Glossary · MES and ISA-95
Quality operations management
German: Qualitätsbetriebsmanagement
In ISA-95 / IEC 62264, quality operations management is one of the four main categories of manufacturing operations management at Level 3. It covers the activities that coordinate, direct and track the functions that measure and report on quality, including testing of materials and products, verification of test results against specifications, and release of materials and products.
- MES
- Standards
In one sentence
In ISA-95, quality operations management covers the Level 3 activities that test materials and products, check results and release them.
Example
Quality operations management schedules the lab tests for each batch, records the results against the specification and releases the batch for shipment.
How it applies
- Engineering: IEC 62264-3 describes this category with the generic activity model: resource management, definition management, detailed scheduling, dispatching, execution management, data collection, tracking and performance analysis.
- Compliance: In regulated industries, test records and release decisions are GMP records subject to data integrity requirements; a system alone does not make them compliant.
- Project management: Assigning the activities of this category to specific systems, such as an MES or a specialized application, clarifies responsibilities and interfaces.
- Documentation: System documentation should state which activities of this category a system performs and which data it exchanges with other Level 3 systems and the ERP. Using the standard's activity names helps readers compare systems and specifications.
Quality operations management vs. quality management system
A quality management system, for example according to ISO 9001, is the organization-wide framework of policies and processes. Quality operations management is the Level 3 operational activity of testing and releasing materials and products.