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Open Access

Standards Outlook: Missing in Action

by Dunmire, Thea

Many of those reviewing the current draft of the revisions to ISO 9001—Quality management systems—Requirements, and ISO 14001—Environmental management systems—Requirements, are asking, “Where have all the documents gone?”...


Open Access

Brought Into Focus

by Liebesman, Sandford

For the first time, the word “risk” is being incorporated into the new version of ISO 9001. Using risk-based thinking and tools such as risk analysis and risk control matrixes can enhance an organization’s risk management approach...


Open Access

Innovation Imperative: Embracing Change

by Merrill, Peter

The revised ISO 9001 provides some great opportunities for innovators, but you must look carefully for those opportunities....


Open Access

A New Look

by Palmes, Paul

There are a few basics any new or seasoned practitioner of ISO 9001 might want to consider as 2015 draws near....


Onward and Upward

by Thomas, Donna

Operational excellence has been a long-time focus for Xerox, the international document management corporation. Before joining Xerox, Affiliated Computer Services shared that same focus....


Which FMEA Mistakes Are You Making?

by Carlson, Carl S.

Focusing on achieving quality objectives and using an FMEA audit process will greatly enhance the FMEA effectiveness....


Brought Into Focus - Liebesman - September 2014 - Online Figures

by Liebesman, Sandford

Templates to enhance your organization’s risk approach....


Open Access

One Good Idea: Steer Your Career

by Goffnett, Sean

An individual development plan (IDP) focuses on developing a quality talent pool by allowing each individual to create a systematic strategy to improve skills and overall performance....


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....


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: Consulting Quandaries

by Schnoll, Les

As a consultant, you sometimes must walk the fine line of being (appropriately) assertive and going too far, thus alienating your difficult clients. You must learn to deal with occasional idiosyncratic behaviors—thus, the consultant’s quandary....


Open Access

Back to Basics: Take Note

by Hart, Vicki

Tips to perfect your note-taking techniques....


Safety in the Skies

by Odigie, Michael; Martin, Royce A.; Courbat, Michael; Sinn, John W.

Embracing the notion of continuous improvement, the aviation industry is endeavoring to redefine and fine-tune the way safety is managed....


Open Access

A Step Forward

by Hampton, Debra M. Hay;

The committee draft of ISO 9001:2015 is significantly different from ISO 9001:2008, and includes new terms and clause structure. It also focuses on reducing risk and applying the process approach....


Standards Outlook: Into the Future

by Reid, R. Dan

During the past 30 years or so, there has been a lot of content in this column and in QP dealing with management system standards (MSS). Well, get ready. ISO MSSs as you know them are about to change, starting as soon as next year....


Open Access

One Good Idea: Bucket List

by Suedbeck, John G.

Categorize and control your risk management audit data....


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%....


Open Access

Words to Work By

by QP Staff

Readers shared their favorite quality quotes and reflected on the wisdom of the words....


Standards Outlook: Work in Progress

by Liebesman, Sandford

ISO 9001:2008 and ISO 14001:2004 are scheduled for major revisions by the end of 2015. Many of the revisions being considered are controversial. In this column, I will only discuss the changes to ISO 9001, but note that changes to ISO 14001 are similar....


Measure for Measure: Careful Comparison

by Bucher, Jay L.

Starting a calibration program from the ground floor can be a daunting task. But it also can help an organization realize it has taken only the first steps in ensuring a quality program....


For the Greater Good

by Badrick, Tony; Kehrer, Sue; Reid, Elizabeth

When the Coffs Harbour Laboratory of Sullivan Nicolaides Pathology in Australia implemented an environmental management system, it realized financial savings, reduced waste and improved operational efficiencies, and saw increased staff engagement....


Expert Answers: October 2013

by QP Staff

Handling incoming inspections ... identifying special processes during an audit...


Measure for Measure: Are You Sure?

by Grachanen, Christopher L.

From a metrological purist perspective, measurement results reported with just an interval do not give sufficient information as to the uncertainty (unlikelihood) that the obtained results are within their stated interval....


Open Access

Back to Basics: According to Plan

by Port, Jonathan

Regardless of the purpose, audits must be properly planned so they’re successful and valuable. Often, this crucial step receives scant attention. The audit process should be divided into three equal parts: planning, execution and follow-up....


3.4 per Million: Operational Definitions

by Kubiak, T.M.

If your organization is like most when it comes to data collection or metric development, little thought is actually given to these processes. I mean, after all, how difficult can it really be?...


Dig Deeper

by Chadha, Rajeev

Sort,store, shine, standardize and sustain (5S) is a lean process for creating and maintaining an organized, clean, safe and high-performing workplace....


Open Access

To All Corners of Kenya

by Darabi, Tiffany

Effective supply chains deliver products on schedule and within budget to customers. Those customers shouldn’t have to think about the behind-the-scenes process or worry about whether the goods will be delivered on time....


Avoiding an Avalanche

by Milliken, Greg

Organizations that make products with rigorous quality requirements face numerous challenges associated with meeting objectives—ranging from complying with standards to operating in highly-regulated and frequently audited environments....


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....


Expert Answers: May 2013

by QP Staff

Lean case studies from IT organizations...


Five at the Forefront

by Scriabina, Natalia

ISO 19011:2011 is an international standard that provides guidance on auditing management systems. Using ISO 19011 is not mandatory, and organizations are not required to reference this standard in their auditing procedures....


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

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...


Open Access

Don't Lose Patients

by Creasy, Todd; Ramey, Sarah

Clinch Valley Medical Center—a for-profit, 175-bed hospital operating in western Virginia and part of a healthcare organization with operations in 18 states—has been undertaking lean Six Sigma initiatives for approximately three years....


Open Access

Back to Basics: Minimizing Chaos

by Gojanovic, Tony

Much has been written about document control and management. But applying these basic principles can help transform a nightmare into a well-managed system....


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%....


Expert Answers: December 2012

by QP Staff

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


Open Access

Quality Around the Clock

by QP Staff

It’s in your DNA. It’s how your mind works. It’s what you do. It’s who you are. When you work in quality, you see things differently. You approach problems and scenarios in certain ways. It happens after you’ve signed off....


Expert Answers: November 2012

by QP Staff

Surveys in the toolbox ... Auditing it all ... Reference materials in ISO 17025 ......


Making Contact

by Metz, Brian

For an organization to be able to truly understand how well it’s meeting customer expectations, more concrete, measureable metrics must be used....


Expert Answers: October 2012

by QP Staff

Finding the right role ... Audit mismatches ... Accuracy in calibration...


(Re)visionary Thinking

by Briggs, Susan L.K.

The preeminent ISO standard on environmental management, ISO 14001, is being revised to incorporate new approaches in the field of environmental management systems and meet stakeholder expectations that have evolved since it was first published in 1996....


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....


Rethinking Treatment

by Muzenjak, Diane; Carboneau, Clark; Galagan, Robert

Changing and improving complex processes in healthcare settings are no easy tasks. They require a systems approach using a variety of quality improvement methods and tools....


The Audit Answer

by Estrada, Angel; Sinn, John W.

Graduate students at Bowling Green State University studied the Quality Systems Educational Collaboration, a program that addresses workforce and technical assistance needs for organizations, and disclosed areas for improvement using Six Sigma methods....


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?...


Expert Answers: May 2012

by QP Staff

Defining quality ... Consolidating certifications ......


Open Access

Beyond the Basics

by Duffy, Grace; Laman, Scott A.; Mehta, Pradip; Ramu, Govind; Scriabina, Natalia; Wagoner, Keith

A movie sequel often can be as, if not more, captivating than the original. Essentially, a sequel builds on the original, continuing a journey with familiar characters and settings, developing ideas and unveiling more insight....


Expert Answers: April 2012

by QP Staff

The right way to roll out Six Sigma ... Dealing with troublesome auditees....


Eradicating Inconsistency

by Udell, Mark; Buffington, Mike

When most people imagine the Orkin man, they visualize a uniformed technician driving a white truck from house to house. What’s probably not as widely known is that the technicians stop at many places other than homes....


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

Email Matters

by Milton, Alec

It is commonly accepted that 80% of data within an organization is unstructured. Emails are considered a part of the definition of unstructured data. But with the right processes, it is possible to get email under control....


Open Access

Back to Basics: Understanding Variation

by Port, Jonathan

Organizations with quality management systems compliant to ISO 9001:2008 are required to take action to eliminate the causes of nonconformities. If determination of variability type is absent from problem-solving methods, it leads to ineffective actions....


Measure for Measure: On Solid Ground

by Bucher, Jay L.

There are a few fundamentals every calibration or metrology department should know to get moving in the right direction....


Online Figures Udell

by Udell, Mark; Buffington, Mike

QP 1 Quality assurance audit workbook / Online figure 1 Branch name: Region #: Date: 08/ 30/ 10 Administrative review results Possible exceptions Total exceptions Standard weight factor Weighted rating Total branch rating Percentage exceptions Commercial...


Get on Board

by El Tigani, Omer Abdel Aziz

Although it is difficult to find a universally accepted definition of what it actually means, quality management is still the dream of every organization on the planet—or at least it should be....


Open Access

One Good Idea: Prevent Memory Loss

by Knapp, Gary

All quality personnel can benefit from a good habit many successful people live by—note-taking and documenting meeting minutes....


Open Access

Career Corner: Hand It Over

by Conklin, Joseph D.

No matter how much you like a task, at some point you can count on passing the baton. When this happened to me following an agency reorganization, the handoff to a new hire went especially well, thanks to this 12-step process....


Online Conklin: The Road More Traveled

by Conklin, Joseph D.; Mazu, Michael J.

After being part of a great team that implemented process management at Plant Able in the XYZ division of Heavymet, I took the show on the road to our sister facility Plant Baker....


Expert Answers: January 2012

by QP Staff

Cost-of-quality reporting ... Auditing options ......


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...


Salary Survey 2011: Part 1, Section 11: Salary by Division Size, Organization Size and Location of HQ

by Hansen, Max Christian

Part 1. Regular Employee Results Section 11. Salary by Division Size, Organization Size and Location of Headquarters Bigger Organizations Mean Better Pay Salary by organization size for U. S. respondents / Figure 1 Salary by organization size for Canadia...


Standards Outlook: Know Your Role

by West, John E. "Jack"

When an organization has stale quality management system processes in the face of dynamic—at times chaotic— uncertainty, the entire system may become irrelevant....


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....


A Decade of Distinction

by Thompson, Matias Gadda; Rosanó, Verónica

In the first six months of 2010, Telefónica Group launched 60 simultaneous quality improvement projects. These 60 projects represent nearly 30% of the total number of improvement projects conducted in the company during the last decade....


Standards Outlook: The Missing Link

by Liebesman, Sandford

In most organizations, quality and finance behave like independent silos, resulting in excessive costs and unhappy customers and investors....


Open Access

Online Figures One Good Idea

by Port, Jonathan D.

Planning Execution Hierarchy Aim Quality manual Procedures Work instructions Forms Records Quality management system documentation pyramid / Online Figure 1 Transforming the document pyramid / Online Figure 2 Aim Quality manual Procedures Work instructio...


Open Access

Healthy Skepticism

by Grenuk, Julie

It’s important not to underestimate the intense, personal nature of change as each employee in the healthcare industry transitions from the familiar paper-driven world to an entirely electronic one....


Measure for Measure: Under the Microscope

by Bucher, Jay L.

Audits are chances to see where improvements can be made and to find areas that can be improved upon. If you approach an audit with the right mindset, it can be a great opportunity for all parties involved....


Supporting Role

by Stimson, William A.

The ANSI/ISO/ASQ Q9000 Series of Quality Management Standards consists of three component standards. Taken together, the standards are components because they form a complete tactical approach to quality management....


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....


Expert Answers: August 2011

by QP Staff

Connecting SOPs and IT ... quality assurance vs. quality control ... looking for remote audits....


Standards Outlook: Hand in Hand

by Cressionnie, L.L. "Buddy"

Beginning July 1, all aviation, space and defense (AS&D) quality management system (QMS) certification body audits were required to be conducted according to a newly released AS&D QMS standard....


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....


Survey Says

by Wise, Thomas P.

To make software quality assurance less taxing, one organization used online survey tools as a creative means of addressing and resolving the difficulties inherent in performing process review data collection with limited resources....


Not Your Normal SOP

by Brewton, Oliver; Culbreth, Tim; Groeger, Hans

To ensure business activities are performed correctly and consistently, it is vital to be compliant to numerous quality, safety and regulatory requirements. One way to do so is to understand and develop thorough procedures—and then follow them....


Standards Outlook: Revisionist History

by Liebesman, Sandford

The latest version of ISO 9001 was published in December 2008. Since then, ISO/TC 176 has created a task group to consider concepts for inclusion in the next revision, which is scheduled for publication in 2015....


The Bright Side of Failure

by Sheffrey, Tom

Nobody wants to be associated with a project that fell short of expectations. But, as any good quality professional knows, failed projects can provide a mechanism for continuous improvement....


Know More, Do More

by Chang, Nancy S.Q.; Gagliardi, Frank A.

If organizations want to take advantage of a changing landscape dotted with new opportunities, products and services, they need to make a substantial investment in educating and retaining a competent labor force....


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....


Expert Answers: January 2011

by QP Staff

Implementing two systems simultaneously ... Cut-off date for ISO 9001:2000 ... Tips for a more effective survey....


Expert Answers: December 2010

by QP Staff

The benefits of certification ... Knowing when to document....


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...


Standards Outlook: Benefit Without a Doubt

by Bucher, Jay

In the typical executive reward system, bonuses are based, in part, on implementing creative solutions to complex problems rather than using standardization. for strategic advantage....


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...


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....


Online Sidebar 2: How much will it cost?

by Orthaber, John

Almost all the costs of implementing ISO 9001fall into one of the following categories: Registration costs: Registrars are free to set their own rates, which are generally predicated on a daily rate per person, plus expenses....


Open Access

Online Sidebars: Keeping Current: October 2010

by QP Staff

In addition, BS 5750 and Z2999, similar series of quality assurance standards, were published in the U.K. and Canada and the quality management system (QMS) standard ANSI-ASQ Z1.15 was published in the United States. Eventually, the ISO 9000 series had bo...


Standards Outlook: The Bottom Line

by Liebesman, Sandford

Quality and environmental managers need to understand the language of finance and the effect of operations on the bottom line, while financial managers need to know how quality and environmental managers can help improve results....


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?...


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?”...


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...


Open Access

One Good Idea: Number Nine

by Navetta, Jim

Keeping the eight lean wastes in mind when creating a process flowchart is a great way to target improvement opportunities. But during the course of several projects, I’ve come across another form of waste....


Measure for Measure: Well Equipped

by Doty, Stephen; Caldwell, Del

If you're experiencing consistent customer dissatisfaction with your product, it's possible your measurement information may be of such poor quality that it prevents you from making sound decisions related to your product or service....


Expert Answers: July 2010

by QP Staff

The "quality police" perception ... cutting down data-entry errors....


Standard Outlook: In Transition

by Cressionnie, L.L. "Buddy"

The 30-month transition period for the aviation, space and defense (AS&D) quality management system (QMS) standard began Jan. 1. With plenty of time to get familiar with the QMS documents, organizations are striving to meet their requirements....


Open Access

Reviving Healthcare

by Kenney, Charles

As a child in rural Connecticut, Don Berwick often was awakened in the dead of night by the piercing ring of a telephone coming from down the hall....



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