The coronavirus pandemic has necessitated a global shift in many sectors, with field inspections being no exception. The presence of the virus presents both safety hazards and health risks. This makes conventional on-site inspections challenging, if not potentially dangerous.
Suddenly, the safety of inspectors and employees, particularly those within manufacturing facilities and healthcare settings, has taken precedence. Indeed, this covid-19 pandemic has urged the need to drive significant changes in how field inspections are conducted. This is mostly true specifically for FDA inspections or other situations where an unannounced inspection may be needed.
Occupational safety has moved to the forefront. At the same time, routine procedures like site inspections have had to adapt quickly to the novel environment.
The Role of Personal Protective Equipment in Field Inspections
One of the immediate responses to the pandemic was the escalated use of personal protective equipment (PPE). PPE became an integral part of the daily routine. This is true, especially for those involved in field inspections. Specifically, this needs to wear face coverings. Its use varied depending on the setting and nature of the inspection. But this is primarily intended to protect inspectors. This has also helped in assisting employers in addressing hazards related to potentially infectious materials, disease control, or other vital COVID-19-related survey activities.
Occupational safety and health administration guidelines require employers to have a written respiratory protection program in place where respiratory protection is necessary. This meant that safety laws had to be adjusted, with updated reporting requirements that included unannounced inspections to ensure compliance.
However, the global rush for personal protective equipment led to supply chain disruptions and subsequent shortages. This had brought a lot of impacts. It requires employers, inspectors, and businesses to seek appropriate substitutes for common face-covering solutions. It’s because even someone fully vaccinated would need to wear face coverings.
This necessity emphasized the importance of having a robust, dynamic, and proactive respiratory protection program. Fit testing became a crucial part of the program. It determines the right fit and type of respiratory protection to use based on the risk and the individual.
In the healthcare sector, providers were urged to take extra precautions. CARES Act funding also helped to provide resources for a testing program on an ongoing basis. As facilities tested positive for the virus, healthcare providers had to not only protect patients but also ensure their safety. This was commonly done by wearing face coverings and other PPE as part of their new normal.
The Shift to Virtual Inspections: Pros and Cons
The COVID-19 pandemic greatly impacts businesses. As one effect, they necessitate the need to accelerate the adoption of digital solutions across many industries. Field inspections also making a significant shift toward virtual inspections. This shift not only offers a reasonable accommodation during the ongoing crisis but also presents a cost-effective alternative to traditional on-site inspections.
The move to virtual methods eliminates the need for travel. It minimizes physical contact. Likewise, it helps prevent transmission of the coronavirus disease. Thereby helping to protect the health of everyone involved, regardless of vaccination status.
Virtual inspections are performed using advanced digital tools. It allows inspectors to assess the conditions and operations of both domestic and foreign facilities from a safe distance. These inspections apply to a wide range of sectors, including pre-approval inspections for drugs, food safety checks, and health administration assessments.
However, despite the advantages, virtual inspections also present some challenges. These inspections depend heavily on technology, requiring all parties to have access to reliable internet connections and adequate devices. Additionally, virtual inspections may not capture some nuances and details that could be evident during on-site inspections.
The validity of virtual inspections has been upheld by many leading health and safety organizations. Still, ongoing efforts to refine these processes and overcome these challenges continue. As the shift towards more virtual inspections seems likely to persist beyond the pandemic.
Occupational Safety: Adapting Safety Laws and Measures Amid Pandemic
In the face of COVID-19, occupational safety laws and measures needed to adapt rapidly to keep pace with the changing circumstances. The primary focus became ensuring the safety of inspectors, employees, and the public.
One of the major changes Covid-19 has made on our workers doing field inspections was the requirement for employers to develop and enforce a respiratory protection program. This is especially a common scenario in industries that require respiratory protection. This included fit testing for respirators and making reasonable accommodations for remote work when possible.
In addition, health and safety agencies issued guidelines and directives to help employers address the specific risks associated with COVID-19. This included information about PPE, sanitation practices, physical distancing, improving ventilation in indoor settings, and procedures to follow concerning vaccination status, respirator use, or when an employee tested positive.
Employers were also required to develop procedures for dealing with employees who refused to comply with safety measures. They practiced this to protect other employees and prevent transmission of the virus. To ensure compliance with these new measures, regulatory bodies, such as the FDA, conducted both announced and unannounced inspections.
New Challenges to the Domestic and Foreign FDA Inspection
COVID-19 posed unique challenges to both domestic and foreign inspections. For domestic inspections, one of the key challenges was ensuring that all facilities, including manufacturing facilities, comply with updated measures to combat safety hazards.
Unannounced inspections became a common practice to ensure adherence to safety laws and measures while warning letters were issued to those failing to comply.
Foreign inspections, on the other hand, faced a different set of challenges. Travel restrictions and safety concerns made on-site inspections in foreign facilities more complex.
To address these issues, regulatory bodies like the FDA resorted to virtual or remote methods for routine FDA inspection. They now relied on information shared by foreign regulatory agencies through mutual recognition agreements. These Covid-19 pandemic changes marked a significant shift in the way foreign field inspections are conducted.
However, the pandemic has also underscored the need for robust and flexible inspection systems that can adapt to unforeseen circumstances. It has driven innovations and reforms that are likely to shape the future of field inspections, both domestically and internationally.
Compliance in Food and Drug Manufacturing Facilities
As we continue to navigate through the pandemic, maintaining compliance in food and drug manufacturing facilities remains a top priority. These facilities are subject to rigorous domestic and foreign inspections to ensure they follow current good manufacturing practice (cGMP) guidelines.
Now, more than ever, the health and safety of employees and consumers rely on strict adherence to these regulations. The FDA has been conducting virtual inspections to address a potential safety hazard while still fulfilling its mandate of ensuring public health.
In addition to regular inspections, both announced and unannounced, the FDA also performs re-inspections and issues warning letters in response to non-compliance. However, the pandemic has revealed weak links in the supply chain. This has resulted in shortages of drug products, including over-the-counter drugs, and disrupted federal food safety programs.
These supply chain disruptions and drug shortages highlighted the need for adequate preparation. It also highlights the need of having the ability to adapt quickly to ensure compliance and address safety hazards and other public health concerns.
In response to these challenges, the FDA has been making concerted efforts to maintain oversight over such operations. This includes granting import alerts and warning letters to manufacturers that fail to meet the requisite safety standards while also focusing on improving the transparency and resilience of the supply chain.
Anticipating Future Changes in Field Inspections
The COVID-19 pandemic has significantly altered the landscape of field inspections. As we have seen, changes were necessitated across the board, from increased use of PPE to the switch to virtual inspections, with the overarching goal of ensuring safety and health.
This period has been marked by rapid adaptations to safety laws, ongoing changes in inspection methods, and increased scrutiny of healthcare providers and manufacturing facilities.
While we can anticipate a return to some normalcy with time, it’s reasonable to expect that many of these Covid-19 changes will become ingrained in the processes of field inspections.
Even as the threat of COVID-19 recedes, the lessons learned during this time will likely inform the evolution of field inspections in the future. As we move forward, the emphasis will continue to be on ensuring health and safety. Yet not just in the face of a global pandemic but as a standard practice.
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