8.3.4 Verification and Validation

Calgirl319

Starting to get Involved
#1
Hello All,
Keeping meeting minutes question, the way our Design procedure is written, it seems to me we have to have a meeting for absolutely every new design and capture meeting minutes. I agree to a certain extent, like in the case of a complicated design (we would have to define "complicated" = high risk designs) but not for absolutely every single design. I don't see in the standard where it says minutes must always be captured or am I not understanding? Can someone please give me thoughts, recommendations, ideas or corrections to how I am interpreting?
 
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Ninja

Looking for Reality
Staff member
Moderator
#2
Leading question:
How do fulfill 8.3.4 for those designs considered "simple"?

Note that meeting and minutes are not required...verification and validation (among others) are...in the effective manner you choose.
We simply put test data in the file...group meetings with minutes would have been a waste of time.
 

yodon

Staff member
Super Moderator
#3
I think there may be 2 things here. What you describe (design review meeting minutes) would seemingly be to fulfill 8.3.4(b). V&V activities are generally test activities.

Probably what you're getting at, though, is a risk-based approach. You can probably slim down the reviews for those 'simple' designs. I would still think you would conduct them and capture meeting minutes, though, as a means to show compliance to 8.3.4(b).
 
#4
Before taking actions, I think there could be a procedure to identify the design requirement. The necessity, gravity, complexity, and so on... Normally, before all tests, there must have some inputs which means after the review of the requirements. There are different designs, so there are different solutions.
 

John Broomfield

Staff member
Super Moderator
#5
Hello All,
Keeping meeting minutes question, the way our Design procedure is written, it seems to me we have to have a meeting for absolutely every new design and capture meeting minutes. I agree to a certain extent, like in the case of a complicated design (we would have to define "complicated" = high risk designs) but not for absolutely every single design. I don't see in the standard where it says minutes must always be captured or am I not understanding? Can someone please give me thoughts, recommendations, ideas or corrections to how I am interpreting?
Each order’s design plan should make this clear:

A. Design exists and is verified as suitable (within the bounds of validated usage).
B. Design exists but needs modification, verification and revalidation.
C. New design required and customer is willing to pay for design in some way or we should retain the IP.

Please note.

Your sales process should make sure you are paid to design corrugated containers for new applications. This can be tricky if it turns out that a corrugated container is not the solution so your process should warn the customer if they are likely to near the limits of the material.

Another complication is that your company may want retain ownership of the design IP because other customers leo have this problem. This is where the sales process interacts with strategic planning.

So, sales can take orders for A, but B and C see need design input.

By now the sales and design processes for B and C should be well established so study them, respect them and make sure the system supports them before asking if they’d like to improve them.

Do not make suggestions until you’ve done this.
 
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