Time (maybe past-time) to evaluate your organization’s business continuity plan and anticipate the potential actions against immigrants, in particular the potential impact of Trump’s proposed immigration policies on the facility cleaning industry, particularly cleanrooms, which could be significant.
Labor Shortage
The cleaning industry, including cleanroom maintenance, heavily relies on immigrant labor. A mass deportation policy could lead to:
Significant workforce reduction: Many cleaning companies employ immigrant workers, both documented and undocumented. A large-scale deportation could severely reduce the available workforce.
Increased labor costs: With fewer workers available, companies may need to offer higher wages to attract and retain employees, potentially increasing operational costs.
Industry Disruption
The cleanroom industry, which requires specialized skills and training, could face particular challenges:
Loss of experienced workers: Cleanroom maintenance requires specific knowledge and expertise. Deporting experienced workers could lead to a skills gap in the industry.
Reduced productivity: As companies struggle to replace deported workers, there might be a temporary decrease in productivity and quality.
Increased costs for clients: Higher labor costs in the cleaning industry could be passed on to clients, potentially affecting industries that rely on cleanroom facilities, such as pharmaceuticals and electronics manufacturing.
Actions to Evaluate
Time to evaluate internal training programs to quickly upskill current and new workers, particularly for specialized cleanroom maintenance. Be prepared for the need to have your staff step in and clean, on the moment’s notice. This is a key action to have in the business continuity plan, and frankly should already be there.
Compliance and Legal Challenges
Beyond that, companies should be evaluating their other plans with broad stakeholders like HR and legal for when law enforcement comes calling as a result of heightened enforcement and audits of cleaning companies to ensure compliance with immigration laws. Remember these cleaners work side-by-side with your staff and quite frankly, are really hard to tell the difference. Are you prepared to side with law enforcement, or delay law enforcement? What is your risk tolerance for navigating the complex legal situations, particularly if long-term employees are suddenly subject to deportation?
While the full extent of the impact remains uncertain, Trump’s proposed immigration policies could significantly disrupt the facility cleaning industry, which will greatly impact every manufacturing site I know. The industry may need to adapt quickly to potential labor shortages, increased costs, and changing regulatory landscapes, while navigating the thorny ethical considerations.
This is not an unexpected accident. It has happened before on a smaller scale. We’ve seen companies like Crowdstrike under-resource their system controls that should prevent this. There is probably a strong case for regulation here. Maybe the EU will do something.
While my flight was only delayed an hour, there were sure to be a lot of grumpy and angry-looking people at Sea-Tac and Logan. I really think if we didn’t have a dysfunctional Congress, we would have seen a real change in how the airline industry is regulated by now.
The pharmaceutical regulations call, repeatedly for business continuity plans. For example, the FDA calls for fairly significant requirements for Medically Necessary Products:
Medically necessary drug products and their components are manufactured all over the world. An emergency situation anywhere in the world thus might affect the availability of drug products in the United States and result in drug shortages. Emergency preparedness for situations that could result in high employee absenteeism is an important goal for manufacturers of drug products and their components. For example, in an influenza pandemic, widespread human outbreaks of illness would be expected in the United States and around the world, resulting in widespread high absenteeism that could hinder normal production activities and cause shortages in the supply of drug products, packaging materials, and drug components. It is therefore vital for industry to prepare before an emergency situation occurs and to develop plans to ensure continuity of operations during emergencies (including, for example, an influenza pandemic, natural disaster, or personnel issue) that would prevent a significant portion of the work force from reporting. It is especially important for manufacturers of finished drug products to be aware of their suppliers’ and contractors’ responses to personnel shortages and, when appropriate, work with them to ensure the availability of high quality materials and services that contribute to the manufacture of MNPs.
You can find less definitive requirements throughout the various health authorities’ regulations and guidances.
So what do we mean by business continuity?
Business continuity is the holistic management process that ensures operations continue and that products and services are delivered at predefined levels (e.g. no shortages, no halt to an ongoing clinical trial). This approach is aligned with ISO 22301 Business Continuity Management Systems.
Business continuity management is an ongoing process based on the plan-do-check-act methodology that is made up of 4 key elements:
Emergency Action and Response Plans
Disaster Recovery Plans
Crisis Management Plans
Business Continuity Plans
Emergency Action Plans
An emergency action plan is designed to respond to an emergency with mitigating procedures to protect, secure and evacuate people to safety. This is more an OSHA thing; chances are your average Quality unit doesn’t end up owning it. Unless you have no HS&E unit, and then you write one.
This plan includes procedures for detecting, warning, and responding to specific potential emergencies such as fire, severe weather, earthquake, medical emergencies, workplace violence, and other potential threats.
Disaster Recovery Plan
Disaster recovery plans are designed to recover from a disaster, usually related to equipment, infrastructure, and information technology. Something big goes boom, how do you restore this vital support system or equipment as soon as possible and minimize downtime and loss of data. Very important for computer system lifecycle, disaster recovery plans should include specific plans for recovery functions, resumption strategies, critical personnel, equipment, services, and external and internal communications.
Crisis Management Plans
Crisis management is all about planning and mitigating situations that have risk, and are usually a lot of management of communications internally and externally. This includes with regulators, health care providers, etc. When we implement SOPs for health authority notifications we are engaging in crisis management planning.
Business Continuity Plans
Business continuity planning identifies and plans for disasters to events that could negatively an organization’s business functions, objectives, income, reputation, and ultimate survival. This planning takes place in advance of the potential disasters or events that could harm an organization. It takes potential disasters and events into consideration with their effects on suppliers, vendors customers, and the organization’s other stakeholders.
In a GxP environment, we are looking at the potential impact of disasters on drug supply and clinical study outcomes (amongst other key activities).
The BCP is all about minimizing the effects of the disaster or event on the organization and returning to normal operations as soon as possible.
These Plans are Interrelated
All four plans are interrelated and should be coordinated. The plans can be combined, but as there are usually very different owners they are often separated.
Documented Plans
The business continuity planning process should result in formal, documented plans that serve as a reference guide in the event of a disaster or event. The existence of the business continuity plans should be well communicated, with individuals with responsibilities having ready access and additional training.
Applying the Risk Management Process
The Business Continuity process should leverage existing risk assessments and sit around it.
Select Team
The team should be multifunctional and very knowledgeable about the organization’s business and the risks it faces. This should be a permanent team, not ad hoc, as this is a living process. You can always bring in ad hoc members for specific questions.
Define Context, Purpose, Scope
At a minimum you are tackling the disruption to product supply and cessation of critical GxP data but there may be other business requirements to tackle. Make sure everyone agrees on these.
Define Terminology
Make sure everyone is on the same page with just what disaster, event, crisis, stakeholder, and business continuity plan (and other important concepts) are.
Agree on the scales for likelihood and severity.
Critical Function Assessment
Identify the business functions that are sensitive to downtime, fulfill regulatory obligations and are vital for maintaining product supply.
Threat Assessment
Identify the threats to the performance of the critical functions.
Utilize a risk matrix to assess the likelihood and severity of the identified hazards and risks.
Develop Business Continuity Plan(s)
After the hazards and risks have been identified, the impact understood and the risks assessed it is time to develop the business continuity plan (BCP). The BCP allows the organziation to survive the event or disaster with minimal disruption. The BCP focuses on mitigating the consequences of the event or disaster that could not be prevented. Recovery strategies for these cosnequences are determined, developed and become part of the BCP.
When many potential risks have been identified, use the risk score to prioritize.
BCPs cover management commitment, team ientification, team responsibilities, mitigation plans, recovery strategies, training, testing and evaluation and continious improvement. Basically the same thing any good plan does.
Mitigation plans are intended to lessen the negative effectis of an event or disaster.
Provide appropriate awareness training to everyone impacted, with more substantial trining to the BCP team.
Verify it periodically and ensure it is continues to be relevant.
Whenever relevant, procceduralize these BCP instructions.
Investigations of a Dog 