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Tooling & Equipment Supplement - Interpreting clause 4.4.2.1

L

Linda Jurasin

#1
#1
In the second edition of the Tooling & Equipment Supplement, element 4, Design Control - Required Skills 4.4.2.1, I need assistance in understanding what environmental characterization means. Can someone help me out?
 
QMS for Medical Device Companies
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B

Bryon C Simmons

#2
#2
Linda,

Good question. Basically, what the intent here is to have understanding of the environment that the product will be used in, and having the understanding of applying those environmental conditions, and their impact on the product, into your design activities. In the case of our product, (returnable packaging), we need to understand the environment of use. (assembly plants, high impact conveyor lines etc)
We take that info into consideration when we design; using heavier materials etc. to increase the durability and reliability of the product.

Hope this helps

Bryon
 
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