There are several challenges that will come along with the implementation of the API Q2 Specification. The first of which is the general comprehension and application of the standard. Your organization will be required to read the new standard and understand the requirements. Then you will need to determine how to blend the requirements into your operations.
Another challenge that Q2 presents is the transition from a process-based to a risk-based management system. Your organization is likely familiar with the process approach (i.e. ISO 9001), but API Q2 requires you to focus more on risk. Not only will this alter operations, but a risk-based system also requires a different workplace mentality.
Your organization likely has many compliance requirements already, and integrating API Q2 with those can present a unique challenge. You will need to devise the most efficient way to comply with API Q2 while adequately managing numerous other requirements.
There will also be some challenges for your organization with respect to supply chain and geographical differences. Complying with new API Q2 requirements will likely alter how your organization operates throughout the supply chain. Organizations in different portions of the world may have different regulatory and cultural differences, which may cause confusion.
It is important that we understand the challenges that the new standard presents. If we are proactive, we can mitigate the impacts and have a smoother transition to compliance.
To discuss how Accupoint Software can help you navigate the challenges of API Q2 compliance, call us toll-free at 800.563.6250.