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Today’s manufacturers must develop products quickly and inexpensively to meet the demands of a competitive marketplace. Rigorous testing to meet North American product certification requirements may prove to be a time-intensive process. If not properly planned, third-party approvals can…
Kurt Boveington
With all of the quality lingo over the years, “right-the-first-time,” “prevention vs. detection,” “total quality,” “Six Sigma,” “ kaizen, ” and “continuous improvement,” Intermec Media, a label converter in Fairfield, Ohio, has taken this to another level and applied these concepts to their own…
Richard Strouse
Internal auditing, when effectively implemented, can arguably be considered the most important tool in the quality system tool box. It’s the primary method for continuously monitoring a company's quality management system (QMS). In fact, the feedback from internal auditing is critical to the growth…
Denise Robitaille
Isn’t it annoying when you call a company to complain about a problem and they won’t even give you the chance to describe what’s wrong? They take down the information that they think is important or whatever the generic form directs them to record. You hang up thinking, “They couldn’t even give me…
Denise Robitaille
E
mpowering people is a cool idea. Giving individuals authority and responsibility has many benefits. It fosters accountability and communicates confidence. It avails people the opportunity to contribute in a manner that allows their voices to be heard. They experience the self-satisfaction of…
Denise Robitaille
A few months back, I wrote about the choices an organization makes regarding its quality management system (QMS). At that time, I talked about the overall system, with particular focus on management’s investment and support.
Today I’d like to spend some time talking about the choices within the…
Denise Robitaille
I recently had a client who went through a pre-assessment in anticipation of his company’s certification audit. It’s kind of like a dress rehearsal for the real thing. Over the years, I’ve discovered that organizations tend to garner more value from pre-assessments than I had originally thought…
Denise Robitaille
Unlike many other requirements in ISO 9001, the subclause dealing with the ISO management representative is rarely the subject of debate. In fact, it doesn’t get nearly as much consideration as it deserves.
Traditionally, it’s assumed that the quality manager gets the job by default. If the…
Denise Robitaille
A farmer was experiencing a serious problem with cranes eating his seed, so he decided to cast a net upon his fields in an attempt to capture the cranes. Along with the cranes, he snared a stork. The stork pleaded for his life saying, "Honorable farmer, I am not like these others who came to steal…
Denise Robitaille
Recently I became aware that the ISO 9001 requirements pertaining to preventive action are sometimes referred to as the “fortune-telling clause.” The deprecating implication is that attempting to implement preventive actions is as silly as relying on a two-bit sideshow palm reader to help you make…
Denise Robitaille
Every once in a while, when I’m doing an audit someone will ask me—in a whiney voice—about some ISO 9001 requirement. The whine sounds something like, “Do we really have to ________?” Fill in the blank with any of a number of “shalls” from the standard. They know they have to, but they’re hoping…
Denise Robitaille
There’s a great scene in The Agony and the Ecstasy where Pope Julius, played by Rex Harrison, reacts to the paint dribbles from Michelangelo’s perpetual work on the Sistine Chapel. He’s processing out of the chapel after Mass and Charlton Heston, in his role as the great artist, has unceremoniously…
Denise Robitaille
Many of us quality professionals have been teased by our families on more than one occasion for applying quality principles to everyday life. “I know you said you did your homework, but I’d like to see the evidence.” Admit it; many of you have been caught using quality speak around the house.…
Martin Zwilling
The processes followed by most small- and medium-sized companies to prepare for or maintain an ISO 9001 registration have been largely manual rather than computerized. Employees are expected to key in or type the required quality documents, physically draw process diagrams, and spend hours…
Denise Robitaille
Last month’s column dealt with how to effectively communicate a finding of nonconformity in an audit report. It’s pretty straightforward: Here’s the requirement; there’s the evidence. They don’t match. Observations, which are now often called opportunities for improvement (OFIs), aren’t so cut and…
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…
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
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…
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…
