1.
PURPOSE
1.1.
2.
SCOPE
2.1.
3.
All materials related to salable products.
DEFINITIONS
3.1.
4.
Defines the methods of product identification and traceability during storage,
production, delivery and installation.
N/A
POLICY
4.1.
Model numbers are assigned by Marketing.
4.2.
Manufacturing Engineers and Engineering Services are responsible for entry of part
numbers and related part number information into the database.
4.3.
Engineering drawings and bills of material assist in identifying parts.
4.4.
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.
4.5.
Product Serial Numbers
4.6.
4.7.
4.5.1.
All final products shall be serialized in order to provide traceability to the
originating work order.
4.5.2.
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.
4.5.3.
Printed circuit boards and sub-assemblies may also be serialized at the
direction of the Manufacturing Engineer.
OEM Serial Numbers
4.6.1.
Many products contain components that are serialized by the original
equipment manufacturer (OEM).
4.6.2.
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.
Production Run ID
REFERENCE ONLY WHEN SIGNATURES ARE NOT PRESENT
Page 2
Exhibit A
Process Flow:
Product Identification
and
Traceability
4.7.1.
Run ID numbers shall be assigned to work orders for sub-assemblies and
Parts Received
final assemblies.
The Run ID is used to associated multiple work orders that
and stocked per
make up Receiving
a finishedNPP
product.
4.7.2.
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.
Work Order Picklist(s)
4.7.3.
number
is used
to associate by the Run ID number at all times during
Product
must
be segregated
sub-assemblies
to final
production
processes
to ensure the correct allocation of work orders to the
assemblies
final assemblies.
generated. The Run ID
4.8.
Serial number
labels
generated and
issued with W.O.
Serial numbers
derived from W.O.
number
4.9.
Identification
Components identified
by part number and
work order number
Product Delivery
Serial Numbers
4.8.1.
serial
numbers shall be recorded on shipping documentation
Yes Final product
required
per Mfg
to provide Engineer?
traceability to the end user (customer) and to the originating work
Traceability
order.
Quality Records
4.9.1.
Final assemblies
traceable to work orders
No
Work Orders and shipping documentation are considered quality records
of 3 years.
Pick parts
W.O.picklist
and sendfor
to Production
andper
must
be maintained
a minimum
5.
PROCEDURE
Identification
Organize and segregate sub-assemblies and final
Sub-assemblies and
final assemblies
5.1.
accompanied by W.O.
6.
assemblies by Run ID number throughout the
production process
See Exhibit A
EXHIBITS
Record OEM serial numbers on Work Order when
required by Mfg Engineer
6.1.
Exhibit A -- Product Identification and Traceability flowchart
Sub-assembly Production Work Orders Complete
Match sub-assembly Run ID numbers to final
assembly Run ID number
Serial number labels applied to final assembly
Final assembly Production Work Orders Complete
Close Work Orders and retain for future reference.
Work Orders become Quality Record for traceability
Record unit serial numbers on
shipping documentation and retain
for future reference.
Finished Unit Serial
Number at Customer's
Location