Search Results for "root cause"

  1. 7 Considerations for Outsourcing Medical Device Complaints
      Investigating medical device complaints can be a time-consuming task. This blog reviews seven considerations for outsourcing medical device complaints. Two different clients of mine recently mentioned that they are overwhelmed by the amount of time required to investigate complaints and to file …
  2. Webinars: Medical Device Quality and Regulatory Requirements
    Training Webinars Available On-Demand New Webinars Scheduled Interview with Aaron Moncur – Test Fixture Design (Free) Tuesday, February 16, 2021 – 3:30 pm EST The following is a list of quality and regulatory training webinars that are available for on-demand purchase from this website…
  3. 7 Steps to Writing a CAPA Procedure Compliant with ISO 13485:2016
    Your cart is empty This article lists seven steps to writing a more effective CAPA procedure, ensuring that your procedure is risk-based and training people effectively. During a recent internal audit, I was performing for a new client, and I noticed that they were not meeting one of the requireme…
  4. Implementing Design Controls – 10 Steps
    The article explains ten steps of implementing design controls, including design plans, design inputs, design review, verification protocols, and risk management. FDA Guidance for Implementing Design Controls The diagram above is called the “Application of Design Controls to Waterfall Design Proc…
  5. Effective Management Solutions for 10 CAPA Program Blunders
    The author provides effective management solutions for ten real-life CAPA program blunders., (i.e., procedures, root cause analysis, closing CAPAs, etc.) Effective Management Solutions for 10 CAPA Program Blunders I am always looking for new and creative ways to help people understand the importan…
  6. How to Utilize CAPA Training To Avoid FDA 483 Citations
    By Guest Blogger – Susan Christie The author discusses how formal CAPA training can help solve the four most common CAPA deficiencies and help avoid FDA 483 citations. Corrective And Preventive Action (CAPA) is considered to be one of the most critical processes in a Quality Management Syste…
  7. Keeping Design Projects on Schedule: Using the CAPA Process
    The author provides two steps to consider taking now and steps to take in the future that will help keep design projects on schedule using the CAPA process. The ability to get new, high-quality products to market quickly is the most important core competency for a company to develop. What is your c…
  8. How to perform a quantitative CAPA effectiveness check
    This article review explains how to conduct a quantitative CAPA effectiveness check, and you will also learn three methods NOT recommended. There are three methods NOT recommended for a CAPA effectiveness check: verifying the procedure was revised, verifying employees were retrained, and making su…
  9. A3 Reports – The Missing Link to Effective CAPA Process Management
    Your CAPA process is the most important process in your Quality System for two reasons. First, CAPA is the tool you use to fix quality problems. Second, your CAPA process is guaranteed to be an area of interest for your next FDA inspector. If CAPA is so important, why do companies still have ineffic…
  10. Internal Audit, CAPA & Management Review
    Roadmap to ISO Certification:   Internal Audit, CAPA & Management Review – FX Audio Conference – November 19, 2013 – 11:30am-12:30pm Internal auditing, CAPA and Management Review are considered the three most important processes in a Quality Management System (QMS). This presentation fo…
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