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
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
27%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
32%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here