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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, ISO 22000, 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.
Quality Measurement Data Specification
According to AIAG News, automotive manufacturers and suppliers lose millions of dollars and weeks of product development time from the lack of interoperability from proprietary quality data collection solutions. The Quality Measurement Data (QMD) Specification enables the seamless exchange of quality measurement information between disparate and proprietary gages and reporting tools, solving this data integration problem by reducing as many as 1,500 data formats to one single open reporting format.
Currently, companies are forced to integrate data to or from numerous disparate data sources. These proprietary, integrated quality data collection solutions cost manufacturers and suppliers enormous amounts of money because of the lack of interoperability among gages and reporting tools.
Now, with the QMD Specification, gages will be able to exchange data used in Statistical Process Control (SPC) and Measurement Systems Analysis (MSA) studies to different reporting tools. Developed in fully extensible XML XSD with an accompanying data dictionary, this document constitutes a common language for quality measurement. It describes a non-proprietary and open standard for variable, attribute, and binary quality measurement data. The QMD Specification helps companies recover some of the costs, wasted time, and resources from data integration by enabling gages to communicate with more reporting tools and reporting tools to accept data from more sources.
The publication is available in CD and electronic document formats for a list price of $78. AIAG members can purchase the QMD Specification at a discounted rate of $39. To purchase, visit the AIAG Web Site or call AIAG at 248-358-3003.
The QMD Specification has been tested and validated by many companies. For more information on the specification, visit the QMD Web Site.
IT Infrastructure Library (ITIL)
The Information Technology Infrastructure Library (ITIL) is a framework of best practice approaches intended to help with the delivery of high quality information technology (IT) services. ITIL outlines an extensive set of management procedures that are intended to support businesses in achieving high quality and value in IT operations. These procedures are supplier-independent and were developed to provide guidance across the breadth of IT infrastructure, development, and operations.
ITIL is published in a series of books (Library), each of which covers a core area within IT Management. The names ITIL and IT Infrastructure Library are Registered Trade Marks of the United Kingdom's Office of Government Commerce (OGC).
ITIL is relevant to anyone involved in the delivery or support of IT services. Whether you are managing day-to-day IT services or establishing and refining existing processes, ITIL can help you apply internationally proven best practices for IT services and support. ITIL has been adopted by hundreds of organizations worldwide, including IBM and Microsoft.
Certification
ITIL certifications are managed by the ITIL Certification Management Board which is composed of the OGC, IT Service Management Forum (itSMF) International, and two examination institutes: EXIN (based in the Netherlands) and ISEB (based in the UK).
EXIN and ISEB administer exams and award qualifications at the Foundation, Practitioner, and Manager levels in IT Service Management.
Organizations or a management system may not be certified as "ITIL-compliant". However, an organization that has implemented ITIL guidance in ITSM may be able to achieve conformity with and seek certification under ISO 20000.
IT Service Management as a concept is related to ITIL which contains a subsection specifically titled IT Service Management (ITSM). The combination of the Service Support and Service Delivery volumes are a specific example of the ITIL ITSM framework which is currently embodied in the ISO 20000 standard.
ITIL Version 3
An ITIL refresh, commonly known as ITIL v3, recently became available and includes five core publications:
1. Service Strategy
2. Service Design
3. Service Transition
4. Service Operation
5. Continual Service Improvement
The Official Introduction to the ITIL Service Lifecycle This document introduces ITSM and ITIL, explains why the service lifecycle approach is best practice in today's service management, and makes a persuasive case for change. After showing high level process models, it takes the reader through the main principles that govern the new version: lifecycle stages, governance and decision making, and then the principles behind design and deployment, and operation and optimization.
Service Strategy
This publication provides a view of ITIL that aligns business and IT so that each brings out the best in the other. It ensures that every stage of the service lifecycle stays focused on the business case and relates to all the companion process elements. Subsequent publications will link deliverables to meeting the business goals, requirements, and service management principles described in this publication.
Concepts and Guidance included are:
Service Management strategy and value planning
Linking business plans and directions to IT service strategy
Planning and implementing service strategy
Service Design
In order to meet current and future business requirements, this publication provides guidance on the production and maintenance of IT policies, architectures, and documents for the design of appropriate and innovative IT service solutions and processes.
Concepts and guidance in this publication include:
Service design objectives and elements
Selecting the service design model
Cost models
Benefit/risk analysis
Implementing service design
Measurement and control
Service Transition
Service Transition focuses on the broader, long-term change management role and release practices, so that risks, benefits, delivery mechanism, and the ease of ongoing operations of service are considered. This publication provides guidance and process activities for the transition of services into the business environment:
Managing organizational and cultural change
Knowledge management
Service knowledge management systems
Methods, practices, and tools
Measurement and control
Companion best practices
Service Operation
By focusing on delivery and control process activities, a highly desirable, steady state of managing services can be achieved on a day-to-day basis. To ensure it is integrated with the rest of the ITIL library, guidance in this publication is based on a selection of familiar service support and service delivery control points. Concepts and guidance in this document include:
Application management
Change management
Operations management
Control processes and functions
Scalable practices
Measurement and control
Continual Service Improvement
Alongside the delivery of consistent, repeatable process activities as part of service quality, ITIL has always emphasized the importance of continual improvements. This publication focuses on the process elements involved in identifying and introducing service management improvements, as well as, deals with issues surrounding service retirement.
Concepts and guidance in this publication include:
Business and technology drivers for improvement
Justification
Business, financial, and organizational improvements
Methods, practices, and tools
Measurement and control
Companion best practices
ISO 20000 Training
Whittington & Associates offers these ITSM courses based on ISO 20000-1:2005:
The American Association for Laboratory Accreditation (A2LA) now offers accreditation for medical laboratories to ISO 15189:2007.
ISO 15189 specifies requirements for quality and competence particular to medical laboratories. It is for use by medical labs in developing their quality management systems and assessing their own competence, as well as, for use by accreditation bodies like A2LA in confirming or recognizing the competence of medical laboratories.
In addition to examining the technical aspects of a lab's operation, the A2LA accreditation process includes a review of its management system. A2LA accreditation attests that a medical laboratory has demonstrated:
competency to perform specific testing procedures
that its quality management system is documented, is fully operational, and addresses and conforms to all elements of ISO 15189:2007
adherence to any additional requirements established by A2LA including measurement traceability and laboratory participation in ongoing proficiency testing
The addition of the ISO 15189 program at A2LA will provide medical laboratories with an additional level of recognition of the excellent service provided to their customers.
The International Aerospace Quality Group (IAQG) is revising the IAQG 9100 family of standards. Since the IAQG 9100 standard is published as AS9100 in the USA, I will refer to it as AS9100 in the remainder of this article.
AS9100 uses ISO 9001:2000 as its foundation, with additional aerospace requirements highlighted in bold, italic type. The ISO 9001 standard is being amended with publication expected in May 2009. This revision is driving an update of AS9100.
According to Buddy Cressionnie in a recent Quality Progress article, the objectives for the AS9100 revision include improving supplier performance and customer satisfaction by:
Focusing on product quality and on-time delivery,
Allowing its common interpretation for auditors and organizations, and
Taking into account newly identified stakeholder requirements.
The first draft of the AS9100 revision is planned for later this year, with publication expected in mid-2009, depending on the release date of the ISO 9001 amendment.
The AS9110 (Maintenance Organizations) and AS9120 (Stockist Distributors) standards are undergoing a similar revision process. Since they use AS9100 as the baseline, they will trail the AS9100 revision by about six months and are expected to be released by the end of 2009.
AS9101 is a checklist that must be completed during other-party audits. It is being revised as a more process-oriented tool and to apply to AS9100, AS9110, and AS9120. The first draft of the revised AS9101 checklist is expected later this year. It will be introduced into the audit process as organizations make the transition to the 2009 versions of AS9100, AS9110, and AS9120.
AS9115 is a new international software quality standard and will be confined to "deliverable" software. It will be framed around the existing Americas standard, AS9006, and will bring in elements of European Technical Report TR9109, ISO 12207, and other standards. It is targeted for release in December 2008.
AS9100 Training
Click on one of the courses below to view its description and class calendar.
The Software Engineering Institute (SEI) has identified three critical dimensions that organizations typically focus on to improve their business: 1) people, 2) procedures and methods, and 3) tools and equipment.
But what holds everything together? It is the processes used in your organization. Processes allow you to align the way you do business. They allow you to address scalability and provide a way to incorporate knowledge of how to do things better. Processes allow you to leverage your resources and to examine business trends.
Of course, people and technology are important. Technology is changing by an order of magnitude every ten years. People typically work for many companies throughout their careers. We live in a dynamic world. A focus on process provides the infrastructure necessary to deal with that ever-changing world and to maximize the productivity of people and the use of technology to be more competitive.
The SEI has taken this process management premise, "the quality of a system or product is highly influenced by the quality of the process used to develop and maintain it," and defined Capability Maturity Models=AE (CMMs) to embody this premise. They contain the essential elements of effective processes for one or more disciplines and describe an evolutionary improvement path from ad hoc, immature processes to disciplined, mature processes with improved quality and effectiveness.
CMMI=AE (Capability Maturity Model Integration) is a process improvement maturity model for the development of products and services. It consists of best practices that address development and maintenance activities that cover the product lifecycle from conception through delivery and maintenance. Organizations from many industries use CMMI, including aerospace, banking, computer hardware, software, defense, automobile manufacturing, and telecommunications.
CMMI models contain practices that cover project management, process management, systems engineering, hardware engineering, software engineering, and other supporting processes used in development and maintenance. CMMI with the +IPPD model also covers the use of integrated teams for development and maintenance activities.
You can download a free CMMI v1.2 Overview at the SEI web site. The overview is 41 pages.
You can download a free copy of the CMMI for Development, v1.2, Technical Report CMU/SEI-2006-TR-008 as a PDF file or Word file. The report is 573 pages.
OHSAS 18001:2007 specifies the requirements for an organization to control its Occupational Health and Safety risks and improve its performance.
OHSAS 18001:2007 has been issued as a British Standard and supersedes OHSAS 18001:1999, which will remain current until 2009.
There have been a number of significant changes made to the standard to reflect its widespread use in more than 80 countries and by approximately 16,000 certified organizations.
The principal changes include a much greater emphasis on "health" rather than just "safety" and significantly improved alignment to ISO 14001:2004 for use of integrated management systems.
The key changes between OHSAS 18001:2007 and OHSAS 18001:1999 include:
The importance of "health" has been given greater emphasis.
OHSAS 18001 now refers to itself as a standard, not a specification or document as in the earlier edition. This reflects the increasing adoption of OHSAS 18001 as the basis for national standards on occupational health and safety management systems.
The "Plan-Do-Check-Act" model diagram is only given in the Introduction, in its entirety, and not also as sectional diagrams at the start of each major clause.
Reference publications in Clause 2 have been limited to purely international documents.
New definitions have been added and existing definitions revised.
Significant improvement in alignment with ISO 14001:2004 throughout the standard.
Improved compatibility with ISO 9001:2000.
A new requirement has been introduced to consider the hierarchy of controls as part of OH&S planning.
Management of change is now more explicitly addressed.
A new clause on the "Evaluation of Compliance" has been introduced, as per ISO 14001:2004.
New requirements have been introduced for participation and consultation, as well as, for the investigation of incidents.
Transition Period
For organizations that have already achieved certification to OHSAS 18001:1999, or are in the final stages of achieving it, a two year "transition" period will allow them to make the change to using the new standard. The transition period will end on July 1, 2009.
For organizations just starting the path towards certification to OHSAS 18001 and looking for guidance, they can still use the sister standard OHSAS 18002:2000, which provides guidelines for the implementation of OHSAS 18001. While OHSAS 18002 is aligned on a clause by clause basis against OHSAS 18001:1999, it does contain valuable advice on what must be done to achieve compliance. A revised edition of OHSAS 18002 is planned for publication at the end of the 3rd quarter of 2008.
Whittington & Associates provides training, consulting and auditing services for
quality systems based on
ISO 9001, ISO/TS16949, TL9000, AS9100, ISO 13485,
as well as, ISO 27001, ISO 20000, ISO 22000, and ISO 14001.
