Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company
In over a dozen years as a sales engineer, and now as manager of that team, I have heard numerous recurring questions raised about specific topics when speaking to clients about their software needs and what processes belong in which systems.
One topic that has arisen over the past few years is best practices for supplier management. Should supplier management, and specifically supplier onboarding and maintenance, be a function of the Enterprise Resource Planning (ERP) system or the Quality System? This is by far the most common and most debated element.
Granted, there are specific functions that revolve around suppliers, such as inventory and in-process inspections, which should always be managed within the ERP system, but I believe the specific function of supplier approval and onboarding belongs in the Quality Management System (QMS). There are a few major arguments for this:
- Regulations such as ISO 13485:2016, 21 CFR Part 820.50, and ICH Q9 & Q10 are tightening their grip on the processes that control supply chain quality in life science companies. Having a system that provides an organization with the functions they need to be compliant to the aforementioned regulations, provides the objective evidence needed to demonstrate adherence to the organization’s supply chain quality processes. The ability to be validated helps prove this in the auditing/inspection process.
- Continuous monitoring of suppliers should take into account many critical quality management processes such as nonconformance management, Corrective and Preventive Actions (CAPAs), audit management, and incoming inspections management. These should all speak to one another in a seamless, integrated fashion to generate a supplier performance rating on a regular basis. Having a Quality system that contains these elements and that can seamlessly produce a rating is a huge benefit.
- Some argue that data from other systems need to be communicated based on Approved Supplier Lists (ASL) and Parts, but through today’s technology, it is very easy for Quality systems to integrate with ERP systems for specific data elements, so there is no really a need to have all supplier functions in one system versus another. Further, quality assurance is a major function of a Quality Management System. Supply chain quality, including supplier evaluation and on-boarding, begins with best practice processes that are repeatable and observable; enterprise QMS is best suited to achieve this.
- Last, but certainly not least, QMS systems tend to be easier to validate, maintain, and upgrade.
For these reasons, it is, and always will be my recommendation that the ERP system be the source of truth for inventory and parts maintenance. However, when it actually comes to Enterprise Supplier Management and the Supplier Performance, the Quality Management System is the gold standard.
Quality In, Quality Out
Exploring Pharmaceutical and Medical Device Supplier Quality Management (Part 1 of 4).