A long while ago an employee told me, "QA forgot that we are working for the same company". His inference was that the Quality Assurance Unit was deliberately looking for faults within his department. GLP Compliance will be difficult to achieve if the Operations Group and the Quality Assurance Unit (QAU) do not understand and respect each other’s role. Building an effective partnership involves investing time to train on the requirements that each area operates under. Training the technical groups of GLP requirements by the QAU unit and educating the QAU on the It should be the goal of the QAU and Ops Group to meet the GLP requirements on the front end rather than at the conclusion of the study. The technicians will become confused about data documentation when some pre-clinical studies are conducted GLP and others conducted [by design] Non-GLP. To that end Operations management must ensure that Standard operating procedures are adhered to, even when conducting non-GLP studies, so that data quality will remain consistently high. Daily quality control inspection of the data by the Operations Group prevents voluminous QAU findings to correct at the conclusion of a study. Tracking internal inaccuracies within the department will aid in preventing repeat errors.
technical subtleties by the Operations Group will ensure that each has full
understanding of the required and feasible data documentation.
Sunday, October 13, 2013
Saturday, August 24, 2013
A short while ago I visited the research headquarters of Eli Lilly in Indianapolis, Indiana. Interestingly enough, some department heads in this robust big Pharma occupied cubicles. A rather egalitarian strategy. More interesting was the large section where the desks had no assignments. The operating theory was that you arrived and sat where you chose for that day. At the time it seemed to be a rather itinerant approach to take. More recently, when visiting the headquarters of Assurex Health (<200 employees) near Cincinnati, Ohio the department heads occupied low-rise cubicles contiguous to the non-management employees, spanning different job functions. It was obvious that the collegial environment was quite conducive to collaborative discussions. Several months ago two cube-dwelling colleagues had standing desks. Clearly the standing desk helps with posture and a number of other positive health issues.
I have a long history of desks: Sometimes private; Sometimes in a cubes; Sometimes with a big window and conference table.
When I had a desk in a large office and in it’s prime location within the organization it could be isolating at times. Being anchored in one location, it was quite convenient to neighboring directors and localized departmental functions. However, for most other activities it was a fair jaunt to get to an activity or to have people make “the walk” to meet with me in my office.
But I have no desk. Nor do I have an office. Equipped with a MacBookPro and a satchel [man-purse] my office is where I land for a few days or weeks. Areas which require added attention get my full attention, in person. The locals at first find it to be a distraction, but they adjust within a few days. I get to witness their daily challenges/offenses, but am also present for their immediate consultation/consolation.
The benefit of the deskless, officeless office is the need to stay organized. Noted organized guy, Blain Lam, keeps organized using the method outlined by David Allen, author of “Getting Things Done: The Art of Stress-Free Productivity”[ISBN 978-0142000281]. The method is straightforward: don’t make a pile, make a file [er… electronic file]. So given my wandering desk it is necessary that I do not have a pile of papers on my [phantom] desk. Thus is born the paperless office by necessity and convenience. More web-based tools are employed than at many facilities and this enables a bit more freedom from stacks of papers.
So while this approach is fairly unique in life sciences, it works perfectly.
Sunday, June 23, 2013
Having recently moved from the wintery north to the tropical Caribbean, my eyes have become attuned to the uniqueness of the flora and fauna. While beach combing yesterday, my son rescued a Portuguese Man of War Jelly Fish. He had never seen one and was careful not to touch it as he was guiding it past the breaking waves.
Turns out the Portuguese Man of War is not really a jelly fish, but instead is a business model of teamwork.
With the help of Wikipedia (which I shall borrow from) I have learned the Portuguese Man of War (PMOW) is not one creature but a team of 4 living components (zooids) that come together to form the PMOW. Let’s break this down:
- The Pneumatophore aka The “sail” represents the organism (organization) as the Chief Executive Officer - Not only the face of the organization, but also sets the goals and strategy. Without the sail the PMOW organization flounders (no pun intended).
- The Dactylozooid (defense mechanisms) or rather Business Development and Marketing – Sends out feelers (literally) and brings in the revenue stream and defends the organization through a sound marketing strategy.
- The Gonozooid (reproduction) or Business Operations- success breeds success. Without the successful execution by the operations component, the organization would be stifled and not grow.
- The Gastrozooid (feeding) or Accounting and SG&A – Optimizes the resources resulting from both biz development and operations to sustain the organization.
Without the teamwork of these zooid business components, the organism would need to outsource their various functions, much like some fruit trees outsource their pollination component to bees. The PMOW is an integration of separate components each performing their role both efficiently and expertly thus proving that each zooid department is critical to the success of the organization.
Is the gonzooid jealous that the pneumatophore gets all of the glory? Well that’s that talk around the salt water cooler anyway.
Tuesday, April 23, 2013
Do you pay for results or effort?
Effort towards a task that ends without a result is called trying. We all know what notable management consultant Yoda said about ”try”. There is no try. Vivid examples of effort:
I tried to complete the pass
I tried to not hit your car
I tried to not spit on your food
A correctly prepared meal
I tried to balance the budget
Profit goals achieved
I tried to keep the clients happy
At the close of the fiscal year, will you reward for goals achieved or goals that had some positive progress towards? A renowned CEO coldly informed us some years ago, ”If you cannot do the job, I will find someone who will”. Aptly put, that CEO only pays for goals achieved, not effort toward the goals. Will your employees step up to that challenge? Do you see value in rewarding effort?
Friday, April 19, 2013
With the current jobs market and the time of year, a new crop of grads will be banging on your door. Some years ago, a supervisor told me that there were so many applicants that one could simply screen by grade point average and only interview the very best students. Best? I would suggest that you also consider hiring some B students. In some cases the B student might be the best choice:
- The B student may mean a longer term employee.
- The B student may mean a more eager learner (in order to advance).
- The B student may not require a premium starting wage.
Don’t get me wrong, the valedictorians have a lot going for them, but they may not be as “hungry” as someone who has been more challenged. What is your experience? Does a high grade point average generally equal the superior employee?
Thursday, April 11, 2013
Work/Life Balance, as any life coach would explain, is critical to not working yourself into a grave. One employee of mine used to say “Keep work at work. Keep home at home”. The point Cathy was trying to make was that if you’ve got problems at home, leave them there and on the other side of the coin, if you’ve had a crappy day at work, don’t go home and make your family miserable about it too.
My twenty-something friend Chris is always pulling late evenings and weekends, because he enjoys it. To him it is not work. Our friend Fritz, a reporter, cannot stop reporting even when he is not at his day job. His twitter feed is often more interesting than his articles due to its prolific nature.
Despite Cathy’s advice, the management at your organization may insist on a say as to how you express yourself outside of work hours and thus taking charge of that work/life balance. How dare they! That should be your prerogative. Or not. Companies ranging as far afield as Microsoft article link and ESPN article link are insisting on controlling their employees outside of work activities/opinions. The point is that what you do outside of work may affect your [keeping your] job. Does that make you “on the clock” even outside of work? Yes. Is it right for them to do so? Yes, if your actions negatively impact the organization.
Example: If your Pastor joined a hate group but only participated in its activities on Saturday’s, that might make you question his value as a Pastor.
What you say/do outside of work can easily affect your value to the organization. Is it after work hours? You’re still on the clock.
Thursday, April 4, 2013
One can view Employee of the Month (EOM) programs with a jaundiced eye. These program are designed to 2) Recognize the employee for actions above the call of duty, 3) Recognize the employee for outstanding work either on a project or with a client, and 1) Put the employee up as an example to inspire the other employees to do a better job. Yes, these are listed out of order because the primary intention is usually to “inspire others”, but that is rarely a publicly stated purpose.
Depending on the company, the benefits range from a financial reward, a fancy lunch with the boss, or a closer parking spot. My experience has been that the last thing an employee wants to do is have lunch with a superior. They’d rather have a nicer lunch with their co-workers.
In some work environments, what inspires some employees to do a better job “next month” in hopes of earning EOM perks may actually cause discord. “Why did John get EOM?, Harry, Jose, and Ethel worked on that project too!” As for John, he is certain to get polite applause when the boss announces this month’s winner. Whispers amongst the audience may be less polite. Not always so, but it depends upon how the co-workers generally regard the winner.
With winners, also come losers. So for a company of 150 employees, there is one EOM and 149 last place finishers. For the coming year 11 more people will earn EOM, leaving 138 who won’t. Will those 138 set their sights on “next year, I’m going to win”? or will they regard the EOM program as a lottery where winning is unlikely, so why buy a ticket?
How is your Employee of the Month program regarded? Is it inspiring or causing discord?