The Process SOP Blues

It seems very odd at first. Why should Life Sciences organizations be so resistant to a change that is so self-evidently valuable? Why push back on something that makes things better, faster and cheaper?

Standard Operating Procedures (SOP) are the basic building block of Life Sciences organizations. Almost always simply a library of lengthy documents, SOPs set out how the organization understands what it does; how it assures itself and its clients and its regulators that it is following Good Practice.

Even in the best managed Pharma organizations, the costs of compliance can be 16% of operating costs; more typically, they will be 20%+ and may even be towards 30% of operating costs.

So - if there was a better way of managing SOPs, how can there be such indifference? How could smart people be so unenthusiastic about a new way of working that would, say, make clinical trials safer while, at the same time, reducing their cost?

At the European SOP conference yesterday, the evidence from several speakers - none of them linked to Nimbus - was compelling: in many ways, some serious, SOPs don't work:

Susan Ollier from QED Clinical Services noted that SOPs may be missing, or contradictory, or out-of-date or uncontrolled.

Steve Nicholas from PharmaAcademy presented supporting evidence from the UK's MHRA regulator. He went on to point out that the SOP document fails because is written to meet two mutually incompatible objectives. SOPs are supposed to be concise and easily understood (to support the process user), while at the same time being an exhaustive training document for a new starter with no experience.

Gareth Turner from PAREXEL noted that 'a lot of what we do is actually quite simple. We've just created a way of making it extraordinarily complex. We need to get back to simplicity.'

The answer, the future for SOPs that was served up in different ways by different speakers, is to adopt a process-based approach.

Going beyond document-based SOPs to thinking in terms of end-to-end process can offer huge advantages. It's the kind that would grab any CEO's attention:

Risk Management - it exposes the gaps and the overlaps that arise from silo-based SOPs. It also provides a comprehensive framework for managing outsourced activities.

Productivity- it makes work easier. Storyboards deliver content, in an easily digestible format, through a personalized intelligent operations manual. And it enables more extensive, and successful, automation.

Governance - it brings together Quality, the QMS and all compliance activities into an integrated management platform.

Performance Improvement - it connects SOPs with KPI metrics. It integrates Quality and compliance with Lean, Six Sigma and other performance improvement programs.

At the Nimbus Inspiring Performance 2011 conference, Novartis shared a brilliant example of an organization that is forging this future, leveraging Nimbus Control to create a smart, holistic perspective on its clinical trials programs.

So WHY is the progress towards process-based SOPs so incredibly slow? It's a question I've never satisfactorily answered until yesterday when the penny dropped. I realised that people's resistance to a process perspective is not job-protection or an inability to think creatively. It's because whenever they are shown process (and we saw many examples of this yesterday) it looks awful.

They know process as swimlanes, pools and numerous symbols (ie the language of BPMN). They see it as technical, in the IT domain, with no sense of design. They see governance processes separate from operational processes. They see process as bottom-up fragments of understanding. So process for them is a loaded and negative term. Presented like this, who would want to use it? It's really no surprise that they push back and switch off.

I wasn't the only one bored, I think. I found this rap on a scrap of paper as I left the conference: