Featured Product
This Week in Quality Digest Live
Risk Management Features
Anjalika Singh
Plan-do-check-act is my secret weapon for finding the (almost) perfect gift
Ken Maynard
How to create a continuous improvement culture in any organization
Gleb Tsipursky
Businesses need to think pessimistically in order to survive
Jennifer Grant
Digital manufacturing can help mitigate down time, even during a pandemic

More Features

Risk Management News
Further enhances change management capabilities
How the nation’s leading multistate cannabis company ensures quality and safety standards
How established companies turn the tables on digital disruptors
Streamlines shop floor processes, manages nonconformance life cycle, supports enterprisewide continuous improvement
Certification bodies can conduct food safety audits and issue certifications of foreign food facilities
How to build your dream team, explode your growth, and let your business soar
Transforming a dysfunctional industry
An invite from Alcon Laboratories
Why not be the one with your head lights on while others are driving in the dark?

More News

William A. Levinson

Risk Management

Coronavirus Risks and Opportunities

Sometimes containment is also the permanent corrective action

Published: Tuesday, March 17, 2020 - 12:03

The Chinese character for “crisis” means danger and opportunity. The coronavirus, aka Covid-19, outbreak has already wreaked havoc in the global economy, curtailed international and even domestic travel, and caused roughly 7,146 fatalities to date around the world.1 The reaction to this outbreak, as driven by corrective and preventive action (CAPA), may however save thousands of lives not only this year but in the future. It should also initiate serious thought as to the desirability of reshoring U.S. manufacturing capability that should have never been sent offshore in the first place, and generate new opportunities in distance networking technologies.

The Automotive Industry Action Group’s Effective Problem Solving manual (CQI-20) defines an outstanding nine-step CAPA process that is applicable to almost any problem a manufacturer might encounter. These are essentially:

1. Recognize that there is a problem.
2. Organize an appropriate cross-functional team.
3. Describe the problem.
4. Contain the problem.
5. Identify the root causes. These are: 
 • The escape root cause, or why the nonconformance was allowed to reach the next internal or external customer
 • The occurrence root cause, or why it happened
 • The systemic root cause, or why the planning process failed to identify the risk ahead of time. The latter can include failure to read across or replicate a completed CAPA for one issue to related activities throughout the organization.

6. Select and test the corrective action. 
7. Implement the corrective action.
8. Prevent recurrence by standardizing and documenting the improvement.
9. Congratulate the team.

In this case, steps 1, 2, 3, and 5 have already been completed. We know there is a problem, and the RNA structure of the coronavirus has been identified. Several vaccines are already in the pipeline but will require roughly a year for clinical trials; this is where they test the corrective action and ensure that it works, and with no undesirable side effects. Moderna Therapeutics’ candidate uses messenger RNA (mRNA) to cause human cells to make the protein that is found on the surface of viruses, but not the virus itself. The immune system then recognizes the protein as hostile and attacks anything that shows up, such as the coronavirus, that includes the protein in question.2

The current focus is therefore primarily on containment, which most quality practitioners disparage as a mandatory but not sufficient countermeasure, as depicted by General Curtis Lemay: “Stop swatting flies and go after the manure pile.” Corrective action consists of removal of the manure pile, and prevention of recurrence means ensuring that it never comes back or appears elsewhere in the organization.

Common sense as well as ISO 9001:2015 Clause 8.7—Control of nonconforming outputs, makes it mandatory to identify and segregate nonconforming product to protect the customer, but nobody recognizes containment as corrective action. CAPA requires elimination of the root cause of the nonconforming work. Coronavirus has created a novel situation, however, in which we will not only have to keep swatting it for a year or even more, but also should continue containment even after vaccines or antivirals eradicate it totally.

When containment is also permanent corrective action

The Centers for Disease Control and Prevention (CDC) has offered the following advice3:
• Avoid close contact with people who are sick.
• Avoid touching your eyes, nose, and mouth.
• Stay home when you are sick.
• Cover your cough or sneeze with a tissue, then throw the tissue in the trash.
• Clean and disinfect frequently touched objects and surfaces using a regular household cleaning spray or wipe.
• Follow CDC’s recommendations for using a face mask. CDC does not recommend that people who are well wear a face mask to protect themselves from respiratory diseases, including Covid-19. Face masks should be used by people who show symptoms of COVID-19 to help prevent the spread of the disease to others. The use of face masks is also crucial for health workers and people who are taking care of someone in close settings (at home or in a healthcare facility).
• Wash your hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after blowing your nose, coughing, or sneezing. If soap and water are not readily available, use an alcohol-based hand sanitizer with at least 60-percent alcohol. Always wash hands with soap and water if hands are visibly dirty.


The only issue on which I might differ with the CDC is on the use of a face mask. Some sources warn that the virus can also invade the body through the eyes, a potential argument for the use of safety goggles, and also that a transmission often occurs when we touch our faces. The latter is something we do almost unconsciously, so the presence of a mask and/or goggles can remind us to stop (or use hand sanitizer first). This is, however, just my opinion and emphatically not medical or occupational safety advice.

Now let’s look at the everyday activities that do not require close contact with other people. I recently went to a local store to discover that not only had all the hand sanitizer been sold out, shelves also appeared empty of rubbing alcohol and even hydrogen peroxide. This suggests that people are taking very seriously the CDC’s advice to clean and disinfect surfaces. The disinfectant wipes offered at the entrances to stores are now being used diligently on the shopping carts and baskets.

I went to a hardware store a few days ago, where I expressed my reluctance to put my finger on a touchscreen. The cashier informed me, however, that they were disinfecting the screen frequently. There have been long-running concerns about the ability of touchscreens to accumulate all kinds of bacteria, noting that some people don’t wash their hands before leaving the rest room. This is not a pleasant thought if you use one in a fast-food restaurant. It now appears that storekeepers are disinfecting their touchscreens because of the coronavirus, and people are also using soap and hand sanitizer far more diligently.

The upside of all this containment action is that soap, alcohol, bleach, hydrogen peroxide, and other disinfectants kill the seasonal flu, and almost certainly the common cold, just as dead as they kill the coronavirus.4 This “collective immune response” to the menace of a virus for which there is no vaccine and that is roughly 2-percent lethal may give us a less severe flu season. The annual vaccine is sometimes not 100-percent effective and “ordinary” flu kills tens of thousands of people every year.

A co-worker once told me he gave up cigarettes for Lent. When Lent was over, he went out to buy cigarettes, and then realized that he had actually quit smoking, and decided to not begin again. It is similarly unlikely that, even after vaccines or antiviral drugs eradicate Covid-19, we will ever want to go back to not washing our hands, not disinfecting touchscreens, and so on. This could in turn suppress the annual illness and death tolls from influenza and similar diseases that have literally plagued our world throughout history.

Live long and prosper?

The handshake has been part of American and European cultures for centuries, but the coronavirus might provide a sufficient upheaval to eliminate this custom. Gael Cooper has recommended the Vulcan greeting gesture from Star Trek.5 In practice, however, some people can apparently not hold their fingers in this manner, and not everybody wants to be a Trekkie. We can, however, look to Japan and India for off-the-shelf solutions that have worked for thousands of years.

Japanese did not shake hands before they learned the custom from Europeans in the 19th century, and they still bow to one another as a sign of mutual respect. The Asian Indian greeting of namaste involves pressing the palms of the hands together and bowing slightly. Its Hindu meaning is “I bow to the divine in you.” The namaste greeting is probably easier to learn than a fully proper Japanese bow, but either will work, and both mitigate against transmission of not only coronavirus but also influenza and the common cold.

The need for sensible sick leave policies

The CDC says, “Stay home when you are sick,” but the problem is that this is often easier said than done. I spent my early career during a time when most people believed that, if they were physically capable of going to work, they should do so. I recall a visit many years ago to another person’s office where the person warned, “Be careful; I have the flu.” I replied that I was glad I had gotten the flu shot, to which he replied, “So am I,” at which point I put considerable distance between us because the vaccine obviously didn’t stop whatever it was he had.

The coronavirus’s lethality has introduced the need for a rapid cultural change along with associated legislative changes. More workers and employers now recognize that people should not go to work if they have something contagious, but many workers have limited sick days, and some have none at all. If they call in sick, they don’t get paid, which is a dysfunctional incentive to come to the workplace with a contagious disease.

Although nothing in this article constitutes formal engineering or occupational health and safety advice, employers should be aware that the General Duty Clause, Section 5(a)(1) of the Occupational Safety and Health (OSH) Act of 1970, 29 USC 654(a)(1), requires employers to furnish to each worker “employment and a place of employment, which are free from recognized hazards that are causing or are likely to cause death or serious physical harm.”6 In addition, “contagious illnesses that employees contract from a co-worker, customer, contractor, or other person while working are generally recordable if they meet one or more of the general recording criteria—such as medical treatment or days away from work.”7 Although the OSHA reference adds that the common cold and seasonal influenza are not recordable, other contagious diseases are. This could conceivably mean that, if an employer’s attendance policies discourage workers with COVID-19 from missing work, and other employees become sick as a result, there would be recordable workplace illnesses.

A strong argument might therefore be made for some kind of sick-time compensation program similar to workers’ compensation to be paid for by contributions from all stakeholders or relevant interested parties: the workers, the employers, and the taxpayers. Workers should pay a share to ensure continuity of their income if they are too sick to work. Employers should pay a share so their employees won’t come to work sick and infect other employees. It is also in the interest of society in general that sick employees not spread coronavirus or even the seasonal flu, so taxpayers should contribute as well. This system would apply to employers that do not already have sick leave policies in place to assure workers that they will not lose their pay if they can’t show up for work, or if doing so would put other workers at risk. The details are up to state legislators and/or Congress, but development of such a program deserves consideration.

The system could also require verification from a licensed healthcare practitioner that the worker is really sick so as to prevent abuses, and an argument can be made that somebody who is really too sick to work is sick enough to require medical attention. Even seasonal flu can be deadly if it turns into pneumonia, so a visit to an outpatient clinic or doctor’s office might be highly advisable for anybody who feels too sick to work.

Reshore U.S. manufacturing

American companies are suffering because of their dependence on Chinese-made products and also raw materials such as the rare earths that are used in electric vehicle batteries. Shipping the jobs and plant offshore might have seemed like a good idea at the time; companies could pay offshore labor a couple of dollars an hour (if even that) instead of the $20 or more that they needed to pay domestic labor. Suppose, however, that China had been somehow able to give them parts, subassemblies, and so on for free, and even cover the shipping costs. Free doesn’t help if nothing is being shipped, and supply chains should have learned something from the earthquakes that idled Japanese factories many years ago.

ISO 9001:2015 does not give explicit attention to the supply chain and continuity of operations, although Clause 6.1—Actions to address risks and opportunities, implies that this requires attention. IATF 16949:2016 is much more prescriptive, and Clause 6.1.2.3—Contingency plans, item c), says the organization shall “prepare contingency plans for continuity of supply in the event of... interruption from externally provided products, processes, and services” for reasons that constitute force majeure. Quarantine of the supplier plant’s workforce would certainly constitute force majeure.

A Google search on “supply chain FMEA” (with quotes) comes up with only 80 or so results, which is surprising due to the ability of any stoppage to cripple an operation (in the absence of contingency plans or alternate sources of supply). The new AIAG/VDA FMEA manual (2019) includes in its severity rating table the impact of a quality failure on the customer’s continuity of operations. A line shutdown of more than one production shift receives a severity of 8, which is the worst possible, short of failures that jeopardize safety or regulatory compliance.

To put this in perspective, Pennsylvania implemented flood mitigation controls after one of our sporadic overflows of the Susquehanna River affected some automotive suppliers; the automakers cannot afford to have their supply chains interrupted.8 Organizations must apply the same thought process to offshore supply chains over which they have even less control and are subject to an even wider variety of risks.

Opportunities for distance learning, conferences, and tourism

Closure of schools in favor of distance learning, again to prevent congregations of large numbers of people, could result in the decision to do away with most classrooms—and their associated capital and maintenance costs—entirely. If distance learning works, there is no reason to go back to the former methods. The school, its grounds, and school buses all cost money, and their elimination would result in lower school taxes and also higher compensation for faculty. Facilities would still be needed for laboratories, shop classes, sports, music, and theater, but a good part of the school building would be unnecessary. The same principle applies to colleges, many of which already offer distance learning and are now relying on it to prevent the spread of the coronavirus. Maybe that new multimillion-dollar classroom building won’t be necessary, and tuition will not need to be raised to cover its costs.

Conferences, conventions, and sporting events are meanwhile being cancelled for fear of contagion. This is a strong argument for online conferencing or virtual conferencing, the technology for which is readily available. Attendees also do not need to spend time or money on travel and lodging. This suggests rapid and widespread adoption of virtual conferencing technology to ensure that conferences are not cancelled with attendant financial losses to the organizers, venues, and also attendees who have paid for nonrefundable plane tickets. This technology also offers a low-cost option for distance participation regardless of the presence or absence of an epidemic illness.

Italy’s tourism industry has been effectively ruined for the foreseeable future, but millions of people would nonetheless like to see Italy. This is a strong argument for virtual tourism or virtual reality tourism (Google brings up results for both phrases). People could conceivably use virtual reality headsets to experience cities, archaeological sites, and parks via drones, robots, and so on whose cameras could be directed in any desired direction. The technology is already here in the form of a one-hour virtual reality tour of the Sistine Chapel.9 The Oculus Quest website offers “Smithsonian Journeys: Venice” for free. “Enjoy over 30 minutes of 3D 360° video shot on location as you learn all about the history and culture of the city.”10 The experience is narrated by Italian history professor Kenneth R. Bartlett. Oculus has another web page that invites users to “travel the world through VR with these globe spanning apps!” some of which are free, and none appear to cost more than five dollars.

Virtual tourists could admittedly not enjoy authentic Italian (or French) restaurants from halfway around the world—or maybe they could. Moley Robotics is developing a robotic kitchen that can download recipes from real master chefs from around the world, and prepare the meals exactly the way the chef intended. If this sounds far-fetched, remember that surgeons can use VR gloves to operate on patients who are on the other side of the world.11 A restaurant in Italy, France, or anywhere else could conceivably license its recipes and techniques for use by virtual-tour businesses that would combine VR tours of any given location with authentic meals from the local restaurants. If time zones are not an impediment, VR tourists might even be able to interact with the actual restaurant’s staff. Excellent virtual reality headsets are meanwhile available for less than $1,000, and therefore well below the cost for even most domestic travel and lodging.

Conclusion

The coronavirus is a clear and present danger to the entire world, but there is little doubt that it can be contained and eventually destroyed with modern medical science. What is important is that the lessons learned from containment, and especially attention to hygiene, be sustained and standardized throughout society to ensure that nothing like coronavirus ever comes back, and also to suppress more mundane but nonetheless costly and sometimes dangerous annoyances like the common cold and seasonal flu.

The coronavirus has also underscored the enormous risks to international supply chains and raised serious questions as to the wisdom of putting one’s fate into the hands of distant suppliers. It has also, however, created opportunities for distance learning, distance conferencing, and virtual reality tourism that are not subject to interruption by epidemics or more mundane issues like travel delays due to weather and similar causes. These options would also offer convenience and lower prices, as well as more opportunities for participation to more people.

References
1. Cheung, Eric. “These are the countries where novel coronavirus cases have been confirmed worldwide.” CNN, 2020. The network cites 3,400 deaths to date as of March 7, 2020.
2. Lanese, Nicoletta. “First coronavirus vaccine trial in the U.S. is recruiting volunteers.” Livescience.com, March 2020.
3. Centers for Disease Control and Prevention. “Coronavirus Disease and Prevention: Steps to Prevent Illness.” CDC, March 2020.
4. Centers for Disease Control and Prevention. “Cleaning to Prevent the Flu.”
5. Cooper, Gael Fashingbauer. “Spock’s Vulcan salute should replace handshakes in coronavirus era.” CNET, March 5, 2020.
6. U.S. Dept. of Labor, Occupational Safety and Health Administration. “Safety and Health Topics: COVID-19.” 
7. Nichols, Bob, and Melo, Caroline. 2020. “When Must Employee Illnesses Be Recorded for OSHA? The coronavirus and other contagious illnesses may qualify.” Industry Week, March 9, 2020.
8. Thomas Lawson, P.E. “Bloomsburg Flood Management Project.” PSPE Keystone Chapter meeting, April 9, 2017.
9. Road to VR. “An Epic Recreation & Guided Tour of the Sistine Chapel Is Now Available on Steam for Free” Nov. 2019.
10. Oculus. “Smithsonian Journeys: Veice.” 
11. Scott, Katy. “How 5G could change everything from music to medicine.” CNN, 2018.

Discuss

About The Author

William A. Levinson’s picture

William A. Levinson

William A. Levinson, P.E., FASQ, CQE, CMQOE is the principal of Levinson Productivity Systems P.C. and the author of the book The Expanded and Annotated My Life and Work: Henry Ford’s Universal Code for World-Class Success (Productivity Press, 2013).

Comments

Risk and Opportunity

I am in total agreement with the vast majority of the points you make, I have one small area  of disagreement. Until such time (and maybe not then) as a virtual meeting or conference occurs in an enviroment similar to the Star Trek holosuite, they will never be as effective or efficient as face to face interaction.

Consider, if you will, recent interactions you may have had, message exchange, email exchange, telephone, and face to face. Which were the fastest and most effective? Telephone was more effective than text, right? Voice cues add much context and meaning to the message. face to face adds visual cues, body language, again enriching the information flow. Then there is the rapid interchange of ideas, building one on the other.

Now, add more people... text rapidly degrades into multiple message trains, a tangle of email trails instead of a unified matrix. At least with voice, we retain the matrix but, as the group grows, it becomes difficult to "take the floor". There is also the matter of being aware of who is speaking. With long standing groups, this becomes easier but, with groups that ebb and flow in attendance, it is an issue.

In short, over the years, I have found that a face to face group can accomplish, in an hour or so, as much work, as much progress, as they could make in a day or so of messages and phone calls.

Long term Containment versus Corrective action

I appreciate your article that relates this current condition to the Quality aspect of CAPA.

But I do not agree that a policy of long term containment is equivalent to Corrective action in the CAPA process.

While it may be true that maintaining the long term containment is the best that can currently be done, Accepting it as the corrective action (and finding the root cause) means that a true corrective action will no longer be pursued.

I have witnessed may companies that essentially end their CAPA doing exactly as you have suggested and when you ask WHY... it is typically that they are tracking a metric which measures the number of days that a CAPA remains open. 

One has to question this metric as a KEY metric for any CAPA process if the process is being "shortcut" just to make sure the metric does not "look bad".

If we set a process to search for the root cause of problems, shouldn't working through the problem be the primary purpose?

Containment vs. CAPA

You are 100% correct that containment is not corrective action, at least not in a manufacturing setting. My understanding is that auditors will issue nonconformances for "CAPAs" whose corrective action is to sort out the nonconforming work, refund the customer's money, and so on without addressing the root cause, and rightly so. In this particular application, preventive action would indeed consist of a vaccine.

On the other hand, in the case of seasonal influenza, the "preventive action" is good for only a year because the virus mutates, and there are fears that COVID-19 can do so as well. The containment action will nonetheless prevent either from reaching epidemic proportions by reducing the effective transmission rate (the average number of people an infected person will infect) to less than 1. In this context, the containment actions of hand hygiene and social distancing could also be regarded as preventive controls that will work against new forms of coronavirus and also seasonal flu.

Containment, in the form of a national 2-week shutdown of almost everything (at the likely cost of 4% of 2020's gross domestic product) would probably correct the problem by destroying the virus totally. I read that flu and coronavirus have two weeks at most (the likely figure is 10 days or less) to find new hosts once they infect somebody. If they don't, they will be killed or inactivated by the host's immune system and never get a chance to propagate. https://www.bloomberg.com/opinion/articles/2020-03-17/coronavirus-emerge...