EWI – Lightening in a Document

First, I’d like to thank  Grant Vokey, Gerard Ipskamp, and Jean-Luc Delcuvellerie for their contributions in the LinkedIn Manufacturing Execution Systems Group discussions.   I find these group discussions to be a rich and thoughtful source for all things MES.

Electronic Work Instructions, what are they?  Good question…  you may not like the answer.   The only way to answer this is to understand, at a high level, what they could be, and at the ground level, how they are implemented in different packages.   

 First, it helps to understand where they’ve come from.  Standard Operating Procedures, SOPs, have been part of the manufacturing environment since production managers could write down instructions.  Typically you’ll find these kind of instructions on the production floor on a laminated sheet (or sheets) hanging at an operation or bound in a humongous book in the quality office for every product and procedure.  They’re a big step in the right direction.  Getting your people to know what the right process is, and following that process is huge.  So…  problem solved?  Not really.   So, thinking that through… what happens when I have a change to the document?   Let’s say R&D has improved the operational procedure for a handful of products.  How does the change happen?  New documents are printed and distributed to the right locations.  When do you change over?  How do you coordinate the release of the document with when you want that new procedure put in place?  And this is really the simplest case.  Let’s consider what else might be in that SOP.  If we include setup instructions, quality inspection instructions, or production data collection instructions in the SOP, this document becomes a living document.  Each area of information may be managed differently, by different groups.   In addition, the information for each may or may not be related.  How do you coordinate this disparate data?  How do you make sure the right data is updated in the document at the right time and appears at the operator when it’s supposed to?

Managing this kind of information in a pure text document is both difficult and ineffective.   This has driven the need for Electronic Work Instructions, EWI.   So… what could EWI be?  Since there isn’t a definition in Wikipedia, I’ll make one up.  It could be an electronic document that contains embedded data fields that can be managed and distributed either automatically or according to some scheduling criteria.   I would add that there are some ancillary functions that actually make this manageable and useful:

• Document Versioning – An important feature, especially useful in a flexible production environment, or where rapid product changes occur.
• Review and Approval – The ability to create/modify a document and route it for review and approval.
• Data Integration – The ability to add or update data fields in the document based on an external data source (e.g.  Control Limits for a given product and operation).
• Distribution Management – The ability to schedule document distribution or initiate distribution based on business rules (such as release coordination with new products).
• Hierarchy – The ability to structure a master document with related sub-documents.  For instance a master document for Product A may contain sub sections for production, quality, safety, sanitation, etc.  Each of these sub sections may be divided into smaller divisions based on operations for instance.
• Security – The ability to control who may read, create, or modify documents.
• Electronic Signatures – Having the ability to record sign-off on a document is incredibly useful.  This is usually the cornerstone of becoming CFR 21 part 11 compliant, providing auditable records that can be easily retrieved and reported.

Once we’ve created a document and know how to publish it when we need to, we also need to be able to control access to it.  Actually, we’d like to coordinate document access with production processes, so that the right document (or sub-section, or sub-section item) is made available based on production conditions.  What conditions?

• Operations – Displaying the right document item based on the production operation
• Product – ditto for the product, usually in combination with Operations.
• Quality Status – Showing the right quality procedure based on sampling results and showing the procedure for further testing/evaluation.  Things like Hazard Analysis and Critical Control Points, HACCP, Corrective and Preventative Actions, CAPA, and Material Review Board, MRB fall into this category.
• Setup or Changeover – Displaying the right document for machine/unit setup based on a product change.
• Sanitation or CIP – Displaying the right document for sanitation or clean in place operations before or after a production run.

All of the above require extensive coordination.  That’s why EWI has become more main stream in MES applications in the last few years.   You mean EWI creation and management in MES?  Well… Yes and no.  Yes, there are packages that have most of the required EWI capabilities in them.  What better way to determine current production state than through MES.  No argument from me.  MES applications typically have an intimate awareness of operations and the production state.  The issue is the information embedded in those documents.  Much of what should be there comes from Product Life-Cycle Management, PLM, applications, Enterprise Resource Planning, ERP, applications, or Laboratory Information Management System applications.   If you create those documents in a MES EWI function, then (if you don’t have some mechanism for automated updates) you have to manage that information in multiple systems.  You just don’t want to go there.  Better to use the MES EWI as a kind of reference engine, letting it retrieve the appropriate document from another location or system based on production conditions. 

So if we only point to the documents we need from MES, where should the documents be created?  No simple answers here.  ERP’s typically have some capability to create and manage these documents.  PLM’s are usually a better place to keep/manage them simply because the majority of the information needed is managed there anyway.  PLM’s also usually have the ability to distribute those data elements (like limits, set-points, sample id’s, etc) to other systems.  PLM’s aren’t for everyone however.  They aren’t cheap and require a resource investment to keep them fed with current and accurate data.  However you choose to implement EWI’s (or a combination of EWI and document management) there are some important factors to consider:

• Minimize the management of document data to as few systems as possible – keeping systems synchronized can be painful and unreliable.
• Use the MES EWI system to refer to documents – freeing the MES EWI function from document management functions simplifies the MES configuration and keeps the data in the system of authority.
• Develop alignment between systems – Making sure the ERP operations and the MES operations share common boundaries will ensure that the right document with the right data arrives at the right time.
•  Data Integration – Mapping out where and how data is managed before implementing an EWI can significantly reduce data integration requirements and significantly increase data accuracy and timeliness.

EWI can make dramatic improvements in production efficiency and quality.  How you choose to implement it really depends on your product mix, production complexity, and to a large part your IT infrastructure.

MESA Part 4 – Laying the Foundation for Change

This posting continues our discussion of how to apply Business Process Management methods to implementing MES. 

In previous discussions we talked about the materials we needed to prepare for a series of Consensus Workshops.  What are Consensus Workshops?  That requires a little background. 

What is a Consensus Workshop?

For the selected functional areas (see below) subject matter experts from each of the affected departments or functional areas are assembled to; review the current As-Is state and shortfalls, generate a To-Be state process flow, determine how the process flow addresses the shortfalls and the company objectives and strategy, develop a list of the gaps between the To-Be state and those shortfalls left unaddressed, and address the change management issues related to the future state processes.

What are the topics for the Workshops?

The full list of topics available for holding Workshops follows the ISA-95 Model:

1. Production Control
2. Quality Assurance
3. Maintenance Management
4. Material and Energy Control
5. Product Inventory Control
6. Production Scheduling
7. Procurement
8. R&D
9. Order Processing
10. Cost Accounting
11. Product Shipping

Some notes on this list:  You can usually combine Material and Energy Control with Production Inventory Control under a single topic Inventory Management (as it is in the MOM).  This allows you to address raw materials, WIP, and finished goods discussions in a single workshop.  If Energy Control is a significant topic, create a separate workshop for it.  Don’t discount the Cost Accounting and Order Processing discussions, they may be short but they can be significant.  For example, determining how product unit costs are evaluated can affect critical KPI’s and incentives.

How do we select the topics?

As you prepare the As-Is state process flows and gather shortfalls for the way you currently do business, a picture emerges of areas that need attention or present opportunities.  You could hold a workshop for each area of the ISA-95 model, one for all the activities in Production Control, one for all the activities in Quality Management, one for all the activities in Procurement, etc.  Do you need to hold a workshop for every area?  That depends on how comprehensively you intend to apply an MES system.  Another way to look at it is to identify those areas with the most problems and the most opportunity for payback.  It’s a trade-off, expediency and short-term payback versus comprehensiveness and longer term payback.

A few of the advantages of selecting a limited number of areas are;

• It is usually easier to determine the true ROI for change.
• It’s easier for participants to understand the value of the change. 
• It requires fewer resources to implement.  

Remember it’s a trade-off.  There are also advantages to the comprehensive approach;

• Having a full picture of the numerous and various interfaces between systems and implementing them one time is much more efficient, 
• Even if you don’t implement all of the future state or To-Be processes you will have a long-term plan to work towards,
• It’s easier to implement full-scale change while you have your foot on the gas.

Next Time:  Creating the Framework for Change

MESA Part 3 – Delivering Value through BPM Workshops

This post continues the discussion of how to apply Business Process Methods to implementing MES based on the ISA-95 standard.

As you recall, we had to develop some material before holding consensus workshops.  It goes something like this :

1. Use the ISA-95 definitions for manufacturing activities and determine those performed
2. Determine the strategy and objectives of top management. 
3. Develop an As-Is state in the form of a process flow for each activity
4. Determine the shortfalls, issues, and requirements for each activity

This material provides the framework and focus for consensus workshops that will be held to determine how to both address identified shortfalls, and to reach the objectives of top management.

So, what do we expect to get out of the workshops?  In order to develop a justification and plan for reaching the aforementioned objectives, we need some supporting material:

1. To-Be Process – This is a process flow that has been modified from the As-Is process flow we bring to the workshop for each activity.  Again, this is a high level flow that shows how the basic activities are performed and the information flows between different activities, systems, and resources.  Don’t forget to put it down on paper.  A textual description of the process flow goes a long way in clearing up the understanding of what’s going on.  I usually put this into a companion document that accompanies the process flow.
2. Systems Footprint – Although we’d like to focus discussion on the process alone, independent of which system performs each.  As much as we’d like to believe we can start over and make everything work in an optimal way, it’s not completely practical.  There are legacy systems that already perform some functions, and initiatives for new systems that will pick up other functions.  Without getting into details, a high-level mapping of functions across existing systems will help to determine what the technical roadmap for implementation will look like.
3. Business Case – Here’s where collecting those shortfalls in the As-Is state really pays off.  If we assign an issues Champion to bring real-life examples of each shortfall, and an estimated cost per occurence, we can start to build a case for ROI.  This goes a long way in addressing the savings and efficiency aspect of the business case, but we shouldn’t ignore lost opportunity costs.  If we consider the revenue impact of reaching the objectives laid out by top management, we can calculate the impact of increased revenue as well.  Consider the example in my previous post “MES for Competitive Advantage.”  During our workshop, we should capture how the To-Be process will address the shortfalls and provide competitive advantage.
4. Change Management – How a company addresses change determines how successful the MES implementation will be.  It’s critical that a Change Management Champion, CMC,  attend every workshop, capture issues requiring change in related functions, departments, and systems.  The CMC will be a liason role that communicates the impact of the proposed To-Be state.  It is critical that the CMC has the full and real support of top management.  Change can be difficult and it will be important to identify areas of resistence, overcoming resistence, and determining the cost for change.  In addition to determining the impact of change, the CMC will also identify those areas that will require either modification of training or additional training.

 This is material that we develop during the workshop.  It doesn’t have to be detailed or pretty.  It does have to address the shortfalls and objectives, so keeping the conversation focused is important.   

What workshops should we hold?  The workshops should be organized at a level high enough to capture one of the major areas in the ISA-95 framework (for example:  Quality, Production Control, Inventory Management, Maintenance, Procurement, etc).  Each workshop will address a series of activities performed for an area.  For instance, a Quality workshop might address:  Test Definitions and Distribution, Testing Procedures (in-line, at-line, off-line),  Material Review Board, MRB, procedures for rework, Quality analysis procedures).  These are by no means complete, but they should address those areas where the shortfalls are significant and are critical to meet the objectives laid out.

Who should attend?  Representative Subject Matter Experts, SMEs, that either appear on the As-Is process flow, or subject to change with the anticipated To-Be process.   As much as manufacturing companies hate to commit these resources to these kinds of workshops, because they were hired to actually produce things, their participation is absolutely critical to the success of the proposed changes.  Without their input and consensus, there will be resistence to change that is not always possible to overcome, and mistakes made in both requirements and implementation strategy that will be costly to remedy.

Next time – Laying the Foundation for Change