In an effort to help people during the COVID-19 pandemic, many makers have applied their knowledge and technology to make Personal Protective Equipment (PPE), especially face masks, and to make medical equipment that is in short supply in some places, especially ventilators. The Center for Disease Control (CDC) provides advice on how to make a mask, including a no sew alternative from an bandanna. ActivArmor, a company making 3D printed casts and braces in my home town of Pueblo pivoted quickly to making 3D printed FDA compliant fitted face masks. GM partnered with Ventec Life Systems to produce ventilators, delivering the first products in mid April.
What does it mean?
Making a fabric face mask requires some thought. Tightly woven fabric or multiple layers do best at filtering out small particles. Loosely woven or stretch fabric have larger holes that allow viruses through. Adding a filter from items available in many households (for examples, coffee filters) may or may not help and may expose the human to other unsafe fibers. The mask needs to fit snugly to prevent air from getting around the edges. Masks should be washed regularly. The wearer should be cautious about touching the mask to adjust it, possibly transferring virus between the hands to the face. But even with those cautions, any face mask may be better than none, at least at preventing the wearer from transmitting the virus to others.
Masks intended for use by medical personnel require even more thought. The FDA describes the differences among types of surgical masks (surgical, isolation, dental, or medical procedure masks). These are meant to be used once and disposed of. Surgical N95 respirators are designed to block “at least 95 percent of very small (0.3 micron) test particles.” The FDA (working with CDC NIOSH) regulates these items. These regulations rely on ASTM standards concerning bacterial filtration efficiency, particulate filtration efficiency, fluid resistance, pressure differential, and flame spread. An ISO standard applies for skin sensitivity and cytotoxic tests “to ensure that no materials are harmful to the wearer.”
Ventilators are sophisticated devices that deliver air to a patient’s lungs, and include controls, monitors, and safety devices to make sure the device is helping, not harming, the patient. Initial excitement by makers cooled down when people realized the difficulty of making a safe and useful ventilator.
What does it mean for you?
The lessons to be learned are about materials, processes, technology, and safety. The biggest lesson is about expertise. Meaning well is sometimes hard to translate into doing well.
Kaoru Ishikawa, one of the founders of Japanese quality, invented the Ishikawa (or fishbone) diagram, in which the causes of a problem in quality are brainstormed and displayed, often in six categories: Man (people), Machine, Material, Method, Measurement, and Mother Nature (environment). The design and manufacture of any product or service has to consider these factors in depth in order to reliably deliver.
People who will do the work must be trained completely. Machines and equipment (including computers) used in production have to be capable of producing products and services meeting the specification of the customer. Materials must be chosen that can stand up to the uses to which they will be put. Methods of production have to be refined and standardized so the desired quality is achieved every time. The measurement devices used in every step must be capable of measuring the desired critical-to-quality measurements. And consideration must be given to how to control the natural variation in the environment so quality is not harmed.
In the face of the global pandemic, it has been heartening to see so many people step up to help – helping their neighbors with food, helping by slowing the spread of the disease, and helping to produce products to support medical care. But designing a product or service and designing the production process to reliably produce that product or service to meet the desired specifications are hard work – and require expertise. The final story about the world’s response to COVID-19 is a long way from being written, but certainly the ongoing battle between respect for and rejection of expertise and the need to identify who actually has expertise will be parts of that story.
In your organization, you provide leadership – in the many forms that can take – but you know that you must select and listen to experts that you can rely on. My field, industrial engineering, provides the expertise you need for producing services and products to meet customer specifications – reliably and consistently. Industrial engineering sometimes seems like organized common sense, but common sense is, regrettably, not always that common, and a task that may seem easy can, in fact, be hard. As I watched the initial efforts to make PPE and medical equipment, I was warmed by the enthusiasm and the desire to help, but dismayed by my knowledge that those efforts would, inevitably, need to be refined and perhaps even abandoned. Meaning well is sometimes hard to translate into doing well. Experts do know more than nonexperts.
Where can you learn more?
Industrial engineering is about efficiency, quality, and safety. It has roots in methods invented by Taylor and the Gilbreths that became time-and-motion studies, mathematical methods of optimization used to improve efforts in World War II that became operations research, quality tools developed by Shewhart, Deming, and others that led to control charts and quality principles, the invention of electronics that led to computers, automation, and controls, and much more. Key ideas are processes, systems, flow, control, optimization, continuous improvement, and safety. Industrial engineers are the engineers who think most about the people. I tell my students that being an industrial engineer means you are always dissatisfied: if it ain’t broke, it can still be improved.
Many professional organizations support the creation and dissemination of knowledge in industrial engineering and the networking of professionals. The lead society for industrial engineers is the Institute of Industrial and Systems Engineers (IISE), which has subgroups for all the specialties withing the field. Other relevant organizations include the American Society for Quality (now called ASQ), the Institute for Operations Research and the Management Sciences (INFORMS), the Society of Manufacturing Engineers (now called SME), and the Human Factors and Ergonomics Society (HFES). If you want to deliver a product or service that meets customer requirements with efficiency, quality, and service, hire the experts: industrial engineers.