Escaping SOP Madness

Torque Management - TPSoP Case StudyHats off to Dee Carri, founder of Torque Management and creator of the TPSoP®, a methodology for translating the typical corporate rainforest of Standard Operating Procedures (SOPs) into visual processes – with sufficient rigour to satisfy the regulatory demands of Life Sciences.

The first case study of TPSoP in action – in a global biotechnology company – is just published (here). It’s a report on a pilot, and the metrics are understandably thin, but it’s the first published proof that the TPSoP methodology can deliver in the real world.

The idea of translating impenetrable thickets of SOPs into useful information that people can engage with is not new. Simplification has been on the strategic agenda for some time – especially in Life Sciences (as I’ve noted before) – and Novartis was making presentations on this theme back in 2011.

What’s different about TPSoP is its rigour. It has built upon the experience of those pioneering projects to create a comprehensive and robust methodology – the results of which we are now seeing proven in practice.

I remember talking with Dee two years ago, when she explained that she’d taken a back seat in the day-to-day operations of her consulting business to create the space to build the foundation for a more complete and watertight approach to ridding the world of SOPs. She’d just emerged, she claimed, from two months in the shed at the end of her garden. Which sounded admirably mad but then most breakthroughs do at first…

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A Simplification Bandwagon Begins To Roll

iStock_000000213421MediumIs business simplification at last moving up the strategic agenda?

In recent discussions with three global organizations,  it’s the senior people who are arguing forcefully for simplicity. Admittedly,  all three are in Life Sciences but my hunch is that it’s a wider quest.

As one CxO put it:

“The world in which [this organization] operates is already complex. It is set to get far more complicated in the next three to five years as we work more collaboratively with clients, partners and service providers. There are going to be far more opportunities to do the wrong thing at the wrong time with the wrong person. Our risks are increasing rapidly. “

She went on to identify one of the root causes:

“At the moment, we deal with complexity by hiding it.  We bury it deep down in inpenetrable SOPs.  We need to expose that complexity. It’s the first step in simplifying our business – and engaging our people.”

Seems to me that she’s right on both counts.  Complexity has to be exposed before it can be reduced (and the direction of travel there is, of course, from a document-defined world to a process-based mindset that leverages the power of visualization).

It’s not just that people can’t contribute to a better way of doing things (or even do their current jobs well) if they don’t understand the big picture – though that is clearly true.

The strategic headlines here are about risk. People working in complex, fast-moving and perilous conditions – firefighters and surgeons, for instance – are drilled in situational awareness.  They are taught never to lose sight of the big picture.

Arguably, global businesses are becoming far more complex, fast-moving and perilous than surgery or firefighting. They require the orchestration of large numbers of people, spread across all regions of the world, and collaborating across organizational boundaries and functional silos. Situational awareness matters more than ever, which is why business simplification looks set to become the zeitgeist.

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© Text Michael Gammage 2013

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