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GMP shock
samedi, juin 6 2009
C.02.006 Interpretation 5 : GMP refresher
Par François Lavallée le samedi, juin 6 2009, 16:02
How can it be clearer? Human Performance Improvement (HPI... yep, training groups are progressively called HPI teams) personnel are frequently asked what is the target audience for a given course or seminar. Hey, we are quite lucky here : the regs dictate it!
mercredi, avril 29 2009
C.02.006 Well-shoed shoe-maker
Par François Lavallée le mercredi, avril 29 2009, 16:04
Do you know the internet? Not the one we use for online shopping but the one that is full of information about compliance. I was looking through the Health Canada web site recently, looking for some inspiration for this very newsletter. Under “what’s new”, I saw a document about the Quality system management and the training program for Health Canada’s investigators. Upon reading it some interesting findings were brought to my attention about the structure of their training program but also on the structure of training per se. Well, well...
mercredi, mars 25 2009
C.02.006 Interpretation 5.4 :documentation
Par François Lavallée le mercredi, mars 25 2009, 16:06
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?
jeudi, février 26 2009
C.02.006 Qualification
Par François Lavallée le jeudi, février 26 2009, 16:21
I like puzzles. Like this one : Why should a supervisor need to be a university graduate to supervise in the manufacturing area but NOT in the packaging area? The Canadian regs are pretty explicit about this. Is a danger to contaminate the product that different from one area to another? Or, more importantly, does the patient affected by a contaminated product see a difference between a product contaminated by a metal particle from the tablet press and one whose integrity was affected by a deficient storage system? What about the young lady taking a contraceptive sample, handed down by her physician after staying in the trunk of a sales rep’s car 3 days at 42℃ or the pre-school kid finding a nitro granule in his daily vitamin, will they ask enquire about the education level of the person responsible to supervise the operations?
jeudi, janvier 29 2009
C.02.006 After all it’s all about people!
Par François Lavallée le jeudi, janvier 29 2009, 16:23
I am always flabbergasted to see the mess whenever the fundamentals are neglected. When we forget to look for the root cause of any problem, we keep having the problem or worse, it gets amplified.
Regulatory training is a requirement. The regulation imposes training on the regulation. What a superb virtuous circle!
What do we do , year after year ? We re-train. Frequently on a very similar topic. Frequently with the same results as far as compliance is concerned.
Almost nothing.
jeudi, novembre 27 2008
The tenth commandment : You shall be in compliance
Par François Lavallée le jeudi, novembre 27 2008, 16:29
Research ,Discipline, Reviewing because you, dear readers, request it.
jeudi, octobre 30 2008
The Ninth Commandment : You Shall Control Quality
Par François Lavallée le jeudi, octobre 30 2008, 09:56
Quality's definition
1. The standard of something as measured against other things of a similar kind; the degree of excellence of something.
2. General excellence of standard or level.
3. A distinctive attribute or characteristic possessed by someone or something.
!
This is straight from the dictionary on my laptop. I really think it is a great definition. 3 great definitions in fact. All of them apply to our industry.
We do talk a lot about quality when pharmaceuticals are involved. Quality control, quality assurance (oh, by the way the latter does not exist in the Canadian regulation... check it out!). Quality this, quality that. And the ninth commandement includes it also. What does quality mean and how does it apply to us... all of us?
Let’s go back to the definition. Or definitionS rather.
Quality's definition
1. The standard of something as measured against other things of a similar kind; the degree of excellence of something.
Measured against something... Hey that sounds like specifications! That is one thing we know about quality. Test our products against what they should be like, look like, act like. Standards, specifications and so on. Boy, do we know about that!
What some people do not realize is that these standards are the same one we impose on ourselves. These standards are the one that WE wrote in our drug application files. I repeat this in earnest : WE DID IT!
This is an important part of the regulation. We wrote the application and told the agency how our products would be tested and what kind of results we expect out of those tests. The least we can do is to respect this, our OWN standards of quality. The investigators do not impose anything, the government is not the evil eye who looks upon our shoulder to check if we deliver quality goods : They merely verify what we, ourselves, said we would do.
We wrote those specs to make sure we could produce quality product time after time and to make sure we had a way to verify that the quality was indeed the same. Every step of the production process, of the packaging process, the storage conditions in-house, etc., everything to make sure the product would be of high quality and affect the life of our clients, the patients, in a positive way.
Analytical methods are designed in such a way to confirm that we do repeatedtly deliver the right products in the right conditions.
These internals rules guide us at all levels.
Rules we agreed upon when we submitted our files for the drug.
Rules that make our companies lighthouses for other companies.
Rules that characterize the pharmaceutical industry.
We should be proud of those rules. Especially in recent years when crises after crises are shaking the meat industry. Those controls were implemented throughout our history (not always crisis-free...) and have been instrumental in building a level of trust with the public unequaled anywhere. Except for the banking system but this has dramaticcaly changed in the last months...
But first and foremost, we should respect those rules. Daily. And to respect them in a way that goes over the simple, vague and void pledge that some people vow. How can we influence our colleagues to ensure that they, too, believe in our sacred motto, this apothegm of compliance : You shall control quality?
For a start, skip the WHAT for a moment and focus on the WHY. The WHAT is covered fully in our procedures. Mostly uninteresting stuff for most people, but required and important nonetheless. But again, skip the WHAT.
Go for the WHY. The most important part of the regs, the lines bewteen the lines. Go deep into that to convey the reason behind the regs. Repeat the pharma mantra (trying saying the last two words very fast 7 times in a row...;-)) : safe and effective! Then go for the specifics. Most people skip the WHY to focus on the WHAT.
DON’T!
Most people (and I mean most people!) just want to do what has to be done and go home. They were told for ages to do just that. But then, look who’s coming for dinner... the Y generation. The WHY generation. We might as well understand ourselves WHY we have all those rules before they start asking questions... Oh, they have started already? GOOD!
Someone, a wise man I forget the name of, said :
“When one understands the WHY one can live with the WHAT”
He is probably dead by now but he was truly a wise man. It is revealing that once we understand the WHY behind our rules we might very well be on our way to comply with the second definition of the word quality.
Quality's definition
2. General excellence of standard or level.
How can a company achieve a level of general excellence if the specifics of it are not part of the culture. “The devil is in the details” goes the popular saying. So it goes for our products and our reputation. Tiny details can be the undoing of a company’s reputation. A faulty bottle with thinner-than-usual walls might seem insignificant to the purchasing clerk who does not understand the specs and order the cheapest commodity instead of the right one. The pH limits are not to be discussed by the analysts but only respected. Examples of minor deviations abound... in every company. And they have ultimately an impact on the general excellence we seek.
Once the details are taken care of, once everybody lives bt the specifications and the standards of quality, the real quality, the general excellence, will be achieved. But in this endeavour, the final mission must always be clear in our mind and close to our heart, the pharma mantra, SAFE AND EFFECTIVE for the clients.
“Seek not to do as the masters did but seek what they what they sought!” Another wise man’s thoughts! And one that allows me to go back to the last definition of quality.
Quality's definition
3. A distinctive attribute or characteristic possessed by someone or something.
What is specific about the pharmaceutical industry?
What is our distictive attribute?
What is the unique QUALITY of pharma?
What is it that distinguishes us from other manufacturing fields?
Any company has one role : Offer to the clients a product or service that will help them, make them better, happier. Same for us. Money comes afterwards. Once the service or product is sold. Money ALWAYS comes when the goods are... good. BUT the pharmaceutical industry is atypical. Our goods not only help or make people happier... Up to a point, several of our product also make our clients stay our clients longer by keeping them alive longer. The average life expectancy of human beings has gone from 50 to 80 or so years in less than a century. I do not think any other product or service has done that to the human race.
Ok, I agree, we DO have a few more rules to follow and respect that most industries. That is the price of quality. That is also the reward to have that distinctive attribute that is so pharma!
Quality, all three of them. Good for us!
Have fun, learn well and stay compliant!
Keep on having fun educating your colleagues!
“Quality is never an accident; it is always the result of high intention and skillfull execution; it represents the wise choice of many alternatives.”
W.S.Foster
"Quality is not an act, it is a habit!"
Aristotle
“Quality means doing it right when no one is looking”
Henry Ford
© 2009 Aliter Concept
Limited reproduction is permitted with written permission from the author
jeudi, octobre 2 2008
The Eight Commandment : You Shall Be Clean
Par François Lavallée le jeudi, octobre 2 2008, 09:54
I am clean, You are clean, Everything is clean!
In our increasingly aseptic world, it is natural to expect a pharmaceutical company to be clean. Extra clean. Totally clean. Our dishwasher soap contains antibacterial agents, our handwhashing soap does too, our shower cabinet are disinfected with powerful chlorine derivatives, we filter our drinking water or buy it in bottles : We do not tolerate any contaminant in our environment. Hey, some even start to sneeze in a more contamination-controlled way. Ours sleeves do suffer from this though!
What about our habits within the plants?
Cleanliness in our plants is first a matter of personnal habits. But also a collective way of thinking. Everything start with oneself however. Then and only then can we start thinking about the others. Not about the RULES we should force onto the others, but rather how to HELP them respect the standards and regulation about cleanliness.
How can we become and stay clean?
A few rules must be respected. The Canadian regulation, well most of the regulations I would say, provide us with a few hints when it mentions the requirement to have written sanitation and health programs, etc. A few important paragraphs about the design of equipments and production rooms are also helpful. Everything is there to help us control contamination.
Control... not eliminate. Contamination is caused by the rooms and equipment, of course, but it is mainly due to humans, their habits and behaviors... more specifically their bad habits and behaviors.
Sometimes, one wonders how different we really are from our cavemen ancestors. Oh, for sure, mammoths and sabertooths tigers are not part of our daily worries (although a recent article in Time about obesity and the recent studies about hierarchal harassement come to mind...), but as far as hygiene is concerned... Remove the chemicals we use to cover up our messes and observe...
- The water bottle that is barely rinced and re-used for weeks.
- The coffee pots that become so dark you have to guess if coffee is still in there or not.
- The coffee mug that always look full (ok,ok guys' mugs!).
- The partial, very partial, cleaning of the restrooms .
- The plates left to grow on the department kitchen countertop.
- The dishtowel used for weeks without a single wash.
- The hand washing, the cruelly absent handwashing!
A recent article in an American newspaper mentioned that only 50% of people (yes, men AND women included) wash their hand regularly. A more recent exercice during a conference on contamination control for one of my clients had the participants vote (using anonymous televoting devices) on their handwashing habits.... And showed similar results if somewhat higher.
We are not there yet! And all the chemicials in the world will not help us! They might even hinder our efforts to fight the bugs by decreasing our normal immune response...
The question is then : WHY?
Are we convinced our employees, our colleagues, understand what is contamination? And how can contamination occur and propagate? It always stuns me out of my wits to realize that the basic scientific education our school system provide to our kids (and we were kids once... long ago... but I remember!) is deficient. For most people at least. Science-educated people included!
Well, I must correct myself here. Most people are now more aware of the latest scientific discoveries than ever before in the history of mankind. Thanks to the TV and now more and more the internet, the all-powerful web, scientific news is covered in a very adequate fashion (and we ALL know that whatever is on the net is obviously TRUE... ;-)). Where the whole things falls apart is when one goes from the TV report to the reality of the kitchen... or the shop floor. The crucial link between the recent scientific advances and the day-to-day habits is frequently missing.
This is where the HPI team comes in!
With the coming workers shortage, our companies will be forced to complete the basic education that our workers lack. Up to a certain point, we are going back to the feudal system when the lord of the land would supply food and shelter in exchange for services. More and more, we will have to provide more training for our inexperienced new workers.
IT IS A GREAT OPPORTUNITY!
The school system cannot adapt rapidly enough for our needs.
BUT WE CAN!
On top of that, the younger generation of workers expect more out of their employer than any group before. What a great opportunity again to make them contribute to solve this challenging situation! These young employees are used to contribute (just read their blogs and twitters) and share (just watch their facebook or myspace pages). They thrive on searching the latest video on youtube, Yahoo and Google. They might even, gulp!, find a solution to your most vexing problem by telling you what your competitor did before you even know you have a problem!!! But they do not know it all.
Our pharmaceutical environment and its strict requirements is most alien to new workers. By adhering to a comprehensive education program from day one the new workers will be up to speed in a few weeks. Not only will they do less mistakes, but they will also be able to detect and help correct current mistakes done by the older employees. The latter might know the environment and its requirements, their mind set might require a few adjustments as far as continuous learning is concerned. Another great opportunity to pair-up the X and Y, veterans and Y, veterans and X and oh yes all the boomers who might not want to depart right away... (Especially these days, during the black September of 2008).
Let’s go back to the drawing board and teach the new generation about the causes of contamination and how to change our behavior to prevent it. Everything you teach must be based on THEIR comprehension of the environment. Not YOURS. The best way to learn about this is to ASK them. And them let them perform.
A great master, Thiagi, told the participants in a conference I attended :
“Let the inmates run the asylum”
Well, they are not crazy, but they do want to run the show. Just show them the rules to respect and listen to their suggestions for the new rules to implement and HOW to implement them. Explain to them that :
- Handwashing is mandatory.
- Mop rotation is mandatory.
- Pipets must not be re-used.
- Construction workers’boots CAN contaminate.
- Etc.
THEN let them find solutions! Involve them in the metrics (yes the metrics, because, as Drucker said “what you value, you measure!”) And watch the wonders...
Oh, and do not forget to remember the most important word in the whole world... their name.
Have fun, learn well and stay compliant!
Keep on having fun educating your colleagues!
"It's not knowing what to do, it's doing what you know."
Anthony Robbins
In a rush for GMP 2008? Looking for an innovative AND compliant way to train?
Aliter Concept’s serious game C2EO is an ideal and quick way to plan your GMP session
© 2009 Aliter Concept
Limited reproduction is permitted with written permission from the author
mercredi, août 27 2008
The Seventh Commandment : Competence (Training, Education an Experience) You Shall Have
Par François Lavallée le mercredi, août 27 2008, 09:52
A nice TEE-off is the best way to start!
Tee off's definition
Verb
[teeing, teed] Golf to hit (the ball) from a tee at the start of a hole*
Nobody will argue that Tiger is a great golfer. And he tees-off perfectly. TEEing-off perfectly is the way to start a great golf game. Receiving the right Training, Education and Experience is, similarly, the right way to start a great pharmaceutical career. And if Tiger does it, why shouldn’t we? He is certainly a model to imitate.
Let’s look at this guy’s career (Most of this info is straight from his web site www.tigerwoods.com... So it must be true! ;-)) :
- He played 48 for 9 holes... at age 3. (To think that I played 108 on a 9 holes pitch&putt at 16...)
- He made the Golf Digest age 5. (Some of us can’t even digest a regular GMP course!)
- He went Professionnal at 16. (Most of us are not even done thinking about our career at 18!)
- Highest career money, over 93M so far and counting. (All of us... haw... Just forget it!)
- But then he says his biggest challenge is to become a better person tomorrow. (A better person?!?!)
Let’s look at his training regimen and compare with our Compliance and Technical Training programs. Italic statements are taken from the web site :
2-10 hours of training a day
7 hours hitting balls
Hmmm... If remember correctly, most of the introductory training programs I have seen in companies is... oh, 2 to 8 hours. Once. Add SOP training... huh... reading... for a few hours. A few days of one-on-one or OJT. Well, no. For some technical job positions (labs, tablet press, granulation, coating, etc.), this can be significantly longer.
By the way, how often does this guy actually work, or shall we say, conduct professional activity? A few hours a weeks? And he trains several hours every day for these few hours! What struck me was the 7 hours hitting balls. 7 hours perfecting his millisecond contact with the ball. 7 hours of training a day for an act that he will perform a few dozen times when he plays golf. A few games every week.
He rehearses his moves for hours. And, mind you, he is a rather decent ball-hitter to start with.
How can we expect our people to be first class employees in a world class plant or company if we do not provide them with more training, more time to refine their skills? And this, in a world that is controlled by a regulation that specifically mention TEE (training, education and experience) as being mandatory!
Let’s look further.
His training is varied, including stretching, cardio, weight lifting and core skills. But overall it is focused and balanced.
A closer look :
The idea is to build the strength I need to crush a golf ball rather than develop big muscle volume. I lift sub-maximal weights at higher reps, sometimes 25 to 50, because I’m going for tone and endurance instead of bulk. Bodybuilders usually lift heavier weights in sets of 6-12 because they’re going for mass.
Interesting! Translation : More short training sessions rather than an intense and prolonged (and sometimes boring!) session right before a foreseen audit.
My program works all of my muscle groups but there are a few areas that need extra focus.
Translation : A general curriculum is important as long as a specific set of training requirements are identified for a specific job position.
Golfers are always hunched over, so it’s important to strengthen the back and shoulders to support good posture.
Hey! Safety is part of a good training curriculum too!
To keep things interesting, I use a mix of weights, resistance and isometric training.
WOW !! "To keep thing interesting...”. That is an important concept for the design of our training programs. Content is important, but the way to deliver it is essential too.
If you keep your muscles guessing, it makes them work harder.
A little surprise will make people think farther outside their usual box!
Flexibility training is a major component of my regimen.
Rings a bell? Who does not wish for polyvalent employees? Cross-training is good... As long as it makes business sense. Mr. Wood does not shoot arrows or kick soccer balls as part of his training regimen.
For golfers, core strength is just as important as flexibility.
For pharma employee, GMP is a core body of knowledge.
My core training builds overall strength and flexibility and helps me maintain an ideal state of posture and symmetry.
My workouts are intense and long, but I listen to my body to avoid injury. I know when I can push it and when I need to back off a bit. I don’t have time for injuries so I train hard, but I train smart.
A well-rounded program with lots of variety helps me avoid burnout and maintain a high level of conditioning.
Fine balance between what is required to be a better person and what his body can take without burning out.
Oh, by the way... Do you think this guy waits for an invitation to participate to a tournament (or a regulatory agency...) to impose all this on himself?
I have read countless stories of great artists, players, athletes and business people. There are a few trends that keep turning up :
1- All of them keep on learning
2- All of them work hard to become better
3- None of them took ”NO” or “ALMOST OK”, for an answer
4- None of them waited for somebody else before acting
5- Most of them preferred to ask for forgiveness rather than permission to try something new
6- All of them aimed high, really high.
I keep wondering : What is missing in our programs to make our people “professional” pharma geeks, almost obsessed with quality and compliance? I keep wondering... Do wee TEE-off properly?
Do we SELECT the right people with the right Educational background? The trend in Europe is to hire employees with University degrees.
Do we TRAIN them sufficiently on the right topics and technical skills? And do we offer frequent refreshers? Technology allows us to provide them with web site, podcast, DVD and virtual reality. Do we keep ourselves ahead of the lot by just reading about all this? The new generation of workers demands more than SOP!
Do we provide our employees and colleague with opportunities to EXPERIMENT a variety of situations and challenges?
I keep wondering... Do we TEE-off properly?
Have fun, learn well and stay compliant!
Keep on having fun educating your colleagues!
"Whatever the mind can conceive, the mind can achieve"
Napoleon Hill
In a rush for GMP 2008? Looking for an innovative AND compliant way to train?
Aliter Concept’s serious game C2EO is an ideal and quick way to plan your GMP session
*Collins Essential English Dictionary 2nd Edition 2006 © HarperCollins Publishers 2004, 2006
© 2009 Aliter Concept
Limited reproduction is permitted with written permission from the author
jeudi, juillet 17 2008
The Sixth Commandment : Installations and Equipment You Shall Maintain
Par François Lavallée le jeudi, juillet 17 2008, 09:49
WHO DUNNIT?
The maintenance of our rooms and equipment are the responsabilities of the engineering and maintenance group. Of course. No, bubba!
The most important word of the 10 commandment, the word that is most frequently used in those few lines is...
YOU.
YOU, YOURSELF, like the image you see in the mirror every morning (and if you see someone else, “pharmaceuticals” will probably have a new meaning for you very soon...). The 10 commandments are everybody’s business. Everybody’s.
We all have the responsability to take care of our rooms and equipment. Some of us, those in the aforementionned department, have a direct and specific responsability to DO something about it. Preventive maintenance, repairs, cleaning and some specific tasks have to be assigned to a specific (and trained!) individual/job position. But, everybody MUST be responsible to detect dysfunctions and other problems. Everybody MUST then speak up and tell their superior (at least!) or call the maintenance guy or gal about the situation.
Sub-part C and D in the the US regs and C.02.004 and 005 in the Canadian regs are very specific about this. Equipment and rooms must be in a state that is compliant, functional and that prevents contamination. Preventive maintenance programs are indeed designed (or at least should be) to avoid non-compliant situations. All programs are potentially failure-prone, even the best ones.
Please make sure that :
1- Your internal standards are good enough to maintain your rooms and equipment in a compliant state
AND
2- That your acceptable failure rate is also at a level that allows you to improve and not spend too much time writing deviation report.
Typically, the PM program will shoot for a 98% perfection score. That is, 98% of the time, the PM routines will be done on time. That allows for some routines to be late without having to write a full-fledged report on the cause of tardiness. I believe you still have to control this, but do not make it too hard on yourself. Each company CAN and MUST decide on the level of quality that will satisfy the customer, the government and still allow the business to go on... for the benefits of the customers. (Note that I did not mention the shareholders (also note the use of the BIG parenthesis!!)... I am a bit of a maverick here, but I do not believe the shareholders should be part of our quality statement... After all, if the customers have a quality product and buy it from us and do not complaint... Our stock WILL go up. No need to drastically CUT on our expenses IF we continue to deliver outstanding products for our customers.
Don’t you think it is time to put quality back in our thoughts? Really. Not quality of the minimum level required to satisfy our shareholder’s craving need of a quick ROI, but rather the type of quality that put us in business in the first place. The type of quality that prompted the founding fathers of our companies to produce a drug to HELP patients. That should be at the heart of our business. Do the right thing, the right way and money will flow. Well, this is it for the early morning philosophy lesson. Let’s close the BIG parenthesis and go back to the main part of the newsletter now.)
When a failure occurs or if/when a PM is not done according to the schedule, humans start to do what they are best at. Trouble-shooting. And trouble-shooting starts with a keen sense of observation. And responsability.
Employees (aren’t we all employees?) must understand the expectations as far as their role regarding maintenance of our rooms and equipment. Everyone must understand that their actions AND their inactions have a consequence on the general compliance level of our companies. Several solutions are available to make sure all employees perform adequately and the Human Performance Improvment (HPI) group can be a great help in implementing them.
Let’s start with a basic training on the essence of the regs and some basic knowledge about validation principles. Validation includes, among other things, IQ and OQ (ok, ok, let’s cut the engineer’s jargon : Installation Qualification and Operation Qualification). Within these validation studies we also find information about the cleaning process, PM programs, SOP, the manufacturer’s insctruction manuals, set-up instructions... Everything required for a given employee to know WHAT must be done and HOW it must be done to achieve a high level of excellence and compliance. Mind you, the WHY it must be done is frequently lacking... hint, hint... more job for the HPI group!!
From this fondamental session, we must supply every employee with additional information to help them perform. Looking for and finding practical solutions and training must be part of the HPI group.
Note the disctinct words I used : solution AND training. 2 different, very different concepts. Training is NOT a solution in 80 % of the cases. Only 20% of the problems are related to human performance per se and can be solved by training or development (and even then...). Most problems, compliance-related or performance-related could be addressed using management tools, ergonomic design, better work environment, easy-to-complete documentation, etc. The HPI group has a tremendous opportunity to help operations find alternative solutions and become, in the process, strategic business partners.
HPI can help operations to perform a real performance and needs analysis. You will find amazing ways to improve the general compliance level of the site or the overall efficiency of the operations... a dream come true! Just be using this most precious and soft-undervalued commodity : your employees. Just listen and act on it.
It all comes down to a few specific lines in the Canadian regs : “People are the most important element in any pharmaceutical operation, without the proper personnel with the right attitude and the right training, it is almost impossible to fabricate, package/label, test or store food quality drugs.” I just love this statement! It embodies everything I believe in. Humans! The final frontier...(well, THAT rings a bell!) Resistance is futile! (another bell...) Humans are ultimately responsible for compliance. Forget systems!
Back to the sixth commandment in relation with the last series of profound statements (;-)).
The best, the only way to make sure in 100% of the cases, not 98%, 100% of the cases that the PM programs and routines are performed on time in the right way is to let EVERYONE know about them!
EVERYONE!
Because everyone is ultimately responsible for their rooms and equipment.
EVERYONE.
Anybody can take a look at the PM, calibration, cleaning tags or logbook and give a call to the specific person responsible to perform the task.
EVERYONE.
Anybody can make sure the machine is functionning properly, be it a compression machine, an HPLC or a PC.
EVERYONE.
Anybody can pick up the phone and leave a message. A detailed message, about the situation and who (that is YOU!) detected it. Don’t forget to leave your phone number or email address. Now, that might seem far-fatched, but most people do not know how to leave a decent message. And some just freeze cold at the sound of an answering machine. Don’t believe me? Just notice how frequently your vox box starts spilling its messages with “huh”...PLEASE learn to leave a decent message... and TELL ALL YOUR EMPLOYEES! Everyone should do this.
EVERYONE.
Well, it looks like I am becoming redundant. This is a sure sign that it is time to stop writing.
Sixth commandment? Maintenance. Make it your commitment. Make it everyone’s commitment.
EVERYONE’S!
Have fun, learn well and stay compliant!
Keep on having fun educating your colleagues!
In a rush for GMP 2008? Looking for an innovative AND compliant way to train?
Aliter Concept’s serious game C2EO is an ideal and quick way to plan your GMP session
© 2009 Aliter Concept
Limited reproduction is permitted with written permission from the author
jeudi, mai 29 2008
The Fifth Commandment : Proper Installations and Equipment You Shall Have
Par François Lavallée le jeudi, mai 29 2008, 09:46
What are the conditions or parameters that one should consider to make a room, a building or an equipment proper? Is it possible to transform an old equipment into something new? How can we adapt the current conditions to make them proper and adequate, to make them compliant with the new “and improved” regulations?
mardi, avril 22 2008
The Fourth Commandment : Your Work You Shall Validate
Par François Lavallée le mardi, avril 22 2008, 09:44
DONE BY : ____________
VERIFIED BY : _____________
How many times should we verify our work? And the work of our colleagues? And why? After all, are we not competent to do things the right way, are we not responsible for our work? And our colleague? Is he not also responsible for his work? Is he not also competent?
Double verifications are part of our environment, our very own pharmaceutical environment, and has been part of it for a very long time. And they are not about to disappear. Although sometimes almost invisible to some people... At least, that could be the reason for their tendency to forget to sign! ...Ah, routine work, when you hold me!
Double verifications did appear for a very simple reason. Single verification were just not enough! Single verifications are still valid... up to a certain point. And, honestly, single verifications could very well be sufficient in several instances. What about the other instances?
WHAT OTHER INSTANCES?
Let’s ponder this. When could one perform and inadequate verification? I can think of multiple scenarios :
- When overtime blurs our eyesight.
- After one (or more) nights of caring for the youngest child’s gastroenteritis.
- When traffic jams elevate your blood pressure (and your boss’!) on your way to work and lower your judgment.
- When you spouse is preoccupied and thus preoccupies you!
- When your boss wants the job done... yesterday.
- When migraine squeezes your brains to a formless pulp.
- When, when, when your are not up to par for the job you are supposed to do.
I will not even mention the dense and numerous documents that were recently issued by QA to make sure the team stays compliant and perfectly aligned with the recent audit findings, the frequent production delays, the new employees who really, but really, does not get it! In short, several situations will prevent any normal human being from doing the right things, the right way at the right time, every time. The same situation will also prevent any other normal human being from verifying the right things, the right way at the right time, every time.
Making mistakes is a very human thing... So goes the old proverb. And that is part of the reason why the second verification is so important. To prevent some mistakes to occur. There are many horror stories we could use to tell our employees how important their role is when performing the second verification. At the same time, those employees should be consulted to make sure we do not OVER DO IT!
Several double verifications could be eliminated to the satisfaction of our employees and auditors. Double verification for eveything send a very clear message : EVERYTHING is as important as EVERYTHING else. And it is NOT the case! Some steps are crucial. Some steps are mildly important. To say that everything is life-threatening in our processes is a false truth. You know it. Your employees know it. The investigators know it too. The way we handle our double verifications is a sign of the way we understand our processes. And the way we control them. THIS is important!!!
Compliance MUST become a tool to produce better products in a safe and effective way. Compliance must become a lever to become more productive. Being productive AND compliant is NOT a dichotomy. It is possible.It is realistic. IF we involve the right people, doing the right things, the right way and at the right time.
Well, that is one of the interpretation of the fourth commandment. Validate your work and the work of others to garantee a safe and effective product to our customers. But then commandement are also subject to interpretation and this one contains a word that probably elicited a different response in most people.
Validation. The big word.
Validation, hard and ugly for a lot of people.
Validation, painful but necessary.
Necessary BUT very, very painful!!
Validation, one of the most important things we can do to ensure our customers that what we do, what we sell, what they ingest, inject or spread is always, ALWAYS done the same way. Whenever the work shift, whoever the team players, day after day, month after month, our products stay the same.
Validated processes, validated analytical methods, validated equipments, validated computer systems, PLC etc., etc. On top of this, add all the IQ, OQ, PQ and any other Q you can think of and BINGO... Rock solid garantee for your products. Take your pill in confidence. You will never have any problem. Never. Promise. All those validation ensure that our products are perfect.
REALLY? Can we really claim loud and clear that BECAUSE everything is validated, everything is, by extension, perfectly safe?
What about that recent piece of information I read in a FDA bulletin (2008-094-15) about this drug (no sir, I will not write any name...) that was supposed to help patients during a diagnostic procedure by relaxing the throat muscles, but, in some undivulged cases, could also kill them. I am sure that the process had been validated, as were the equipement etc., etc. But somebody “forgot” to put this information in the documents... Fortunately, this cases are far and few in between the rest of the good stories. But the fact remains : Validation, validated studies, validated equipment are not the ultimate garantee.
The only validation that is our conduit to perfect products is the human validation. The final verification done by a human being, a consciencious human being who considers all the procedures and the plethora of tiny details that are not documented anywhere and using the intuition that is so unique to the humain brain and heart.
DONE BY : ____________
VERIFIED BY : _____________
2 simples lines.
2 of the most important lines in every document.
2 lines that are a witness of our compliance and respect towards the public.
2 lines that are the reflection of our organization’s human capital.
2 lines to demonstrate that our human capital has also been validated... educated, trained and certified.
Have fun, learn well and stay compliant!
Keep on having fun educating your colleagues!
© 2009 Aliter Concept
Limited reproduction is permitted with written permission from the author
jeudi, avril 3 2008
The Third Commandment : Your Work You Shall Document
Par François Lavallée le jeudi, avril 3 2008, 09:42
Ever heard of documentation errors? New employees are trained on good documentation practices as soon as they are hired, but too frequently do we still see documentation errors on the floors, in the labs... and in the offices! We train them on the multiple documents they will have to use and also explain that these documents are a garantee for the public. These documents are a proof of our integrity and our commitment to provide safe and effective drugs.
Hmm... commitment... absolute compliance, faultless... For a reason that is not too clear to me sometimes, these words do not seems totally... well... really heart-felt.
When we look at the state of our documents, the real documents, the one that our employees used on a daily basis, we cannot fail to see the same errors being repeated again and again. The same deviations to the same documentation rules. The same simple rules of documentation.
We have to ask oursoulves a little about the deep motivation of our employees. Are they really committed to compliance? It certainly does not SEEM to be the case if we look at the sheer numbers of documentation mistakes that have to be corrected on a daily basis. Why? Our documents are numerous, complex, of varied forms and formats, filled-in under pressure and all in all, from company to company, approximately 99% error free.
99% perfect.
Only 1% of them have a documentation error to be corrected. We are talking here about 1% among millions of data entries. Not bad after all! Calculate the number of documents that circulate in your site (including change control, SOP, batch record, deviation reports, etc.), multiply this by the average number of data entries for each document (a comment, a name, a number, a signature, a time, a weight, a volume added, an initial, etc.) and divide this number by the number of individuals in the company. The numbers I usually come up with is between 7 500 and 20 000 data entries per individual per year. And all this is 99% perfect.
YEAH!
Well, you must have read other numbers on the internet. 1% error is the equivalent (Canadian numbers) of 100 000 letters lost every hour in Canada, 200 unsafe landing at the Montreal airport annually and the list goes on... Our documentation performance in the pharmaceutical industry does not deserve a medal.
Oh well, I can hear some well intentioned managers say that all theses mistakes are CORRECTED before the batch is released. Ok, I can take this. But aren’t we always talking about quality and this “right the first time” motto? Correcting the mistake is like asking the pilot who crashed at the airport to put the plane back in the air and re-land it.. safely this time. In real life, you do not get a second chance. You cannot push “reset” and have three more lives. We are not in a video game...
The rules of documentation can help us document systematically. These rules are simple, simple to understand, simple to apply and implement everyday. They are so obvious and useful that people tend to use them at home too! Unfortunately, they do not solve the problem of documentation errors. They are a part of the solution and not the whole solution.
If one considers the tools offered to our employees to document properly one has to wonder why they cannot do better! Procedures? Yep, numbers of them! Training on documentation? Yes sir! At least once a year in some companies. Rules of documentation? Simple and easy. Something must be missing....
- What about not having a decent pen?
- What about complex documents?
- What about too many documents?
- What about documents designed for QA instead of line employees?
- What about the somewhat heavy process to improve those numerous documents? Change control in some company is quite a beast to tackle with!
- What about the number of time one has to initial, date, sign, add a comment in a document or worse yet, in a multi-lined table!!! And do not forget to cross-out any, and I mean ANY blank space!
Our documentation processes are complex. Our documents are complex and the results of several audit-related modifications... So complex that we lose sight of the real purpose of some forms. Too frequently, these self-inflicted audit-induced revisions were done before the auditors left the premises and promised to be an interim change... 5 years ago... Until the next audit comes or a burst of documentation errors makes itself visible... Spontaneously appearing out of thin air. Yeah right.
And I will not touch on the subject of the photocopied-photocopy that was photocopied from a photocopied photocopy... So many copies of copies that you have to bend you neck to see clearly the angled form and oh, yes... These 8-font prints that used to be more than a evil-looking smear in the lower left corner... Was that a lot number? No wonder our employee and dazed and confused sometimes.
Those same employees, stuck with this paperwork and frequently blamed for their lack of professionalism and rigor, those employee who most of the times just want to do their job in the best way possible. They will do everything to do it right. And the human brain is immensely creative to find ways around obstacles, genuinely creative!
I sometimes wonder if we, as leaders and managers, would go to the same kind of effort to ensure everything is adequate? GMP are a lot more than just a series of rules and procedures. GMP are a way of life. Most employees have an intuitive understanding of this. But then, what is our roles in this? Our roles, as managers and leaders, is to make sure our employees can do the work they are paid for. We must help them perform. After all, and we sometimes forget this, THEY make the company going. As far as documentation is concerned we must ensure that :
- The documentation rules are respected
- The documents they use are adequate
- Any problem is documented and addressed swiftyl
- Any document requiring a change is treated quickly!
Therefore, the follow-up is the real crux of the matter. Oups... MANAGEMENT DEFICIENCIES again...
Follow up is where it all fails. Forget about training design when looking for the cause of failure of that new documentation program. Forget about flawed forms? Forget about re-training employees. Forget about measuring the details of your documentation errors.
Just follow-up. Every day. With each team. In every production room, every lab, every workshop. Just follow-up. Help your team document properly. Review their documents with them. Play the auditor and review a few batch records yourself. Ask why it was not done adequately. Just follow-up. And keep at it!
FOREVER!
This is your job. First and foremost. Stay close to the real world. We shall follow-up with growing confidence. We shall follow-up in the field and in the labs. We shall follow-up in the warehouse and in the workshops. We shall never surrender!! Hmm. I got carried away here!
For more information on Documentation rules take a look at the wiki on Good documentation rules http://perfectdocs.pbwiki.com and feel free to modify it!
Have fun, learn well and stay compliant!
Keep on having fun educating your colleagues!
© 2009 Aliter Concept
Limited reproduction is permitted with written permission from the author
jeudi, janvier 17 2008
The 10 commandments
Par François Lavallée le jeudi, janvier 17 2008, 18:10
Each month, Aliter Concept offers a reflection on a theme asociated with GMP. Never had to understand, always interesting (well, most of the time!) and opiniated -Hey! Nobody said it is a perfect world! To de-dramatize GMP and to make everybody read about them on a regular basis.