Being Bimodal

May 28, 2020

By Stephen McCarthy


The five imperatives of all Quality Leaders

Regardless of industry or company size, all Quality leaders share these five key imperatives.

Arguably, I place product quality as paramount. In life sciences, more than any other industry, product efficacy is vital; does it do what it was designed to do? These two ensure patient safety, the ultimate accountability of the industry. Next comes continuity of supply of both existing and new product.
Finally, compliance.
I intentionally, and perhaps provocatively, put compliance last in this list. We know from data that a company can have a good compliance record but that may not necessarily be accompanied by good product quality, while the converse is frequently to be true: a company with good product quality tends to have that accompanied by a strong compliance performance.
These five things core accountabilities are connected. The Quality Management System is called a system, not because it is executed in a software platform but because it is designed to be an interconnected, closed loop of processes that inform quality by design. Quality transfers that design into manufacturing, quality of manufacturing and supply all the way to patient. Then, from the patient back to continuous improvement of the initial design and manufacture, and ultimately through the end-of-life of that product.

Product quality is complex
The quality of medical products is, of course, a complex topic. Simply put, it could be defined as a measure of how well that product meets established specifications and tolerances when tested against them.
However, there are so many opportunities for quality events to effect product quality along the complex value chain, especially when we consider that value chain starts with ideation, discovery, design and development – and ends all the way out at the patient.
Those specifications and tolerances have to be designed into the product. Quality By Design (QBD), Critical To Quality (CTQ) flow down: design for manufacture, supplier selection, raw material selection. All of these front-end aspects can affect product quality.
Then imagine all the touch points on product, just on the factory floor alone: raw material incoming inspection, raw material storage, ordering, picking; manufacturing equipment calibration and performance; environmental controls, human intervention, finishing and packing, testing and release; shipping, distribution, storage, stability, and usage once product leaves the factory. These represent the countless opportunities for quality to be adversely affected.
Compliance is still a challenge
It’s interesting that we still see so much priority given to complying with regulation over the other four of these imperatives. For me, compliance is just the ticket to the game.
For many firms, compliance is still the number one goal of their quality organization. But if that’s the case, then the regulators have unintentionally created the opposite effect to that they set out to create. Their purpose is, and always has been, to promote and protect public health, not to cause manufactures regulatory nightmares. Talk to any of them today, and they will tell you that is true. I’ve discussed it just recently with several offices of the US FDA, and we were clearly aligned on that thinking.
But let’s get real for a moment.
The fact is that, while we should place compliance in its appropriate position of priority, it is a daily challenge for even those most mature of companies. Often large firms have some inspection taking place in some facility by some regulator, every single day of the year. Small and mid-size firms still struggle to meet even the basic requirements of increasing challenging and ever-changing regulation, so I don’t want to downplay the importance and significance of the problem.
The FDA and other global regulators establish and enforce regulations to assure public health and patient safety.
It can be difficult to feel it when you are a medical product manufacturing plant under inspection, there has clearly been a discernable rebalance on the part of most global regulatory agencies, as they became more risk-based in their approach.
Bi-modality and the macro industry trends affecting quality
While these five things are front and center of the quality professional's mind every hour of the day, increasingly over the past five years they are faced with a bi-modal challenge.

Mode 1 is about operational stability, predictability, efficiency and incremental continuous improvement often characterized by the need to drive down Total Cost of Quality (TCoQ). Mode 1 is risk-averse and focused on prevention. Mode 1 can be seen as these micro challenges effecting quality.

Mode 2 is exploratory. It is about innovative, creative out-of-the-box solutions. Mode 2 is about speed and big-step changes. It is risk-tolerant and proactive, where fast failure is allowed. Digital transformation and Industry 4.0 epitomize Mode 2.

For Quality, Mode 2 can be characterized by seven macro industry trends:

  1. Process complexity and variability

  2. Pace of innovation

  3. Novel medical product

  4. Industry 4.0

  5. Supply Chain Complexity

  6. Patient Centricity

  7. Total Cost of Quality (TCoQ)

How might these trends materialize?
While our tireless quality leader is buried under existing and mounting pressures of complex change controls, customer complaints in the thousands, product recalls, inspections in multiple manufacturing sites at any given time, increased and diversified suppliers – now the head of R&D is asking for unique quality system capabilities to support development of an amazing novel product that will have far reaching patient benefits, and the head of Engineering is in their office needing quality system innovation for the digital, ‘factory of the future’ that was recently approved. Furthermore, their Business Unit President is projecting double-digit growth, which, while a great problem to have, one knows will not be accompanied by double-digit increase in headcount in the Complaint Handling Unit and the Chief Quality Office and Chief Financial Officer have estimated TCoQ at over 20% of total operations and set a target to reduce it below 10% in the next three years.
The technology solution provider must be bimodal too
It has long been established that a company in this industry that aspires to achieve the promise of Proactive Quality as a differentiator will have agile, integrated, and scalable enterprise quality systems, be patient-centric in their operating model, utilize advanced, predictive analytics, have optimized their Total Cost of Quality, and embraced bimodality. That is not achievable without their chosen technology solution partner being bimodal too.

That’s why the balance of competing tensions between Mode 1 and Mode 2, vitally inform the very vision, mission, and resulting product and solution strategy and roadmap for Sparta Systems.

As we reviewed this strategy and roadmap with FDA earlier this year, they too reiterated the importance of caring for the needs of the industry, not only in the rapidly approaching future but in the here and now.
We gave them that assurance and make that same promise to our customers as we work together to deliver the promise of proactive quality.
In this series, Sparta Systems shares insights about macro and micro industry trends that affect quality in such a bi-modal manner. Learn more about how Sparta is proactively solving for those challenges and opportunities by redefining the acronym SaaS from simply Software As A Service, to Solution As A Service. Read more about how Sparta is strengthening its relationship with global regulators, becoming a trusted strategic partner to the manufacturer, and fundamentally, systematically changing the ‘c’ in cGMP.

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