A risky business? Increasing quality and efficiency by understanding risks
May 20, 2015
When you think of risk and the lab, the first thing that probably pops into your mind is personal safety. But the risks you encounter each time you start a study or pick up a pipette go beyond carcinogens, sharps, and infectious diseases. Here’s a thought experiment that illustrates this point:
Thought experiment 1
You are at home about to embark on a risky endeavor—a trip to the store. Wait, what could be risky about a trip to the store? Depending on how you choose to get there—what mode of transportation and what route you take—you can encounter different degrees of personal safety risks, just like in the lab. From traffic accidents to routes through unsafe neighborhoods, no trip to the store is without some (often) small but quantifiable amount of peril.
But there are other kinds of risks involved in the trip to the store.
What if you’re not sure if the store has the item you need in stock? Do you still go? What if going might make you late for an important meeting, but not going means you won’t have that perfect gift ready in time for your child’s birthday?
What if it’s a store you’ve never been to before, and your GPS system is taking you in an unexpected direction? Do you trust the GPS?
What if your trip to the store makes you late picking up your seven-year-old from school? Are you willing to risk a ticket and go 5 mph over the speed limit rushing to the school? 10 mph over? 25 mph over?
Back at the lab
Just as with our hypothetical trip to the store, the research environment is filled with a number of risks in addition to personal safety ones. What I’ve found in my interactions with researchers and lab managers, is that labs could be doing more to clearly articulate these important non-safety risks and develop an understanding of their ability to tolerate these risks. Labs that operate in regulated environments are already familiar with risk management approaches—ISO standards are a basic building block of risk management policy in many organizations—but every lab could benefit from a risk tolerance assessment and a risk management plan. By understanding your lab’s risk appetite and tolerance and then developing a good risk management plan, you can increase both the quality and the efficiency of your operations.
So, what are these risks? That depends on your lab, the type of work you do, and the consequences that your actions have. One example that we often encounter at Artel is the question of how often to calibrate pipettes.
Pipetting as a risk
When you view pipetting and the potential for transferring an incorrect volume as a risk, then you’ve taken the first step in understanding how often your lab needs to calibrate your pipettes because calibration frequency depends on how much risk you’re willing to take.
Thought experiment 2
Imagine you’ve just calibrated your pipette and have the green light that it’s working fine. What about the next day? In all likelihood, the pipette is probably still calibrated and dispensing accurately, but it’s also possible that, in the intervening time, the pipette was dropped, or it was left on its side and sample got into the pipette shaft, or some other unfortunate incident led to damage to the pipette and it’s now operating outside of acceptable tolerances. This could potentially compromise every single experiment from that day onwards to the next calibration date. Is that a risk your lab can take?
For some labs, calibrating pipettes quarterly or even yearly makes sense as the type of studies they’re doing can work within broad specifications, and/or the consequences of 12 weeks/months of slightly-out-of-spec pipetting are not as great as the expense and inconvenience of a more frequent calibration schedule (learn more about pipette calibration frequency here).
But for other labs, pipettes used in mission critical assays are checked every morning, or immediately before the critical assay.
Understanding your risks, risk tolerance, and appetite for risk
Typically, it’s the lab manager who needs to assess the lab’s activities, flesh out the risks, and create the management plan. Because each lab is unique, with different goals and consequences as the results of their studies, it’s difficult to create specific recommendations for developing a risk management plan. Instead, I recommend looking at general risk management frameworks and approaches.
A good place to begin is with guideline EP23-A Laboratory Quality Control Based on Risk Management from the Clinical and Laboratory Standards Institute (CLSI). While this document is created for clinical labs, it’s applicable to every lab in principal, and has a good hands-on approach with checklists and relevant situations. You can use this document as a starting point to think about:
- All the different types of studies your lab conducts,
- The goals of those studies,
- The different ways those goals might not be met,
- The consequences if those goals are not met,
and focus on the most likely scenarios.
For example, a basic research lab might want to consider pipette calibration and equipment maintenance frequencies, training for new personnel, the consequences of cloning failures, the likelihood of an unclear experimental result, and/or the availability of critical reagents.
In addition to EP23, there are a wealth of more general references on risk management, risk tolerance, and risk appetite (see Additional Resources below). While these documents don’t have the same specificity for the life sciences, they provide a framework that can be used to guide your own thinking on risk.
Risk appetite can be complex. Excessive simplicity, while superficially attractive, leads to dangerous waters: it’s far better to acknowledge the complexity and deal with it, rather than ignoring it.2
Optimizing risk management for greater quality and efficiency
The life science lab is a risky environment, where risk can be defined in terms of personal safety, experimental quality, and achieving research or study goals. By taking an afternoon or series of afternoons to consider the different risks that can occur in your lab, and developing a plan to manage them, any lab—not just those in regulated environments or in manufacturing—can increase its effectiveness, quality, and efficiency.
- Executive Summary: Risk Appetite & Tolerance
- Q&A: EP23-A Laboratory Quality Control Based on Risk Management; Approved Guideline from the Clinical and Laboratory Standards Institute (CLSI)
- Organization: The Risk Management Society
- Organization: The Institute of Risk Management
Download Lab Report 6: Calibration Frequency for Pipettes
About the Author
A. Bjoern Carle
A. Bjoern Carle, PhD, is a Product Manager at Artel, where he supports product development, scientific marketing, regulatory affairs and technical training efforts. Dr. Carle earned his B.S. at the University of Stuttgart (Germany), his M.S. and PhD at the University of Cincinnati, and performed post-doctoral research at Harvard Medical School / Massachusetts General Hospital.
1. “Risk Appetite and Tolerance,” The Institute of Risk Management. By The Institute of Risk Management. Web. March 15, 2015 at https://www.theirm.org/knowledge-and-resources/thought-leadership/risk-appetite-and-tolerance/
2. Richard Anderson. “Risk Appetite & Tolerance Executive Summary,” The Institute of Risk Management. 2011.