The changing state of safety in manufacturing

For businesses that experienced a lull in Food and Drug Administration inspections during the pandemic, or have never faced one at all, the prospect of a visit from the FDA might be cause for alarm. 

That trepidation might be greater in some industries, such as pharmaceutical manufacturing, that experienced up to triple the number of site visits year over year in 2022, bringing the frequency back up to pre-pandemic norms. 

Whether a manufacturer of medical parts or a packaged food maker, the reality is that in-person surveillance inspections are a part of normal operating procedure, and year-round readiness is important to not just remain FDA-compliant, but to guarantee a safe product that meets high quality standards. 

Read on for a refresher on how FDA inspections work and how to be prepared. 

When to expect an inspection

There are three main types of inspections a manufacturer may undergo: 

• Surveillance inspections: Used to monitor the manufacturing process and the quality of distributed drugs, the FDA uses the findings to evaluate whether a manufacturer is complying with the agency’s Current Good Manufacturing Practice requirements. 
• Pre-approval inspections: Conducted as part of the review of an application to market a new drug, device or biologic, these inspections are used for approximately 20% of application reviews by the agency. 
• For-cause inspections: Inspections that are triggered when the FDA has reason to believe that a facility has manufacturing quality issues or when the agency wants to evaluate corrections that have been made to address previous violations. 

While the latter three three types of inspections are triggered by approval processes, violations or other irregularities, all manufacturers must be ready for a surveillance inspection, which don’t follow a prescribed frequency, FDA spokesperson Charles Kohler said. 

Surveillance inspections are based on risk factors outlined in the FDA’s “risk-based site selection model,” which it uses to guide how to prioritize different sites for review. Factors include the company’s compliance history, as well as any “inherent risks” of the product manufactured. 

High-risk food facilities in the U.S. are to be inspected at least once every three years, while lower-risk food facilities are to be inspected at least once every five years, according to the FDA. 

Rob Dongoski, global lead for food and agribusiness at Kearney, said that industries with higher risks might, for instance, include poultry and pork, given salmonella and listeria outbreaks the sectors have respectively experienced in recent years.

How to prepare for an FDA surveillance inspection

Documentation is key to passing an inspection.

One of the best starting places for a small- to medium-sized manufacturer is to have a solid quality management system in place, said Kearney strategic operations partner Azaz Faruki. In the past, business owners used physical binders with dividers to organize their documents; these days, people might find an electronic version or template easier to use. 

A QMS houses all manufacturing processes and employee training and includes details about every ingredient that touched a product. An especially important element to a QMS is a manufacturer’s device history record, which contains all documentation related to the production and tracking of the device.

A complete device history record should include a material control list, routing information and all certifications related to the product, said Chuck Hansford, director of advanced development at medical device and aerospace manufacturer Tecomet. 

Manufacturing leaders should make it a habit to track, certify, date and train employees on every single material and device that is used to manufacture a final product. 

Such thorough recordkeeping came in handy during an audit eight years ago, Hansford, said, when he worked for a manufacturer of implants. The customer whose design the implant maker was manufacturing had done a poor job of keeping documentation, but their own diligent recordkeeping saved the company from an FDA notice. 

“We had everything. I mean, we even had letters from the OEM to show that we built their products per their requested requirements,” Hansford said. 

The FDA spokesperson confirmed that not including written documentation of procedural responsibilities related to quality control is one of the common deficiences found during surveillance inspections. 

To avoid these pitfalls, Hansford recommends that manufacturers make mock inspections a regular part of their year. 

Tecomet has specific people within its internal quality system that regularly facilitate complete simulations of audits. At any given simulation, a facilitator might request to see where the team keeps its files or check whether documents are organized under the correct date, number or name. 

“They're harder actually in most cases than the auditors themselves,” Hansford said. 

What happens during a surveillance inspection?

If you are a U.S.-based manufacturer, FDA surveillance inspections usually happen without little to no notice. 

In the midst of such spontaneous visits, manufacturers should remember basic protocols, such as appointing a staff member to be the primary in-person contact for the FDA auditor and ensuring all workers adhere to day-to-day safety protocols, Faruki said.

“Sometimes people believe that they don’t need to put a hairnet on, but that's a violation, and that's gonna get you dinged,” Faruki said, adding that manufacturers should make any visiting inspector adhere to the same basic principles as their staff on-site. “That person's a visitor, and they need to adhere to the same policies and guidelines.“

During an inspection, the facility should additionally be prepared to answer questions regarding the types of products made on-site, responsibilities of various personnel, the types of trainings conducted at the facility and additional compliance program items, according to the FDA spokesperson. 

The length of inspections can vary depending on the size of the inspected facility, number of unit operations performed at the site and number of significant observations made during the inspection. Audits can last anywhere from several hours to multiple days. For instance, Hansford said that for one inspection in which a single product was reviewed, the audit lasted four hours. 

What can happen following an inspection?

Hansford noted that every manufacturer should expect to receive “inspectional observations” after an audit. 

An observation doesn’t necessarily mean that something was found to be faulty or in noncompliance on-site, but can mean the inspector found a process or other aspect of the site that can be improved, Hansford added. 

“Your firm can and should respond to the [inspectional observations] during the discussion with the investigator,” according to agency guidance. “In fact, corrective actions or procedural changes that were accomplished immediately in the presence of the investigator are regarded as positive indications of your concern and desire to voluntarily correct discrepancies.”

If the company receives a notice of noncompliance, Faruki said that it’s helpful to suggest mitigation measures while inspectors are still present, as well as the steps your organization has already taken to stay compliant. 

“If you go through the mitigation measures you've identified already, and what you're doing to close that gap — there may be some flexibility to at least show the rigor of what you're trying to do as an organization,” Faruki added. 

When it comes to inspections, Hansford insists that “if you have nothing to hide, you have nothing to worry about.”

In August, the U.S. Chemical Safety and Hazard Investigation Board called on chemical companies to prepare for hurricane season after National Oceanic and Atmospheric Administration scientists predicted a 60% chance of an above-normal Atlantic hurricane season in 2023.

Across the U.S., 746 chemical facilities were at risk of being affected by category 4 or 5 hurricanes, according to a 2022 Government Accountability Office report.

“Hurricanes and other extreme weather events can severely damage chemical facilities and cause chemical accidents that put nearby communities and facility workers in serious risk of harm,” CSB Chairperson Steve Owens said in a statement. 

There are several steps chemical manufacturers can take to protect their facilities from the threat of hurricanes. For example, companies should identify natural hazards that could occur at their facility and assess their risk level, such as by consulting the National Hurricane Center’s storm surge map, and create an emergency plan, according to the Center for Chemical Process Safety.

The CSB also called on the Federal Energy Regulatory Commission (FERC) — a federal agency that regulates the transmission of electricity, natural gas and oil — to take action and ensure electrical systems are protected from hurricanes and other high-wind extreme weather to prevent power losses at chemical facilities.

“With this hurricane season predicted to be even worse than usual, chemical companies need to act now to make sure that their facilities can withstand the impact of a hurricane or other extreme wind event, including having reliable back-up generators in case there is a loss of power to a facility,” Owens said.

Learning from the past

CSB cited two chemical facility incidents caused by hurricanes over the last six years as examples of what can happen if plants aren’t prepared for extreme weather.

In August 2017, residents near chemical manufacturer Arkema’s Crosby, Texas plant were evacuated for a week after Hurricane Harvey caused equipment flooding and failure in the facility. The failure caused chemicals to decompose and burn, as well as to release smoke and fumes, which exposed 21 people to the decomposing material fumes. 

And during Hurricane Laura in August 2020, a fire broke out and damaged buildings storing trichloroisocyanuric acid, or chlorine used for pools and hot tubs, at water treatment product maker Bio-Lab’s facility in Westlake, Louisiana. The substance came into contact with water, resulting in a chemical reaction that caused the fire and decomposition of the substance.

The fire released large amounts of hazardous gases, shutting down a nearby highway for nearly 28 hours and prompting a shelter-in-place for nearby residents, as well as causing a power outage. 

Bio-Lab invested $250 million to rebuild the facility, which reopened in November 2022.

“It’s a reminder to all facilities, including chemical manufacturers, that they should prepare for these disasters that are becoming more intense and more frequent now,” Alfredo Gómez, director of Natural Resources and Environment at the U.S. Government Accountability Office, told Manufacturing Dive.

Risk management plans

As the effects of climate change become more profound and impact industrial activities in the U.S., Gómez and the GAO are working to ensure companies consider these concerns when planning chemical operations and safety. 

The office conducted a report in 2022 that recommended the Environmental Protection Agency ensure facilities, including chemical manufacturers, consider risks from climate change.

Federal data found that roughly 31% of the 10,420 chemical facilities in the U.S. are located in areas affected by climate change’s heightened impact, such as through flooding, storm surges and rising sea levels.

Facilities that produce or handle hazardous chemicals are required to develop a risk management program to catch, prevent or minimize the outcome of an accidental release.

“So [chemical facilities] are looking for guidance to help them understand the risks that they’re facing from these natural hazards, which are being compounded by climate change,” Gómez said. “And then once they identify the risks, then how to manage the risks, what do they do about them.” 

Gómez cited the example of materials manufacturer Covestro, which creates a response plan for its Baytown, Texas, facility before every hurricane season. The plan covers issues such as how the company will dispense resources for emergency response and ensuring trained staff are available during and after the storm to prevent chemical incidents.

“That’s an example of how a chemical manufacturer can make sure that their people are trained, that they’re working with first responders and that they really have thought about what are the risks that are facing them and what are their plans to deal with it,” Gómez said. “And it’s important because they have these hazardous chemicals that they’re producing, but that they’re also making sure that they’re safeguarded.”

The Department of Labor proposed that chemical-making titan 3M pay $312,518 in penalties due to two safety violations at its plant in Prairie du Chien, Wisconsin, according to a Nov. 7, 2023, announcement.

The federal agency’s Occupational Safety and Health Administration inspectors began investigating the site after a worker died getting caught in a fiber roll machine in May 2023.

The same machine caused one worker’s death last year at 3M’s facility in Alexandria, Minnesota. Shortly after the fatality, 3M assessed its equipment at its U.S. and Canadian plants last May and concluded the machine was a hazard.

“The tragedy of another employee’s death in Wisconsin is compounded by the fact that the 3M Company completed a corporate-wide review and determined powered rollers were hazards in need of safety improvements,” Bill Donovan, OSHA Administrator in the Chicago region, said in a statement. “The company must address these hazards immediately to protect employees from serious injuries or worse.”

OSHA determined that 3M failed to use procedures that disabled the fiber line roll machinery to safeguard workers as they set up the production line. The federal agency also concluded that the chemical giant allowed workers to bypass machine guarding to cut and remove fibers from the rotating powered rollers and the floor, putting workers at risk of getting caught in the equipment.  

3M had 15 business days from receiving the citation on Nov. 6, 2023 to comply, meet with OSHA’s area director, or challenge the findings, according to the release.

The company is currently in the process of evaluating OSHA’s citation and proposed penalties as well as working with the Department of Labor, 3M told Manufacturing Dive in an email.

“The safety and health of all our employees is our top priority, and we are deeply saddened by this tragic incident,” 3M said in a statement. “Over the last six months, we have worked closely with federal workplace safety and health regulators in connection with their inspection of our Prairie du Chien worksite. In addition, 3M has continued to implement improvements and investments to help prevent similar incidents in the future, and communicated these improvements to our employees at the worksite.” 

Ohio tile maker Nox US is facing nearly $546,000 in Department of Labor penalties for repeated safety violations and numerous worker injuries, including a finger amputation earlier in 2023.

Owned by South Korea-based Nox Corp, the penalties follow $1.2 million in fines waged against the company in October 2022 following 14 worker injuries at the plant since 2017, including "numerous cases of severe amputations," according to the department. The plant employs approximately 200 workers.

Nox is currently contesting the penalties related to three 2023 inspections, including two in May and one in March, according to an Occupational Safety and Health Administration spokesperson, as well as the 2022 penalty.

The company could not immediately be reached for comment about its latest penalties. OSHA has only communicated with Nox officials based in the U.S., the spokesperson said.

After an initial inspection in March and a follow-up in May 2023, the department cited Nox with 10 violations related to the facility's lack of safeguards for employees, as well as for repeatedly violating Department of Labor regulations.

OSHA conducted yet another inspection at the Fostoria, Ohio, factory in June 2023, following a reporter of a worker suffering chemical burns. The site is Nox’s sole U.S.-based location.

"Despite repeated citations and penalties, the company continues to expose employees to dangerous hazards and allows them to operate unguarded machines,” OSHA Regional Administrator Bill Donovan said in a statement. “NOX US is failing to meet their legal responsibility to provide employees with a safe and healthy work environment, and they must change the way it operates before another employee is needlessly injured.”

Nox's safety issues landed the company in the Department of Labor's Severe Violator Enforcement Program, which puts concentrated resources to inspect companies that willfully and repeatedly violate federal safety regulations. The program currently has 111 companies in it from region five, which includes Minnesota, Wisconsin, Michigan, Illinois, Indiana and Ohio, according to an OSHA spokesperson.

OSHA will remove a company from the program at least three years after verification of abatement of the violations, including paying all penalties, addressing all hazards, received no additional citations related to previous violations and has received one follow-up department inspection.

Nox's penalties are the second-highest Department of Labor fines in Ohio this year. The penalty was behind only the Cincinnati-based food manufacturer Zwanenberg Food Group, which received $1.9 million in fines in April for 11 repeated and willful violations, including a worker's leg amputation.

The tile maker's $1.2 million 2022 fine was the highest violation last year in the state, according to department data. The company has been cited at least five times since 2017.

Injuries are an ever-present threat in the manufacturing world. In 2021, the manufacturing industry was preceded only by the healthcare and retail industries in its rate of nonfatal work injuries and illnesses. 

AI is poised as a way to address many of the hazardous elements of manufacturing workplaces. The technology can help limit employees’ exposure to loud environments, unwieldy machinery and dangerous tasks by streamlining processes and helping workers focus on less physically risky activities. 

In manufacturing, many of AI’s potential benefits are concentrated in replacing the cause of the most common workplace injuries. These include “musculoskeletal disorders, mainly from overexertion in lifting and lowering, and being struck by powered industrial trucks and other materials handling equipment,” according to an OSHA spokesperson. 

There are several ways to reduce those points of risk, with the most dangerous manufacturing tasks standing to benefit the most. 

In industrial settings, autonomous vehicles such as drones and robots can be used to perform dangerous tasks, including inspecting pipelines, tanks, and other structures, said AI startup Alpamayo co-founder Christoph Netsch. Here, hazards due to worker fatigue, forgetfulness or other human error are significantly reduced.

Maintenance activities often bring an increased risk because it can require workers to go outside of standard safety protocol and “improvising,” Netsch said. These processes can be supported by predictive AI, which can monitor asset conditions in real time and reduce the amount of maintenance needed.

For memory chip maker Micron, early detection of a machinery malfunction via thermal imaging can mean the difference between “making a simple repair and replacing an entire piece of equipment,” which besides being costlier, can mean more risks to the worker. 

With some AI tools, a workplace that’s already digitized or is in the practice of collecting data from various sources is necessary to implement these tools, Netsch said. 

He gave the example of one gas turbine factory that remotely operated gas and oil platforms. In such a setting, establishing a predictive maintenance diagnostic service required workers to first “implement a uniform data structure,” so that data coming in from different sources was standardized.

Some of the easiest ways to implement AI in the workplace are systems employees can bring into the field without significant digitization of the organization. Computer vision, for instance, is a standalone tool that can detect if workers aren’t wearing protective equipment, or even if there are anomalies in production environments. It works because automated systems can detect hazards at a rate that humans cannot replicate.

Virtual training is another area in which AI has the capacity to make the process easier to integrate into operations. While AI cannot serve as a true substitute for real-life scenarios, it can still help prepare workers, according to Muilenburg Manufacturing Consulting founder Michael Muilenburg.

“[If you’re a firefighter], you don't want to light a building on fire every single day,” Muilenburg said. “You can use virtual reality to simulate that.” 

While the potential benefits of this technology can translate to a reduction in injuries and improved workplace safety, introducing any new element into a manufacturing site introduces a new set of risks that managers should account for.

Whether it’s an industrial robot or automated pallet wrapper, workers should be made aware of the unique hazards associated with working around these machines, said an OSHA spokesperson. Otherwise, they simply risk replacing one source of hazards with another.

Muilenburg said he’s an advocate of a hybrid approach, in which AI and workers can each use their strengths in tandem. He cites one company which opted to have people, not robots, working the assembly line, “frankly because humans were better at it,” while AI-powered robots were responsible for the final inspection of the parts. 

“That approach was really good because the robot was more consistent than the human eye at catching these these little deviations,” Muilenburg said. “So I thought that was a great application of the humans adding the value and the robot simply inspecting and qualifying the final result.”