Quality Risk-Management Principles and PQRI Case Studies - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Quality Risk-Management Principles and PQRI Case Studies
A PQRI expert working group provides case study examples of risk-management applications.

Pharmaceutical Technology
Volume 35, Issue 7, pp. 72-76

Risk-assessment supporting tools

Table I: Common risk-management tools.
A key early step in the execution of a risk analysis is to determine the appropriate risk-assessment tool, or methodology. There is no single best choice for any given assessment process, and the selection of the appropriate risk methodology should be based on the depth of analysis required, complexity of the subject risk of concern, and the familiarity with the assessment tool. Based on the industry examples reviewed by the PQRI–MTC working group, risk ranking and filtering (sometimes referred to as risk matrix) and flowcharting were the most popular tools used for basic risk-assessment activities. Correspondingly, failure-mode effect analysis (FMEA) appeared to be the most frequently used methodology for more advanced risk analysis. Some examples demonstrated the power of combining tools to help with more complex analysis. For example, fault-tree analysis (FTA) or a fishbone diagram can be used to initially scope and evaluate the fault modes of a particular problem and be used to feed a hazards analysis and critical control point (HACCP), or a similar tool to evaluate overall system control and effectiveness can be used. Table I provides a list of generally well-recognized risk-management tools.

Table II: Severity categorization.
Each risk subject and assessment warrants consideration of the applicable descriptors of potential risk and related consequences. Ideally, firms should establish a guidance document ahead of any risk analysis, such as the one provided in Table II, to help guide the risk-assessment process and provide for consistency in decision-making company-wide.

Risk trainers. In assembling this collection of case studies, the authors recognized the benefit of providing industry with additional background on core risk methodologies. Training tools for the application of risk ranking and filtering, FMEA, FTA, and HAZOP are available online with the web version of this article at http://PharmTech.com/PQRIstudies. These tools are meant to facilitate greater familiarity with the risk methodology used in each corresponding case study.


blog comments powered by Disqus
LCGC E-mail Newsletters

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

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here