Putting the "c" into Leadership: A cGMP Perspective
Putting the “c” into Leadership: A cGMP Perspective! That's right, the "c" stands for current!
I can tell you a story about a firm that had some GMP issues. Defects, high waste levels, customer complaints – all were pointers that said there was a serious issue. Management called an all employee meeting. The data was presented. Issues and resolutions discussed. I lost count of “Do it right the first time” statements – my assumption is that someone had read a book regarding this point and wanted to use it. The “workers” listened intently and seemed to have some good suggestions. At the end of the meeting, everyone went back to their areas. I followed the workers…
My curiosity was too much. How did the meeting go over with the employees? What were they going to do now that management had clarified that doing it right the second or third time around was not acceptable??
Watching the workers get back to … well…working, the supervisors came around to inform them that their quota for the day was still the same. There was no leniency for the meeting – get back to work!!! The point had been made. Despite Quality discussions, the main fact hammered home that day was – get product made, meet the numbers, we don’t care if the product is rejected or reworked.
Send me an email at [email protected] to get your two complimentary booklets – Infusing GMPs Into Your Organization’s DNA and Great Work Performance. These two items can start a monthly dialog regarding the infusion process. You can also simply email me directly at [email protected]
Flashback…
Many years ago, I started on a process to learn Latin. It seemed pretty simple and, I’ll have to admit, sounded like a cool idea. After all, being out there with colleagues saying, yes, I know Latin, was something that put me ahead of others in some strange way. My first goal was to buy a small book that had all of the Latin lessons in one reference. I read it several times. Some of it was confusing and I could get different meanings out of it. Then I started practicing it. People that professed knowledge in Latin gave me insight but it often contradicted with others. My firm also gave me conflicting information. Much to their credit, however, we did have one all day training session in Latin per year.
Sound insane? Would you anticipate that anyone would gather an understanding of Latin by this approach? No…probably not.
Then I have a question for you – why do we treat GMP knowledge in a similar fashion? Note that I didn’t say training – I say knowledge!
We have an orientation – you know, everyone has to go through it. If you even teach GMPs, you have to go through it!!! Then there is the rush to get you into use – operations, packaging, maintenance, laboratory, auditing, etc. You have to be productive!! The drive is on – produce something!
That’s the issue, isn’t it? We work in an FDA regulated Industry which can prove to be a paradox. We’ve all been there – make more, make it better, keep it controlled, slow down. The “ying” of doing it faster and the “yang” of doing it slower and controlled.
Recently, I got this video that demonstrated perfectly the “Ying and Yang” concept. It’s here if you would like to see it:
https://www.youtube.com/watch?v=Kz7j2ZinSmE
In short, it shows two teams facing each other in a rowboat that are paddling their hearts out and going nowhere fast. Both sides working harder, managers out there yelling, the company provided the best equipment….but, ultimately, they were working against each other.
Yes – I know…so what? This is the nature of the beast. Can’t do anything about it so why are you showing me this video?
What if I told you that there is a way?
What if there was a way to “infuse” GMPs into your organizations DNA? Sounds like a good marketing thing, right? Well, let me say that I’m not a marketing person – my background is Quality Compliance in Pharmaceuticals and Medical Devices.
How The GxP Infusion Process Works
Of all the discussion of GxP, it all equates to one thing – Great “Work” Performance!! The key to infusion is simply turning the "M" in GMP around to make it a "W".
When you look at your organization, you should see three things: The "Work Force", "Work Place" and "Work System". Infusion takes into consideration the Individual as well as the Organizational profiles.
This infusion process was put together because we were tired of seeing the same issues over and over and … well, you get it. It’s time to think differently. Time to get off the gerbil wheel and make a real difference. Infuse the passion and power of GMP insight into your organization’s DNA so that YOU own it!!
Here's that offer again:
Send me an email at [email protected] to get your two complimentary booklets – Infusing GMPs Into Your Organization’s DNA and Great Work Performance. These two items can start a monthly dialog regarding the infusion process. You can also simply email me directly at [email protected]
And I can tell you right now that this infusion process is NOTHING NEW – this is not a “new approach”, book of the month club, new fad approach!!! Harness the power of infusion already at your organization – like the video shows, the power, the tools, the knowledge is already there, we just have to start rowing in the same direction!