During my consulting career – both while working full time within a company and as an external consultant – one of the most common issues has been the failure of the company to provide useful acceptance limits for performance parameters for a product.
- No limits whatsoever
- Clearly unachievable limits
- Limits that could not be evaluated (often non quantifiable limits)
Limits are important because matching observed performance to limits (assuming the limits are correct) prevents releasing a product too late or too early:
- Late – Delaying product release
- Attempted early – Having the product rejected or delayed by the FDA
- Early – Having the product rejected by the marketplace
Any of the above is bad for the financial health of a company.
So why is it so difficult for this fundamental market requirement to be established? I’m not sure.