Supplier Quality

Background

ECI was engaged by a medical device manufacturer to lead Supplier Quality remediation activities in response to 483 and Food and Drug Administration Warning Letter Observations and ensure readiness to the European Union Medical Device Regulation (EU MDR).

Approach and Solution

ECI engaged a Senior Quality Engineer to work with the client on determining the scope of the FDA compliance activities as well as new supplier qualification activity in preparation for a new product to be launched globally.

Comprehensive Action

ECI worked with the client and identified wide-ranging supplier non-conformances, such as:

• Supplier Management process enhancements needed to comply with FDA and EU MDR requirements
• Missing supplier audit schedule
• Poor Approved Supplier List (ASL) management
• Missing Supplier Corrective Action Requests (SCARs) follow-up
• Missing supplier audit finding follow-up
• Interpretation of the Corrective and Preventive Action (CAPA) system to send timely updates
• Updates to Quality Agreements (QA) needed

This assessment concluded that a 2023 audit schedule needed to be developed to be able to prioritize EU MDR activities since most of the need was to evaluate and qualify new suppliers. The Approved Supplier List (ASL) was reviewed against the new supplier list which identified a total of 11 new USA on-site audits needed to be performed. These audits were categorized into a risk priority order based on the client's supplier risk categories.

In addition, 2 CAPAs required ownership to drive compliance activities to completion and provide monthly status updates to the agency.

ECI developed detailed audit schedules and trackers, including FDA remediation activities to ensure timeliness and visibility to leadership. This allowed our client to prioritize the appropriate elements for the FDA remediation and EU MDR supplier readiness activities to stay within the new product launch timeline and commitments to the agency.

Remediation activities consisted of:

• Supplier Quality SOPs and associated documents updates and implementation per FDA and EU MDR compliance
• Development and release of a 2023 supplier audit schedule and ownership of 2 CAPAs related to the FDA compliance issues
• On-site Supplier audits and follow-ups on audit findings
• 1 additional CAPA support due to a notified body audit finding
• On-going and new SCARs support
• Updates and maintenance of the ASL
• Negotiated Several QA documents to closure and signature with suppliers
• ASL Management - Ensuring supplier's documentation is stored correctly and reconciled per procedure

This undertaking was completed over 12 months and the activities completed by the ECI team included:

• 26 of Supplier Management SOPs and associated documents completed
• 2 FDA CAPAs completed
• 1 additional CAPAs support
• 11 on-site audits completed
• 4 SCARs
• 85 ASL updates completed and maintained (suppliers)
• 69 new potential suppliers to be added to the ASL (by request)
• 2 Supplier audit scheduling updated and maintained

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Results

The ECI team has successfully completed on-site audits as per the updated 2023 schedule to add new suppliers. They have expertly qualified suppliers and added only the approved ones to the client's QMS and documentation system, using a thorough risk-based approach. All activities were accomplished in a timely manner and in full compliance with the strict EU MDR and FDA regulations.

Lastly, 2 CAPAs associated with the FDA observations were completed within the timeline and no additional observations were found within the supplier management workstream after the agency re-inspection.