Goodbye To The SOP As A 50 Page Word Document

NapkinEverything points to this as an inflection point (scientific napkin view – left).

There’s an increasing number of people in Life Sciences looking for a better way of managing the knowledge that has traditionally been deposited in a vast library of SOP documents that are read, mostly, just by authors and auditors.

In the past two weeks, I’ve been engaged with two organizations searching for an alternative process-based approach. Both want to minimise the number of SOPs – even eliminate them altogether. Their strategic drivers: compliance and performance improvement.

From the compliance perspective, they want end-to-end process visibility, and governance, that will highlight the overlaps and inconsistencies inherent in lengthy stand-alone SOP documents. They see higher levels of process adherence resulting from higher levels of process understanding.

They also want to build more flexible high performance cultures – and recognise that is underpinned by organizational process maturity. So they want to connect people with process, and embed it in their way of working. Their start point is to make the knowledge currently buried in SOPs easily accessible to people doing real work, through end-to-end process perpectives and role-based storyboards. They also want to integrate process with real-time performance metrics. And to adopt it as the language and framework for collaboration on continuous improvement.

Kudos to Novartis, which has been the leader in this transformation. But the adoption of end-to-end process as a better way to manage and improve highly complex organizations, operating within a world of rigorous regulatory regimes, now looks like an idea whose time has come.

Cracking Complexity At Novartis

Anne SaletesIn a video just released, Dr Anne Salètes, Head of Training and Continuous Improvement for Global Clinical Operations at Novartis, brings to life the challenges when precision and attention to detail become barriers to collaboration in complex global operations.

At the Nimbus IP11 conference in London in September, Dr Salètes’ presentation told the story of how Novartis adopted Nimbus as its platform for managing processes and Standard Operating Procedures (SOPs) in clinical development.  Novartis is a leader in process-based SOPs: adopting end-to-end process as its business language, transforming content buried in libraries of Word documents into holistic business perspectives.

Dr Salètes’ mainstage interview with Richard Parker on the morning of the conference has now been released as a video. In the course of that discussion, Dr Salètes talks about some of the benefits of a process-based SOP model.

She describes how patient safety and data validity are, of course, the paramount  concerns. But in organizations as large and complex as Novartis, the precision and risk aversion that underpin that safety culture can become significant barriers to cross-silo collaboration.

She notes the value of visualization and simplicity of presentation:  “Our people are extremely precise,” she says, “but it is very difficult to find skilled people who are extremely precise and who can see the big picture. What we are bringing them is a better view of the big picture. ”

By creating an end-to-end representation of Novartis’ clinical operations processes: “We are bringing everyone to the same view.  We are all challenging the same view. We can see how we can improve'”.

The benefits of a process-based approach are not just in performance improvement and Lean programs.

Novartis now has a common view of regulatory jurisdictions globally, which makes it easier to ensure compliance.  Even more significantly perhaps, end-to-end perspectives also discourage silo-based approaches to compliance – the temptation to think: “This is my little area and that’s where I have to be compliant”, as Dr Salètes describes it. It enables each person and team to understand and play their part in end-to-end compliance.

It’s a funny thing that when many people think of process, their first thought is of complexity.  But Novartis is another example that process, when it’s properly conceived, can be the key to cracking complexity and enabling effective collaboration.

© Text Michael Gammage 2013