Regulatory Requirements Pertaining to Supplier Management Audits
There are two fundamental elements of the ISO 9001:2000 standard that specifically address the purpose and importance of supplier management audits:
- Organizations must make certain steps regarding purchased products and services that they should meet specified purchase requirements agreed upon when the vendor was initially selected.
- Organizations must evaluate and choose suppliers based on their ability to offer products and services that meet the organization's requirements which can be effectively identified by conducting 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.
Audit Software for Conducting Supplier Management Audits
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:
- ISO 9001:2000
- Current Good Manufacturing Practice (cGMP)
- Supplier Management Audits Compliant to IOP Standards
- UN Supplier Code of Conduct
- British Retail Consortium (BRC) Global Standards
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:
- Supplier management audits approval status
- Contact information
- Recent information regarding a supplier audit
- CAPA reports
- Approved parts lists
- Supplier Ratings
- Links to quality assurance auditing and analytics reports
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:
- Creating new suppliers within the system
- Viewing lists of suppliers
- Searching for suppliers that meet audit requirements
- Importing supplier information
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 Supplier Management Audits
To learn more about the supplier management audits software from MasterControl, please feel free to contact a MasterControl representative.