The business of tracking information, materials and financials as they move across the supply chain has long been riddled with complexities. This is especially true for manufacturers managing quality and regulatory compliance activities across global business entities, systems and processes – from supplier, to manufacturing subcontractor, to wholesaler to retailer. Even in the information age where data access and sharing are easier than ever before, manufacturers face new sets of IT and operational challenges in the quest to protect sensitive data, optimize the management of standard operating procedures (SOPs), and continually improve performance.
Successful supply chain management requires the effective coordination and integration of workflows across the entire manufacturing operational landscape to ensure that all activities related to a product’s lifecycle are recorded, traceable and compliant. In this pursuit, one of the greatest challenge’s manufacturers face is the ability to monitor the full lifecycle of a product– from the point of its origin, which involves the sourcing of various materials and components — to the point of consumption, whether by the mass market or within a specific customer installation.
Further complicating these efforts are the various sets of standards and regulations manufacturers must comply with designed to ensure the quality and safety of products delivered, be they cosmetics, food, pharmaceuticals or nuclear systems.
Enterprise Information Management (EIM) is a solution designed to improve the management of all structured data and unstructured content that is critical to manufacturing business operations, helping simplify the age-old complexities that have plagued supply chain efficiency and compliance efforts.
Using an intelligent information management system, manufacturers can exercise greater control over unstructured content such as CAD drawings, product sheets, certificates, specifications, invoices, purchase orders and bills of material (BOM) as well as structured data objects such as customers in a CRM system or projects in an ERP solution. The ability to connect unstructured content with structured data objects with an EIM solution has many benefits, such as enabling backward traceability and proof of compliance across the entire product lifecycle.
This paper addresses the issues facing today’s manufacturers and the benefits afforded to procurement, quality control and supply chain managers, as well as to business partners, through the implementation of an EIM solution.
Paperless Quality Management Yields Improved Performance
According to a study by Aberdeen Research, 53 percent of manufacturers surveyed are still utilizing paper-based systems for quality management. The report stresses that implementing manual systems to manage quality and production processes is merely a stopgap as performance cannot be accurately improved – a limitation that defies the core tenet of manufacturing processes. More than 60% of best-in-class manufacturers have migrated away from manual quality systems, and consequently, experience 13% higher operating margins when compared to their paper-based counterparts. These benefits are like those experienced by manufacturers leveraging EIM for information and quality management.
Electronic-based systems not only help to improve quality performance, but they also enable manufacturers to validate compliance with the various standards and regulations they must adhere to such as ISO 9001: 2015, NQA-1 (Nuclear Quality Assurance-1), 21 CFR Part 11 or numerous other FDA or EU regulations.
In the manufacturing environment, nearly every process is documented and controlled under the guidance of internal SOPs and/or external mandates — be it equipment operations, product assembly or maintenance procedures. EIM solutions are effective platforms for managing all manufacturing documents and processes and provide a record of all related compliance activities.
Streamline Backward Traceability Across The Supply Chain
There are key drivers behind a manufacturer’s quest for greater visibility into the product lifecycle across the supply chain, and the desire to enable backward traceability. First, manufacturers are casting a wider net for sourcing materials to help reduce supply costs and increase profit margins. As a result, they are procuring more components from a constantly growing network of global suppliers. At the same time, industry is seeing a significant uptick in outsourcing operations, yet also aiming to make manufacturing processes more competitive and profitable. Both trends require streamlined processes together with suppliers, subcontractors and distributors in order to optimize the management of product recalls notices, replacements and repairs, while also ensuring external partner compliance with internal and regulatory-sanctioned quality and safety processes.
Furthermore, manufacturers are facing increased demands for transparency from customers, business partners and regulatory agencies for everything from real-time project status to proof of supplier certifications.
In addition to verifying compliance, backward traceability is a critical tool in the event of recalls, warranties and repairs. With the ability to log training processes, factory floor incidents and corrective actions, along with supplier certifications, manufacturers can automate the processes of pinpointing quality vulnerabilities in the event of a recall and share up-to-date information as it relates to maintenance and repairs. Without a holistic record of all manufacturing processes and documentation from product origin to distribution, the process of reactive response to unexpected incidents can be devastating to customer loyalty and brand-affinity.
At Vigor, a large volume of project and process documentation needs to be traceable, from the earliest stages of development through the life of the product, which could span 150 years. By using an EIM solution to capture every project component (contracts, authorizations, suppliers, etc.) and organizing those pieces in chronological order and around sets of processes, Vigor gains important visibility into its supply chain.
Just as Vigor requires periodic audits from its suppliers, it too must provide an audit trail of all supply chain activities to comply
Practical Application: A More Intelligent Way to Handle Bills of Lading
So, what does Enterprise Intelligent Information Management look like in a real scenario common to the manufacturing industry?
One of the most critical documents in the manufacturing industry is a bill of lading (BoL). The three principal purposes are (1) it acts as a receipt for shipment, (2) it demonstrates the contract of carriage and (3) serves as a document of title. All details needed to process the progress of goods through the supply chain are contained in the BoL. It also serves as a guide to invoice those goods correctly.
How can an EIM platform help manage Bills of Lading?
The most obvious answer lies in intelligent capture — a process of scanning documents on site and suggestion contextual cues to classify those documents. With intelligent capture, processing BoLs is more efficient and integrated with accounting processes. No more manual data entry. Users can automatically extract, classify and validate BoL data against core systems.
- Increase on-time shipments with higher throughput and fewer errors
- Produce invoices faster and minimize the time-to-revenue collection
- Process more BoLs with fewer mistakes at a reduced cost
- Assign employees to more valuable tasks beyond manual data entry
CAPTURE Gather logistics documents from any source and any location across the enterprise
EXTRACT Content on paper becomes information that can be validated and with your core system
PROCESS Smart workflow that uses business rules and hierarchies to process tasks identify exceptions, and highlight mismatches
INTERFACE Get validated, enhanced logistics data into your ERP or core business applications
DOCUMENT Record electronic copies to support customers and internal controls and audits
Must-Have Tools For Automating Manufacturing Processes
Data shows us the best-in-class manufacturers are those that have migrated from manual processes to electronic automation of quality processes. But to do so effectively, they must rely upon a system that can control all the information assets and workflows that are critical to manufacturing processes to enable backward traceability and continually improve performance. A technology solution should provide businesses the following tools and features to track the entire lifecycle of a product, thus priming them for the most successful manufacturing outcomes:
Fast Access to Manufacturing Information – No Matter Where It Resides
EIM systems enable manufacturers to eliminate information silos created when important data and documents are scattered among different business systems, departments and devices. With EIM, content is not tethered to a specific location – it can be accessed and synced between various systems and devices – with no duplication of content. And with the ability to link structured data (such as ERP-native data) with unstructured content (such as purchase orders, invoices, product delivery documentation, etc.), manufacturers gain a 360-degree view of all aspects of their supply chain. This approach enables manufacturers to trace a product (and all its components) through the distribution network to the end customer and execute backward traceability to the supplier-level in the event of quality issues or events.
Security and Permission Controls
EIM systems can be extended to authorized suppliers and distribution partners to ensure security is controlled across the supply chain. With advanced security and permission controls, manufacturers can link any external party, service or good to part of a process, providing controlled and secure transparency.
Sophisticated security and permission controls are critical to monitoring supply chain quality processes (such as SOP management and tracking of training/learning requirements), and serve to verify that only the necessary certificates, material declarations and safety data sheets are accessible to specified classes of personnel and/or partners.
In a manufacturing environment, any new version of an SOP must be authorized with a supervisor’s signature. Similarly, when new employees or partners access and read training manuals, quality managers must be able to prove that they have done so. With integrated e-signature capabilities, EIM systems capture proof of authorizations and process completion, and if any significant deviation is discovered, a related CAPA can be documented and implemented across the supply chain in near real-time. With e-signatures, manufacturers can track change controls to verify that the impacted individuals have read and understood the new SOPs associated with the CAPA and provide proof of adherence to both quality processes and change controls.
The ability to organize, capture and recall up-to-date documentation, training and manufacturing processes demands time-stamped audit trails. To meet these requirements, EIM solutions organize and manage all quality-related documents and associated processes with complete version history, security, workflow and publishing.
This feature is particularly important to manufacturers in heavily regulated industries, where proof of compliance is both stringent and on-going.