4.4 QMS Processes
AGE has adopted a process approach for its management system. By identifying the top-level processes within the company, and then managing each of these discreetly, this reduces the potential for nonconforming products and services discovered during final processes or after delivery. Instead, nonconformities and risks are identified in real time, by actions taken within each of the top-level processes.
Note: Not all activities are considered “processes” — the term “process” in this context indicates the activity has been elevated to a higher level of control and management oversight. The controls indicated herein are applicable only to the top-level processes identified.
Top-Level Processes
The following top-level processes have been identified by AGE Management:
| Process | Description |
|---|---|
| Quoting & Contract Review | Customer requirements intake and contract evaluation |
| Purchasing & Inventory | Supplier selection, purchasing, and stock management |
| Production & Delivery | Manufacturing, inspection, and product delivery |
| QMS Planning and Management | System-level quality planning and oversight |
| Evaluation and Improvement | Audits, analysis, corrective/preventive action |
These process groups are described using tools such as documented procedures, process maps, flow diagrams, matrices, schedules, and charts.
Process Monitoring
The effectiveness of each process and its subsequent output is measured and evaluated through:
- Regular internal audits
- Quality inspections
- Data analysis
AGE uses (QSP-4.4) Key Performance Metrics (KPMs), linked to our objectives, to control and monitor our processes. We also assess risks and opportunities inherent to each process. Trends and indicators relating to:
- Nonconformities
- Objectives and corrective action
- Monitoring and measurement results
- Audit results
- Customer satisfaction data
- Process performance
- Conformity of products
4.4.1 Outsourced Processes
Any process performed by a third party is considered an “outsourced process” and must be controlled. The type and extent of control to be applied to the outsourced process takes into consideration:
- The potential impact of the outsourced process on the company’s capability to provide product that conforms to requirements
- The degree to which the control for the process is shared
- The capability of achieving the necessary control through the purchasing contract requirements