e-Newsletter


Whittington Newsletter )
QMS, EMS, Information Security, Services Management, and Six Sigma December 2009
In this Issue
  1. Web Archiving
  2. On-time Delivery
  3. Revised 14 CFR 21
  4. ISO 9004:2009
  5. Medical Labs
  6. Critical Safety Items
  7. AS9100C Timeline
  8. Class Schedule
  9. Featured Books

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.


Web Archiving

A Web page that is here today, may not be around tomorrow. A new standard, ISO 28500:2009, Information and Documentation - WARC File Format, will ensure that the vast and often valuable information posted on the Web is not lost when a page changes or disappears.

ISO 28500 provides a file format known as WARC (Web ARChive), which offers a convention for concatenating multiple data objects into one long file. The format can be used to build applications for harvesting, managing, accessing, and exchanging content.

For a long time, keeping track of the staggering number of Web sites and pages posed a difficult challenge for digital curators and archivists, and resulted in countless lost data. With WARC, ISO 28500 takes Internet archiving to the next level by enabling the effective management, structure, and storage of billions of resources collected from the Web and elsewhere.

Standardization on the WARC format offers a guarantee of durability, and will help Web archiving become part of the mainstream activities of heritage institutions, by for example, fostering the development of new tools and ensuring interoperability between collections.

The WARC format is an extension of the ARC file format, which has been used by the Internet Archive since 1996, and by numerous heritage institutions to store "Web crawls" - which represent extracts of entire Web pages and their links.

The motivation to extend the ARC arose from the discussions and experiences of the organizations within the International Internet Preservation Consortium (IIPC) - whose core mission is to acquire, preserve, and make accessible knowledge and information from the Internet for future generations. IIPC members were finding it increasingly difficult to store and manage the growing volume of information coming from the Internet.

According to the ISO technical committee that developed ISO 28500, several applications are already WARC compliant, such as the Heritrix crawler for harvesting, the WARC tools for data management and exchange, the Wayback Machine, and NutchWAX. And, I noticed that the Library of Congress is already using the WARC format to harvest web sites.

You can order ISO 28500:2009 at the ANSI Standards Store at this web page.

On-time Delivery

The QuEST Forum is a unique collaboration of service providers and suppliers dedicated to improving quality and performance in the telecommunications supply chain. The QuEST Forum has helped unify the global telecom community through the implementation of TL 9000, a telecom-specific quality standard that builds on ISO 9001.

TL 9000
The performance data requirement of TL 9000 sets it apart from other quality management standards. TL 9000 certified organizations must submit TL 9000 measurement data using predefined counting rules to the QuEST Forum's partner, the University of Texas at Dallas. Security and anonymity are maintained during the submittal, storage, and reporting of all TL 9000 measurement data.

Through the compilation of industry statistics, such as industry average, best-in-class, and worst-in-class, the measurement data enables QuEST Forum members to identify opportunities for improvement, as well as, compare themselves to their competitors and set meaningful improvement goals. Furthermore, an organization's quality management system based on TL 9000 serves as a platform to support the continual improvement of these measurements.

Study
The QuEST Forum commissioned the publication of a study to ascertain the state of telecom quality as evidenced by the TL 9000 measurement data. Since the amount of TL 9000 data covers 47 TL 9000 measurements, 126 product categories, and 869 registrations, as a starting point, the study focused on a single TL 9000 measurement, On-Time Delivery, across a sample of representative product categories for the two-year period, 2007-2008.

Summary
Over the study period, the average on-time delivery improved from 75% to 81%. The range of results improved from (31% to 98%) to (72% to 99%). The Worst-In-Class average improved from 30% to 54%. To see the full report, go to this TL 9000 web page.

Conclusion
A major premise behind QuEST Forum's inception was that as organizations used TL 9000 data to drive improvement, the net effect over time would be an overall improvement in the quality of the telecom industry. Based on the study results, it appears the founding intent of the QuEST Forum and TL 9000 - to improve telecom quality - is being realized.

The study also vividly illustrates the importance of the TL 9000 measurements and the valuable insight they can provide. Without a common measurement system the study would not have been possible. The TL 9000 measurements provided for the secure collection of anonymous data both derived using accepted definitions and reported in a common format.

While many certified organizations that faithfully use TL 9000 attest to the improvements in quality derived from utilizing TL 9000, this study confirms these statements. The benchmark data derived from the TL 9000 measurement data will hopefully be used to drive meaningful improvement targets for certified organizations and the industry as a whole.

Revised 14 CFR 21

The Federal Aviation Administration (FAA) recently published significant revisions to 14 CFR 21, the regulations that govern the design, production, and continued airworthiness of U.S. civil aircraft. These changes become effective April 14, 2010.

The FAA is amending its certification procedures and identification requirements for aeronautical products and articles. The amendments will update and standardize those requirements for Production Approval Holders (PAHs), revise export airworthiness approval requirements to facilitate global manufacturing, move all part marking requirements from part 21 to part 45, and amend the identification requirements for products and articles.

The changes also standardize the quality system requirements for PAHs so that all PAHs comply with the same set of quality system requirements, regardless of the product or article produced.

Quality System Requirement

This final rule prescribes a PAH's requirements for controlling the quality of the product or article it manufactures. The FAA has imposed additional PAH quality system requirements designed to achieve overall improvement of the PAH's quality system.

The quality system consists of fourteen specific quality system requirements. As described below, it is important to note that those fourteen quality system requirements are scalable, depending on the size and complexity of the PAH and of the product or article produced. Some of these requirements were already mandatory prior to this rulemaking and have been retained. The remaining requirements also have already been incorporated by industry for years and used voluntarily as ''best practices.''

Prior to this rulemaking, holders of different production approvals complied with, and were audited to, differing sets of requirements. For instance, if a manufacturer produced a Parts Manufacturing Approval (PMA) part and a Technical Standard Order (TSO) article, the manufacturer was subject to different quality and marking standards for each part it produced.

Today's requirements are now applicable to Production Certificate (PC) and PMA holders and TSO authorizations alike. This final rule relieves PAHs from having to maintain, and the FAA from having to oversee, multiple PAH systems and procedures. Hence, this final rule will increase regulatory efficiency.

Two of the sections in 14 CFR 21 relating to the quality system are included below.

21.137 Quality System

Each applicant for, or holder of, a production certificate must establish and describe in writing a quality system that ensures that each product and article conforms to its approved design and is in a condition for safe operation. This quality system must include:

(a) Design data control. Procedures for controlling design data and subsequent changes to ensure that only current, correct, and approved data is used.

(b) Document control. Procedures for controlling quality system documents and data, and subsequent changes, to ensure that only current, correct, and approved documents and data are used.

(c) Supplier control. Procedures that:
(1) Ensure that each supplier-furnished product or article conforms to its approved design; and
(2) Require each supplier to report to the production approval holder if a product or article has been released from that supplier and subsequently found not to conform to the applicable design data.

(d) Manufacturing process control. Procedures for controlling manufacturing processes to ensure that each product and article conforms to its approved design.

(e) Inspecting and testing. Procedures for inspections and tests used to ensure that each product and article conforms to its approved design. These procedures must include the following, as applicable:
(1) A flight test of each aircraft produced unless that aircraft will be exported as an unassembled aircraft.
(2) A functional test of each aircraft engine and each propeller produced.

(f) Inspection, measuring, and test equipment control. Procedures to ensure calibration and control of all inspection, measuring, and test equipment used in determining conformity of each product and article to its approved design. Each calibration standard must be traceable to a standard acceptable to the FAA.

(g) Inspection and test status. Procedures for documenting the inspection and test status of products and articles supplied or manufactured to the approved design.

(h) Nonconforming product and article control. Procedures to ensure that:
(1) Only products or articles that conform to their approved design are installed on a type-certificated product. These procedures must provide for the identification, documentation, evaluation, segregation, and disposition of nonconforming products and articles. Only authorized individuals may make disposition determinations.
(2) Discarded articles are rendered unusable.

(i) Corrective and preventive actions. Procedures for implementing corrective and preventive actions to eliminate the causes of an actual or potential nonconformity to the approved design or noncompliance with the approved quality system.

(j) Handling and storage. Procedures to prevent damage and deterioration of each product and article during handling, storage, preservation, and packaging.

(k) Control of quality records. Procedures for identifying, storing, protecting, retrieving, and retaining quality records. A production approval holder must retain these records for at least 5 years for the products and articles manufactured under the approval and at least 10 years for critical components identified under § 45.15(c) of this chapter.

(l) Internal audits. Procedures for planning, conducting, and documenting internal audits to ensure compliance with the approved quality system. The procedures must include reporting results of internal audits to the manager responsible for implementing corrective and preventive actions.

(m) In-service feedback. Procedures for receiving and processing feedback on in-service failures, malfunctions, and defects. These procedures must include a process for assisting the design approval holder to:
(1) Address any in-service problem involving design changes; and
(2) Determine if any changes to the Instructions for Continued Airworthiness are necessary.

(n) Quality escapes. Procedures for identifying, analyzing, and initiating appropriate corrective action for products or articles that have been released from the quality system and that do not conform to the applicable design data or quality system requirements.

21.138 Quality Manual

Each applicant for, or holder of, a production certificate must provide a manual describing its quality system to the FAA for approval. The manual must be in the English language and retrievable in a form acceptable to the FAA.

To see the full FAA Final Rule for 14 CFR 21, view this PDF document. http://edocket.access.gpo.gov/2009/pdf/E9-24821.pdf

ISO 9004:2009

ISO 9004:2009 The just-published new edition of ISO 9004 provides organizations with a model for "sustained success" in today's complex, demanding, and ever-changing environment.

ISO 9004:2009, Managing for the sustained success of an organization - A quality management approach, is the third edition of the standard first published in 1987. It is intended to support the achievement of sustained success by any organization (regardless of size, type, or activity) through a quality management approach.

While the initial goal is to ensure the production of quality products and services that will lead to the achievement of customer satisfaction, the longer-term purpose is to ensure the economic survival of the organization. The new edition of ISO 9004 gives guidance on how an organization should adopt a systematic approach to achieve this sustained success.

ISO 9004:2009 provides guidance for the continual improvement of an organization's overall performance, efficiency, and effectiveness based on a process-based approach. It focuses on meeting the needs and expectations of customers and other relevant parties, over the long term, and in a balanced way.

Compared to ISO 9001:2008, ISO 9004:2009 provides a broader perspective of quality management, particularly for performance improvement. It will prove useful to organizations whose top management wishes to move beyond ISO 9001, in pursuit of ongoing improvement, measured through the satisfaction of customers and other stakeholders.

ISO 9004:2009 allows organizations to enhance the quality of product and service delivery to their customers by promoting self-assessment as an important tool to enable organizations to:

  • benchmark their level of maturity, covering leadership, strategy, management system, resources, and processes
  • identify their strengths and weaknesses
  • identify opportunities for either improvements or innovation, or both.
The self-assessment tool may become a key element during the strategic planning processes in any organization.

The objectives of customer satisfaction and product quality are extended in ISO 9004:2009 to include the satisfaction of interested parties and the performance of the organization. The combination of ISO 9001 and ISO 9004 will allow you to get the most of your quality system.

ISO 9004:2009 replaces ISO 9004:2000 by making substantial changes to its structure and contents based on eight years' experience of implementing the standard worldwide, and introduces changes intended to improve consistency with ISO 9001 and other management system standards. An example of an important change in the structure of ISO 9004 is that the "body" of the standard starts with the chapter giving guidance on how to manage an organization aiming for sustained success and not how to build a quality management system.

Although ISO 9004:2009 complements ISO 9001:2008 (and vice versa), it can also be used independently. It is not intended for third-party certification, regulatory, or contractual use, nor as a guide to the implementation of ISO 9001:2008. To help users get the best out of the standard, an annex gives a clause-by-clause correspondence between ISO 9001:2008 and ISO 9004:2009.

Medical Labs

Medical laboratories accredited to ISO 15189:2007 are recognized as meeting the management system principles of ISO 9001:2008 according to a joint communiqué by ISO (the International Organization for Standardization), ILAC (the International Laboratory Accreditation Cooperation), and the IAF (the International Accreditation Forum).

The ISO-IAF-ILAC communiqué was issued to address the misconception that medical laboratories accredited to ISO 15189:2007 do not operate a recognized management system. Until now, accredited medical laboratories were often requested by their customers to undertake the additional step of certification to ISO 9001:2008 to demonstrate that they were in full control of their processes.

This recognition will reduce redundant, costly, and time-consuming audits and, at the same time, enable medical laboratories to better meet their customers' needs.

Note: ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories. The standard is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognizing the competence of medical laboratories.

While ISO is the developer and publisher of ISO 15189 and ISO 9001, it does not carry out auditing and certification. These services are performed independently by accreditation and certification bodies. ISO does not control such bodies, but does develop voluntary International Standards to encourage good practice in their activities on a worldwide basis.

ILAC is the world's principal international forum for the development of laboratory accreditation practices and procedures and the promotion of calibration and testing laboratory and inspection accreditation. This accreditation ensures that decisions on international trade, public health, and environmental issues are based on reliable, reproducible, and accurate data. As well as working in other fields, national accreditation bodies that are members of ILAC assess and declare the competence of medical laboratories against the requirements of ISO 15189.

IAF is the world association of accreditation bodies and other bodies interested in the accreditation of conformity assessment bodies providing certification and inspection services. Its primary function is to develop worldwide programs of accreditation that promote the elimination of non-tariff barriers to trade. Accreditation bodies declare the competence of certification bodies in the fields of management systems, products, services, personnel, and other similar programs of conformity assessment.

Critical Safety Items

AS9017:2009, Control of Aviation Critical Safety Items, is now available. It is intended to prescribe consistent requirements for CSI management for organizations and suppliers who perform work for prime contractors receiving direct contracts from U.S. government agencies.

The contractor, which receives the initial government contract, will receive their CSI requirements directly from the U.S. government agency and be required to maintain a CSI management system that ensures compliance to all requirements.

The flow down of this standard is in addition to any specific contract clauses, e.g., Federal Acquisition Regulations, Defense Federal Acquisition Regulations, required by the government to be flowed to sub-tier sources.

The standard will be auditable with the expectation that the prime contractor will flow CSI requirements to the supply chain and periodically assess, audit, validate, and recognize compliance to AS9017 per their own processes. All manufacturers of CSIs must comply with the requirements of AS9100 or a technically equivalent quality management system standard.

Special process suppliers may meet this quality management system requirement through their Nadcap certification. Any operation, process, or other action associated with the new manufacture of any CSI must only be performed by sources meeting the applicable requirements of AS9017.

You can order AS9017 at this SAE web page.

AS9100C Timeline

The International Aerospace Quality Group (IAQG) has announced a new timeline for the transition to the aerospace standards published in 2009:

AS9100:2009, Requirements for Aviation, Space, and Defense Organizations
AS9110:2009, Requirements for Aviation Maintenance Organizations
AS9120:2009, Requirements for Aviation, Space, and Defense Distributors


Transition Schedule

The IAQP sanctioned auditor training is expected to be available by April 30, 2010. The following 14 month period, ending July 1, 2011, is to provide time for trainers and auditors to be trained, and for certification bodies to be accredited to the AS9104-1 standard.

Certification of organizations to the new standards (AS9100, AS9110, or AS9120) can start any time after the accreditation of a certification body to AS9104-1. After July 1, 2011, all audits must be against the applicable new standard. AS9100:2004 will be canceled on July 1, 2012. The transition plan and related guidance materials are to be published by December 31, 2009.

Supporting Standards

AS9101:2009, Audit Requirements for Aviation, Space, and Defense Organizations, is expected to be published before the end of this year. It will replace the current audit checklists, AS9101, AS911, and AS9121. All certification audits must be conducted in compliance with this standard.

AS9104-1, Requirements for Oversight of Aerospace Quality Management System Certification Programs, is expected to be published by April 2010. All certifications of organizations to the 2009 versions of the aerospace standards must be completed in compliance with this updated standard.

Upgrade Audits

AS9104-1 will include revised audit day tables. An upgrade to one of the new standards during a scheduled surveillance audit will use the "recertification" audit day table. A certification upgrade during a recertification audit will use the "initial" audit day table.

Auditor Training

IAQG sanctioned training for all AA and AEA auditors will be required prior to those auditors conducting a certification audit to the 2009 versions of the aerospace standards. This sanctioned training will be developed by a training firm selected by IAQG.

The training materials, exam, and training for trainers will be made available to other training providers and organizations. However, the training providers and other organizations wanting to train aerospace auditors for authentication must be approved. The sanctioned training will be the only training accepted for re-authentication of auditors for the 2009 aerospace standards.

AS9100:2009 Differences

You can download a PDF file from this AS9100 page at our web site to see the detailed differences in AS9100:2009 compared to AS9100:2004:

Class Schedule

Root Cause Analysis

ISO 9001:2008
Understanding ISO 9001:2008 (1 Day)
ISO 9001:2008 Requirements (2 Days)
Implementing ISO 9001:2008 (2 Days)
Quality System Documentation (2 Days)
ISO 9001:2008 Internal Auditor (3 Days)
ISO 9001:2008 Lead Auditor (4 Days)

ISO 9001:2008 Internal Auditor (2 Days - Onsite Only)

ISO 14001:2004
ISO 14001:2004 Requirements
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

© 2000-2009 Whittington & Associates, LLC

Featured Books

You can view the selected quality, environmental, and six sigma book abstracts by clicking on one of the categories below:

The books can be ordered online via Amazon if you decide to buy a copy.

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