A couple of years ago, contract manufacturer Sparton Corporation faced increasing demand for high-quality, highly complex products that were delivered as quickly as possible. The multisite contract manufacturer serves highly regulated end markets, including the medical device industry. With customer needs that range from advanced robotics and lasers to sophisticated medical devices, product quality is of utmost importance to meet complex regulatory requirements. To meet its increasing demand effectively while also meeting compliance and traceability requirements, the company found itself monitoring numerous data sets across multiple facilities.
To advance its world-class manufacturing operation, Sparton implemented Aegis’ FactoryLogix MES across several sites to establish a “single source of truth” for all manufacturing data. Today, access to a unified data set in real time allows operators to enforce quality control and reduce risk. This article examines the reasons behind Sparton's decision to implement FactoryLogix as a manufacturing execution system (MES) solution. It also looks at how using a big data analytics approach has allowed Sparton to provide customers with a most effective and efficient approach to regulatory compliance.
The Challenge: Disparate Sources of Data Limit Deep Traceability
To ensure safety for the end user — the patient — medical manufacturers must deliver only the highest quality products. Regulatory requirements from FDA include Title 21 CFR Part 11, which states that manufacturers must establish a system of controls, electronic documentation, and audit trails. In the event of an audit or recall, full product and process traceability must be available through a device history record (DHR) or electronic device history record (eDHR). Compliance with this regulation requires collection and control of thousands of data points.
In 2014, each Sparton facility had its own method for collecting data, which was a combination of Microsoft Access databases, Excel documents, and homegrown applications. Reliance on multiple data systems and paper-based work instructions limited shop floor visibility. This created costly rework and long turnaround times for customers. These disparate data systems also made deep traceability difficult to achieve.
Sparton considered two separate strategies to address these challenges:
- A solution based on the traditional approach to traceability — with compliance and traceability as the single end goal.
- A solution based on a single source of manufacturing truth, which would ultimately result in multiple advantages, including compliance and traceability as by-products.
The Decision: MES Establishes a Single Source of Manufacturing Truth
The traditional approach to traceability views changing regulations as a burden and attempts to simply do as little as will meet the requirement. While this strategy is one means to an end goal of compliance, it is shortsighted in that it does not adapt to prepare manufacturers for future changes in the regulatory landscape.
During their decision-making process, Sparton management realized that all existing challenges could be addressed by implementing an MES. This smart factory approach would leverage data from robots, conveyors, testers, inspectors, sensors, and scanners to support complete process improvement and would result in full traceability as a by-product.
Alternative Options: ERP and Homegrown Systems
As part of their formal request for proposal process, Sparton considered multiple solutions, including extending its existing enterprise resource planning (ERP) system and expanding its homegrown solution. Designed to handle the financial planning aspect of Sparton's business, the company's ERP system did not allow for detailed CAD-to-BOM comparisons and the capture of critical data from the shop floor. The option to further develop its own internal solution would further compound the number of data sources and would take many months of customization to be fully functional.
Selecting an MES for Compliance, Adaptability, and Data Integration
Sparton required one consolidated software package that spanned all of its needs, including a system capable of enforcing the tightest quality-control measures to ensure safety to the end user and assist in compliance with specific regulations. The contract manufacturer needed to provide complete eDHRs with subassemblies and e-signatures to support FDA 21 CFR Part 11 for customers in the life science industries. The company also looked for a quality management system that validated continuous improvement to support AS9100C certification for their aerospace and defense customers.
Traceability to track factory processes and minimize the scope of any product recalls was another main component in MES vendor selection. After review, Sparton found that FatoryLogix offered the most comprehensive system for tracking serialized product for medical and defense customers. The software would introduce a paperless or digital factory system to manage the entire digital thread from importing design data, through revision control and work instructions and bill of materials to final dispatch, along with control of revisions and engineering changes.
“We had multiple requirements to facilitate FDA compliance and ITAR compliance. When we made our selection, we needed accurate and real-time eDHRs to tell where the product was and who worked on it through any point in the production process. Product genealogy and traceability was critical because we had to be able to prove all steps, sub-assemblies, and components that went into the top-level part,” says Ryan Wells, information systems manager at Sparton.
Given its diverse product portfolio, Sparton also chose this MES based on the system's advanced adaptability including integration with new and legacy production machines as well as other ERP and product lifecycle management (PLM) systems. It also included the ability to adjust to batch-mode processing, lot-mode processing, and serialized processing for both printed circuit board assembly (PCBA) and box-build applications.
Finally, the MES was chosen based on its data integration model and the software's capacity for bidirectional communication with machines. Aegis’ vast library of xLink adapters would allow for an out-of-the-box connection into Sparton's multiple machines. The universal system database found in the MES would transform the disparate data types into streams of standards-based data that could then be harvested for detailed analysis.
Advanced Reporting to Fulfill Traceability Requirements
Based on the diversity of its customers, Sparton needed a single system that could slice data sets in multiple ways depending on changing needs and regulations. This functionality would provide customers with the highest level of manufacturing insight based on precise data. In addition, the ability for operators to configure and generate their own reports would ease the burden on the IT department and speed up the reporting process.
FactoryLogix makes all of these data available via comprehensive trace reports that extend far beyond the materials content records. Reports that serve as eDHRs include the product's genealogy, the route, the operators and machines and times the unit passed through them, test results, parametric data, quality data, rework and replaced component history, machine data, recipes, packaging records, tooling used, and even the personnel that approved the release of the production order to the floor. With drag-and-drop dashboards and mobile interfaces that operate in real time, the MES allows staff to build custom reports in a simple manner, without any knowledge of SQL, scripting, or IT.
Implementation and Deployment: A Tiger Team Approach
To implement the MES as efficiently as possible, Sparton created a “tiger team” comprised of MES users from four different facilities. This synergized MES group created a standardized, cohesive system that helped de-silo communications as each site's deployment progressed. There were some cultural barriers to change resulting from different definitions of what MES meant at each facility. Focusing on one cohesive definition of MES and a single data set helped speed adoption and effective implementation.
The speed of deployment of Sparton's MES averaged four months across multiple facilities. Integration included merging the MES with all existing systems including material movement through its ERP system, back-feeding of all shop floor data back to other systems, and configuring its shop floor dashboards to display a combination of MES, ERP, and PLM data.
Training of operators took place through Aegis’ FactoryLogix University, which offers users the flexibility to learn the software through on-site or online courses. Some users attended instructor-led training courses at Aegis headquarters, while others attended remote online training sessions from their own locations.
The Result: Improvements in Quality Control through One Data Set
Today, a consolidated data set across facilities allows Sparton management to “lift lid off the factory” to monitor critical quality information and enables subsequent corrective action in real time. Early defect detection is possible through triggered alarms on the factory floor that will stop the line when a defect threshold has been met. Material and tooling setup and certification — a critical component for reverse traceability lookups — is enforced.
The software is configured to stop users from proceeding if they are not trained or certified, and it verifies that only personnel with the appropriate clearances or training status are permitted to work on specified orders, jobs, and lots. The MES supports FDA CFR Part 11 through electronic signatures and approvals, training verification, and two-factor authentication. The software also supports ITAR compliance by providing the highest level of security in the form of active directory security support, where user rights and roles within the system are mapped to the users in the corporate active directory.
The Result: Risk Reduction with a Paperless Factory
The paperless factory model in the MES provides a documentation system that is guaranteed to be under control at all times. Incorrect documents are prevented from presenting on the shop floor, helping minimize the risk of defective product leaving the factory and reducing the risks associated with non-compliance. Revision control is no longer manual but fully automated and ensured throughout the factory. Interactive visuals with guaranteed current and proper parts list and CAD information increases assembly quality, inspection reliability, and diagnostics and repair accuracy. Access to digital DHRs provides documentation of all processes, verifying that training records are current, equipment is qualified, the right materials are used, and all data is recorded.
The Result: Increased Visibility from a Connected Digital Factory
The fully integrated MES allows for real-time collaboration and data sharing, including computer-aided design diagrams and 3D images. The consolidated system allows for complete traceability, extending back to the process planning and even to R&D and design via CAD data. The ability to reference a single data set has improved communication between engineering, production, and operations, allowing Sparton's business to pivot quickly in response to customer changes. Just by scanning a unit, the correct revision assembly instructions, videos, CAD image, BOM information, and all associated work practice instructions and supporting documents can be made immediately available at every point along the route. The MES tracks the entire production flow from start to finish, including materials used, tools, operator and machines involved, to provide keys against which a group of serialized units can be recalled.
The Business Benefits: Future Proofing and Return on Investment from MES
As today's regulatory requirements evolve and customer demands for greater traceability follow suit, Sparton has an easily configurable system in place to quickly respond to these changes. Implementing the right MES solution has allowed the manufacturer to future-proof its processes because the scope of the MES can easily adapt to changing requirements without custom engineering.
The single cohesive set of data now provided through the MES uncovers hidden correlations across multiple plants, enabling continuous manufacturing process adjustments. Since implementing a consolidated data set, some of the measurable improvements seen at Sparton's facilities include the following:
- A return on the company's software investment was realized in just four months.
- 5 percent reduction in defective parts per million.
- A drop of 30 percent in the average assembly rework time.
- Deep traceability available all the way down to individual reference designators.
- Across six sites, Sparton displays more than 25 custom dashboards and reports with an average development time of one hour.
As Sparton continues to take on new customers, it plans to expand the MES to its facility in Ho Chi Minh City, Vietnam. The company has also recently implemented FactoryLogix R3's Logistics module at several sites, further optimizing resource scheduling and incoming quality control, and introducing a mobile app that increases operator mobility throughout the factory floor and stock room.
Beyond the pressure that all manufacturers face to remain profitable in the market, Sparton faced simultaneous demand from customers and regulatory authorities to produce the highest quality products. Using a holistic big data analytics approach to integrate disparate data sources across multiple facilities allowed Sparton to enhance quality control while achieving end-to-end traceability as a by-product.
Access to the right data, at the right time now allows the company to make well-informed and proactive business decisions. Implementing Aegis FactoryLogix MES to harvest, analyze, and store factory-critical information has resulted in quantifiable improvements in enterprise-wide visibility and has reduced risk.