A never-ending paradox!
Annex 1 implementation brings home a bag of excitement and anxiety! Let me explain! Excitement-because it means that almost all process will require a fresh look, and Anxiety-because one might step on foot-hold traps or mines! That paradox is not limited to putting a strategy on paper alone but embraces a multitude of operations in a manufacturing line.
Like it always has been- Creating a framework for control is easy, but ensuring it works consistently, every time, is a struggle. Mechanisms to establish controls for a variety of unit operations is easy, but ensuring it becomes fail-safe is a struggle. Stepping away from the professional line of thought will help bring a perspective to the ongoing struggle for conquering control.
As a child or a student, one would be wide-eyed when the word 'control' was uttered. We know that parents and teachers get innovative (carrot & stick) with selling the concept of control to outliers in a class or at home; more the outlier, higher is the quotient of innovation. As a teen, the paradox of control and struggle becomes even more deep and personal; predictably, almost everyone has a story or two to narrate. With a relationship or being married, the complexities of the circle of life gets even more wound-up and yet this paradox continues to exist.
Getting into a work atmosphere, this struggle to control confounds everyone and all most of us do is learn to manage the paradox.
With Annex-1 and its implementation, the case seems to be the same. That paradox has not disappeared and neither will it. Bracing up with documents will neither make it disappear nor will it make it easy. This is simply because the fundamental principles do not change.
Variation in a process or in people-behavior is the biggest enemy of consistency. Eliminating variation needs deep knowledge, which in turn is wedded to wisdom and the asks for achieving this for all aspects of life is tough!
That struggle for achieving CONTROL is real. The faster we realize this reality, the faster we learn to manage that paradox. Management is not elimination. Is this a lesson that is the need of the hour?
Executive Coach | Advisor - MNC Subsidiaries | European | German JV Boards in India | Ex-Managing Director, Sartorius India Group, Author
1 年Ivy Louis love it…the line, ‘Creating a framework for control is easy, but ensuring it works consistently, every time, is a struggle…’ strikes it on the head?? One may call this struggle’, Management- more learnt thru Practice than theory!
Senior Sterility Assurance Adviser at Cytiva
1 年Dear Ivy, This article resonated and I am reminded of Simon Sinek talking about the playing the 'infinite game'. The goals of a contamination control strategy or compliance to Annex 1 are good goals, However control is not won on paper or with design. Not sure if we can eliminate variation, but we should strive to understand and detect it.
Director Consulting Operations at CONVAL group
1 年The laws of physics also rely on predictability and are tied down to mathematical derivatives. However, the black holes defied these laws. It was only Stephen Hawkins who defined this, and became known as the Hawkins radiation. Ivy, you are the Hawkins in the world of information paradox.
Head QA at Ipca Laboratories Limited
1 年Very meaningful Article! “Excitement & Anxiety” makes this complete in all sense. Conceivably (certainly in my opinion); Anxiety is first stage of Excitement. Later on; Knowledge (in Practice), shapes it in absolute. Thanks for sharing!
Head - Global Regulatory Affairs - Wockhardt Limited/Member Board of Advisors at Greatfour Systems Inc./Member, Scientific Body of the Indian Pharmacopoeia Commission
1 年Dear Ivy - Insightful and well articulated. Reading the lines in the last but one paragraph - "Eliminating variation needs deep knowledge, which in turn is wedded to wisdom" - When do one turn wise, while one may have immersed oneself in the ocean of knowledge - is a question I have. Further, therefore, is being knowledgeable preferred or being wise preferred given the paradigm... Regards,