By John Farris
Failure to recognize the role of safety in business success in the biopharmaceutical industry can be costly, as accidents, incidents, and the potential for resultant regulatory and legal actions will slow down the organization in its objectives to gain approval for new therapies. An even greater cost is the potential for injury to the company’s greatest asset — its employees.
It is not uncommon for successful research-based organizations that are focused on discovery of new and innovative human disease therapies to struggle with what appears to be a fundamental component of their business — the safe handling of commercial and novel chemicals and the establishment of a systematic approach to safety. As opposed to other types of industrial activity, research-based organizations are often led by scientists who have spent a career working in and leading technical groups with significant freedom to act and where an environment of innovation is encouraged. While scientists may come from larger pharmaceutical, biotechnology organizations, or academia, nonresearch staff functions were handled by others.
Small entrepreneurial biotech organizations must be somewhat free of bureaucracy by both design and necessity in order to survive. In these companies, “lean and mean” is a goal where capped funding must be spent on product development and the business plan forecasts several years of operating without profits. Every “head” counts, and rarely can the organization afford an experienced health and safety professional as a full-time staff member. Rather, someone is usually assigned environmental health and safety (EH&S) tasks in addition to other job duties, with the intent to be compliant with governmental regulations.
The EH&S issues facing smaller biotech companies can remain small and manageable for an extended period of time, but what happens when the biotech company has a breakthrough and develops a successful product or products? Meteoric growth can occur in these companies, with profits funding expansion of several types — R&D program expansion, facility expansion, and geographic expansion — and more employees. EH&S staff positions frequently lag behind the biopharmaceutical expansion curve, and it is not common to view these positions as “business-critical.”
The newly successful research-based organization can now find itself in the manufacturing business, working with numerous contract organizations and with far-flung operations. The EH&S function rarely keeps up with the growing demands, and it is almost certain that a well-integrated systematic safety function will not have evolved.
Effective Characteristics and Actions
The following characteristics of effective safety systems are provided, based on experience with pharmaceutical and biotechnology technology companies that integrated safety into their business before or early in their business growth cycle.
Top management articulates its expectations regarding safety to the entire organization and participates at a visible level in the safety effort.
Supervisors and managers are held accountable for initiating proactive safety activities.
Supervisors are aligned in their commitment to safety across the organization such that appropriate safe behaviors are common in all workplaces.
The organization uses every employee to achieve the articulated safety expectation.
An effective training program is in place that features key elements relevant to research.
A safety committee program exists that is valued and supported by management.
The primary function of the EH&S department is one of a technical and interpretive resource to the organization.
The previous characteristics are interrelated and will be further described below.
The leaders of a company must actively support the safety process. Clearly stating what the expectations are for safe behavior, mutual support, and organizational resources to achieve a safe and healthful working environment is often the one piece that is missing in biopharmaceutical companies struggling with this issue. If the leadership is not formally aware that safety is largely a matter of behavior and that modeling the correct behavior is fundamental to success in this area, then the organization cannot be expected to develop this sense on its own. In fact, it is our experience that if the message of high expectations for safe behavior is not regularly stated by the leaders of a company and not clearly stated along with the company’s values, a deterioration may be seen in the attitude toward safety even by those who come from companies with an evolved safety culture. Implicit in the leadership and management role is the modeling of safe behaviors themselves. Safety within an organization is ultimately the responsibility of the top executive. This individual should endeavor to create an inspiring integrated vision of the value of safety to the business.
Safety actions must be measured and used as part of the performance evaluation process for all supervisors and managers. However, it is a mistake to measure only the accident and incident rates required by regulatory agencies. This is measuring the “defect rate” and does little to focus the organization on the desired outcome — a safe and healthful working environment. What should be measured are steps that all those who supervise others can take to promote safe behaviors and safe conditions. These steps by supervisors can include regularly inspecting the area for hazards and documenting deficiencies, correcting deficiencies promptly, correcting unsafe behaviors appropriately, participating in safety activities (including sending employees to training prior to working with hazardous materials), investigating root causes of incidents and reporting them, and supporting those on the safety committee and those involved in other safety-related activities.
Supervisors should form a mutual support network and agree, along with the leadership and the EH&S technical resources, on the safety rules of the organization. Once established, every supervisor should agree that the rules will be followed and applied consistently regardless of department. This seems like a basic concept; however, a sure way to undermine the safety program is to allow an unsafe behavior in one area and not tolerate it in another. Inconsistent application of the agreed-upon safety rules from area to area will send mixed messages to employees about the company’s commitment.
Effective training prior to working with hazardous materials also seems like a “given” for scientific organizations. However, it is our experience that biopharmaceutical organizations make major assumptions in this regard. It is assumed that those with advanced degrees have knowledge of the safe handling of hazardous materials, when in fact it is rare that specific safety training is part of the academic curriculum even for those with chemistry degrees. While some universities may have required coursework in radiation safety or biosafety, the abstract concepts of working safely with novel pharmacologically active materials (or “potent compounds”) are not taught. Highly effective safety programs in companies with a strong safety culture will require thorough safety training in laboratory safety, biosafety, radiation safety, environmental protection, and potent compound safety prior to allowing anyone to work with these materials.
Role of the Safety Committee
A safety committee program is required by regulations in the United States and in many parts of the world. A safety committee program does not necessarily need to be effective to have the appearance of meeting regularity requirements. However, such a program can also be effective at creating and maintaining a safety culture if the committee program is well-established. The elements of an impactful safety committee include a chairperson from the management level (not the EH&S department), representation from all key operational areas, generation of action items with assigned responsibilities and target completion dates, minutes of meetings circulated across the company, access to top management for resources to complete actions, and recognition by the organization for member participation.
Role of the EH&S Department
The last characteristic of an effective safety program is the existence of an EH&S technical group. The existence of such a group by itself will not ensure that a safety culture exists and, in fact, can be expected to fail without the other six characteristics being implemented to some degree. The EH&S group should be responsible for program development, regulatory anticipation, interpretation and interface, detailed accident investigation, inspection and auditing (internally and potentially of contractors), identification of issues for management, and training. Furthermore the group should serve as a technical resource for the organization to address complex situations, establish technical tools related to products, and serve as the advisor to the safety committee. The EH&S group should not be responsible for safety enforcement. This seems counterintuitive at first glance. Upon further study, it is clear that the relatively few safety professionals within an organization cannot be in all workplaces at all times. While more time in the facility reviewing work practices and conditions would be desirable, it is a practical reality that if the EH&S group is to be effective at the recommended responsibilities listed here, the group will not have more than about 25% to 30% of its time to be out in the organization’s workplaces. Only the supervision of a given area can be effective at safe behavior enforcement. The EH&S group must develop organizational skills to work with the operational and other staff functions within the company to gain input and acceptance of its initiatives. For example, new policies and safety rules should be developed in concert with key managers from the affected areas prior to gaining top management support. Failure to do this will ensure resentment and a lack of cooperation in the implementation of the policy or rule and deteriorate efforts at creating a mutual support network.
Establishing an effective safety program depends on a variety of factors, with a particular focus on actions that establish, enhance, and reinforce daily safe behaviors. Organizations that have been effective in establishing a safety culture follow many, if not all, of the characteristics mentioned here.
Leaders in biopharmaceutical companies can measure where they stand in this regard by reviewing these characteristics and candidly evaluating their organization’s approach. The E. I. duPont de Nemours company (“DuPont”), long considered one of the safest companies in the world, has established relatively simple criteria for measuring safety effectiveness within an organization. According to DuPont, there are three levels of safety integration.
The first level is called “Dependent,” and it is characterized by the approach where safety for employees is based on rules, regulations, and discipline. The second level is called “Independent,” and it is characterized by employees who take voluntary action to look out for their own safety. The third and most evolved level of safety is called “Interdependent,” and this level is characterized by a work environment that includes teamwork, cooperation, and employees clearly looking out for each other.
A clear objective for speeding new therapies to market is common among almost all biopharmaceutical companies. It is also common for top and midlevel managers to recognize employees as a company’s most valued asset. Enhancing productivity and speed to market as well as valuing employees are all served by the development of a strong safety culture; however, this can be an elusive goal. Adoption of the characteristics listed here and the determination of the organization to reach the third “Interdependent” level is recommended to establish and maintain the desired strong safety culture.
About The Author
John Farris is president & CEO of SafeBridge Consultants, a professional firm providing health and safety services to pharmaceutical, chemical, and biotechnology industries. He is a certified health professional whose career has been inside the pharmaceutical industry, including years at the executive level.