How to take the right decision: Upgrade or replace the current MES?

 

In the first part of our blog on Pharma MES migration “5 good reasons to upgrade or replace your Pharma MES” we discussed the signs that show you that you need to do something about your MES system.

The second part is about decision-making: When is the right moment to change? And should the MES system be upgraded or replaced?

Please read more and feel free to add your thoughts and comments.

The right moment for a change

The timing of any planned upgrade or replacement is very much linked to the reasons why the company decides that it is necessary to do it. You should be crystal clear about the risks, impacts and benefits to the business drivers for making the change. This in turn will help you to determine the timings.

The urgency depends on the current situation – which are the internal and external factors you have to consider?

1.   Reliability issues: Make a quick decision – it might be urgent!

Any problem which results in the risk of lost or corrupt data forces the company to make a quick decision to upgrade the system in the shortest possible timeframe. This kind of problem can lead to rejected product, or in extreme cases, put patient safety at risk.

If the system’s performance is suffering, the company has to decide by what degree it is affecting the overall operational performance, and for how long are they prepared to accept this.

2.   Support issues: Take your time!

Where the decision to upgrade the system is driven by costly and restricted support availability, the timelines are often not as urgent. It is very unusual for a vendor to stop supporting a particular version without sufficient notification, and system knowledge does not disappear overnight

3.   Technological factors: Align with other IT programs!

As we discussed earlier, one common reason for the need to upgrade is compatibility with other IT and shop floor systems. Frequently the timing of an upgrade project can be affected by the schedule of other IT programs, (e.g. a corporate ERP roll out or major upgrade of an automation system). These other programs can both delay or bring forward the timing of an MES upgrade, particularly as the same resources are often required for the project teams and they must be executed with minimal disruption to operations.

4.   Business benefits: Fixing urgent problems?

Depending on the nature and scope of the existing MES solution, the expected business benefits that will be achieved from an upgrade could influence the decision. If the benefits contribute to fixing current problems which are causing the company pain, the timing of the upgrade will be more urgent. If the benefits are seen as more long term or are in areas where there is no particular high management focus, the urgency is not as great.

The crucial question: Upgrade or replacement?

Once a company has decided that something needs to change with their current MES, they are basically faced with 3 options:

  • Upgrade to the latest version of the existing MES system
  • Replace with an MES from a different vendor
  • Expand the use of functionality from other systems in the operations landscape

The MES should always be considered in the context of Manufacturing Operations Management (MOM). MOM methodology considers all of the systems involved in the manufacturing process, including ERP, Automation, LIMS, Historian etc. You should have a clear idea of which system will be used to fulfill the business needs and on the required interaction between these systems.

You should therefore assess and determine carefully the future MOM architecture!

4 things that could undermine your preferred option

Even if there appears to be a preferred option from the outset, a couple of factors should be taken into consideration before making a final decision. It may seem initially that an upgrade of the existing system with the same vendor is the easiest option. This may or may not be the case, but the effort involved in this kind of upgrade can be comparable to an alternative solution

1.   Migration effort

Whichever solution is chosen, there will almost certainly be data to be migrated into the new system(s). This means that the company needs to assess the resource efforts required for the following activities:

  • Writing the programs for automatic migration
  • Manual entry of data directly into new system
  • Validation of data migration and data entry
  • Process redesign to make use of new functionality
  • Validation of revised processes
  • Operational impact (system downtime)

2.   Level of customization

The level of customization of the current MES can have an impact on the choice of replacement system. There are companies who try to use the system as close to the standard system as possible, adapting their processes if necessary. Others require maximum flexibility of their processes and allow a high degree of customization to meet their needs. The first category is likely to find that upgrading to the latest version from their existing MES provider is easier. Companies with highly customized systems are likely to prefer systems which are flexible with regard to customization.

It is quite common for companies to change their strategy regarding the desired level of customization. If there is a change in strategy from high customization to ‘off the shelf’, an assessment must be made of the functionality which is not available as standard in the potential solutions, Then it has to be decided for each missing piece of functionality how the business requirements will be met without it, or what the impact will be of allowing a restricted level of customization. There is usually a compromise solution found which is somewhere on a sliding scale between the two approaches.

3.   Standardisation strategy – is one solution for all sites OK?

Closely linked to the desired level of customization, is the company’s strategy regarding standardisation. This can relate broadly to the following areas:

  • IT application landscape
  • Diversity of manufacturing, quality assurance, and supply chain processes
  • Multi-site interaction

As mentioned earlier, it is very common for companies to rationalize their supplier base and IT application landscape. This can lead to the selection of strategic partners, e.g. vendor X is the chosen supplier for MES systems for all divisions of a company. This approach is very common for companies where manufacturing processes are similar across divisions.

However, if there is a very diverse range of manufacturing processes across the company’s divisions, it may not be possible to meet all of the business requirements with a single solution without a considerable level of customization. In this case, an assessment should be made, (based on the manufacturing processes) of implementing more than one solution if this makes sense, (e.g. vendor Y for batch processes and vendor Z for discreet manufacturing).

Some companies require close interaction between various manufacturing sites, (e.g. identical processes copied from one site to another). In this case a solution which allows easy transfer of data between systems (copy and paste of process templates), or multiple site usage of the same system should be considered.

4.   Don’t forget the lessons learned from experience with current MES

As the company has already gone through the experience of implementing and operating an MES, there are lots of lessons which have been learned and which will be invaluable to making a decision on an upgrade or replacement.

You should ask yourself – and answer honestly – the following questions:

  • Were the business benefits achieved?

One of the most important questions asked of any system implementation is whether the expected business benefits were actually achieved. Due to the different drivers for business case development within different organizations, this is not always an easy question to answer. Many companies simply don’t have the data (before and / or after) to be able to make an accurate objective assessment of the benefit achievement. There are, however, plenty of companies which have good data from business KPIs which give quantifiable proof of the level to which the benefits were achieved.

No matter to which type of company you belong, both the availability and lack of these performance measures can help with the decision making process. Companies who have objective data can use these to identify areas where greater benefits are required and can analyse where improvement could be made. Companies without this data, should at least have some of the ‘after’ data available from the current systems. This can be used as a baseline for setting targets for benefit achievement of the upgraded solution.

  • Do you feel at ease with the vendor?

The relationship with the vendor of the existing and proposed solutions are a key factor when considering the available options. Many companies have built up a good partnerships with their current vendor. This is an important part of any business and it can make people very reluctant to consider other options.

Find out further points to consider when making a vendor base decision in our HGP MES Migration White Paper Part 1

  • Clean up of the functional requirements – which ones are dispensable?

One thing which a planned upgrade can prompt is a review of the functional requirements for the system. It is common during the lifecycle of an MES for companies to add functionality which is not fully utilized by the end users. This can be an ideal opportunity to assess under-utilized functionality and either ensure that it will be used in future, or that this functionality is removed.

  • Need a process redesign?

By reviewing the KPIs (where available) and by discussion with the current system users, an upgrade or replacement project presents the opportunity to review the processes which are dependent on the MOM systems. This review will identify areas for improvement and contribute to the user requirements gathering process which should take place. Jump at the chance to redesign the processes and deliver greater business benefits!

  • How can integration issues be avoided?

One of the common problems that companies experience with MES implementations is difficulty with the integration between various components of the MOM landscape. You should definitely look at any problems encountered in the initial project and apply measures to avoid them from happening again. This experience will undoubtedly have an influence on the choice of vendor and systems integrator.

  • What is your roll-out and implementation strategy?

Another factor which must be considered is how the upgrade / replacement will be rolled out, both at individual sites and across multiple sites. Again, you should review the strategy used for the original roll-out to see if there are any learning points that can be used. Depending on the results of this review, a company may decide to use a different approach for the upgrade. This decision can also have an influence on the solution choice, prompting questions in the following areas:

  • Can the vendor support a fast, multi-site roll out?
  • Should the company use more/ less external resources?
  • Will it be necessary to use old and new systems simultaneously?

Conclusion

As we have discussed in these 2 blog articles the reasons for wanting to upgrade or replace an MES usually come from a combination of several factors which all add up to a certain complexity. This complexity and the dependence of manufacturing operations on the existing solutions make the decision for upgrading or replacing an MES not an easy one.

However we all know that we will face a certain moment when we are forced to make this decision, as we will experience with the current MES non acceptable reliability issues, support issues, technology issues, or the need to adapt to new strategic directions. In order to provide maximum benefit to manufacturing operations, we must be clear about how and which solution to be selected – upgrade or migration to an entire new platform.

The second part of this article will discuss how to plan and execute an MES / MOM migration project.

Recommended Reading

The Hitchhiker’s Guide To Manufacturing Operations Management: ISA-95 Best Practices Book 1.0, Charlie Gifford, 2007 ISA

The Road To Integration, Bianca Scolton, 2007, ISA

MES Guide For Executives, Bianca Scholton, 2009, ISA

Defining an Operations Systems Architecture, White Paper #44, MESA International

MES Selection – Best Practices, White Paper #11, MESA International

ISA-95.00.01 Enterprise-Control System Integration – Part 1: Models and Terminology
ISA-95.00.02 Enterprise-Control System Integration – Part 2: Object Model Attributes
ISA-95.00.03 Enterprise Control System Integration – Part 3: Activity Models of Manufacturing Operations Management
ISA-95.00.05 Enterprise-Control System Integration – Part 5: Business-to-Manufacturing Transactions
Annex 11 EudraLex, The Rules Governing Medicinal Products in the European Union

 

MES Migration White Papers

A series of articles discussing migration aspects of MOM / MES solutions for the healthcare industry

Part 1:        Considerations for upgrading or replacing existing MES solutions

Part 2:        Planning and executing MOM / MES migration projects

Part 3:        Healthcare industry MOM / MES solutions market overview (to be published soon)

Authors

Tim Owen

Tim Owen was a healthcare industry professional with over 30 years experience, specialising in the implementation of paperless manufacturing and manufacturing execution systems, business process analysis and process modeling.

He was member of the Global Center of Excellence for MES at Novartis Pharma where, as Business Analyst he supported the implementation of MES at various production facilities.

For the last four years Mr. Owen provided consultancy services for MES implementations and, most recently, enterprise level Serialization initiatives. Sadly, Tim passed away before his time in January 2016.

Thomas Halfmann

Thomas Halfmann is co-founder and managing partner of HGP. HGP is a healthcare industry consulting company with regional headquarters in Switzerland, Germany and Singapore. Before founding HGP, Mr. Halfmann was Global Head Biopharmaceutical Operations IT and Head of the Global MES Program, both at Novartis. Mr. Halfmann is an expert in paperless manufacturing, track & trace, business process analysis and modeling, project management, quality management, and computer system validation with more than 20 years experience in the pharmaceutical and healthcare industry.

Mr. Halfmann provides advisory and strategy consulting for implementation of MOM (manufacturing operations management) and MES (manufacturing enterprise systems) solutions with more than 15 years experience specializing in the MES arena.

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