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  • Washington Letter: FMEA as a Packaging Tool
    By Stephen Barlas, Washington Correspondent A July report on medication errors by the Institute of Medicine (IOM) underscored the utility of Failure Modes and Effects Analysis (FMEA) in managing risk. The FDA already endorses FMEA, describing it in a June Quality Risk Management guidance document
  • FMEA: A Risk-Based Approach to Sterility Assurance
    or impending failure. A detection rating was assigned based on Table 1 criteria. After this process, the Risk Priority Number for each FMEA line item was calculated and ranked by RPN. The first level of analysis was to create a dot plot of the RPN values from the table. The RPN numbers are mainly
  • FMEA: A Risk-Based Approach to Sterility Assurance
    method of improving sterility assurance using a risk-based approach. This initiative focused on the use of Failure Mode and Effects Analysis (FMEA) to identify potential weak points in the sterility management process. The manufacturing facility described here is still early in its life cycle. Thus
  • FMEA: A Risk-Based Approach to Sterility Assurance
    By Craig Alexander, P.E., Monsanto Co. Product recalls, consent decrees, 483s, lost batches. We all know what happens when drug manufacturers lose control of a critical quality parameter, or fail to estimate infrastructure needs. Experts agree that data monitoring, trending and analysis are all
  • Designing Safer Products Proactive Hazard Analysis
    Hazard analysis is the foundation of many other product-safety activities. The objective of productsafety efforts is to correct or address safety problems. There are many types of hazard analysis: Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and Preliminary Hazard Analysis
  • Medical Device Link .
    GUIDE TO OUTSOURCING: RISK ANALYSIS A growing number of medical device manufacturers have adapted tools used by automotive and other manufacturers. This is particularly true for risk plans known as failure mode and effects analysis (FMEA) and their operational counterparts, control plans
  • Medical Device Link .
    Meet MD &DI's Editorial Advisory Board Medical Device & Diagnostic Industry Revise the risk analysis (i.e., FMEA, FTA, etc.) as needed throughout the transition to account for the outsourcing configuration and new packaging. Prepare a concept document to capture (in general terms
  • Inventive Troubleshooting
    Modes and Effects Analysis (FMEA) and Hazard and Operations Analysis (HAZOP). These methods attack problems by organizing the available information in ways that sometimes let solutions fall out by inspection. FMEA, for example, forces developers to categorize failure modes, put a number on the degree
  • Process Excellence in the Manufacturing Value Chain
    aims, systematically, to eliminate variation by Defining, Measuring, Analyzing, Implementing and Controlling processes, abbreviated as DMAIC. Within Six Sigma projects, a variety of tools are employed. These include: Failure Mode and Effects Analysis (FMEA) - a systematic group of activities

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