Product Samples related to Design And Development

L

lrowe

I am in the middle of helping my company compile their first Design and Development process (We are ISO 9001:2000 but were exempt from D&D until now) and an interesting scenario has come up. We probably send out 20 samples of our product a month and of those maybe 2 will lead to a production level order. The samples that are I feel should invoke the D & D process are ones that are some variation of existing product that the customer wants to "Try Out" to see if it is a good fit for their product. How do I avoid having to do a design review, verification, and validation for every sample sent out since we won't know ahead of time if it will truly lead to a new product? If we had to do the full D & D every time we sent a sample we would be bogged down big time in meetings and paperwork.

Thanks

Larry
 

Jim Wynne

Leader
Admin
How do the products/things you're referring to come into being? Unless it's by magic, you're doing some sort of design and development to produce them, no? It's an interesting question. If the products you're referring to aren't actually salable in their "sample" condition, then technically they're not "products," at least not in the sense used in the standard. What I'm wondering is what happens when a customer accepts a sample and places an order. Do you do the D&D work after the fact? That doesn't make any sense.
 
L

lrowe

Jim,

Previously, we got our formulations directly from the world headquarters (in Japan) for established products. We would just duplicate the recipe here and that was the justification for the D & D exemption (the registrar seemed to be OK with it) I just started here in February and I recognized that this situation had changed and we were now doing design and development by virtue of coming up with new formulation of existing products. I just trying to find the trigger to do full blown D & D based on what has been requested from our customers with no guarantee that this is what will meet their requirements until they have tried the sample.

Larry
 

Miner

Forum Moderator
Leader
Admin
I have used a design procedure that has three classes of design. The lowest level is a slight modification of an existing design, The second level is a significant modification of an existing design. The third is completely new design.

The lowest level uses a highly streamlined version of the total design process. The second incorporates more elements, and the third uses all elements.

We also provided many samples of which a fraction resulted in orders. These samples were considered prototypes and did not receive production labels, but prototype labels and part numbers. The paperwork clearly stated that these were samples and not intended for use in production.
 
A

arin_23

What I'm wondering is what happens when a customer accepts a sample and places an order. Do you do the D&D work after the fact? That doesn't make any sense.


Well!!!! Well!!! Well!!!

A very good brain teaser pointed out by Jim. If we follow the clause no. 7.3.6; there is a comment that "......validation shall be completed prior to the delivery or implementation of the product......".

I understand by using the term "product sample" Irowe is referring to as the prototypes.It is evident that the steps till clause no 7.3.6 should be followed irrespective of batch production or pilot production.

Only 7.3.7 mentions about"......Evaluation of the effect of the changes on the constituent parts and product already delivered......".( I understand the products delivered in batches and under mass production)

I assume, the best process will be to maintain the raw data till validation for every new design application, if you receive a PO from the client then go for formal documentation along with the batch...the raw data will act as a guideline.

Or else what is the harm in going for a formal design documentation??? You can show your Top management that the design team has worked really hard :D ( Jokes apart) !!!! Moreover , the documentation will act as historical data for your future endeavors.

Cheers:cool:

Arindam
 
A

arin_23

I understand by using the term "product sample" Irowe is referring to as the prototypes.It is evident that the steps till clause no 7.3.6 should be followed irrespective of batch production or pilot production.


Sorry Larry!!!

I missed out your name in my previous post.

Cheers:cool:

Arindam
 
A

Agochar

Begs the question - how to control the wild and crazy sales team --- they want to immediately send prototypes to various customers. This product is non-sterile and labeled not-for-human-use with part number. Good enough? We are initiating a sample logbook too - controlled by the sales team ??
 
O

orangeisenergy

I have used a design procedure that has three classes of design. The lowest level is a slight modification of an existing design, The second level is a significant modification of an existing design. The third is completely new design.

The lowest level uses a highly streamlined version of the total design process. The second incorporates more elements, and the third uses all elements.

We also provided many samples of which a fraction resulted in orders. These samples were considered prototypes and did not receive production labels, but prototype labels and part numbers. The paperwork clearly stated that these were samples and not intended for use in production.

Miner-
Could you provide more details on the leveled process for D&D? I am trying to do this with my company, and it would be very helpful to have more information on how it has been done elsewhere! :D
 
O

orangeisenergy

Begs the question - how to control the wild and crazy sales team --- they want to immediately send prototypes to various customers. This product is non-sterile and labeled not-for-human-use with part number. Good enough? We are initiating a sample logbook too - controlled by the sales team ??
I have this same question!!! This is often practiced at my company. We label "for Research Use ONLY, not for IVD" (as we make IVD devices- agar and broth in patented devices- so our product is more the container than the agar/broth). We often have people doing research wanting us to send them samples of medium that we don't currently make- often it is just a hydrate and pour (commercially available) agar. Do we need to do D&D process on this for research use only samples? And if we intend to then sell it as a product? I understand the D&D process if we are formulating the medium, but not sure how to simplify for these "hydrate and pour" situations...
Thanks for the insight in advance!
 

Miner

Forum Moderator
Leader
Admin
Miner-
Could you provide more details on the leveled process for D&D? I am trying to do this with my company, and it would be very helpful to have more information on how it has been done elsewhere! :D
What specific questions do you have? This could potentially be a very wide area.
 
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