The U.S Food and Drug Administration has already recalled 57 drug products, six medical devices, 123 food and beverage products and seven dietary supplements at this writing. And there’s still five months left in 2020 …

There are various reasons for the recalls, including broken ampuls (a sealed glass or plastic container for one dose of a sterile medicine), chemical or bacterial contamination, impurity, mislabeling, incorrect dosing cups, defects, material weakness, etc.

As we’ve seen during the COVID-19 pandemic, there has been a shortage of hand sanitizers and face masks in stores as people have bought up the available supplies from store shelves, so companies in other industries have tried to help fill the void. However, just this month there were recalls in the United States and Canada for hand sanitizers that contained methanol and a hazardous grade of ethanol.

These are the types of issues that slip through the cracks in a Quality Risk management program. The FDA provides the Q9 guidance, derived from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, better known as ICH, to the life sciences sector to identify, control and monitor the risks in all stages of product development. It is designed to ensure the product is safe and effective for the end consumer. Q9 outlines risk strategies, skills and tools to manage operational risks including the need for risk communication.

The core risk tools in the Q9 include Failure Mode and Effects Analysis (FMEA), Hazard Analysis Critical Control Point (HACCP) and Hazard and Operability (HAZOP) studies, among others. These are the best qualitative risk techniques that have been used in other industries over the past few decades to help identify operational risks in almost every product development and manufacturing stage. The effectiveness of these methodologies is based on how well the risk studies are conducted and how that risk information is communicated with the various stakeholders inside and outside the company.

To state the obvious, the safety and efficacy of the final product depends on the comprehensiveness of the risk identification, risk control and risk monitoring throughout the product development, manufacturing, distribution or end-of-life stages. Risk communication is the glue that links these pieces together and makes the Quality Risk Management system work.

What can companies do to coordinate risk communication cohesively so that the right quality risk information from the risk studies is processed at the right time to prevent issues? There are a few different aspects to this.

First, you should generate high-quality risk data. It is worthwhile to check if your risk tools are designed to produce high-quality risk data sets for you and if they are tailored to your company’s products and processes. These risk methodologies have evolved gradually over several decades, and today there are matured variations depending on the application you are using. The modern HAZOP technique, for instance, incorporates the Layers of Protection Analysis LOPA principles while the FMEA now uses the action priority rating instead of the traditional risk priority numbers. The HACCP, too, has been modified to be used in the biotechnology and pharmaceutical industries.

Second, the risk data should be aligned with meaningful metrics and indicators. Successful risk management programs have meaningful leading and lagging quality and risk indicators. Examples of quality indicators used in pharma and food industries, according to research published in the Journal of Pharmaceutical Innovation, are rejected batches, cost of bad quality, loss during process, number of complaints, number of product defects, percentage of Corrective and Preventive Action Plans (CAPAs) done in target time, etc.

Examples of risk indicators are outstanding actions associated with high-risk scenarios, incidents with on-site and off-site safety impacts, types of controls (procedural, engineering), common causes, etc. This risk data needs to be reported at the right frequency. Additionally, there should be mechanisms in place to address the identified issues in a timely manner, such asa safety intelligent mindset of the personnel supported by customized workflow solutions to complete resolution.

Miscommunication is often the root of most problems. So, an end-to-end, robust risk communication system that triggers the right resolution steps seems obvious. That way, we can all feel safe using those hand sanitizers and masks and knowing they will help us get through the pandemic together.

Advanced Risk Assessment – Quality Risk Demo Video

Learn how Sphera’s Advanced Risk Assessment solutions work in practice to help Life Sciences and Pharmaceutical Manufacturers improve how they conduct quality risk assessments.

View the Video


Narenderpal Marwaha is a seasoned operational risk management consultant with 18 years of experience at Sphera in product, project and training management, and consulting. He has worked with various customers in the manufacturing and process industries including precious metals, mining, defense, consumer goods, automotive, electronics, aerospace, and oil and gas. As director of product management, he helped to develop numerous applications and solutions for both quality and process safety management. He is a skilled risk assessment facilitator and trainer of various risk analysis techniques including HAZOP, What If, LOPA and FMEA.

Our Website uses cookies, which are small files sent by a Web server to your computer and often maintained on your hard drive. These are not programs that can damage your machine; they simply enable us to recognize your browser when you revisit our site. No personal information is stored in a cookie nor can such information be used to identify you. You may disable cookies in your browser; for more details please refer to the help function of your browser. However, please note that some of our Website features or services may not function properly without cookies.