Search Results for "root cause"

  1. 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…
  2. 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…
  3. CAPA Advice – 15 Tips for Creating an Effective CAPA Form
    Your cart is empty This blog reviews 15 tips for creating an effective CAPA form, including CAPA source, description of the issue, investigation of the root cause, and more. The reason for creating a “great CAPA form” is to improve the effectiveness of your CAPA process. Anyone in your compa…
  4. Client Testimonials-Medical Device Academy
      Client Testimonials-Medical Device Academy “While searching for guidance on how to validate an IFU, I came across the webinar on ‘IFU Validation and PMS’ sponsored by Medical Device Academy. It was very helpful – not only did I get an understanding of validating an IFU but learn…
  5. CAPA Training Remediation Case Study: Hundreds of Open CAPAs
    This blog presents a CAPA training case study related to hundreds of open CAPAs, and how to effectively remediate this issue using a CAPA filter to avoid “death by CAPA.” Years ago, when I took my first CAPA course, the student sitting next to me explained that he was taking the course a…
  6. An Auditor’s Best Practices in Issuing a Major Nonconformity
    From the opening meeting through the audit and closing meeting, the author describes an auditor’s best practices in issuing a major nonconformity. As an auditor, one of the most important (and difficult) things to learn is how to issue a nonconformity—especially a major. This is usually don…
  7. Preparing for ISO 13485 Certification in 5 Steps
    The author provides five steps in preparing for the ISO 13485 certification process, and his insights and tips for each step are reviewed. A LinkedIn connection of mine recently asked for sources of good guidance on ISO 13485 registration. I wrote a blog recently about Quality Management Systems…
  8. 10 FDA Inspection Strategies that DON’T Work
    If you were just notified of an FDA inspection and you don’t think you are ready, using tricks to hide your problems is a huge mistake. I have heard a few recommendations over the years for “secrets” to hide those problems. In this post, I share my favorite “secrets”…
  9. Supplier Management: Who Should Be Conducting Supplier Audits in Your Company?
    This blog reviews which a vital supplier management issue, which personnel should be conducting specific types of audits for the company. Today, I would like to start by asking a question: Who does supplier audits at your company? I believe that there are three primary purposes for conducting supp…
  10. When to Initiate a Corrective And Preventative Action (CAPA)
    This blog reviews the differences between a corrective action and preventive action, and when to initiate a corrective and preventive action. I’ve completed almost 100 audits in the past two years, and I review the Corrective Action and Preventive Action (CAPA) process during every single aud…
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