Business Operations 'quality'

It is time to revisit a phrase that is often cited, and readily ignored thereafter… “Everybody owns quality.” If that is true, then why is it that the Quality function within life sciences companies is most often limited to certain business processes that are considered traditionally deemed to be managed by the Quality group? Why don’t life sciences companies utilize the Quality function to build ‘quality’ into the very fabric of their operations and then manage it thereafter? Why not proactively and holistically manage the ‘quality’ of the entirety of your business operations, not just a limited number of business process workflows that reactively address problems, after the fact? Why not?

Quality in the Life Sciences Industry

The fact of the matter is that the Quality function is often ‘siloed’ within a business because the Quality function is only considered by a majority of business leaders as a necessary cost of doing business within the highly regulated life sciences industry. I believe that the underlying reason for their paradigm is because the life sciences industry, unlike many other industries who don’t have the same profit margins, hasn’t internalized the concept that ‘quality’ is free, made famous by Philip Crosby. That is a case the life sciences Quality professionals need to make.

As a young Engineer, working within a medical device manufacturing company, I was once chided by an excellent Quality Leader who disapproved of my financial consideration of a ‘quality’ issue that I was involved with. This person was a wonderful leader, and I am very thankful to have learned quite a lot from her. However, I still believe that she was wrong in her teaching that ‘quality’ and cost should not be considered together. In retrospect, I choose to believe that she may have meant that reactively remediating ‘quality’ issues is very different from proactively addressing the ‘quality’ of business operations workflows to ensure a ‘quality’ outcome. I guess I will never know. That was long ago and she has since passed. I now believe that, outside of product development activity, that particular Quality organization was limited to reactively managing emerging ‘quality’ issues and doing so without regard to the cost of the associated corrective action.

I now believe outdated and reactive Quality Management paradigms must be replaced with an updated and proactive ‘quality’ management paradigm. This would then establish a foundation of managing all operational business process workflows to create a ‘quality’ outcome. This should be done to better ensure the profitable realization of results that matter to the business as a whole. This would also reduce rework activity and avoid costly remediation associated with the narrow focus of managing a limited number of business processes that are traditionally managed by the Quality group. The return on the investment (ROI) of proactively addressing operational ‘quality’ would reduce the cost of ‘quality’ management and ensure that ‘quality’ IS free because ‘quality’ adds value.

It is Now time to rethink and realign out dated paradigms in the life sciences industry. Mgmt-Ctrl, Inc. offers a transformational framework that provides management control over operational ‘quality’, enabling a more profitable outcome for your business. Gross Profit = Sales Revenue – Operational Expense.

As a company seeks to mature operationally for growth, it must possess an operational strategy for 'quality' management that will further enable effective business operations, with efficient operational execution, for sustained profitability of the business. Why? Operational growth brings new levels of complexity that must be responsibly managed to ensure the ongoing operations remain effectively efficient as the business grows.

“A system must have an aim.? A system must create something of value, in other words…results.?? - W. Edwards Deming

What about the Food and Drug Administration?

Some consulting firms want you to believe that there is great mystery in resolving FDA enforcement actions. There really isn’t. Why then do they say that? Because it is big business. They will readily provide a full remediation of FDA enforcement actions and lengthy quality system rebuild, at an annual cost of hundreds of millions of dollars, literally. However, they only address a small portion of business operations process workflows and not the entire system.?

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. This requires managing all operational business process workflows to create a ‘quality’ outcome.

It is widely understood and accepted that the capability for a ‘quality’ outcome is created with intention, it won’t just happen on accident, or automagically. Instead of waiting for the FDA to ‘suggest’ costly remediation, you could invest in a less costly and less chaotic path forward that will address the entirety of your operational business process workflows. Proactively embedding ‘quality’ and ‘control’ into your business operations will serve you extremely well when the FDA visits in their oversight capacity. What’s that old phrase? Pay now or pay later? However, establishing an operational ‘quality’ management solution for all of the right reasons comes with far less cost and chaos than doing it under duress. Additionally, providing the Agency with a roadmap of the ‘quality’ journey that you are on, and an understanding of where you are in that journey, will typically result in a positive outcome when they do visit. The FDA wants you to succeed just as much as you do because they support the same industry.

Are you ready to begin your transformational ‘quality’ journey? We can help.

To begin, just call. (844) 349-2272, Email. [email protected], or visit. PQMcoach.com for:

1 - Information about the PQM operational ‘quality’ management solution is available to the business community to provide an understanding of the PQM strategy and framework.?

2 - Education, in the form of coursework, is available to describe the establishment of the? Plan – Do – Check – Act phases of the PQM operational ‘quality’ management solution.

3 - Coaching is available for ongoing support in your PQM journey, to help keep you on track.

4 - Resources are available, as needed, to support your PQM journey, for timely results.

5 - Services are also available for specific processes associated with management control over ‘quality’, in support of ongoing and continual improvement for sustained success.

“Whenever you see a successful business, someone once made a courageous decision.” - Peter Drucker

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