2nd Business Process Excellence for Pharmaceuticals, Biotech and Medical Devices (2 of 2)

Business Process Excellence for Pharmaceuticals, Biotech and Medical Devices, The Brewery, London, April 2011 (2 of 2)

John Riddell and Elisabeth Goodman, RiverRhee Consulting¹

For part 1 of this blog see: 2nd Business Process Excellence for Pharmaceuticals, Biotech and Medical Devices (1 of 2) http://wp.me/pAUbH-40

Application to ‘other’ environments (1): biotech

Simon Orchard, Vice President Biotech Operations Europe, Pfizer, described applying Operational Excellence in a Biotech environment from facility and process design through to technology transfer and start-up.  In the design phase a key issue was to build in flow and takt, rather than gravitate to maximising volume.  The main opportunity was with simplification as the process.

In the technology transfer phase a structured process was used and efforts needed to be made to avoid a moving target.  Learning points were centred on building in the development of cleaning, taking time to plan including carrying out risk assessments to explore what could go wrong, and the difficulties of establishing a truly integrated cross-functional team from functional areas which were globally spread.

At start-up a problem was encountered with below specification results.  The team had the option of looking to increase results overall, or decrease the variation.  The latter was selected and a DMAIC approach followed, involving a key decision to suspend the plant start-up, i.e. get it right from the start and resolve it while focus and resource is there (and not moved onto the next project).

Application to ‘other’ environments (2): laboratories

Daniela Jansen and Donna Wall, Waters outlined how opportunities to lean documentation, data handling, sample preparation and QC decisions can reduce laboratory lead times.  The focus of their case study was to improve flow and eliminate non value adding steps through the introduction of data management in the interface between instruments and SAP/LIMS.  Manual data entry was addressed resulting in a major reduction in data input time and the quality of data improved as did its security and opportunity for manipulation.

The case study that Donna shared revealed how lab space had been saved.  The issue of each instrument having its own PC was addressed through the introduction of acquisition servers.  The lab team also analysed equipment utilisation over a 24 hour period and improved it through changing working practices.  When asked if there were other aspects (other than technology) Donna said that simple things need to be done and that metrics created an awareness that made things happen quicker.

Application to ‘other’ environments (3): clinical development

Nadine DeDecker, Director Strategic Business Improvement, Jansen R&D, reminded us that the second output of our industry is knowledge, and that value stream mapping can address information creation (as well as product creation).  Her case study showed how she started by addressing Phase 2 and 3 processes as the area with the most process improvement opportunities.  This led to standardisation of processes and the development of a common language, collaborative working, role-based training and, process improvement.  One of the biggest challenges though, is finding the best place to start.

Does process excellence limit innovation?

This was the title of a group discussion led by Craig Johnstone, Director Chemistry and Value Chain Leader, AstraZeneca.  An audience poll indicated that about 40% thought that Lean Sigma was pro-innovation, non-one thought that it killed innovation, and about 60% declined to vote many of them having experienced real pushback from their colleagues in R&D.  Craig’s suggestion, and the discussion that followed on the whole supported this, was that it was how Lean and Six Sigma were deployed that determined the extent of innovation.

Mitali Sharma, Senior Executive, Accenture, suggested that a combination of ‘Lean Innovation’ (simplifying and streamlining) and ‘Open Innovation’ (collaboration externally and engagement internally) were needed to change the Pharmaceutical R&D model and so enable R&D to not only “do the right projects”, but “to do them right”.

Keith Russell, Global Director Lean Six Sigma, AstraZeneca, described how ‘Design Thinking” can be applied to innovation as a process.  He discussed how this can be used to identify value for customers (internally or externally) to identify needs, in product design and programme design (through definition of requirements, features and strategy), and in programme execution (by focusing on core processes).  Keith’s approach, which is derived from QFD (Quality Function Deployment) recognises that R&D requires increased as well as decreased variation, and the exploitation of divergent thinking, in a controlled way.

The conference ended with Stephen Walker, Director, R&D Continuous Improvement Lead, Pfizer, and Charles Aubrey leading 2 respective focus groups on BPE in Drug Discovery, and in Manufacturing and Engineering.  They were useful opportunities to reflect further on points raised during the course of the 2 days.

Notes and further reading:

1. RiverRhee Consulting enhances team effectiveness using process improvement, knowledge management and change management.  Follow the links to find out more about RiverRhee Consulting and about Elisabeth Goodman and John Riddell
2. Ten Top Tips for Successful Lean and Six Sigma Implementation – RiverRhee Consulting – February 2011 http://wp.me/p1jPm6-D
3. Operational Excellence and Knowledge Management in an R&D Laboratory Environment http://wp.me/pAUbH-3P