Kari Miller, Regulatory & Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
In the past few years, there has been a lot of focus on how organizations manage their suppliers. The reality for most is that their supply chains are getting longer, the need to work through those supply chain is getting shorter, and the regulatory requirements with regard to supplier management are becoming more broadly encompassing.
The most critical medical device regulatory requirements – ISO 13485:2016, ISO 9001:2015, 21 CFR Part 820, and EU MDR – have increased focus on the manufacturer’s responsibility for supplier performance. For instance, in the pharmaceutical industry, 21 CFR part 211 and ICH Q10 specifically address the management of suppliers.
When looking at regulatory requirements, whether 21 CFR Part 820 or 211, ICH Q10, ISO 13485, or the myriad other regulatory standards, one thing is clear. An organization will be held accountable for the quality of the materials or services they are receiving from their suppliers, as that quality affects the quality of the product they are delivering. So how is an organization to manage their suppliers in a way that ensures quality?
Organizations are expected to apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external suppliers, based on their ability to provide processes, or products and services, in accordance with that organization’s requirements. They must also document and retain documented information of these activities and any necessary actions arising from the evaluations and the supplier monitoring activities.
To effectively manage a supplier from evaluation to monitoring and reevaluation can be an arduous task. The process starts with supplier evaluation that requires, most commonly:
- supplier site audits/inspections
- document reviews
- financial reviews
- engineering and quality reviews
- QMS audits
Ensuring quality requires supplier performance monitoring including monitoring and measuring:
- incoming material inspection results
- supplier non-conformances
- supplier CAPAs
- supplier audits
- supplier notices of change
Maintaining supplier ratings and risk factors are key to minimizing risk within your own organization. Doing all of this in a global economy can be challenging.
Shortening the Supply Chain
As the pressure mounts on Life Science organizations to more closely manage their suppliers, it has become increasingly critical to ensure transparent communication and visibility between the two. This can be challenging as extended supply chains are becoming longer and longer.
A Quality Portal that offers dependable, secure communications between manufacturers and suppliers, ensuring data accuracy, is key to shortening cycle times within the supply chain. This is achieved through inclusion and participation of the supplier in the organization’s supplier quality management transactions such as providing CAPA investigations, CAPA action plan implementation, and responding to Supplier Audit findings.
A Quality Portal is just one component of an overall Supplier Quality Management Eco-system. Organizations need to continually evolve their supplier quality eco-system to ensure proper supplier management and regulatory compliance, while reducing cycle times with ongoing supply chain expansion within the medical device, pharmaceutical. and overall Life Sciences industry. After all, time is short, supply chains are long, and compliance is required.
Aligning Both Sides for Quality
Pilgrim Quality Solutions’ Quality Portal provides bi-directional capabilities to allow external suppliers to participate in your quality processes. It is being released in conjunction with the latest version of Pilgrim’s SmartSolve CAPA Management to enable suppliers to complete CAPA investigations and related actions. Contact us to learn more about SmartSolve, Pilgrim’s Enterprise Quality Management Solution, and Pilgrim’s Supplier Quality Portal.
SmartSolve Supplier Quality Management
5-Minute Overview Video
Learn how you to implement a Risk-based Incoming Inspection Process and more.