The Transformation to Process-Centered Organization - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

The Transformation to Process-Centered Organization
Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?


Pharmaceutical Technology
Volume 37, Issue 1

The role of senior management

When it comes to making a difference, senior managers actually have few levers they can pull. If they want to make change quickly, the options reduce further. The one change that always remains open is organization change. Many senior managers choose to pull this lever as a first option, particularly if they are under pressure to improve performance, reduce cost, or simply to be seen to be doing something. Nothing gets attention more than an organization review that potentially disrupts the status quo. The problem is that organization change can be tricky and may not always lead to the desired result.

So should the new organization models and theories being talked about be taken on board? How relevant are they to a closely regulated environment like pharmaceutical manufacturing, and, if adopted, how should they be implemented?

The dilemma is that from a cultural perspective, the pharmaceutical industry is rooted in the "command-and-control" mindset where strong oversight, clear policies, and meticulously defined procedures drive behavior. The requirement is on the employee to learn how a task is to be done and to consistently execute that task again and again (and not necessarily to ask questions why). Managers and supervisors are there to define the task, to ensure it is done right every time by suitably trained people, and to solve problems when they occur. Compliance is key. Experts such as engineers, quality professionals, and support staff are also (highly) trained to focus on their own specialist areas.

There is no doubt that changes where production operators are given more responsibility for simple maintenance routines, quality control, and batch scheduling, for example, confront existing paradigms. This reality can be seen to be controversial. However, the professionalism and capability of the people that oversee the industries manufacturing sites are more than adequate to ensure these changes evolve in a way that maintains product quality and patient safety.

For senior managers looking to make an impact, it often makes sense to leave the organization change lever to last position on the list. It then becomes an effective tool with which to make business improvement and cultural change permanent.

Understanding the difference between success and failure lies not in organization theory, even though it is important to take change management factors into account. It lies in a "back-to-basics" philosophy where material paths are simplified and shortened, knowledge flows to where it is needed, people are given a wider variety of skills training, and wasteful non-value adding activity is eliminated.

Simon Chalk is director of the BioPhorum Operations Group,


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here