Search Results for "root cause"

  1. Redirection of Root Cause Analysis old page
    This page has been moved…https://medicaldeviceacademy.com/root-cause-analysis/ …
  2. 5 Tools for Root Cause Analysis and How to Perform a CAPA Effectiveness Check Webinars
     5 Tools for Conducting Root Cause Analysis – Free Webinar and PowerPoint Download “You cannot plan corrective actions if you don’t know what the root cause is.” –Rob Packard, Founder, Medical Device Academy This webinar includes information on – Key elements…
  3. Success – Here is your Free Root Cause and CAPA Check Webinars and PowerPoints
    Click Here to download your free Webinars and PowerPoints: Make sure you also receive our CAPA Toolkit – Click Here How to Improve Your CAPA Process Toolkit includes: Recorded One-Hour Webinar (.mov format) Native PowerPoint File (.ppt format) CAPA Report Form (FRM-009) CAPA Register Form …
  4. Root cause analysis – Learn 4 tools
    The author describes four tools (Five Why Analysis, Is/Is Not Analysis, Fishbone Diagram, and Pareto Analysis) and how each one can help conduct effective root cause analysis. Quality problems are like weeds. If you don’t pull them out by the root, they grow right back. Training on the 4 Tools Mo…
  5. Does your FDA inspection plan need to be proactive first?
    Maybe you need an FDA inspection plan. Does everyone in your company know what they need to do when FDA inspectors arrive at your facility? Be proactive and don’t just let FDA inspections happen. You need to have an FDA inspection plan, and that plan needs to cover the roles and responsbiliti…
  6. Are you a little curious, or fascinated by competitive warning letters?
    Did you know you can download competitor inspectional observations to learn which quality issues are likely to result in warning letters?   Not long ago the FDA published their Inspectional Observation Data Sets. They are Excel spreadsheets of the dreaded 483 inspection observations and warning let…
  7. How to get ISO 13485 certified, time for success?
    In this article, you will learn how to get ISO 13485 certified, and you will be successful while avoiding the stress that tortures other quality managers. There is a big difference between being ISO 13485 certified and being compliant with ISO 13485:2016, the medical devices quality management sys…
  8. What’s the difference between PMS, PSUR, and PSR?
    This blog is intended to help clear your justified confusion if you are wondering what the difference is between PMS, PSUR, and PSR.   The nine most terrifying words in the English language are, “I’m from the Government, and I’m here to help.” That quote is from a speech…
  9. Changes triggered by COVID19 in your quality system
    The 2020 global pandemic has changed life as we know it, but this article focuses on three crucial quality system changes triggered by COVID19. Last night my daughter Gracie mentioned that her teacher assigned an essay to write about three changes triggered by COVID19 in her life. The three things …
  10. NSE letter: A CAPA plan for your 510k process
    Cry, complain, call the reviewer…you might feel a little better, but you received an NSE letter, and tomorrow you still can’t sell your device. Instead, try approaching an NSE letter like a CAPA investigation. What is the issue? The FDA determined that your device is not substantially equiv…
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