Division or Address / Doc. No. / Rev. No.
Division or Address / Date: / Page XXX of x
ISO Procedure
Product ID and Traceability
Approved: ______
title Name
Approved: ______
title Name
Approved: ______
title Name
Approved: ______
title Name
Approved: ______
title Name
Change Record
Rev / Date / Responsible Person / Description of ChangeA / Name / Initial Release
Distribution List
(list the departments that receive controlled copies)
1. Purpose
• To identify a product from the receipt of material through product installation.
• To maintain historical records of the item.
• To be able to trace assemblies and selected subassemblies through serialization.
• To define the methods which must be used to provide product identification and traceability integrity by means of labeling, bar coding, and serialization.
• To provide procedures for identifying and tracking major components, modules, test results and final product during all stages of production, and delivery.
2. Scope
This procedure applies to all parts manufactured and sold.
This procedure ensures that adequate controls are designed in the manufacturing process to provide identification as required throughout the process.
3. Responsibilities
<Job title> assigns serial numbers to assemblies and maintains the completed record.
<Job title> keeps track of serial numbers by maintaining the database.
<Job title> ensures proper labels are present at each operation requiring a label.
<Job title> ensures labels are properly stored and identified to prevent mix-ups.
4. Procedure
4.1 Written Procedures
Product identification from receipt through production, delivery, and installation is described in <name of procedure(s) or work instruction>.
<Job title> applies <identification marking> according to the <work instruction>.
4.2 Component Parts
Where required by contract, component parts are traceable to the manufacturer.
<Name of record> displays a record of traceability. The <name of record> indicates <items>. <Job title> enters the information onto the <name of record> through <activity>.
<Job title> applies identification number onto the product parts.
<Job title> applies labels to component parts. The label indicates <items>. The revision level is identified on the label and is traceable to drawings and associated ECOs through <activity>.
Component parts can be tracked using the <documents> and <frequency> shipments. This information is maintained <location>.
The <name of system> tracks items received from the vendor by associating the purchase order number an inventory location and pick.
4.3 Serialization
The following items are serialized: <items>. <Job title> is responsible for assigning serial numbers.
<Job title> enters the serial numbers into the <name of logbook>.
<Job title> gives the serial numbers to <job title> who applies the serial number to the part.
<Job title> <method> the serial numbers from the unit onto <name of record>.
4.4 Traceability to Customer
Finished product is traceable to the customer through serial numbers associated with <name of customer record>. The packing list and outside packaging include the serial number of the unit. <Job title> verifies the serial number on the packing list matches the serial number on the box.
5. Related Documentation
<Bill of Materials>
<Serial Number Logbook>
<History Card>
<Database>
<Packing List>
<Sales Order>
Contract Review
Document and Data Control
Process Control
Inspection and Test Status
Handling, Storage, Packaging, Preservation and Delivery
Quality Records
<list of work instructions>
Controlled Copy, Do Not Duplicate For Internal Use Only