MES Systems and Benefits

Definition

With so many different variations of MES (Manufacturing Execution Systems) in use today, it can be difficult to define exactly what MES is and how it is used. The use of the system will vary from company to company.

Manufacturing Execution Systems can be defined as systems that record and control the execution of a manufacturing process from raw material to the finished project. Depending on the product being manufacturing and the level of complexity involved, the systems can be simple or complex.

MES generally exists as the layer between the process control (level 2) system and the ERP enterprise resource planning (level 4) system.

The pharmaceutical industry is a shining example of how MES systems can be used for maximum benefit.

Since their inception, most manufacturing organizations have relied on paper records, Paper SOPs (Standard Operating Procedures) and processes to manufacture batches of product.

Although functional, paper records have numerous challenges that can lead to some major issues for the manufacturer.

1. Paper can go missing
2. Paper can get damaged
3. Hand written records can be difficult to read
4. Paper records can be easily falsified
5. There is no accurate verification of timestamps
6. Paper records can be completed anywhere
7. Paper SOPs cannot be 100% enforced or policed.

The removal of paper from manufacturing processed is a major objective of many companies.

MES systems eliminate completely the problems of paper but there is still the challenge of Data Integrity to be considered.

Regulation

For well over 20 years the worlds regulatory bodies have been calling for and providing guidance on the use and implementation of a computer system-based method of producing and maintaining manufacturing batch records.

Many organizations throughout the world have eliminated and reduced paper processed in pursuit of the many benefits can come with the use of MES. There are however still many manufacturing facilities that continue to use paper processes and records as a means of managing manufacturing.

The reasons why some companies stick with paper are:

1. Paper is tangible and flexible
2. People like the tactile form of paper
3. Out of spec or adverse situations can be managed with paper
4. Paper is cheap to run
5. MES systems are expensive to implement
6. MES can be disruptive to the business during implementation
7. Old habits die hard

What are the benefits of MES?

Depending on the use of the system, the benefits of MES can vary greatly. Some of the main benefits include:

1. Removal of paper from the process
2. Faster review time of manufacturing records
3. More accurate records
4. Time stamped audit trails
5. Recording of user access
6. Ensuring people can only follow a consistent process
7. Improved quality
8. Reduced Data Entry Errors
9. Improved productivity

The case for the removal of paper records

The case for the removal of paper records may seem obvious but there are numerous benefits for example.

Within the software system every transaction is time stamped and therefore it is very easy track the sequence and timing around each event and activity associated with manufacturing and actual product.

The main benefits of Manufacturing Execution Systems include:

• Removal and reduction of paper records (including equipment log books) for the reasons detailed above.
• Reduction in production review and quality review activities
• Ease of Batch Reporting
• Improved quality via consistent manufacturing by enforced workflows (i.e. people can only to the right thing)
• Reduce time to prepare for regulatory audits
• Improved quality metrics
• Increased transparency
• Over time improves peoples’ behaviours
• Free up man-hours for more value-add activity

Investigations into manufacturing problems are much easier when using an MES system because all activity is recorded and is a is traceable back to a specific events or conditions.

Equipment and work efficiency can be measured much more precisely with system timestamps.

Underpinning all of these advantages is the main reason for implementing an MES system and this is patient safety. That is the ultimate goal and standard.

Company Leadership Must Drive the Culture

As with all initiatives and journeys upon which a company may embark must have the sincere support of the company leadership. The manufacturing leader’s mindset is hardwired to keep production moving and keep high volumes of product leaving the plant and entering into the supply chain. This is a valuable character trait and is an essential contributor to the success of many organizations.

Underpinning all of these advantages is the main reason for implementing an MES system and this is patient safety. That is the ultimate goal and standard.

When operators are driven down the road of enforced workflows (using and MES system), i.e. they must to the right thing at the right time, as opposed to filling in paper records whenever is convenient, the initial high-level observation is that the new system has slowed down activity on the line.

While enforced workflows can indeed slow operations down slightly, is this a fair price to pay for compliance and quality? Looking at one single facet of the operation can be short sighted. A wider view needs to be taken if the full benefits of MES are to be acknowledged. Instead of measuring one single element of the process, look at the end to end benefits and savings.

In removing paper from the manufacturing process, many types of human error are removed. For every manual signature or data entry removed, a verification of that entry is removed. Hand written data entry errors occupy a huge time portion of the batch review and release process.

Given time, MES can reap many benefits but pharmaceutical manufacturing company leaders must be patient focused and not numbers focused. In these organizations, (and there are many) the leaders make it clear that the priority is to serve the patient at the end of the supply chain. The patient takes the ultimate risk with the end product.

Summary

When implementing MES on a new site or existing facility, be clear on the reasons why MES is being implemented. Set a clear vision for the organization.
Ensure everyone in the organization knows why it is being implemented, what the benefits are and how it will be used.

Keep patient safety at the forefront of the implementation. That is the only standard.
Measure the benefits post implementation and how they compare with expectations.
Nothing is final or ever 100%. The best systems will continue to evolve with the needs of the business and the industry.

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