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Statistics Roundtable: What's Meant by 'Capability'?

by Hare, Lynne B.

Time and again, you hear the question: “Is this process capable?” “Of what?” I want to ask. It hasn’t learned any new moves since the Macarena, so I’m not sure. Very funny. But we really need to know whether it can produce product within specification....


Expert Answers: July 2014

by QP Staff

Building an effective QMS ... understanding medians...


Measure for Measure: Calculating Uncertainty

by Grachanen, Christopher L.

In metrological circles, there are many different statistics and figures of merit used to gauge the quality of measurement data....


3.4 per Million: Conducting FMEAs for Results

by Kubiak, T.M.

Today’s world is fraught with risk. A failure mode and effects analysis (FMEA) is a prevention-based, risk management tool. Its real value is reflected in its use as a long-term, living document....


Insurance Policy

by Minckler, William

Using a quality-centric approach, the Ohio Department of Job and Family Services in 2012 embarked on an initiative to create an enterprise content management system to manage, safeguard and accelerate the use of key informational assets....


Open Access

Back to Basics: Curve Your Enthusiasm

by Phillips, David

Microsoft Excel includes built-in functions that make drawing OC curves easy. This column focuses on attribute (pass/fail) single sampling plans that can be modeled with the binomial distribution....


Virtual Voices

by Wigent, Dave; Sinn, John W.; Adams, Mike

Social services departments in seven Ohio counties and a university banded together to serve an influx of applicants and improve service by implementing a virtual call center....


Measure For Measure: Pass or Fail

by Grachanen, Christopher L.

The calibration certificate—commonly referred to as a calibration report—is the documented evidence that a piece of test equipment was, at some point, determined to be within or out of its intended operating specifications....


Statistics Roundtable: Unraveling Bayes’ Theorem

by Anderson-Cook, Christine M.

Many of us have a love-hate relationship with conditional probabilities. Yet they are a function of our daily lives. We update our knowledge with new information, and what we believe evolves as new information gets integrated into our thought processes....


Open Access

Probing Probabilities

by Hooper, William

Let's do a little experiment from an article published in the New England Journal of Medicine in 1978. Suppose you are tested for a rare disease that occurs in the population at about 1%. The test is 95% accurate....


Open Access

Back to Basics: Calculated Risk

by Sherman, Peter J.

A formula for balancing the cost of risk and uncertainty....


Open Access

Breaking Down Barriers

by Liu, Shu

To leverage the benefits and prepare for the challenges big data present, quality professionals must change their mindset, get more data, upgrade their skills and expand their roles in the big data universe....


Follow the Fundamentals

by Snee, Ronald D. ; DeVeaux, Richard D.; Hoerl, Roger W.

New technology for acquiring, storing and processing data is being introduced at an ever-increasing pace. In 2012, the White House launched a national “Big Data Initiative.” According to IBM, 1.6 zettabytes of digital data are now available....


Statistics Roundtable: Providing Better Insights

by Doganaksoy, Necip; Hahn, Gerald J.; and Meeker, William Q.

In an earlier Statistics Roundtable column, we advocated for the use of degradation testing (that is, monitoring change in a quality or performance characteristic) instead of time to failure....


Expert Answers: November 2013

by Laman, Scott A.

Sampling plans for reliability testing...


Open Access

Quality vs. Safety

by Ghaleiw, Mustafa

In the oil and gas industries, quality can no longer be viewed as a nice-to-have feature. Today, quality must be considered a top priority to ensure safety throughout an organization’s operations and processes...


Ready, Set, Go

by Lawson, Edward

Organizational progress is generally driven by the identification of goals and objectives. Strategic planning, which defines goals and objectives, is a formal process in organizations, regardless of size....


Innovation Imperative: The People Principle

by Merrill, Peter

Successful innovation does have a secret sauce—people. For successful innovation, we need to involve everyone in our organization....


One Good Idea: Probable Cause

by Broccoletti, Moreno

An approach that standardizes the unwritten rules that make root cause analysis effective is proposed in this column....


Standards Outlook: Checking the Checkers

by Russell, J. P.

ISO 19011:2011—Guidelines for auditing management systems provides guidance for managing audit programs. Clause 5.6 provides guidance on improving an audit program, just as other departments in an organization are expected to continue to improve....


Measure for Measure: Into the Unknown

by Shah, Dilip

For estimation of measurement uncertainty, both Type A and B uncertainty contributors may need to be considered, depending on the parameter that is being estimated....


Innovation Imperative: Getting a Jump Start

by Merrill, Peter

In last year’s July issue of QP, I wrote about what a career in innovation might look like. In this column, I want to provide you with some ways to get there....


Open Access

Back to Basics: Light Bulb Moment

by Force, Scott

NEWLY CERTIFIED Six Sigma Black Belts often struggle with understanding how the various quality tools work together. It took me a few projects before I began to see linkage. As I teach and mentor new Belts, I use an analogy that hits close to home....


Parts of the Process

by Aguirre-Torres, Victor; López-Alvarez, Maria Teresa

Repeatability and reproducibility studies are based on the concept of variance components estimation. This is a remarkable achievement of statistical science because people usually think in terms of means and trends, not variation around a mean....


The Power of Prediction

by Kruger, Gregory A.

Inconsistent supplier delivery can negatively impact an organization’s ability to serve its customers. Using quality and statistical methods can help predict demand and minimize the impact of supplier inconsistency....


Open Access

Balancing Act

by Montgomery, Eda Ross; Neway, Justin

With common quality methods and standards in place, manufacturing organizations share a daunting challenge: an increased volume of electronic and paper-based data collected during process development and manufacturing....


Innovation Imperative: Risk and Development

by Merrill, Peter

In my first Innovation Imperative column, I wrote that, in short, innovation is a risky business. In this month’s column, I am going to move beyond identifying the nature of the risks we must address and look at how we manage those risks....


Statistics Roundtable: One Size Does Not Fit All

by Hoerl, Roger W., Snee, Ronald D.

The need to improve is ever present in all endeavors and will continue to be so. We live in a dynamic world. As predicted in the second law of thermodynamic and entropy, the world will continue to change....


Heart of the Matter

by Aba, Eli Kofi; Hayden, Michael A.

The goal of most processes in the manufacturing and service industries is to produce products or services that exhibit little to no variation. Variation is defined as “where no two items or services are exactly the same.”...


Open Access

Paving the Way

by Anderson-Cook, Christine M.; Borror, Connie M.

Data and information are at the heart of good investigations and decision making, but are all kinds of data the same? What are the major categories and types of questions to ask to collect and analyze data?...


Standards Outlook: What’s Cooking?

by Schnoll, Les

The U.S. Federal Drug Administration Food Safety Modernization Act is another milestone in food safety—the latest step to supplement hazard analysis and critical control point programs that have been mandated for a variety of commodities....


Statistics Roundtable: Let's Be Realistic

by Anderson-Cook, Christine M.

Decision making is all about understanding and comparing trade-offs between choices: What benefits are possible, what are the risks and can they be mitigated, and what will each of the alternatives cost?...


Standards Outlook: Keeping Watch

by Russell, J.P.

Supply chain management is important to ensure organizations can compete in the global market. Organizations continue to focus on core competencies, resulting in greater dependence on high-quality materials and services from suppliers....


Expert Answers: February 2013

by QP Staff

Root cause analysis...


Why Certify?

by Laman, Scott A.; Korkuch, Dana; Kohler, Rene; Drobnick, Rudy; Kramer, Robin; Gardner, Pete; DiPuppo, Janet G.; Krothapalli, Sowmya;

These stories are told by people at different stages of their careers. One of the things they have in common, however, is they’ve carefully considered the costs and benefits of ASQ certification....


Rain Gauge

by Fulton, Lawrence V.

The Six Sigma define, measure, analyze, design and verify process is appropriate for exceedingly complex engineering construction problems that require the use of simulation and design of experiments....


Statistics Roundtable: Follow the Rules

by Hare, Lynne B.

Despite appearances to the contrary, I am not old enough to have participated in the first discussions of control chart rules....


3.4 per Million: No Specification? No Problem

by Breyfogle, Forrest W. III

In a column earlier this year I referenced a nine-step approach for determining an organization’s long-lasting operational metrics and how to decide where to focus improvement efforts so the entire enterprise benefits....


Statistics Roundtable: Improve Your Evaluations

by Meeker, William Q.; Doganaksoy, Necip; Hahn, Gerald J.

In an earlier Statistics Roundtable column, we described how the conclusions you can draw from statistical analysis of limited life data can be bolstered by appropriately incorporating engineering knowledge and experience into the analysis....


Open Access

One Good Idea: Keep Moving

by Robinson, Jeffrey A.

Many decision makers do not properly distinguish uncertainty from risk. When this occurs, there’s a tendency to spend too much time studying the problem, leading to a phenomenon often called “analysis paralysis.”...


Measure for Measure: First Step Toward Disaster

by Grachanen, Christopher L.

Users who take it upon themselves to forego calibration without adequately evaluating the impact of their decision within a specific measurement application increase the likelihood of making a bad measurement-based decision....


Clever Combination

by Flori, Albert

As software use increases in safety-critical applications, we must implement quality improvement tools and techniques to identify software failures before they have a critical effect on the completed system or a fatal effect on the end user....


Pick Your Spots

by Sherman, Peter J.

In the rush to achieve results, lean Six Sigma programs can get derailed because projects are pushed through the organization, leading to the selection of the wrong projects and suboptimizing the entire enterprise’s goals....


Standards Outlook: Game of Chance

by Russell, J.P.

Risk is a popular word being added to the standards and procedures lexicon, but it’s a massive topic that can be confusing. It can get even more complicated when you try to put risk in a box....


3.4 per Million: The Significance of Simulation

by Kubiak, T.M.

The certified Six Sigma Master Black Belt body of knowledge, introduced in 2010, included the subject of simulation and, specifically, digital process simulation. This is refreshing because this tool is often omitted from lean Six Sigma training....


Open Access

Back to Basics: Solid Proof

by Suedbeck, John G.

In general, the audit process is similar across most industries. To effectively evaluate risk, we need an understanding of the reliability of the audit evidence obtained. But how do we best assess the reliability of audit evidence?...


Open Access

One Good Idea: Complicated Comparison

by Bower, Keith; Germansderfer, Abraham

Limited data availability complicates an assessment of whether two populations are comparable. A statistical tolerance interval (TI) can be used to set the comparability criteria....


Online Table One Good Idea

by Bower, Keith M.; Germansderfer, Abraham

QP . www. com 1 Difference between � A and � B in standard deviation units Two onesided t- test approach Tolerance interval approach 0 0.943 0.999780 0.5 0.880 0.999207 1 0.688 0.995534 1.5 0.413 0.979853 2 0.176 0.928468 2.5 0.050 0.802227 3 0.009 0.5...


Open Access

One Good Idea: Branch Out

by Landauer, Edwin G.

It can be difficult to identify the appropriate discrete distribution to use when attempting to determine probabilities in a particular situation. The decision tree can help you determine the appropriate distribution....


Expert Answers: February 2012

by QP Staff

The best way to eliminate errors ... Adjusting to a new auditor....


Fail-Safe FMEA

by Rodríguez-Pérez, José; Peña-Rodríguez, Manuel E.

The appropriate use of quality risk management can help organizations comply with regulatory requirements, such as good manufacturing practices or good laboratory practices....


Open Access

Innovation Imperative: Risky Business

by Merrill, Peter

Norm Larsen celebrated 39 previous failures when he named his breakthrough new product WD-40. His example proves that innovators can’t be afraid to fail....


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....


Statistics Roundtable: Gage R&R Reminders

by Hare, Lynne B.

Major characteristic specification limits of a popular brand were 3% and 4%. Product with lower than 3% lacked consumer appeal, and product with greater than 4% had reduced shelf life....


Open Access

Salary Survey 2011: Land the Big One

by Hansen, Max Christian; Wilde, Nancy J.; Kinch, Eileen R.;

Certification holders—or those thinking about obtaining certifications—should know that these assets make them more attractive to potential employers. In most cases, a certification offers the most value when it is held by a professional whose job duties ...


Statistics Roundtable: Use What You Know

by Meeker, William Q.; Doganaksoy, Necip; Hahn, Gerald J.

Engineers and managers often must make important decisions in situations in which there is substantial uncertainty because of limited data. In some such cases, the data analyses can be bolstered by incorporating engineering knowledge and experience....


Open Access

Back to Basics: Turning 'Who' Into 'How'

by Thomas, Kenneth

When things go wrong, the goal should be to move away from trying to determine “who” was at fault and quickly transition into a problem-solving mindset of “how” to make things better....


Statistics Roundtable: Under the Limit

by Mason, Robert L.; Keating, Jerome P.

Engineers often encounter a wide spectrum of issues pertaining to the data they collect from experiments. A particular problem of concern arises when the quantity to be measured falls below the detection limit of the measuring apparatus....


Open Access

Site Seeing

by Yu, Louis W.; Urkin, Esther; Lum, Steve; Kenett, Ron S.; Ben-Jacob, Ron

Assessing exposure to risk events and initiating proactive risk mitigation actions must be a priority of organizations worldwide. Fortunately, there’s a conceptual and methodical approach to conducting a risk-based quality audit....


Statistics Roundtable: Not Significant, But Important?

by Seaman, Julia E., and Allen, I. Elaine

In March 2011, the Supreme Court ruled that even if a result from a controlled clinical trial was not statistically significant, it still might be important....


Statistics Roundtable: Complaint Department

by Hare, Lynne B.

PERHAPS YOU KNOW what goes on in most corporate complaint departments. Given euphemistic names such as “consumer affairs” and “consumer response,” their business is still the same....


Perspectives: Wake Up and Smell the Cookies

by Diepstra, G. Keith

MY RECENT TRANSITION from the automotive sector to a company in the food industry held some unusual surprises: • The overall equipment effectiveness, capabilities and yields were shockingly low in the food industry....


Results May Not Vary

by Johnson, Louis; McNeilly, Kirk

Controlling manufacturing processes so that products meet customer specifications is difficult. In such situations, factorial experimentation can be the key to understanding the impact of each process input on the process outputs....


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....


Expert Answers: April 2011

by QP Staff

Size matters when remedying poor quality ... Examining process capability indexes....


Statistics Roundtable: Knowing There Are Unknowns

by Allen, I. Elaine; Seaman, Julia E.

DO THE ITEMS that people carry in their pockets or purses make them more likely to develop cancer? In an epidemiological study on the development of lung cancer in the population, is carrying matches an important variable?...


Don't Leave Learning to Chance

by Howard, John C.

Whether in a college statistics course or a refresher session in a statistical quality control course, it is important for students to understand probability distributions. Fortunately, a simple in-class exercise can achieve that end....


Doomed to Fail

by Caffrey, Noel G.; Medina, Candace G.

Ben looked around his new office, happy to still have a job but apprehensive about his new position. He had just been reassigned after his boss’s boss, the CEO, decided the continuous improvement initiative he had been leading was just not working out....


Online Table Statistics Roundtable

by Meeker, William Q., Doganaksoy, Necip, and Hahn, Gerald J.

com 1 StatiSticS Roundtable Months in service to date Number of units at risk Estimated conditional failure probability during the fifth month from now Estimated expected number of failures during the fifth month from now 1 25,438 0.0001289 3.28 2 25,386...


Online Sidebar Statistics Roundtable

by Meeker, William Q., Doganaksoy, Necip, and Hahn, Gerald J.

In making such calculations for times beyond the next 24 months, the in-service months that exceed a total exposure over 36 months (adding the months to date to the number of future months) are excluded. Moreover, the estimated expected number of failures...


Expert Answers: November 2010

by QP Staff

Significant vs. meaningful ... explaining mean time between failures ... the importance of preventive maintenance....


Open Access

Back to Basics: Take Another Look

by Daniel J. LeSaux

The use of several strategies to monitor and improve the overall effectiveness of the quality management system is included in ISO 9001, paragraph 8.0, “Measurement Analysis and Improvement.” Two of these are often used independently while...


Statistics Roundtable: Predicting Problems

by Meeker, William Q., Doganaksoy, Necip, and Hahn, Gerald J.

Manufacturers must frequently predict the number of future field failures for a product using past field-failure data, especially when an unanticipated failure mode is discovered in the field....


Mixed Signals

by Anderson-Cook, Christine M. , Lu, Lu, and Morzinski, Jerome

It's no surprise when statistics students or colleagues from outside the discipline don’t immediately understand advanced statistical terms and concepts such as “kriging” or “probit regression.”...


Expert Answers: October 2010

by QP Staff

Assessing your audit ... control charts and process capability ... keeping lab instruments in check....


Statistics Roundtable: A Sample Plan

by Anderson-Cook, Christine M., Lu, Lu

Often, there are situations in which you might want to draw a representative sample from a finite population to characterize some aspects of its distribution....


Open Access

Keep It Simple

by Dalal, Adil F.

In his book, My Life and Work, Henry Ford laid out the basics of the lean system. But, if he and others have been able to use elements of lean successfully, why does it seem so many lean and lean Six Sigma initiatives fail?...


Measure for Measure: Calibration Evaluation

by Shah, Dilip

What do you do when a supplier does not have accreditation to the required quality standard? How about when the particular test or calibration item is not covered under the scope of accreditation?...


Expert Answers: September 2010

by QP Staff

Soft-dollar savings ... crisis management's effect on quality....


Statistics Roundtable: The Statistical Engineer

by Mason, Robert L., and Young, John C.

Many engineers working in processing industries often are overwhelmed by the amount of data available to them. Until recently, most industries collected only a small amount of information on their processes....


Open Access

Sustainable Future

by Scriabina, Natalia; Cort, Gary

The new international standard ISO 9004:2009—managing for the sustained success of an organization—a quality management approach, brings quality management to a new area of sustained success. The standard adds a new term, sustained success...


Expert Answers: August 2010

by QP Staff

Interval approach to random samples......


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....


Statistics Roundtable: Poisson Power

by Hare, Lynne B.

The Poisson distribution may be the Rodney Dangerfield of statistics. It doesn’t get the use—and respect—it deserves. Yet, when applied properly, it can aid the decision-making process considerably....


Statistics Roundtable: Imputation Explanation

by Allen, I. Elaine; Seaman, Julia E.

The United States recently completed its 23rd federal census of population. The first census was mandated by the U.S. Constitution and carried out under Thomas Jefferson in 1790....


Open Access

Where to Start

by Hayes, Bob E.; Goodden, Randall; Atkinson, Ron; Murdock, Frank; Smith, Don

Companies are viewing the Toyota situation as a cautionary tale rife with lessons that can benefit all organizations. To help drive those lessons home, QP recruited five quality experts, each of whom broke down one aspect of the fallout....


Standards Outlook: Prevent Defense

by West, John E. "Jack"

Effective preventive action requires focus and attention, both of which can be addressed via a method that starts with prioritization and ends with improvement actions....


Brewed Awakening

by Gojanovic, Tony; Jimenez, Ernie

Manufacturers often rely on an established network of distributors to move finished goods to retailers and consumers. A typical U.S. beer maker may depend on a network of 500 distributors to deliver its beverages to more than 700,000 retail accounts....


The Next Chapter?

by Reidenbach, R. Eric

A new version of Six Sigma shifts focus from reducing defects and cutting costs to growing an organization’s market share by identifying targeted products and markets and creating customer value....


Open Access

Safe Landing

by Jeppsen, Bryan

Paramount to improving customer service is better understanding what the customer deems to be important and implementing the changes. To meet that challenge, JetBlue Airways used text analytics software....


Statistics Roundtable: Outlier Options

by Seaman, Julia E.; Allen, I. Elaine

Even in basic statistics courses, we teach that outliers in a data set can pose big problems. We often teach that visually examining data can help identify outliers. Beyond detection, few textbooks devote much time to statistically assessing outliers....


3.4 per Million: Insight or Folly?

by Breyfogle, Forrest W.

In lean Six Sigma, much training effort is spent on conveying the importance of having a measurement system so that consistent and correct decisions are made relative to assessing part quality and process attributes....


Statistics Roundtable: Divide and Conquer in Reliability Analyses

by Doganaksoy, Necip; Hahn, Gerald J.; and Meeker, William Q.

All product is not created equal. Some units are more likely to fail in service than others. Thus, in reliability evaluations, you need to identify subpopulations with different failure susceptibility....


Statistics Roundtable: Interval Training

by Anderson-Cook, Christine M.

Choosing the right type of interval provides a means of supplementing an estimated quantity with an appropriate calibration of the uncertainty associated with that value....


Open Access

Tune Up

by Allen, I. Elaine; Davenport, Thomas H.

Six Sigma has many meanings. In its simplest context, Six Sigma can be defined statistically as the attempt to achieve near-perfection by having no more than 3.4 errors per million opportunities, or being 99.997% correct (or defect-free)....


Expert Answers: July 2009

by QP Staff

Setting up a corrective action document ... Dock-to-stock for medical devices ... Questions about confidence intervals....


Keep on Truckin’

by Adrian, Nicole

In July 2005, a transportation representative at Bayer MaterialScience identified a potential problem with the way the company chose its shipping carriers. Bayer, a global manufacturer of polymers used as raw materials for products such as compact...


Open Access

FMEA Minus the Pain

by Ramu, Govindarajan

Failure mode effects analysis has stood the test of time as a powerful risk assessment tool for products, processes and systems....


Measure for Measure: Standard Definition

by Shah, Dilip

It's important to establish metrological traceability as it is defined in ISO/IEC Guide 99:2007. In this column, other ISO/IEC Guide 99:2007 definitions pertaining to measurement uncertainty are discussed....


Statistics Roundtable: Predicting Success

by Allen, I. Elaine; and Seaman, Christopher A.

Considering that a phase three efficacy clinical trial for a potential new product could cost nearly $100 million, spending time in simulation activities before fully committing to developing a new product has proven to be worthwhile for more companies....



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