WBF conference winds up

The last day of the WBF conference in Mechelen, Belgium last November was completely dedicated to best practices and pitfalls in the application of ISA95 and to surveys about MES and ISA95.

More than 150 people from 17 countries visited the European conference of WBF that took place last November in Mechelen, Belgium.

The last day of the conference was completely dedicated to best practices and pitfalls to avoid in the application of ISA95 and to surveys about MES and ISA95.

Wim de Bruyn and Bert van Brechem of the University of Gent gave a presentation about the use of MES software in companies that are FDA-regulated.

They said that such companies have to implement their information and control systems following a very strict validation process.

It is very expensive to validate applications; about 10 to 50% of the cost of an application is related to validation.

So in the not unusual case that a pharmaceutical company uses four hundred software applications that all have to be validated, this leads to enormous costs.

But the FDA says that not every application has the same priority when it comes to validation.

How can a company determine this priority for an application?.

They will have to assess the risk of the application.

A risk assessment identifies the unexpected and unwanted events and determines for each risk its probability, frequency, severity and detect ability.

Then the risks are selected, assessed and numbered based on a chance x effect calculation.

The higher the result, the greater the risk.

Note that GAMP provides a guideline for risk assessment.

In the end, you have a long list with risks, but it won't be possible to take measurements for every risk.

The company will have to focus.

What does this all have to do with MES?.

GAMP IV aims at all kinds of software systems.

Companies that use MES software may use standard software solutions, configurable packages or add-ons.

Different levels of validation are needed for different applications.

Complete validation means that the design and build phases of the application go together with some specific test phases, based on GAMP's V-model.

This validation level is suitable for the add-ons.

Normal validation means auditing the quality procedures of the software supplier.

This validation level belongs to configurable data.

And then there is the possibility of user acceptance tests and study of published reviews.

This validation level is suitable for standard MES software applications.

Note that ISPE has developed a GAMP guideline for validation of MES systems.

Jose Gramdi of the University of Troyes explained that ISA95 can help to shorten delivery times, to minimise scrap, to optimise throughput time and to better align maintenance with the production schedule.

"For continuous improvement purposes the availability of an information system is essential".

"ERP systems are only part of the solution".

"They do not provide all the required information".

"ISA95 defines the information needed to realise the improvements mentioned earlier".

"ISA95 also defines how the ERP level and the MES level can exchange this information".

Erna Noordkamp explained how Ordina applied the ISA95 object models for the development of a software layer between ERP and MES systems that are available on the market.

"Such systems can not be connected without adding functionality".

"That functionality has to take care of adding information to orders from the ERP system and changing the information structure".

Noordkamp showed how the ISA95 object models formed the basis for this software and how the translation was made from ISA95 concepts and terminology to ISA88 concepts and terminology.

"This translation is needed because the batch functionality in MES systems is based on the ISA88 standard, whereas the orders from the ERP system are received in ISA95 format".

The framework that Erna Noordkamp described takes care of this translation from ISA95 product segments to ISA88 master recipes and from ISA95 production requests to ISA88 control recipes.

B2MML (Business to Manufacturing MarkUp Language), an XML implementation of the ISA95 standard, was developed by a WBF working group.

B2MML has already been applied in various projects and systems, for example by Citect.

Elspeth O'Brien discussed the steps in vertical integration projects, in which B2MML is applied.

"There are many good reasons to integrate ERP and MES systems, for example the reduction of paperwork, improved scheduling and the availability of better information in ERP systems" O'Brien said.

"Interfaces have to be very flexible, because the boundaries between systems are, in reality, often in a slightly different place than ISA95 defines".

"Companies are confronted with already existing systems that are not compliant with ISA95".

"Many disciplines are involved in ERP to MES integration projects".

"It is important to know who the stake holders are, in other words: which people will be confronted with the effects of the integration projects".

"It is crucial to develop and maintain a thorough communication plan".

"This is the basis for change management, for training and for the involvement of employees".

"B2MML contains nine schemas, but you don't need to apply them all in an integration project".

"You could start with a pilot project, a 'proof of concept', and start with realising just a part of the complete integration".

O'Brien recommends that companies should define sub-projects.

"This will spread the costs and the projects will be less complex".

"When designing the interface, every instance of the schema has to be documented".

"Define the frequency of the message, document where the information comes from and describe the information", O'Brien said.

"It is important to schedule a lower production yield target during the implementation phase".

"This way the company is better prepared for the start up problems".

"For factories that produce 24/7 the availability of current information in the MES system is essential".

"But ERP systems are often in maintenance for about six hours a month".

"Of course an MES system can not wait for the ERP system to be available".

"The MES systems puts it messages in a queue and doesn't have to worry about what happens with the message".

"The middleware layer takes care of this: it takes the message from the queue, translates it and sends it to the ERP system".

O'Brien concluded with some points of concern for integration projects: "Pay attention to risk management; minimise the amount of possible issues".

"Also take care of good project management, including a communication plan that focuses on the stake holders".

"Empower the right people with the right knowledge".

"Two surveys about MES were presented: one by Reinoud Visser from Atos Origin in co-operation with WBF and one by Jan Snoeij from Mesa".

"In his MES Experience Survey, Visser paid attention to the opinion of all parties involved in MES projects".

"Almost 20% of the responses were from end users, mostly from Europe and the United States".

"The other respondents were MES software suppliers, system integrators and consultants".

"The survey makes clear that most of the MES projects take six to twelve months".

"The design and specification phase usually cost more than 20% of the budget, while the implementation phase takes about 30%.

"Half of the MES projects cost less than US $500,000".

"15% of the projects cost more than US $2,000,000".

"On the whole end users are content with the support by suppliers, except database support and 24/7 support".

"These aspects seem to be poorly supported".

"End users also appear not to be very aware of the existence of user groups".

"It is remarkable that SAP is on the list of most mentioned MES software suppliers, together with GE Fanuc, Siemens Orsi and Wonderware".

"MES software is mostly used by the food, pharmaceutical, automotive and electronics industries, according to this survey".

"Licence costs appear to be the biggest part of the cost of an MES project".

Jan Snoeij presented the Mesa survey "Metrics that Matter", conducted by Julie Fraser of Industry Directions in September 2006.

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