LONG READ
How industry is reacting to the Covid-19 pandemic
To assess the initial measures taken across the industry, BioPhorum ran a Covid-19 Workforce Protection Survey with the Senior BioPhorum Connect. This was to identify gaps and best practices, help refine and guide the industry approach, and enable the alignment and adoption of best practices.
Colette Ranucci, PhD, Associate Vice President, Global Technical Operations, Global Biologics and Sterile Operations, at Merck & Co., Inc., Kenilworth, NJ, USA, said of the process, “As we find ourselves in the midst of this pandemic, it has been extremely valuable to have a forum where industry leaders can share current and evolving approaches and responses. Incorporating tools such as the Workforce Protection survey to establish a benchmark provides the opportunity to continue to brainstorm, share and leverage best practices as the industry continues to refine its approach in response to the uncertain and evolving circumstances.”
“The group’s initial conversations helped create a sense of assurance and camaraderie,” said Shishir Gadam, Vice President, Cell Therapy Global Manufacturing Science and Technology at Bristol-Myers Squibb. “My overwhelming sense is that our response strategy is largely in line with industry’s, but the validation of our response has been a huge value.”
Jacob Bentsen, Head of Facility & Security at FUJIFILM Diosynth Biotechnologies, agreed and added, “It has been of great value to meet people in similar businesses and with similar challenges, because companies react differently to the same type of risk. The skills and positions of the members create a very qualified Phorum.”
The survey results reflect a point in time during a fast-moving situation (early summer 2020) and a second survey is being undertaken to understand how members’ Covid-19 responses to workforce protection have changed and to look at some areas in more depth.
The survey questions were grouped into six areas and the main responses are discussed below.
Personnel protection and safe working
For all organizations, workforce protection policies are multi-layered to account for corporate, national and local requirements (with considerable flexibility needed to accommodate differences across multiple government levels).
The survey showed that more than 80% of companies have conducted a structured risk assessment, often done within a business continuity or other response framework.
“In terms of business continuity,” said Bentsen, “I gained some excellent input and experience, and the group helped me understand the concerns and priorities of others.”
Bentsen added that his company decided that sites should act as independent factories but work to a company framework. However, “when it came to specific actions and precautions, it was up to local sites to decide as there are some differences between their situations and national guidelines.”
To ensure social distancing, most businesses have implemented a range of physical and temporal controls, such as 2m distances between desks, one-way systems for people flows and physical barriers (e.g. screens).
Unsurprisingly, as many knowledge workers are based at home, the majority of organizations (86%) have very low levels of building occupancy, often between 25-50% of pre-Covid-19 levels.
Companies also said that special arrangements, beyond the use of PPE, are being widely adopted where social distancing is not possible, such as redesigning manufacturing setup layouts and reducing the number of people in close contact with each other.
The most commonly provided PPE are hand gel, masks/visors and gloves and early concerns about supply have eased, with 97% of businesses being able to increase their PPE inventories. Nearly all told us that cleaning routines in facilities and offices have intensified with an additional focus on high-traffic areas.
Vulnerable staff (e.g. immunosuppressed) are working from home in the majority of organizations (91%), and a similar proportion has been provided with safe-working training, such as videos on mask use. Many additional safeguards are being considered, including location logging, contact tracing and tighter access control to buildings.
Companies also said they are enhancing their psychological support for their workforce, such as regular calls with supervisors and offering a psychological hotline. Many have developed plans to ‘cocoon’ critical employees for a defined period on-site to reduce their social contacts and risk of infection.
“I think the pandemic’s isolation aspect definitely impacts people, and one-on-one interactions have been vital for supporting staff, said Gadam. “We have also used things like special escalation pathways for any one-off situations that need to be managed so that no situation is left unanswered or unmanaged.
“The most impactful thing in our company is how the leadership team has empowered people managers to make the best decisions that will allow us to continue making business progress,” Gadam added, “while acknowledging that each employee’s situation is unique.”
Remote working/working from home
Beyond the usual web-meeting applications (e.g. Zoom and Teams), most businesses do not use remote-working technologies. However, remote working is encouraging innovation in business practices, such as using augmented reality glasses and electronic signatures.
Recognizing the increased risk of cyber attacks with remote working, IT groups are enhancing security and user awareness through actions such as extra training and using cloud technologies and data encryption. Virtual exchanges are widely replacing audits, inspections and other physical interactions, but it is unclear to what extent this will continue in the long term and they may be a short-term expediency.
“The discussion we have started on virtual audits and inspections is on the mark,” said Gadam, “and probably one of the most impactful things we should be talking about. Virtual audits and inspections are here to stay.”
Gadam added the extent that companies are comfortable sharing their experiences would be incredibly impactful. “For example, the FDA has published guidance on how it wants to manage site inspections during Covid-19. Complementing this with the experiences of sponsors on how inspections are arranged and managed will be really useful.”
It is expected that the new ‘normal’ will include working from home 1–2 days per week, and some organizations might even consider formally splitting office/home time to reduce their business occupancy need to 50%.
Workplace design for people protection
Most businesses (85%) have no plans to eliminate touch screens, instead preferring to increase the sanitization of surfaces. Just over half of companies said they had eliminated indirect personnel (e.g. supervision and management) from the manufacturing space.
Nearly all companies have initiated low-density working environments to 50% or less of pre-Covid-19 levels. At the same time, over half are planning to redesign their offices and working spaces to allow social distancing (e.g. eliminating open-plan offices, reducing hot-desking and adding more screens between people). Slightly over half of businesses told us that they had initiated plans to minimize physical touchpoints, such as door handles, by using automated openers or even eliminating some doors completely. However, significant redesigns are not a common trend.
“We have not made drastic changes to the infrastructure or building designs,” said Bentsen. “We put up some physical barriers, plastic glass, etc., but these are minor design things. At a site level, we introduced guidelines on how to move around, sit, eat, sanitize and meet, but these are more around people’s behaviors rather than the site and structures.”
Gadam said that his company’s focus is on implementing proper controls and procedures to ensure that people can execute the work in the labs and in manufacturing to meet the social distancing protocols.
Staggered work start/finish times is a very common action to limit the close contact of staff, and the majority of organizations have implemented self-contained teams where possible (e.g. with no cross-team working or swapping team members). Around half of companies have taken special measures to help staff safely travel to and from work, such as requiring them not to use mass transport methods.
A very high proportion of businesses have made new arrangements for supplying food and drink to their workforce, such as offering take-out food and protective screens for cashiers, while removing self-serve items. For the vast majority of organizations (94%), workplace design for workforce protection applies to all types of facilities, not just manufacturing locations.
Testing and tracking infection risk
Most companies said they support PCR testing for workers with Covid-19 symptoms – but mainly through physicians and local healthcare providers rather than the testing being provided on-site. Also, the majority do not do serological (antibody) testing of workers displaying Covid-19 symptoms, while only one company told us it did serological testing for workers not displaying symptoms.
Checking the temperature of employees and visitors before site entry is typical for most businesses. Temperature self-testing by employees or visitors is the usual method, but EHS staff, company nurses and third-party contractors are also often used. However, in many cases, private areas are not provided to conduct temperature testing.
All organizations measure and report infection cases, although most (71%) are not measuring past exposed cases to determine potential immunity levels.
Plans to track people to trace their contacts in the case of infection do not exist in most companies, although nearly all have a clear process to follow-up suspected Covid-19 cases. Many also only allow direct workers and contractors who support production to be on site.
Two areas provided extra levels of detail in the survey responses: Technology use and Return to work.
Return to work
As we continue to emerge from the Covid-19 lockdown and try to find the ‘new normal’ in biopharmaceutical operations, BioPhorum members have been navigating how their businesses return to work (RTW).
The survey assessed how industry was reacting to Covid-19 to identify and share best practices that would help guide its reaction to the crisis.
Again, looking at RTW in more detail provided extra insight into the more general comments on RTW noted above.
Social distancing
Most organizations have implemented a range of physical and temporal controls to ensure social distancing. These include visual markers to segregate/define workflows and taped-off areas that are restricted. As expected, companies place a lot of emphasis on physical distancing, although this varies between countries with distances ranging between 1–2m.
Occupancy rates
Some companies are starting with a low returning occupancy, e.g. 15–30%, which will be increased in small increments based on the number of Covid-19 cases and restrictions being relaxed. However, the upper range will only generally be around 50–65% maximum occupancy, with some areas remaining at their initial returning levels.
Close-working
More than 60% of organizations have made special arrangements for close-working situations. Some of these are physical restrictions to limit close contact (e.g. plexiglass barriers and redesigning the layout of manufacturing setups), while others include the more common face shields and masks, which are primarily used during prolonged close work.
Cleaning protocols
Across many businesses, cleaning routines have intensified with an increased frequency and attention on high-traffic areas and touchpoints, with some buildings being sanitized at weekends. Cleaning approaches range from the simple (e.g. hand washing) to the complex (e.g. sanitization of office areas using fogging systems).
Workspace redesign
A small majority of organizations are planning to redesign offices and working spaces for social distancing. Some companies are using Covid-19 as an opportunity to review longer-term office configurations of existing buildings or new build/major renovations.
Phased approach
Most businesses have a stepped approach to RTW with 2–3 defined phases. The phases are structured (e.g. essential manufacturing staff first, then support staff and finally ‘others’) and require approval before transition to the next phase. Transition is often determined by business requirements and predefined measures (e.g. infection rate and PPE availability).
Return to lockdown criteria
A small majority of companies have defined return to lockdown criteria, although most will defer to local authority and government guidance, particularly if infection rates start to increase. Some will base decisions on the ‘effective reproduction number’ (Rt) data and will monitor the number of new cases per number of staff at sites as RTW progresses.
Lessons learned
Industry is at the initial stages of RTW but some early learning points are emerging. RTW is complex to manage and should be done cautiously with a clear plan that must be flexible to local conditions. Guiding principles (e.g. focusing on staff safety and protecting operations) can help ensure a smooth RTW that has employee buy-in while allowing delivery of supply.
Technology use
The use of technology in its many forms was a recurring theme in the survey. Drilling down into its role in the workplace provided some specific insights into the more general comments on technology use noted above.
Remote working technologies
Most organizations do not use remote working technologies beyond the typical ‘web meeting’ applications. However, examples of other technologies being considered include WhatsApp groups and a web radio for employees in France.
The ability to remotely monitor laboratory equipment already exists in some companies, which enables them to use a ‘hybrid’ schedule, where staff visit a site to set up laboratory work, then monitor it remotely from home.
Innovations and tools
There are many examples of technology and new ways of operating that are driven by remote working. These include online collaboration tools (e.g. Trello), digital whiteboards (e.g. JamBoard) and electronic document signatures.
One area that is gaining ground is the use of smart and virtual/augmented reality glasses (e.g. Google Glass and HoloLens) and the use of virtual content. These technologies are being used for tasks such as remote on-the-floor support and virtual/remote inspections.
A common thread in survey responses is an increasing realization that many ‘knowledge workers’ can operate effectively from remote locations.
Cyber security risks
Unsurprisingly, IT departments recognize that enhanced security and user training is needed with increased remote working. Improved controls are being driven by local and global IT departments, especially following increased ‘phishing’ incidents.
Many organizations have reviewed their IT controls and made improvements where necessary, including ensuring all systems and software are using the latest patches, installing the Microsoft BitLocker file encryption process and using cloud technologies.
Remote access to shop floor performance data
Accessing shop floor data and key systems (e.g. analytics) remotely was already in place for most companies before the pandemic. However, the lockdown has increased its importance, with some companies further leveraging their existing capabilities for shop floor access.
Virtual management
Virtual routines for Kaizen, GEMBA and safety visits are emerging from the need to minimize people in facilities.
Physical GEMBA walks have generally been reduced or stopped. At the same time, virtual meetings are being conducted more often with virtual dashboards and video streaming being used for communication (using products such as Microsoft Stream).
There are also layered approaches being used for management/leadership visibility, e.g. managers are allowed on the shop floor with senior leaders only being required when it is critical and then only temporarily. However, the picture is a little mixed.
Digitization of the cGMP space
More than half of companies plan to speed up their plans for digitization in their facilities.
Example technologies include video streaming, virtual/augmented reality, smart glasses, AI applications and automation.
Gadam said that he had seen increased innovations that may become common practice. “Adversity drives innovation. We are aggressively evaluating video technology and live-streaming for critical operations, where subject-matter experts can observe an operation and confirm its accuracy or provide real-time feedback to the operators in our manufacturing process”
However, some businesses were planning to progress with digitization regardless of Covid-19 and will continue implementing their existing strategies.
Staff training
Most organizations have reduced or replaced face-to-face training with a virtual approach, although some have only postponed their planned activities. E-learning was already a training option for many, but there is an increased focus on using augmented/virtual options.
Some businesses are undecided about how to deliver their future training, particularly GMP-related activities, but many recognize that face-to-face training can be more effective than virtual.
Conclusion
The speed with which Covid-19 has impacted the biopharmaceutical industry has required an almost unprecedented response from organizations. But respond it has.
The BioPhorum Workforce Protection Survey shows that – despite fast-changing corporate, local/regional/national government requirements – companies have reacted quickly to keep their workers safe while trying to minimize the impact on day-to-day operations. Existing business continuity or other response frameworks have been crucial to formulating a speedy, coordinated and measured response.
Physical and temporal controls to ensure social distancing are extensive and include everything from screens/barriers to one-way systems. Most companies have adopted special arrangements (e.g. PPE) where social distancing is not possible, and cleaning routines have intensified with a focus on high-traffic areas.
Companies recognize the need for additional safeguards, and location logging and contact tracing mechanisms are being used by some. They also appreciate the criticality of some staff and segregating teams is widely used to reduce infection risk.
As expected, there is a lot of focus on testing, tracking and reporting infection risk. While most organizations support PCR testing for workers, this is mainly through physicians and local healthcare providers. Most companies do not do serological or antibody testing, often because of concerns about the unreliability of tests. Temperature self-testing by the employee or visitor is common, although in most cases private areas are not provided for this.
How companies operate is also being affected by the pandemic. Remote access to shop floor data has increased in importance, while the need to minimize people in the facilities has meant that virtual management routines (e.g. Kaizen) have emerged. Some companies also accept that work areas may need to change and redesigning office/workspaces – not just manufacturing locations – is now happening, as is staggered start/finish times to minimize staff contact.
Working from home has been a seismic shift for many businesses, and web-meeting applications are now standard. Some organizations are taking the opportunity to innovate their business practices and even accelerate their digitization plans in cGMP facilities. Homeworking has required an extra focus on IT security, which may be needed in the longer-term as there is an expectation that some working from will become the norm.
In many cases, actions have resulted in very low levels of occupancy compared to pre-Covid-19 levels. How this will impact long-term building occupancy rates remains unclear, but organizations will be looking at their property portfolios carefully and assessing their future needs.
“We are following a very thoughtful recovery plan that is guided by the shared global principles and local health official guidance,” said Gadam. “However, we are still carefully prioritizing who really needs to be on-site to ensure business continuity.
He added, “Long-term, once we return to a fully-recovered state (a ‘green’ state, which largely corresponds to full protection through a vaccine), then we hope to get back to some level of normalcy. I expect that as there will be a greater level of openness to alternate ways of working such as remote work and flexible hours.”
Technology has always played a crucial role in biopharmaceutical operations. However, the Covid-19 lockdown has meant BioPhorum members have not only been looking at how it can be used to maintain business operations, but how to innovate for the future.
As businesses begin to consider a return to work, this will only be through strict controls and a phased approach, and decisions will be prioritized by corporate and local requirements. However, the survey responses show that companies have focused on the more immediate phases of the pandemic and a spotlight on travel is only starting to come to the fore.
Unsurprisingly, the well-being of staff is a core message in the survey responses. It is a high priority, especially for those that are vulnerable, and there is an increased focus on safety training, communication and psychological support. Through their workforce protection actions, organizations are acknowledging not only their responsibility to keep staff safe but that it makes business sense.
“Our people are our greatest asset” might be a well-worn phrase, but this BioPhorum survey shows that it has never been more true.
