Lean Pharma: Tackling Compliance Obesity

Not to put too fine a point on it, Quality and Compliance are often completely out of control in PharmaLand.  No-one doubts the need for uncompromising quality and compliance. But the way that this is delivered in Pharma today is not just over-engineered and over-expensive, it’s become a source of risk in its own right.

Things can get to a point in obesity where surgery is the only way out. Everything I see suggests that we’ve reached the point where only a radical new approach can slice through and remove the multiple, overlapping layers of complexity to expose and manage the true compliance essentials underneath.

In a recent workshop with a Pharma organization, we were attempting to condense several dozen SOPs into a standard global process. The SOPs were often vague, long-winded, contradictory and only tenuously linked to the Quality and Compliance manual. So while the formal SOPs are consulted, in practice, they are usually ’supplemented’ by informally ’asking an SME’.  

That’s of course when the SOPs are readily available. Recently a global process owner offered to print out for me the two ‘foundation’ SOPs for his process. It took him 15  minutes to find one of the SOPs - and that was in the dedicated Sharepoint site for this particular process.    

These  organizations are not unusual: as far as I can see, this is close to the Pharma norm. The people involved are bright, conscientious and endeavor to act with integrity at all times. But they are overwhelmed with unclear and sometimes conflicting information.  In CMMI terms, these are organizations operating near to the lowest point on the process maturity curve: Quality and Compliance is often being delivered through a culture of heroes.

Most Pharma organizations are pursuing programs to simplify, to standardise and to eliminate non-value-add (NVA) activities. But often quality and compliance functions are barely touched.

It’s a nettle that has to be grasped.  Outsourcing and re-shaped business models can only go so far to deliver the required levels of performance improvement.  Quality and compliance isn’t going away. In fact, the reverse. The compliance burden is set to grow rapidly as Pharma expands into emerging markets and branded generics, and develops global operations in an increasingly multipolar regulatory world. With the costs of regulatory non-compliance spiralling, it’s not difficult to imagine that Quality and Compliance may soon be the largest single NVA in many organizations.

The liposuction equivalent for Compliance obesity is, of course, the adoption of a process management platform. In a client workshop I supported last week, that team succeeded in condensing numerous SOPs into a single standard global definition of Validation.  We spent two days creating the two top levels of the process model.  The power of process visualization, the rigor of a process hierarchy, and the constant pressure to describe things simply, in the language of the user, led to real agreement on a standard global process.  

There’s plenty of detail to be added. And the activities in this process, and its regional and site variants, will need to be cross-referenced to the library of quality and compliance requirements. But eventually, and after completing the review and authorisation cycle, it will be published - and delivered to process users as easy-to-follow role-based storyboards.  

It’s an approach that’s absolutely rigorous. It’s also multi-dimensional. It’s designed to manage complexity. It supports rich what-if analytics.  But, critically, it’s also focussed on simplicity, on user adoption and enabling real work.  Which is why it’s the key to Lean Quality and Compliance – and to continuous improvement. 

A Process Platform, Not A Process Tool

It’s true that ’platform’ sounds like Marketing-speak.  But there’s an important distinction between a process tool and a process platform.  And it’s not widely appreciated, which is why so many organizations continue to waste so many millions of dollars on process tools that can never deliver what they are looking for: operational excellence and continuous improvement.

TIBCO Nimbus Control is a process platform.  Others will no doubt catch up, but it remains the leader. It creates an integrated business management platform that underpins quality and compliance. It enables collaboration on performance improvement within a robust governance framework.   It orchestrates every aspect of business transformation. It delivers the content that supports real work, to every desktop and mobile, and it engages people across the enterprise in continuous improvement. And to achieve this, to create this platform for operational excellence, it uses the language and rigor of end-to-end business process.    

A tool is for a particular and more limited purpose. A process tool tends to be focussed on the needs of a project, and to be discarded afterwards, its content filed away. Whereas a process platform assumes re-use and longevity, a mindset of sustainable excellence

Process tools can be essential – in software package configuration or other automation projects, for instance. But, at best, they can only provide a complete view of the enterprise from the perspective of what’s automated.  Whereas a process platform aspires to create a joined-up and holistic view of the enterprise. 

Process tools have dominated up to now. And they are a big reason why process thinking has taken so long to penetrate the C-Suite.  Execs can see that, by and large, process tools offer only IT perspectives on the enterprise. Even worse, they are usually also incomplete and ungoverned, and describe process in the language of IT. 

Process platforms are the future. There’s still C-Level resistance in some organizations - mostly because both process tools and process platforms start with a visualization of process as boxes and lines.  So, at first glance, they are both ‘just process drawing tools’. Yawn…

But how process is visualized matters enormously.  Organizations that choose the language of a process tool, such as BPMN or EPC, which are focussed on automation and the needs of an IT audience, will get very different results from organizations choosing to adopt the language of a process platform, such as Nimbus UPN, which sets out to describe end-to-end processes in a way that everyone can understand.    

And, anyway, a process platform is about boxes and lines as much as Shakespeare is about words and sentences.

Reduced to basics, it’s true to say that the Bard just wrote words and formed sentences like every other playwright and poet. ”To be or not to be? That is the question.”  It’s words in a sentence. But Hamlet is a tragedy that has moved audiences for over four hundred years. It has meaning and value far beyond the words from which it is composed.

Less dramatically, a process platform too has meaning and value to the enterprise far beyond the activity boxes, lines and diagrams from which it is composed. I’m not exactly confident that it’s going to be around in four hundred years – but, for the foreseeable future, the process platform is the essential enabler for operational excellence and continuous improvement.

Selling Process Excellence

Great animation What Is Process Excellence? just published by the Process Excellence Network (PEX).  The story behind the video is interesting as well.

It’s good because it de-mystifies process.  Too many people think that process is the domain of the IT crowd or the Quality manager or some elite strategy unit.  This video challenges all that.

It spells out how process is just another way of describing the work we do. Its message is that process is about how organizations create and deliver value to their customers.  It’s process that enables organizations to get aligned for success. So it’s on point.

But here’s the really interesting thing about this video. It’s intended to help PEX members – overwhelmingly Lean, Six Sigma and PI people – to sell their Process Improvement programs to their C-Level execs.

But hang on, I hear you say, why on earth do execs need to be sold on Process Improvement programs? Surely they welcome them with open arms? Aren’t the PEX community received as heroes in the C-level suite? 

Strangely, no. In many organizations, the Lean Sigma and PI crowd operate at surprisingly low levels, and even feel vulnerable. And there is some serious evidence that supports C-Level skeptics.

So many PI teams are now looking at new approaches, and tools to support them.  Thought leaders here want to get beyond PI projects. They want to focus instead on programs to build organizational process maturity.  They aspire to CMMI Level 5 capabilities – they are searching for process excellence as standard, and a culture of continuous improvement.   

This new approach to PI demands different tools. Process fragments in Visio or on brown paper, or in the techical language of IT, just can’t deliver this. 

Actually, it’s not even a tool that’s required any more. Sustainability demands a business management platform. A platform that:

• provides an integrated and holistic process model of the enterprise, linking the enterprise value chain, or target operating model, directly with the operational reality
• visualises end-to-end processes in a way that is intuitive, and in the language of the business
• overlays processes with performance metrics, business controls, quality and compliance
• provides a governance framework that enables all process stakeholders to collaborate on the analysis, design and implementation of change 
• blends process with documents, metrics and training - and delivers it to every desktop and mobile device as a personalized ‘intelligent operations manual’, connecting process with getting real work done, and making it easy to engage in continuous improvement.  

With this kind of platform in place, the insights and expertise of the Lean Sigma and PI community can be fully leveraged. OK, maybe not conquering heroes – but properly valued.

Goodbye To The SOP As A 50 Page Word Document

Everything 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.

The Power of Process Visualization

My colleague Craig Willis has an interesting post out today on the power of process visualization in enabling collaboration. In process discovery especially, a well-run workshop forces the process actors to let go lazy intuition and really understand what’s happening:

The act of talking through and visualizing a process can often, in my experience, actually improve the effectiveness of that process without any attempt to change it.

I’ve believed it ever since I saw it with my own eyes, many years ago, soon after I joined Nimbus.  In a day-long workshop with the stakeholders on a core process for a major utility client, we established that the three functional silos involved each had a slightly different take on the process.  These subtle differences meant that this organization employed 250 staff to deal with the (largely avoidable) process exceptions.

All process visualization tools are not the same of course.  It’s quite possible (and still amazingly common) to create visualizations that are simply process fragments, often written in an arcane technical language, and with the complexity of a wiring diagram.      

At the end of that extraordinary day with the utility client, that group of senior people had, as a group, drawn just five boxes on the screen.  But it was the nuances in the top level of that core process that were the root cause of the process exceptions and the resulting costs. As ever, simplicity forced clarity, and that – together with a joined-up end-to-end perspective – is where the value so often lies. 

Interestingly, the process visualization tool itself is only part of the answer. The methodology matters hugely. Nimbus Control is a superb process management platform – but it’s the simplicity and rigor of the Nimbus UPN methodology which enables it to deliver results like this.

Why Process Excellence Will Underpin Next Generation Pharma

Organizations across the planet are grappling with how to fundamentally re-invent themselves, and at an ever-increasing pace of change. But few industries face the challenges of Pharma, which may traditionally have been seen as conservative and slow-moving, but is set to undergo a rapid revolution driven by a stark new competitive landscape.

As McKinsey, not given to hyperbole, summarised it last month:

“This dramatic situation requires Big Pharma executives to envision responses that go well beyond simply tinkering with the cost base or falling back on mergers and acquisitions… A bolder, more radical approach to Big Pharma’s operating model must become a realistic planning scenario.”

A Wake-Up Call For Big Pharma – McKinsey Quarterly, Dec 2011

It’s an exciting time to be working in process management and in Life Sciences. Because whichever you look at the challenges facing Pharma, the answers most often link directly to process excellence.  

It’s not just that a true process management platform can enable and orchestrate all the actors involved in transformational change. It’s fundamental to success in other ways too:

Collaboration. It’s the ideal governance framework for the collaboration with third parties that will become increasingly common.  

Outsourcing. It’s the ideal service management framework for a world where blends of shared services, outsourcing and multisourcing will be far more common. 

Performance Improvement. It’s the ideal framework for Lean and Six Sigma initiatives, for sustainable change, and for continuous improvement.

But is this possible – what is a true process management platform? For my money, it has to:

• provide integrated and holistic views of end-to-end processes, in the language of the business (not IT-speak)
• integrate process with documents, KPI metrics, risk and controls, quality and compliance,  training and task support 
• provide the collaborative framework and governance that enables process stakeholders to drive performance improvement
• deliver process to the desktops and smartphones of people doing real work – through Storyboards and a personalized ‘intelligent operations manual’
• be truly ‘the way we work’ – not an artificial construct owned by IT or Quality.

I do feel extraordinarily lucky to be joining the Nimbus-TIBCO Life Sciences consulting team at this time.  Visionary clients, bright colleagues and huge potential.  And they pay me for it.

When Precision Prevents Improvement: Cracking Complexity at Novartis

In 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 has adopted Nimbus Control 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’”.  

But 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. 

(cross-posted from Sourcing Shangri-La )