All Features
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…
Denise Robitaille
Good morning, everyone. On behalf of Galactic Registrars Interstellar Network (GRIN), I’d like to express our appreciation to your organization for selecting us as your ISO 9001 registrar. Before we begin the audit, there are a few items we need to cover. This is standard auditing protocol. Certain…
Robert Kozak
Adding value by auditing using the process- and metric-driven approach requires new methods and an increased focus on supplier performance metrics (i.e., scorecards). A change in how auditors work the process approach is evolving, with more sophisticated techniques, more rigorous testing and…
Denise Robitaille
I was recently asked to write about the ISO 9001:2000 requirements that are still giving folks a hard time. Recent audits that I’ve conducted have led me to conclude that there are several clauses that continue to give us heartburn.
The issue that seems to come up most frequently relates to…
Denise Robitaille
I’ve long been frustrated, both as an auditor and as a consultant, by the unique exemption most organizations extend to distributors. It’s a common practice for purchasing personnel to excuse distributors from the vendor qualification requirements they apply to most of the other companies they do…
tesobicribebrothocrugutrevowrouunibrivebudrufrowrophitruslel
How did your quality system get so complex and redundant? Many companies established their quality systems after having purchased a software program with a “canned” quality manual and procedures. Software companies try to subliminally sell you the concept “more is better.” Purchasing companies…
Denise Robitaille
Perhaps the single most pervasive reason top management resists the implementation of a quality management system relates to our failure, as quality professionals, to demonstrate the return on investment. We do a less-than-stellar job of demonstrating to executives the financial value implicit in…
Michael Stanleigh
ISO 10006:2003, guidelines for quality management projects, was released in the fall of 2003. This standard is creating the next wave in our understanding of project managing processes. But how does ISO 10006 compare to the Project Management Institute’s Project Management Body of…
Denise Robitaille
There’s a marauding infestation of adverbs and adjectives that infiltrate the text of quality documents and operating procedures, wreaking havoc wherever they are found. The leader of this menacing bunch is called “All.” Among his compatriots you’ll find “Never,” “Always,” “Every” and “None.”
When…
Craig Cochran
Lean means doing the most with what you have. It’s efficiency and intelligence. In the modern economy, lean is a fact of life. Management systems must absolutely be lean, or they will be abandoned as impractical dinosaurs. In the October 2003 issue of Quality Digest, we began exploring…
