A medical device manufacturer (legal manufacturer) developing therapeutic lasers and based in the United States had their contract manufacturer based in India. The contract manufacturer was responsible for the development and production of therapeutic lasers as per the service agreement. The contract manufacturer was bound to undergo a supplier audit in line with the requirements of ISO 13485:2016 to ensure ongoing surveillance of supplier activities by the manufacturer. The legal manufacturer sought Elexes’s support in conducting an audit of its contract manufacturer.
To conduct a supplier audit at the contract manufacturer’s facility and ensure compliance with the ISO 13485:2016 standard requirements by verifying adherence to the agreement signed between the legal manufacturer and supplier.
Approach and Solutions
Phase I: Audit Planning
- An Audit team with the appropriate expertise qualification and experience was shortlisted and the Lead Auditor was finalized.
- An audit plan was prepared by the Lead Auditor. This plan consisted of the following:
- Scope of the audit in line with the supplier Agreement
- Audit Criteria
- List of attendees
- Description of processes to be covered each day, time allotted for audit of each process, personnel to be interviewed for each process, and the location of the audit for each process.
- Draft a Supplier Audit Checklist to record the evidence provided by the supplier against the checkpoints listed in line with the requirements of ISO 13485:2016.
Phase II: Audit Execution
- A pre-inspection meeting was conducted by Elexes’s Audit team at Supplier’s facility for a brief introduction of the team members and finalization of the Audit Schedule.
- The Lead Auditor interviewed the Auditee as per the audit schedule and took samples of records to record evidence against each of the requirements stated in the audit checklist. The following areas were audited in specific:
- Document and record control procedures and records
- Change control procedure and notification of changes to the Legal Manufacturer
- Product cleanliness procedure
- Personnel training records
- Device manufacturing procedures and Production records (Device History Records – DHR)
- Equipment calibration records
- Incoming inspection records for raw materials
- Non-conforming material procedures and records
- Corrective Action / Preventive Action (CAPA) procedure and records
Phase III: Audit Closure
- The Lead Auditor drafted the audit report and communicated the findings to the Auditees. Some of the significant findings observed during the audit were:
- The definition of the term “Complaint” was not provided in the documented procedure for complaint handling against the requirements of Clause 8.2.2 of ISO 13485:2016 and the term was not consistently understood across the organization, as a result there were some discrepancies observed in the decision making of whether or not something is a complaint.
- The finished product inspection records were not satisfactory as per Clause 8.2.6 of ISO 13485:2016 and did not reflect the impedance inspection on the power supply cord.
- The Auditee/Supplier was provided a specific time frame for addressing the deficiencies observed during the audit inspection and submitting a corrective action plan to the Auditor.
- The Corrective Action plan was submitted well within the allowed time frame and verified by the Auditor.
- The audit was closed and the audit report was provided to the Legal Manufacturer by the Lead Auditor.
Supplier audits are an essential part of a manufacturer’s Quality Management System which not only helps a manufacturer in evaluating their suppliers on an ongoing basis, but also helps a manufacturer in demonstrating compliance with the regulatory requirements for different countries. The key to a successful supplier audit is in the selection of appropriate personnel who have years of experience working in the medical device industry and who possess the required expertise in conducting such audits.
Are you looking to conduct a supplier audit for your organization?
Look no further, Elexes is here to help you. Our dedicated team of auditors with years of experience is ready to support medical device and IVD manufacturers throughout the supplier audit process. Contact firstname.lastname@example.org today!