Outsourcing Facility Safety for Biomanufacturing

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As the life-science industry increasingly outsources noncore functions, some companies are finding that managing the expanding web of safety and environmental requirements associated with various functions is, in turn, growing vastly more complex. As multiple third parties handle numerous noncore activities, the risk — and headaches — of monitoring them effectively is a growing challenge by any standard.

At first glance, the lowest-risk solution for many organizations may seem to be managing associated safety programs with in-house personnel and programs. After all, strengthening sensitive safety systems and associated regulatory compliance can and should be an organizational priority. However, given the growing complexity of today’s safety and compliance systems, outsourcing key facility safety programs may be the most strategic option. In fact, a strategic outsourced provider with environmental health and safety (EHS) expertise can reduce an organization’s risks and help maximize its bottom line.

The Case for Outsourcing Safety Management: Managing facility safety requires capabilities that generally are not central to the life science business. Transferring EHS management, along with associated operations, to a qualified outsourcing partner allows a life-science company’s own employees to keep their focus trained on the core work of developing and delivering life-saving medicine to patients.

At the same time, using outsourced providers with personnel who are EHS experts in their scope of operations actually can mitigate safety and compliance risks that a life-science company had been managing internally. Applying best practices and lessons learned from experiences in working with multiple companies can be a critical element in improving EHS.

Outsourcing places work beyond a company’s direct oversight. So it is essential to partner with a facilities safety operations team that is trained and certified for working in environments with sensitive equipment and potentially hazardous materials.

Four Key Considerations

In addition to multiple business-driven selection criteria, biopharmaceutical companies should consider four specific criteria in identifying a partner with the appropriate EHS qualifications and experience: history, skills, training, and trasparency.

Relevant Record of Success: Request documentation of a potential partner’s previous safety performance and compliance work in life science facilities. The provider should be willing and able to provide lagging metrics (e.g., injury rates for employees and subcontractors and number of environmental incidents) and leading metrics (e.g., the number of good catches/positive observations, safety training completions, quantification of safety communications and processes, verification reviews and safety inspections). Finally, look for partners who will administer a procurement review and verification of key metrics for their own vendors and subcontractors.

Comprehensive Skills: Search for partners with deep EHS resources to ensure they can manage all your company facilities — geographic location, functionality, and technical needs notwithstanding. A service provider should be able to deliver EHS expertise wherever needed, with local teams of dedicated EHS professionals who can adhere to the relevant national, state, and local safety and environmental regulations. Confirm specific EHS capabilities ranging from US Occupational Safety and Health Administration (OSHA) regulatory expertise through incident investigation, EHS management system development and installation, and construction/project safety support, to environmental expertise, hazardous waste management, and waste treatment operations.

Continual Training: A strong partnership candidate will be able to ensure that its employees and contractors possess the optimal skills and knowledge base. Such a service provider should be able to prove its commitment to the “safety-first” mindset with the education and awareness to support it. Every member of the ideal EHS team must be equally equipped to consistently deliver on standard operating procedures (SOPs) across all facilities. Your prospective partner also should constantly reinforce its team skills with continuing education programs, facility visuals of safety standards, and postincident workshops.

Dedication to Transparency: The right EHS partner will demonstrate open and honest information flow. Its team will ensure that your executives are up to date on all facility risks, supplying investigation reports of incidents and key insights that help to prevent similar future events. The provider will also develop safety and injury reports categorized by workgroup, location, and activity. With such tools, bioexecutives can evaluate performance trends, minimize uncertainty, and optimize facility performance. An EHS service provider also should have mechanisms for sharing performance information and best practices across similar operations to improve overall safety for all its life science clients.

Confidence Is Key

Ultimately, the success of EHS in outsourced activities will be based on your partner’s ability to deliver its services with consistent expertise. With the right services provider in place, a biopharmaceutical company can look forward to fewer safety risks, enhanced profitability, and increased accountability for safety — and the immeasurable value of increased peace of mind.

About the Author

Author Details
Ed Ryczek, CSP, is director of environmental health and safety for Jones Lang LaSalle Americas, Inc., 400 Interpace Parkway, Building D, First Floor, Parsippany, NJ 07054; 1-908-329-0965; ed.ryczek@am.jll.com.

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