hgp mes migration part 1

MES Migration 1

A series of articles discussing migration aspects

of MOM / MES solutions for the healthcare industry

Tim OwenThomas Halfmann

MES Migration

Part 1 : Considerations for

upgrading or replacing existing MES solutions

MES Migration 1

Overview

Manufacturing Execution Systems have been around in one or other form since the early 1980s. Many healthcare

industry companies implemented a variety of different MES solutions during the 1990s and 2000s and obviously

these are now near or at the end of their lifecycles. Companies like Siemens, Werum, Rockwell, Emerson and

others have migrated their solutions either to new technology platforms or developed entirely new MES solutions.

Also functionality of MES solutions has increased since the 1990s to cover all manufacturing processes from

API production through secondary manufacturing to packaging, including material management, equipment

management, and electronic batch recording.

Although integration with other shop floor and enterprise systems is common on a limited scale, it is still quite

rare for companies to operate a fully integrated Manufacturing Operations Management (MOM) approach. This

is understandable as technological and budgetary restrictions have previously made full integration a difficult

goal to achieve. Over time however, the vendors of MOM systems have made integration technically simpler and

they have also extended the functionality of their solutions, so there is more opportunity to reduce the number

of different applications in the manufacturing landscape.

The questions facing companies with older generation MES installations fit broadly into four categories:

· Does the existing MES need to be upgraded?

· When is an upgrade or replacement really needed?

· Which solution is best for the current needs of the business?

· How should the upgrade or replacement be executed?

This series of articles discusses some of the factors which need to be considered when deciding on an upgrade

or replacement of an existing MES.

MES Migration 2

Does the current MES need to be upgraded or replaced?

The reasons for wanting to upgrade or replace an MES usually come from a combination of several factors.

The diagram below breaks these reasons down into 5 categories and shows a high level process flow of the steps

needed to assess the business drivers:

1. Reliability issues

The most urgent reason that a company may need to upgrade or replace their MES is if the existing system is

displaying problems with reliability. Usually this will show itself by performance problems, e.g. slow response

times, frequent system re-boots etc.

A more serious symptom of system reliability problems, particularly in regulated industries, is the risk of data

corruption or loss. With this kind of problem, there is obviously a compliance issue. This can lead to scrapping

of product, or in the worst case it can put patient safety at risk.

Determine date of obsolescence

Perform risk assessment

Assess projected support costs

Assess impact on MES

Plan mitigation according

to risk level and projected costs

Feed results into business case

Continuousimprovementopportunity

Prioritize CI initiatives based on business benefits

Use initiatives as input to

business case



Determine date of obsolescence


Assess projected support costs

Assess impact on other MOM systems




Review actual and potential issues



to risk level


Strategic decision

Perform impact assessment of

decision on operations

Assess costs for impact mitigation

Analyze impact and cost to ensure

alignment with strategy


ObsoleteSupporting

Systems

ReliabilityIssuesObsolete MESImprovement

OpportunityStrategicDecision

Business drivers for MES upgrade or replacement

MES Migration 3

2. Support issues

As MES vendors develop new versions of their solutions using the latest technology, they become less interested

in putting resources into support or further development of older versions. This results in either no support for

the obsolete version, or limited support at an increased cost. The vendors want to put their best people’s effort

into supporting and developing their latest products, so there is a risk that the quality of support will also be

reduced or compromised.

An alternative to using the vendor or an external partner for support, is to provide this resource either internally

or by a third party service company, like an engineering or consulting firm. This is sometimes the only option

for a company which wants to keep running an obsolete MES version. The danger with providing the support

internally is that it is usually dependent on a few experienced specialists who may retire or leave the company,

leaving a knowledge gap that puts the business at risk.

3. Technological factors

Technology issues are related to both the MES platform itself and also to other systems which are used in the

manufacturing operations environment.

The most obvious things which will directly affect the MES are the database and operating system versions.

As we have seen with the MES vendors, the database and operating system vendors will eventually make their

older products obsolete. This means that there will come a time when the latest version will not be compatible

with the existing MES. This in turn means that if the MES is not upgraded or replaced, the company has to either

continue on an unsupported platform, or to customize the MES to run on a supported version, if possible.

A big consideration when deciding the need for an upgrade is the overall manufacturing IT landscape that the

MES is operating in. Typically, healthcare companies with MES implementations have interactions with some of

the following systems to a lesser or greater extent:

· ERP

· Laboratory systems, e.g. LIMS

· Automation systems, e.g. SCADA, DCS

· Computerized maintenance systems

· Data historian

· Measuring equipment, e.g. scales and others

These external systems are all continuously being upgraded to use the latest technology too,

so compatibility of interfaces with the MES should be looked at closely.

4. Opportunity to improve

Most of the technology issues we have discussed have focused on the ability and risks involved in maintaining

an existing MES in a changing environment. Another major factor in the decision to upgrade or replace the MES

is the opportunity to take advantage of technological breakthroughs which can deliver even greater business

benefits to a manufacturing organization.

MES Migration 4

Over the years, MES vendors have constantly made improvements to their products. Areas where these

improvements have been made include the following:

New functionality based on experience with customer’s processes

· Simpler and standardized interface design

· Greater data handling capability

· Improved user interfaces

· Use of mobile technology

· Improved capability for communication with automation and historian systems

· Reduced infrastructure costs

· Easier parameterization and customization (depending on strategy)

· Less dependency on customization (depending on strategy)

The last two points here indicate the different requirements driven by different company strategies. Some

companies (usually where they have similar processes at all their facilities) prefer to have a standard, ‘off the

shelf’ system. Whereas other companies (usually where there are very diverse processes in the organization)

prefer a system which can be easily customized to meet the very specific process requirements of all of their

functional areas. These strategies are an important factor later on, when the decision of which system to choose

when upgrading or replacing the MES.

All of the above technological improvements to the solutions can help to deliver real business benefits which

would otherwise be too costly, or even impossible to achieve with older generation MES solutions. So another

major driver to upgrade may come from requirements out of an overall program to achieve the company’s ever

stretching business objectives.

5. Strategic direction

Sometimes the need to upgrade or replace an MES can come from a strategic decision made at corporate level.

It is common for companies to have objectives aimed around reducing the number of IT vendors, have a reduced

number of applications on the shop floor, or to provide a harmonized IT architecture across multiple sites. In

these cases, the focus should be more on the solution to be chosen rather than if the upgrade or replacement

needs to be made.

Using the recommendation given by ISA-95 might be a good starting point to determine the strategic direction

of the future manufacturing operations environment.

MES Migration 5

When should the upgrade be planned?

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 in the first place. As we have discussed in the first section, it is strongly recommended

to assess the risks, impacts and benefits of the business drivers for making a change. This in turn will help to

determine the timing of any implementation.

The initial urgency depends on the current situation that the business is operating in, taking consideration of

internal and external factors as follows:

1. Reliability issues

Any problem which is resulting in the risk of lost or corrupt data forces the company into making a quick

decision for upgrading the system in the shortest possible timeframe. This kind of problem can lead to rejected

product, or in extreme cases it can put patient safety at risk.

If the system’s performance is suffering, then the company has to decide how much it is affecting the overall

operational performance, and how long it can live with this.

A harder decision to make is when potential reliability problems are identified, which have not yet manifested

themselves. In these cases, it is important to perform a formal risk assessment of the potential faults in order

to make an informed decision on the timing of the upgrade.

2. Support issues

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. It is also unusual for support costs to increase

so significantly in the short term that an urgent upgrade needs to be made. Any support or obsolescence based

decision does again need to be assessed against the risk of that support not being available when the business

needs it or with the level of quality required. The same factors need to be considered if it is the MES itself, or the

database or operating system which is no longer supported.

3. Technological factors

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. The coordination of multiple

IT programs is very much influenced by the strategic direction which the company is driving towards.

MES Migration 6

4. Realization of business benefits

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 of when to plan the execution. If the benefits contribute

to fixing current problems which are causing the company pain which has the management’s attention, 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 not particularly high management focus, the urgency is not as great.

Upgrade or replacement – Which solution should be chosen?

Once a company has decided that something needs to change with the current MES, they are faced basically

with 3 options to meet their business requirements:

· Upgrade to the latest version of the existing MES solution

· Replace with an MES from a different vendor

· Expand 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. The company should have a clear idea of which system will be used to fulfill the business

needs and on the required interaction between these systems and assess and determine carefully the future

MOM architecture.

Regardless of which option will be chosen, there are certain steps which should be performed before a final

decision is made. The diagram below shows a high-level process flow of these steps:

Process to assess which option best fits the business needs

Replace with new

MES vendor

Replace with other MOM func-

tionality

Eliminate non-viable

options

Produce solution shortlist

Perform detailed analysis

of options −RFP

Upgrade existing

MES solution

Evaluate user

require-ments

Evaluate viable

options − RFI

Options

MES Migration 7

Things to consider when choosing the preferred option

Even if there appears to be a preferred option from the outset, the factors below should be taken into considera-

tion 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 not too different to an alternative solution and it should not be underestimated. A review of the different

options can be helpful to a company to re-enforce and understand the business strategy relating to MOM,

which may have changed since the initial MES implementation.

1. Migration effort

Whichever solution is chosen, there will almost certainly be some data which currently lives in the MES and will

need to be migrated into the new system or systems. It is very unlikely that it is feasible to migrate all of the

required dataautomatically. Even if this were the case, it would result in a like for like solution, so any benefits

which might be gained from using new functionality could not be taken advantage of. This means that the

company needs to assess the resource efforts required 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.

Most companies fall into one of two categories. Firstly, those who try to use the system as close to the standard

system as possible, adapting their processes if necessary. Secondly, those who require maximum flexibility

of their processes and allow a high degree of customization to meet their needs. A company from the former

category is likely to find that upgrading to the latest version from their existing MES provider is easier than if

they had a lot of customization. Companies with highly customized systems, (and who wish to keep to the same

strategy), are likely to prefer systems which are highly configurable and flexible with regard to customization.

It is quite common for companies to change their strategy regarding the desired level of customization based

on experience gained during their initial roll outs. If there is a change in strategy from high customization to ‘off

the shelf’ system, an assessment must be made of the functionality which is not available as standard in the

potential solutions. For each missing piece of functionality, the company must assess either how they will meet

the business requirements without it, or what the impact will be of allowing a restricted level of customization.

In reality, there is usually a compromise solution found which is somewhere on a sliding scale between the two

approaches.

MES Migration 8

3. Standardization strategy

Closely linked to the desired level of customization, is the company’s strategy regarding standardization.

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.

But 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 these 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. Lessons learned from experience with current MES

As the company has already gone through the experience of implementing and operating an MES, there are

valuable lessons which have been learned and which will be invaluable to making a decision on an upgrade or

replacement.

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 after) to be able to make an accurate objective assessment of the benefit achievement. Others have

based their business case on factors which are sometimes seen as non-qualitative, (e.g. compliance, quality)

and therefore they also do have objective evidence of benefit delivery. There are, however, plenty of companies

which have got good data from business KPIs which give quantifiable proof of the level to which the benefits

were achieved.

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 identifyareas where greater benefits are required and can

analyze where improvement could be made. Companies without these 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.

MES Migration 9

Relationship with 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. Some points to

consider when making a vendor base decision are as follows:

· Are you getting the best commercial deal from the current vendor?

· Is a new vendor offering a commercial benefit which may be short term to attract your business?

· Are the vendor’s strategic goals in alignment with your company’s strategy?

· Does the relationship with the vendor depend on a few key individuals?

· What is the support model for the current and the future MES?

Review of functional requirements

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, particularly where some degree of customization is allowed, for

companies to add functionality which is not fully utilized by the end users. The upgrade or replacement process

can be an ideal opportunity to assess under-utilized functionality and either ensure that it will be used in future,

or that the need for that functionality is removed from the user requirements.

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. Based on the possibilities available by introducing new technologies, there is potential to redesign

the processes and deliver greater business benefits.

Integration issues

One of the common problems that companies experience with MES implementations is difficulty with the

integration between various components of the MOM landscape. It is very important to 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.

Roll-out and implementation strategy

Another factor which must be considered for any upgrade or replacement program is how it will be rolled out,

both at individual sites and across multiple sites. Again, the company 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?

MES Migration 10

Conclusion

As we have discussed in this article, 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 already existing solutions make especially 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 of the existing MES or migration to

an entire new platform. The second part of this series of articles 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

MES Migration 11

MES Migration

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

Authors

Tim Owen is a healthcare industry professional with more than 15 years experience.

Mr. Owen is an expert in 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 supporting the implementation of MES as business analyst at various production sites. Since

2011 Mr. Owen provides consultancy for MES implementation projects.

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 in MES projects.

Contact Details

Please address all correspondence to:

Thomas Halfmann

Halfmann Goetsch Partner AG Phone +41 61 544 00 00

St. Alban-Vorstadt 94 Mail thomas.halfmann @ hgp.ag

CH – 4052 Basel Web www.hgp.ag

Regional Headquarters 12

Corporate Headquarters

Halfmann Goetsch Partner AG

St.Alban-Vorstadt 94

4052 Basel

Switzerland

info @ hgp.ag

+41 61 544 00 00

Asia / Pacific Headquarters

HGP Asia Pte. Ltd.

110A Telok Ayer Street

Singapore 068579

Singapore

asia @ hgp.ag

+65 6636 5101

German Headquarters

HGP Deutschland GmbH

Karlstraße 2

79650 Schopfheim

Germany

deutschland @ hgp.ag

+49 7622 666 86 60

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