8.1 Operational Planning and Control
AGE has established documented quality plans and procedures that describe processes and controls to be applied and the records required. During this planning phase, management and/or assigned personnel will identify:
- The quality objectives and requirements for the product
- Verification, validation, monitoring, inspection and test requirements
- Processes, documentation and resources required
- Criteria for product acceptance
- Resources necessary to support operation and maintenance of the product
The output of quality planning includes documented quality plans, resource requirements, processes, equipment requirements, procedures and design outputs.
Planning Activities
Such planning is accomplished through:
| Item | Activity |
|---|---|
| A | Determining the requirements for the products and services |
| B | Establishing criteria for the processes and the acceptance of products and services |
| C | Determining the resources needed to achieve conformity to the product and service requirements and to meet on-time delivery |
| D | Implementing control of the processes in accordance with the criteria |
| E | Determining, maintaining and retaining documents and records to the extent necessary to have confidence that the processes have been carried out as planned |
| F | Determining the processes and controls needed to manage critical items, including production process controls when key characteristics have been identified |
| G | Engaging representatives of affected organization functions for operational planning and control |
| H | Determining the process and resources to support the use and maintenance of the products and services |
| I | Determining the products and services to be obtained from external providers |
| J | Establishing the controls needed to prevent the delivery of nonconforming products and services to the customer |
8.1.1 Operational Risk Management
Operational risk management is conducted to manage the risks related to product and service realization requirements. See QSM-6.1 for the risk and opportunity management framework.
8.1.2 Configuration Management
AGE plans, implements, and controls configuration management activities as appropriate to its products and services in order to ensure the identification and control of physical and functional attributes throughout the product life cycle. This is defined in the documented procedure Configuration Management. This includes:
- Document control for configuration documents
- Change control for configured items
8.1.3 Product Safety
Operational controls shall be implemented to assure product safety during the entire product life cycle. These activities may include:
| Item | Activity |
|---|---|
| A | Assessment of hazards and management of associated risks |
| B | Management of safety critical items |
| C | Analysis and reporting of events affecting safety |
| D | Communication of these events and training of persons |
8.1.4 Counterfeit Parts Risk Mitigation Policy
Counterfeit parts pose a serious threat to both the company and our customers. Regardless of how counterfeit parts (electronic, mechanical or other) enter the supply chain, they can jeopardize the performance, reliability and safety of our products.
Definition of a Counterfeit Item
A Counterfeit Item is defined to include, but is not limited to:
- An item that is an illegal or unauthorized copy or substitute of an OEM or OCM item
- An item that does not contain the proper external or internal materials or components required by the OEM or OCM, but is represented as such
- An item or component thereof that is used, refurbished or reclaimed but the seller represents as being a new item
- An item that has not successfully passed all OEM or OCM required testing, verification, screening and quality control but that seller represents as having met or passed such requirements
- An item with a label or other marking intended to mislead a reasonable person into believing a non-OEM or OCM item is a genuine OEM or OCM item when it is not
Counterfeit Parts Policy Requirements
| Section | Requirement |
|---|---|
| 8.1.4.1 | All employees involved in purchasing and inspection shall be trained in counterfeit part identification |
| 8.1.4.2 | Purchasing shall use only suppliers that are the original manufacturer, sources with express written authority of the original manufacturer, or authorized aftermarket manufacturers |
| 8.1.4.3 | Unless specifically exempted by the Quality Manager, all purchase orders shall require vendor supplied certification. All critical components shall be traceable to the batch and vendor |
| 8.1.4.4 | Receiving shall quarantine any suspected counterfeit parts, complete a Receiving Product Deficiency Report and immediately notify both the Purchasing Manager and the Quality Manager |
| 8.1.4.5 | The Purchasing Manager and Quality Manager shall investigate each such report. On initial determination that a counterfeit part has been received, all parts from that batch shall be quarantined and the supplier shall be removed from the approved vendor list |
| 8.1.4.6 | The requirements of this section shall flow down to all sub-contractors supplying parts purchased on behalf of AGE from outside vendors |