Dan O’Leary, president at Ombu Enterprises, LLC, started an interesting discussion on LinkedIn’s Corrective and Preventive Action Group. He was wondering where the term “root cause” came from.
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Risk management is a sore point for a lot of start-ups during their product development programs. FMEAs, FTAs, ISO 14971- the sheer number of acronyms alone is staggering! I excitedly introduce you to another one – the MHL, or Master Harms List. Aligning product failures identified in risk management activities with their corresponding clinical harms sometimes becomes very labor intensive. In attempting to ensure that all relevant harms associated with a product’s component failures are captured, the engineer is presented with an expansive list of possibilities. Consumer risk is a permanent priority: thorough risk analysis is forever coupled with patient and physician safety. Drawing from multiple sources and inputs - whether from other hazard analyses, customer complaints, instructions for use or otherwise - the engineer may become overwhelmed with the plethora of available data and overlook some of the simpler and more frequently occurring harms. The preparation of an MHL gives you a leg up on the competition by giving you a “one-stop-shop” for all of your harms and eliminates the difficult task of assembling a coherent list from a multitude of sources.
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This article is based on a presentation the author gave at the FoodSafetyTech Conference on May 17, 2013 in Chicago.
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Do we do a good enough job at identifying the real issue or are we in such a hurry to meet a requested deadline that we simply take the word of the requestor? How do we know we are truly solving the issue and not just meeting a request?
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We’ve all heard about quality management journeys or trips down the quality lane. I heard someone recently equate quality to following the yellow brick road. Quality similes are usually about pathways but this week, I read a new description.
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If you’re working in the medical device industry, chances are you’ll be heading for MD&M West in Anaheim next week. MD&M West is the world’s largest medical OEM event.
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Each year, there seems to be a buzzword that pervades the business community. This year, I recall hearing the word “collaboration” more than ever. For most organizations, the word is synonymous with “participate.”
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Anyone who keeps an eye on the FDA’s website for enforcement actions and warning letters knows that violations pertaining to corrective action and preventive action (CAPA) are among the most common issues cited by the agency (1).
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Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!
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It seems like the clinical research world is often thought of in terms of pharmaceuticals. Clinical trials are often referred to in Phases, such as “a Phase 2 study of a new drug” or “a Phase 3 randomized clinical study with a placebo control.” Although clinical trials for medical devices have many similarities to those for pharmaceuticals, there are some necessary differences in the way the trials are designed and carried out. And in some cases, for medical devices, clinical trials may not even be required!
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So you’ve implemented a new software system, and you’re supposed to go live with it in four weeks. It has taken you months to get to where you are: months bordering on a year. You’ve had to let some of your normal job responsibilities slide because of how much time this implementation is taking, but it can’t be much longer, right? You go through your checklist: Is the system configured the way you need it to be for your company? Check; or at least you think so. Are your documents imported and easy to find? Check; well, you can find them, but you honestly don’t know how your end users will find them. Do you have a support group at both your company and the software provider on the ready? Check; kind of. The people in your group went through the same training as you did so that means they know at least as much as you do, and you have a business card from the software trainer and the number for tech support if something goes wrong. Have you developed and distributed the end-user training? Hmmmm, no. Well, that can’t be too hard, right? Just take a couple of screenshots, write some steps, and bang—you have end-user training.
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“If it isn’t written down it didn’t happen” is drummed into everyone working within the pharmaceutical industry.
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Two years after the Food and Drug Administration Safety and Innovation Act (FDASIA) became law, the FDA has taken a step forward in requiring electronic submissions under FDASIA. Do you know how this new requirement is going to affect your submissions?
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Quality guru Ken Peterson has dedicated his career to helping organizations like Abbott Laboratories, Kodak, and IBM devise better quality management solutions that allow them to maximize efficiency and resolve problems faster. In the first of a three-part series of complimentary webinars available from MasterControl, Peterson breaks down quality management into three distinct segments: quality events, issue review, and corrective and preventive actions (CAPA). You can view the free webinar in its entirety here. No registration is required to access the recorded presentation—just click and play!
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It’s not enough to come up with a corrective action for a quality event. It’s critical to have the right action that actually fixes the problem and prevents it from recurring.
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A previous post to this blog covered some of the highlights of a recorded MasterControl webinar that discusses best practices for corrective and preventive action (CAPA) systems. The free recording is presented by quality expert Ken Peterson, a prominent consultant who has decades of experience with risk management, customer service, and CAPA systems. Peterson has devoted his quality expertise to a long list of successful companies such as Pfizer, Abbott Laboratories, Kodak, and IBM.
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Global Food Safety Conference 2014 kicked off recently in Anaheim, California with a record-breaking attendance. It seems that everyone is concerned about the condition of the food they eat, if they have it to eat.
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According to a study by Gartner Research, nearly four in ten major software purchases end up as “shelfware,” i.e., software that is purchased and never implemented or only marginally configured and/or deployed. Why? Often, it is because of the application itself or the perceived unresponsiveness of the software vendor’s implementation consultants. Rather than compromise efficiency, or redesign proven processes which took years to develop and implement, an organization will opt to delay or abando
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There were so many people everywhere you went that it felt like a real crush. I’ve got to tell you that a foot massage every night would have been really useful. “
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In a tough economy, quality professions often find themselves having to convince management that swapping their paper-based QMS for an electronic one is worthy of the expense and will translate into bottom-line, as well as compliance, benefits. While the regulatory and legal drivers for automating your quality processes are irrefutable, the frequently overlooked operational and business opportunities enjoyed by organizations that implement an electronic QMS are equally compelling. Simply put: compliance is good for business, and the right QMS software can help you transform your compliance challenges into tangible business advantages.
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