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Revamping Supplier Quality blog


The FDA found that not following your procedure is a problem.

A multibillion dollar client had a supplier quality process that was not being executed, and was not aligned to regulations (2CF820.50). Suppliers were not being audited at the prescribed regularity, some suppliers rated as low risk were making high risk parts, and others supplied product that did not meet current specifications. The results of an FDA inspection resulted in a Warning Letter that ultimately required third party audit certification. The organization had to react by proposing a plan to halt distribution of two product lines in order to focus on a permanent and comprehensive systemic solution.


Develop and implement a realistic, high performance process.

R&Q was brought in to plan, lead, and execute the remediation. This entailed driving a timely restart of the two suspended product lines. Our project management directed a gap analysis of the Approved Supplier List (ASL) and a process modification to ensure inactive suppliers were removed from the ASL. R&Q developed and owned the supplier audit plan, improved the part qualification and special validation processes, and provided appropriate training covering these changes. Monthly quality business reviews with suppliers were implemented to monitor quality and warn of potential negative trends. As of a result, a number of suppliers needed to be put on probation requiring additional attention to bring them to a satisfactory state. Additionally, supplemental R&Q staff performed audits of the supplier base (250+ suppliers) based on risk classification. 10 supplier quality engineers executed part qualification activities on over 4,000 parts/sub components. During this process R&Q actively engaged with suppliers, design engineers, and quality engineers in a variety of ways, including material review boards, change review boards, part redesign, and re-supplying of qualified materials.



Re-establishment of both product lines on 16-month target.

Supplier part qualifications, special process validations, supplier audit results, vendor order packages, and production records related to the first batch of products in each line were assembled. The results of the revamp effort were presented to the third party auditor who reviewed the new processes and associated records for adequacy. Results of the thorough audit allowed resumption of distribution of the two product lines on schedule. Successful results from subsequent quarterly audits have allowed continued production for over a year after initial approval.


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