- Auditing
- Cost of Quality
- Customer Satisfaction and Value
- Data Quality
- Global Quality
- Human Resources
- Innovation
- Inspection
- ISO 14000
- ISO 9000
- Leadership
- Lean
- Metrics
- Metrology
- Problem Solving
- Process Management
- Product Development and Recall
- Project Management
- Quality Assurance
- Quality Control
- Quality Management
- Quality Tools
- Six Sigma
- Standards
- Statistical Process Control (SPC)
- Statistics
- Supplier Quality
- Teams
- Total Quality Management
- TL 9000
- ISO/TS 16949
- ISO 22000
- Compliance
- Certification/Registration (management system Standards)
- Risk Management
- Customer Experience Management
- Customer Requirements
- Food Safety
- Economic Case for Quality
- err
Aerial Coverage
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....
Managing Expectations
One condition is vital for initiating, implementing and sustaining a viable quality initiative: management support. Surprisingly, very few articles and books on quality even mention this need, let alone what to do if support isn’t there....
Expert Answers: November 2009
The TOPS way of getting to the root cause ... Repair vs. rework...
Building a Consensus
A new tool, the consensus chart, can drive improvement activities identified during the development or operation of a quality system process....
Starting Line
So, you’ve volunteered (or, as one of my coworkers says, you’ve been “volun-told”) to lead your company through the implementation of ISO 9001. Now what do you do?...
Standards Outlook: The Right Approach
The process approach is at the heart of a quality management system (QMS) defined by ISO 9001. And, as everyone knows, it’s necessary to have the old ticker checked out from time to time....
Back to Basics: Testing, Testing, 1, 2, 3
Just as it is important that a product function properly, the product manual must also work. Owners or product users must be able to easily find the information they need to use an item effectively. To achieve this objective, the content and organization...
Expert Answers: July 2009
Setting up a corrective action document ... Dock-to-stock for medical devices ... Questions about confidence intervals....
Don't Just Talk the Talk
Many companies and organizations talk big about knowing the best way other businesses and groups can work to drive continuous and process improvement. Often, these businesses don’t take their own advice. Once in a while, however, a group comes along...
Expert Answers: June 2009
Auditing management systems ... ISO 9001 trouble ... Crunching the numbers for product specifications....
Take a Bite Out of Inefficiency
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....
Expert Answers: April 2009
Auditing your new company ... ISO 9001 coverage ... Dealing with wishy-washy management....
Small Change, Big Impact
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....
Expert Answers: March 2009
Return policy ... restructuring activities ... sample size....
Standards Outlook: To Launch or Not to Launch
Having quality professionals on medical device product development teams eliminates last-minute conflicts....
Contacts That Count
A team dedicated to improving member contact rates at Healthways Inc. pulled just about everything from its lean Six Sigma toolbox while working on a project and was recognized in ASQ’s International Team Excellence Award competition....
Building From the Basics
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....
Measure for Measure: In No Uncertain Terms
Because ISO/IEC Guide 99:2007 harmonizes terms for many different industries, it is important to take a closer look at all the terms. In this column, I will examine measurement uncertainty and metrological (measurement) traceability....
ISO-lating the Problem
When two healthcare organizations were searching for a way to better manage their activities, both turned to ISO 9001:2000 in the hope that the standard could organize their practices and help them improve service to patients....
Salary Survey 2008: Looking at the Numbers
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
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...
Perspectives: In Crisis, Give Credit to Quality
The financial industry needs a quality framework for manufacturing and controlling complex mathematical models, technological systems and financial data. Therefore, if Congress enacted strict quality standards for financial data and its distribution, the ...
Salary Survey 2008: The Complete Report
51 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...
Expert Answers: November 2008
Workplace recognition ... Choosing the right chart.
In your particular case, your production run rate is 30 pieces per hour, so you have a variety of charts available to you, including attribute charts. PPAP provides flexibility in how much documentation must be submitted to the customer as evidence the PP...
On the Same Page
Memorial Hermann’s first priority has always been to deliver quality healthcare (see sidebar, "About Memorial Hermann"). Every hospital in the Memorial Hermann system also has developed self-directed Medicare action plans. For hospital systems like Memori...
Career Corner: Something Worth Catching
CAGS stands for capability + adaptability + growthability + sustainability. It’s a formula for success in any field....
3.4 per Million: Putting It All Together
For companies that have been asking themselves how to achieve even more improvement, the answer lies in developing a comprehensive process management system that integrates three critical components....
Standards Outlook: Down With Silos
Businesses today have multiple management systems, including financial, quality and environmental. Unfortunately, these management systems usually do not talk to one another....
A Dose of DMAIC
Ruby hospital, a multispecialty for-profit facility in Calcutta, India, was the first in Eastern India to embrace ISO 9001 and is the only one in the country to have successfully deployed a Six Sigma improvement program....
In the Know
More and more organizations are choosing outsourcing as a necessary means of remaining competitive in the global economy. Quality professionals must consider building a body of knowledge completely dedicated to the subject of quality in outsourcing....
Standards Outlook: Ensuring Supplier Quality
I've worked in the medical device and pharmaceutical/biotechnology industries, and I've concluded that when it comes to quality, the medical device world is at least 20 years ahead of its drug-world cousin....
The Road to Improvement
Registration of public organizations to the ISO 9001 quality management standard can be difficult because of their complex operations and extensive documentation....
10 Auditing Rules
All auditors receive training in the basics of planning, conducting and reporting audits. Unfortunately, this is the only training many ever receive....
Career Corner: A Ready Résumé
Using performance review notes is the best way to keep your résumé ready. Any notes you prepare before a performance review are fodder for updating the current job section of your résumé. After 10 minutes of cutting, pasting and editing, the part of Kostu...
Standards Outlook: Off to a Good Start
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....
Two Are Better Than One
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....
Measure for Measure: A Clearer Picture With RCA
The next step to crafting a successful quality assurance program is conducting root cause analysis (RCA) to examine the individual nonconformities, and then performing trend analysis to determine the most significant nonconformities and the root cause....
Career Corner: Do You Deserve a Raise?
Do your homework: Know what metrics your boss is measured by, the financial status of your company, the factors in the external environment that are impacting the company, your personal worth to the company (past, present and future) and how your personal...
The Great Debate
Two auditors meet over breakfast. One is a quality management system (QMS) auditor and the other an environmental management system (EMS) auditor....
Standards Outlook: How to Manage Risk in a Global Economy
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....
A Gold Medal Solution
By using quality tools, a team from Boeing came up with solutions that eliminated the unsafe conditions that occurred during installation of the details in aircrafts' tailcones....
Back to Basics: An Appreciation for Documentation
Isn’t completing the task more important than completing the paperwork? Why do organizations spend valuable time and resources generating and maintaining paperwork systems?...
Expert Answers: March 2008
Outlook on outsourcing ... When does Six Sigma suffice?...
Sharpen Your Auditing Skills
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....
A Less Costly Billing Process
Applying lean Six Sigma techniques can identify root causes, streamline the billing process and reduce errors. After describing the concepts of lean and Six Sigma, this article illustrates how companies can apply lean Six Sigma techniques to identify root...
QMS Certification: Down With Disillusionment
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
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...
Statistics Roundtable: Back to the Future
Now more than ever, we need to use the kind of critical thinking and deeper process knowledge that predates the explosion of technology and software. By identifying and applying key aspects of the data mining process and then using them in novel...
Part I Section 1 Salary by Job Title (Regular Employees)
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...
Improving the Internal Audit Experience
Employees don’t always understand how audits relate to ensuring the use of good business processes. Many don’t realize the significant process improvement benefits that can be achieved from an internal audit experience. Cerner Corp. developed...
Eight Steps to Sustain Change
Improvement projects often focus on a problem, its measurement, analysis, and eventual solution, but fail to consider how improvements will be permanently integrated into the daily routine. Resistance is a natural response to change, but it can be...
Achieve Compliance Through CI
Using Six Sigma tools for continuous improvement (CI) is a proven method for meeting or exceeding FDA requirements for medical devices. Optical Integrity Inc., a manufacturer of medical devices, used the Six Sigma define, measure, analyze, improve...
ASQ Team Says QMS and EMS Standards Support SOX
The intent of the Sarbanes-Oxley Act (SOX) was to make the financial system of control more transparent and to reduce the incidence of corporate fraud. It soon became evident, however, that compliance with the law’s auditing requirements would be...
Army Aviation Depot Does an About Face
A few years ago the Corpus Christi Army Depot (CCAD), which provides maintenance, repair, and overhaul of the Air Force Pave Hawk helicopter, was in danger of losing the contract because of problems with turnaround time and cost overruns. CCAD’s...
Back to Basics: Plan Experiments to Prevent Problems
An experimenter's ability to minimize mistakes often comes with experience. Unfortunately, this experience often results from past problems, surprises or confusion....
Standards Outlook: TL 9000 Measurements Handbook Release 4.0
The Quality Excellence for Suppliers of Telecommunications (QuEST) Forum is the global society dedicated to the quality of telecom products and services. The forum has developed and maintained a single common set of telecom...
From One-Man Show to Baldrige Recipient
Mesa Products Inc., which manufactures and installs cathodic protection systems for underground piping and other metal structures, was the recipient of the Malcolm Baldrige National Quality award in the small business category in 2006. Mesa’s quality...
Career Corner: Full-Time Quality Manager or Part-Time Quality Consultant?
As companies become leaner and the workforce becomes older, it seems the use of highly qualified quality assurance consultants would be an attractive alternative to hiring full-time regular quality managers....
10 Quality Basics
In an overview designed to give quality newcomers a glimpse of the knowledge they need to succeed, ten regular Quality Progress contributors write on 10 basic quality topics that are fundamentals essential to surviving in a quality role. Topics covered...
Quality Glossary
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...
Back to Basics: It's Just Paperwork?
Understanding the need for document control
When I was a teenager, my mother gave me a diary and a bit of advice: "Say what you think, but be careful what you write."...
Measure for Measure: Managing the Measurement System
ISO 10012:2003 helps you plan your total measurement system....
Standards Outlook: New Version of TL 9000 Released
The global telecommunications industry, an important part of the global economy, will reach $1.3 trillion in revenues by the close of 2007....
Merging Quality Cultures in Contract Manufacturing
When EPIC Technologies acquired the Siemens Electronic Manufacturing Center operations in Johnson City, Tennessee, it became necessary to merge its quality culture with those of its new subsidiary while continuing to keep its original customers happy....
Salary Survey – 2006
Full Survey
44 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' Quality Experience and Highest Level of Education Online Section 9. Salary by Number of Years in Current Pos...
Salary Survey – 2006
Regular Employee - Section 1. Salary by Job Title
Standard deviation: Standard deviation is a FIGURE A PART 1. REGULAR EMPLOYEE RESULTS Section 1 Salary by Job Title Comparison of Salaries of Full- Time And Part- Time Employees 4,731 ( difference) 77,049 ( 2006) 72,318 ( 2005) 4,777 ( difference) 71,584...
Consultants' Style: Sometimes Less Is More
When medium to small organizations decide to become ISO 9001 or ISO 14001 registered, they often rely heavily on consultants for training, gap analysis, documentation, and management system development. However, because consultants are expensive, these...
Standards Outlook: Developing the Voluntary Healthcare Standard
The new Automotive Industry Action Group (AIAG) voluntary standard for healthcare delivery is in its second review, with an anticipated launch no later than early 2008. AIAG also is pursuing partners for the publication from the healthcare sector....
Getting Credit for Service
Experian Marketing Services (EMS) considers quality management a critical part of its commitment to its clients. Last year EMS looked to ISO 9001 certification as a way to extend its established project management program. EMS identified more than 100...
Standards Outlook: Do Environmental Management Systems Improve Performance?
The debate regarding the value of environmental management systems arises from a lack of comparable, quantifiable data demonstrating companies with a formal EMS produce less environmental emissions, discharges and waste than companies without one....
Measure for Measure: Four Steps to Ensure Measurement Data Quality
Part one of this column, published in July, posed four questions you should ask to ensure your measurements are providing data that are good enough for the given application....
Measuring the Cost of Quality for Management
Over the years, few organizations have adopted a reliable method for measuring and reporting cost of quality (COQ) and used it to improve operations. Since the avoidance of reduced profits from quality initiatives is seldom measured or reported by...
No Longer Lost in Translation
Language barriers and communication delays can disrupt a company's plans to survive and thrive in a global economy. The pursuit of quality also depends on bridging the communication gap. Without communication there can be no bridge from quality theory...
Measure for Measure: Four Steps to Ensure Measurement Data Quality
Millions of measurements are made every day in this country, ranging from the very simple to the extremely complex. Unfortunately, many do not obtain valid results because they make unrealistic assumptions about their measurement capability....
Digesting Complicated Processes
Businesses today face the challenge of balancing innovation with the need to maintain control of processes. The introduction to ISO 9001 contains a process model called the process approach that is based on the plan-do-check-act (PDCA) cycle and can be...
Standards Outlook: Process Auditing and Techniques
Process audits are highly focused, but their effective techniques are not always understood. Because there is no sanctioned process audit standard, anyone can claim to be doing process audits....
Core Roles in a Strategic Quality System
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,...
A Community College's Long-Term Commitment
Committed leadership is essential to maintaining a focus on continual improvement in any organization. Dallas' Richland College proved this when, under the leadership of long-time president Steven Mittelstet, it became the first community college to...
Back to Basics: Best Practices in Auditing
Organizations conduct audits to examine a business process and evaluate the process’s compliance with internal and external requirements. They also use audits to implement continuous improvements. Internal and supplier audits allow management to:...
Standards Outlook: New Ideas and Expanded Use
With more than a half million organizations certified or registered to ISO 9001 and 14001, many say the development of management system standards (MSSs) has ended. But wait; is this really where things end? I would say the answer is no....
Standards & Registrars Directory
TS TR TL RS QS MD 9KS 14K 9K CR CE AU AS TR CS SPC QS 9KS 14K 9K CS VD6 TS TR TL SPC QS MD 9KS 14K 9K CS CE AU AS TS TR SPC 9KS 14K 9K CS AU AS TS QS MD 9KS 14K 9K CSD AU AS 9KS 9K CR AU VD6 TS TR SPC QS MD 9KS 14K 9K CS VD6 TS RS QS 9KS 14K 9K CSD CS AS...
Standards Outlook: QMSs and EMSs Support Financial Management Systems
The Sarbanes-Oxley Act (SOX) was adopted in 2002 in response to scandals, such as the ones at Enron and WorldCom, and other misuse of corporate resources. In 2003, Paul Palmes and I started an effort to integrate...
Faster Turnaround Time
In 2004, North Shore University Hospital (NSUH) used Six Sigma to reduce bed assignment delay turnaround time that made it difficult to balance capacity needs. A capstone project revealed incorrect use of the hospital's bed tracking system. The goal was...
After Six Sigma - What's Next?
A systematic scientific approach is fundamental to dealing with problems of variability that cause costly defects and quality problems. This idea has remained the foundation of numerous incarnations of quality management and is the basis of the current...
Reflections on the Future of Quality
Over the years, the intent of quality systems has evolved from enhancing customer satisfaction by meeting their needs to improving overall organizational performance and capabilities. But quality management systems have always lagged behind evolving...
Salary Survey – 2005
Full Survey
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' Quality Experience and Highest Level of Education Online Section 9. Salary by Number of Years in Current Pos...
Salary Survey – 2005
Regular Employee - Section 1. Salary by Job Title
org Standard Minimum Maximum deviation Count Mean Median Full- time employees Analyst $ 24,500 $ 120,000 $ 19,048 132 $ 57,327 $ 54,500 Associate 15,000 106,000 20,593 49 54,119 52,000 Auditor 23,000 160,000 18,503 179 58,646 56,000 Black Belt 27,580 125...
How Do You Begin?
So, how did I begin in quality? I began knowing basically nothing about it and evolved my knowledge over 13 years....
Corral Your Organization's Knowledge
One useful method of determining organizational performance is to assess how well it manages critical knowledge. Definitions of knowledge management may vary, but they generally fit into one of four categories: Information technology, organizational...
Six Ways To Benefit From Customer Complaints
Customer service is one of the few areas where service organizations can achieve an advantage in a competitive marketplace. Six ideas are presented to help organizations improve business performance through the handling of customer complaints....
ISO 9000 In Service: The Good, the Bad, and the Ugly
When the Centers for Medicare and Medicaid Services began requiring ISO 9001 certification for its new business contracts, claims processing contractor Palmetto GBA decided to pursue certification for its existing contracts as well. Getting a...
Genentech Error Proofs Its Batch Records
Like other firms subject to Food and Drug Administration (FDA) regulation, Genentech must provide complete and accurate documentation of processes. In September 2003 an error-proofing project was launched by the good manufacturing practices core team at...
Clean House With Lean 5S
Lack of organization in the workplace wastes time and lowers productivity. By implementing a lean 5S system – sort, set in order, shine, standardize, sustain - organizations can create a clean, well ordered, and disciplined work environment. Many...
Calibration: What Is It?
According to the The International Vocabulary of General and Basic Terms in Metrology (VIM), metrology is "the science and practice of measurement." Metrology is critical to all the physical, chemical and biological sciences and the...
FMEA--Something Old, Something New
Managing risk is not optional for organizations. Clause 0.1 of ISO 9004 mentions risk management in the same breath with cost and benefit considerations as being important to an organization, its customers and interested parties....
Developing Best in Class Processes at NASA
In addition to its well-known space activities, NASA performs many other engineering activities. Developing processes to ensure the quality and safety of systems is of paramount importance in achieving mission success. For this reason, NASA has created...
Quality Management's Role in Global Sourcing
Globalization and the evolution of quality management systems from a focus on controlling product conformity to a much broader focus on overall enterprise capability have resulted in the need to redefine the role of quality management in dealing with...
Corrective vs. Preventive Action
Quality professionals frequently express confusion about the difference between corrective and preventive action. Corrective action deals with a nonconformity that has occurred, and preventive action addresses the potential for a nonconformity to occur....
Keep It Internal
Most people in the metrology community are familiar with calibration laboratories. But what about companies that want to meet the FDA's current good manufacturing practices, comply with the ISO requirements, or strive to find the cure for cancer?...
Sarbanes-Oxley and ISO 9000
Critics say ISO 9000 doesn't measure up to robust quality programs such as Baldrige Award criteria, lean and Six Sigma, and they complain about the law's excessive documentation requirements. Yet by providing records and internal controls, the...
