Regulation Drives Companies to “Paperless” system, but they Need to Integrated

Regulation is a growing principle required in solutions. The growing demand is coming from increased government regulations on industry around environmental impact, or trace-ability, really driving “Accountability” for actions and being able to determine history fast. Not all the drive is coming from government regulation requirements, in many industries it is being driven by the consumer as a value differentiator for the products.

So we are seeing investments in serialization systems in Life Science and Food and Bev, which extend the existing packaging lines, and are integrated to MES and ERP systems.

But the area that is interesting to me is not this section it is the implementation of “paperless strategies” removing the “clipboard” and replacing it with some forms based software. I have reviewed 3 of these systems, that are driving consistency in capturing of information. Within built rules that drive the user to capture the required points, take the required actions in order to satisfy the particular regulation or combination of regulations required for shipping that product.

While the shift to “paperless” has been a goal for a long while and people have headed down this when implementing a MES (Manufacturing Execution System), this is logical as the drive to paper less in integrated to operational events and practices. Providing an end to end trace-ability, and view into the manufacturing history of the solution.  

What concerns me what I started to see in Oil and Gas, Mining, F & B is these isolated event/ forms capturing systems that are put in isolated from the production/ operations system. Yes they may have some events and points integrated but the procedures are not an extension of the operational system. The captured data is in isolation of from operational/ production data, it should be captured along with the production records of what materials were consumed, who was operating the machine, and what product was going thru the system.

We seeing in the integrated solutions, the tradition operational/ mes system, being extended with a Business Process Modeling system, introducing workflows that can be configured to be triggered from the real time operational systems at Scada/ DCS or at the operational levels. Driving the capture, check, validation of process data boundary violation, or required capture to align with “inspection requirements “ from the ERP. The workflows natively interact between the systems, just extending the process operational processes but provide forms to drive intuitive actions, and capture. 

The most important part is that these are extendable and customization so that your companies capabilities, uniqueness can be captured as “best practices”. Most of all these are not separate systems they native extensions of the MES/ Supervisory automation, Quality applications driving the results and information back into the consistent repository.

So as you look going paperless, avoid doing it in isolation of the other systems, it must be extension, so that the operational process and practices from execution, to quality process, and process management, and extended with regulation requirement in a native way both from an operational experience process as well as data / information integration.

ISA-95 “Vertical” and “Horizontal” Integration

ISA-95 is an international standard which has been used for 20 years; recent transformations in operations management and computing technology has caused some to question its importance.

ISA-95 has now become extremely important – it is necessary to understand what this standard does before we can understand its importance.  This standard is an “information exchange model” focused on “level 3” (operations management functions), with specifications for information exchanges between level 4 (enterprise software) and level 3, and level 3 to level 3.

Before 2010, many operations management implementations were relatively simple, using what the author calls “vertical” integration – the dominant pattern was exchanges between level 3 and level 4, such as the following example:

In recent years, more industrial facilities have adopted the use of operations management software, including many more software components, and more customer industries, such as petroleum refining, mining etc.  For many implementations, the dominant pattern is exchanges between level 3, such as the following example:

In the above diagram, several of these activities are often implemented with multiple applications, such as work management, electronic logbook, laboratory information management, material movement tracking, data reconciliation etc. – some implementations have more than 20 applications for a single site, with multiple sites (a few dozen in a large petroleum company, several hundred in a large food and beverage company).  Much of the information exchange is level 3 to level 3 or what the author calls “vertical” integration.

So, why has ISA-95 become very important now?  One of the main reasons is that information is exchanged 10-100 times more frequently, with 10-100 times more detail.  Materials have sub materials – even mining, petroleum refining and petrochemicals deal with molecules or groups of like molecules.  Lots have sub-lots; work has much greater detail.  Determining the suitability of a previously trusted software application (including the ubiquitous Excel files) for this information exchange becomes easier when assessed against this standard.

ISA-95 and Operations Transformation "How is the Cloud Entering S95 models"

The ISA-95 standard has been in place for over 20 years, and recent progress in operations management transformation and Cloud adoption have triggered questions about this standard.  The author offers an observation:

•        ISA-95 is also essential for radical technology transformation using Cloud.

Currently, there is a lot of hype and misinformation about Cloud, especially for industrial operations.  3 patterns appear from this marketing activity:

How can architecture decisions be made?  Consider the following information model in light of the 3 implementation options summarized above:

Wherever these functions are implemented in different locations (with or without Cloud), what mechanisms are necessary for requirements such as “business continuity”, “access control” etc.?  How much context must be exchanged between sites and the Cloud to recover from network and Cloud outages?  Only an appropriately detailed and standardized information model can help.

ISA-95 focuses on the functions of operations management; it is independent of the implementation, including technology and location.  It is the foundation for designing, implementing and evolving architectures for operations management transformation, especially when Cloud is adopted.

ISA-95 and Operations Transformation

Tyhe questions around S95 where and how to use continue to grow, especially as the guidance for operational system alignment, we though it was time to give an update.

The ISA-95 standard has been in place for over 20 years, and recent progress in operations management transformation and Cloud adoption have triggered questions about this standard.  The author offers an observation:

·         ISA-95 is essential for higher performing operations who are implementing sustainable improvements, in conjunction with best practices such as lean.

Higher performing operations often have the capability to achieve and sustain best practices which directly produce best business performance.  A key enabler to this improvement is exchanging operations knowledge in more detail and more frequently.  Examples include:

•          Tracking of containers in high-volume continuous food cooking, so that successfully cooked containers can be recovered after a machinery failure with compliant tracking and reporting.
•          Assessment and tracking of ore grades in mining from the pit to the port, including in the stock piles and in the rail cars, so that yields and prices can be optimized.
•          Assessment and tracking of chemical components in petroleum refining and petrochemical manufacturing, so that yields and costs can be optimized.
•          Detailed and accelerated distribution of new manufacturing instruction in consumer-packaged goods, food and beverage and discrete/aerospace manufacturing, so that new products can be introduced much faster.

Each of the above examples depend upon exchanging “insight” in great detail throughout the manufacturing/processing and its associated supply chain.  Lean principles can be reliably applied, including eliminating wasted work; specialists can reduce time spent on producing useful information and focus on continuous improvement.

ISA-95 provides an information exchange model, and standardizes how activities are defined and relate to each other, such as quality, inventory, maintenance, production and the notion of “work”.  Sets of information are exchanged as “events”, and the relationships between activities and events are standardized.  Without this information exchange model, knowledge workers don’t have a sustainable operations management system, and as a result, the organization doesn’t have sufficiently useful information.

How can architecture decisions be made?  Consider the following information model in light of the 3 implementation options summarized above:

Wherever these functions are implemented in different locations (with or without Cloud), what mechanisms are necessary for requirements such as “business continuity”, “access control” etc.?  How much context must be exchanged between sites and the Cloud to recover from network and Cloud outages?  Only an appropriately detailed and standardized information model can help.

ISA-95 focuses on the functions of operations management; it is independent of the implementation, including technology and location.  It is the foundation of high performance operations management transformation.