Six Sigma August 2009
In this Issue
  1. ISO/TS 16949:2009
  2. TL 9000 R5.0 Handbook
  3. 4-Day Lead Auditor
  4. Root Cause Analysis
  5. More CMMI Classes
  6. AS9101D Checklist
  7. Class Schedule

Greetings!

Welcome to the Whittington & Associates e-Newsletter! Visit and bookmark our web site.

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.

For more information, go to the QuEST Forum and TL 9000 web sites.

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
Book Cover

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
  • Implementation, follow-up, and standardization
MANAGEMENT/ORGANIZATIONAL ISSUES AFFECTING RCA PROJECTS

COACHING/FACILITATING ROOT CAUSE ANALYSIS

STATISTICAL HYPOTHESIS TESTING AND MS EXCEL


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.

You can enroll at this web page at our web site.

AS9101D Checklist

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.

Class Schedule

Root Cause Analysis

ISO 9001:2008
Understanding ISO 9001:2008
ISO 9001:2008 Requirements
Implementing ISO 9001:2008
Quality System Documentation
ISO 9001:2008 Internal Auditor
ISO 9001:2008 Lead Auditor

ISO 14001:2004
Implementing an EMS
ISO 14001:2004 Internal Auditor
ISO 14001:2004 Lead Auditor

ISO/TS 16949:2002
ISO/TS 16949:2002 Internal Auditor
ISO/TS 16949:2002 Lead Auditor
Understanding and Implementing ISO/TS 16949:2002

Core Tools
Advanced Product Quality Planning
Design Failure Modes Effects Analysis
Process Failure Modes Effects Analysis
Production Part Approval Process
Statistical Process Control
Measurement System Analysis

AS9100B:2004
AS9100 Internal Auditor
Implementing AS9100
AS9100 Lead Auditor

ISO 27001:2005
ISO 27001 - Understanding an ISMS
ISO 27001 - ISMS Implementation
ISO 27001 - ISMS Internal Auditor
ISO 27001 - ISMS Lead Auditor

ISO 20000-1:2005
Understanding ISO 20000
Implementing ISO 20000
ISO 20000 Internal Auditor

ISO 13485:2003
Understanding ISO 13485:2003
ISO 13485:2003 Internal Auditor
Implementing ISO 13485:2003
ISO 9001 Lead Auditor - ISO 13485 Emphasis

Capability Maturity Model Integration
Introduction to CMMI v1.2

Six Sigma
Introduction to Statistics
Green Belt Certification
Black Belt Certification

Books
See our list of ISO 9001, Auditing, and Six Sigma books. Includes book descriptions and links to Amazon.

© 2000-2009 Whittington & Associates, LLC

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