Any organization manufacturing products or supplying services that involve receiving parts from suppliers should have an audit system in place for conducting an efficient and effective supplier management audits.
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There are two fundamental elements of the ISO 9001:2000 standard that specifically address the purpose and importance of supplier management audits:
In relation to the supplier management audits, the U.S. Food and Drug Administration (FDA) Guide to Inspections of Medical Device Manufacturers stipulates, in accordance with 21 CFR 820.50 and , that:
Particular attention should be paid to custom components and those components that would require special handling or storage to maintain their integrity. Be wary of situations where a manufacturer has relaxed specifications because the supplier could not meet the original specifications which can be identified by conducting supplier management audits.
Although CPG 7151.02 prohibits FDA access to a company's reports pertaining to supplier management audits, the documentation and procedures that indicate conformance with 21 CFR 820.50, Purchasing Controls, and 21 CFR 820.20(3)(c), Management Reviews, are subject to FDA inspection. For all the reasons mentioned above, an effective solution for conducting these audits is highly recommended.
The MasterControl software system for conducting a supplier management audit (MasterControl Supplier) facilitates compliance with a wide range of standards pertaining to a supplier audit such as:
Regulatory standards like these recommend that organizations document all results of a supplier audit, in addition to customer-related activities that could lead to nonconformances are built in the supplier management audit software.
The MasterControl Supplier solution is designed to facilitate compliance by offering an easily maintainable approved vendor list (AVL).
MasterControl's Supplier solution tracks and stores information derived from the supplier management audits automatically, just as it does other supplier-related activities such as non-conformance reports, CAPAs, and supplier deviations. MasterControl Supplier™ maintains information about the supplier audit on the audit report which is stored in a centralized repository.
The MasterControl Supplier solution allows users to supervise suppliers on the AVL on an ongoing basis. It also supports the successful fulfillment of a number of qualifications for a supplier, such as the supplier survey, supplier audit, and process validation.
MasterControl securely stores and maintains all of a suppliers vital information such as:
The information pertaining to the supplier data, which includes the supplier audit, is maintained in a single, centrally located repository. MasterControl's supplier management audits offer users a variety of functionality options including:
The MasterControl supplier management audits system can track and trend the results of an audit report or a supplier audit, as well as CAPAs and deviations.
To learn more about the supplier management audits software from MasterControl, please feel free to contact a MasterControl representative.