product trace ability
TRANSCRIPT
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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. D EFINITIONS
3.1. N/A
4. POLICY
4.1. Model numbers are assigned by Marketing.
4.2. Manufacturing Engineers and Engineering Services are responsible for entry of partnumbers 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 partnumber or other identification to enable positive identification of the material or
product throughout storage, handling, processing, and delivery.
4.5. Product Serial Numbers
4.5.1. All final products shall be serialized in order to provide traceability to theoriginating 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 thedirection of the Manufacturing Engineer.
4.6. 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 serialnumbers. Manufacturing documentation is used to communicate therequirement. OEM serial numbers are recorded on the Work Order that thecomponent was issued to. This provides traceability of OEM serial numbersto specific work orders in the event of product recall or service requests bythe OEM.
4.7. Production Run ID
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4.7.1. Run ID numbers shall be assigned to work orders for sub-assemblies andfinal assemblies. The Run ID is used to associated multiple work orders thatmake up a finished product.
4.7.2. The Run ID numbers assigned to a final assembly work order should matchthe Run ID number of all the sub-assembly work orders allocated to the final
product.
4.7.3. Product must be segregated by the Run ID number at all times during production processes to ensure the correct allocation of work orders to thefinal assemblies.
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 andmust 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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P a r t s R e c e i v e d
a n d s t o c k e d p e r
R e c e i v i n g N P P
W o r k O r d e r P i c k l i s t ( s )g e n e r a t e d . T h e R u n I D
n u m b e r i s u s e d t o a s s o c i a t e
s u b - a s s e m b l i e s t o f i n a l
a s s e m b l i e s
S e r i a l n u m b e r l a b e l s
g e n e r a t e d a n d
i s s u e d w i t h W . O .
S e r ia l n u m b e r s
d e r i v e d f r o m W . O .
n u m b e r
R e c o r d O E M s e r i a l n u m b e r s o n W o r k O r d e r w h e n
r e q u i r e d b y M f g E n g i n e e r
S e r ia l n u m b e r l a b e l s a p p l i e d t o f i n a l a s s e m b l y
R e c o r d u n i t s e r i a l n u m b e r s o n
s h i p p i n g d o c u m e n t a t i o n a n d r e t a i n
f o r f u t u r e r e f e r e n c e .
E x h i b i t A
P r o c e s s F l o w :P r o d u c t I d e n t i f i c a t io n
a n d
T r a c e a b i l i t y
C l o s e W o r k O r d e r s a n d r e t a i n f o r f u t u r e r e f e r e n c e .
W o r k O r d e r s b e c o m e Q u a l i t y R e c o r d f o r t r a c e a b i l i t y
S u b - a s s e m b l y P r o d u c t i o n W o r k O r d e r s C o m p l e t e
F i n i s h e d U n i t S e r i a l
N u m b e r a t C u s t o m e r 's
L o c a t i o n
T r a c e a b i l i t yF i n a l a s s e m b l ie s
t r a c e a b l e t o w o r k o r d e r s
S e r i a l N u m b e r s
r e q u i r e d p e r M f g
E n g i n e e r ?
O r g a n i z e a n d s e g r e g a t e s u b - a s s e m b l i e s a n d f i n a l
a s s e m b l i e s b y R u n I D n u m b e r t h r o u g h o u t t h e
p r o d u c t i o n p r o c e s s
P i c k p a r t s p e r W . O . p i c k l i s t a n d s e n d t o P r o d u c t io n
M a t c h s u b - a s s e m b l y R u n I D n u m b e r s t o f i n a l
a s s e m b l y R u n I D n u m b e r
F i n a l a s s e m b l y P r o d u c t i o n W o r k O r d e r s C o m p l e t e
Y e s
N o
I d e n t i f i c a t i o nC o m p o n e n t s i d e n t i f i e d
b y p a r t n u m b e r a n d
w o r k o r d e r n u m b e r
I d e n t i f i c a t i o nS u b - a s s e m b l ie s a n d
f in a l a s s e m b l i e s
a c c o m p a n i e d b y W . O .