By: Matt Kopecky
November 2008
What most organizations require is corporate-level, stringent process control.
Beyond the perennial concerns of profitability and competitive advantage, life science organizations have a number of responsibilities to carefully consider each day. Particularly in the area of environmental health and safety (EH&S), organizations must ensure the safety of their workers and test subjects, protect the community and environment from any hazards associated with production or development, adhere to governmental safety regulations, and maintain the integrity of their corporate brand. The complex manufacturing processes organizations have are designed to control the working environment to ensure quality production, high productivity yield, safety, compliance, and overall efficiency. However, sometimes the processes themselves are not flexible enough to guarantee these results.
Given these seemingly contradictory requirements, software vendors are developing solutions to address these issues. Today, there are modularbased software products on the market that promise to provide organizations with this level of support. However, these products often operate within the global organization as isolated, non-integrated technical systems that do little in terms of corporate centralization and process harmonization. Such programs fall short in perhaps the most critical element of EH&S. They fail to provide a holistic, macro view inside the inner-workings of the business to help ensure internal and external standards adherence.
This article will explore the myriad of business challenges manufacturers face, as well as current solutions many of them use today in an attempt to meet requirements. This piece will then discuss the adverse impact these ill-equipped “quality control” systems can have on the organization and what programs are available today to satisfy these complex requirements while maintaining a profitable, viable business and corporate image.
SAFETY CHALLENGES
Life sciences companies are at the forefront of advanced research and development and regularly work with new chemicals, processes, and manufacturing methods. These green-field approaches often lead to new discoveries that can offer a profound benefit to the world. Still, these innovative discoveries do also come with a certain amount of risk — i.e., potential harm to those performing these tests and the subjects of those experiments, as well as public safety in terms of potential environmental hazard. When a manufacturer identifies a weakness in the area of equipment, process, or chemical testing, it is imperative that the problem stops there before causing further damage. A centralized EH&S quality management system can help stop these potentially damaging developments in their tracks, across the organization. In turn, this will minimize the negative impact on all internal and external constituents.
For example, imagine if a clinical technician found a breakdown in a critical testing process in a cleanroom, and was unable to efficiently and effectively communicate this to his or her counterparts across the global life sciences organization. Unfortunately, this happens all the time. When such a problem occurs, the department affected is only equipped with the communication and safety documentation equipment necessary to inform those within earshot. Those employees working in similar facilities and testing environments across the world would never get the benefit of receiving the same critical information. It is quite easy to see how such a safety and drugdevelopment integrity problem could then propagate throughout a large, international company posing serious risks to all involved.
ENVIRONMENTAL/COMMUNITY HAZARD
Life sciences organizations work with dangerous materials on a daily basis and have strict policies and procedures with which to dispose of such waste safely. Nevertheless, sometimes the risks posed by these dangerous elements lie beyond the control of those tasked with handling them safely. Take for example a drug development services company that was using poorly constructed protective packaging to transport highly sensitive drug samples from one location to another. Workers noticed infiltration during transport that would compromise the viability of the sample. If this problem was not caught in time, the implications to a large study could be very serious causing delays, increased costs, and perhaps safety concerns. Now imagine this exact same process, under these very same conditions, was taking place across the company’s 36 other global facilities simultaneously — unbeknownst to those working closely with it. It is easy to see how problematic such a situation could become if not handled efficiently and properly in a centralized and standardized manner.
If this organization had an integrated environmental health and safety management system that consolidated and shared all such reporting across the company in a streamlined, centralized fashion, any problem could be reported, shared, prevented, and corrected before it ever becomes a widespread disaster. Without such a system, this type of problem could have a negative impact that could easily spiral out of control.
REGULATORY COMPLIANCE
In these high-risk industries, governmental regulatory compliance and reporting is a business imperative that cannot be left to manual processes and paper-based reminder mechanisms. These governmental checks and balances are put in place to ensure overall health and safety. In the U.S., agencies such as OSHA, EPA, and FDA require life sciences companies to document and report on all safety matters to ensure proper corrective and preventative action is taken.
If a firm neglects to update and file its air and wastewater permits, its leak detection and repair (LDAR) documentation, or its OSHA Form 300A (Summary of Work-Related Injuries and Illnesses), it leaves itself vulnerable to hefty penalties and could put its own staff and customers at risk for injury or death.
Centralization of such procedures and documentation management helps organizations remain diligent on all these matters. Without a central system, permits may not be filed on time, reports may not be submitted, forms may not be completed, and a company could be in violation of one or more safety regulations. Manufacturing organizations and their constituents cannot afford such neglect. A standardized, comprehensive EH&S system can provide businesses the protection they need to remain compliant, safe, and in control of critical matters.
BRAND INTEGRITY
Large, public organizations are under tremendous scrutiny to perform well these days — perhaps more than ever before. While safety performance and compliance can affect an organization’s financial results, anything negative that occurs in the safety area can put an organization’s brand reputation in jeopardy. This can have a serious, detrimental impact on its overall financial performance — not to mention the negative PR impact.
Chemical spills, soil, water, or air contamination that affect public safety can cripple a business’ integrity in the eyes of its stakeholders. The key to containing the negative impact on all parties is to manage these events early on at a company-wide level that is designed to stop a problem before it has an enterprise-wide domino effect.
A properly designed and configured, centralized, and integrated EH&S system provides organizations with a superior level of both regulatory compliance and brand/image protection. If such a mechanism is not in place, when incidents occur, they can snowball and adversely impact an entire organization. In serious, high profile cases these events can be severe enough in the eyes of the public and Wall Street to impact a business’ ability to raise capital, conclude business partnerships, expand market dominance, and could significantly affect shareholder value.
INTEGRATED, HOLISTIC, AND CENTRALIZED EH&S SYSTEMS
Centralized and integrated enterprise software systems are currently available on the market that can address these challenges. Their ability to harmonize, standardize, and enable corporate-level communication, visibility, and operational transparency is what makes them so effective. These same systems in turn also drive other bottom-line performance enhancements within the organization in terms of efficiency, cost reduction, process improvement, product quality, risk mitigation, and so much more.
Here is how these types of centralized systems work: The software system is installed at an enterprise level with certain corporate-wide rules and policies that are mandated across the business. At the departmental or geographic level, teams are able to customize the software to best fit their needs, while adhering closely to all corporate compliance requirements. This gives each office or department the ability to interact with the software in a way that makes the most sense for their specific business requirements and workflow demands while not interfering with company-wide regulations.
Since all relevant activities are entered into a single, integrated system, the organization is given both micro-level visibility down to small, day to day operations in any area of the business as well as macrolevel reporting and data aggregation to see the collective impact of such dispersed events.
Specifically, such systems afford a business the following types of benefits, and more:
- Globalized harmonization around a common philosophy, approach, and goals
- Standardized definitions and processes at the corporate and business level
- Flexibility for site level variations
- Automated workflow, reporting, and event tracking
- Accountability assigning and tracking
The inclusive and automated enterprise software systems discussed in this article proactively deal with events that could negatively impact an organization in a diligent, accountable way while also working to make continuous environmental health and safety improvements that prevent such problems from ever occurring.
In the end, what matters most in the world of safety and security is that everything possible is being done to ensure overall well-being of all parties involved. When even the slightest preventable oversight or issue occurs, business reputation and even individual lives may be at risk. Organizations need to examine their global safety tracking and reporting systems frequently and make sure they are meeting current organization needs and regulatory requirements.
Matthew Kopecky is Product Manager at Sparta Systems, Inc. Mr. Kopecky held numerous analyst and development positions at Johnson & Johnson Corporate before joining Sparta Systems in 2004. Mr. Kopecky spent his first years at Sparta implementing TrackWise systems at life sciences organizations as a Product Specialist and has been a key contributor and manager with the company’s Solutions Architecture team. www.sparta-systems.com
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