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Thomas R. Cutler

Quality Insider

Outsourcing OSHA Compliance Functions

Relief for overburdened quality departments

Published: Tuesday, June 9, 2015 - 15:02


As regulatory compliance expands with fast-changing, ever-growing requirements, safety and quality professionals are falling behind. Senior management, particularly among small and mid-sized manufacturers, delegates the function of safety and quality without fully comprehending the scope and rigor required to maintain compliance to the U.S. Department of Labor Occupational Safety and Health Administration (OSHA).

Short-staffing, tight budgets, and too much work make the deadlines, training, and documentation requirements mandated by OSHA a veritable nightmare for many quality assurance managers. They are tasked with avoiding noncompliance lawsuits and fines, but without the option of adding staff, many quality assurance managers are looking at hiring third-party experts to create a customized OSHA compliance program.

U.S. Compliance Corp. based in Excelsior, Minnesota, has more than 1,000 clients using its Compliance Fundamentals program to achieve and maintain health and safety compliance. U.S. Compliance Corp. and its clients partner to set up a schedule of regular onsite visits. The first visit to a facility is devoted to a comprehensive assessment. This allows the consultant to identify areas of noncompliance and prioritize regulatory liabilities. At the end of the first visit, there’s a review of findings, identification of any gaps in existing programs, and a strategy developed to bring the company into compliance as quickly as possible.

Companies with multiple sites must also meet regulatory requirements at all local, county, state, and federal levels. Compliance requirements aren’t the same in all jurisdictions, and keeping up with them enterprisewide isn’t easy. Minnesota and California, for example, require that employers maintain a level of safety management systems that focus on methods to reduce or eliminate hazards in the workplace.

“Minnesota’s plan is known as the AWAIR, and California’s is I2P2, both essentially the same thing,” reports Carlos Galindo, an OSHA advisor for U.S. Compliance Corporation. “They are state-mandated programs that implement safety committees, site inspections, and employee participation and hazard reporting. Some states, like Oregon, require that monthly safety meetings are held with employees.”

Fagron, headquartered in St. Paul, Minnesota, has also outsourced its OSHA program. The company has been a U.S. Food and Drug Administration (FDA)-registered pharmaceutical supplier since 1980, adhering strictly to current good manufacturing practices (cGMP). Bulk pharmaceutical ingredients (BPI) are purchased from reputable, registered, and validated manufacturers. Fagron’s strategy focuseds on optimizing and innovating pharmaceutical compounding. As an R&D scientific pharmaceutical-compounding supplier, Fagron widens the therapeutic scope of the prescriber to enable tailor-made pharmaceutical care. Through its activities, Fagron supports the unique selling point of the pharmacist and improves the patient’s quality of life. Michael Barder, director of QA and Regulatory Compliance for Fagron, engaged an outside compliance firm in December 2014 to assist with Minnesota’s AWAIR compliance and establishing approximately 20 programs.

“Site chemical safety awareness has increased,” Barder notes. “This was by design when creating the program priority.”

Similarly, Fredrick S. Mulvany is a chemist/EHS manager for Sierra Paint, also based in Minnesota. “We’re uniquely positioned to provide world-class products and service to our customers,” he says. We’re a midsized company with the technical capabilities of the largest in our industry. We have some of the most experienced chemists and technicians in the industry, but I’m far from an expert on the requirements needed to satisfy our company’s environmental and safety needs. We’re  too small to dedicate an individual solely to satisfy these needs; my main job function at Sierra is to develop new products for sale, not take care of the EHS issues. The functions performed by these compliance experts make it manageable for me to ensure compliance.”

Top OSHA challenges and how outside compliance resources are most helpful

There are some basic regulations best suited for compliance assistance.

Blood-borne Pathogens (BBP) 29 CFR 1910.1030
The regulation requires manufacturers to identify employees that have potential exposure to pathogens in a plant or facility (exposure determination) as well as to have a written exposure control plan to eliminate or minimize employee exposure to blood-borne pathogens. The regulation requires companies to conduct an annual audit of the BBP program, provide initial and annual BBP training for required employees, as well as offer Hepatitis B vaccinations to employees who have occupational exposure to BBP.

Expert third-party compliance professionals develop an exposure control plan and assist in obtaining proper BBP kits and equipment. They also train all employees who might come in contact with blood-borne pathogens, and provide materials for tracking and completing Hepatitis B vaccinations, as required.

Control of Hazardous Energy 29 CFR 1019.147
This regulation requires formalizing a lockout/tagout (LO/TO) program for use when maintaining, cleaning, or adjusting machinery where unexpected equipment activation could cause injury. It requires that manufacturers develop machine-specific procedures and complete periodic inspection of authorized employees. It also requires that the manufacturer provide initial and periodic training of employees.

Again, outside compliance experts can quickly and cost-effectively provide a written LO/TO program as well as help with the selection of LO/TO equipment and materials. As with other OSHA regulatory issues, outside vendors are quite effective in delivering the training to affected and authorized personnel. With an objective perspective, these compliance teams can conduct an annual review of the program and the effectiveness of the LO/TO system, and set up the system for periodic inspections.

Emergency Action Plan 29CFR 1910.38
This regulation requires that manufacturers have an emergency action plan and trained personnel to assist in the safe and orderly evacuation of employees in an emergency.

While necessary, this is rarely part of day-to-day production issues. Again, third-party resources are quite effective in developing an emergency action plan. They distribute copies of the completed plan to appropriate agencies and parties, and set up and manage an onsite emergency response teams (ERT). These teams provide employee awareness training, facilitate periodic onsite fire drills, and assist in the required annual review of the plan.

Ergonomics General Duty Clause, Section 5(a) (1) of the Occupational Safety and Health Act of 1970
Although no specific federal OSHA standard regulates this topic, OSHA uses the General Duty Clause to ensure employers take ergonomic considerations into account when setting up and evaluating employee work areas. When there have been high workers’ compensation claims or even higher absenteeism rates, compliance teams periodically come into the operation to conduct training on ergonomics and prevention of back injuries. 

Fall Protection 29 CFR 1910.21-23 and 29 CFR 1910.66-67 General Duty Clause, Section 5(a) (1) of the Occupational Safety and Health Act of 1970
This compliance regulation requires that manufacturers assess the facility to ensure employees aren’t exposed to unprotected open-sided floors, leaking edges, floor holes, or runways. It also stipulates that the company must evaluate facility tasks to ensure employees are not exposed to a risk of falling when performing service at elevation.

Companies are required to protect employees from the risk of falling from surfaces above 48 in. in height through the use of approved guardrails where feasible, and incorporate the use of personal fall-arrest systems when working at elevations outside of an approved railing or guardrail system. They are also required to train employees on the proper use and care of the personal fall-arrest systems used at the facility, and inspect all fall-arrest systems prior to each use.

Again, because these considerations fall outside the scope of daily operations, expert compliance firms can be retained to evaluate the potential for fall hazards while developing and maintaining a written fall-protection program. Consultants work with the site as well as with fall-protection equipment vendors to obtain appropriate fall-protection equipment, while facilitating the implementation of a fall-protection equipment inspection process. Fall-protection awareness training with affected employees is conducted, and there’s a periodic review of the written program.

Formal Accident Prevention Program, Safety Committee General Duty Clause, Section 5(a) (1) of the Occupational Safety and Health Act of 1970
It’s recommended that manufacturers create a safety committee and develop an accident prevention program (also known as an injury and illness prevention program). Compliance advisors assist to establish goals and objectives for inclusion in the site plan. After implementation of the plan, the compliance experts audit the program to determine overall effectiveness and meet with the safety committee  to discuss the program, emergency response, and safety topics. 

Overhead and Gantry Cranes 29 CFR 1910.179
This regulation doesn’t apply to every manufacturer. It requires that manufacturers establish a formal program for inspecting all hoist cranes on a frequent (daily to monthly) and periodic (monthly to annually) basis. Third-party compliance experts provide a written program to assist in the completion of necessary inspection as well as provide employee awareness training.

It starts with an assessment and calendar of compliance

U.S. Compliance Corp. provides Sierra Paint with a safety and health “compliance calendar” that outlines when submittals are to be made and when training is required. The facility currently employs 85–90 people working two shifts, so doing the training internally can be quite cumbersome.

As Sierra Paint has grown, so have the reporting requirements. This has demanded more time and resources from a finite resource pool. New OSHA requirements, such as the globally harmonized system (GHS) of classification and labeling of chemicals as well as safety data sheets (SDS), have been a huge drain on resources, especially for smaller businesses like Sierra.

The cost of ignoring OSHA: lives and fines
On the OSHA website is a voluminous list of “What’s New” in the past 30 days. It’s clear that the cost of ignoring OSHA is unacceptably high. Here's a small sampling:
• May 14, Region 6: Proper protections could have saved four DuPont workers killed by gas
• May 12, Region 5: U.S. Aqua Vac cited in death of diver in a pond in New Albany, Ohio
• May 12, Region 5: Auto parts manufacturer ignores safety rules for machines, puts workers at risk of amputation and being hit by equipment
• May 12, Region 1: Forever 21 Retail store in Connecticut among those endangering employees because of obstructed emergency exit routes
• May 11, Region 5: OSHA cites Burnett Dairy Cooperative for failing to ensure employees’ safety after man dies in a grain bin
• May 11, Region 3: Pennsylvania duct manufacturer faces more than $1 million in fines as workers suffer dozens of injuries, including crushed and amputated fingers
• May 6, Region 4: DHC Contracting knowingly put workers at risk of trench collapse hazards at a Guyton, Georgia, work site
• May 5, Region 4: Sabel Steel Service exposes workers to unsafe levels of lead as well as fall and electrical shock hazards
• April 30, Region 5: OSHA again cites Tip Top Roofing for failing to provide workers with fall protection
• April 30, Region 5: Workers exposed to amputation hazards at Vista Window Co.

OSHA fines are often very high, but more important, lives are lost for failing to follow safety regulations. Bringing in OSHA experts who know what’s new and what’s required is cost effective to keep up with new compliance regulations.

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About The Author

Thomas R. Cutler’s picture

Thomas R. Cutler

Thomas R. Cutler is the President & CEO of Fort Lauderdale, Florida-based, TR Cutler, Inc., (www.trcutlerinc.com) Cutler is the founder of the Manufacturing Media Consortium including more than 6000 journalists, editors, and economists writing about trends in manufacturing, industry, material handling, and process improvement. Cutler authors more than 500 feature articles annually regarding the manufacturing sector and is the most published freelance industrial journalist worldwide. Cutler can be contacted at trcutler@trcutlerinc.com and followed on Twitter @ThomasRCutler.