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Expert Answers: November 2013

by Laman, Scott A.

Sampling plans for reliability testing...

Standards Outlook: World View

by Liebesman, Sandford

The global economy has provided organizations with many opportunities that didn’t exist even 10 years ago. On the other hand, the internet and extensive outsourcing have “flattened” the Earth, presenting organizations with many new risks....

Open Access

One Good Idea: Ultimate Originality

by Sundararajan, K.

When developing products for a new market, innovative ideas are essential. A tool that can be used to spark innovative new product ideas is the ideate, define, design and validate (IDDV) method....

A Tangled Web

by Dougherty, Jim; Lengel, Wylene

In simple terms, software as a service is on-demand access to software via the internet. It seemingly eliminates the installation and testing of the software by the customer—or does it?...

Open Access

Safe and Secure

by Scott, Bill; Krempley, Mark

Organizations everywhere are expected to do more with less in all areas of business. Safety and risk management are not necessarily immune when organizations must make difficult decisions about cuts in personnel and funding....

Reaching Out

by Blumenthal, Cynthia

In his Pulitzer Prize-winning novel Middlesex, Jeffery Eugenides describes life at Ford Motor Co. in the 1920s, detailing how unskilled workers tried to match the calculated pace of assembly lines and a manufacturer that made almost every part itself....

Open Access

Certification at Work

by Roberson, Russell L.; McKaig, Brian

Organizations face difficult decisions every day: where to invest, how to focus employees and how to drive a competitive advantage in their markets. A decision to launch employee training cannot be taken lightly....

Online (Singer)

by Singer, Donald C.

Media/ incubation time Experiment design tSa/ 3d tSa/ 5d r2a/ 3d r2a/ 5d CFU Product + PW + 2 days 30 10 240 380 Product + PW + 5 days < 10 < 10 < 10 < 10 Product + WFi + 2 days 10 20 160 180 Product + WFi + 5 days < 10 < 10 < 10 < 10 PW = purified water...

Open Access

What Have We Learned?

by Reid, R. Dan

In a general way, the disaster in Japan provides us with a good context to see what lessons can be learned from fundamental quality management science....

Open Access

Two in One

by Razzetti, Eugene “Gene” A.

The terms risk analysis, risk assessment and risk management—often used interchangeably—can mean a variety of different concepts and metrics. There is no one single approach to risk management....

Standards Outlook: Under Control

by Schnoll, Les

Medical device manufacturers must ensure the design and process are reliable, and must produce devices the same way every time. The FDA believes the quality, safety and effectiveness of a device are established during the design phase....

3.4 per Million: The Right Decision

by Mader, Douglas P.

As the Six Sigma Academy led large deployments at Allied Signal, GE and other organizations in the 1990s, one of the great benefits realized was linking define, measure, analyze, improve and control-based project improvement to financial performance....

Open Access

Career Corner: Risks, Relationships and Rewards

by Whitacre, Teresa

Employers, employees and independent contractors alike have been affected by the turbulent economy. We see it all around us, whether at firms we own, organizations at which we work or businesses we patronize. Nonprofits are experiencing the same types...

Standards Outlook: Major Upgrades

by Reid, R. Dan

The new fourth edition of the Chrysler, Ford and General Motors (GM) Potential Failure Mode and Effects Analysis (FMEA) Reference Manual, which was released last year, is a significant upgrade from the third edition published in 2001....

Small Change, Big Impact

by West, John E. “Jack”

Little has changed in the fourth edition of ISO 9001, which was issued late last year by the International Organization for Standardization. ISO 9001:2008 contains no new requirements, so the transition should be painless for most organizations....

Off the Ground

by Edmund, Mark

None of the 4,000 fasteners that were hand drilled into the fuselage of any C-17 cargo plane was misaligned or had gone missing. For years, Boeing has been building these top-notch planes. It just wanted to build them better....

Standards Outlook: How to Manage Risk in a Global Economy

by Liebesman, Sandford

The global economy has provided opportunities that didn’t exist just 10 years ago. But the flattening of the Earth via the internet and extensive outsourcing to countries such as China and Mexico have also presented organizations with many risks....

Using FMEA to Assess Outsourcing Risk

by Welborn, Cliff

Although outsourcing is a growing trend among U.S. businesses, there are risks involved and not everyone benefits from such arrangements. The advantages of outsourcing must be weighed against risks and go beyond cost savings. Without a systematic...

Standards Outlook: Increase ISO 9001's Value

by Liebesman, Sandford

ISO 9001 describes a basic, effective quality management system (QMS). Compliance to it is the starting point toward achieving excellence in an organization. Additions to an ISO 9001 compliant QMS can act as the first steps toward excellence....

Core Roles in a Strategic Quality System

by Imler, Ken

When establishing and maintaining a strategically viable quality system, senior management defines the roles played by groups, departments, or functions within the organization using risk/benefit analysis to determine the best fit in terms of logistics,...

When Worlds Collide: Lean and Six Sigma

by Snee, Ronald D.

Facing unprecedented pressure to improve performance across the board, organizations cannot afford to forego the benefits of either Six Sigma or lean....

Scope Projects in 10 Steps

by Harvey, Jean

The manufacturing sector has long recognized that effective change must be managed in small increments without losing sight of the big picture. Professional services, however, present other factors that require a different approach to mitigating risks....

Management System Integration: Can It Be Done?

by McDonald, Mary; Mors, Terry A.; Phillips, Ann

In October 1996, the International Organization for Standardization, known as ISO, issued the final version of ISO 14001, an international standard for environmental management systems (EMS)....

Open Access

The Message Is Clear

by Hopen, Deborah

This abstract is based on the ]In 2002, the CGISS division of Motorola won the Baldrige award in the manufacturing category. Through strict process improvement measures, the division was able to increase its direct customer loyalty, customer...

Column: Standards Outlook: Ensure Medical Device Safety

by Schnoll, Les

A safe medical device is one that does not injure a patient, user or caregiver. Processes and procedures that ensure the manufacture of safe and effective products should be inherent in a medical device manufacturer's quality system....

Column: Frontiers of Quality: Design for Six Sigma

by Mader, Douglas P.

You need more than standard Six Sigma approaches to optimize your product or service development

Many organizations believe design for Six Sigma (DFSS) is a design process when really it is not. DFSS is an enhancement to an existing new product development (NPD) process that provides more...

Open Access

Costs of Trust for E-Business

by Daughtrey, Taz

With the spread of e-business, organizations face a two-fold dilemma: how to reassure customers they can safely share personal information, and how to minimize the risk the data might be falsified or subsequently compromised....

Column: Emerging Sectors: Cleaning Up With SPC

by Prevette, Steven S.

Statistical process control is playing a role in a huge environmental project at a nuclear weapon production site

The U.S. Department of Energy's (DOE) Hanford Nuclear Site played a pivotal role in the nation's defense beginning in the 1940s when it was created as part of the Manhattan Project. The current environmental clean-up...

Exploiting the World's Most Recognized Standard

by Palady, Paul

Tremendous progress has been made recently in the harmonization of world standards through the efforts of recognized standard-setting organizations. But it may not be possible in an era of expanding technology and diversified systems to achieve such...

Open Access

Finding the quality work you want on the Web.

by Hutchins, Greg

In our last column, we discussed the three basic types of job sites--company sites, general job databases and job auction sites. Post your resume, respond to some ads and go through the job search process. Online job searching is not like traditional job ...

Old Tools - New Uses: Equipment FMEA

by Cotnareanu, Teodore

A preventive maintenance program can benefit from the modification of process FMEA (failure mode effects analysis) into maintenance FMEA. Before implementing the FMEA itself, it is necessary to: assemble an FMEA team well represented and led by...

Explosion of New Products Creates Challenges

by Maguire, Miles; Hagen, Mark

New product development in the Innovation Age needs new quality tools and techniques to meet customer expectations and fast-paced change. Rapid innovation is evident in the explosive growth of patent applications, led by companies like Eastman Kodak,...

How to Use FMEA to Reduce the Size of Your Quality Toolbox

by Vandenbrande, Willy W.

Failure mode effects analysis (FMEA) is applicable to risk analysis in environmental management systems. For environmental risk analysis, the usual FMEA process is modified with scoring guidelines for severity of environmental impact. Then the...

Considerations for Global Supplier Quality

by Bossert, James

Assessment of international suppliers occurs in two steps: initial investigation and supplier visit. In the initial investigation, data are gathered about the company and the country. This includes background information on the company as well as...

Product Assurance Structure and Management

by Bieda, John

The main components of product assurance are: cost-of-quality management; just-in-time training; product assurance planning; and quality and reliability tool application. Product assurance applies simultaneously to hardware and software aspects of...

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