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Focus on identifying the non-conformances in quality process, production, packaging process, engineering changes, shipment and invoicing at the vendor's site. Training and Accountability All the high quality machines, processes and tests may well go down the drain if the vendor's workforce is not fully prepared to implement them. Make it mandatory that the supplier has appropriate training program for new employees to meet the current GMP quality requirements. Accountability is the key if you want the supplier to maintain integrity and consistency. If management comes forward to own the responsibilities for routine issues, employees will be encouraged to perform their parts in a dedicated manner. General Organisation A well-organized and clean manufacturing facility reduces the chances of hazards and contamination. By auditing the vendor's workplace, you can have a fair idea of how seriously the employees take their work. Do they pay attention to details? Organizational culture in the workplace apprises you of various facets of the supplier and may improve your confidence in them.
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