Quality by Simplicity: Simplify your process, elevate your Quality and reduce your Complexity 🏆
Are complex procedures and documentation hindering your quality, compliance and efficiency efforts?
In the highly regulated world of Pharma and Medical Device industries, meeting regulatory requirements and maintaining compliance is crucial to ensure patient safety, product efficacy, and market position. However, the complexity of these regulations, as well as the procedures and documentation required to meet them, can often be overwhelming.
The birth of complexity in regulated areas can have various causes and can sneak into organizations seamlessly, making it easy to overlook. The results, however, are clear and often severe and devastating for the company, product, employees, and ultimately the patients.
In this series of articles, we’ll explore the power of simplicity and how it can elevate your quality and reduce complexity.
The first example we’ll discuss is the problem of overly complex procedures and documentation. Here are some of the biggest culprits and our recommendation for strategies to tackle them:
🚫 Not Setting the Right Level of Requirement and Compliance
While meeting regulatory and product quality compliance requirements and documenting them are crucial for patient safety and license to operate, overly complex processes, overly detailed procedures, and documentation can hinder rather than help. Moreover, it is an ineffective and demotivating way of working.
✔ Anchor the regulatory requirements in your QMS system at the right level and in a clear way.
✔ Avoid any requirements and restrictions that do not have roots in regulatory or product requirements nor fulfill a business need.
✔ Be clear on what is regulatory, product, compliance, or business requirements.
🚫 Not Process Mapping Before Implementation
It’s crucial to map your process to reduce non-value-adding activities and have a simple process flow. Complex process flows lead to a long and ineffective lead time, and weaken the collaboration between departments.
✔ Map and visualize the process, documentation, approval, and roles and responsibilities before implementation.
✔ Remove non-value-adding activities and complex spaghetti diagrams for the process flow.
✔ Ensure smooth and clear handshakes between departments.
🚫 Quick Solutions
Often, overly complex procedures, with a complex, meaningless, inefficient process, introduce a lot of mistakes resulting in deviations, CAPAs or the need to change current procedures. Conducting CAPA, deviation, or handling a change request are vital processes, as they introduce changes and updates to the affected process.
✔ Conduct a proper cause analysis before introducing any changes or updates- what do you want to solve?
✔ Remove old processes when adding new ones.
Don’t let complexity hinder your compliance efforts. Simplify your processes and documentation to elevate your quality and reduce complexity 🏆 . If your company is facing similar challenges, reach out to us for help. Leave a comment below and let us know what you think.
