QA ... not radical enough?

I have read with interest Penelope Przekop’s guest column “The Growing Value of Quality & Compliance Professionals in Decentralized Pharma” published in Outsourced Pharma this week.

It is an enthusiastic stance on the value and contribution of seasoned Quality & Compliance (Q&C) professionals “with the breadth and depth of industry knowledge that affords them detailed understanding of both health authority regulations and regulators and the drug development process from early phases through commercialization.” She argues that the increasing specialization and complexity, sophisticated technical and computerized solutions, number of vendors in clinical trials mandates the strong input and oversight by Q&C professionals. Criticizing that Q&C is not represented at the top of companies and compliance is not the key concern at the inception of new pharma companies, she portrays Q&C professionals as those who will rescue the industry by being focused on quality and integrity in clinical research while other lack the regulatory expertise and experience to do so.

Being a seasoned Quality Assurance professional for 30 years, I guess I should be flattered by such praise on the value of Q&C experts.

Well, I am not.

Rather, I feel awkwardly put off and confused. I agree to many points raised in the guest column, in particular with regard to the developments in the clinical research industry over the last decades.

Some decades ago, regulations emerged in response to ‘bad things’ happening, scandals and misconduct and just ignorance of good scientific practice. I cannot remember a time looking back to this era that Q&C professionals were considered to be indispensable by senior management in ensuring quality, but they were often portrayed as the police, those that make trouble and provoke extra work. Their questions and comments, even though justified, were considered a nuisance. Q&C’s main task was to perform audits, check on others’ work and come up with lists of deficiencies that need to be addressed to make it right again. A very reactive approach to Quality Management at that time.

Of course, we have evolved since and, in the era of Quality by Design and Quality Risk Management, our work should now be entirely proactive and forward-thinking, shouldn’t it?

That is not exactly what I experience in interactions with colleagues in this field. The Q&C profession is far from fully maximizing the potential which this ‘new age’ – or shall I say ‘new normal’ offers: Radical rethinking of our approach to audits, new ways of interacting to share knowledge and expertise and novel approaches to enhance a quality culture in the organizations.

If Q&C professionals appear undervalued, what are the reasons for it? Have we – and to which extent – contributed to this perception? What did we miss? Apparently, we have not been able to sell our value to senior management so that we deserve a seat on their table. But be careful: It would be wrong to conclude that the absence of a Q&C expert on the C-level means that the C-level is blind and deaf to information and expertise from Q&C professionals.

Portraying Q&C professionals as the saviors of clinical drug development without any hint of self-criticism is undeserved. Devaluing the contribution of other parties to the success of clinical trials does not automatically increase the value of Q&C teams. In as much as we criticize others, we must be open to scrutinize our own behavior and actions. Q&C professionals are far from being perfect, despite the ‘quality’ in the name. We should be humble, as we also have blind spots, make errors and are far from being perfect.

Let’s be more demanding and radical in our own approaches instead of simply looking suspiciously on the novel approaches and radical changes to the way clinical trials are conducted now and in the future.

Here are some questions to reflect about and take action:

• Instead of performing ‘training’, do we truly invest in ‘education and development’?
• Instead of performing periodic SOP reviews that confirm the status quo, are we prepared to challenge the need for and contents of each SOP? They are not carved in stone.
• Instead of focusing on ‘inspection readiness’, are we ready to replace this term with ‘feeling at ease to be scrutinized at any time’?
• Instead of cementing ‘audits’ as the only tool in the hands of Q&C professionals, have we developed a variety of approaches and models for interaction and assessment?
• Instead of performing audits as a reflex to noncompliance observed, do we critically explore if an audit would be the best and only option in eliminating or mitigating the noncompliance?
• Instead of perceiving deviations as a failure, do we really focus on the root causes and the opportunity to learn from them? Remember, it is not the individual that failed, but the system that was insufficient to prevent the failure. Are we courageous enough to celebrate the ‘greatest learning of the month’?
• Instead of performing ‘back end’ activities such as audits (which by definition are always reactive and retrospective), do we hone our activities that support project teams in preventing weaknesses and errors in clinical trials? Do we really focus on prevention rather than detection?
• Instead of asking the stinging questions during the audits, why don't we ask them as early as possible in the clinical trial? Do we teach others on how to come up with these critical questions in the first place instead of relying on Q&C?
• Instead of complaining that Q&C is not involved early enough, have we asked why this is the case and without blaming others?
• Instead of criticizing the existing quality culture, do we foster communication and encourage sharing information with Q&C without fear? How open is our ‘open door’?