Thursday, December 30, 2010

Congratulations!!! Mr. Sajja Murali Mohan for Achieving 28 PDUs by PMI

Mr. Sajja Murali Mohan from Tech Mahindra, Hyderabad who recently completed his Black Belt course with us has been granted 28 PDUs by PMI
We congratulate him!! Congratulations on your continued effort to maintain your PMI credential!

PMI ID Number: 884314
Category: Cat 4: Other Program Provider
Activity Title: Six Sigma Black Belt
Date Started: 25 Nov 2010
Date Completed: 28 Nov 2010
For Credential: PMP/PgMP
PDUs Claimed: 28
PDUs Earned: 28
Each credential cycle lasts three years. During that time, you have to earn and report the required amount of PDUs to maintain your credential. Please refer to the section
Maintain Your Credential
on PMI.org to see PDU requirements per credential. You can also review the Continuing Certification Requirements (CCR) section of the respective credential handbook online to review the criteria for PDUs.
You will be able to view this activity on your online transcript immediately by logging in to the CCR System.
If you have any questions or concerns, contact PMI at customercare@pmi.org.
Thank you - PMI Customer Care

Friday, December 24, 2010

" AEROSPACE’S AS9100 QMS STANDARD " by Eugene M. Barker

Representing the first international effort to formulate a quality management system standard for the aerospace industry, the two-year-old AS9100 is beginning to show its long-term value.

The standard supplements ISO 9001 by addressing the additional expectations of the aerospace industry. Already, reports along this complicated manufacturing chain attest to among other benefits AS9100's contribution to more consistent verification methods and fewer verification audits. 

Initially released in October 1999 by the Society of Automotive Engineers in the Americas and the European Association of Aerospace Industries in Europe, and shortly thereafter by standards organizations in Japan and Asia, AS9100 was a cooperative effort of the International Aerospace Quality Group (IAQG).

As such, it combines and harmonizes requirements outlined in the SAE's AS9000 and Europe's prEN9000-1 standards.

Recently, AS9100 was revised to align with ISO 9001:2000.

Separating "whats" from "how tos"
 
AS9100 defines additional areas within an aerospace quality management system that must be addressed when implementing an ISO 9001:2000-based quality system. Typically, these requirements are included within robust aerospace quality systems. The industry experts who wrote the standard and the representatives who approved it all agree that these additions are essential to ensure product, process and service safety and quality. 

Although the standard outlines industry "whats" for a quality management system, the "how tos" were deliberately left out and remain the system designers' responsibility. This reflects the AS9100 writing team's, and my, belief that how-to information stifles continuous improvement.
All quality systems must be designed to meet the specific needs of the users. And although AS9100 identifies areas to address within the aerospace industry, system designers are encouraged to first establish a robust quality system that's both effective and efficient. This system should be a holistic entity with practices spanning multiple functions and processes within the business.

For example, regulatory requirements are critical functions within the industry. The requirements within AS9100 are complementary to contractual and applicable law and regulations. Those implementing a quality system compliant with AS9100 must ensure that the additional requirements of their customers, regulatory agencies (such as the FAA and the JAA) and local, state and national laws are also referenced within the system's documentation.

Aerospace requirements and ISO 9001
 
Within AS9100, additions and clarifications have been made to most areas of ISO 9001:2000. Although the specific requirements of that standard don't fall within this article's scope, a discussion of the primary areas where ISO 9001 overlaps with AS9100 will benefit those implementing the aerospace standard. Some additional expectations relevant to the aerospace industry follow. Most are based upon existing best practices, which are collected and formatted in AS9100 to ensure that manufacturers meet the industry's expectations.
 
The AS9100 standard provides guidance for managing variation when a "key characteristic" is identified. Keys are features of a material, process or part in which the variation has a significant influence on product fit, performance, service life or manufacturability. AS9100 requires that an organization establish and document a configuration management process.

Planning product realization is essential for effective and efficient processes. The standard emphasizes planning for in-process verification when a product can't be verified at a later point. Tooling design must also be considered when process control methodology is used to ensure that process data will be captured.

The AS9100 standard includes extensive supplementation in design-and-development functions. This isn't surprising given the complexity of aerospace products and customers' expectations for reliable performance during a protracted period of time. The European prEN9000-1 standard provided many of these additions. Both standards cover planning for design-and-development activities and ensuring interim control points during the design process. Design outputs are supplemented to provide identification of key characteristics, and the data essential for the product that will be identified, manufactured, inspected, used and maintained is detailed.

Notes are included for both design-and-development verification and validation highlighting traditional areas of emphasis. Additionally, AS9100 provides information on areas of verification documentation and validating testing and results.

Managing suppliers throughout the aerospace supply chain remains a major challenge for the industry. The chain is very long, and within the supply base, there are sources that serve multiple industries. Because the industry is so dependent upon this supply chain, it isn't surprising that AS9100 includes a number of additional expectations for identifying and maintaining suppliers. Supplier approval is just one step in the process of managing suppliers.

Effectively communicating requirements is essential. The standard lists seven specific areas for consideration. They range from clarifying engineering requirements to managing test specimens and right of access to suppliers' facilities.

The industry typically relies upon one of three methods for product acceptance. An organization might conduct a receiving inspection, perform the inspection at the supplier's facility or formally delegate product acceptance to the supplier. Procedures for determining the method of supplier control are required, as are the processes used when employing these methods.
But no element of supplier control is more important than understanding that a supplier is responsible for managing its suppliers and sub-tier suppliers. This includes performing special processes that are frequently subcontracted to processing houses. The supplier must use customer-approved sources; however, ensuring that the processing is properly performed is the supplier's responsibility.

Product safety and quality control

Manufacturing a product as sophisticated as an airplane or space vehicle requires special attention during the production processes. It's important, for example, to ensure that the correct revision of the engineering documentation is being used and documented within the work instructions, and that work performance is recorded. This frequently requires a specific reference to the person performing the work. Controlling production processes is essential to demonstrate that operations have been correctly performed. This is especially important when conducting special processes that don't lend themselves to after-the-fact inspection techniques.
 
The industry frequently relies upon tooling and other production equipment, including computer-controlled machines, to fabricate and assemble products. This equipment often forms the basis for product acceptance. In these cases, it's essential to demonstrate the integrity of these tools and machines and to develop a process that will ensure adequate oversight of the entire process.

Aircraft are designed to perform for 50 years or more, and properly maintaining the aircraft is essential for continued safe operation. Thus, servicing requirements are an important part of the total quality system. These include maintenance and repair manuals as well as the actual servicing work. Again, record-keeping is important in documenting the work performed, the equipment used and the people doing the work.

Some products require traceability of part or all of their components. This requirement may be imposed by contract, regulatory agency or internal need. In any case, AS9100 provides the essentials of an effective traceability program.

Using measuring devices of known accuracy and this may include computer-assisted measuring and test equipment is essential in the verification process. Maintaining a calibration history of this equipment and documented proof that it's reviewed and verified periodically underlies the entire metrology system. 

Diagnosing the quality management system's health and using this information to guide improvement activity is important for efficiency and effectiveness. Internal audits performed by competent personnel are a vital input into this health measurement system. AS9100 provides some additional expectations regarding internal quality audits.

Detailed first-article inspections are frequently performed to demonstrate product conformance to engineering requirements. Documenting the actual inspection and test results is an established method of demonstrating initial item acceptance. The standard provides general direction in this regard and suggests that AS/EN/JISQ9102 be consulted for further guidance. Another international aerospace standard, called AS9102 and developed by the IAQG, outlines a methodology for performing and documenting first-article inspections.

When things don't go as planned, AS9100 gives directions for controlling and disposing nonconforming material. This includes specific requirements for contacting the customer for authorization when using or repairing a product that doesn't conform to engineering requirements.
 
Verifying compliance to AS9100
 
More than 60 percent of IAQG members have implemented the AS9100 standard internally and are flowing it down to their suppliers. Most members will require suppliers to comply to the updated version of AS9100 (which is aligned to ISO 9001:2000 and supercedes older ISO 9000 standards) beginning in December 2003. This is consistent with the transition from the old ISO 9001 standard to the new version.

Organizations within the industry differ in their compliance to AS9100 verification requirements. Some use their own external auditors to verify suppliers' quality management systems. Others share the results of their quality system audits with suppliers in the industry. Most provide suppliers with copies of external audits. Most permit suppliers to share the audit results with other customers, too.

Increasingly, the industry is using the results of third-party registrars as a means of demonstrating a quality management system's compliance to AS9100. The Americas Aerospace Quality Group, working with the Registrar Accreditation Board, has established a process and requirements for auditors performing audits to AS9100 and registrars granting supplemental registrations. The process includes additional training and practical experience and ensures that auditors are competent and that registrars are experienced in the industry. The AAQG has created a Registrar Management Committee to oversee this important function. Its methodology is defined in SAE AIR5359. Europe and Asia are developing equivalent methods.

The Federal Aviation Administration has determined that AS9100 is "a comprehensive quality standard containing the basic quality control/assurance elements required by the current Code of Federal Regulations (CFR), Title 14, Part 21." Both the U.S. Department of Defense and NASA have reviewed the standard and have published guidance material on using the standard for contractual requirements.

As AS9100 becomes established within the industry, the standard's benefits become apparent. Two obvious ones are a reduction in multiple expectations and a consistency in verification methodology. Both prime manufacturers and their suppliers are pleased with the results. Suppliers report a reduction in verification audits and an increased consistency in expectations. As a direct result, suppliers' customers are seeing a reduction in oversight costs and an improvement in supplier performance.

Additional information on the philosophy behind the specific additions within AS9100 are available in the AS9100 technical requirements chapter found in The ISO 9000:2000 Handbook published by ASQ Quality Press in 2002.
 
About the author
Eugene M. Barker is a technical fellow at The Boeing Co. responsible for quality industry association interfaces. He led the industry writing team that drafted SAE AS9000 and chaired both Working Group 11 of ISO TC20 and the International Aerospace Quality Group that developed AS/EN9100. Barker is also a fellow of the American Society for Quality, a member of the Registrar Accreditation Board board of directors and a founding member of the IAQG.

Thursday, December 23, 2010

ISO 9004:2009 Is Out and It Sure Looks Different

by Denise Robitaille
The new revision to ISO 9004 came off the press in the last quarter of 2009. It is significantly different from its predecessor. ISO 9004:2009 embodies the quality management principle relating to continual improvement. The technical experts made bold strides in their quest to address market needs by producing a standard that would help organizations maintain and improve their quality management systems over time. While that was the stated intent with the 2000 version, the fact is that the majority of users considered it a road map for implementing ISO 9001.
Individuals who were familiar with the 2000 version will have several questions. The first is: “Where’s 9001?” In ISO 9004:2000 the entire text of ISO 9001:2000 was embedded into the standard. The clauses, by and large, mirrored ISO 9001 and the structure was identical. Those who utilized ISO 9004 as a how-to guide for ISO 9001 had no trouble finding the relevant clauses. The only problem with that approach is that ISO 9004 was not intended to be a handbook on how to implement ISO 9001. It was intended, as the title plainly indicated, to provide “Guidelines for performance improvements.”
Performance improvements” sounds like a great idea. Until you ask yourself the next question: “Why?” What is the value in improving performance? Within the answer lies the crux and purpose of both ISO 9001 and ISO 9004. That answer is found in ISO 9004’s new title—“Managing for the sustained success of an organization—A quality management approach.”
It’s not good enough to achieve ISO 9001, proudly displaying the coveted certificate on the wall. To conform to the requirements of ISO 9001, it’s important to maintain the quality management system that has been established. It’s important to consistently fulfil requirements found in multiple sub-clauses relating to establishing objectives (5.4.1), monitoring and measuring product and processes (8.4), reviewing changes that could affect the quality management system (5.6.3), and striving for continual improvement (8.5.1).
So ISO 9004:2009 is about what you do after you’ve established and implemented your quality management system to keep it going and to make sure both you and your customers continue to derive benefit from your organization. They get a reliable supplier and you get to stay in business. It also addresses one of the basic truisms of our universe: things change. Hence, the new ISO 9004, and particularly the annexes, is heavily weighted toward monitoring and periodically assessing so that you can respond to change.
The new version of ISO 9004 was structured to facilitate this quest. The sub-clauses flow from the organization’s environment, to strategic planning, through resource management to managing processes, to monitoring and analyzing, and ending up with improvement, innovation, and learning.

Think of it like this: “This is who we are. This is the big plan for the organization. This is what we have to work with. This is how we do things. This is how we figure out what’s working and what isn’t. And these are the things that will allow us to still be around tomorrow—this is how we plan for our future.” Any of these can, and probably, will change over time. How your organization handles those changes will determine your “… sustained success.”
Under the first sub-clause we look at who we are. We also look at stakeholders, or as the standard refers to them, “interested parties.” This concept is situated early on in the standard because interested parties are directly relevant to our organization now and in the future. You could say they are an element of our identity. Interested parties can be customers, stockholders, employees, suppliers, and society at large, just to name a few. Changes with any of these interested parties affect our organization.
The next sub-clause talks about strategy and policy. I think this is a great step forward. It illustrates the very tight bond that should exist between the real business of the business and the quality management system. For too long top management in many organizations has considered the quality management system, and its requirements for management review and management involvement, as an odious infringement on their sanctum sanctorum. Time is overdue to recognize that a good quality management system is in harmony with strategic goals and planning.
Consideration of resources is another key factor that often changes over time. Monitoring what resources currently exist and which will be impacted by changes such as turnover of personnel, slower cash flow, cost of fossil fuel, and scarcity of raw materials, sequels directly into the next section dealing with managing processes. It’s impossible for processes to remain consistent when support such as resources and infrastructure are changing.
You’ll note throughout the emphasis on monitoring. This is carried through to annexes that give you tips on how to assess your organization. Doing it once gives you a starting point. But the assessments, just like any other effective monitoring tool, needs to be utilized cyclically to achieve any real benefit. The annexes are a useful guide; but you can also devise your own methodology to assess your organization. Whatever method you use, make sure that your assessment reflects inter-dependencies and interrelations between various factors. The results should help you identify what needs to be enhanced, what needs to be discarded, and what needs to be improved.
Use ISO 9001 to build a great quality management system. Use ISO 9004 to maintain it and to help it to become even greater.

Sunday, December 19, 2010

Protecting Consumers from Poor-Quality Chinese Products

 by Mike Richman
Options for prevention and detection
Yes, it happened again. According to a recent Associated Press story, drinking glasses produced in China, featuring comic and superhero characters, have been discovered to contain extremely high levels of lead. Excessive amounts of cadmium were revealed in the glasses as well.

This has been a repeated and particularly troubling topic, especially because many of these products are marketed to children. It’s clear that the methods being employed to combat this problem have been unsuccessful. So what are some options?

“This is a systemic problem and the root cause for most of it belongs to the importers, not the manufacturers,” says Stan Salot, president of the ECC Corp. and co-author of the IECQ HSPM QC 080000 standard that certifies manufacturer compliance to hazardous substance process management.

“As an international third-party certification program, QC 080000 requires a self-assessment by the manufacturer to determine what its hazardous substance processes are,” says Salot. “Based on this knowledge, the manufacturer sets about putting the process and testing controls and procedures in place to ensure that its products are manufactured in accordance with buyer specification as well as applicable regulations.”  
The first step in ensuring prevention is a willingness on the part of U.S. importers to demand compliance from their partners overseas. Cost is a key factor in these relationships from the outset, but U.S. importers must understand the true cost of poor quality if and when these consumer products are found to be defective. These risks cannot be simply assigned in terms of lost sales, either—the costs of bad public relations, lost customers, and potential fines and lawsuits are often incalculable.

“Companies go to foreign countries to have their products manufactured for many reasons, the main one being lower cost,” agrees Salot. “One of the primary ways this is possible is that there are fewer, in some cases no, regulatory control over the materials and /or methods used to produce the products.”

This may be changing, however. A recent
Quality Digest Daily article reports that China has notified the World Trade Organization (WTO) of prospective legislative changes to nation’s handling of hazardous substances in consumer products. It’s a small step that specifically addresses only electronics, but it is an acknowledgement that Chinese leaders recognize the problem and are addressing it.

China’s massive economic expansion has been fuelled by consumer product exports, and it’s clear that the nation’s government will do what it takes to ensure the continuance of that growth. OK, but let’s say that an importer does all its due diligence in terms of certification of its overseas manufacturing partners, but it still wants to inspect products for levels of hazardous substances. What kind of testing equipment is available to ensure compliance?
X-ray fluorescence (XRF) testing is one method. “XRF uses X-ray energy to determine what elements or metals an object contains and how much of those elements or metals are present,” explains Kim Russell, business development representative for Olympus Innov-X Systems, a manufacturer of testing and inspection equipment. In comparison with laboratory inspection methods, XRF testing is easier, faster, and less expensive—and non-destructive, too.

“Handheld XRF units incorporate a miniature X-ray tube, detector, and filters along with full data processing and presentation capabilities,” says Russell. “The analyzer window is placed on the object and the trigger is pressed to deliver enough energy to eject electrons of the inner atomic orbitals out of their resting place. When electrons from the outer orbitals replace the ejected inner orbital electrons, they give off energies that essentially are signatures of the elements or metals in the object. For instance, if lead is in an object, it will show up at 10.55 and 12.61 keV, the signature energy of lead. The intensity of the signal at the signature energy determines how much of the element or metal is contained in the object.”
XRF testing allows importers to spot-check finished products. Even better, inspection tools such as these can also be used further upstream, at the site of production, to confirm that products and components are within allowable ranges for toxic heavy metals—not only lead and cadmium, but mercury, chromium, and bromine, too. In this way, products that don’t meet specifications can be rejected and destroyed before they’re even loaded for export. Having this safety valve in place can also reduce the amount of product that slips through the cracks and gets into the hands of consumers, most likely via Internet marketers.










Thursday, December 9, 2010

Snake Oil, Anyone? - By Taran March - contributing editor for Quality Digest (9th Dec 2010)

Johnson & Johnson’s over-the-counter medications promise quality, deliver lawsuits.

All told, more than 200 million bottles of J&J products have been recalled this year


Late last month the FDA filed another Form 483 on the Puerto Rico plant, a 10-page indictment clearly showing that neither McNeil nor J&J had managed to address basic quality issues. Among the report’s findings were distribution of drugs that failed quality requirements, failure to identify product defects during routine testing, failure to detect incorrect expiration dates on drug labels, failure to adequately investigate product problems, failure to follow laboratory controls, and inadequate training of lab staff. 


Pretty sad, huh? This from a company founded in 1879 by Robert McNeil, who purchased a Philadelphia drugstore for $169 to use as a retail pharmacy. McNeil’s son helped establish McNeil Laboratories in 1933—the start of the Fort Washington facility that was closed this year—where early versions of acetaminophen were created. Johnson & Johnson bought the company in 1959. All the elements of can-do, feel-good American enterprise were scrupulously built in; all, in the space of a year, negligently stripped away. 


And what about Johnson & Johnson, presumably McNeil’s guiding hand? Unlike Toyota, which also suffered expensive recalls and loss of face this year, J&J seems to have distanced itself from the McNeil epicenter. Where Toyota made a point of broadcasting its response to its own series of recalls (see this  Quality Digest Daily article as an example), Johnson & Johnson has said nothing. At its news page, a single sentence in small type tersely directs consumers to McNeil’s recall page, www.mcneilproductrecall.com


By contrast, when Toyota had its massive recall, it did not create a web page called “CTSacceleratorpedalrecall.com” (CTS is the company that actually manufactured the accelerator pedal systems used in the recalled Toyotas). Toyota’s recall site? www.toyota.com/recall. That’s what owning up to your mistakes is about. It’s called corporate accountability. 


Johnson & Johnson is barely paying lip service to what quality assurance really means. Until it does better, its promises have about as much value as snake oil hawked at a medicine show.

Tuesday, December 7, 2010

First Set of 2011–12 Baldrige Criteria - Online - by NIST

(NIST: Gaithersburg, MD) --

The Baldrige Performance Excellence Program has announced that the 2011–2012 Criteria for Performance Excellence for businesses and nonprofit organizations are now available to download.

The criteria serve as the standard for selecting the annual recipients of the Malcolm Baldrige National Quality Award, and as a road map for organizations worldwide seeking improved strategy and operations by pursuing performance excellence.

The other two editions of the 2011—2012 criteria—for health care and education—will be available on the Baldrige website later this month. 
 
The Baldrige criteria work as an integrated framework for managing an organization. They are simply a set of questions focusing on seven critical aspects of management that contribute to performance excellence: leadership; strategic planning; customer focus; measurement, analysis, and knowledge management; work force focus; operations focus; and results.

This year’s revisions to the Business/Nonprofit criteria emphasized two themes: dealing with the increasing complexity of enterprise leadership and management, and improving customer engagement. The criteria now include the concept of “intelligent risk-taking” and an improved “line of sight” set of links that should take an organization from a strategic environment to the execution of its operations in a logical sequence. The category on customer focus has been reorganized to improve the flow of logic and now addresses the use of social media as an important contributor to capturing the voice of the customer. 

Named after Malcolm Baldrige, the 26th Secretary of Commerce, the Baldrige Award was established by Congress in 1987 to enhance the competitiveness and performance of U.S. businesses. The award is not given for specific products or services. Since 1988, 86 organizations have received Baldrige Awards. 

The Baldrige program is managed by the National Institute of Standards and Technology (NIST) in conjunction with the private sector. 

Paper copies of the criteria will be mailed on request. For more information,e-mail baldrige@nist.gov or call (301) 975-2036.

Monday, December 6, 2010

Green Belt & Black Belt Courses to be Held in Mumbai, Pune, Bangalore between Dec 2010 to May 2011.

  AIQM: DATES SIX SIGMA COURSES BETWEEN DEC 2010 – MAY 2011


SR.
LOCATION
LEAN SIX SIGMA GREEN BELT COURSE DATES
LEAN SIX SIGMA BLACK BELT COURSE DATES

1.
MUMBAI

  • 17,18,19 Dec 2010

  • 25, 26, 27 Feb 2011

  • 15,16,17 Apr. 2011



  • 06,07,08,09 Jan 2011


  • 05,06,07,08 May 2011
2.
PUNE

  • 24, 25,26 Dec 2010

  • 11, 12, 13 Feb 2011

  • 01,02,03 Apr. 2011



  • 26,27,28 Feb, 01 Mar. 2011


  • 09,10,11,12 Apr. 2011
3.
BANGALORE

  • 18, 19, 20 Feb. 2011



  • 17,18,19,20 Mar. 2011

For further details contact at 
E-mail - director@aiqmindia.com directoraiqm@gmail.com