You may have missed this news headline amongst all of the global upheaval we’ve been bombarded with recently. This was yet another eye-opening and serious example of what can go catastrophically wrong if your business suffers a process compliance failure.
Somehow 110,000 packs of Boots medication (Paracetamol in this case) reached the shop shelves with the internal packaging stating that it is actually Aspirin! This is not the trivial mistake it might first appear to be. The consequences of someone taking the wrong medication could be life threatening for some individuals – leading to significant legal consequences for Boots, not to mention the significant brand damage from having to make such a large scale and public product recall undermining trust in their products. It may also result in a significant regulatory fine for Boots (and their suppliers), not to mention the time and resource associated with investigating how such a mistake could have occurred in the first place.
This error is almost certainly down to a failure of compliance somewhere in their internal processes – something somewhere was missed by someone. Pharmaceutical companies have rigorous, complex, multistep Standard Operating Procedures (SOPs) to review, check, and approve the design & implementation of labelling on all medication packaging. The problem is how do they monitor, control and audit that end-to-end labelling process on a continuous basis when it can be running multiple times simultaneously for different drugs in different geographies, spanning multiple individuals, teams and suppliers.
It is not a trivial challenge. A DIY spreadsheet will quickly become bloated and out of control, whilst trying to use a tool like SharePoint or Monday.com can be unwieldy, difficult to implement and very expensive to scale (akin to using a sledgehammer to crack a nut!). What you need is a light weight, low cost, highly secure oversight tool that can:
- track every process instance across multiple platforms, teams & organisations
- capture every step & interaction
- automate where possible
- provide real time end to end visibility & control
It also helps to have a team of process design & optimisation experts to help you implement it (something you won’t get from Monday.com or Microsoft!).
This is exactly what we’ve been doing at Maly over the last 15 years for our pharmaceutical clients using our no code Okuda tool! We started our entrepreneurial journey tackling exactly this specific use case (drug labelling) and have since expanded to all manner of process compliance challenges across different sectors (e.g. financial transaction control, recruitment, ethical & sustainable manufacturing).
If this news story highlighted potential risks to your operations, or you’d like to avoid being the headline for a process compliance failure drop us a line – we’d love to chat!