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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....


Necessary Measures

by Johnson, Louis; Deaner, Maureen;

Learn the difference between standard and expanded gage repeatability and reproducibility (R&R) studies and how expanded gage R&R helps clarify measurement system variation....


Expert Answers: June 2014

by QP Staff

Driving service quality ... Evaluating equipment...


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....


Standards Outlook: Do You Really Understand?

by Russell, J.P.

The challenge for quality professionals for the next decade is to achieve a deeper understanding of our profession and its purpose....


Open Access

Looping in Quality

by Awofala, Dele

The quality loop framework provides organizations with a structured approach to integrating quality throughout the product assembly process—from the workstation to the customer....


Expert Answers: March 2014

by QP Staff

Defining the customer ... incoming inspections...


Expert Answers: December 2013

by Wagoner, Keith; Pylipow, Peter E.

Measuring customer experience ... SPC for low-volume assembly....


Open Access

Salary Survey 2013: Behind the Results

by Hansen, Max Christian

The 2013 Salary Survey was sent to ASQ 44,945 members. There were 7,504 individual responses, for a response rate of 16.7%....


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....


Raising the Bar

by Bertels, Thomas; Buthmann, Arne

Many large organizations have invested in operational excellence initiatives. Some organizations are motivated by potential cost savings, while others are looking for culture change or a common language for solving problems....


Standards Outlook: The Missing Key

by West, John E. "Jack"

Past perceptions about conformity to ISO 9001 suggest an organization may have a good quality management system, but it can still produce junk. But ISO 9001 does provide reasonable assurance that the output of the system will meet customer needs....


Expert Answers: June 2013

by QP Staff

Auditee refuses nonconformance report ... Customer service quality in the banking industry...


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....


Open Access

One Good Idea: Form by Design

by Coleman, Lance B.

Filling out simple forms should be easy, right? Yet, how many of us have had the experience in which a simple and easy-to-follow form took more than one time to fill out 100% correctly?...


Open Access

Apples to Oranges?

by Surak, John G.;

Consumers around the world demand safe food. Through the years, retailers and food companies have pushed their suppliers to have food safety systems and improve on them. The drive started with suppliers being required to have third-party good GMP audits....


Open Access

March 2013 One Good Idea - online figures

by Coleman, Lance B.

CAPA process swim lane diagram / online Figure 1 Phase 1: Initiation Phase 2 and 3: Investigation and Corrective Action Issue CAPA number Enter CAPA info into log Notify quality manager CAT investigation CAT investigation Identify issue Meet with process...


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....


Open Access

Online Figures - Vanicek

by Vanicek, Vera

daily volume Total time ( hours) Drug receiving/ reconciliation 0: 51: 00 0: 51: 00 Injectables ( RT) 0: 01: 09 25 0: 28: 45 Pump receiving 0: 01: 32 9 0: 13: 48 Pump assigning ( existing) 0: 01: 43 7 0: 12: 01 Pump assigning ( NP) 0: 07: 00 1 0: 07: 00 ...


Online Figures - Ramsay

by Ramsay, Owen

Year Verct( dys) # Rpts FinRpts InvTech #_ Staff 2003 296 31 13 1.00 216 2004 829 24 11 2.24 190 2005 309 22 12 1.65 210 2006 222 22 9 2.35 225 2007 171 17 5 3.58 247 Verct( dys) = verification of claims cycle time # rpts = number of reports for the boar...


Standards Outlook: Corrective Action Challenge

by Reid, R. Dan

The purpose of corrective action is to prevent the recurrence of the problem. There are usually many actions that can be taken to address the problem, ranging from incremental changes to innovative solutions....


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....


Expert Answers: January 2013

by QP Staff

Six Sigma staffing ... Calibration vs. verification ......


Salary Survey 2012: Crunching the Numbers

by Hansen, Max Christian

The 2012 survey was sent to 54,337 members. Of the 6,857 individuals who started the survey, 6,857 completed the questionnaire for a response rate of 11.2%....


Standards Outlook: Get in Front of the Problem

by West, John E. "Jack"

Considering the unfortunate fact that product recalls and their disastrous results seem relatively common, it’s curious why so many organizations resist formal efforts to address preventive action....


Salary Survey 2012: Part 1, Section 1: Salary by Job Title

by Hansen, Max Christian

Figure 1 includes results for: x Full- time employees, part- time employees, x U. S. employees, Canadian employees, International employees Salary by job title for U. S. respondents / FIgUre 1 46,884 50,558 53,970 56,246 57,718 69,279 70,094 72,261 74,13...


Expert Answers: December 2012

by QP Staff

A better supplier scorecard ... Inspecting your suppliers ......


Open Access

Perspectives: Added Structure

by Trotter, A. Mark; Calabrese, Rick; Huang, Li-Chung; Krumenaker, Alice; Palm, Ulo

Global good manufacturing practices (GMP) and regulatory guidelines ensure the “safety, identity, strength, quality (and) purity of drug(s).” Manufacturing and quality control testing of approved drugs fall under these GMP regulations....


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....


Measure for Measure: According to Specifications

by Shah, Dilip

My previous column discussed the averages and computation of different standard deviations. On the heels of that, it makes sense to discuss basic measurement considerations and specifications....


Open Access

Perspectives: Relying on the Basics

by Diepstra, Keith

It’s difficult to improve a process that isn’t running. Equipment reliability from a manufacturing equipment perspective is typically the purview of maintenance teams and may include watch-over by the engineering team....


Open Access

Standards Outlook: What's Old Is New Again

by West, John E. "Jack"; Hunt, Lorri; Croft, Nigel H.; Jarvis, Alka

The time appears to have finally come to start another major revision of ISO 9001. But before moving forward, it’s a good idea to look back at where we’ve been....


Open Access

Salary Survey 2011: Slow and Steady

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

A single organization’s actions may be reported several times if multiple employees of that organization responded to the survey. Director: Oversees all aspects of an organization’s quality or business improvement efforts, such as developing and administr...


Measure for Measure: True Meaning

by Grachanen, Christopher L.

The term “calibration” can mean different things to different people, depending on their education and experience, and whether they are suppliers or consumers of calibration services....


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....


Put JIB on the Job

by Hannon, Christine; Grossman, Steven

An organization implemented a proven training program that improved quality and efficiency plantwide during the recession, positioning it to perform at higher levels when demand increased after the economy recovered....


Standards Outlook: Taking Control

by Russell, J.P.

Organizations need controls to ensure objectives are achieved. It’s management’s job to establish, implement and monitor controls, and the auditor’s job to determine whether they are adequate....


Standards Outlook: Spring Into Action

by West, John E. "Jack"

In a lot of organizations, quality is relegated to the status of a long-forgotten initiative the organization “finished.” In these cases, what should a quality professional do?...


Open Access

For Starbucks, It's in the Bag

by Johnson, Louis; Burrows, Sarah

When voice-of-the-customer data showed Starbucks Coffee Co. needed to improve the packaging of its one-pound coffee product, it set out to learn the effects of process parameters on the key packaging quality characteristics....


Expert Answers: March 2011

by QP Staff

Explaining rework verification ... Getting management involved ... Measurement confusion....


Standards Outlook: Remote Control

by Russell, J.P.

When you start talking about remote auditing—or e-audits—around a group of auditors, you will hear plenty of strong opinions. Some auditors are vehemently opposed, while others are open to the idea....


Open Access

Salary Survey 2010: Not Out of the Question

by Hansen, Max Christian

Every year, QP’s Salary Survey sparks countless questions for quality professionals and gets them thinking about their careers and personal development: How do I compare with others? What can I do get ahead? Are things getting better out there?...


Salary Survey 2010: The Complete Report

by QP Staff

experience by gender / FIGURE 2 More than 20 years 10.1- 20 years 6.1- 10 years 3.1- 6 years $ 6,000 Male Years of experience in quality profession Years of experience in quality profession Female $ 4,000 $ 2,000 0 $ 2,000 $ 4,000 $ 6,000 1- 3 years Less...


Open Access

Get Your Ducks in a Row

by Orthaber, John

The ISO 9001 quality management system has been around since 1987, and it is generally acknowledged that the system produces some fairly significant benefits, including improved profitability, higher sales and better employee morale....


Open Access

3.4 per Million: Firefighting With DMAIC

by Snee, Ronald D., Gardner, Edgar C.

As quality professionals, we like to solve problems by finding root causes and putting fixes in place. As a rule, we don’t like to fight fires, but sometimes we have to....


Expert Answers: October 2010

by QP Staff

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


Handle With Care

by Evans, Marilyn

An internal auditor walks into a drug manufacturer’s production area and sees three containers staged outside the weighing room of the formulation section. She asks the first container, “Where are you from, stranger?”...


Now What?

by Carboneau, Clark; Banks, Jon; Armijo, Tony; Zondlo, John A.

This is the story of one organization’s efforts to develop and implement a dissemination process that would consistently spread its improvement solutions across all facets of the organization....


Open Access

Bull's-eye

by Murphy, William H.

All companies want to build a stronger brand by ensuring customer satisfaction. Along the way, of course, the companies want to make a profit....


Quality in the First Person: Seek and You Shall Find

by Knapp, Gary

In March 2009, I joined a small computer numerical control (CNC) job shop’s management team as quality manager. I started there after having worked for 11 years in quality management and having had experience developing new projects, launching new...


Standards Outlook: Better Together

by Russell, J.P.

Even if everything is done appropriately during an audit, following up on the findings is just as important because it gives meaning to the audit....


What Do You Say?

by Krzykowski, Brett

With the help of an arsenal of lean tools, Boeing homed in on the root cause of its troubles, created equipment to address the issue and saw drastic improvements that earned it a bronze award at the 2009 International Team Excellence Awards....


Measure for Measure: Supplier Demand

by Shah, Dilip

If an organization is registered to ISO 9001 or accredited to ISO 17025, it needs to ensure the inspection, measurement and test equipment it sends out for calibration has measurement traceability. It also needs to evaluate its calibration supplier....


Open Access

Perspectives: TPS Troubles

by Leggett, Steven C.

It’s only natural to link the TPS to Toyota’s safety problems. But is the system the problem? And should organizations that employ a version of the TPS be concerned about their systems?...


Window of Opportunity

by Chadha, Rajeev; Kalra, Jay

By employing lean Six Sigma, a supplier for one of the Big Three automakers met its goals and developed technology that is projected to be applicable to any and every automobile—from two-door coupes to full-size vans—within five years....


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....


0210 Standards Online Only

by Schnoll, Les

Manufacturing approves or manages release of drawings for each phase of the product development process ( PDP) per the drawing release procedure . Change control defined by the preproduction design change or production design change procedure Make and b...


Test Run

by Ramu, Govind

In 2008, 14,906 people took ASQ certification exams, and 9,394 of these people—or 63%—passed. So how can you avoid being one of the certification exam takers who will not pass this year?...


Open Access

Salary Survey 2009: Lingering Effects

by Bemowski, Karen

Like almost everyone, quality professionals are feeling the effects of the economic recession. In all, 4.9% of respondents to QP’s 23rd annual salary survey indicated they are unemployed, retired or laid off....


Salary Survey 2009: The Complete Report

by QP Staff

52 section 6 Salary by Number of Work Hours Online section 7 Salary by Nonexempt vs. exempt Status Online section 8 Salary by Number of Years in Current Position Online section 9 Salary by Number of Years in Current Position and in the Quality Field Onli...


Aerial Coverage

by Clifford, Jim

To harmonize requirements across the supply chain for the management of the Department of Defense aviation CSIs, a standards publication group has reconciled final industry comments and is preparing to publish a new aviation, space and defense standard....


Expert Answers: November 2009

by QP Staff

The TOPS way of getting to the root cause ... Repair vs. rework...


Standards Outlook: Trust, but Verify

by Russell, J.P.

Grouping product, service and process audits together is somewhat natural, because a process audit may include a product or service audit. I’ve dubbed the combination a verification audit....


Standards Outlook: Remaining Relevant

by West, John E. "Jack"

Without changes, ISO 9001 risks becoming irrelevant on the world stage. So, what new ideas should be included in the next edition?...


Think Again

by Sahi, Sonny

If we stop and contemplate why we think of audit results as pass or fail, we may become more aware of how our mentality affects the way we behave during an audit and how that mind-set influences others....


Score One for Improvement

by Leip, Terry

Five years ago, Intel’s IT organization decided to improve internal customer satisfaction and the efficiency of IT projects with a CMMI-based process improvement activity to develop standard processes for project management....


Measure for Measure: Conscientious Calibrations

by Grachanen, Christopher L.; McGee, Terry L.

There are compelling reasons for an organization to get certified to a standard, but one that gets overlooked is the impact on the environment....


Expert Answers: July 2009

by QP Staff

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


Standards Outlook: Effective Audit Programs

by Russell, J.P.

Today's organizations need to be agile and responsive to the changing requirements in private and public business sectors. Properly directed, internal audit program resources can help an organization stay focused and uncover improvement opportunities....


Open Access

Can Do

by Wilson, Steven

Executing a food-systems audit brings with it a series of specific issues to consider. When performing an audit in a country that is not their own, however, auditors face additional challenges. With proper planning, those challenges can be overcome....


Take a Bite Out of Inefficiency

by Nuhfer, Dina; and Walters, Thomas

Providing consistent and effective service or product requires a consistent and effective framework for implementing, maintaining and improving tactical and strategic operations. Dentistry is no different....


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....


Standards Outlook: Dynamic Duo

by Liebesman, Sandford

Lean and Six Sigma are two methods aimed at improving the quality of an organization’s operations and its financial results. Both concentrate on customer satisfaction and improved business performance....


Open Access

Standards Outlook: To Launch or Not to Launch

by Schnoll, Les

Having quality professionals on medical device product development teams eliminates last-minute conflicts....


Open Access

Building From the Basics

by Rooney, James J.; Kubiak, T.M; Westcott, Russ; Reid, R. Dan; Wagoner, Keith; Pylipow, Peter E.; Plsek, Paul

Quality control is about models, methods, measuring and managing. It’s about uncovering a problem and finding the solution. It’s about using the right techniques at the right time to make things better....


Open Access

Salary Survey 2008: Looking at the Numbers

by Bemowski, Karen

Mean salary: The mean salary is the average salary for that particular group. Manager: Ensures the administration of the company’s quality, process and business improvement efforts within a defined segment of the organization. Quality engineer: Designs, i...


Standards Outlook: Conducting a Document Review

by Russell, J.P.

Some industry sectors require documentation that has word-for-word traceability between the MS documentation and audit criteria. For internal audits, document reviews can be part of a routine audit of an area, rather than a separate document review. Docum...


Open Access

Back to Basics: Clearing SPC Hurdles

by Laman, Scott

Statistical process control (SPC) has provided significant cost savings for companies that are fortunate enough to implement it fully. However, implementation challenges can overcome the best of intentions....


Standards Outlook: Automakers Shift Manual Into Another Gear

by Reid, R. Dan

The Automotive Industry Action Group (AIAG) published the second edition of the Advanced Product Quality Planning (APQP) and Control Plan Reference Manual this summer....


Open Access

Small Business, Big Feat

by Adrian, Nicole

Efforts to continuously improve employee and customer satisfaction, and business practices led PRO-TEC to a Baldrige award. The company has incorporated many best management practices, including lean manufacturing and continuous improvement, and relied on...


Open Access

10 Auditing Rules

by Kausek, Joe

All auditors receive training in the basics of planning, conducting and reporting audits. Unfortunately, this is the only training many ever receive....


Two Are Better Than One

by Nanda, Vivek "Vic"

Management need and my personal curiosity recently led me to take a closer look at the Sarbanes-Oxley Act (SOX). My work pointed out similarities and differences between SOX and ISO 9001....


Standards Outlook: Off to a Good Start

by Russell, J.P.

Clause 6.2.6 of the U.S. supplement for the International Organization for Standardization's (ISO) auditing standard provides guidelines for establishing initial contact with the auditee....


Measure for Measure: Feather in Your QAP

by Niemann, Craig A.

One of the most important functions in a calibration laboratory is the quality assurance program (QAP), which is crucial in creating a culture where technicians buy into using process improvement to produce a quality product....


Sharpen Your Auditing Skills

by Kausek, Joe

Effective audits require effective audit planning. One of the best tools to help guide both the planning and execution of an audit is the audit checklist....


Open Access

QMS Certification: Down With Disillusionment

by Gyani, Girdhar

Conformity assessment and international standards that cover products and quality and environmental management systems provide mechanisms to ensure the quality of goods and services, but a recent survey reveals that the various certification bodies...


Salary Survey-Regular Employee and Self-Employed Consultants Results

by QP Staff

45 Section 6 Salary by Number of Work Hours Online Section 7 Salary by Nonexempt vs. Exempt Status Online Section 8 Salary by Number of Years of Quality Experience and Highest Level of Education Online Section 9 Salary by Number of Years in Current Posit...


Part I Section 1 Salary by Job Title (Regular Employees)

by QP Staff

Standard Minimum Maximum deviation Count Mean Median Full- time employees Analyst $ 30,000 $ 145,000 $ 19,951 206 $ 63,694 $ 60,000 Associate 21,000 200,000 26,118 96 61,756 56,500 Auditor 18,000 170,000 22,697 258 66,392 65,000 Black Belt 34,000 149,845...


Turbocharge Your Preventive Action System

by Sittsamer, Murray J.; Oxley, Michael R.; O’Hara, William

A layered process audit (LPA) is an ongoing chain of simple verification checks to make sure a defined process is followed correctly. This powerful management tool can improve safety, quality and cost savings by amplifying problem solving systems and...


DFX and DFSS: How QFD Integrates Them

by Jiang, Jui-Chin; Shiu, Ming-Li; Tu, Mao-Hsiung

The differences in concept and application between design for excellence (DFX) and design for Six Sigma (DFSS) are discussed, and it is shown how they can be effectively integrated by using quality function deployment. Quality must be built into a...


3.4 per Million: Use DMAIC to Make Improvement Part of the Way We Work

by Snee, Ronald D.

Faster, better, cheaper. That’s what organizations across almost all major industries must now do to remain competitive....


Standards Outlook: ISO 14001 Hits 10-Year Mark

by Briggs, Susan L.K.

It has been 10 years since the ISO 14001 standard on environmental management systems (EMSs) was first published....


The Innovation Process and Quality Tools

by Walker, H. Fred; Levesque, Justin

Cost control and product quality are only capable of sustaining competitive advantage. It takes product or service innovation to create competitive advantage in a global marketplace. Innovation consists of a series of steps like any other business or...


QFD's Evolution in Japan and the West

by Jiang, Jui-Chin; Shiu, Ming-Li Shiu; Tu, Mao-Hsiung

Although the theory of quality originated in the United States, early industrial applications predominantly took place in Japan. Yoji Akao conceived quality function deployment (QFD), a concept that is a vital management tool for new product...


Measure for Measure: Challenges of Instrument Innovations

by Payne, Graeme C.

Humans are innovators. We are always inventing new materials, methods, devices or ideas. From time to time, certain innovations cause major, unforeseen shifts in theory and practice....


Quality Glossary

by Nelsen, Dave

Five years after it published its first glossary of quality terms, ASQ has revised that glossary with updated definitions and new entries, many from the lean glossary published in 2005. This reference of terms, acronyms, and prominent figures in the...


Standards Outlook: Why a New ISO 9004?

by West, John E. "Jack"

In the rush that is today's business environment, we often worry more about details than we do the big picture....


Open Access

Standards Outlook: Environmental Standards Development--Why You Should Be Involved

by Briggs, Susan L.K.

At the last meeting of the U.S. technical advisory group on environmental management, attendees discussed the important issues being decided at the subcommittee meetings of International Organization for Standardization technical committee (TC) 207....



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