EIM Helps Manufacturers Streamline Backward Traceability, Drive Quality Management and Ensure Regulatory Compliance Across the Supply Chain
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 is 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 challenges 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, transportation equipment 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 EIM 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 percent of best-in-class manufacturers have migrated away from manual quality systems, and consequently, experience 13 percent higher operating margins when compared to their paper-based counterparts.
These benefits are similar to those experienced by manufacturers leveraging EIM for information and quality management. For example, Roal Ltd., one of the world’s largest enzyme manufacturers, exports 90 percent of its products worldwide. The company produces enzymes used by baking, food and feed industries, as well as active agents found in everything from detergent to textile fabrics.
As a biotech company, quality and information management are essential to Roal’s operations, and ISO certifications require that they establish and maintain up-to-date information management practices. Before implementing an EIM system, non-conformances in the production department were documented on handwritten pieces of paper, which were later submitted to the quality control unit to be logged into Excel spreadsheets. The process required multiple steps across various operational departments, and compliance reporting was disjointed and time-consuming.
Since replacing paper records with intuitive online forms within their EIM system, it has become quick and easy for factory floor employees to complete documentation for non-conformance events in real time. And with the ability to connect those forms to people and related workflows, Roal can now monitor incidents and corrective actions, and make more data-driven decisions to better optimize production and quality processes.
Paper-based processes are simply out-dated and cannot be expected to meet modern manufacturing demands. EIM solutions can help manufacturers control, record and continually improve quality processes and performance. Roal maintains a wide range of quality documents, many of which require periodic review and updates. With their EIM system, those documents are assigned a period of validity and, in advance of expiration, responsible departments and personnel are notified via email. If a quality document reaches its valid-till date without update or approval, the document then becomes inaccessible to all permissioned users. Offering the capability to assign metadata attributes to documents, people and processes and automate their connected workflows, EIM unleashes new benefits— benefits that are not afforded by manual, paper-based processes.
Record Quality and Supply Chain Compliance Activities
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.
France-based Lessonia is a manufacturer of cosmetic products and a supplier to the world’s largest beauty brands such as L’Oréal, Estée Lauder and Johnson & Johnson. The company works with a wide range of customers – from small cosmetic companies to the most respected and trusted providers of beauty products around the globe.
Lessonia partnered with French consulting firm Sedasis to deploy an effective method of managing documentation associated with Good Manufacturing Practices (GMP) and at the same time become more responsive to customer inquiries while offering the highest level of security.
Lessonia manufactures several hundred cosmetic products and must manage documentation and audit trails. For each shipment lot, the company must develop analysis certificates, product specifications, delivery notes and invoices with lot serial numbers. All of this documentation needs to be stored in a safe and secure repository, but also made easily accessible to various people and partners across the supply chain. Using an EIM solution, Lessonia is able to define and track the processes critical to GMP, and ensure that supporting documentation is both accurate and up-to-date. As a result, the globally dispersed staff can now collaborate on all commercial documents from each manufacturing batch including invoices, orders and technical files. As an added benefit, compliance reporting is now automated for periodic audits conducted by several different organizations.
There are few industries under greater levels of scrutiny and regulatory requirements than the nuclear sector.
Vigor is a diversified industrial company that builds and modernizes large vessels and fabricates equipment and systems for hydro, nuclear and aerospace industries. The company’s Nuclear Division serves three heavily regulated segments: The Department of Defense (DOD), the Department of Energy (DOE) and commercial nuclear markets.
In its organizational-wide commitment to quality and safety, Vigor tracks the compliance events that are relevant to industry regulations, including both 10 CFR 50 Appendix B (enforced by the Nuclear Regulatory Committee/NRC) and ASME NQA-1, the nuclear quality assurance measures aimed at controlling the safety of products within nuclear facilities.
There are a number of compliance activities that Vigor needs to monitor and audit , and it does so using their EIM solution. For example, as a nuclear supplier, Vigor maintains strict requirements for its subcontractors, which must be certified by audit before a project advances in the manufacturing process. In addition, Vigor’s Nuclear Division has rolled out its own internal supplier performance program to measure the quality and efficiency of supplier network partners. The ability to capture historical progress, incidents and corrective actions offers Vigor the backward traceability capabilities needed to further optimize quality and safety at every point in the supply chain.
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 responsive 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 with 10 CFR 50 Appendix B and NQA-1.
For Brown McFarlane, a global steel processing and manufacturing company based in Stoke-on-Trent, United Kingdom, having a digital documentation trail is critical for backward and forward traceability. With its products deployed offshore in waste and recycling applications and within other high-risk environments, the company must ensure that the metals it uses can be verified to meet stringent quality and material standards.
Certificates from independent testing labs are provided with the sourced metal, and the connection between the metal used in each installation and its associated certificate is key: Brown McFarlane customers are not allowed to operate their installations without these certificates.
Keeping track of thousands upon thousands of test certificates – as well as providing fast and easy access to them — has presented a document management challenge for the company. After wrestling with this challenge for years, the company now uses an EIM system to manage the process. EIM has given Brown McFarlane a paperless and more streamlined approach to certificate management, allowing its team to work more efficiently and reduce operating costs. And whereas previously the company had several people assigned to certificate management to keep up with demand, by digitizing and automating the process with its EIM solution, these Brown McFarlane employees now have more time to work on other aspects of the business.
Must-Have Technology Tools for Automating Manufacturing Processes
Data shows 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 in order 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.
E-Signatures: 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.
Audit Trails: 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.