The Promise and Threat of Quality Risk Management - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

The Promise and Threat of Quality Risk Management
Using risk assessment properly can provide industry with a unique tool for quality control.


Pharmaceutical Technology
Volume 35, Issue 2, pp. 38-40


Jason J. Orloff
As a tool for the appropriate prioritization of resources, quality risk management (QRM) holds great promise for patients, government, and industry. Just as great, however, is the potential for QRM to degenerate into a non-value added exercise of identifying noncritical, improbable, low-risk scenarios indefinitely. The key to which way it goes is understanding a typical distribution of uncontrolled systems, that is, the Pareto Plot.

As a statistician, I have never been comfortable with subjective risk analysis. The process is fundamentally imperfect because it cannot anticipate the unknown. Furthermore, it lacks the rigor of actuarial risk analysis, which is beyond all but the most critical factors related to safety and efficacy. After conducting tremendous research and development to turn data into process knowledge, it seemed a disappointing end to boil all the information down to a human judgment call. Translating that effort into a subjective scale of 1 to 10 for severity, probability, and detectability left me wanting more than a notional approximation. However, after three days of discussion with the authors of the International Conference on Harmonization's quality guidelines, Q8, Q9, and Q10, at an ICH workshop in Washington, DC, last fall*, I've gained a new understanding of risk assessment's value.

Risk assessment enables subject-matter experts to say to the best of their ability, "This is important, and that is not." Risk assessment is not a perfect tool by which analysts can anticipate all dangers—known and unknown—but it is valuable precisely because we cannot anticipate all danger. Risk assessment provides a framework within which to capture the knowledge upon which we have made risk-control decisions. Within this framework, learning can be fed back for capture and future review. The QRM process then enables management to establish priorities and move a project forward from the laboratory to manufacture with an understanding of, diligent control of, and conscious acceptance of risk.

Because risk assessment and control fundamentally rely on hypothesis, judgment, and expert opinion, it is open to endless attack and argument. The resolution of which must be the test of reason. The goal is to draw a line between the "vital few and trivial many" scenarios. This pattern was first recognized by Dr. Joseph M. Juran in 1951 when he coined the Pareto Concept of Quality, giving us a powerful conceptual and visual tool.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
20%
Attracting a skilled workforce
28%
Obtaining/maintaining adequate financing
12%
Regulatory compliance
40%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here