This article marks the last in a series of six intended to provide a holistic primer on the field of quality risk management QRM. The first article, Quality Risk Management Risks Associated with Medicinal Productsdiscussed the difference between intrinsic and extrinsic risks and clarified the scope of QRM efforts.
It was followed by Quality Risk Management Quality Risk Management QRM and the Product Life Cycle [link] discussed the relationship between QRM and quality by design, the pharmaceutical quality system, and post-approval change management. This article explores challenges with QRM implementation that are shared by many within industry. After 10 years of quality risk management QRM experience in the pharmaceutical, biopharmaceutical, and medical "Validating sterile filtration overcome the fear of failure" industries, I have had the opportunity to discuss QRM implementation with practitioners across the globe.
Over time, I have identified several challenges that appear to permeate the industry as a whole, each of which poses a unique and very real challenge to the fully effective implementation of a QRM program. This article explores each of these challenges and explains the ways in which they might sabotage QRM efforts.
Misconceptions Regarding Quality Vs. Over the years, I have formed a habit of asking industry practitioners to sketch their understanding of the relationship quality and compliance using a Venn diagram format. Venn diagrams are graphs of interlocking circles that are often used to demonstrate the relationship between categories, including the relative size or contribution of each category as depicted by the size of a given circle and the level of similarities and differences between categories as depicted by the extent to which the circles overlap.
A pattern in these Venn diagrams emerged early on, and has been reinforced many times at multiple industry conferences. The vast majority of industry practitioners draw a diagram similar to that shown in Figure 1. Typical Venn diagram sketched by industry practitioners to illustrate the relationship between quality and compliance. This diagram implies that most of industry believes there are aspects of quality that are unrelated to compliance, and more worryingly, that there are aspects of compliance that are unrelated to quality.
With this being the paradigm under which some members of industry operate, it is not surprising that quality culture has become a topic of concern with regulators, since this opinion could embitter personnel to compliance and QRM-related activities if the value is not understood.
This Validating sterile filtration overcome the fear of failure a serious challenge to the enhancement of QRM effectiveness in industry, since the difference between quality and compliance or compliance and effectiveness is fundamental to understanding the role that QRM plays in the pharmaceutical and biopharmaceutical industries.
In addition, QRM offers industry an opportunity to define what quality looks like for its patients, products, and businesses, beyond the basic requirements associated with regulatory compliance. As a result, the Venn diagram showing the relationship between quality and compliance through the lens of QRM looks more like that shown in Figure 2. Venn diagram of quality and compliance through the lens of QRM. In this model, compliance is wholly encompassed by quality, such that all compliance-related activities add to the quality of the product, and the circle representing quality has been enlarged based on the knowledge gained through QRM.
This is the purpose of QRM; in ensuring that compliance supports quality and quality is based on risk management principles and practices, the patient is adequately supported. It appears that some members of industry perceive QRM as a mechanism to do less, shrinking the amount of resources needed to perform an activity, rather than reallocating available resources to focus more on things that are critical and less on things that are not. Many industry practitioners consider the lack of concrete, actionable guidance in ICH Q9 and regional regulations adopted from this guideline to be a challenge associated with QRM implementation.