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.