Life Sciences Quality Management

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Far too many business leaders have witnessed something that can only be referred to as “Qualicide”, resultant from a lack of understanding that the intrinsic aspect of ‘quality’ is only the ‘ante’ [1] to enter the and play well in the game of business. Qualicide is all too often the result of costly remediation efforts associated with Quality System remediation efforts within the highly regulated life sciences industry that doesn’t actually result in an improved performance capability for the business. That need not be the case with a structured approach to reimagine and/or refresh your capability to manage the ‘quality’ of the Quality System for business performance.

Achieving success in the ‘game’ of business stems from a workforce that efficiently executes the work of the Enterprise by transforming their time ($$$) into effectively obtaining the results that matter to the business. However, effectively efficient business operations don’t just happen by accident, they are resultant from the intentional utilization of an approach to operational performance management that enables management control over operational ‘quality’ and does so for a net positive affect upon the ongoing management of Operational Expense.

Gross Profit = Sales Revenue – Operational Expense (cost of operations) 

In the world of business, performance is the name of the game… Performance for results that matter to the business: effective process + efficient execution = performance.

A business has three main areas of focus for operational excellence (OpEx) efforts:


This conceptual view of OpEx focus within a business can be translated into high-level business capabilities, with the following considerations:

The business needs to operate in a manner that ensures effectively efficient operations:

  • Effective involves "producing a result that is wanted."
  • Efficient involves "producing desired results without wasting materials, time, or energy."

A business process can be considered effective if it produces a desired result, even if it utilizes some unnecessary resources to do so. However, when a business process is additionally considered to be efficient, not only does it produce the requisite result(s), but it also does so while utilizing the minimal resources that are necessary to obtain the requisite result(s).

What does a Regulatory Agency need?

Regulatory agencies have a mission to protect and promote public health by making sure that safe and effective devices and/or drugs are available. ‘Safety’ is defined as freedom from unacceptable risk. ‘Unacceptable risk’ exists when a device and/or drug is identified that poses “an unreasonable risk of substantial harm to the public health.”

The ‘state of the art benefit’ of patient safety is a Risk Management concept. The ‘state of the art benefit’ of patient safety is established through a comparative understanding of post-market product ‘quality’ and is achieved when the overall residual risk experienced with the use of a specific product and/or service is in alignment with the level of ‘risk’ that is inherent with the use of competitively marketed products. 

The Agency expects life sciences companies to have a high-level of ‘management control’ over product and/or service ‘quality’ to ensure the state-of-the-art benefit of patient safety.


[1] The term ‘Ante’ is a poker term used to indicate the initial bet that allows a player to enter the game. The contextual use of this term emanated from a life sciences professionals’ (John Watkins, retired) characterization of ‘quality’.