In the manufacturing world, anything can be outsourced—except accountability.
Any company that relies on suppliers and vendors to provide services or products must also bear the responsibility for managing their supply chains adequately. Meticulous supplier quality management is particularly essential for regulated companies. For example, the FDA mandates that all manufacturers must “establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements” (21 CFR Part 820 Subpart E – Sec. 820.50). In this case, “establish and maintain” means that the procedures have to be documented well enough to stand up to inspections and audits. To ensure that supplier documentation is properly maintained in a secure location, a robust (yet easily accessible to authorized personnel) electronic supplier quality management system (QMS) is critical to success.
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Typical Supplier Quality Management Predicaments
Tracking supplier information, parts, materials, and services can be the most difficult facet of supply chain management. In addition to those illustrated in the graphic above, common supplier quality management problems that companies face include:
paper-based systems: Many companies almost exclusively use Excel spreadsheets to manage supplier quality information. In instances where a company has hundreds of suppliers, disorganized paper-based systems devolve to the point of chaos.
Decentralized, disparate repositories: Data for suppliers is often maintained in multiple locations, usually in some kind of mixture of paper files and electronic systems that have not been validated. This makes accurate reporting and trending incredibly difficult.
Lack of visibility: Many companies’ supplier quality management methods do not provide sufficient insight into each division’s supply chain (a headache that corporate QA professionals know all too well).
Duplicated and wasted efforts: Inefficient supplier quality management processes often result in the same supplier being re-qualified over and over again.
Enterprise-wide inconsistency: Problems inevitably arise when supplier standards aren’t consistent across corporate divisions or when inter-departmental communication about supplier status is unclear.
The Solution: Electronic Supplier Quality Management Systems
Software systems that have been specifically designed to manage supplier quality give users in all departments—quality, IT, management, or even authorized external users—a single interface to access all current and pertinent supplier documentation. Using an electronic supplier quality management system, companies are able to monitor Approved Vendor Lists (AVLs) with ease and make all supplier-oriented processes easier. Consider the supplier-related tasks that your organization could benefit by automating, such as:
Supplier status (state of compliance, contact information, approved parts/components/materials, etc.)
Management of approvals at the individual part or service level
Analytics and reporting of supplier data (with filtering and trending capabilities)
Access to AVLs (enterprise-wide, in real time)
Integration with other quality processes (CAPA, audit, deviation, risk, etc.)
A user-friendly interface that provides a “Supplier View” of all the documents and records related to each supplier is immensely beneficial for manufacturing professionals that need real-time verification of whether or not a particular vendor is approved. A top-shelf supplier quality management software system should also have built-in configurable templates that include custom fields and options such as numbering series and lifecycle as well as dynamically filtered analytics reports and virtual folders.
Who Benefits from a Supplier Quality Management Software Solution?
Consider some of the divisions in your company that could run more efficiently with a supplier quality management software solution. Some of those departments may include:
Quality: Professionals in quality departments need instant access to all relevant, up-to-date supplier status information and vital quality data such as approval status, contact information, recent audits, nonconforming material reports, contracts, approved goods/services lists, supplier ratings, and analytics reports. An electronic supplier quality management system gives these professionals easy access to this information in a centrally located, secure location.
IT: A web-based platform can relieve the burden on IT personnel because it allows all parties (both internal and external) involved in supplier management to stay connected from virtually anywhere. Also, a broad range of software validation products and services are available on the market to choose from, according to an organization’s individual risk assessment and regulatory requirements.
Executives/Managers: Since a supplier quality management software system provides the ability to share supplier qualification data across geographically dispersed divisions, costly duplicated efforts can be eliminated and time to market can be accelerated. Plus, managers and executives can expect an automated supplier quality management system to offer greater visibility into all supplier-related operations.
For More Information on Supplier Quality Management
If your organization uses products and/or services from suppliers that could potentially impact product quality, you need an effective and comprehensive supplier management program to manage all of your supplier-related information. To learn more about electronic supplier quality management systems, visit the MasterControl Resource Center or contact a MasterControl representative.
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.