Manufacturing defects and deficiencies seem to be on the rise, particularly from the many products being imported from overseas destinations.
Of particular concern are the incidences of such manufacturing quality issues as particulates in final formulations. Whether they be unidentified colored specks or precipitates, or more serious glass particles, for example, the concerns of regulators such as the FDA are the same.
These types of defects as noted in the link below (glass particulates), highlight that companies have serious deficiencies in their quality system management at their manufacturing facilities.
At SMART Consulting Group we not only specialize in QMS establishment and operations, but we also supply expert consulting services to remediation situations that full short of prevailing regulatory standards and industry expectations. Working closely with FDA on existing serious Warning Letter and Consent Decree situations (connected with these types of issues), has enabled us to establish processes that help companies meet standards without resorting to inefficient measures that make it difficult for companies to operate.
As Lean specialists we harness process excellence approaches to manage manufacturing issues without sacrificing compliance.
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