All Features
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…
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…
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? I once had a client who was going through the company’s registration assessment for ISO 9001. The client…
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…
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…
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…
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…
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—…
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…
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…
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…
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…
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…
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…
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…
Denise Robitaille
Have you ever wondered how to demonstrate to a manager the rationale behind the ISO 9001 requirements for competence and training? It isn’t uncommon to find quality managers, consultants or auditors sputtering through an explanation of this requirement, trying to describe to others what seems…
Denise Robitaille
Perhaps one of the hardest persisting sells for the average quality professional is the challenge of effectively communicating the benefits of preventive action to senior management. The sales pitch is twofold: 1) defining the concept and 2) providing concrete examples that are applicable to the…
Denise Robitaille
I often get asked: “What’s the best software package?” Individuals are usually looking for guidance in selecting a program to manage corrective actions, facilitate document revisions, track equipment maintenance or handle transfer of information about some other processes. With our increased…
Paula Esty
This article reviews management review in the latest ISO 14001 standard revision, including the management review requirement update and system recommendations for ISO 14001:2004 compliance. The updated ISO 14001 environmental management system (EMS) standard includes a clarification to the…
Denise Robitaille
The Abbott and Costello routine “Who’s on First?” is one of the greatest comic treasures of our time. Bud Abbott begins listing the improbable names of his team players: Who, What and I Don’t Know (the three basemen), while a befuddled and increasingly frustrated Lou Costello tries to nail down the…
Denise Robitaille
It’s logical to expect the purchasing process to fall under the purview of the purchasing department. However, the reality is that in most organizations there are people from different departments who generate purchase orders and sign contracts. Not all procurement is done by the purchasing…
Denise Robitaille
Occasionally, when I’m waiting for a flight, the small talk with fellow travelers will meander into discussions about the purpose of our respective trips. When I tell them that I’m on my way to conduct an audit, they immediately jump to the conclusion that I’m a certified public accountant (CPA)…
For years, many companies have expended countless dollars and painful hours to comply with the various requirements of ISO 9001. Now, some of these companies are being asked to meet the provisions of Carnegie Mellon’s Capability Maturity Model Integration (CMMi). In its former guise as CMM,…
Denise Robitaille
I was channel surfing the other day, looking for some local news that would tell me why I had woken up to a power outage that had lasted the better part of the morning. I don’t usually watch TV during the day, so I had no idea what stations carried noon time news broadcasts. As I was flipping…
David Parlagreco
The concept of establishing goals and flowing them throughout an organization isn’t new in business or in quality management system standards. In ISO 9001:1994, the establishment of goals was done via the quality policy, following a review of effectiveness in meeting these management goals. QS-9000…
