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Regulatory Requirements Pertaining to a Supplier Audit
There are two fundamental elements of the ISO 9001:2000 standard that specifically address the purpose and importance of a supplier audit:
- Organizations must make certain that purchased products and services 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
In relation to the supplier audit, the U.S. Food and Drug Administration (FDA) Guide to Inspections of Medical Device Manufacturers stipulates, in accordance with 21 CFR 820.50 and 820.80, 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.
Although CPG 7151.02 prohibits FDA access to a company’s reports pertaining to a supplier audit, 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 a supplier audit is highly recommended.
Audit Software for Conducting a Supplier Audit
The MasterControl software system for conducting a supplier 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)
- IOP Standards
- GLOBALGAP
- UN Supplier Code of Conduct
- British Retail Consortium (BRC) Global Standards
- HACCP
- SSOP
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.
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 a supplier audit 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:
- Approval status
- Contact information
- Recent information regarding a supplier audit
- Non-conformances
- CAPA reports
- Contracts
- 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 offers 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 system can track and trend the results of an audit report or a supplier audit, as well as CAPAs and deviations.
To Learn More
To learn more about the audit software from MasterControl for a supplier audit (or an internal audit), please feel free to contact a MasterControl representative.
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