How To Implement Manufacturing Execution System In Pharmaceutical Industries
Yogendra Yadav
Director of IT | Enterprise Architecture Foundations, Career Management, Strategy Planning
A Manufacturing execution system or MES is a computer software system that governs goods' operational production, from raw materials to finished goods. Implementing this type of system has several different benefits, including more efficient management and monitoring, improved quality, reduced errors, increased productivity and improved worker safety. These systems can also be customized to suit the needs of each company individually.
Introduction
?MES or Manufacturing Execution System, is a software application that helps manufacturers to track and manage the production process from start to finish. It provides real-time data on equipment status, materials, inventory, and labour so that managers can quickly identify and address problems in the production line.
?MES systems are typically used in medium to high-volume manufacturing environments such as the pharmaceutical industry, where they can help improve product quality and reduce manufacturing costs. This blog article will discuss how to implement an MES system in a pharmaceutical manufacturing environment.
What is a Manufacturing Execution System?
?A Manufacturing Execution System (MES) is a software application that provides visibility and control over a company's manufacturing operations. It bridges the gap between an organization's enterprise resource planning (ERP) and shop-floor levels.
?The primary purpose of an MES is to ensure that the manufacturing process runs smoothly, efficiently and as per the quality standards set by the management. To do so, it collects data from various machines and systems on the shop floor and provides real-time insights into the ongoing production. Decision-makers can use this information to take necessary actions to improve productivity or address quality issues.
?An MES also enables the execution of Manufacturing Operations Management (MOM) processes such as work order management, scheduling, material tracking, etc. It can also be used for advanced applications like predictive maintenance, supply chain management, etc.
?In general, an MES should provide visibility into all aspects of the manufacturing process and be configurable enough to support different manufacturing environments.
?How to Implement MES in Pharmaceutical Industries
MES, or Manufacturing Execution System, is a software system designed to manage and optimize production in manufacturing industries. Pharmaceutical companies can use MES to track and control the production process, from raw materials to finished products, as well as to manage quality control and compliance with regulations.
There are many different MES software systems available on the market, so it is essential to choose one that will fit your company's specific needs. Some factors to consider when selecting an MES system include the following:
?-The type of manufacturing process used (batch, continuous, etc.)
-The size and complexity of the production operation
-The level of integration with other business systems (ERP, PLM, etc.)
-The budget for the project
?Once you have selected an MES system, you must implement it in your production operation. This process typically includes the following steps:
?1. Define the scope of the project and create a project plan.
2. Train employees on how to use the system.
3. Configure the system to match your company's processes and data requirements.
4. Test the system in a pilot program before rolling it out across the entire organization.
5. Monitor and fine-tune the system after it has been implemented.
Why MES?
?There are many reasons to implement a Manufacturing Execution System (MES) in pharmaceutical manufacturing. The most important reason is to improve quality and compliance. A well-designed MES can help ensure that products are manufactured according to their specifications and provide real-time visibility into the manufacturing process so that issues can be identified and corrected quickly.
?Other benefits of implementing an MES include reduced production costs, shorter lead times, and improved customer satisfaction. An MES can also help facilitate regulatory compliance by providing a complete record of all manufacturing activities.
?If you are considering implementing an MES in your pharmaceutical manufacturing operation, there are a few things to keep in mind. First, it is important to choose a system that is configurable and scalable to meet your specific needs. Second, involve all relevant stakeholders in the planning and implementation process to ensure buy-in and successful adoption of the system.
?Project Management and Communication Issues
?The first step in implementing a manufacturing execution system (MES) is clearly understanding the project's objectives. Once the goals are understood, the next step is to develop a project plan that considers all of the necessary resources, tools, and personnel.
?Once the project plan is in place, it is important to communicate it to all stakeholders. This includes those who will be directly involved in the implementation and those who will be affected by it. Since this project needs input from a diverse set of functions such as engineering and maintenance, plant production team, Quality assurance team, IT infrastructure team, computer system validation team and IT production informatics team, it needs very well coordination among them. Clear and effective communication is essential to ensuring that everyone is on the same page and understands what needs to be done. Project management and communication are two critical aspects of any successful MES implementation. By planning and communicating with all stakeholders carefully, you can increase your chances of success.
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?Strategy and Benefits of MES Implementation
The benefits of a manufacturing execution system (MES) are many and varied but can be summarized as follows:
1. Increased Efficiency and Productivity: An MES can help to streamline production processes, leading to increased efficiency and productivity.
2. Improved Quality Control:?By automating quality control processes, an MES can help improve product quality.
3. Reduced Costs:?An MES can help to reduce costs by reducing the need for manual labour and eliminating errors and waste.
4. Improved Traceability:?An MES can help improve traceability throughout the manufacturing process by tracking production data.
5. Increased Customer Satisfaction:?By ensuring that products are manufactured correctly and meet customer specifications, an MES can help to increase customer satisfaction levels.
It is important to validate the MES before implementation to realize these benefits. The validation process should ensure that the system meets the specific requirements of the pharmaceutical company and that it will function as intended in the production environment.
The first step in validating an MES is to define the validation scope. This includes identifying all relevant user requirements, functional specifications, interfaces and business processes that will be affected by the system. Once the scope has been defined, a validation plan should be created which outlines how these requirements will be verified and tested.
The next step is to install the MES in a test environment and perform functional testing. This testing should cover all aspects of system functionality, including data collection, processing, storage, retrieval, reporting and interface with other systems. After functional testing has been completed successfully, performance testing should be conducted to verify that the system meets required performance levels such as throughput, response time and capacity.
An MES can improve product quality by providing real-time data on production processes and equipment performance. This allows for the early detection of issues and implementing of corrective actions. An MES can also optimize production by reducing downtime, rework and scrap. In addition, it can provide complete traceability of products throughout the manufacturing process. The most apparent benefit is tracking and managing production data in real-time. This can help identify issues and problems as they occur rather than after the fact when it may be too late to do anything about them.
Other benefits of MES implementation include improved communication between different departments within the company, reduced costs associated with errors and rework, and increased customer satisfaction due to improved product quality. In addition, an MES can provide valuable data that can be used for planning and decision-making purposes. Also, it helps in creating a knowledge base of past failures based on each production batch data. This generates the raw data that can fuel artificial intelligence algorithms to perform predictive and prescriptive data analytics. This further help in real-time production monitoring and enables us to take precautionary measures much before the batch failure resulting in lower production costs.
Overall, the advantages of implementing an MES far outweigh the disadvantages. An MES can be a powerful tool that helps a pharmaceutical company run more efficiently and effectively.
Implementation Strategies for MES
An MES implementation can be a complex undertaking, but there are a few key strategies that can help ensure a successful outcome.
1. Define the business objectives for the MES implementation. What are the specific goals that need to be met for the project to be considered a success?
2. Assess the current state of the manufacturing operation. This step will involve looking at all aspects of the process, from how orders are currently being managed to how data is being collected and used.
3. Develop a comprehensive plan for the MES implementation. This plan should address all aspects of the project, from the installation's technical details to training employees on how to use the new system.
4. execute the plan with care and attention to detail. This is the most critical step in successfully implementing an MES, as any mistakes during this phase can jeopardize the entire project.
5. Review and assess performance after go-live. Once the new system is up and running, it's important to take stock of its performance against the original objectives set for the project. This will help identify any areas where further improvement is needed.
Top reasons for failure in implementing manufacturing execution systems
There are many reasons why implementing a manufacturing execution system (MES) can fail in pharmaceutical industries. One of the most common reasons is that the MES system needs to be better suited to the specific needs of the pharmaceutical industry. Another reason is that the MES system may need help to handle the volume of data and information required by the pharmaceutical industry. Additionally, integrating an MES system into existing business processes and systems can be challenging and, if not done correctly, can lead to failures. Finally, change management is critical when implementing an MES system; if not done correctly, it can also lead to failures.
Manufacturing systems key vendors in pharmaceuticals
The global pharmaceutical market was valued at $1.22 trillion in 2017 and is expected to reach $1.63 trillion by 2023, growing at a CAGR of 5.5% during the forecast period (2018–2023). The major drivers for the growth of this market are:
With the increasing competition in the pharmaceutical market, it has become important for companies to focus on manufacturing efficiency and quality. A manufacturing execution system (MES) is a software application that helps manufacturers to track, manage, and optimize their production process. MES provides real-time data about production activities, which helps in reducing production costs, improving product quality, and shortening time to market.
Some key pharmaceutical manufacturing systems market vendors include Siemens AG, Dassault Systèmes SE, Oracle Corporation, ABB Ltd., Rockwell Automation Inc., Schneider Electric SE, and Honeywell International Inc.
Conclusion
In conclusion, a Manufacturing Execution System (MES) can significantly benefit pharmaceutical companies by improving efficiency and quality control if you're thinking of implementing an MES in your own business, research and work with a reputable provider who can help you get the most out of the system. - Yogendra Yadav
Business Partner @ Shell | Strategy Advisor, Optimization, Facilitation, MBA Candidate
2 年The only thing missing in this article is counter view hence add a pinch of salt to make it more delicious :-). MES systems are not always the best option for big and high-volume manufacturing environments such as the big pharmaceutical industry, oil and gas or food processing company to Implementing an MES system with high run and maintenance cost in scope. This may lead to increased costs due to the need to purchase the system and managed efficiently. The achilles heel is the limited ability to interface with cross functional enterprise level applications at L4 network, gap interns of ML & AI capability and missing end to end solution because no single vendor have those the expertise and desired domain knowledge. In conclusion, while an MES system can be beneficial to a pharmaceutical company, but it is important to weigh the potential benefits in 360 degree view. Just keep business value in centre and not the technology while selecting the MES system as most of the time it's over promised and under delivered.
Deputy manager
2 年Thanks for sharing valuable information Sir