Search Results for "root cause"

  1. Integrating usability testing into your design process
    This article explains how you should be integrating usability testing into your design control process–especially formative usability testing. Why you should be integrating usability testing into the design We recently recorded an updated usability webinar and released a usability procedure (…
  2. ISO 14971 Risk Management Updates in ISO/DIS 14971:2018
    This article describes updates being made to the ISO 14971 Standard in the new draft version released for comment in July 2018. There are two versions of ISO 14971 that are currently available. The first is the international version: ISO 14971:2007. The second is the European normative version: E…
  3. Purchasing Controls and Supplier Qualification
    This article identifies the requirements for purchasing controls and supplier qualification procedures, as well as best practices for implementation. Purchasing Controls Sourcing suppliers in the medical device industry is not as simple as going on the internet and finding your material and purchas…
  4. Implementing Procedures for CAPA, NCMR & Receiving Inspection
    The article shares lessons learned from implementing procedures for a new ISO 13485 quality system. This is the second in a series. The first month of procedure implementation was covered in a previous article titled, “How to implement a new ISO 13485 quality system plan in 2016.” Typically, I…
  5. FDA 483 Inspection Observations Pareto Chart for FY 2015 Data
    This article presents a Pareto Analysis of FDA 483 inspection observations from FY 2015. It compares the trends observed with a similar Pareto analysis that was performed a couple of years ago on FY 2013 data. Method of Data Analysis for FDA 483 Inspection Observations The FDA posts Excel spreadshe…
  6. Minimum Data Points Constituting a Trend Is 3?
    This article explains why three is never the right answer, and this article explains why asking how many minimum data points are needed to identify a trend is the wrong question. Recently a client sent me an email asking the same question about data analysis in two different ways. The first questio…
  7. Case Study Part 2: Packaging CAPA Preventive Action and Corrective Action
    This article explains details of implementing a CAPA preventive action and corrective action for packaging issues. Specifically, containment measures, corrections, corrective actions, and preventive actions to address the root cause identified in part 1 of this case study. Comparing Incoming Inspec…
  8. Case Study Part 1: Packaging Complaint Investigation
    This article explains how to perform a packaging complaint investigation using a case study example of flexible packaging that was found open by a customer. This is part one of a two-part article. The second part will focus on the CAPA Process. Specifically, containment measures, corrections, correc…
  9. Strategic planning of a mock FDA inspection
    This article shows you how to think strategically when you plan a mock FDA inspection to ensure that you successfully prevent an unpleasant FDA inspection. For the past couple of years, several clients have asked me to conduct mock FDA inspections to prepare them for a potential FDA inspection. I a…
  10. How to create a risk-based CAPA process
    This webinar explains how to create a risk-based CAPA process, and you will learn how to implement corrective and preventive actions step-by-step. Your cart is empty When is the webinar on how to create a risk-based CAPA process? The risk-based CAPA webinar was last recorded on April 5, 2017. We …
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