Services for Pharma and Life-Science

 

 

General aspects of quality and quality costs

 

Quality may be defined as the timely and compliant implementation of regulatory requirements at an optimized cost-benefit ratio. It is difficult to budget quality costs, because partly they are hidden costs which result from under or over compliance. In the domain of optimal compliance the quality costs and the compliance with regulatory requirements are well-balanced (see GxP Compliance).

 

Optimal Compliance

 

Compliance risk (non-compliance):
In the case of under regulation the quality costs are apparently low, but they may increase significantly in the case of authority complaints or customer reclamation. The consequence can be the loss of confidence and therewith delayed business opportunities or breakdown of business relations. Reasons for underachievment in compliance can be:

Efficiency risk (over-compliance):
In the case of over compliance a loss of productivity can be caused if the operating expense for the sustainment of the quality system is too high and consumes a major part of the resources. Otherwise the overstated requirements can not be realized completely by the personnel and cause a demotivation of the personnel, leading factually to the same consequences as non-compliance. Reasons for over-compliance can be:

 

It is our objective to lead you to the optimal compliance domain.