FMEA for ISO 13485 Risk

FMEA Tool to Simplify Risk Management

Sunday Business Systems has made Failure Mode Effects Analysis (FMEA) into a better tool managing risk in your ISO 13485 quality management system. The unique FMEA database provides a scalable, capable and easy-to-deploy method for:

• Developing and executing risk-reduction plans
• Analyzing performance
• Developing improvement approaches
• Integration with other risk management tools such as Strengths, Weaknesses, Opportunities & Threats (SWOT) analysis – also included in our overall quality management SBS Quality Database

Key Features:                                                                                                                    

• List items, process steps, or functions
  • Identify Failure Modes for each
• Identify effects and severity
• Identify causes and frequency
• Identify current controls and detection level
• Develop multiple actions associated with this failure mode
  • Assign owners and due dates
  • Establish verification and validation criteria
• Electronic signature for management approval
• Rich set of reports
  • Track open actions and delinquent due dates

Making FEMA Simple, Powerful and Manageable

FMEA benefits are best realized when it is employed across a process, product or problem set. But disjointed data capture and reporting such as multiple spreadsheets, report formats, and unmanaged access can cause the process to break down. The SBS FMEA database solves these and other challenges by:

• Providing a simple, effective way of managing a range of FMEA’s across many groups, projects, and locations
• Enabling an effective and documented means for meeting the needs for global application of risk management required in the latest quality, environmental and safety management standards
• Increasing visibility of the FMEA and its recommendations through concise reporting, tailored to the level and expertise of user classes/types through standard FMEA formats
• Ability to easily track FMEA status and then the actions required to address the FMEA outputs (i.e. risk management, process improvement, etc.)
• Accountability via embedded project management functions such as electronic management approval signatures, easy-to-identify delinquencies/stalled actions, “single-click” email reports and data export

SBS FMEA Database Advantages

• 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
  • Runtime version of Access is available as a free download

FMEA Process Overview

SBS FMEA Database identifies effects severity, cause frequency and current controls and detection levels for individual items, process steps or functions. It also supports developing multiple failure mode associated actions, assigning owners, due dates, and verification/validation criteria.

Try it Now, Free

If you have Microsoft Access Database installed, you can immediately download LINK and install our free, fully functional demonstration software. (For those without Microsoft Access, download and install the free Microsoft Access Runtime and then download the database demo.) This will provide the SBS FMEA Database software to all workstations on your local network as a common, convenient software platform.

Easy Installation

• Download the demo database
• Save or copy the FMEA.accde file to a designated folder on your Network File Server
• Once purchased, register the demo database (enter the Product Key)
• Ensure all Workstations have
  • Microsoft Access or the free Runtime version of Microsoft Access
  • Read and write privileges to the designated folder on the Network File Server

About SBS

Sunday Business Systems is an innovative provider of quality systems management software including:

• Corrective and preventive actions (CAPA)
• Quality audit management
• Employee quality training
• Document control
• Calibration management
• Supplier management
• Surveys for customers, suppliers or others (i.e. satisfying “context of the organization” requirements)
• Communication/continuous improvement
• Shop floor control

SBS also offers customization of any of the above software and in-depth training for its implementation.