Company Name
Division or Address
Division or Address
Product ID and Traceability
Doc. No.
Rev. No.
Date: 6/28/2016
Page 1 of x
ISO Procedure
Product ID and Traceability
Approved:
__________________________________________________
Name
title
Approved:
___________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Change Record
Rev
Date
A
Responsible
Person
Description of Change
Name
Initial Release
Distribution List
(list the departments that receive controlled copies)
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Division or Address
Division or Address
1.
2.
Product ID and Traceability
Doc. No.
Rev. No.
Date: 6/28/2016
Page 2 of x
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.
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
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Division or Address
Division or Address
Product ID and Traceability
Doc. No.
Rev. No.
Date: 6/28/2016
Page 3 of x
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>
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Division or Address
Division or Address
Product ID and Traceability
Doc. No.
Rev. No.
Date: 6/28/2016
Page 4 of x
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