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Most companies understand that the collection of data can be valuable but often don’t really rationalize what they want to collect.
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In the second webinar of a three-part series from MasterControl, quality expert Ken Peterson demonstrates how companies can develop better corrective and preventive actions (CAPA) to ensure quality and compliance. In the second installment, Peterson focuses on key decision points and the types of actions that should be taken depending on the quality event. He points out the importance of containing issues at the department level, if possible, before moving them into a formal CAPA process. Peterson discusses four possible actions to be taken when dealing with quality events: no action (the “wait and see” approach), corrections (with a focus on the immediate situation or containment), corrective actions, and preventive actions (to preemptively deter issues from occurring in the future).
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Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products. For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others.
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MasterControl will provide demonstrations of its document management and quality management solutions at the 30th Society for Quality Assurance (SQA) Annual Meeting to be held April 6-11, 2014 at the Cosmopolitan of Las Vegas in Las Vegas, Nevada.
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A previous blog post provided an overview of a portion of quality guru Ken Peterson’s “Taking Effective Action” webinar (the second of a three-part series) that outlines the keys to successful CAPA programs. This post summarizes the remainder of the second webinar in the series which can be viewed here.
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We present a summary of available options to request additional review of FDA decisions or actions, including how to choose an option when a stakeholder has reasonable grounds to disagree with FDA/CDRH’s decision. It is worthwhile to note and get familiarized with the available options. However, it is recommended the stakeholder try to avoid having such situations in the first place.
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After writing, revising, and signing the finalized audit report, most independent auditors move on to their next project.
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More and more regulated companies are using electronic quality management systems, but the concept of software validation remains a mystery to many engineers and quality professionals. In this article, I will try to shed light on the underlying goal of software validation within the context of FDA guidelines and offer a practical strategy.
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I recently had the opportunity to chair a track and present a session on FDA and a Global Regulation in Practice at the MD&M West Conferen Trouble-Free Validation with MasterControl (1:38)ce. The conference was held at the Anaheim a Convention Center from Monday, February 10th through Thursday February 13th, 2014. Below is a summary of the proceedings for Day 2: NAVIGATING THROUGH THE PMA AND 510(K) SUBMISSION PROCESSES.
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The ability to adapt to change is critical to the success of any business. However, for companies that operate in FDA-regulated or ISO-certified environments, adapting to change and more importantly, being able to control it, is critical to maintaining compliance. Of course, it’s not just regulatory agencies that are demanding higher-quality products; today’s more sophisticated consumers expect the medicines, automobiles, and devices they purchase to be safe and effective, too. They also expect them to cost less and be developed more quickly and efficiently. Better, safer, faster, cheaper…it’s a tall order for any regulated company. Organizations that respond quickly to increased regulation and consumer sophistication will become inherent market leaders. How does your company respond to change?
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Many would chuckle at this story as a simplistic analogy. Yet, there are many lessons from this example that could apply to a medical device facility. No, it’s not a controlled document in the sense most understand it. But the owner would not want it to be this morning’s breakfast menu during dinner, or to display last year’s prices. Nor would she want it to show meal options that are not available.
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The FDA has increased focus on the effectiveness of failure investigations during recent inspections. A review of recent 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to really identify root cause.
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A few years back, I helped an international holding company assess the operations of their portfolio of companies. They wanted to know things like, “How Lean is the operation at each company?” “How far along is each company in its Six Sigma improvement journey?” And “What are the common opportunities and strengths we can build upon?” I visited company sites, reviewed operation activities, collected data, and interviewed executives and staff. I found that in many ways, the foundation for excellence in operations can be boiled down to a single, simple question: “How do you define quality?”
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One of the most effective audits I ever participated in started with a systems-naive auditor asking a simple question: "Imagine I'm a sample arriving at your loading dock. What happens to me?" We proceeded down the trail together, following the sample through the processes of accessioning, analysis, reporting, and storage.
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Whether we’re practicing Lean or Six Sigma, what we’re really targeting is process improvement. The process could be technical, commercial, or a support-process to the standard order-to-delivery process within the context of our manufacturing environment. All too often, manufacturing executives mistake a sequence of activities to be a process. That’s simply not the case. So, what makes a good process?
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In the past 10 years that I’ve been working with highly regulated companies, I’ve seen many organizations find out the hard way that quality does not occur by accident. Quality requires good planning, design, and execution.
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In the wonderful world of medical device regulation, a manufacturer may find it easy to become confused with FDA rules. When your product moves to the international market, there are new rules that must be followed to get your product to market.
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In my experience working in medical device product development and product management, maintaining the design history file (DHF) posed daunting challenges because it was a process that continued throughout the lifecycle of a product. Even years after a medical device is launched, it’s not uncommon for the technical lead to revisit the DHF because the product is undergoing an iteration or it’s being launched in another part of the world.
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When W. Edwards Deming famously said, “We are being ruined by ‘best efforts,’” he was conveying the idea that simply striving to improve—even with laudable effort—can actually have the opposite outcome. How can this be? How could good intentions and diligent work ever possibly sabotage us? Well, they do all the time.
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From SOPs and procedures to CAPAs and deviations, most regulated companies maintain document-based and form-based processes for compliance and business reasons. How do you get approval for your documents and forms? How many processes do you have and how long is your approval cycle time for each one?
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