Mayday! Mayday! These "Unknown Unknowns" Can Torpedo Your QMS

Are knowledge gaps leading your  quality efforts off course?

In psychology, people talk about knowledge and learning in terms of four levels: what we know, what we think we know, what we know we don’t know, and what we don’t know we don’t know. In the life sciences, the fourth level, what we don’t know we don’t know (or unknown unknowns, for short), carries the most risk in quality and compliance. If you are in a leadership position, the risks are even higher. After all, how can you provide the appropriate resources or strategic direction while operating in a knowledge void? Many executives learn quality and compliance through a sort of “school of hard knocks.” They make QA and compliance decisions based on what they already know or think they know (assumptions), often missing the mark completely. This causes unnecessary delays and can kill a promising product or company. The trick is to be able to recognize (and admit) when you don’t know you don’t know something, and then use the appropriate critical thinking process, at the appropriate time, to gain the knowledge or resources you need to create organizational success. It sounds easy in theory, but it can be tricky in practice.

This article is related to the Toolkit: Quality Management System (QMS) Toolkit from MasterControl. To get the full details, please download your free toolkit.

Navigating Knowledge Gaps

When thinking about not knowing what you don’t know, picture a submarine. Because light does not penetrate very far into the ocean, a submarine must navigate through the water virtually blind. It relies on three things to “see” underwater: exact positional information from its inertial navigation system, a device that uses gyroscopes and accelerometers to estimate the course through water without any external input or data (in quality, a QMS); updated sea charts (in quality, standards and regulations); and effective leadership. Typically, the leadership culture on a submarine is much different from the rigid, hierarchal culture on surface ships. On a submarine, the crew is small and works together in close quarters. Any member of the crew can comfortably talk to the captain or rely on a fellow crew member to coach him or her on a particular process until he or she gets it right. Shared responsibility is in everyone’s best interest because a lack of knowledge of systems or processes on a submarine can have catastrophic consequences, which is why knowledge and safety are valued over formality and pride. In his book, “Turn the Ship Around: A True Story of Turning Followers into Leaders,” David Marquet, a retired Navy officer and former captain of the USS Santa Fe, a nuclear-powered submarine, discusses the dangers of leading a culture of followers in a high-pressure environment where there is no margin for error (sound familiar?). After unwittingly issuing an impossible order, which his crew tried to follow despite knowing it was wrong, Captain Marquet realized the limitations of the traditional leader-follower approach. In a nutshell, when a leader is wrong in a top-down culture, everyone in the organization goes down with the ship. On the other hand, shared responsibility and decision-making boost morale and make effective leaders more effective. Marquet began treating his crew as leaders, empowering—even expecting—them to take control. Soon the USS Santa Fe was achieving the highest retention and operational standings in the Navy. I think we can apply many of these same leadership lessons to our work in the life sciences.

What We Know

In an LNS Research Quality Management Survey of more than 500 life sciences executives, one in three said they consider quality to be more of a department than a responsibility. This “quality as a department” mindset may be due to lack of support from senior management, who may or may not truly understand the quality management philosophy. Regardless of its origin, it can lead to many challenges such as reactive quality issue management, which is stressful and highly prone to error, and quality being seen as a policing function. Effective quality management requires people who have broad organizational knowledge that can be used to manage each quality process (design control, CAPA, risk, etc.), from concept to commercial release or transfer. If you have departments or divisions that toss products (and responsibilities) to the next team once they have finished with their part, you have no way to guarantee quality or to know if the handoff is being managed correctly. Correction of this “quality as a department” mindset is possible, but it must start at the executive level.

Assumptions That Will Steer You Off Course

Many companies incorporate quality (and compliance) as an afterthought rather than as a part of their strategic critical thinking processes. When organizations assemble a team, they look for very smart people, such as engineers or Ph.D.s in their relevant fields, with the implicit assumption that these people already “get it” when it comes to quality. This is a dangerous and flawed thinking. Mistakes and oversights happen, especially during the design process. In my experience, many companies exclude or fail to perform technical reviews at the end of each of design phase (e.g., concept and charter; feasibility; design and development; design verification; etc.), although the stage-gate process is a widely acknowledged project management best practice. Assuming that everyone “understands” quality or abides by the same best practices puts the very organization at risk. You cannot make that kind of assumptive leap. Having smart people on your team is not enough. Empowering them is not enough. Quality and compliance must be incorporated, i.e., documented, into your operational excellence strategy and shared by the entire company. That’s the first step toward holistic quality management. The next step is to invest the time and resources necessary to foster the transformation. Such resources might include third-party quality audits to pinpoint areas for improvement; clear, concise SOPs and work instructions; and access to the latest technology and documentation about quality trends and regulations.

What We Think We Know (But Don’t)

Some organizations delay implementing quality and compliance strategies because they think it will take valuable time and slow momentum and time to market. On the contrary, a good quality strategy will accelerate, not delay the development and realization processes. This is made possible through the use of technology, such as enterprise quality management software (EQMS), which standardizes and improves data collection, supplier visibility, and harmonizes traditionally disparate processes and systems. According to LNS, when the ability to identify risk factors across operations is introduced, median successful new product introductions (NPIs) are increased by as much as 24 percent. Another way to accelerate your progression to harmonized quality is by having people on board who understand systematic quality and their role within it. Unless people fully know what they are supposed to do, they cannot (and will not) do it well. I once saw a multi-million dollar piece of equipment destroyed on its first run because the “qualified” operator was not given all of the information he needed. He had been trained and passed all of the tests but wasn’t told about the consequences of dropping the stationary head of the machine onto a rotating base. He knew how to push the buttons correctly, but his understanding did not go beyond that, so the company lost millions. As a leader, it is your responsibility to ensure that everyone in your organization fully understands his or her role and can work together cooperatively without stepping on each other’s toes or performing redundant tasks. This understanding has to go beyond quotas or specifications. It must incorporate consequences as well. These concepts are becoming more explicit as quality standards cycle through their current revisions.

Incorporating Quality at Every Phase

If you build quality in from the beginning with Quality by Design (QbD), Design Control or Process Analytical Technology (PAT), you eliminate risk and accelerate the overall process. Taking the time to identify critical parameters and set the design characteristics with appropriate design control protocols, such as risk planning, may seem like a delay, but they ultimately save time and expense. This is where significant ROI can be the differentiator in the rationale for an executive’s decision to invest in resources (technology, people, knowledge). As an example, I recently worked with a medical device startup that applied these kinds of resources, and in doing so designed and produced an approved Class II product for sale in less than eight months. On the other hand, if quality isn’t factored in until preapproval or even manufacturing, it is probably too late to avoid challenges and delays due to risk without developed control measures. Talk to any quality professional or manufacturing expert about what happens when you delay implementing a quality and compliance program and the words “luck” or “take-a-chance” are always implicit in the conversation. Relying on luck or even relying on what you think you know about quality and compliance is taking an enormous risk.

Quality Done Right

To do quality right, you must use the right information and set up the right tools and protocols so quality transfers across business units (R&D, manufacturing, quality), across disciplines (chemists, engineers, statisticians) and across processes (document control, CAPA, risk management) at every stage of the process. You need to understand the data generated from one quality process and use it to improve the entire system, as an integrated collection of processes. As I said before, it is important to have one person, or a team of people, who has full organizational knowledge and understands the role of quality at every stage. It is also important for that person to ensure that everybody understands his or her role in the bigger picture at every stage of the process. A well-managed quality and compliance system, implemented early and deployed effectively, can eliminate risk and save time and money at every stage of the development process. Acknowledging that there are things that you don’t know you don’t know is a good first step because it starts the process of finding the right advisors and implementing systems that fill the knowledge gaps. The danger is in assuming that you, or someone else in your organization, have it covered—when chances are you probably don’t.
Walt Murray, CLA, CSSMBB, is the CEO of ARC Experts and a valuable part of MasterControl’s Quality and Compliance Consulting (QCC) services team. He has 32 years of quality, environmental and health and safety experience, and has conducted more than 300 audits for regulated Fortune 500 companies.  
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