8.5.1 Control of production and service provision
Harrington Signal Inc. plans and carries out production and service activities under controlled conditions. Controlled conditions shall include, as applicable:
- The availability of information that describes the characteristics of the product
- The availability of work instructions, as necessary
- The use of suitable equipment
- The availability and use of monitoring and measuring devices
- The implementation of monitoring and measurement
- The implementation of release, delivery and post-delivery activitiesQuality, with assistance from Manufacturing, is responsible for ensuring any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement are validated. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.
- Validation shall demonstrate the ability of these processes to achieve planned results. Validation documentation for these processes will include, as applicable:
- Manufacturing Procedures, Routers, Inspection & Test Procedures, and Service Procedures define Harrington Signal Inc.’s plan for manufacturing and service. These procedures provide detailed planning of all phases including the methods and equipment to be used and workmanship criteria. This detailed planning will be documented for each product in the form of work instructions, drawings or specifications.
- Defined criteria for review and approval of the processes
- Approval of equipment and qualification of personnel
- Use of specific methods and procedures
- Requirements for records
- Revalidation
8.5.2 Identification and traceability
All personnel are responsible for identifying the product, by suitable means, throughout the process from receipt of material through shipment of the final product. Product identification will be provided by using Harrington Signal Inc.’s part numbering system to assign unique identification for all components and internally manufactured parts. Where not otherwise obvious due to part shape, color, etc., tags, labels, and routers are used as appropriate to clearly identify products and materials throughout the manufacturing process and in storage.
Personnel performing monitoring and measuring activities are responsible for clearly identifying the product status with respect to monitoring and measurement requirements. To ensure that only items, assemblies or final products that have passed required tests and/or inspections proceed to the next operation or process, all products or assemblies will be appropriately labeled, tagged, stamped, or accompanied by routers or check-out sheets to properly indicate their inspection status. The inspection status shall clearly indicate pass or fail as appropriate.
In products where component traceability is a requirement, the Router or Work Order will be used to record the unique identification of the traceable components used in the final product. Product traceability will be provided by the use of a serial number system (label) for all completed products.
8.5.2.1 Reference Procedure
QP1150 Identification and Traceability
8.5.3 Property belonging to customers or external providers
Harrington Signal Inc. shall exercise care with customer property while it is under our control or being used. The Receiving Department shall identify customer-supplied product upon receipt and verify it is correct and not damaged. Stockroom and Manufacturing personnel shall protect and safeguard customer property provided for use or incorporation into the product while it is in Harrington Signal Inc.’s possession. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be recorded on a Nonconformance Report and reported to Purchasing & Customer Service for notification to the customer.
If the customer property is intellectual property, it is received directly by Manufacturing (Test Department). Appropriate safeguards to protect the confidentiality of intellectual property shall be taken. The Test Department shall contact the Manufacturing Manager who then shall contact the customer directly if the intellectual property is lost, damaged, or found to be unsuitable. Records of these situations may be a letter to the customer or a memo to the customer file.
8.5.3.1 Referenced Procedures
QP1160 External Property Control
8.5.4 Preservation
All personnel shall handle materials, components, and products in a manner that preserves the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection.
Preservation shall also apply to the constituent parts of a product and includes items such as special storage requirements, Electro-Static Discharge (ESD) protection, and monitoring of shelf life. Details of appropriate preservation controls are included in Receiving, Manufacturing, and Inspection procedures.
8.5.4.1 Referenced Procedures
8.5.5 Post-delivery activities
Post-delivery activities are important to Harrington Signal Inc. We actively listen to our customers, soliciting feedback and regularly collecting information on the nature, use and intended lifetime of our products and services through active survey collection. Warranty data is examined and potential undesired consequences associated with our products and services are noted for possible action. Our specific Warranty is established on a client by client basis. Click Here for a listing of our client by client warranties.
8.5.6 Control of changes
Management reviews and controls all changes for production or service provision and documents the results, the person(s) authorizing the change, and any necessary actions.
Revision History:
| Revision | Date | Description of Changes | Approved By |
| 0.0 | 07/03/17 | Initial Release | Jim Theesfeld |
| 1.0 | 8/17/18 | Digitized version | Todd Gifford |