Author Archives: greg

#43 – AVOIDING THE CAPA CALAMITY – KEN PETERSON

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Anyone working in quality management is familiar with references to “Death by CAPA” or “CAPA Kills.” The industry is rife with similar catch phrases. The “truth” is they are not far from the “truth.” When my friend from FDA originally coined the expression “death by CAPA,” it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all that needed to be examined was always caught. To avoid your own CAPA calamity, let’s examine two key distinguishing features of a good approach to CAPA management. Continue reading →

#43 – DO YOU KNOW THE COST OF A BAD HIRE? – ELIZABETH LIONS

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Elizabeth Lions PixYou know the one. The one that comes in late or calls in on Monday mornings right before a major project is launched. Or the employee that is constantly negative, bringing down the team because they always have to be right. Or the employee that you just cannot coach,  no matter how hard you try to test your leadership skills.

According to a Forbes article by David K. Williams, the cost of a bad hire can run you anywhere between $25,00-$50,000. These hidden costs quickly add up when you look at a recruiter’s salary, job postings, interviewing, training and related equipment like phones, desks and computers. Continue reading →

#43 – QUALITY MANAGEMENT SEEN THROUGH THE MANUAL – T. DAN NELSON

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T. Dan NelsonA quality manual is supposed to describe a quality management system (QMS), a system of processes working together to output product. A quality manual defines a QMS, whether or not ISO 9001 certification is among management’s objectives.

OPERATIONS AT THREE LEVELS
A work instruction (level three QMS documentation) describes operations at an activity level. It describes how specific activities are supposed to be carried out. “Insert nut A onto bolt B and torque to 20 lbs.” Defining operations according to ISO 9001 requirements at this level, instead of defining them according to internal processing requirements, is not useful to anyone, nor is it necessary. Continue reading →

#43 – RISK MANAGEMENT IN THE ACQUISITIONS CYCLE – JULIUS HEIN

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Julius HeinIf you are a manufacturer, a supplier or a customer, your overall objective when you want to buy a product is complete satisfaction with the performance, maintenance and support. These are exactly the objectives of the International Quality Management System Standards.

The best way to explain the objectives of the Standards is by using an example and walking through the whole acquisition cycle. Continue reading →