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
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here