Before an impending FDA Pre-Approval Inspection (PAI), a cardiovascular device manufacturer contacted GCI in order to assess and remediate 3 key areas within their existent quality management system. One of these areas was the client’s supplier management system governed by 21CFR820.50.
In response to the client’s needs, GCI quickly assembled a Balanced Team comprised of one team leader and 4 appropriately experienced engineers. The team approached the project using a modular implementation process, based on industry best practice aligned with the regulatory requirements. Starting with the assessment phase; the team reviewed and conducted a gap assessment of existing documentation associated with the supplier quality system, such as standard operating procedures (controls), as well as all supplier files and data (records). The subsequent phase consisted of remediating the gaps that were identified from the previous assessment phase. The remediation phase included assurance of robust supplier files through the generation of missing documentation, correcting existing documentation, and executing supplier audits and validations where necessary. In order to ensure successful project execution, GCI’s team collaborated with the client’s existent receiving inspection team and quality organization to align with, while simultaneously updating, the supplier management system standard operating procedures (SOPs). The SOPs were created and modified to meet the regulatory requirements, align with the best industry practices, and fit the company’s quality message. Following the SOP creation, GCI quickly reviewed and updated the approved supplier list (ASL) and conducted desktop and on-site supplier audits to ensure the quality of the received components.
For the remediation effort, a supplier criticality ranking was established and utilized to prioritize critical supplier management tasks. This activity prioritized the remediation of more than four hundred components, records and the generation of one hundred ninety eight supplier files with appropriate, compliant documentation. Concurrently, prospective and retrospective validations where completed as well as the auditing of all nine critical suppliers within one month.
After the successful completion of PAI, GCI’s team stayed on in order to complete remaining remediation activities such as the auditing, desktop and on-site, of the remaining one hundred thirteen non critical suppliers, to address resultant supplier related CAPAs and SCARs, and to provide day to day supplier quality support to the organization. In addition, the team steered on-site and remote meetings with all critical suppliers to express the company’s new supplier management requirements and convey the business quality message. In order to create long term sustainability, GCI developed a new quality supplier department through the hiring of local resources. The new staff worked closely under GCI’s direction to ensure continuity of supplier tasks and transfer of knowledge.
During the course of this project, GCI continually focused on being highly collaborative with the client, and as such, the team incorporated feedback from the senior leadership into the final documentation and execution approach. The project was a success due to zero PAI observations from the FDA related to the supplier quality management system as well as the development of a sustainable, compliance supplier management department. GCI was successful at driving all supplier management efforts including supplier audits, supplier controls (scorecards, quality records, etc.), assessment of supplier changes on product quality, and addressing any supplier corrective actions.