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What is FMEA Studio?

Revolutionize the development and adjustment of FMEA, Process Flow Diagrams, and Control Plans with unprecedented efficiency. Although the FMEA methodology can be complex, FMEA Studio's automated capabilities greatly minimize the chance of mistakes. Its intuitive interface allows for effortless document sharing with colleagues, fostering better communication. The software supports a range of risk indices, such as RPN, SOD, and CN, along with corresponding evaluation methods. You can evaluate FMEA risks using both 2D and 3D risk matrices, which enriches your analytical process. The ranking of parameters—whether it be Severity, Occurrence, or Detection—is streamlined through customizable ranking tables, tailored to meet your unique needs. Furthermore, FMEA Studio features a structural tree that aids in visualizing structure, function, and failure analyses, making complex information more digestible. Editing tools are easily accessible via a handy right-click menu, ensuring a smooth workflow throughout every stage. All these features collectively not only boost productivity but also enhance collaboration among team members, leading to superior results. Ultimately, FMEA Studio empowers users to tackle risk management with confidence and clarity.

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.

Media

Media

Integrations Supported

Microsoft Excel

Integrations Supported

Microsoft Excel

API Availability

Has API

API Availability

Has API

Pricing Information

$89 per user per month
Free Trial Offered?
Free Version

Pricing Information

$135.00/one-time
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

FMEA Studio

Company Website

www.iqasystem.com/fmea-studio/

Company Facts

Organization Name

Sunday Business Systems

Date Founded

2004

Company Location

United States

Company Website

sundaybizsys.com/fmea-database/

Categories and Features

Categories and Features

Risk Management

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

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