Life Sciences manufacturers are heavily regulated and therefore intensely focus on meeting compliance requirements and managing process and product quality and safety risks.
In order to ensure that things are done “first time right”, thousands of Standard Operating Procedures and Work Instructions are created, rigorously maintained and distributed throughout the organization. Each of these documents provides a step-by-step description of how a process or activity should be done. Unfortunately, documents are fine for reading at a desk, but hardly usable while working. These documents are mostly used for training, but no one really knows whether they are truly followed as there is no execution trace.
In order to ensure that things have been done right, hundreds of checklists are created and regularly filled in during inspections. Most checklists are still paper based and generate quite some non-value-added administration. Traditional inspection forms, whether paper-based or digital, are hard to use while doing a job that requires you to use both hands. Moreover, checklists are a passive registration of what’s good and what’s not. They don’t provide an adequate solution for how to escalate issues effectively and to ensure that they get solved.