MasterControl Supplier Deviation™
phone: 800.825.9117web: www.mastercontrol.comemail: firstname.lastname@example.org
MasterControl Supplier Deviation™
The supply chain for FDA-regulated companies poses many challenges. Suppliers are considered an extension of thecompany 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 specications. Under very specic circumstances,exceptions from the written specications 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.
How can MasterControl help you?
Many of MasterControl’s regulated customers rely on our integrated suite to automate the process of collecting andcontrolling data critical to compliance. MasterControl Supplier Deviation creates a formal process where suppliers can
request an exception to written specications. Materials are shipped only after the appropriate individuals have reviewedand approved the request and provided proper justication.The solution offers exibility in terms of design, routing, and user and security roles to adjust to the way you work. Itprovides advanced tracking functionality, incorporates escalation, and offers best-practice features that prompt userswith selected data to reduce data entry and avoid mistakes common in manual data entry. Captured data is stored in anODBC-compliant database, enabling reporting and in-depth analysis through our powerful built-in Analytics tools.
Here’s how MasterControl Supplier Deviation addresses some of the major challenges companies face in establishing and
maintaining forms-based processes.
Unavailability of Objective Data on Supplier Performance:
In environments without a formalized or with a paper-based supplier deviation process, objective
data on a supplier’s performance can be hard to come by.
Collection and Analysis of Supplier Deviation Data:
MasterControl Supplier Deviation stores all data on every
requested supplier deviation. This data can be analyzed in
detail and serve as an input to your supplier managementprogram.
Arrival of Nonconforming Material at your LoadingDock:
Without a formalized supplier deviation program,
suppliers may ship rather than investigate in case of
“minor” non-conformances. Processing at the loading dock
and returning unacceptable material after undergoing theincoming QC process creates unnecessary costs anddelays.
Communication of Issues before Material is Shipped:
MasterControl Supplier Deviation allows a supplier to
request an exception to specication before material
is shipped. This eases the pressure on your quality
department to accept the material and increases efciency.
Inefcient Paper Forms System:
A paper-based formsprocess can be plagued with inefciency and such issuesas: lling out the wrong form, not completing the right form,
and sending the form to the wrong person.
Cost-effective Automated System:
automates forms-based processes such as Supplier Deviation and offers best-practice features thatprompt users with selected data. It automates routing,notication, escalation, and approval for faster turnaround.MasterControl is Web-based, so employees, customers,and suppliers can participate in forms-based processes(i.e., data input and verication) from virtually anywhere.