The video is part 5 of 8 in the video series on supplier risk management. This video will assess what the state of the facilities say about site management. The supplier audit program for contract development and contract manufacturing should rate management engagement and involvement with the site. Supplier Risk Assessments show demonstrating high compliance maturity have adequate and well-maintained facilities. A well-maintained facility is a window into management engagement at the site. Equipment and facilities that are in a poor state of repair signal poor management engagement. Poor management engagement is a bigger red flag than the state of the facilities themselves. This part of the assessment is not reviewing equipment and facility qualification and maintenance. Those area are reviewed as part of the overall QMS assessment. This assessment looks for a structured program to ensure facilities are maintained and clean (not just the production areas), workspaces show are orderly and there is an absence of clutter. Five S programs reinforce cGMP compliance of the facility. Five S stands for Sort, Set in order, shine, standardize, and sustain. While 5 S is not required, a good program shows the active engagement of management a lower compliance risk.
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