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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
    By Craig Alexander, P.E., Monsanto Co. Using the criteria in Table 1, the FMEA team met several times to evaluate each line item generated during the brainstorming sessions. For each line item, the team reviewed the potential effects of a failure. This led to the assignment of a severity rating
  • 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
    . This categorization made it easier to break the list down into smaller sections for the FMEA. Failure Mode
  • 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 that
  • Equipment Design Review & FMEA Success Story
    A US provider of medication handling systems to hospitals and long-term care facilities was failing to make significant progress on the alpha system for an innovative approach to medication management. The company engaged the services of Pre Automation Solutions to validate the business case,
  • Medical Device Link .
    , to systematically reduce risks, issues, and defects in their products. FMEAs and control plans are proven techniques not only for mitigating risk, but also for driving continuous improvement. An FMEA is a technique that enables identification and prevention of process or product errors before they occur (see
  • Embracing Risk
    regulatory bodies, the medical community, and most importantly, the public. The tools for quantifying this risk are tried and true. Tools such as Fault Tolerance Analysis (FTA), Failure Modes and Effects Analysis (FMEA), Hazard Analysis and Critical Control Point (HACCP) have been used by industry

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