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MasterControl Supplier Deviation™

MasterControl Supplier Deviation™

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Published by mastercontroldotcom
The supply chain for FDA-regulated companies poses many challenges. Suppliers are considered an extension of the company and thus must be shown to be FDA-compliant themselves. They have to be evaluated, audited and monitored. Their shipments have to be tested for compliance with a material’s specifications. Under very specific circumstances, exceptions from the written specifications can be made after appropriate review by the quality and engineering departments. However, waiting for this assessment until after the shipment has arrived at your loading dock puts undue pressure on your quality department and creates unnecessary costs in the event that a delivery is declined.
The supply chain for FDA-regulated companies poses many challenges. Suppliers are considered an extension of the company and thus must be shown to be FDA-compliant themselves. They have to be evaluated, audited and monitored. Their shipments have to be tested for compliance with a material’s specifications. Under very specific circumstances, exceptions from the written specifications can be made after appropriate review by the quality and engineering departments. However, waiting for this assessment until after the shipment has arrived at your loading dock puts undue pressure on your quality department and creates unnecessary costs in the event that a delivery is declined.

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Published by: mastercontroldotcom on Jan 06, 2011
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05/12/2014

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MasterControl Supplier™
phone: 800.825.9117web: www.mastercontrol.comemail: info@mastercontrol.com
MasterControl Supplier™
 
Vendors providing goods and services to companies doing business in regulated environments are only 
qualied to supply specic products and services. As such, these suppliers must be accurately tracked ona company’s approved vendor list (AVL). The AVL must be continually managed and monitored, a complex  process that becomes exponentially more difcult as product designs and manufacturing processes changeover time. Further complexities arise as increasing numbers of suppliers interface with or are managed by different departments and divisions across the company.
How can MasterControl help you?
Here’s how MasterControl Supplier™ is giving companies the capability to efciently manage and approvevendor lists and effectively track supplier quality and supplier status.
ChallengesMasterControl Solution
Tracking AVL manually:
Maintaining and controllingan approved vendor list is complex and error prone,particularly when supplier quality information is kept inseparate systems or tracked manually via spreadsheets.
Centralized, connected system:
With MasterControl,all supplier status and quality information (such as non-conforming material reports) is automatically containedin a single, easy to access location. In addition toproviding an easily maintainable AVL, MasterControlSupplier features a user-friendly interface for accessingall documentation and records related to each supplier.
Complications with new parts and manufacturers:
As engineering teams develop new designs, contractmanufacturers and parts must be identied and addedto the AVL. To be placed on the AVL, a supplier must bemonitored on an ongoing basis and must successfullyfulll a number of qualications, such as supplier surveys, supplier audits, and process validation.
Automated tracking:
MasterControl automatically
tracks and stores supplier information derived fromaudits, non-conformance reports, supplier deviations,and CAPAs. This electronically managed informationcan then be easily compiled for supplier qualityratings. Furthermore, suppliers can be approved usingMasterControl’s robust approval workow technology.
 
Difculty to add and track approved parts and
suppliers:
As new parts and suppliers are addedand as suppliers’ approval status changes, accurateand current tracking of parts and suppliers becomesincreasingly more elaborate and difcult.
Simplied adding and tracking of parts and
suppliers:
With MasterControl, goods or servicescan be added to the “approved to supply” list simplyby linking the goods/services to a specic supplier inMasterControl. Suppliers, conversely, can be addedthe same way. If a part is linked to a supplier that isnot approved, the link will be disabled until the supplier becomes approved or reapproved. All of this informationis easily obtainable via MasterControl’s built-in reporting
tool.
Duplication of supplier qualication efforts:
Asnew goods and services are added and as suppliers’approval status changes, accurate and currenttracking of outsourced goodsand/or services becomesincreasingly more elaborate and difcult.
Web-based platform:
MasterControl’s Web-basedplatform makes accessing supplier data easy andefcient. Geographically dispersed divisions have theability to share supplier qualication data with others inthe corporation, potentially cutting out costly duplicationof effort and speeding time to market.
 

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