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Description
Create a simple, efficient Quality Management System (QMS). You can install on your local server, or use our Cloud QMS solution. ISO 9001:2015 requires risk-based thinking. Risk Assessment: Failure Modes Analysis (FMEA) Implement risk-based strategies for ISO 9001, ISO 14971. Identify failure modes for each item or process. Identify the effects and severity. Identify the causes and frequency. Identify current controls and detection levels. Multiple actions should be taken in response to this failure mode. Assign owners and due dates. Establish verification and validation criteria. Management approval can be obtained by electronic signature. User login: Define passwords and privileges. Rich set of reports. Track open actions and delinquent due date. Microsoft Access is free to download. To further analyze the data, export it to Excel. Common, easy-to-use software platform
Description
Failure Mode and Effects Analysis (FMEA) is a systematic technique aimed at identifying potential failures in a given system, along with their causes and consequences. This approach proves to be a powerful tool in enhancing quality management processes. It is essential to adhere to standards set by organizations such as ISO, AIAG, and VDA. Ensuring data consistency is crucial, particularly in the control plan and process flow diagram. Additionally, one must possess the capability to conduct various analyses, including PFMEA and DFMEA, while also being familiar with RPFMEA, LFMEA, MFMEA, SwFMEA, and UFMEA methodologies. This breadth of analysis can significantly improve risk assessment and decision-making in product development and manufacturing.
API Access
Has API
API Access
Has API
Integrations
Azure SQL Database
Microsoft 365
Sunday Business Systems
Pricing Details
$135.00/one-time
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Sunday Business Systems
Founded
2004
Country
United States
Website
sundaybizsys.com/fmea-database/
Vendor Details
Company Name
PQ-FMEA
Website
pq-fmea.com
Product 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