Risk Assessment 101

The Food and Drug Administration co-sponsored another round of industry workshops in 2005, featuring presentations on the risk-based approach to compliance. It now appears that the pharmaceutical industry has begun the transition to risk-based compliance programs. This move results because they can then justify focusing their resources and dollars on the higher risk elements of their business. The 2005 sessions examined some recommended risk assessment tools and methods, and how to apply them in the pharmaceutical industry. It was clear from the 2005 workshops that FDA generally supports the move to risk-based decision making.

Risk assessment tools, used properly, identify high-risk process elements and critical components, and facilitate a firm’s management in making decisions to achieve the best impact for your compliance dollars. They also provide a road map for documenting these decisions for future reference, such as during an FDA site inspection. Whole books are available on risk assessments; therefore, this article is a quick look at medical gas risk assessments from the 100,000-foot level.

Many people think risk assessments are just for equipment and manufacturing processes. Actually, the process is quite adaptable, and these tools and techniques frequently are used to facilitate reviews of business processes, such as installing or upgrading computer and e-commerce technology, or adding new products or business services. Risk assessments are not just for FDA “stuff” either. Risk-based reviews are an integral part of the flammable and spec gas business, and have been a part of effective safety programs globally for decades.

The first step in performing a risk assessment is selecting the team. A single person cannot do an effective job. While not everyone on the team needs to be a risk assessment expert, each team needs at least one individual familiar with conducting risk assessments. Other key people include someone who understands the process or facility under review, and someone knowledgeable in company procedures and regulatory requirements. It is important to appoint a team leader to keep the team on track, someone as a scribe to keep notes, and it may be desirable to have a process or design engineer on the team. Typical risk assessment teams comprise between four and seven members.

While there are many tools available to assess risk, the gases industry appears to have settled on the Failure Mode and Effects Analysis (FMEA) method. Often, when preparing to validate a process, the output of the FMEA then goes through a second analysis called the Hazard Analysis of Critical Control Points (HACCP). This tool is very effective in focusing the scope of a validation onto the critical elements.

There are three basic steps to the FMEA:

  1. Review each potential failure mode in the process to understand the potential severity of that occurrence.
  2. Assess the likelihood of that failure occurring.
  3. Determine the potential for detecting the failure.

Each one of the three steps is assigned a number, such as from 1-10. Multiplying the three numbers together results in something called the Risk Potential Number (RPN). The higher the RPN for a particular failure mode, the higher the risk and the more attention you need to pay to that issue. Typically, firms set a threshold RPN level, above which a failure mode is too high of a risk. For these high risks, the team goes back and looks at other ways to either control or detect the failure, reassigns a new number and re-computes the RPN.

While the actual mechanics of performing a risk assessment are a bit more sophisticated, the core concept of reviewing potential failure modes and making decisions on whether the current controls and detection capabilities are adequate to prevent a serious hazard is both simple and powerful.

Performing an effective risk assessment is not something that is beyond the capability of the average GAWDA member. The main ingredients to getting started with risk assessments are some training in performing a FMEA, process knowledge, common sense and the desire to do a good job.

Gases and Welding Distributors Association
Meet the Author
GAWDA Medical Gases Consultant J. Robert Yeoman is managing director of B&R Compliance Associates LLC in Lehigh Valley, Pennsylvania. Members can reach him at 610-837-6782 and at bob.yeoman@brcompliance.com.