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Denise Robitaille
“Nonfulfillment of a requirement.” That’s the clear and concise definition of a nonconformity offered up by ISO 9000:2005–“Quality management systems—Fundamentals and vocabulary.” The definition leaves little room for ambiguity. A nonconformity is the identification of an incident involving either…
Denise Robitaille
Control of quality records: Can there possibly be a more boring requirement? You can feel the yawn coming on as you read through the requirements of ISO 9001 subclause 4.2.4.
Not only are you required to keep records, you’re required to have a documented procedure that describes how you maintain…
In last month’s column, I postulated that the hazardous-substance-free movement represents a major paradigm shift and creates demanding requirements for industry, creating a much higher bar of performance for business. QC 080000 IECQ HSPM can be a help.While the increasing demand for business…
Girdhar J. Gyani
The ISO 9001 series of standards is the most widely used in the world and specifies requirements for an organization’s quality management system (QMS). The standard is designed to enable the organization to have a customer orientation, a people (staff) orientation, and a business orientation.…
Denise Robitaille
What data are the best to gather? What processes should you be tracking? What are your metrics telling you? In observing various organizations’ attempts to fulfill ISO 9001 requirements around subclause 8.4—“Analysis of data,”–I’ve noticed a recurring problem. Companies allow the requirements of…
Last month, I shared some perspectives about the current state of the hazardous-substance-free movement and trends that are propelling its influence. This month I’d like to discuss what I think these trends mean to industry and the potential usefulness of QC 080000 IECQ HSPM.The European RoHS and…
Denise Robitaille
Subclause 6.2.2 of ISO 9001 is ubiquitously referred to as the training clause. That unfortunately narrows the focus to only one aspect of the requirement. The subclause is situated in the section of the standard that relates to provision of resources. It doesn’t simply require that training be…
This column and the next two take stock of the current state and future of the hazardous-substance-free (HSF) movement and its effects on industry, and share my perspectives on the potential effects of QC 080000 IECQ HSPM. A vision of the future: The industry will forevermore be held…
Denise Robitaille
Three blind men sat in the market place. One said to the others: ‘Would it not be a wondrous thing to know the nature of an elephant?’ His companion agreed, ‘Yes, it would indeed be wondrous.’A merchant standing nearby overheard the men’s conversation. He went over to the trio and said, ‘I…
This month we provide the basics for compliance with the European Union’s Directive 2002/95/EC—“On the restriction of the use of certain hazardous substances in electrical and electronic equipment.” This directive is commonly referred to as “RoHS,” for Reduction of Hazardous Substances…
Denise Robitaille
Many of you have probably had the occasional insane day when you thought: “This job would be so much easier if we didn’t have customers to deal with.” Apart from the demands for price concessions and the requests for unreasonable deliveries, there are a whole group of customer traits that can drive…
Dennis Bradley
Europe’s Reduction of Hazardous Substances (RoHS) directive identifies six hazardous substances and their maximum permissible levels within electrical and electronic equipment. RoHS imposes upon producers of such goods responsibility for knowing whether their finished products contain…
Denise Robitaille
How do we conclude that a nagging, recurring blip has become serious enough to justify taking action? How do we assess the significance of anomalies—isolated occurrences and scattered, seemingly unrelated events? Can we objectively distinguish those factors that suggest an escalating…
In a previous column, we discussed the importance of the IECQ quality assessment systems for electronic components, a certification scheme of the International Electrotechnical Commission. The IECQ mission is to provide a business-to-business quality certification scheme that serves industry by…
Dennis Bradley
Previous columns have addressed some of the topics that provide a foundation for understanding the scope and complexity of the worldwide movement to achieve hazardous-substance free (HSF) products and production processes. This month, let’s take a look at how people have been behaving and why they’…
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…
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 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…
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…
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…
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…
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…
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…
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…
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…
