Showing items tagged as Corrective action and preventative action (CAPA)

  • Sound Risk-Based Decision Making in Process Validation

    13 March, 2014 by Robyn Barnes, Marketing Communications, MasterControl Inc.

    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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  • Making the Business Case for Implementing an Electronic QMS

    18 March, 2014 by Lisa Weeks, MasterControl Inc., Marketing Communications

    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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  • Taking Effective Actions: CAPA Webinar Part 2

    25 March, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    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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  • MasterControl 's Ken Peterson and Patricia Santos-Serrao Featured SQA Speakers

    1 April, 2014 by Robyn Barnes, Marketing Communications, MasterControl Inc.

    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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  • Making SMART Choices When Managing Quality Events: More Helpful CAPA Tips

    2 April, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    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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  • Conducting an Effective Failure Investigation: Going Deep Enough to Hit Root Cause

    24 April, 2014 by Christine Park, Quality Architech, Christine Park & Associates

    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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  • 7 Steps to CAPA Success

    10 June, 2014 by David R. Butcher, Marketing Communications, MasterControl

    A formal Corrective Action/Preventive Action (CAPA) can be a powerful tool for meeting current regulatory requirements. Done right, the systematic investigation of the root causes of identified problems or identified risks will prevent their occurrence or recurrence. For many companies, however, a crucial obstacle to CAPA success persists: adequate documentation of actions taken to achieve quality success.

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  • Why Do Corrective Actions Fail?

    23 September, 2014 Ed Grounds, President Integrated Solution Providers Software, Inc.

    Each year, the most popular learning course we provide is targeted at developing the skills necessary for our customers’ associates to implement their corrective action programs effectively and efficiently. Throughout the years, we have been asked the same question hundreds of times, “What are the most common reasons corrective actions fail?” Usually this question is asked during the corrective action learning session by a management team member hoping that we will deliver the message to the other team members that they are failing. Normally, we turn the question back around to the group and ask them why they think their corrective action program fails. The most common answers we hear are: limited time, resources, training, or not knowing which tools to use.

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  • Basics: Documenting a Real QMS

    18 December, 2014 T. Dan Nelson, Consultant

    Using ISO  parlance, a management system is designed to achieve objectives.   In the case of a quality management system (QMS), the most basic objective is to succeed by satisfying customers.  A QMS is a system designed to satisfy customers by providing them with timely, quality products and services.

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  • Risk Management: A Primer for Lean Quality Assurance

    6 January, 2015 Gina Guido-Redden Co-Founder, Coda Corp USA

    In this article, we will take a closer look at what is becoming perhaps the most useful tool in the belt of today’s quality professionals: risk management.

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  • CAPA Should Not Be a Dreaded Four-Letter Word

    5 February, 2015 Cindy Fazzi, Editor, MasterControl Insider

    In a regulated environment, CAPA is a requirement for addressing and mitigating deviations and nonconformances. A quick review of FDA warning letters indicates it’s a dreaded four-letter word for many companies cited for violations.

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  • FDA Audit Practices: the 10 Most Commonly Cited Drug GMP Deficiencies of 2012-2013

    10 February, 2015 Ken Christie COO, VTS Consultants, Inc.

    If there is one word within the life science industries that causes concern and anguish it is “audit.” As with any evaluation process, the success of getting through a regulatory audit is a combination of preparedness with regards to what to expect, knowing the current regulations that apply to your product and knowing what tends to be the areas of deficiencies in audits performed. All of these items can be researched on the web and the time and effort to review and provide training on them will serve companies well.

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  • Infographic: How Evolved Is Your Quality Management System?

    17 March, 2015 Lisa Weeks, Marketing Communications, MasterControl

    Quality management systems (QMSs) have steadily evolved over time. The sophisticated systems of today are a far cry from the primitive paper-based systems of the past. They're faster, leaner, greener and just plain better. How did we get to where we are today? And is your company at the top or bottom of the QMS evolutionary chain? View the infographic, or keep reading to learn more about the evolution of the enterprise QMS.

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  • How to Tip Off a GCP Auditor in 25 Words or Less

    21 May, 2015 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    When our GCP auditors conduct training and deliver guest lectures, they frequently hear those questions from class attendees. Sometimes the tip-off is something very subtle that requires the keen eye of an experienced auditor to notice. And other times, not so much.

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  • CAPA and Root Cause Analysis for the Food Industry

    2 June, 2015 Dr. Bob Strong, SAI Global Assurance Services

    A thorough and effective CAPA can provide many benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections.

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  • Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

    28 July, 2015 Kelly Thomas, Atlantic Validation

    Successfully completing a FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection management techniques can help mitigate the risk of receiving an observation for compliance gaps. This article will provide insight on understanding the inspector, discuss how to prepare for and manage the actual Inspection, describe follow-up activities required for close-out, as well as describe real-life lessons learned.

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  • Education And Corrective Actions: The Solid Foundation Of Food Safety Culture

    20 August, 2015 Sam Lewis, Associate Editor, Food Online

    There is no doubt about it; it is getting more and more difficult to be a successful food processor or manufacturer. The supply chain continues to grow and become more complex, food safety regulations across the globe are becoming increasingly stringent, consumer preferences are constantly evolving, and the food industry’s workforce seems to be continuously changing. All of these trials amplify the importance of managing risks, keeping the public safe, and maintaining consumer loyalty to your brand. So, what can you do to manage this incessantly-growing number of risks?

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  • Hacking GMPs: Deliberate Attacks or Accidental Workarounds?

    17 September, 2015 Vivian Bringslimark, President & Owner, HPIS Consulting, Inc.

    The subtitle tells it all. Most employees don’t come to work with the intention to cause harm, fail or make mistakes intentionally. Yet mistakes, errors, and failures happen. According to Sidney Dekker, author of The Field Guide to Understanding Human Error, “mismatches between written guidance and operational practice always exist”. I’s due to “the amount of increasingly tight constraints of procedures” (p.8). There have been some occasions where following a procedure could have caused a deviation if it weren’t for an astute technician who questioned the “GMP” rule. Talk about a GMP dilemma, “always follow the SOP” but don’t create a deviation either. Alas, we have a classic example of a white hat hacker.

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  • How Donald Trump and/or Hillary Clinton Would “CAPA the USA” if Elected in 2016

    3 November, 2015 Marci Crane, Marketing Communications, MasterControl

    Although a long list of candidates make up the list of “eligibles” for the 2016 Presidential election, it’s fairly apparent that the two most conspicuous candidates are, respectively, Democrat Hillary Clinton and Republican Donald Trump. These two candidates, though liked and disliked by various population pockets across the United States, have certainly managed to make names for themselves within their various areas of expertise.

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  • New Developments in IEC 60601 Amendment 1 & Risk Management: Part I

    19 January, 2016 Mark Leimbeck, Program Manager, UL EduNeering

    When the 3rd Edition of IEC 60601 was published, two significant changes from the 2nd Edition were introduced: first, an expansion in the scope of the Standard from Basic Safety (only) to include Essential Performance; and second, introduction of a requirement for assessment of the Risk Management process applied by manufacturers in developing their medical devices.

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