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Product Trace Ability

This document defines methods for product identification and traceability during production. It requires that all materials for products be identified with part numbers to enable tracing throughout production, storage, and delivery. Final products and components are to be serialized to associate them with work orders for traceability in case of recalls or service requests. Serial numbers and work order IDs must be recorded on documentation to trace products to customers and original production runs. Work orders and shipping documentation are maintained as quality records.

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43 views2 pages

Product Trace Ability

This document defines methods for product identification and traceability during production. It requires that all materials for products be identified with part numbers to enable tracing throughout production, storage, and delivery. Final products and components are to be serialized to associate them with work orders for traceability in case of recalls or service requests. Serial numbers and work order IDs must be recorded on documentation to trace products to customers and original production runs. Work orders and shipping documentation are maintained as quality records.

Uploaded by

svmadhavaram
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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1.

PURPOSE
1.1. Defines the methods of product identification and traceability during storage, production, delivery and installation.

2.

SCOPE
2.1. All materials related to salable products.

3.

DEFINITIONS
3.1. N/A

4.

POLICY
4.1. 4.2. 4.3. 4.4. Model numbers are assigned by Marketing. Manufacturing Engineers and Engineering Services are responsible for entry of part numbers and related part number information into the database. Engineering drawings and bills of material assist in identifying parts. Materials used for salable product should be identified by suitable means with a part number or other identification to enable positive identification of the material or product throughout storage, handling, processing, and delivery. Product Serial Numbers 4.5.1. 4.5.2. All final products shall be serialized in order to provide traceability to the originating work order. Serial numbers should be derived from the originating work order number. Information can then be obtained from the work order including start dates, completion dates and components used for a specific production run. Printed circuit boards and sub-assemblies may also be serialized at the direction of the Manufacturing Engineer.

4.5.

4.5.3. 4.6.

OEM Serial Numbers 4.6.1. 4.6.2. Many products contain components that are serialized by the original equipment manufacturer (OEM). The Manufacturing Engineer specifies the requirement to record OEM serial numbers. Manufacturing documentation is used to communicate the requirement. OEM serial numbers are recorded on the Work Order that the component was issued to. This provides traceability of OEM serial numbers to specific work orders in the event of product recall or service requests by the OEM.

4.7.

Production Run ID
REFERENCE ONLY WHEN SIGNATURES ARE NOT PRESENT

Page 2 4.7.1. Run ID numbers shall be assigned to work orders for sub-assemblies and final assemblies. The Run ID is used to associated multiple work orders that make up a finished product. The Run ID numbers assigned to a final assembly work order should match the Run ID number of all the sub-assembly work orders allocated to the final product. Product must be segregated by the Run ID number at all times during production processes to ensure the correct allocation of work orders to the final assemblies.

4.7.2.

4.7.3.

4.8.

Product Delivery 4.8.1. Final product serial numbers shall be recorded on shipping documentation to provide traceability to the end user (customer) and to the originating work order.

4.9.

Quality Records 4.9.1. Work Orders and shipping documentation are considered quality records and must be maintained for a minimum of 3 years.

5.

PROCEDURE
5.1. See Exhibit A

6.

EXHIBITS
6.1. Exhibit A -- Product Identification and Traceability flowchart

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