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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
  • Failure Modes and Effects Analysis
    What could go wrong. Electronic engineers often use FMEA (Failure Modes and Effects Analysis) in the design process as a discipline to meet quality standards for regulatory or customer requirements. At Stilwell Baker, we think FMEA also has a place in the product development process-even when
  • Increasing Reliability through Oil Analysis
    . CMMS (A-L). CMMS (M-Z). Condition Monitoring. Failure Analysis. Fleet Management. Job Request System. Maintenance Audit. On-the-job software. Other. RCM/FMEA. Safety/Lockout/Tagout/Environmental. Shutdown Management. Spare Parts Analysis. Tool Control. Searchable Software Database. Free Software
  • 2001 "Root Cause Analysis " Survey Results
    software. Other. RCM/FMEA. Safety/Lockout/Tagout/Environmental. Shutdown Management. Spare Parts Analysis. Tool Control. Searchable Software Database. Free Software Downloads. by Package Name. by Software Type. by Restriction Type. Tools. Benchmarking. Current Survey. Discussion Forum. News. M-News
  • Condition Monitoring of Steam Turbines by Performance Analysis
    /Reliability/LCC Modelling. CMMS (A-L). CMMS (M-Z). Condition Monitoring. Failure Analysis. Fleet Management. Job Request System. Maintenance Audit. On-the-job software. Other. RCM/FMEA. Safety/Lockout/Tagout/Environmental. Shutdown Management. Spare Parts Analysis. Tool Control. Searchable Software
  • Root Cause Failure Analysis - Understanding Mechanical Failures
    . Availability/Reliability/LCC Modelling. CMMS (A-L). CMMS (M-Z). Condition Monitoring. Failure Analysis. Fleet Management. Job Request System. Maintenance Audit. On-the-job software. Other. RCM/FMEA. Safety/Lockout/Tagout/Environmental. Shutdown Management. Spare Parts Analysis. Tool Control
  • Medical Device Link . Risk Analysis: A Never-Ending Part of Risk Management
    tools used in the risk analysis process are the failure mode and effects analysis (FMEA)/ FME and criticality analysis (FMECA), which is a bottom-up approach starting at the component level, and the fault tree analysis (FTA), a top-down method. Campbell said that FMEA might typically involve

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