I just came back from an Analytical Services Program (ASP) Workshop hosted by the Department of Energy (DOE) in Covington, Kentucky. The ASP is a program sponsored by the DOE that attempts to ensure that data from analytical environmental laboratories contracted by the DOE are valid, reliable and defensible. The ASP has a TSDF function that includes insuring that DOE low-level radioactive and mixed waste disposal is accomplished in accordance with all applicable regulations and protects human health and the environment.
I had been away from DOE environmental work for a while and it was very interesting to walk into the discussion not knowing what had been going on the past few years. I came away with two general impressions:
- Many of the same folks continue to exert Herculean efforts to support remediation and monitoring in an extremely complex environment of technical, organizational and regulatory challenges and
- Some things smacked of “déjà vu all over again.”
The first of these further increased my respect for those professionals who continue, year in and year out, to deal with mountains of legacy issues we inherited from the cold war. Few can appreciate how complicated, difficult and frustrating it can be to try to make responsible decisions on how to protect human health and the environment from many years of ignorance and neglect. During the panic days of WWII and the Cold War, many risks were taken with toxic chemicals and radioactivity materials for the sake of national security. Now many of these decisions have to be “undone” in a far more savvy and risk averse world. That some of these projects can indeed succeed – like the Fernald cleanup – is a testament to the tenacity of these professionals.
On a less happy note, some of what I heard was disturbing. It seems that, even after all these years of effort, laboratory data fraud just will not go away. Of course, I had not been totally unaware of this. I was personally aware of at least one major laboratory group that had significant problems in the past couple of years. What was a bit surprising was that several such incidents were discussed at the meeting. This gives cause for some concern, especially in light of continuing DOE budget cuts. It is highly unlikely that the ASP will be able to increase the number of audits it performs. If the anecdotal evidence given turns out to be something of a trend in the laboratory industry, this could lead to serious consequences for some high profile remediation projects.
This may be disturbing, but it is nothing new. The history of the environmental laboratory business has been regularly punctuated by data fraud – some of it comically amateurish and some of it cunningly sophisticated. I have seen various forms of fraud. I have seen “bad choices” made on a small scale where the appropriate “corrective action” was merely a reprimand and additional training. I have seen fraud on such a massive scale that 18 months in a Federal penitentiary was lenient.
With few exceptions data fraud requires three elements:
- Greed
- Ignorance
- Intimidation
Although “greed” can be just a form of laziness (e.g. not wanting to do what is required because it is too hard), the kind of greed that creates significant data fraud only exists in the higher levels of management. That level can be anywhere there is strong awareness of a profit motive. Frequently this is first found at the senior laboratory management level. Nevertheless, today we often find a “network” of laboratories where a very strong profit motive is imposed on laboratories by a disconnected, executive management structure. When that management structure drives profitability without a balanced emphasis on quality – including resources necessary to ensure quality – fraud is not long in coming.
Ignorance is also a necessary ingredient. Fraud cannot exist in a professional environment where participants can access technical and human resources. Few people really want to live in a world where the truth is consistently hidden, lost or ignored. Sure, they might imagine or “interpret” their way around a quality factor here or there due to fatigue or confusion, but few will persist in doing what they know to be wrong unless they feel trapped. If supplied with qualified support most will use that support to get out of a fraudulent setting. When organizations do not provide adequate professional support to workers who would like to do the “right thing,” small infractions grow into more general conspiracies.
And finally, few really outrageous frauds can be perpetrated without significant intimidation by someone in power. At some point we all take stock of just how much we are willing to suffer for our scruples. It is just not as likely that someone in desperate need of a job will take as uncompromising position on an ethical issue as someone who feels they have options. Likewise, in an environment where speaking up is severely punished, few will speak up. Where there is intimidation, data fraud is but one of many possible disasters on the way.
So…does the ASP look for these? Does the ASP look holistically at laboratory management systems – including the executive management level? Does it look for a “reasonable balance” between profit motive and quality resources? Does it look into the organizational knowledge base? Does it look into the management culture? If not, will the ASP be able to meet its objectives – especially with a shrinking budget and fewer opportunities to do on-site audits?
Toward the end of the Workshop we did some brainstorming about possible improvements. The context included consideration of DOE budget cuts. I had suggested that the ASP begin to think about investing in the QC people in the laboratories. I was suggesting that they be brought into the “program” as professional partners to assist in continuously improving program quality and reliability. The idea would be to “build in” rather than “inspect in” quality. This is based on one of Dr. Edward Deming’s 14 principles. For a quick summary of those principles go to: http://www.tek-dev.net/TQM.html .
Now I would like to expand on that thought. What is needed is LESS inspection and MORE investment into the whole system of delivering data reliably. It has little to do with the actual specifications around Blanks, CCV’s, Calibration Curves and the myriad of specific, quality data elements to be delivered reliably. They are the actions we want taken reliably and not indicators of the reliability of the quality system. The ability to consistently deliver the appropriate data, including supporting documentation (e.g. Blanks, CCV’s, Calibration Curves, etc.) is the measure of the reliability of the whole quality system. Is that reliability being measured? Is that reliability being improved? Do we know the frequency of blown holding times, resampling, rejected data, etc.? Are we extending our “root cause” analysis to the entire system which includes not only the laboratory, but contracting issues and site planning and performance? Do we even know “customer satisfaction rates” or “project success” rates? Have we even looked at how to measure final outcomes such as these? If not, are we really measuring the quality of the program so that we can even discuss improvements? Could it be that we are so focused on the technical details that we are missing an opportunity to make huge program improvements?
Let’s begin with an honest assessment of where we are? Do we have the right people in the right places? In the ASP? In the labs? At the sites? We might, but I remember the days when the lab QC guy was the village idiot who was a danger to himself and his peers in the lab. You know, the guy who swapped out his capillary column using a 12” crescent wrench. Yeah…that guy. Well maybe that’s changed, but has it? Is the QC person more than an overworked clerk? Is this now a quality professional who is connected to and respected by the very highest executive managers? If not, is executive management really connected to quality? Are similar connections in place within the ASP and the DOE sites? Are people empowered to make things work?
And what about the managers? Do they personally engage in quality improvement? I’m not talking about being conversant in the detailed specifications, but deeply engaged in their organization’s quality improvement process. Do they make sure the “door is open” to quality issues? Do they invest in the quality people? Do they ever show up on the “back shift,” the remote location or drop in on an ASP audit? Are they game to take on some of the responsibility for the quality of the entire program? Is that commitment at a high enough level to ensure that adequate resources are invested? Is that commitment more than just a cynical, “What’s in it for us?”
There’s no question that the ASP has come a long way toward improving laboratory data quality for DOE projects. No one can deny that. But what’s next? How can we rethink the way we do things so that we can improve quality and reliability while dramatically reducing costs? How can we engage the quality management resources in DOE, in the ASP and in the DOE laboratory community so as to multiply our limited resources? How can we create a world class, distributed quality management systems that embodies the best of what has been learned to date and leaps beyond that? The TQM process and a correct reading of ISO 17025 can give us some guidance, but it will take serious cooperative and innovative effort on the part of many players to create a new way of doing quality management in high profile environmental remediation. Making this work with all the complications, all the technical and contracting challenges will not be easy – but neither was the successful closing of Fernald. Are not the current budget cuts the perfect time to come up with a breakthrough that completely changes the game?
Stites & Associates, LLC, is a group of technical professionals who work with clients to improve laboratory performance and evaluate and improve technology by applying good management judgment based on objective evidence and sound scientific thinking. For more information see: www.tek-dev.net.
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