Hardness permanent, definition

Osmond defined hardness as that property possessed by solid bodies in a variable degree to defend the integrity of their form against causes of permanent deformation and the integrity of their substance against causes of division. This definition includes the idea of wear and is more applicable to metals than to rubbers. 

One of the oldest definitions of hardness is that due to Osmond (1895) who, having analysed 14 known hardness measurement methods, stated that the concept of hardness should be understood as the resistance of a material to permanent deformation under concentrated forces acting on a small area of the metarial... . This definition, although most comprehensive and at the same time characterizing most closely the nature of hardness, has not been accepted into common usage. 

The static three-batch validation exercise, the applied derivative of the definition above, has started to look antiquated, if not counterproductive, to regulators because it is seen as stifling innovation. Through the years, both the industry and regulators have worked hard to establish documented evidence that supports the picture of permanent static control. By the year 2000, neither side was happy with their creation. The industry felt burdened with administrative systems documenting processes that were, in fact, not under permanent static control, and everyone knew it (see Reference 3). Recent criticism leveled at the industry specifically from regulators pointed out that... 

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