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Designing Requirements
Denise Robitaille
Auditing clause 7.3 of the design and development section of ISO 9001 can be a challenge for the auditor and the auditee. Unlike purchasing, manufacturing, shipping or order processing, it’s rarely carried out on a regular or consistent schedule. The level of activity ranges from the…
Selling the Solution
Denise Robitaille
Years ago, when my kids were in middle school, I volunteered as a coach for the Future Problem Solvers, a competitive academic program designed to help young people develop the creative thinking skills they will need as tomorrow’s leaders.While the bulk of the time was spent teaching…
QC 080000 Technical Requirements
QC 080000 IECQ HSPM calls for a process management approach to the management and reduction of hazardous substances in products and processes. It utilizes familiar conventions from the ISO standards world, while calling for a full review and understanding of the technical issues that…
Where There’s a Will . . .
Denise Robitaille
The adage “The pen is mightier than the sword.” is hackneyed, accurate and profound. I’ve done several pieces on the influence of words. The simple fact is that how we say something often matters as much as what we’re saying. It’s a wondrous phenomenon, one that is too often taken for…
The IECQ Global Solution for HSF
Last month’s column provided background on the International Electrotechnical Commission, one of only three standards-setting bodies recognized by the World Trade Organization. Readers may have asked, “So what?” The answer is that one of the three “schemes” within the IEC has provided…
The Emperor’s New Clothes
Denise Robitaille
Surely you remember the tale of the emperor’s new clothes, a wonderful story filled with multiple quality training opportunities. There was an emperor who was pompous and vain. One day, two scoundrels came to the palace, presenting themselves as tailors from a distant land. They said they had woven…
Now and Then
Dennis Bradley
In March 2005, EIA/ECCB-954, "Electrical and Electronic Components and Products Hazardous-Substance-Free Standard and Requirements" was developed and released as a U.S. national standard. In April 2005, the IECQ management committee agreed at its annual meeting in the United Kingdom to…
Things Change
Denise Robitaille
Blame is one of the most useless, albeit pervasive, reactions that surround problem solving. For many people, the initial reaction when something goes wrong is: “Who did this?” The less-than-subtle implication underlying this question is: “I want to know who screwed up.” Some may even…
This and That
Last month’s SBGi on HSF column, “Now What?,” focused on the emergence of RoHS and WEEE as part of the global hazardous-substance-free (HSF) movement. This month, we’ll look at what has been happening in the electrical and electronics equipment industries and in the European Union…
Look, But Don’t Touch
Denise Robitaille
I was recently asked to comment on the ISO 9001 requirements regarding external documents. My first reaction was to point out a distinctive subtlety in the actual text of the requirement. Many users have gotten into the habit of referring to this category as “external documents” when in fact, the…
Can ISO Standards Be Bad for Your Company?
Brandon Kerkstra
For 20 years, I have worked with many companies to achieve a variety of registrations. As a sales manager, auditor, consultant and trainer, I have noticed that a number of companies haven’t realized the benefits that they expected from standards registration. Some of them have actually become worse…
Now What?
Chip Evans
This is the first of a series of articles intended to share with Quality Digest’s readers key aspects of the global movement toward hazardous substance–free (HSF) products and processes and how they affect organizations. SBGi helps producers of electronic and electrical products prepare…
Buy One, Get One
Denise Robitaille
Don’t you love it when you go to the store and they have a “BOGO” sale? BOGO, as in buy one, get one. Who can resist the attraction of being able to get two things for the price of one?
What’s in a Number?
Denise Robitaille
I have long maintained that renumbering procedures from the defunct ISO 9001:1994 standard to reflect the numerical scheme of ISO 9001:2000 is an exercise of questionable value. After all, aren’t they just numbers? What difference can it possibly make if your purchasing procedure is…
For Want of a Nail
Denise Robitaille
"For want of nail a shoe was lost For want of a shoe a horse was lost For want of horse a rider was lost For want of a rider a battle was lost For loss of a battle a kingdom was lost And all because of a horseshoe nail." In researching the origins of this familiar cautionary maxim, I…
Helping Your Suppliers Help You
Denise Robitaille
A few months ago, I wrote about the importance of understanding your customers’ requirements. We looked at requirements that exceed the traditional scope of product specifications such as labeling, packaging and documentation.This month, we’ll take a look at how we communicate our…
Push Back
Denise Robitaille
As an auditor, I have a hard time maintaining my composure when individuals tell me they’re unhappy with their registrar and yet have taken no action to address the matter. If clients are dissatisfied with the conduct of an auditor or service they’re getting from their certification…
Tackling the Tough Problems
Denise Robitaille
It’s the week after the huge annual trade show—the opportunity for you and the rest of your industry to showcase your companies and to rollout your latest, greatest blow-the-competition-out-of-the-water product offerings. Unfortunately, instead of having a working model to demonstrate—…
Benefitting from Supplier Corrective Actions
Denise Robitaille
Part of the problem with corrective actions has long been the proliferation of requests for things that just don’t meet the criteria. Significant progress toward selecting the problems that warrant corrective action has been made in recent years. This has improved the image of corrective actions…
The ISO 9001 Environment Clause
Denise Robitaille
Some ISO 9001 requirements simply don’t get as much attention as others. One such example is found in clause 6.4, which relates to work environments. It states: “The organization shall determine and manage the work environment needed to achieve conformity to product requirements.” What…
Tempus Fugit
Denise Robitaille
Time is arguably one of the most precious and least quantified resources that organizations possess. It’s a uniquely intangible, yet indispensable, feature of any process or activity. Things occur over a span of time. It’s an indisputable characteristic of our universe and is so self-evident that…
Realizing Value From Audit Findings
Denise Robitaille
It’s been my experience as an auditor and as a consultant that the overwhelming majority of corrective actions originate from customer returns. The good news is that the corrective action request (CAR) process is being utilized to address the cause of these problems. Unfortunately, CARs that arise…
The Standard Answer: Ship Shape
Denise Robitaille
How is it possible to ship customers the right product, on time, and still fail to fulfill their requirements? Most organizations do a pretty good job of determining what product the customer wants. Based on what I’ve observed during surveillance audits, they’ve also improved their processes for…
Only One Correct Action Process
Denise Robitaille
A recurrent theme that dominates discussion on the establishment of corrective action programs is the practice of channeling problems through multiple conduits for assessment and resolution. Organizations inadvertently fragment their corrective action process by trying to address problems and…
The Art of Interviewing
Denise Robitaille
I’ve long been a proponent of involving as many individuals as possible in corrective action, both during the root cause analysis phase and during the development of the action plan. Middle managers, supervisors, machine operators, customer service representatives, shippers, software test engineers…

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