 |
Whittington Newsletter |
 |
| QMS, EMS, Information Security, and Six Sigma |
September 2006 |
|
|
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.
|
|
What are Layered Audits? |
|
What are layered audits? They are a system of audits performed by multiple levels of management, from supervisors up to top management. The intent is to frequently audit key process characteristics to verify process conformity.
Layered audits have proved so valuable, DaimlerChrysler requires their suppliers of production parts and components to conduct these audits on all manufacturing and assembly lines. The purpose is to ensure ongoing conformity, thereby improving process stability and first-time through capability.
There are two types of layered audits: 1) Process Control audits and 2) Error and Mistake Proofing Verification audits. Supervisors conduct process control audits once per shift. Plant management performs process control audits once per week. Delegation of this responsibility is not acceptable except in unusual circumstances.
Error and mistake proofing verification audits are conducted once per shift by qualified employees. Set-up and maintenance personnel, as well as, quality auditors, are typically viewed as qualified.
Layered audits consider multiple topics, e.g., documentation, process parameters, product quality, safety, and housekeeping. And, it is expected that people audit their own work and that their managers audit that work.
For more information on DaimlerChrysler’s requirements for Layered Audits, see section 4.2.9.1 in their Customer-Specific Requirements for use with ISO/TS 16949.
|
|
Next ISO 9001 Edition Delayed to 2009 |
|
The planned publication date for the next revision of ISO 9001 and ISO 9004 was to be third quarter of 2008. Since the working drafts for these standards were not approved for elevation to committee drafts at the recent ISO/TC 176/SC2 meeting, the new projected date for their publication is mid 2009.
The next ISO 9001 is being referred to as an Amendment and the next ISO 9004 as a Revision. Although not formal ISO terms, they are being used to convey the level of expected changes to the standards.
The ISO 9001 amendment will be limited to clarifications. The document is expected to retain all the clause numbers and titles from the 2000 edition. The ISO 9004 revision is expected to include more substantive changes to encourage more usage.
|
|
Bilingual Workplaces |
|
“Bilingual Workplaces? No, non, nyet, nein.”
Bill Levinson wrote an article for the Quality Insider on the problems of translating and maintaining work documents in multiple languages. He prefers another option, requiring English as a second language.
He quotes from Genesis 11:9, which says, "Therefore is the name of it called Babel; because the Lord did there confound the languages of all the earth."
Mr. Levinson believes this verse contains a valuable lesson for today: a multiplicity of languages makes it harder to run a workplace effectively.
He asks us to consider, for example, a workplace that issues work instructions in English and Spanish. Every time a work instruction is changed, someone must translate it into Spanish. Technical translations are expensive and, even worse, increase the chance of introducing an error.
This problem can be circumvented somewhat if the job can be entirely described by pictures. However, the author states, the kind of job that can be described without words is essentially a job for illiterate workers.
He continues by saying it is impossible to have effective cross-functional and cross-shift teamwork in a Tower of Babel. Literacy in English is, therefore, a reasonable job requirement for employment in the United States.
Mr. Levinson relates that Henry Ford treated English as a requirement when immigrants from Germany, Poland, the Balkans and a multitude of other countries sought work in his factories. The immigrants didn't have to know English, but a willingness to learn was a condition of employment.
The author concludes that the best policy is, therefore, not to try to run bilingual workplaces, but to provide mandatory classes in English as a second language for employees who don't speak English. The cost of the training will probably be offset by not having to translate documents into another language.
To see the full article, go to Quality Insider.
|
|
ISO 23026:2006 for Internet Practices |
|
The ISO 23026:2006 standard is titled "Software Engineering - Recommended Practice for the Internet - Web Site Engineering, Web Site Management, and Web Site Life Cycle".
This standard defines recommended practices for World Wide Web page engineering for Intranet and Extranet environments, based on World Wide Web Consortium and related industry guidelines.
This recommended practice does not address stylistic considerations, or human-factors considerations, in Web page design beyond limitations that reflect good engineering practice. Its contents include:
- Scope, purpose, and conformance
- References
- Definitions, terminology, abbreviations and acronyms
- Design practices
- Server, HTTP, and site considerations
- Header information
- Body information
The purpose of the standard is to improve the productivity of Intranet and Extranet Web operations in terms of locating relevant information, and efficient development and maintenance practices.
You can order ISO 23026:2006 for $150.00 at the ANSI web site.
|
|
Auditing Legal Requirements |
|
Part of audit planning is determining the audit criteria, in other words, the policies, procedures, and requirements used as the reference for comparing audit evidence.
The primary types of requirements are:
1. Customer, as expressed in orders and contracts
2. Company, as found in policies and procedures
3. Standard, such as ISO 9001:2000
4. Legal, as defined in statutes and regulations
Unfortunately, legal requirements are often ignored during internal audits. And, that omission would be a nonconformity.
ISO 9001:2000, clause 7.2.1.c states that organizations must determine statutory and regulatory requirements for their products. In addition, clause 7.3.2.b requires design inputs to include applicable statutory and regulatory requirements.
According to clause 5.1.a, top management must communicate the importance of meeting customer, as well as, statutory and regulatory requirements. The legal requirements in this context are quality and product-related, not health, safety, or environment-related.
Auditors must first identify the applicable legal requirements for the area to be audited. Ask the legal staff, contract group, and audited area itself about any process or product legal requirements. According to ISO 9001:2000, the requirements should have been identified.
For the organization to meet the legal requirements, they must have access to the statutes and regulations. Ensure they are available for reference.
If the applicable legal requirements have been determined by the organization, see how they monitor for any new or changed legal requirements. Then ask for evidence that the organization is conforming to the requirements.
If there is proof legal requirements are not being considered, then issue a nonconformity report. Or, if there is evidence that the organization is in violation of a legal requirement, then issue a nonconformity report.
For more information on auditing legal requirements and other quality subjects, go to the ISO 9001 Auditing Practices web site.
|
|
ANSI Z10:2005 for Health and Safety |
|
The American National Standards Institute (ANSI), along with the American Industrial Hygiene Association (AIHA), has developed and released a voluntary consensus standard for Occupational Health and Safety Management Systems.
ANSI Z10-2005 provides critical management systems requirements and guidelines for improving occupational health and safety. Experts from labor, government, professional organizations, and industry formulated this valuable standard after extensive examination of current national and international standards, guidelines, and practices.
Z10 provides the blueprint for widespread benefits in health and safety, as well as, in productivity, financial, performance, quality, and other organizational and business objectives.
It includes sections on Management Leadership and Employee Participation, Planning, Implementation and Operation, Evaluation and Corrective Action, and Management Review. Appendices address roles and responsibilities, policy statements, assessment and prioritization, audit information, and much more.
Z10 was also designed to be compatible with ISO 9001, ISO 14001, and other management systems. A Z10-based management system is geared to reducing and preventing accidents, as well as, accident-related loss of lives, time, and resources.
Z10 is basically the American equivalent of OHSAS 18001 and can be applied to any type of business, organization, or industry that wishes to manage its risks for health and safety in the work place. A copy can be ordered at the ANSI web site for $65.00.
For information on the legal implications of Z10, read the article at the ASSE web site.
|
|
Class Schedule |
|
|
|
Quality and Lean Conference in Atlanta |
|
ASQ’s Southeastern Quality Conference has joined with IIE’s Lean Conference to deliver one powerful conference on October 30-31, 2006 at the Crowne Plaza Ravinia in Atlanta, GA.
Over 50 educational sessions will be included, along with an exhibit hall with the latest in Lean and Quality tools. Conference Proceedings will be available on a CD.
Optional tours of local companies with successful Lean and Quality operations will be available, as well as, pre- and post-conference workshops.
The Conference Tracks include:
- Aviation
- Communications
- Corporate Culture
- Defense
- Healthcare
- Lean Enterprise
- Lean Services
- Lean Tools
- Manufacturing
- Methodologies & Case Studies
- Quality Engineering
- Quality Management
- Quality Systems
- Six Sigma
- Software
Larry Whittington will speak in the Quality Systems track on “How to Audit the Difficult Areas of a Quality Management System”. Some areas in a quality management system are harder to audit than others. Find out how to assess:
1. Undocumented Process
2. Legal Requirements
3. Resource Management
4. Continual Improvement
5. Preventive Action
6. Internal Audits
7. Process Effectiveness
Larry will examine the applicable ISO 9001:2000 requirements for each of these difficult areas and make suggestions on how to more effectively audit them.
If you are a member of ASQ or IIE, the fee for the 2-day conference is $395 if paid by September 1, $495 if paid by October 20, and $595 if paid on-site.
If you are not a member of ASQ or IIE, the fee for the 2-day conference is $545 if paid by September 1, $645 if paid by October 20, and $745 if paid on-site.
The fee for students attending the 2-day conference is $195 if paid by September 1, $245 if paid by October 20, and $245 if paid on-site.
You can download the Conference Brochure to view the session abstracts and to submit your registration.
| Quick Links... |
|
|
|
 |
 |
|
