Business Process Excellence in Pharma, Biotech and Medical Devices – April 2010 – Key Themes

An integrated approach to Strategy, People, Process, Content and Technology is central to the success of business process improvement.

Elisabeth Goodman, Owner and Principal Consultant, RiverRhee Consulting, opened the conference with the importance of these themes in achieving Business Process Excellence (BPE).  She also came back to them in a later presentation ( describing the role that each has to play in implementing BPE as a cultural change.  These turned out to be the central themes of the conference.

Business process improvement initiatives will be more effective if integrated with organisational strategy.

Pat O’Sullivan, VP and General Manager, Genzyme, gave an excellent account of how Genzyme deliberately chose Lean in 2008 as a key component of their new vision, strategic plan, KPIs (Key Performance Indicators), key enablers and initiatives.  They chose Lean as a methodology that would enable them to fully engage and mobilize the whole organisation, and so achieve individuals’ and the organisation’s potential.  Their goal was to reduce the cost of production by one third, via new ways of working, by 2012.  They are well on track to achieving that.

Gerald Bradley, Chairman, Sigma, reminded us of the importance of defining anticipated benefits when introducing change at the organisational level, as well as at the portfolio or project level. He gave us an in-depth approach of how we could achieve that, through benefits realization management and also how to tie individual improvement opportunities back to organisational strategy.

Business process excellence will not be achieved if people are not engaged.

Dawood Dassu, R&D Global MBB, AstraZeneca, and Derek Hill, Continuous Improvement Specialist, Pfizer (supported by David Hampton, VP at Rath & Strong), gave us excellent overviews of the approaches they have been taking to engage people in an R&D rather than a manufacturing context.  Dawood Dassu described roll out in the Discovery part of R&D, in Chemical Compound handling and in Lead Optimisation to the point that all R&D sites have now deployed Lean, and benefits are being seen through the whole R&D value chain.  Derek Hill described how Yellow Belt training has been really effective in changing mindsets as well as in getting people engaged.

Yolande Vanhove, Vice President, Business Excellence, Janssen Pharmaceuticals, described how HR can play a pivotal role in enabling engagement through their role in recruitment and performance reviews.

Many of the presenters reiterated the challenges and importance of ensuring that leadership is fully engaged and committed.  Mike Serena, Managing Director and Partner for Pharmaceuticals & Medicines, TBM Consulting, put this across strongly.  Those involved in business process improvement need to be zealots (the ‘Z’ in Kaizen), and should not start unless the company is ready, committed, and prepare to address the consequences when opportunities for improvement and challenges are identified.

It’s all about process!

Examination of business processes is of course key to process improvement!  However, the process of implementing business process improvement itself is a key consideration.  Yolande Vanhove gave us a very useful overview of her 4 Phase approach to implementation: stabilize processes, optimise flow, focus on pull, integrate with suppliers and customers. She and her team assess and support this approach on a site-by-site basis.

David Everitt-Newton, Director of Operational Excellence & Master Black Belt, Carefusion, reminded us of the need to focus on design excellence, as well as process improvement, and of how we can more effectively listen to the customer as we look to develop excellence as a habit.  Bill McIntyre, Six Sigma Training Director, BSI Group, also reminded us to consider internal customers: it may be both easier and more productive to focus on these when people are further removed from their external customers (e.g. patients and health care providers).

Content: we need to use the data and information from our metrics and documents.

Tom Cochrane, Business Process Development Manager, Napp Pharmaceuticals, and Peter Lodge, Advanced Manufacturing Consultant reminded us of how essential metrics are for process improvement, and of how powerful they can be both in developing our understanding of our processes, and in demonstrating success.  Likewise, there is no point in spending lots of time on developing documents such as FMEA (Failure Mode Effect Analysis), if we do not then reference and use them as living documents.

Technology can help us.

Although there was little explicit mention of the role of technology, we had some powerful illustrations of how it can help with visual dashboards or monitoring of data e.g. though Mike Serena’s description of plasma / touch screens and wireless Andon lights immediately outside lab areas, and an escalating series of alerts to managers’ Blackberry phones if anomalies are not being addressed.

Closing thoughts:  Lean and Six Sigma can provide opportunities beyond the obvious, but the timing has to be right.

Process improvement can engender creativity and innovation.

Craig Johnstone, Value Chain Leader, CV&GI, AstraZeneca, gave a well-researched and thoughtful account to counteract popular misconceptions of process improvement being ‘anti-innovative’.  Instead, he suggests that processes are there to enable people to add value; the removal of waste surfaces new problems and so acts as a stimulus for new ideas; standardization is only today’s best: tomorrow needs to be better.

Look for the right opportunities, at the right time.

John Pedersen, Vice President, NNE Pharmaplan reminded us, through his ‘garbage can’ model, that the acceptance of new ideas, or new ways of working are often dependent on the right people being in place to respond to these, at the right time.

The ripple and buffalo effects, chocolate cakes and windsurfing!

Graeme Moody, Team Leader, Lean Sigma Black Belt, CV&GI, used a few analogies in his presentation!  The ‘ripple’ effect describes how people ask to get involved in Lean and Six Sigma projects once they see others succeed, and the shift in attitude towards the importance of data.  The ‘buffalo’ effect suggests that once one, perhaps less critical, process has been improved it becomes easier to improve another that may be more in the path of the ‘stampede’.  Similarly, an R&D organisation is ‘like a chocolate cake’!  It may be easier to tackle more robust layers at the base of the cake first: such as secondary processes, before working up through primary processes, projects, portfolios, and the soft icing on the top: disease strategy.

As for windsurfing, Graeme suggests that the moment we are all working towards is when we have stopped falling into the water, achieved perfect balance, clipped our harness onto the sail, and can be carried along weightlessly by the wind in a perfect harmony of man, machine and environment!

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