Quality Risk Assessment

Analyzing corporate risk factors and presenting the risks in a clear and action-ready format. Generica QMS Risk Assessment module is based on internal audit results,current year audit planning, inspection results and manufacturer properties. This module assists the corporate quality team to better plan, conduct and analyze quality activities; senior managers can view a scoreboard that covers the organization’s quality areas and consistently provides an accurate quality risk picture.

Generica QMS is used for managing global risk processes. The Quality Risk Assessment module can be implemented as an independent solution or as an integrated module among the wide Generica QMS platform.

Generica Quality Risk Assessment solution provides internal site risks map, ensures the quality team resources are utilized at the right place, improves quality and reduces company risks. Generica Quality Risk Assessment algorithm is bases on several parameters, such as site classification, audit, inspections and more, and it can be easily configured to the company’s risk metrology. With Generica QMS corporate risk assessments are performed more efficiently and effectively.


Generica brings Quality Risk Assessment functionality right into users’ familiar work environment by allowing users to keep using standard tools such as Word, Excel and PDF. This capability is thanks Generica's smooth integration with those type of tools, enebling users to remain working from those programs, while leveraging Generica's functionality from inside teh original documents. As a result Generica increases user productivity, while helping to ensure regulatory compliance.

Generica Quality Risk Assessment includes a pre-defined solution and best practices, but can also be easily configured to meet company’s specific processes and needs.


To achieve full coverage of Quality Risk Assessment the following functionality is available:

  • Quality Risk Assessment Model/Algorithm using:

    • Sites classification (e.g. site type, site size, site Llcation, product type, product market, etc.)

    • Audit results (e.g. last Aadit, number of critical observations, number of repeat observations, etc.)

    • Inspections results (e.g. last inspection date & rate, inspection gap analysis & trends, number of inspection observations)

    • Management factoring

  • Risk Map

  • Trends Analysis

  • Integration with Audit Planning module

  • Management dashboards & graphs (management, auditors, site QA head)

  • Periodic reports