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FMEA Process
FMEA process overview

  FMEA = Failure Modes and Effects Analysis

  • Risk Assessment: Failure Modes and Effects Analysis (FMEA)
  • Implement risk based strategies for ISO 9001:2015, ISO 14971
    • Identify failure modes for each process or item
      • Identify effects and severity
      • Identify causes and frequency
      • Identify current controls and detection levels
    • Develop multiple actions associated with this failure mode
      • Assign owners and due dates
      • Establish verification and validation criteria
  • Electronic signature for management approval
  • User login: define user passwords and privileges
  • Rich set of reports
    • Track open actions and delinquent due dates
  • Build a simple and efficient Quality Management System (QMS)
  • Implement risk based thinking required by ISO 9001:2015
  • Easy to use
    • Collaborative platform
    • Simple, menu driven user interface
    • Easy to train users
  • Convenient, intuitive forms
    • Can restrict users to control data integrity
  • Rich set of reports
    • Easy to identify delinquencies, stalled actions
    • Reports may be emailed with a single click
    • Export data to Excel for further analysis
  • Built using Microsoft Access
    • Common, convenient software platform
    • Free runtime version of Access is available from Microsoft

Note: For the demo version, log in as employee = AdminĀ  Password = admin

Download the FREE DEMO, if you have Microsoft Access 2007, 2010, 2013, 2016/Office 365 (32 bit or 64 bit) installed.


If you do not have Microsoft Access installed, 1) download and install the free Microsoft Access Runtime and then 2) download the database demo above.

Contact Us If you have Microsoft Access 2003 installed.

If you want a PowerPoint presentation showing features, benefits set-up and use of the FMEA Database Tutorial, download the Tutorial.

If you want an introductory tutorial showing common tips and tricks to make the most out of using Microsoft Access, download the Tutorial.


Buy FMEA Database Software

Single User License:
5-User License:
Unlimited User License:
Source Code
Value Licensing

Licensing is based on concurrent or simultaneous users – not CPU based.
One Price

No annual maintenance contracts are needed!
Additional Users
Additional users may be added at a later time by simply purchasing and entering a new activation code.


  • Microsoft Windows XP, Vista, Windows 7, Windows 8/8.1, or Windows 10
  • 64 MB of RAM
  • 40 MB of available hard disk space
  • If you do not have Microsoft Access installed, you may download a free runtime version from Microsoft by clicking here.