Quality Management
System
A QMS system is indispensable in many industries as it
ensures regulatory compliance. Furthermore,
Brighteye's quality management system offers
track & trace, reaction plans, digital signatures,
and many other ways to make the quality manager's job easier.
What is a Quality Management System?
A Quality Management System (QMS) is a software-based solution that supports the quality control process. It standardizes the entire procedure. Quality control tools also enable a continuous improvement loop by documenting the process and segmenting it into four different parts: planning, control, assurance, and improvement.
The advantages of QMS
Implementing a quality control system paves the way to competitive advantage with the following benefits:
- Enhance rule conformity and comply with strict sector regulations.
- Improve risk management and reduce overall risks.
- Improve product quality and customer satisfaction.
- Boost efficiency and eliminate waste.
Brighteye's QMS: outstanding quality control
The Quality Control module enables companies to define the specifications or features of a product that will be tested for quality and the process and timing of quality tests. It records the results of quality tests and passes the results from one operation to the next. The test results determine the further processing course of the lot, and indirectly, the final quality of the finished product.
The six elements of Momentum's QMS
1. Quality Test Execution
- Manage, direct and monitor the execution of quality test planning
- Push scheduled and unscheduled (automatically triggered) quality tests to the shop floor
- Determine and adopt the further processing course of lots in real-time, based on test results
2. Track & Trace
- Record materials consumption and trace the origin of materials
- Ensure lifecycle information for all production lots such as what operations were performed on which lots and machinery, which raw materials and packaging materials were used and what stock movements were associated with the operations
3. Audit Trail
- Compliant with regulatory requirements like those issued by the U.S. Food and Drug Administration in 21 CFR Part 11
- Ensure full traceability of materials and manufacturing processes for even the smallest production lots, such as manual changes of process parameters
- Generate detailed reports for audit purposes
4. Statistic Process Control (SPC)
- Determine process parameter targets for automated or manual measurements
- Generate detailed reporting for root cause analysis and Total Quality Management (TQM)
- Allow automated or manual manipulations within preconfigured margins to meet expected results
5. Quality (Reaction) Plans
- Define test specifications of a product or process
- Configure the process and timing of quality tests
- Record the results of quality tests and pass the results from one operation to the next
- Trigger alerts or automated manipulations depending on the test results
6. Digital signature
- Designate operations that require additional validation, such as through the re-entry of login credentials or approval by supervisory personnel
- Push to shop floor applications for swift certified validation acts
- Complementary with personnel competences (shop floor HR in APS) and rules and roles
Momentum Application Modules
Brighteye’s Momentum software platform includes five modules that collectively constitute a comprehensive and fully integrated MOM solution.