Failure Modes and Effects Analysis

FMEA-Pro is a desktop software solution that helps individual users more efficiently conduct Failure Mode and Effects Analysis.  FMEA-Pro helps to better analyze product designs and manufacturing processes, shorten the time it takes to conduct risk assessments and achieve more thorough FMEAs.

 

Currently in Version 8 and available as a single-user license, FMEA-Pro improves quality, productivity and safety while providing a means for reviewing product and process designs and ensuring compliance with regulations and standards. 

 

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  • Regulatory Compliance – FMEA-Pro helps organizations with the implementation of their quality, risk, and reliability programs based on company or industry standards and guidelines including: SAE J1739, ARP 5580, ISO 9001, Advanced Product Quality Planning (APQP), Reliability Centered Maintenance (RCM), MIL STD 1629A, 882, ISO/TS 16949, VDA 6.1.
  • Accommodates various worksheets and forms related to FMEA and quality planning
  • Assists in hazard analysis in all variations of FMEA, including Design, Process, Application, Service, and Machinery FMEAs
  • Knowledge-base– comprehensive professional libraries available, including fully customizable risk-ranking scales
  • Linked Diagram feature provides a visual representation of data by linking worksheets to the process maps
  • Supports the following techniques:Failure Mode and Effects Criticality Analysis (FMECA); Control Plans, Design Verification Planning and Reporting (DVP&R), Gage Plans; Process Mapping, Process Flow Charts; FMEA-based Reliability Centered Maintenance

 

Using Stature will allow you to link Design FMEAs and Process FMEAs on a consolidated web-based platform 

Process Hazard Analysis

PHA-Pro is a time-efficient and flexible Process Hazard Analysis desktop software tool that helps individual users to conduct Process Hazard Analyses (PHAs) like HAZOP and What-If Analysis. 

 

Currently in Version 8 and available as a single-user license, PHA-Pro assists individuals with the implementation of risk studies easily and thoroughly, resulting in more comprehensive Process Safety Management compliance and safer business processes.  

 

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  • Regulatory Compliance – PHA-Pro helps organizations with the implementation of their risk policies and programs based on company or industry standards and guidelines including: Process Safety Management (PSM) programs under OSHA 26 CFR 1910.119; EPA Risk Management Program; Seveso II Directive; Control of Major Accident Hazards (COMAH); IEC 61511; ANSI/ISA S84.00.01
  • Flexible and User-Friendly– PHA-Pro is adaptable to a variety of industries and safety and reliability methodologies
  • Accommodates various worksheets and forms related to PHA and risk management
  • Knowledge-base– comprehensive professional libraries available, including fully customizable risk-ranking scales
  • List of Reference feature creates an unrepeated list of recommendations and links them back into the study, allowing users to record and track progress, and navigate quickly through the studies
  • Pre-formatted Industry Standards: Hazards and Operability – HAZOP; What If / Checklist; Preliminary Hazard Analysis – PrHA; Layer of Protection Analysis – LOPA; Target Safety Integrity Levels Assignment – SIL; Hazard Analysis and Critical Control Points – HACCP

 

Using Stature will allow you to link different types of PHAs on a consolidated web-based platform 

Failure Modes and Effects Analysis - for Medical Device and Biopharma Companies

FMEA-Med is a desktop software solution that helps individual users more efficiently conduct Failure Mode and Effects Analysis.  FMEA-Med helps medical device and pharmaceutical manufacturers better analyze product designs and manufacturing processes, shorten the time it takes to conduct risk assessments and achieve more thorough FMEAs.

 

Currently in Version 8 and available as a single-user license, FMEA-Med improves quality, productivity and safety while providing a means for reviewing product and process designs and ensuring compliance with regulations and standards.

 

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  • Regulatory Compliance – FMEA-Med helps organizations with the implementation of their quality, risk, and reliability programs based on company or industry standards and guidelines including: enhanced compliance with 21 CFR, Part 11 (regulating the use of electronic records and signatures); FDA 21 CFR Part 820 QSR (cGMP); Medical Devices Directive (MDD); ISO 13485; ISO 14971; ISO 9001; SAE J1739, ARP 5580; IEC 60812
  • Flexible and User-Friendly– accommodates various worksheets and forms related to FMEA and quality planning and keeps documentation live as required for compliance with major industry quality standards
  • Knowledge-base– comprehensive professional libraries available, including fully customizable risk-ranking scales
  • Linked Diagram feature provides a visual representation of data by linking worksheets to the process maps
  • List of Reference feature gives you an unrepeated list of your recommendations in a separate, pre-formatted table with references hyperlinked back to the worksheets
  • Supports the following techniques:Design and Process FMEA; Hazards and Error Analysis; Healthcare FMEA; Functional, Software, Interface, and Detailed FMEA; and Process Mapping

 

Using Stature will allow you to link Design, Process and Healthcare FMEAs on a consolidated web-based platform

Security Vulnerability Assessment

SVA-Pro helps chemical facilities to improve their security systems through detailed Security Vulnerability Assessments (SVAs), identifying vulnerability risks, producing and tracking recommendations, and sharing the information with key stakeholders.

 

Currently in Version 8 and available as a single-user license, SVA-Pro is a desktop software tool that improves the efficiency of SVA studies to help optimize work time, minimize work stoppages and reduce the potential for undesirable events.  

 

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  • Effectively delivers the SVA methodology developed by the Center for Chemical Process Safety (CCPS) through a Licensing Agreement with the American Institute of Chemical Engineers (AIChE)
  • Regulatory Compliance – SVA-Pro is designed to help organizations put corporate-wide security policies and programs into place and aid in the adoption of regulations in the future. SVA-Pro has pre-formatted industry standard templates for: CCPS's SVA; API/NPRA's SVA for Petroleum and Petrochemical Industries; RAMCAP – Risk Analysis and Management for Critical Asset Production
  • Accommodates various worksheets and forms related to SVA and risk management
  • Knowledge-base– comprehensive professional libraries available, including fully customizable risk-ranking scales
  • Data linking features connect the different parts of your study, increasing consistency across your studies by automatically replicating data in the appropriate areas
  • List of Reference feature gives you an unrepeated list of your recommendations in a separate, pre-formatted table with references hyperlinked back to the worksheets

 

Using Stature will allow you to link different SVAs on a consolidated web-based platform 

Job Safety Analysis

RiskSafe is a desktop software application for conducting Job Safety Analyses (JSAs) that assists individuals in performing thorough JSA studies and identifying workplace safety hazards.

 

Currently in Version 8 and available as a single-user license, RiskSafe is an efficient and cost-effective desktop documentation tool for job safety that helps companies create safety work environments. 

 

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  • Regulatory Compliance – RiskSafe supports hazards and risk assessments of the following regulations and standards: U.S. Occupational Safety and Health Administration (OSHA) 1910 regulations; Canada Occupational Health and Safety Regulations (SOR/86-304); National Occupational Health and Safety Commission Australia (NOHSC); CSA Standards; Control of Substances Hazardous to Health Regulations (COSHH); ISO Standards; OHSAS 18001:1999 Clause 4.3.1; U.S MIL-STD 882D; BS 8800; ANSI B11.TR3; ANSI-RIA R15.06 (Robotics Standard); BS EN 1050
  • Accommodates various worksheets and forms related to Job Safety and Job Task Analysis
  • Knowledge-base– comprehensive professional libraries available, including fully customizable risk-ranking scales
  • List of Reference feature gives you an unrepeated list of your recommendations in a separate, pre-formatted table with references hyperlinked back to the worksheets
  • Preformatted industry standard templates for: Job Safety Analysis (JSA), Job Hazard Analysis (JHA), Job Task Analysis (JTA), Behavior-Based Safety (BBS) Analysis, Confined Space Analysis, Ergonomics, Machine Safety Analysis, Workplace Risk Assessment, and more

 

Using Stature will allow you to link JSAs, JTAs and other risk assessments on a consolidated web-based platform 

Fault Tree Analysis

Fault Tree Analysis (FTA) is a top-down approach for analyzing pre-event failures with systems in development, beginning with the top event (the potential failure), then determining all the ways it can occur. Similarly, post-event failures can be analyzed to find the root cause of the failure. FTA-Pro facilitates compliance with safety and regulatory requirements, allowing companies to reduce design defects, product recalls and production downtime. The result is an increased ability to produce safe, reliable, high quality products.

 

Currently in Version 4.0 and available as a single-user license FTA-Pro is a desktop software solution that helps individuals improve their FTA process, reducing the time, manpower and cost involved. 

 

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  • Regulatory Compliance – FTA-Pro helps you comply with a variety of regulations, including: IEC 61025; NASA Fault Tree Handbook with Aerospace Applications; NUREG 0492
  • Flexible and User-Friendly:FTA-Pro can be configured to meet your specific needs and helps you complete fault-tree analyses in three independent calculation engines – verifying your results on a fault-tree at least three times
  • Methods and Calculations Included in FTA-Pro: Qualitative System Analysis - carried out through the use of minimal cut sets; Unreliability System Analysis Methods - Cross Product, Cut Set Summation, Esary-Proschan, Exact Probability Calculation, Monte Carlo Simulation; Importance Measures – Birnbaum, Criticality Importance, Fussel-Vesely, Risk Achievement Worth, Risk Reduction Worth
  • Event Failure Modeling – FTA-Pro allows you to choose from several different models, including Constant Probability, Constant Failure Rate with Repair, Weibull Distribution, Dormant, Spare Event and more
  • Common Cause Failure Models - FTA-Pro supports the four different CCF models, Beta Factor Model, Alpha Model, Multiple Greek Letter (MGL) Model, Beta Binomial Failure Rate (BFR) Model

 

Using Stature will allow you to link different calculations and fault trees on a consolidated web-based platform