Using EHS Software to hurtle your potent compound safety program over the “Green Wall”

In this post, I discuss applying the concept of the Green Stairway to your potent compound safety program, and how EHS software can help advance your program up the stairs. If you enjoy the article, give it a “Like.”

ehs softwareBack in 1990, in the Journal of Corporate Environmental Strategy, an article titled “Hitting the Green Wall: Why Corporate Programs Get Stalled” was authored by Sheldon. Then in 1995, a follow-on article titled, “The Green Stairway: Surviving and Flourishing in Environmental Management” was authored and published by Nadler. These two articles are excellent and should be required reading for any EHS manager.

Applying the “Green Wall” concept to Your Potent Compound Safety Program

When first published, the Green Wall concept was framed around corporate environmental programs. As presented by Shelton, the Green Wall concept states:

“The Green Wall is a point at which the overall organization refuses to move forward with its strategic environmental management program, and the environmental initiative stops dead in its tracks as if it has hit a wall. Companies that have hit the Green Wall are caught in the one step forward, one step back phenomenon in their environmental programs. Although individual program activities are moving forward (giving the impression of progress), others may stall.”

Let’s now apply this concept to your potent compound safety program. Back in the mid-1980’s there became an increase awareness of how exposure to active pharmaceutical ingredients (APIs) can cause adverse effects in employees. A flurry of activity ensued and people were hiring occupational toxicologists to develop occupational exposure limits (OELs) and control banding schemes. In addition, IH’s were hired to perform exposure monitoring and containment validation; and engineers to develop engineering controls solutions were put to task. Progress was made and all was good for EHS departments within the life science world – staff increases, budgets swelled, and EHS could do no wrong. But alas, then in early ’92, something happened, there was the biotech bubbled burst. The promise of biotech had not turned out as planned. Stocks of publicly-held companies collapsed, and investments in young companies dried up. As expected, layoffs occurred, budgets slashed, and EHS wondered “what happened?” Why did we hit a wall?

Well, we didn’t learn from our colleagues in other industries. The Green Wall concept tends to imply that there was this temporary wall that we needed to get over and once we did that we could get back to the business of making steady progress. Unfortunately, as Nadler said, “..there was no steady progression; never had been, there never would be.” The progress that had been made was due to invoking fear onto management, implying that there would be significant liabilities if we didn’t have an excellent program. While partially true, in many cases it wasn’t and all it would take is management change or a bad quarter to send any efforts spiraling downward. Tough as it was, when the economy got tighter, things got worse. As indicated by Nadler, this was due to two major factors:

  • Downsizing is now structural, not cyclical. It used to be that companies cut staff during bad times/added back during good times. It used to be that EHS Departments were immune during the bad times – maybe just cut some expenses, lay low, and hope no one notices. Not anymore – in the bad times companies cut staff and that headcount is never reappears. In the good times, like the rest of the organization, EHS is now expected to invest in technology, such as EHS software to increase productivity and manage workload without increasing headcount. The mantra “Do more with less” became the norm.
  • Corporate structure is now dynamic, not static. No more large corporate EHS groups to tell the business units what to do. Sure there are corporate auditors to keep everyone honest, but even that role can be outsourced. EHS tasks are now pushed down to the local units with their own EHS “staff.” Lean and mean is the standard. This “EHS professional” may also be the plant manager, purchasing manager, and facilities on the side. The EHS staff from corporate were now either spun off into the local business units or evolved into “shared services,” which Nadler called a “halfway house to outsourcing.”

Making and measuring progress

So, in the context of this situation, how do we make and measure progress in our programs? First, we need to recognize that life science companies are not in the business to do EHS work. Companies exist to serve the needs of customers, while providing shareholder value. Companies need to do this in the most cost-efficient, safe, and ethical manner possible. Any EHS strategy needs to fit within that framework. You need to think about how you are going to manage your EHS program in the most efficient way possible, such as implementing EHS software to manage the routine. To do otherwise, will be at your demise. Running around sitting on committees, receiving awards, and giving speeches at conferences is not well received by management if your compliance programs are a train wreck.

Let’s now measure where you are in your program. Again, adapting from Nadler, the steps up the stairway that lead over the “wall” are presented as follows:

  • Denial: “We have no EHS problems. Drugs are designed to help people. What’s everyone worried about?”
  • Tolerance: “There are no real potent compound problems, but “they” (consultants, customers, EHS manager) are stirring things up, so we have to do something to show our customers when they audit our facility.
  • Acceptance: This is just how it works, we have to have a “program” and somebody needs to do it, but I’m glad it’s you and not me.
  • Pursuit of Excellence: A world-class company needs a world-class potent compound safety program. In fact, we should go out and get some kind of certification in this stuff so we can hang a plaque in our lobby to show our customers. We might even do a press release.
  • Functional integration: These concerns have to be part of everyone’s job, not another job that gets done after the “real work” gets done. Everyone needs to understand the whole process. In needs to be integrated into every step of our business – product development, planning, budgeting, training, etc.
  • Sustainable Competitive Advantage: These issues can affect the whole value chain – from suppliers, customers, competitors, partners, and employees. The better we are at anticipating and executing at these issues, the better we will be at succeeding as a business.

Ask yourself honestly, “Which step are we on in the above stairway?”

Three implications

Nadler presented 3 implications of the stairway. These included:

  • This is a stairway, not an escalator. Programs and people do not move up the stairway automatically. Every step is hard work and takes planning and teamwork. Sustainable processes must be in place, not one-time shots in the dark.
  • This is a two-way stairway. It’s hard to fall up the stairs, but easy to fall down the stairs a long way. Things can get better as well as get worse. It takes work just to stay in place.
  • There is no guard rail or bannister. Programs can get cut, the champion of the program can leave the organization, or forced to retire. Your well-establish program without a leader goes over the side and declines rapidly.

Improving your chances of moving up the stairway.

What’s the best way to improve your chances of moving up the stairway and not falling back. Start with the base compliance issues. Make sure that you have solid systems in place to manage these issued. Do it efficiently. EHS software such as Affytrac can help immensely. In addition, it ensures that you don’t get knocked off the stairs when a key person leaves the organization. Constantly think about integration into the organization and make progress everyday! Please give it a “Like.”


About Dean Calhoun

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Dean is the President and CEO of Affygility Solutions. Affygility Solutions provides environmental, health and safety software, potent compound safety, industrial hygiene, containment validation services to the pharmaceutical, biotechnology, and medical device industry. "Dean's Google+ Profile"

Affygility Solutions - provider of potent compound safety, webinars, and compliance management software