LAB

from 2021 November Ethanol Producer Magazine

COPRODUCTS

REPEATABLE PERFORMANCE: Whether working with high-tech lab instruments or everyday lab products like pipettes or sample bottles, adhering to standard operating procedures ensure that each lab team member knows how to perform a procedure independently and reproducibly without error.

PHOTO:PHIBRO ETHANOL

The Basics of Ethanol Plant Laboratory Quality Management

Ethanol Producer Magazine talks with Phibro Ethanol’s Dr. Andrew Hawkins about the essentials of top-tier LQM, including good training, recordkeeping, SOPs and more. By Tom Bryan

CONTRIBUTION: The claims and statements made in this article belong exclusively to the author(s) and do not necessarily reflect the views of Ethanol Producer Magazine or its advertisers. All questions pertaining to this article should be directed to the author(s).

Ethanol plant labs are the nerve centers of modern biofuel production: they are data generation hubs, troubleshooting resource centers and product quality check points. Producing ethanol and coproducts to today’s exacting specifications, with optimal efficiency and uptime, requires facility-wide discipline and, in the lab, steady adherence to a comprehensive quality management program.

Ethanol Producer Magazine recently caught up with Dr. Andrew Hawkins, director, laboratory services, Phibro Ethanol—who presented on laboratory quality management (LQM) at the International Fuel Ethanol Workshop & Expo in July. Here’s what he had to say about LQM.

EPM: Dr. Hawkins, at the 2021 International Fuel Ethanol Workshop & Expo in Des Moines, Iowa, you spoke about the keys to successful LQM. Briefly, what are the basic tenets of a lab quality management program, and how is the history of LQM—which you discussed at the FEW—relevant to today's lab practices?

Hawkins: We can learn from other industries that have applied a holistic approach to quality. LQM is a system that takes a 360-degree view of quality so that products and processes are of the highest standards possible. The basic principles of a good LQM program are not just solid procedures, but also well-trained staff, data recording, validation and calibration, and clear communication amongst all involved. EPM: Explain the role of QA/QC in an ethanol plant LQM program.

Hawkins: Quality assurance (QA) and quality control (QC) are two major components of a successful LQM program. QA covers in-process steps taken to ensure the process being monitored is as good as it can be. Things like well-trained staff, standard operating procedures, regular instrument validation and calibration—all are QA tasks. This systematic approach assures us the process is operating the best it can (i.e., the plant is efficiently making high quality ethanol). QC is a checkpoint to make sure the products—ethanol and each coproduct—meet all the specifications that customers expect when they receive that product. EPM: Explain the importance of SOPs in the U.S. corn ethanol industry. Why are they a vital component of training, and ultimately top-tier LQM?

Hawkins: Standard operating procedures (SOPs) are a way to clearly communicate and document all steps necessary to perform a procedure or task. SOPs are like a recipe for a cake—they tell us all the steps needed, in sufficient detail, so the outcome is a good cake! In the ethanol plant, SOPs ensure each staff member knows how to perform a procedure independently and reproducibly. Let’s say that procedure is measuring the amount of water in final ethanol product. A good SOP ensures each person does that measurement the same way, that the result is accurate, and that the same result would be had if a different staff member did the test. Along with training (i.e., how to use, validate and calibrate an instrument), SOPs are an essential backbone to a good LQM. EPM: Ethanol plant labs are the data hubs of the facility. Data recording is obviously a critical best practice in the lab. What are some of the top reasons for recording data, either by hand or digitally? Is it done correctly enough of the time? And what are the risks of not doing it consistently or accurately?

Hawkins: Data recording is a crucial component to good LQM. If it isn’t written down, it didn’t happen! Good data recording means as we learn more about our process, we have all the data needed to go back and do a deep dive for analysis and improvement. Sometimes, data recording is our best defense at solving a complex problem that we didn’t even notice until later. Let’s say we need to determine the root cause of an infection. Sometimes, solving that issue means gathering timing of valves, operations in the process from control room notes, and lab data all together to understand how to avoid the issue in the future. Good data records extend beyond just writing information down—they include an organizational scheme that is easy for others to understand so that data can be retrieved and accessed again in the future. EPM: Talk about how the LQM best practices you discussed at the FEW, in essence, define and govern Phibro’s own LQM program—Phibro CertiPhiedTM—which ensures that your own products meet exacting levels of quality and consistency when they arrive at an ethanol plant’s gate.

Hawkins: LQM practices are the backbone to Phibro’s trademarked CertiPhied program. In our Phibro Ethanol laboratory, we have our own metrology program and electronic data records to ensure our equipment is always working. Accurate data is the foundation of consistency and reliability. Once we know we can measure things accurately, we measure key properties of our products to ensure they meet specifications. The specifications were in turn developed to ensure that a product performs exactly how a customer expects in their plant, each time it is used.

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