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Quality Manual |
8 – Operations |
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Section 8.5.2 | Section Revision: A | Revision Date: 3/30/2017 |
8.5.2 – Identification and traceability | ||
Approved By: Dave Zirkelbach | Date: 3/30/2017 |
GENERAL POLICY
Product and process information and appropriate work instructions are established and are communicated to relevant personnel. Operations and production processes are monitored and controlled, and are validated where appropriate. Equipment used in distribution processing and for monitoring and measurement activities are maintained. Methods for product release and delivery are defined.
Materials, components, and parts are identified. When required, traceability of materials and processes is recorded and maintained. Inspection and test status of product is identified to ensure that only product that has passed the required inspections is dispatched.
Customer-supplied products, if ever maintained, are controlled in the same manner as are purchased products. If ever maintained, Customer-owned tools, equipment, software, or other property are marked to indicate ownership. Any Loss, damage, or unsuitability of a customer’s product is recorded and reported to the customer.
Appropriate handling, storage and preservation methods are implemented to prevent product damage or deterioration. Receipt and dispatch to and from storage areas are controlled. The condition of products in stock is regularly assessed.
PROCEDURAL POLICIES
3. IDENTIFICATION AND TRACEABILITY
3.1 Product identification
3.1.1 Where appropriate, documented procedures have been established and maintained for identifying the product by suitable means from receipt, during all stages of order fulfillment, and throughout product realization.
3.1.2 During all stages of receipt, putaway, and order fulfillment, products are identified by labels, or the labeled containers in which they are held.
3.1.3 Rules and activities related to identification of products are governed by Operational Procedure QOP-75-03, Product Identification and Traceability. Additional relevant procedures are: QOP-75-01, Production Control; QOP-74-03, Verification of Purchased Product; QOP-82-05, Final Inspection; and QOP-75-06, Packaging, Labeling and Shipping.
3.2 Traceability
3.2.1 Dee Electronics maintains traceability under certain circumstances, as described in the written procedures, but traceability is not required of Dee Electronics by any other entity. Records of traceability are maintained in accordance with procedures.
3.2.2 Activities related to establishment and maintenance of traceability are regulated by Operational Procedures QOP-75-03, Product Identification and Traceability, and QOP-75-01, Production Control.
3.3 Inspection status identification
3.3.1 The inspection and test status of product is identified by suitable means, which indicates the conformance or nonconformance of product with regard to inspection and tests performed. The identification of inspection and test status is maintained, as identified in the documented procedures, throughout the order fulfillment process to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is dispatched.
3.3.2 Distribution/Order fulfillment and Assembly personnel authorized to carry out inspections and testing are responsible for identifying product inspection status. All personnel handling products are responsible for maintaining the identification.
3.3.3 Incoming products that have passed the receiving inspection are moved to putaway staging areas/carts. Products that have not passed receiving inspection are moved to a Hold Area. Detailed rules for identifying inspection status of purchased products are provided in procedure QOP-74-03 Verification of Purchased Product.
3.3.4 Status of an in-process inspection is identified by current location and labeling of product or assembly, as well as electronic verification records resulting from bar code scanning/computer verification or written records. Each subsequent step verifies the that previous step was completed correctly. Operational procedure QOP-82-04, In-process Inspections, provides more detailed instructions.
3.3.5 Products that pass the final inspection are placed in Shipping Process Carts/Pallets area that is designated and used only for this purpose. In addition, products passing final inspection have an electronic Ship Authorization Record. Rules for identifying inspection status of final authorized products are provided in procedure QOP-82-05, Final Inspection.
3.3.6 Products that fail any inspections or tests are moved to identified Hold Areas. Whenever a nonconforming product is identified, the nonconformity is documented using a Corrective Action Report (CAR/RMA) Form QF-85-02-01. Procedure QOP-83-01, Control of Nonconforming Product, instructs on how to identify and process nonconforming product.
ASSOCIATED DOCUMENTS
QOP-75-01 Operational Procedure: Operations Control
QOP-75-02 Operational Procedure: Work Instructions
QOP-75-03 Operational Procedure: Product Identification and Traceability
QOP-75-04 Operational Procedure: Product Handling and Preservation
QOP-75-05 Operational Procedure: Storage Areas
QOP-75-06 Operational Procedure: Packaging, Labeling and Shipping
QOP-74-03 Operational Procedure: Verification of Purchased Product
QOP-82-04 Operational Procedure: In-process Inspections
QOP-82-05 Operational Procedure: Final Inspection
QOP-83-01 Operational Procedure: Control of Nonconforming Product