What is FMEA Database?

Develop a straightforward and effective Quality Management System (QMS) which can be hosted on your local server or accessed via our Cloud QMS option. Adhering to ISO 9001:2015 mandates the incorporation of risk-based thinking. Conducting a Risk Assessment through Failure Modes and Effects Analysis (FMEA) is essential for implementing risk-based strategies aligned with ISO 9001 and ISO 14971. It is crucial to identify potential failure modes for every item or process, assess their effects and severity, determine the underlying causes and their frequency, and recognize existing controls along with their detection capabilities. A series of actions must be initiated in response to each identified failure mode, with clear assignment of ownership and due dates. Additionally, it is important to set up criteria for verification and validation, which can be approved by management through electronic signatures. User login protocols should include defined passwords and privilege levels, while a comprehensive suite of reports will facilitate tracking of unresolved actions and overdue tasks. Microsoft Access can be downloaded free of charge, and for deeper data analysis, the information can be exported to Excel. This system operates on a commonly used software platform that is both accessible and user-friendly, ensuring that organizations can maintain high standards of quality management effortlessly.

Pricing

Price Starts At:
$135.00/one-time
Price Overview:
Multiple user licenses are available. Licensing based on concurrent users.
Free Version:
Free Version available.
Free Trial Offered?:
Yes

Integrations

No integrations listed.

Screenshots and Video

FMEA DB Main Menu

FMEA DB Main Menu

Company Facts

Company Name:
Sunday Business Systems
Date Founded:
2004
Company Location:
United States
Company Website:
sundaybizsys.com/fmea-database/
Edit This Page

Product Details

Deployment
SaaS
Windows
On-Prem
Training Options
Documentation Hub
Online Training
Webinars
Support
Standard Support

Product Details

Target Company Sizes
Individual
1-10
11-50
51-200
201-500
501-1000
1001-5000
5001-10000
10001+
Target Organization Types
Mid Size Business
Small Business
Enterprise
Freelance
Nonprofit
Government
Startup
Supported Languages
English

FMEA Database Categories and Features

Risk Management Software

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment