Medical Device and Diagnostic (MD&D) Manufacturing Execution Systems (MES)

Definition.

Medical Device & Diagnostic (MD&D) Manufacturing Execution Systems (MES) are software solutions that ensure quality and efficiency are built into the manufacturing process.  MES also provides error-proofing to systematically enforce that product is made right the first time, every time through paperless manufacturing (electronic device history records, or eDHR). Manufacturing Execution Systems connect multiple plants and provide visibility across sites and even vendors’ live production information, integrating easily with equipment, controllers and business applications. The result is complete visibility, control and manufacturing optimization of processes across the enterprise.


Article.

In the highly regulated medical device industry, it is essential for manufacturers to achieve full FDA compliance and, at the same time, have access to valuable information from the manufacturing process to achieve significant improvement in product quality, operating efficiency, time-to-market performance and ultimately, customer satisfaction. MD&D Manufacturers can do this through Medical Device Manufacturing Execution Systems (MES), also known as paperless manufacturing solutions (eDHR).

Many MD&D manufacturers operate in paper environments, but paper systems are passive, and do not provide control needed to improve product quality and maximize efficiency. MD&D manufacturers use Manufacturing Execution Systems (MES) to maintain the required as-built electronic audit trail of all manufacturing activity, which includes mandatory electronic signatures and verified data collections as examples.  MES enforces business rules to error-proof processes and if exceptions occur, provide immediate feedback in the form of alarms or non-conformance actions.  All this information is stored in a database that can be searched an analyzed to quickly contain issues.

MD&D Manufacturing Execution Systems monitor and synchronize manufacturing activities across globally distributed plants and link them in real-time to the enterprise for optimal performance. MD&D Manufacturing Execution Systems (MES) track product and order details on the plant floor, collect transactions for reporting to financial and planning systems, and electronically dispatch orders and manufacturing instructions to shop floor personnel. MD&D Manufacturing Execution Systems (MES) eliminate human error in manufacturing by providing real-time quality data checks, yield monitoring, automatic enforcement of specifications and business rules, and as-manufactured lot, batch, device or unit traceability – all resulting in improved product and process quality, and higher productivity. Paperless manufacturing (eDHR) via the use of Manufacturing Execution Systems (MES) helps to reduce scrap and eliminates paperwork errors and redundant checks. MD&D Manufacturing Execution Systems (MES) provide the flexibility to model and change complex processes and enforce them immediately. MD&D Manufacturing Execution Systems (MES) also provide the real-time feedback needed to quickly identify and resolve issues for continuous product and process improvement and optimization of manufacturing processes.

Benefits:

  • Waste Reduction – eliminate non-value added activities such as process delay, excess WIP, resource downtime and paperwork
  • Improved Visibility, Flexibility, and Responsiveness – change processes as demand dictates, using simple visual tools and taking advantage of the most efficient production methods
  • Continuous Product Quality Improvement – proactive responses to exceptions and quality problems, immediate access to quality data, management reports, analytical tools to improve produce and process quality
  • Risk Mitigation – Quick retrieval of information that can definitively limit the scope of a quality problem or potential recall. Automatically prevent devices in question from being shipped

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