| Policy: | Harrington Signal Inc. shall develop, implement, and maintain product realization processes under controlled conditions which produce goods/services that conform to requirements. |
| Purpose: | To describe processes followed in the manufacture, inspection, and packaging of product for the customer’s use. |
| Scope: | This procedure applies to all personnel involved in the manufacture and handling of Harrington Signal Inc. products and their components. |
| Responsibilities: | The Manufacturing Manager is responsible for managing Harrington Signal Inc.’s manufacturing processes, ensuring that all personnel, materials, and equipment needed to create and maintain the manufacturing schedule are available and able to function as expected. The Manufacturing Manager is also responsible for ensuring that Manufacturing personnel receive adequate training to perform their assigned duties and that they have complete, accurate, and up-to-date manufacturing documentation.
The Manufacturing and Quality Managers are responsible for producing Harrington Signal Inc.’s end product(s) in a manner that ensures quality and meets statutory/regulatory and customer requirements. Stockroom Personnel are responsible for picking product components and sending them to Manufacturing. The Inspection & Test Departments are responsible for monitoring and measuring manufacturing (i.e., product realization) processes, to ensure Harrington Signal Inc. products conform to requirements. |
| Definitions: |
Enterprise Resource Planning (ERP) – Information system or process that coordinates manufacturing resources (e.g., production scheduling, parts purchasing, inventory handling, external provider interaction, customer service, and order tracking).
Key characteristic – Special feature of a material, part, or process, variation of which will significantly influence a product’s fit, performance, service life, or manufacturability. Key characteristics are essential to meeting product goals are identified so that the Company’s resources can be focused on those items. Product realization – Act of bringing a product or service into existence (aka, “manufacturing the product”). “Realization” is a broader term than “manufacturing” or “production”, so its use is increasing as services make up a larger share of the economy. |
Procedure:
1.0 Manufacturing control
1.1 Harrington Signal Inc. shall apply suitable methods for monitoring and, where applicable, measurement of manufacturing processes in accordance with QP1180 PROCESS MONITORING-MEASUREMENT. These methods shall demonstrate the processes’ ability to produce results that conform to internal and external requirements.
1.2 When planned results are not achieved, correction and corrective action, as appropriate, shall be taken in accordance with QP1040 CORRECTIVE ACTION.
1.3 Methods of production control include:
| · Kitting work orders | |
| · Production scheduling |
2.0 Product REALIZATION
2.1 The Manufacturing Manager shall assign the work order for the first operation on the Routing (build instructions) to competent persons, including any required qualification.
2.2 The Lead/Operator shall prepare the work area by verifying that:
- Appropriate documented information (production plans, work instructions, layouts, diagrams, control plans, inspection sheets, labeling, etc.) is in place and key characteristics are understood.
- Required tooling, measuring resources, personal protective equipment, and or storage containers are available.
- Equipment setup is completed, the work area is clean, and production equipment is ready (good working order).
- Raw materials, parts, subassemblies, etc., required on the work order are available.
2.3 The Operator shall follow the operating instructions on the Build Instructions. The Build Instructions shall indicate or reference the appropriate production documentation.
- If the operating instructions call for traceability of the product and component parts, the product and components shall be identified throughout the production process in accordance with QP1150 IDENTIFICATION AND TRACEABILITY.
- If customer property (parts, technical drawings, work instructions, etc.) is used in the production process, Production shall handle such material in accordance with QP1160 EXTERNAL PROPERTY CONTROL.
- Each operator is required to inspect the results of his or her own work.
- If the instructions call for the Quality or Test Technicians to conduct an inspection, the manufacturing operator shall forward the part(s) to the Quality/Test Technicians (next section).
- 2.4 When the operation is complete, the operator shall complete the status tag and forward the product and work order packet to the next operation on the Router.
3.0 Inspection and Testing
3.1 The Quality and Test Departments shall inspect/test Harrington Signal Inc. products in accordance with requirements, to verify the quality and conformity of parts.
Devices used in inspections shall be calibrated in accordance with QP1170 MONITORING-MEASURING RESOURCES CONTROL.
3.2 All Harrington Signal Inc. inspections and test instructions are to be performed in accordance with approved inspections and test instructions which detail how the inspection, verification or test is to be performed.
3.3 Inspection and test instructions are to include references to any special equipment, materials or forms to be used and are to be reviewed, approved and distributed in accordance with Documented Information Control Procedures.
3.4 The Automated Optical Inspection Scanner (AOI) is being used by inspection and test personnel to inspect boards that have come through the SMT line or through the Wave machine. The SMT operators also are trained to run boards through AOI. This would include first piece as well as production runs. The data collected is used by the Post Wave operators to repair boards as needed.
3.5 The inspector/tester shall initial or stamp the status tag, indicating whether the part passed or failed inspection/tests.
3.6 Non conformances identified during an inspection or test shall be tagged, documented and processed in accordance with QP1030 CONTROL OF NONCONFORMING OUTPUTS.
3.7 The status tag shall accompany the product through packaging and labeling, final verification, and final release.
4.0 Packaging and Labeling
4.1 The Packaging operator shall apply required labels to product packaging in accordance with QP1150 IDENTIFICATION AND TRACEABILITY.
4.2 The operator shall package finished products according to work instructions for the product.
4.3 The operator shall apply box labels to the packaged product in accordance with work instructions and stage the product for release in the appropriate area.
4.5 If the product is a component to be used in a subsequent operation, the operator shall place the product in an appropriate container and attach a tag, indicating the component name/ID and work order number on the tag. The operator shall include a shop router, as needed.
5.0 Final VERIFICATION AND Release
5.1 Packaging personnel shall verify that the product, as packaged, conforms to requirements.
5.2 Packaging personnel shall review all documentation in the work order packet to verify that it is complete.
5.3 Inspection and Test personnel shall verify that all inspections and testing have been performed and that the product has passed all required inspections and tests. If reworked nonconforming parts, materials, etc., have been included in the product to be released, the Quality Inspection shall verify that reworked product inspections have been performed and that the reworked product has passed all inspections.
6.0 Manufacturing CHANGE CONTROL
6.1 The Manufacturing Manager shall ensure continuing conformity with requirements by verifying that all changes to production or service provisions:
- Are properly documented;
- That the documented information contains the person(s) authorizing the change; and
- That the documented information contains any necessary actions arising from the review.
Effectiveness Criteria:
- Product completed by due date
- Meeting due dates consistently
- Low/falling reject and waste disposal rates
- Elimination of quality/safety defects
- Amount of nonconforming product released to (or found by) customer
- Reduction, elimination, or prevention of product recalls
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 |