Process Excellence in Pharma: And The Winner Is…

The Firm With The Process Platform! [Gasps, wild applause, cheers..]

Harvey Weinstein is said to have transformed perceptions of a ‘quirky retro-wonder’ – and so won, against an outstanding field, a Best Picture for The Artist.

But even the legendary Mr Weinstein might struggle with another underdog, the world of process excellence. Two data points from last week illustrate the Pharma challenge.

The PEX Network report Business Process Excellence in Pharmaceuticals, which has some credibility (it surveyed 600+ process improvement specialists, 39 from Pharma) points up the realities:

  • Big Pharma led the way in adopting operational excellence programs, and typically continues to have more full-time resources working in process excellence. Big Pharma is also heavily invested in Lean and Six Sigma programs.
  • But more than 40% of Pharma respondents reported that interest in process improvement ‘had peaked’, or that their process improvement program was ‘experiencing declining returns’ or even was ‘at risk’.  More than 20% expected their operational excellence budget to decline in 2012.

Which just confirms what’s already evident to any Pharma observer:  that the industry’s huge investment in process excellence programs has had only limited success.

Why has progress been so difficult in Pharma? A meeting last week with a Head of QA provided the second data point, perfectly illustrating two of the biggest barriers to operational excellence in Big Pharma.

This person had a refreshing candor, admitting freely that their organization had so many SOPs that they couldn’t possibly see the wood for the trees. And that it was a ‘nightmare’ explaining to an auditor how it all fitted together.

Which illustrates the first big barrier: compliance requirements have driven Pharma into a weird world where knowledge about the joined-up real world is ‘understood’ through SOP fragments.  Bizarrely, these SOPs are often inpenetrable, overlapping and confusing for the user – and yet they underpin compliance.

We talked about how leaders like Novartis are moving to process-based approaches that could also address this organization’s SOP challenges.  The discussion came to a polite but abrupt end when we moved on to discuss how a process platform could also enable Lean and continuous improvement. That was way outside of the QA scope, and so not relevant.

Which illustrates the second big barrier: that Pharma organizations are more than usually silo-oriented. It’s a natural response to a very complex world but it’s dysfunctional behavior in the context of operational excellence.

Ultimately, even Harvey Weinstein’s influence is second to box office performance. And that’s why The Firm With The Process Platform will take the Oscar eventually, as case studies and ROI build the momentum towards its triumph.

Because our hero firm will have the joined-up perspectives that enable its people to see the big picture, and to get engaged in continuous improvement.  They will collaborate effectively across functional silos. They will have the visibility and governance framework to manage outsourcing progams far more effectively.  And they will reduce the cost burden of quality and compliance – while at the same time increasing its effectiveness.

A true Hollywood ending, in fact.

This entry was posted in Continuous Improvement, Cracking Complexity, Integrated Compliance, Next Gen Pharma, Process Excellence, Process Platform, Process SOPs, Shared Services and Outsourcing, Sustainability and tagged , , , . Bookmark the permalink.

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