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, 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
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!
Because everyone is ultimately responsible for their rooms and equipment.
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.
Anybody can make sure the machine is functionning properly, be it a compression machine, an HPLC or a PC.
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.
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.
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


Click here for the seventh commandment


Do not forget to share !
Use the icons below to share to LINKEDIN , FACEBOOK and Twitter!

Par François Lavallée, M. Sc.


© Copyrighted material Aliter Concept 2015. Please do not print or copy without permission from the author.

BUT DO SHARE IT using the social network buttons !!