C.02.006 Interpretation 5.4 :documentation
Are we becoming crazy?
I once participated in a discussion on LMS. Learning Management System. Another one of those systems that our IS department just loves to install… and validate! Another one of those systems everyone loves to hate. It does a great job in managing our training documentation but at what cost?
During the discussion, participants were asking questions like these:
How do we ensure the employee’s curriculum are up-to-date?
How do we make sure employees are trained on time?
What about job changes?
Who is responsible for the follow-up? Supervisors?
Not the training department!!
Who will perform the data entry of all those changes?
By the way, what is YOUR LMS? SAP? Isotrain? Plateau? The latter is apparently a very popular one.
Did anyone do a benchmark among peers to know what is the best one? No, said the rep… trust me.
Endless discussion.?Pointless discussion.
I almost got up screaming!
Aren’t we taking the forest for the trees? Where is « Training » in all this?
We all thought long and hard about LMS and documentation and in some case, too long and too hard. We have put a lot of effort into follow-up systems, hiring the right people to do the data-entry and managing the system. We have had to think about the validation to make sure part 11 was respected, but while doing this the real challenge was left unattended : delinquent, deficient training of our employees.
At least if we had been doing the right thing about documentation…
The regulation stipulates that training activities must be kept in training files. No mention of LMS…
The problem is not really how we document but rather the constant flow of employees, postings for new jobs, endless changes with SOP (sorry but a comma is missing here.. and you should not use CAPITALS all over the place and… aarrrgh!), new corporate policies, etc., etc.
The LMS is far behind.
Technologically speaking, we are there. The software are powerful and relatively flexible to suit our needs and the processing power of the computer (if upgraded frequently enough) usually supports adequately the software.
Technologically, we have arrived.
Most companies put impressive efforts to get there, but, I must admit, without real desire to perform. It is all a matter of opinion, you will have guessed it already. We are now at the turn of a technological tide simply because the regulatory pressure forces us to do so. The regs suggest to use electronic control of the document, to do a better job at controlling documents.
But just who will do the data-entry? Systems are so complex today that 5 days are typically required to train the chosen few who will eventually do the entry tasks. Since these great softwares were programmed by… programers, the end-user was frequently taken out of the picture. Graphic User Interface was a great concept from the start, but I still feel that the guys think in DOS! Ask anyone who is untrained to do data-entry and wait for the worst to happen… ah yes… do not forget to back-up your data!
Should your trainers do their own data-entry? In that case, their training profiles would probably include an item about data-entry training… The loop is closed : you must train the trainers!
Would it not be simpler to automate all this? Web sites supply ample examples of automated data-entry. If you ever purchased anything online you had to fill in the forms yourself, you double-checked it yourself (when asked to verify by a pop-up window). If you participate in a discussion forum or write e-zine, if you subscribe to a e-newsletter or decide to join the growing ranks of Second-lifers… YOU fill in the forms.
Who verifies the accuracy of the data? How many people at amazon.com, ebay.com or other web sites double check YOUR data? Who adds your name to the distribution lists?
Programs were designed to take care of that by serious and diligent people. The latter worked hard to design a program in order to work less, or not at all, for the data-entry process. Oh, I stand corrected. Who does the data entry on the web?
What about this? Letting the trainee take care of him own training record (we are talking about a trust issue here, a serious issue in itself)? Talk about responsibility when an auditor or FDA investigator asks to see a given record? I can just picture the scene with the « delinquent » employee who did not do the data-entry appropriately, with huge sweat beads rolling form the forehead to the tip of his nose and, drip-drip, subtly salting his coffee.
Apart from the comical aspect of the last scene (my right brain suddenly acted up… again!) I can just imagine a tablet-press operators or an analyst, doing a login before completing a task and receiving automatically the authorization to do so, based on his training record. Not authorized? The employee would receive automatically the reason for this, probably a missing item in the training profile. The SOP would automatically be sent to him, accompanied by the evaluation. Once completed the employee would send the info to the database and… be given access to whatever room/equipment/task he was about to complete. The system would also send advanced warning of training items to be expired… By the same token, if an employee spots a mistake in a procedure, he could simply send a note to the author to request a change in the protocol.
Not at all.
In fact, I was describing a system that was advertised in oh, 2001? The technology is here. Some companies are already using it.
What do we need to make his happen?
FIRST: a strong desire from management to invest.
SOP or job aids already available
Available trainers or coaches
Training profiles or curriculum
Linked rooms, equipment etc.
Wireless portable interactive device, a W-PID or PDA
The best in all that is that it would be relatively cheap. A iPhone, ipod touch or similar device is now less than 300$.
Every employee could receive one upon hiring.
THE device would be full of required SOP to read, podcast on HR benefits, company history, company product, motivating clips from the president of the company etc. If you go with a WiFi compatible device, instant updates would be sent from the intranet. If you do no go wireless, you would need to plug in the device regularly… but wireless will soon rule anyway…
GPS are even already available… you could track time-in and time-out that way. Move over, punching machine! As a bonus, you could even know if an employees spends too much time in the bathroom…. Hey, they might even have a smoke detector… OK, OK, Big Brother is looming… We do not have to go that far but imagining continuous revision and update of SOP training. It is just one step away. JIT training. Well supported by trainers, training planning would be a cinch.
How much for all that?
Not at all!
An LMS would roughly cost 50K to implement (conservative estimate for the software and validation package only) and maybe 10-20K for the annual licensing fee (conservative estimate).
Let’s pretend this is for 250 people.
250 x 300 = 75K. About the same ball park figure for the first year, and add 10% turnover annually (of course the departing employees should bring their ipod back but… sometimes they would forget).
BUT look at these predictions:
Reduction of data-entry time
Elimination of training sessions provided just-in-case
Less production time lost due to training
Increased employee responsibility and morale
More respect in individual learning pace
More input form employees to revise SOP
More motivation to do the right thing, the right way, at the right time
We could be on our way to implement a learning culture. A learning organization.
Unfortunately, returning to the documentation requirements, I am not convinced our companies implement LMS for the right reasons. Most managers see training as a cost to be added to the expenses column of the balanced sheet. Oh, I totally agree that LMS ARE indeed a heavy expense. If only we were to use technology as a lever and not as an end in itself we could go much farther to really implement a learning organization with wireless interactivity as a bonus!
THIS is the currently available technology.
THIS would be a LMS based on human needs.
THIS would mean success!
Otherwise, I think we should not waste our time, money and huge amounts of our scare resources and energy on LMS. Let’s rethink carefully our paper systems, let’s involve supervisors and trainers a little bit more to make sure our work teams are well managed and trained. Let’s spend a little more time on the shop floor.
Wow. All this while reading a single interpretation of the regs.
How many coffees did I drink this morning?
Have fun, learn well and stay compliant !
Keep on having fun educating your colleagues!
« Many of the things you can count, don’t count. Many of the things you can’t count, really count. » Albert Einstein
Par François Lavallée, M. Sc.
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