Medical Health Care FMEA

Failure Mode and Effect Analysis and Risk Analysis for Medical Applications
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FREE Tools (MS Excell): Automatic FMEA    FMEA TOOLS2    fmeaIII  wwodbridgegroup

Byteworx FMEA Software

The global standard FMEA software of the Ford Motor Company, Byteworx FMEA is a powerful, cost-effective and easy-to-use tool for developing and maintaining your Failure Mode and Effects Analysis documents. Features include:

  • Design, Process, Concept and Machinery FMEA types
  • versatile data-entry libraries and rating tables
  • automatic “red light-green light” FMEA Quality Check
  • integrated Process Flow and Control Plan
  • automatic calculation of Special Characteristics and RPNs
  • import and export from FMEAPlus, Excel, Word and HTML formats
  • comprehensive reports including Top RPN, Top Criticality and Action Status

A free, time-limited evaluation copy of Byteworx FMEA is available on request – please visit www.byteworx.com for more information

FMEA Software - Increasing the Benefits of Your FMEAs

Review success stories from our customers and learn how other businesses and industries are advancing their use of FMEAs. The database, reporting features, and ability to link design and process assist users in improving efficiency, making more informed decisions, avoiding costly errors, and saving dollars. Our site provides detailed information on the software product, how you might implement it, as well as helpful hints on how to improve your overall FMEA implementation.

FMEA - Analisi dei modi e degli effetti dei guasti (In Italian as you perhaps already noticed)

Le normative QS 9000 richiedono l'applicazione di tecniche FMEA ai prodotti ed ai processi. FMEA, precedentemente utilizzata in settori specifici (aerospaziale, nucleare), è ora sempre più diffusa nel settore automobilistico.
FMEA permette di organizzare ed analizzare cause ed effetti dei guasti, distinte per i vari sottosistemi. Ai guasti vengono assegnati indici di probabilità (di accadimento) P, gravità G e rilevabilità R, che definiscono un indice di priorità di rischio (IPR) da 1 a 1000. Un sistema di gestione verifica l'esecuzione e l'efficacia delle azioni correttive pianificate per la riduzione di questo indice. Apposite macro permettono di preparare rapporti e presentazioni conformi ai formati VDA, AIAG, BS e QS-9000. FIAT in preparazione.

Customer Driven Systems - AutoDCP Quality Management Software

AutoDCP provides you keyboard-free fast construction of industry standard quality documents including the Process Flow Diagram, Design FMEA, Process FMEA and Control Plan. AutoDCP also provides you with fast implementation of engineering changes, line-balancing and process improvement efforts.

AutoDCP is designed and manufactured in the United States, though it is used and supported abroad. It is not only the single best FMEA software available, but is the only FMEA software which bridges the Design FMEA to the Process FMEA to Corrective Actions.

PlanTech's SCIO software solutions

FMEA Software - Increasing the Benefits of Your FMEAs
Review success stories from our customers and learn how other businesses and industries are advancing their use of FMEAs. The database, reporting features, and ability to link design and process assist users in improving efficiency, making more informed decisions, avoiding costly errors, and saving dollars. Our site provides detailed information on the software product, how you might implement it, as well as helpful hints on how to improve your overall FMEA implementation.

Easy-FMEA
A simple risk analysis improvement tool which prepares design and process failure modes and effects analysis (FMEA) documents conforming to most industry standards including QS9000.

You can create, edit, store, preview and print failure modes and effects analysis documents with a facility to create a read-only ADOBE.PDF file containing the document. A tailor-made FMEA program easier to use than a spreadsheet or word processor but just as effective.

A time-limited version of Easy-FMEA is available to download. This program can be converted into an unrestricted system with a registration code provided by Retriever Technology after a licence has been purchased.
TDC FMEA

Le logiciel AMDEC qui capitalise vraiment vos études de risque Produit / Process, et qui enregistre tout l'historique grâce aux AMDEC génériques.
Nos clients témoignent qu’ils obtiennent avec TDC FMEA, dans les 10 mois après la formation au logiciel, des gains significatifs de temps (jusqu’à 50%) dans la réalisation de leurs AMDEC.

SCIO™-FMEA professionalisiert Ihr Engineering u.a. durch:

- Vergleichbare Risikoprioritätszahlen über Bewertungsstandards
- Höchste Aktualität der FMEA-Daten durch globalen Zugriff
- Einfaches Handling der FMEAs
- Unkomplizierte Auswertung der Risikobewertung
http://www.reliability.com/proact/leap_software.htm

LEAP™ is a unique software tool that uses probabilistic data (basic Failure Modes and Effects Analysis) or historical data (Opportunity Analysis) to identify the "significant few" -- those 20% of events that cause 80% of losses. LEAP™ assesses what COULD or DID go wrong in any process and applies values to measure the impact on an organization. The result? Reactive work stops and productivity takes a quantum leap

RelFMECA Software

RelFMECA is Failure Mode, Effect and Criticality Analysis Software for the automotive, consumer electronic, aerospace & defence, and general manufacturing industries.
More info:  t.liu@ytforever.com

FMEA Software for Hospitals

Krouwer Consulting has been developing an integrated fault tree/FMECA application to help hospitals identify risks and propose mitigations. A fault tree is a top down cause and effect diagram that is useful in identifying risk. A FMECA (Failure Mode Effects and Criticality Analysis) allows one to propose mitigations for the risks identified in the fault tree. These tools are commonly used in engineering and are also described in the ISO document, 14197: APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES. JCAHO requires healthcare organizations in the USA to perform one FMEA a year. A tutorial and manual will accompany the software.  Email: jan.krouwer@comcast.net

 Achieving Zero-Defects Quality Software (FMEA & Beyond)

EPSYS is a new cutting edge software to help organizations achieve manufacturing excellence. Today your organization’s competitive advantage is effectively solving problems; tomorrow it will be mastering methods of prevention. Error proofing and designing for six-sigma are the battle grounds of world class organizations and where your competition is heading. Prezign provides a 100% web based solution solution which links all the traditional quality tools (D & P FMEA, Control Plans and Process Flow Diagrams with powerful error proofing and DFSS analysis. Email: todd.mielke@prezign.com

Interactive Failure Modes and Effects Analysis Tool

 Primarily intended for healthcare, but generalized for use in any environment, the Interactive FMEA Tool on QualityHealthCare.org is a powerful environment for defining your process, evaluating the impact of potential changes, and tracking your process improvement over time. Email: ebailey@ihi.org

http://www.eigenworx.com
We have recently released the software FMEAworx, which is a web-based software solution allowing manufacturing corporations to conducting their FMEA analysis. It supports analyzing the cause-and-effect mechanisms of failure effectively with a bulit-in FMM (Failure Mode Mechanism) diagram Editor.
http://www.noweco.com/sfmeae.htm.
NOWECO Northwest Controlling Corporation Ltd. : FMEA Software Tool

PathMaker is a software to run management projects such as FMEA: It does not only allow to create the well-known FMEA form from a template which may be re-designed by the user. It further also to plan the creation of FMEAs and act upon any findings.

http://www.sydvest.com
Sabaton FMEA
is a flexible and easy-to-use FMEA tool, and yet it provides advanced features. In Sabaton, four issues have been given particular focus: (1) Fully user definable analysis set up. You may select from a range of predefined analysis templates, and you can change the analysis set up and save it as a new template, even in an ongoing analysis. (2) Improve the analysis efficiency and quality, a.o. through the supporting hierarchical break down of the system, the powerful copy/paste features (including "paste special" and "paste external"), as well as through various features keeping track of, and viewing the analysis progress. (3) Old analyses provide basis for new, a.o. it is easy to start with an earlier analysis as a basis, or to copy/paste from earlier analyses. Further, by using predefined failure mode libraries linked to the component type. (4) Efficient reporting through user definable report templates. All reports can be saved in PDF format for electronic distribution. Other export formats are also available.

Further, Sabaton is developed to support you conducting analyses according to international standards such as ISO 9000, SAE J1739, SAE ARP5580, IEC 60812, BS 5760-5 or MIL-STD 1629. Calculation of RPN-number and other measures are available through fully user definable equations. Criticality analysis is offered by use of criticality or risk matrix with fully user definable matrix set up. Finally, all labels and other text that on the analysis form may be edited, thus analysis reports can be set up in different languages.

Further information about Sabaton FMEA, and a fully functional demo version, is available at the Sydvest web-page; http://www.sydvest.com.
http://www.drmtech.com
DRM Technologies has developed a reliability and maintainability modelling and documentation tool that can be used by tooling and equipment design engineers, plant and other personnel during the concept, design and build/install phases of the equipment life cycle.  eRAM NotesT allows the user to model and evaluate multiple R&M characteristics early in the design phase that will direct the team in pinpointing areas for design improvements. These design improvements can result in R&M tradeoffs of increased reliability of components and/or making the component more maintainable.
The heart of eRAM NotesT is its WEB based application, bridging the communication gap between the tooling and equipment supplier, plant, and engineering to ensure the documentation, reports and calculations are standardized to add stability to the R&M process.

eRAM NotesT allows multiple users to access the same job file and review failure modes, weak link analysis, component reliability data, life cycle costs, MFMEA and other important elements affecting the downtime of the equipment.  This fourteen-module, single-point documentation source standardizes the calculations for:  MTBF, MTTR, Availability, Reliability, Life Cycle Costing and Thermal Analysis. 

MFMEA Module - Develops the Machinery FMEA used to identify past corrective actions to remove failures from next design revisions.
o Helps identify potential design deficiencies before releasing equipment to production.
o Meets SAE J1739 FMEA requirements and addresses TE supplement reporting.

For more information, please contact Doug Malcolm or Carla Malcolm (Sales/Marketing) at (586) 978-8810, or email carla@drmtech.com.
http://www.noweco.com/sfmeae.htm
FMEA with PathMaker

PathMaker is a software to plan, do, check and act on management projects. You can do more things in PathMaker than just creating an FMEA. You can control the entire FMEA project. To do so PathMaker contains several tools such as:
- Flowcharts to display the process which you like to investigate
- Brainstorm/Affinity-Tool to search for failure modes
- Cause & Effect diagram to analyse the failure causes
- Consensus Builder to assess severity, occurrence and detectability by voting.

PathMaker contains a meeting feature including agenda and minutes enabling teams to create FMEAs and create preventive actions.

   

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Medical Health Care FMEA

Failure Mode and Effect Analysis and Risk Analysis for Medical Applications
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