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Why is initial production units, lots, or batches, or their equivalents required for Design Validation?

ltcmff

Starting to get Involved
#1
hi,
according to 820.30(g),design validation should be performed on initial production units, lots, or batches, or their equivalents.

what is the purpoe of this requirement? the design verfication do not have the same requirements.
how to demostrate the equivalents

can anybody help to clarify further?
thanks in advance.
 
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Ajit Basrur

Staff member
Admin
#2
hi,
according to 820.30(g),design validation should be performed on initial production units, lots, or batches, or their equivalents.

what is the purpoe of this requirement? the design verfication do not have the same requirements.
how to demostrate the equivalents

can anybody help to clarify further?
thanks in advance.
You have combined both Design Verification (820.30 (f) and Design Validation requirements (820.30 (g).

In Design Verification, the intent is to confirm that output meets input requirements, while

Design Validation establishes by objective evidence that specifications (specified requirements) conform with user needs and intended use(s); therefore, initial production units, lots, or batches (or their equivalents) are considered.
 

ltcmff

Starting to get Involved
#3
thank you for your prompt reply.
the product is also design output .
from the usability point, early validation or formative valiation are required. so i am still not sure why initial production units are the mandotory requirement for design valition ,but not for design verification.
 

yodon

Staff member
Super Moderator
#4
Design verification may require use of prototypes, debug equipment, test fixtures, etc. As @Ajit Basrur points out, you're focusing on the requirements (design inputs). I like the analogy for verification: "did we build it right?"

Validation, since the focus is on user needs and intended use, needs to be as close to production as possible to ensure the results are valid. The comparable analogy for validation is "did we build the right thing?"

Does that help? Do you have a situation in particular that you're struggling with?
 
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