EnviroLink Forum

In another thread there was the beginning point of a discussion concerning PhDs and funding. The funding does not require a situation where the PhD (or other scientist) has to ignore everything to make the funding group happy.

The first example is tenure and how many with tenure have developed unusual positions in relation to their schools. Another would be the governmental funded scientists, which get the money up front or over time and without the need to meet any outcome. Some research does imply a specific outcome, such as the search for treatment, or whatever, but not all does.

Many commercially funded scientists are in similar situations. The results of their research is eventually expected to result in some profitable outcome for the commercial entity, which is why so much pure research is funded by the government. Commercial research is generally more focused, but still not always tied to profit. Failures can sometimes result in new products, such as the issue with the "failed" glue product that fromed the basis for Post0it notes.

The key is not as much where the funding originates, but what "strings" may be attached and how the scientist handles the situation.

_________________
With friends like Guido, you will not have enemies for long.

“Intellect is invisible to the man who has none”
Arthur Schopenhauer

"The difference between genius and stupidity is that genius has its limits."
Albert Einstein

Some personal reflections on this.

We are accredited by a national organization, which in turn allows the various states to perform the accrditation for their state, but requires the acceptance of all other member states for any accreditiation granted by any other member state.

There is a biannual on-site audit to determine the status of the laboratory. There is also a requirement to undertake proficiency tests (PT) on a semi-annual basis and report those test to the agency, if there are any available. In our case there are no PT samples for the analyses for which we are accredited. We have, however developed an internal program where we generate our own audits and analyze them to ensure our quality. This worked well for about 20 years until the last on-site audit. The PhD who undertook the audit wanted the reports on the internal audits we performed each week. We use some of the audits to check systems which are a concern as a troubleshooting process, which also irked the PhD we had as QA Officer. The SOP stated that we were to use two of the audits (known and a blank) per month as a PT audit, which is six times more than their requirement for PT audits and left us with several to use in troubleshooting. The auditor did not like the fact we used the audits for troubleshooting and threatened to shut our operations down if we could not "correct" the "problems" with them. Things like using an audit to follow a really nasty set of samples to ensure the system was clean was to be "corrected" so the audits would always pass.

I pointed out the frequency and the SOP requirements, but to no avail. I finally offered to reclassify the samples as something other than audits, but his position was if we analyzed ANY sample with a known concentration we had to pass it within a reasonable criteria. I finally had to just show him that it was a purely internal program and since it was such a concern was terminated as far as we were concerned. It did potentially impact the quality of the processes, but there was no way to work with him on it.

Now, I spoke with another PhD with another lab, which had a similar program and is making an application for accreditation with the same agency. That PhD told me how to handle it when I told him about our experiences. His plan was to change the nomenclature as I had proposed and had been rejected. When I pointed that out he then proposed an "unofficial" program which was not documented and thus never revealed to the auditors. I pointed out the questionable ethical position that created, only to be told that we knew much more than the auditors about this type of program. Our expertise was supposedly justification for bypassing the instructions of the auditor and putting our accreditation in some small jeopardy.

I would really like to get a realistic approach from someone, but it seems the dueling PhDs are never going to be close.

_________________
With friends like Guido, you will not have enemies for long.

“Intellect is invisible to the man who has none”
Arthur Schopenhauer

"The difference between genius and stupidity is that genius has its limits."
Albert Einstein

You didn't happen to notice him with his head up his ass during the audit, did you?

If this has worked for 20 years and there's no concern over getting the same guy next time, I'd keep doing exactly what you've been doing. How dare you use standards in troubleshooting! Seriously. What a goob.

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TANG SOO!

I have pushed for accreditation in our section of the industry for years, but sadly to say this guy and the other which take turns with our audits are two of the better auditors. Both have advanced degrees and some background, but do not seem to understand the differences in the air arena versus the soil and water methods. The focus seems to be less about what we do, but what we say we do and how we document it.

_________________
With friends like Guido, you will not have enemies for long.

“Intellect is invisible to the man who has none”
Arthur Schopenhauer

"The difference between genius and stupidity is that genius has its limits."
Albert Einstein

Sounds as if he didn't like you using PT samples for both audits and troubleshooting. If that's correct, spell out in your SOP, in advance, which PT samples are to be used for audits and which are to be used for troubleshooting. Don't just segregate the products though. Publish two distinct (but similar) procedures, each with their own product.

Pretty thin, huh?

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TANG SOO!

I have been "discussing" the new audit program the accreditation organization is proposing with their committee. The previous audit program was operated by the U.S. EPA until Congress started playing with funding, so now it will be privatized. In the process of trying to determine the better choices in how the audits should be designed and used, I was informed of some things happening in the field during the last audit program. The administrators were not as well informed as they could have been or they would not have allowed what appeared to be an analysis of the audits directly from the container prior to any other work being done. The audits are collected through a trap and into a canister. The trap is processed and both fractions are analyzed to report the correct concentration ... in theory. Since there are physical limitations as to what can be in the audits, our analyzers can determine the correct concentration without the treatment of the trap, which is where most of the handling and resulting errors occur. There are also a couple of ways less complex analyzers can be used for the same determination.

Once this information was passed on I recognized the description of one of the simple methods to make the determination. I duly noted it to the committee along with a means by which such simple systems could be removed from the ability to make such a determination. It was something the regulatory community had already proposed to better mimic the "normal" sources being monitored. This was rejected because they did not have sufficient data on the addition and what data they had indicated the fail rate was higher when it was used. When it was pointed out the fail rate might be more correctly determined for the real samples, the reply was that there had to be a 95% pass rate under their mandate, so it did not matter. Later discussions ended with me being told the audits were not to determine fraud, just whether the could be passed or not. Here I thought the audits were to determine whether the procedures were being used correctly and the results of the actual samples could be trusted to be accurate representations of the emissions.

So far the accreditation program I pushed so hard to see created has introduced multiple levels of paperwork to document what is supposed to happen, increased costs for fees to become accredited in each state individually, and a series of audits, which by themselves could double the costs of the normal tests and tell us nothing other than the ability to report audits correctly. Between people indicating they do "special" things for the audits, people analyzing the audits to determine what their report should say, and the new possibility that the lab could have to pay for any retesting if the audits fail seem to set up the situation where the lower ethical position will have a huge advantage in the future market and the regulatory emission information may actually get worse.

_________________
With friends like Guido, you will not have enemies for long.

“Intellect is invisible to the man who has none”
Arthur Schopenhauer

"The difference between genius and stupidity is that genius has its limits."
Albert Einstein

I tried that, but since there are no true PT audits anything we analyzed with a known concentration was potentially a PT audit in his eyes. It did not seem to matter that we did them in a pattern, for a specific reason, and had separated the procedure for how we would do an internal PT sample. We have four systems so each one would get an audit and a blank every month, either when we had a concern, maintenance, or just normal rotation at the end of the month. In order to know if there was contamination not detected by the procedures defined in the methods we used both a blank and a known because some contamintation seemed to show up in blanks and others in samples with organics in them. This process had already shown us where we should check for contamination in areas with which the methods were unaware could be contaminated. We may be able to restart the program once the new accredited audits are available, but we may not have time then either. The old program had two audits with wach set of samples which were collected in the field. The new program may include two additional audits for the lab to collect and recover. We may not have the time for our internal checks with all of the new audits coming in. The scary part is the cost of the four audits will exceed the analytical costs of the samples by a significant amount.

_________________
With friends like Guido, you will not have enemies for long.

“Intellect is invisible to the man who has none”
Arthur Schopenhauer

"The difference between genius and stupidity is that genius has its limits."
Albert Einstein

The first on-site audit for accreditation was unlike any other audit I had seen. We had been audited by clients prior to special high profile projects and I expected this type of review. We provided all of the documentation prior to the audit concerning our QA/QC, copies of the SOPs, calibration, MDL studies, resumees, report format, and anything else they wanted to see. The audit started off with questions about the paperwork, moved to the lab to verify the capability of equipment, etc., and ended with a series of PT audits they made up for us. There were usually two to three PhDs with one to two support people for two to three days of the audit. Thus a 40 man/hour coverage during the on-site audit was expected.

The first on-site audit was from a very southern state known for political corruption, which should have been a clue. The single auditor, which based on education/experience would have been the support person in the other audits, had not looked at the documentation provided, so the first day was spent going over the QA manual and SOPs. The second half day ... almost ... was spent trying to get him to leave my office and look at the lab before he left. He only got one foot in the door before turning around to leave.

Every audit has to have something found to make it a true audit. Usually the "dings" are unimportant and are easily changed if everything is in good shape. The major "dings" from the audit were that we did not have a "mission statement" in our QA manual and a series of other paperwork additions, which were equally unimportant. If there had been anything amiss there would have been no way to catch it.

The next on-site audit cost was going to increase by over 2000% because they were contracting audits for anything out of their state to a private firm, so we moved to the current primary accrediting state from the northeast. It is still a better run program than the southern one from my experiences.

_________________
With friends like Guido, you will not have enemies for long.

“Intellect is invisible to the man who has none”
Arthur Schopenhauer

"The difference between genius and stupidity is that genius has its limits."
Albert Einstein