Company Name Product ID and Traceability

Division or Address Doc. No. Rev. No.

Division or Address Date: - Page 1 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 Description of Change

Person

A Name Initial Release

Distribution List

(list the departments that receive controlled copies)

Controlled Copy, Do Not Duplicate For Internal Use Only

Company Name Product ID and Traceability
Division or Address Doc. No. Rev. No.
Division or Address Date: - Page 2 of x

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>.

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Company Name Product ID and Traceability
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<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
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Company Name Product ID and Traceability
Division or Address Doc. No. Rev. No.
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<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