Manufacturers are becoming increasingly aware that supplier management solutions are critical to the quality management process. Major companies are making the move to automated solutions that help control the end-to-end supplier lifecycle. This is critical to quality management because an effective supplier management solution can monitor supplier parts issues, identify risk, and help evaluate supplier performance.
Sélectionnez toutes les ressources que vous souhaitez télécharger.
Vendors providing goods and services to companies doing business in regulated environments are only qualified to supply specific products and services. Companies must monitor how their vendors are performing using information from audits, non-conformance reports, supplier deviations and CAPAs. Tracking these issues using spreadsheets can become an administrative nightmare; an automated supplier management solution can simplify identifying vendor quality issues.
With a small number of vendors, it's a fairly simply task to track who is performing well and which vendor to cull from the approved vendor list. As a business grows and becomes more reliant on external vendors, they become more exposed to delivery disruption, vendor bankruptcy and supply shortages. FDA reports the most commonly identified deficiencies in supplier management solutions include:
FDA has begun increasing their focus on pharmaceutical and medical device companies' supply chain management. FDA recently began urging companies to take active steps toward managing suppliers and create more rigorous supply chains.
The Pharma Consulting Blog reports that FDA Commissioner Dr. Margaret A. Hamburg has stated that under her leadership, "the industry can expect to see a more aggressive posture with respect to enforcement. It is expected that the FDA will be provided additional funding to support the enforcement. For this reason, it is believed that companies who manufacture, import and distribute FDA-regulated products will be visited more often by the FDA."
This means the FDA will focus heavily on supply chain management and companies should be developing strong supplier management solutions.
Vendors providing goods and services to companies doing business in regulated environments are only qualified to supply specific products and services. As such, these suppliers must be accurately tracked on a company's approved vendor list (AVL). The AVL must be continually managed and monitored, a complex supplier management system that becomes exponentially more difficult as product designs and manufacturing processes change over time. Further complexities arise as increasing numbers of suppliers interface with or are managed by different departments and divisions across the company.
Avec le logiciel de gestion des fournisseurs MasterControl, toutes les informations concernant l'état et la qualité des fournisseurs (telles que les rapports de non-conformité matière par exemple) sont enregistrées automatiquement dans un emplacement unique et facile d'accès. Outre la simplicité de gestion de la LFA, MasterControl Supplier offre une interface conviviale permettant d'accéder à tous les documents et enregistrements associés à chacun des fournisseurs.
MasterControl supplier management solution automatically tracks and stores supplier information derived from audits, non-conformance reports, supplier deviations, and CAPAs. This electronically managed information can then be easily compiled for supplier quality ratings. Furthermore, suppliers can be approved using MasterControl's robust approval workflow technology.
With MasterControl's supplier management solution, goods or services can be added to the "approved to supply" list simply by linking the goods/services to a specific supplier in MasterControl. Suppliers, conversely, can be added the same way. If a part is linked to a supplier that is not approved, the link will be disabled until the supplier becomes approved or reapproved. All of this information is easily obtainable via MasterControl's built-in reporting tool.
La plateforme Web de MasterControl facilite et optimise l'accès aux données fournisseurs. Des services éloignés géographiquement peuvent ainsi partager des données de qualification avec d'autres membres de l'entreprise, ce qui évite de refaire un travail de qualification coûteux déjà effectué par d'autres et permet de commercialiser les produits plus rapidement.
To learn more about supplier management solutions, please feel free to contact a MasterControl representative.https://www.mondaq.com/unitedstates/article.asp?articleid=83898