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Showing items tagged as Process

  • "We're Different!" Overcoming the Challenges of Applying Lean Principles to Knowledge Work

    27 April, 2017 MasterControl

    If you are applying lean management principles to R and D, life science, or other knowledge work processes, you’ve probably heard the "we're different” argument. It usually goes something like this, “You can’t apply lean process improvement techniques to creative work because everything we do varies."

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  • Ignoring This Overlooked Risk Management Metric Leads You Down The Path To The Dark Side

    13 October, 2016 by Ed Rusch, Vice President, Corporate Marketing, Elemica

    Hurricanes. Power outages. Socio - geopolitical upheavals. Train derailment. Road closures. Contamination in a supplier facility. Terrorism, cyber-attack, sabotage or industrial espionage. Labor unrest. Global pandemic. Fires, floods and natural disasters. These incidents are not a work of science fiction and the number of them that can negatively affect the supply chain are real and virtually limitless.

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  • Accelerate Time-to-Market by Improving Process Validation

    24 May, 2016 James Jardine, Marketing Communications, MasterControl

    Process validation, a general term for critical disciplines such as risk mitigation/management, quality assurance and change management, is something that far too many life science manufacturers only worry about when a product is just about to go to market. That late in the game, though, it can be hard to produce the required and relevant information that has accumulated during years of product development. In a recent article in PharmTech titled “Reducing the Documentation Burden in Process Validation,” Patricia Santos-Serrao, RAC, of MasterControl explains how regulatory agencies define process validation as it pertains to the collection and evaluation of data from the process design stage all the way through to commercial production.

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  • MasterControl Revs Up Improvement

    28 April, 2015 Craig Gygi, Executive VP Operations, MasterControl

    The de facto standard for excellent business operations is Lean Six Sigma. Only five years ago you could not say that. But today, in every industry and in every geography, companies have figured out that the principles and practices of Lean and Six Sigma are the world-class standard for designing, configuring, improving, and controlling business.

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  • After Five Years, Compliance-First Approach is Still Obstacle to Improving Product Quality

    3 March, 2015 Dan Matlis, Founder and President, Axendia

    Five years ago we looked at the road blocks to improving product quality.  In the intervening years there has been little change by most Med-Tech Companies.  The matter of Product Quality vs. Compliance recently has been given a push toward the Quality side by efforts made by the FDA.  The four-part whitepaper reveals how aligning process improvement initiatives with technology platforms and an integrated approached to product quality can help Med-Tech organizations improve produc

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  • Risk Management in Clinical Research: Process and Application

    29 January, 2015 Emily Haglund, Clinical Auditor, IMARC Research Inc.

    Recently, two key pieces of guidance were released from Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding risk based approaches to clinical research. These documents include FDA’s “

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  • How to Design for Compliance: Tips for Getting (and Keeping) Your New Product on the Market

    30 October, 2014 Lisa Weeks, Communications Specialist, MasterControl

    Having a great product does not guarantee success. The road from concept initiation to commercial release is a long and arduous one. Success depends upon not only understanding the new product development process, but also the FDA submission process, and the complex interplay between the two. Many companies underestimate the value of a carefully thought-out submission strategy. They focus solely on product development and treat the approval process as an afterthought. Others are so eager to get their product to market, they rush the design and testing processes and end up with a product that’s dogged by costly delays or, worse, unmarketable.

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  • Six Easy Criteria for Targeting a Good Process

    6 May, 2014 Jason Piatt, President, Praestar-Consulting

    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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  • How Do I Follow The Trail?

    1 May, 2014 by Jamie Colgin, President, Colgin Consulting, Inc.

    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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  • Quality Beliefs Determine Behavior

    29 April, 2014 by Craig Gygi, Executive Vice President Operations, MasterControl Inc.

    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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  • An Introduction to Metrics Collection and Usage

    20 March, 2014 by Christopher Ball, Senior Professional Services Consultant, MasterControl Inc.

    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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