Cost Targets as Design Inputs in your DHF (Design History File)

Do you guys put cost targets as design inputs in your DHF, some other place, or use them at all?

Thanks!

Re: Cost Target as Design Input

I am sorry, it is the end of my work day so my brain feels a little soft... what is DHF please?

Re: Cost Target as Design Input

Design History File

The FDA, in its document (broken link removed) describes cost as a consequence, as in cost of poor quality, and doesn't include cost targets among inputs (see section C).

But if you wanted to include a file or referencing a study showing cost savings curves by reducing inefficiencies or errors, I would think that could be part of the review. In order to shorten the time-to-market cycle and/or reduce costs of inefficiency/error, the "Check" stage of every project should include performance of the project, but many times this stage just addresses the item or service being designed.

sshankle said:

Do you guys put cost targets as design inputs in your DHF, some other place, or use them at all?

Thanks!

Click to expand...

If you refer to unit cost - then definitely yes, it is a design input. For instance, if you try to design a disposable device that costs to make $0.1, the resulting design will be very different from one corresponding with a $1 unit.

Sorry to resurrect an old thread, but I am in this position at the moment and figured adding to this was more beneficial than starting a new thread.

Having a CoGs requirement definitely educates your design, however the other consequence of this is that if it is in a user or system requirement, per the FDA, you need to either validate or verify this requirement. It feels like there should be a "business needs" document that is separate for these types of requirements. Is this a common practice in organizations? Or do people just ignore the requirement in their V&V stages?

I have put cost of goods into the Design Inputs and adding up front that we will verify it by generating a bill of materials and estimated assembly cost. Confirmation of the actual costs were entered later. As long as we were not trying to be too precise in the original cost requirements, no one saw a problem with this.

Cost is important to the business but outside the scope of QSR. I would not include them in your DHF as they become visible to regulators. Mature orgs manage cost carefully but establish a clear boundary of what's in (DHF) and what's out (cost, for example) of the documented scope of the QMS. I have been at industry forums where FDA indicated they have asked for this sort of information in the cases where the device manufacturer included it in scope of Design Controls.

Good question. I've always included it in the DHF, but where I see conflict is it's not a requirement as in it's not in the design requirements, it's in either a marketing requirements or business requirement document, that is separate from the DI's.

I would not since then you need to think about a design input for "hourly rate for an employee to assemble <$25/hour." Cost of electricity to heat the building? What about the depreciation of capital goods or inventory? How much inventory to stock? It gets wild quickly. Price elasticity?

Any costs incurred by "Costs of goods sold" are handled plenty well by accounting as their core business.