- Cost of Quality
- Customer Satisfaction and Value
- Data Quality
- Environmental Manag. and Sustainability
- Innovation
- Inspection
- ISO 9000
- Leadership
- Lean
- Metrics
- Metrology
- Problem Solving
- Process Management
- Product Development and Recall
- Quality Assurance
- Quality Control
- Quality Management
- Quality Tools
- Reliability
- Safety
- Six Sigma
- Social Responsibility
- Software Quality
- Standards
- Statistics
- Supplier Quality
- Teams
- AS9000
- ISO 26000
- Risk Management
- Economic Case for Quality
- Product-Service Design
Avoiding an Avalanche
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....
Balancing Act
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
Lean case studies from IT organizations...
Five at the Forefront
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....
One Good Idea: Form by Design
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?...
March 2013 One Good Idea - online figures
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...
Don't Lose Patients
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....
Back to Basics: Minimizing Chaos
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
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
A better supplier scorecard ... Inspecting your suppliers ......
Quality Around the Clock
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
Surveys in the toolbox ... Auditing it all ... Reference materials in ISO 17025 ......
Making Contact
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
Finding the right role ... Audit mismatches ... Accuracy in calibration...
(Re)visionary Thinking
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
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
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
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....
Back to Basics: Solid Proof
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
Defining quality ... Consolidating certifications ......
Beyond the Basics
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
The right way to roll out Six Sigma ... Dealing with troublesome auditees....
Eradicating Inconsistency
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
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?...
Email Matters
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....
Back to Basics: Understanding Variation
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
There are a few fundamentals every calibration or metrology department should know to get moving in the right direction....
Online Figures Udell
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
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....
One Good Idea: Prevent Memory Loss
All quality personnel can benefit from a good habit many successful people live by—note-taking and documenting meeting minutes....
Career Corner: Hand It Over
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
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
Cost-of-quality reporting ... Auditing options ......
Salary Survey 2011: Slow and Steady
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
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
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
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
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
In most organizations, quality and finance behave like independent silos, resulting in excessive costs and unhappy customers and investors....
Online Figures One Good Idea
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...
Healthy Skepticism
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
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
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
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....
Certification at Work
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
Connecting SOPs and IT ... quality assurance vs. quality control ... looking for remote audits....
Standards Outlook: Hand in Hand
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
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
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
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
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
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
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
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
Implementing two systems simultaneously ... Cut-off date for ISO 9001:2000 ... Tips for a more effective survey....
Expert Answers: December 2010
The benefits of certification ... Knowing when to document....
Salary Survey 2010: Not Out of the Question
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
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
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....
Back to Basics: Take Another Look
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...
3.4 per Million: Firefighting With DMAIC
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....
Get Your Ducks in a Row
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....
Online Sidebar 2: How much will it cost?
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....
Online Sidebars: Keeping Current: October 2010
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
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
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
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?”...
Sustainable Future
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...
One Good Idea: Number Nine
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
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
The "quality police" perception ... cutting down data-entry errors....
Standard Outlook: In Transition
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....
Reviving Healthcare
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....
Now What?
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....
Bull's-eye
All companies want to build a stronger brand by ensuring customer satisfaction. Along the way, of course, the companies want to make a profit....
Standards Outlook: Taking Responsibility
Social responsibility and sustainability are issues that have gotten the attention of most countries around the world, and they're growing in importance in quality circles....
Customer Focus Sparks Invention
To reduce customer complaints and remain profitable, Littelfuse’s facility in the Philippines designed a voice of the customer (VOC) project. The executive team or project champion and project sponsor help the team set goals and expectations, and provide ...
Standards Outlook: Under Control
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
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...
One Good Idea: Cut Down on Redundancy
We devised a solution to help staff and auditors better understand which standard operating procedures (SOPs) were applicable and why—a form dubbed the SOP applicability worksheet (SAW)....
Career Climb
You don’t need to be jobless in today’s economy to feel stressed and apprehensive about your current situation. You don’t need to be reminded there aren’t any guarantees in today’s world....
Standards Outlook: Above and Beyond
Much has happened in the last year to aerospace industry quality management system standards, three of which were updated to account for ISO 9001:2008. They were also expanded to be more inclusive of broader market requirements....
Test Run
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?...
Salary Survey 2009: Lingering Effects
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
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
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
The TOPS way of getting to the root cause ... Repair vs. rework...
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....
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....
