Without aligned process improvements across Regulatory Affairs, Quality and Pharmacovigilance/Drug Safety, pharma companies risk limiting their overall market performance, says MAIN5’s Tobias Hitziger.
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Multiplying market challenges mean pharma R&D organisations have no choice but to make their operational processes as efficient as possible if they are to remain commercially viable. Yet, today, across pharma Regulatory Affairs, Quality and Pharmacovigilance/Drug Safety functions, process rigour is wedded tightly to standard operating procedures (SOPs), ensuring a standardised way of working. These snapshot definitions of processes do not, of themselves, foster efficiency nor effectiveness however.
Even where processes are improved and optimised over time, as long as these improvements are confined to a single function or sub-area the benefits will be limited to that context. Problems commonly arise at points of handover, e.g. between teams working in the same department, or as workloads pass between different functions (or out to a service provider, and then back again). If the interfaces inhibit seamless continuity or clear visibility, momentum may be lost.
Thinking laterally is key to extending process improvements
Where companies take a more holistic view, which places the focus on the output of processes and the goals this is designed to serve, there are multiple gains on offer. These range from true improvements to overall efficiency, as well as new clarity about roles and requirements within each process. These developments, in turn, can inform new IT systems implementation, as well as outsourcing arrangements – ensuring that these deliver maximum value. It makes good business sense, then, to review and optimise processes on a broader scale.
Fuller process transformation requires a more extensive review of what is going on, on an end-to-end basis. Without that, the potential benefits will always be compromised.
Barriers to progress
So why hasn’t more progress been made, given the scope for holistic process improvement? What is holding back pharma R&D organisations from being bolder and more innovative in their process transformation?
Culturally, some reservations are linked to an instinctive fear of extended transparency, especially during inspections. Where processes are viewed, treated and managed more holistically and continuously across the traditional boundaries or departmental divides in a process management suite, there may be concern that inspectors might extend their curiosity and raise their gaze when reviewing current procedures. This concern is heightened where companies use business process management (BPM suites) to represent their entire process landscape within a single system (with the risk that inspectors can freely “jump” from one process to another). Yet, if processes have been well-defined and are running smoothly, in a closely-tracked way, the ability to see all of this at a glance is a positive development.
More practically, it is the lack of clear process definition (beyond the scope of individual SOPs) that is the greater sticking point. It is only when process owners and process ‘customers’ (those on the receiving end of the output) are agreed on what a good process looks like that this knowledge can be applied effectively to streamline it. This is because, in many cases, there has been a loss of sight of the deliverables of processes, and who and what they are designed to serve - beyond inspectors’ satisfaction that no corners are being cut; that procedure repeatability is ensuring the highest standards of quality, safety and regulatory compliance of a created output. If the output is ultimately wrong, for instance, any gains in ‘throwing it over the wall’ more swiftly will be lost. If the output is a document (e.g. part of a regulatory dossier) which fails to meet the requirements, it will be sent back to the author - creating a costly and timely rework cycle.
Another common fear of investing in real process change is linked to concerns about the likely resources this will consume, both financial and in terms of people’s time – potentially detracting from business as usual. As long as process reviews and transformation plans are designed for and adapted to the particular needs of the organisation, the justification for the improvements become clear and these barriers to change are soon brought down.
Steps to delivering wider improvements
True process improvement, especially end-to-end transformation across an extended environment, needs to start with clear, ideally in-person communication between the main parties involved – the process owner(s), process participants and the process customer(s). The goal of this should be to identify the most efficient process to create the output as expected by the customer leveraging experiences where repeated issues emerged in the past (e.g. repeated pushback, rework cycles.
Alongside, or to help provide a focus for, discussions about scope for process improvements, process stakeholders can harness intelligent “process mining” tools to identify common bottlenecks and repeat loops.
The greater the scope of the process elaboration, and the broader the range of stakeholders, the greater the timescale needed to evaluate, redesign and optimise the new agreed scenario.
Again, staying focused on the common goals will be important – such as improved and more effortless compliance; greater clarity for all parties about what is needed, when and why; and the scope to alleviate resource pressures through the targeted automation of labour-intensive tasks using appropriate technology (e.g. modern RIM capabilities).
The payback
Once good, streamlined and aligned processes are in place, teams can pull this content and create SOPs. Clear definition of process roles (“swim lanes”) meanwhile can help identify the specific activities linked to them. This in turn could be used to inform role-based training, for the individuals fulfilling the processes.
Ultimately, good process elaboration, oriented towards the process customer, enables greater operational efficiency. It also makes it much easier to introduce new technology systems and features, since well-described processes inherently force robust descriptions of user requirements. Certainly, no business ever suffered from having a better understanding of its end-to-end processes.