System and Method to Determine the Total Cost of Regulatory Compliance and the Total Cost of Product Quality

A method for determining the cost of regulatory compliance of a product of an equipment manufacturer, the method comprising:

• providing a server for hosting the system on a network including an interface to the system for use by users;
• establishing access to a time and expense database accessible by the server wherein the time and expense database stores time entries of users tasked with compliance related matters where time entries may be associated with a particular product and for a particular time period, and expenses related to compliance related matters by product type;
• inputting data by at least one user on an input device to the time and expense database;
• calculating a total cost of compliance by the server from entries in the time and expense database according to an equation as follows:
• Total Cost of Compliance=ΣInternal+External+Delay+Probability of Failure
• Where,
• Internal=number of hours of staff time spent working on compliance related matters multiplied by a corresponding hourly rate for each staff member and the cost of activities and operations attributable to compliance, including but not limited to supplies, equipment, tools, office space, utilities, and travel;
• External=Expenses of regulatory license and certification fees, laboratory fees, shipping notification costs and other fees attributable to the cost of testing, approval and certification for compliance of product;
• Delay=Expenses associated with delayed entry of product to market due to compliance issues;
• and
• Probability of Failure=Expenses attributable to a failure of a product multiplied by a probability that a failure will occur;
• and
• providing a total cost of compliance report calculated by the server from entries in the time and expense database to at least one user on the input device.