I’ve seen this one mostly from people outside the immediate realm of drug discovery, well-meaning people who just can’t believe that this is how it works. The harm comes when these well-meaning folks decide that the problem is that the industry is just behind the times, and that we wouldn’t have to do it this way if we’d just adopt some modern management techniques – ISO whatever-thousand, umpteem-sigma, Quality Assurance Tiger Team Circle Continuous Improvement Metrics, or what have you. Harm generally ensues.
h/t
There is a generation (or perhaps more correctly, type of person) that is easily-led and confused enough to rely on computers and software for many of the important answers to real questions.
I’m not necessarily referring only to the older generation (many of whom are indeed quite capable when it comes to computers) but mostly the squirts who think they’re being erudite and wise by being able to copypaste from Wikipedia.
Beleiving (and rejecting rational thinking) that you know something when you do not is worse than being ignorant.
In defense of quality management systems and TQA six sigma manufacturing programs, these are industry tools that have raised the overall quality and customer service of most North American industry to global standards, ISO and TQM have worked in some of the largest corporate pharma operations.
However, quality systems can do nothing for an operation that is lacking in core competencies ( IE the creative staff have no talent, discipline or focus.)
In this case quality systems can do nothing for an improv operation where inventing applications for chance hap hazard discoveries reveals an industry not so much in need of a quality system but of core talent and a defined purpose.
I hate to see what we’d be surfing the net on if the consumer electronics industry operated on the talent/competency level this ad hoc drug company does.
Well Six Simgma , Matrix Management ISO-9000 etc. are all well meaning , but they tend to remove the common sense that is required in any endeavor.
ISO-9000 is not about quality. It is ALL about documentation , procedures and repeatability.
You can build a piece of crap that doesn’t work and it can be qualified as ISO-9000 compliant … as long as you build all the rest exactly the same !
reminds me of the raw sewage leaking into a stream in Ottawa and going unreported, ‘because there was no protocol to follow to report such an occurrence’! Sad, isn’t it, when common sense takes a back seat to common sense?
reminds me of the raw sewage leaking into a stream in Ottawa and going unreported, ‘because there was no protocol to follow to report such an occurrence’! Sad, isn’t it, when common sense takes a back seat to protocol?
Quality control processes may work well for manufacturing, but not for invention.
Actually, ‘lucky guesses’ are not haphazard and random. They are a documented mode of thought, called ‘abduction’ in differentiation from deduction and induction (see Aristotle and Peirce).
Deduction is necessary reasoning, which works from an ideal model and ‘deduces’ relations from that model. The old ‘all men are wise; Socrates is a man; therefore, he’s wise’.
Induction is data gathering, repeated data gathering. It doesn’t provide a theory but instead presumes one; however, induction focuses on the weight of data as evidence of..the weight of data. Majority, so to speak.
Abduction comes up with a new hypothesis, a new theory. It is actually the first step in scientific reasoning. It begins, like induction, with data collation but it then moves on to, one can say, surprise about this data. Because it begins without a theory but accepts that a theory underlies the facts..and seeks that theory. So, a ‘surprising fact is observed’. Hmm, if such and such were a theory, then, these facts would make sense. That’s abduction.
The best thing we could do to streamline drug development is to lighten the regulatory load – and for developed countries to respect each others’ approvals.
If a drug has been developed and tested in a civilized country like Australia, Japan or Europe there’s no reason they should be kept off the market for years here while more pointless paperwork and redundant testing is done. It costs millions and keeps potentially life-saving or at least life-enhancing medication from patients for years. And of course it greatly increases the costs.
I know someone in a high-tech industry who is suffering from over-management in the name of quality and process control.
Part of his job is to keep the network running, which entails fixing little bugs that may come up from time to time, which is a regular occurence. But to fix even the smallest of bugs, he needs a work plan in place and documentation approved. A five-minute fix requires an hour of documentation and approval.
He’s tried convincing them to name the regular maintenance as an on-going project, but to no avail.
The company is also suffering on the “invention” side…so, logically (sarc), the company is laying off the technical staff and hiring more project managers. Yea, that’ll work.
Two things:
– Education does not guarantee intelligence.
– The application of quality “processes” to a “creative” endeavour will unlikely be successful.
Was taking a bath part of the quality process that Archimedes employed?
ET, all true, but abduction invariably results in anal probes.
woodporter – not funny. Don’t trivialize a vital mode of thought.
Aristotle’s term for it is epagogue; Peirce, with his extensive analysis of the three types of thought used deduction, induction and abduction.
Abduction is the only mode for coming up with new hypotheses. And it’s not a form of induction; Peirce felt that human beings, with the capacity for reason, have the ability to observe reality and then, come up with new hypotheses or major premises about what’s going on in the world. This process can’t be controlled or mechanized.
Big companies are loath to admit that much of their technology comes from inspired individual thought and inspiration. Managers fear individualism , because they cannot control it.
Here is a bizarre story which is true , relating to Matrix Management , which attempts to define what a worker can and cannot do … doing something which relies on common sense can actually get the employee reprimanded.
The high tech company was installing a large number of new systems , and a particular module was experiencing high failures in the field , and the module were taking up too much space in the incoming inspection area , so “Homer Simpson” was told to assign a special room to house the failed modules.
Eventually the installation guys in the field began calling home asking “Where are the modules?” . Home answered … “You have them” … it was like Abbot & Costello’s Whose on First.
Meanwhile “Homer Simpson” was busy filling the room with modules. It finally came to a head when “Homer Simpson” went to his manager and requested another room , because the first room was full !
“Homer Simpson’s” task was to put the returned modules in the room … he followed Matrix Management doctrine perfectly.
ET
You are right on the money. I have studied A LOT of medicinal chemistry and the process of new discoveries of drugs is fascinating. My favorite is the discovery of cephalosporins (an antibiotic) from bacteria growing in the sewers of Sardinia.
Creativity/invention can’t be quality controlled. And I think the lack of arts training and appreciation for quality art (music, visual, dance, acting etc) is making the next generation more compliant/easity led.
Many Nobel prize winners in the science fields had near professional ability in the arts BTW.
The gentleman is describing something I’ve noticed a lot over my adult life. People try to apply the manufacturing management model to EVERYTHING, from medicine to daycare, and are shocked and surprised when it fails horribly.
The manufacturing model has its roots in the 19th century’s efforts to work the slack out of their factories. It works really well for many (but not all) forms of high tech manufacturing, where all the variables care closely controlled. It also works in fast food resteraunts.
It fails in medicine generally (HMOs!), and research science, education and society in my personal experience. Engineers will pipe up on their end, but I suspect they also will have horror stories to tell.
The manufacturing model is a very good hammer. Unfortunately, everything in the world is not a nail.
Mmmmm, sounds like the thing we can have a Royal Commission on. That is government’s default process to finding answers, not that they ever do.
ET:
woodporter – not funny. Don’t trivialize a vital mode of thought.
I’m a researcher myself in the geophysical industry – when I find the time. Wanna know something virtually all good researchers have? A sense of humour, a desire to play.
Good researchers are like Peter Pan. They’ve never bothered to quite grown up.
Creativity and in particular discovery cannot be regulated in the production sense because they are not about production, they are about serendipity. Serendipity is a chaotic dynamic phenomenon. Regulations are tools that we use to mitigate against and damp out chaotic dynamics in production systems. Ergo, regulations are the antithesis of discovery and creativity.
Vitusius:
I don’t completely agree with you. Some discipline and regulation can be an aid to the creative process.
Having said that, most researchers are bored stupid by bureaucracy. The reason they get into research in the first place is the excitement of the chase. The people who create things like “Total Quality Management”, on the other hand, have a deep abiding love of control.
I have yet to have someone in the front office ask me what scientific discoveries I’m going to make in the next fiscal year, but they’ve come close.
Roger that, Rabbit, I never completely agree with myself either. Fineman said, if I may paraphrase, Senator, if I knew the answer, it wouldn’t be called research. Einstein said, most discoveries are not signalled by “aha!”, but rather by “that’s funny”. Einstein also said that the pursuit of truth and beauty is something to which we can always remain children. If we place too many regulations on our pursuit of truth and beauty, we will be prohibited from finding them.
Brian nailed it. I have seen procedures that have worked for years, are efficient and don’t cost an arm and a leg turfed to be replaced by ISO procedures that only serve to slow down the process, making it cost more and in many cases producing an inferior product.
Brian nailed it. I have seen procedures that have worked for years, are efficient and don’t cost an arm and a leg turfed to be replaced by ISO procedures that only serve to slow down the process, making it cost more and in many cases producing an inferior product.
All you have to do to meet the various “quality” standards is to write what you do and then do what you have written. And pay the ransom^^^^^^fee, of course.
This is easier said than done in a dynamic environment such as engineering.
But it does become important when dealing with computers and software, as what software does is very often non-transparent.
I don’t agree, Paul. It depends on the software. Production software benefits from different rules than does discovery and creative software. The system I have been working on for the last ten years has both kinds of software. We apply different rules to each kind.
many discoverys are made because some fool asked a stupid question, that turned out not to be stupid at all:p
If Hill had followed the doctrine of Matrix Management or “ISO whatever” or Six Sigma , he would not have allowed his scientific curiosity to discover nylon.
http://query.nytimes.com/gst/fullpage.html?res=9B05E4DC1739F932A35751C0A960958260
” …In the late 1920’s, Dr. Hill was a member of a Du Pont Company team studying the behavior of certain molecules that chain together to form larger ones, called polymers. The chemists were engaged in pure research, though finding a substitute for silk was in the back of their minds.
In 1930, while trying to create ever-larger structures by adjusting the amount of water in a batch of carbon- and alcohol-based molecules, the team came up with a concoction that Du Pont’s research head, Wallace H. Carothers, thought useless.
But Dr. Hill was intrigued after sticking a heated glass rod into a beaker containing the material and finding that it stretched and pulled, like taffy, and that it became silky when stretched at room temperature. Soon, Dr. Hill and his colleagues were playing with the material in the corridor, and finding that it could be shaped into strands that were remarkably long and strong.
The substance, of course, was nylon, although it would not be so named until it was introduced at the 1939 World’s Fair in New York.
… ”
woodporter – not funny. Don’t trivialize a vital mode of thought.
I thought it was funny. LOL ET and a stick up the rear somehow go together.
[quote]Having said that, most researchers are bored stupid by bureaucracy. The reason they get into research in the first place is the excitement of the chase. The people who create things like “Total Quality Management”, on the other hand, have a deep abiding love of control.
[/quote]
Rabbit,
I come from Engineering Project Management; all these exotic tools are from the “Support” administrative side of Corporations. Large Corporations have defined bureaucracy’s that have policies that frequently collide with Mission Critical Projects. It was my job to make sure that “Well Meaning Rules & regulations” didn’t impact the creative process.
I can say that I have “technically” violated or side stepped GE Rules & Regulations without fearing the “Neutron Jack” axe. That is because the role of supporting divisions like Finance, Purchasing, Corp Law is to SUPPORT. If, as a manager, you have the confidence to put your name on a policy deviation Memo… the System will gladly comply. Management tools are simply methods that must change with the situation.
The Creative process is strange indeed. I have a friend up in the California High Country that Co-Founded what was an Engineers Company focused on unique Engineering. They became very successful and the dreaded Corporation Structure followed. He told me that he got his best ideas while taking a shower…Some times his showers lasted 3-4 hours. That’s a hard process to copy!