Product Samples related to Design And Development

O

orangeisenergy

#11
"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."

For the above referenced process with 3 levels.
We make IVD devices- agar and broth in patented devices- so our product is more the container than the agar/broth, but we have many different agars/broths in our device. These are all different products. We can buy a commercially available agar and hydrate and pour it (minimal D&D), or formulate our own agar or broth (full D&D) or design an entirely different device to put our agars/broths in (full D&D). My question is how did you structure the 3 tier D&D process? Our process does not currently have any exception to do an abbreviated D&D process, but I would like to write this into our process. Having an example or insight from it being done would be very helpful!
 
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Johnson

Involved In Discussions
#12
The statement of "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." may have two indications:
1. ISO9001 standard was considered not realy help but bring somet. That's why ISO9001 standard has being improving in the past 30 years.
2. The requirements of ISO9001 was not interpretered correctly. In fact, it is the company's decision how the validation and verification should be conducted. If the validation was only meeting and paper. It may means the validation process and method is not correct. We need to find a way that really add value to the company.
 

Miner

Forum Moderator
Staff member
Admin
#13
Start by creating a matrix. Each row is a specific D&D task, and you will have three columns for the three levels of design effort. The highest level of design effort will include 100% of the design tasks. Then look at the minimal design effort scenario and mark the design task that are relevant to that scenario, then finally the intermediate design effort.

Also consider that there are two approaches that should be combined when doing this. First, certain design activities may be totally unnecessary for the minimal design scenario, while others might be scaled back, but not eliminated. For example, a Design FMEA would not be eliminated, but would be scaled back to cover only those portions of the design that have changed.
 
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