The Lean Machine

Risk Management

Systematic consideration of risk while making decisions is best conducted with robust risk management software. Taking a proactive approach to risk creates a more stable business environment and can be applied to virtually every aspect of your company.

Risk Management

The FMEA Software module (Failure Mode and Effect Analysis) is used to proactively consider the risks associated with a process, product or part. FMEA Software can be a very useful tool in the beginning stages of development, as it can focus a multi-disciplinary team of employees on the issues that could ultimately lead to mistakes, re-work, and unhappy customers.

Features of our FMEA Software Module
Establish team members, and their area of responsibility during the FMEA project.
Link Actions from the analysis to either Corrective Actions or Document Change Requests.
Automatically calculated a RPN (Risk Priority Number).
Conduct Process or Product FMEA projects.
Customize your own start up checklist for FMEA projects.

Risk and Opportunities

The Risk and Opportunities module was developed in response to the changes in ISO 9001:2015 to address section 6.1 - Actions to address risks and opportunities.

This module allows the company to throw a risk analysis net over their entire company in a way that can be customized and organized in a way that best suits their risk management strategy.

This approach ensures that both an adequate effort is made, yet that effort doesn’t eat into valuable value-added resources, thus striking an appropriate balance between value added and risk management activities.

Whereas the FMEA module takes a project approach to the scope of the risk analysis, the Risk and Opportunity module can be linked to a variety of TLM Modules, thus providing ample flexibility to look at risks from multiple angels.

Features of the Risk and Opportunities module

  • Link risk analysis to a variety of TLM modules.
  • Create before and after Risk Priority Numbers (RPN) numbers.
  • Customize the color coding of Severity, Occurrence and Detection risk values.
  • Customize RPN formula in system settings.
  • Link Risks to 8 different TLM modules in support of Actions (CAPA, Events, Documents, Meetings, etc.)
  • Link risks to assets to comply with ISO/IEC 27005 Information Security.
  • Assign Risks that appear on the TLM Dashboard.
  • Evaluate all Risks based on RPN created from any TLM module.
QMS Software
Most quality management software (QMS Software) platforms consist of document control, audit management, non-conformance tracking, corrective action, and employee training, however, our QMS Software is expanding to more areas of the business, depending on the QMS needs of your company.
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Our QMS Software is backed by a 100% success rate for ISO Certification On The First Try!
If you have any questions or want more detailed information, do not hesitate to call us.