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 endeavour 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 rigour 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 continuous improvement.