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What is FMEA-Pro?

Effectively managing quality risk poses a significant challenge in the absence of a robust knowledge management system. To overcome this obstacle, it is crucial to implement systems that can accurately identify, capture, manage, and share essential documents and information. Sphera’s FMEA-Pro software offers a versatile framework that supports various FMEA methodologies and includes specialized tools for handling risk data, which ensures that suitable controls are put in place. This software integrates critical quality information across both design and manufacturing processes, aiding organizations in meeting the quality expectations of their customers. Moreover, Sphera’s FMEA-Pro software enhances profitability by utilizing a standardized method to thoroughly assess inherent risks. Additionally, Sphera's enterprise Advanced Risk Assessment tool enables organizations to consistently identify, evaluate, and reduce the impact of operational risks. This comprehensive approach significantly bolsters overall operational efficiency and fosters resilience against potential challenges. Ultimately, integrating these innovative tools allows businesses to navigate complexities more effectively, leading to improved performance and customer satisfaction.

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

Azure SQL Database
Microsoft 365
Sunday Business Systems

Integrations Supported

Azure SQL Database
Microsoft 365
Sunday Business Systems

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
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

Sphera

Company Location

United States

Company Website

sphera.com/failure-mode-effects-analysis-software-fmea-pro/

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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