Reducing the Risk in Risk Management - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Reducing the Risk in Risk Management
A firm grasp of probability and ongoing re-evaluation are key.


Pharmaceutical Technology
Volume 35, Issue 8, pp. 36, 39

Include top management. They can delegate work but not the responsibility of a mission critical process. Note that risk management is a not an event but an ongoing reevaluation. Management must fight the danger of complacency, distraction, and stagnation. Risk analysis cannot simply become window dressing for the regulators. Risk reduction is costly, and management reflects the importance of the task with support, finances, and resources.

At least one person in the risk team must understand probability well enough to teach it to the other members. Few people have studied probability and even fewer have practical experience of using probability. Real life probability estimation is much more difficult than textbook exercises. Yet, probability theory is the core of determining risk.

Risk assessment cannot be seen as a check-the-box activity; it is a serious issue and requires serious effort and commitment. The success of the assessment is a direct result of the skill, education, and experience of the company's team members. Technical experts are absolutely necessary even if external experts must be called in. All stakeholders must work to agreement.

Industry in general is less interested in the risk of an everyday occurrence, such as the risk of failing the moisture test for the next production run. What is more important is estimating risks such as a recall or another Heparin type tragedy. The difficulty in doing so is compounded by the lack of information and actionable data. In the absence of historical data, we are left with a gut-feeling, which can often underestimate the risk. The best experts must be consulted.

"For every complex and difficult problem, there is a solution that is simple, intuitive, easy to understand—and completely wrong." —Anonymous

Estimating probability and severity on scales of low, medium, and high (or on a scale of 0–4) are so simplistic as to be almost worthless; like using third grade English to study a college subject. Formal training in probability is needed to advance beyond this simplistic approach.

Finally, focus on the patient, build for the future, collect relevant data, and store it for easy access and analysis. Expand the knowledge base of the team and the company. Learn from others and learn advanced probability theory. Continue to refine and improve. Only through our best efforts can industry say with confidence that it understands the risks facing patients.

Lynn D. Torbeck is a statistician at Torbeck and Assoc., 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314,
, http://www.torbeck.org/.

Reference

1. N. Popper, Chicago Tribune, June 13, 2011.


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
29%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
13%
Regulatory compliance
31%
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 WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
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
Source: Pharmaceutical Technology,
Click here