QP1150 Identification & Traceability

Policy: Harrington Signal Inc. shall identify process outputs, as necessary, to ensure the conformity of products and services.
Purpose: To define the methods and responsibilities for identifying the status of outputs with respect to monitoring and measurement requirements throughout manufacturing and service provisions.
Scope: This procedure applies to all personnel involved in the manufacture and handling of Harrington Signal Inc. products and their components.
Responsibilities: Receiving is responsible for identifying raw materials, parts, components, etc., as they are delivered to Harrington Signal Inc., confirming completeness and initial acceptability of incoming orders, and moving inspected items to appropriate areas.

Manufacturing (Processing) is responsible for maintaining parts, components, materials, and finished product identification through final processing and packaging.

Manufacturing and Quality are responsible for maintenance of identification and traceability records, where required.
Definitions: Finished product – Product that will undergo no further processing or transformation within Harrington Signal Inc.

Material – Elements or substances of which something is composed or can be made (including, but not limited to: raw and processed material, parts, components, assemblies, and other items which may be worked into a more finished form in performance of a contract).

Traceability – Ability to trace path, history, application, or location of something (document, work product, part, subassembly, etc.) by means of recorded information.

 

Procedure:

1.0           Identification and Traceability – GENERAL

    1. Proper recordkeeping and identification are key ingredients of traceability. When done correctly, Harrington Signal Inc. information shall show that:
      • Correct procedures have been followed from start to finish;
      • All materials (parts, components, etc.) used in manufacturing are identified;
      • Harrington Signal Inc. is capable of responding promptly and effectively in the event that nonconforming material is identified. See QP1030 CONTROL OF NONCONFORMING OUTPUTS.

2.0           identification / traceability

    1. Harrington Signal Inc.’s identification and traceability system shall enable identification of incoming material from immediate suppliers, through manufacturing, handling, and storage, and on to the distribution of its end product to customers.
    2. Harrington Signal Inc. shall maintain identification of product configuration to identify differences between actual and intended configuration.

 

 

3.0           Identifying / TRACING ITEMS

    1. Receiving shall maintain records of incoming parts in accordance with QP1210 RECEIVING AND INSPECTION.
    2. Quality shall maintain documented information on all items inspected for traceability purposes in accordance with DOCUMENTED INFORMATION CONTROL procedures.
    3. Employees responsible for packaging and storing Harrington Signal Inc.’s products shall ensure product containers are clearly labeled with the following information, at a minimum:
      • Part ID
      • Quantity.
    4. Stockroom personnel or the Receiving Clerk shall complete all marking of the product. Stockroom personnel shall initiate the Status Tag, HS# 780-0563 upon release of kits to manufacturing to maintain product identity. For individual materials/parts awaiting incorporation into product, the parts shall be identified by placing in marked bags, bins, etc.
    5. All Manufacturing personnel shall maintain product identity by completing the Status Tag and keeping it with the product as it moves through each stage of the process.
    6. At a minimum, Shipping shall record the following information, in addition to requirements listed above, upon releasing product to the shipper/customer:
      • Name of the firm receiving the Company’s product;
      • Receiver’s location / address; and
      • Contact information (phone / fax number, e-mail address, etc.).
    7. All product/part information shall be maintained in accordance with DOCUMENTED INFORMATION CONTROL procedures.

4.0           Identification/TRACEABILITY REVIEW

    1. All purchased and customer supplied materials and parts intended for incorporation into Harrington Signal finished product shall be assigned and marked with a part number. All printed circuit board assemblies, with the exception of a few, shall contain a barcode label for traceability purposes.
    2. For customer complaints or recall notices, Harrington Signal shall trace its product’s (products’) components as far back as is possible. In the case of a complaint or recall, Harrington Signal Inc. shall provide as much information as is available and needed by the requesting party.
    3. Harrington Signal Inc. shall investigate the problem in accordance with QP1030 CONTROL OF NONCONFORMING OUTPUTS and if necessary, take action to resolve the problem in accordance with QP1040 NONCONFORMITY AND CORRECTIVE ACTION.Effectiveness Criteria:
  • All Harrington Signal Inc. products and components are traceable from their suppliers, throughout Harrington Signal Inc. processes, and on to customers.
  • In the event of product recall, products are traced promptly and completely and are accounted for in their entirety.

 

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