The Lean Machine
The Lean Machine - Faster Continuous Improvement  
Excellence through IntegrationAugust 2010
In This Issue
What is RASS?
No Problem, is big Problem
Lean ISO 9001
The CAPA Handbook
Open Office Templates
The Developer's Corner
Update News
What is RASS?
TLM Enterprise
You are probably aware by now that applications can either be installed on your computer, or you can access them on the Internet through your browser. 
 
Of course there are pros and cons of each strategy that effect security, ease of use, user experience, etc.
 
RASS is a thin client, like a browser, that allows access to an applications native interface, so there's no development restrictions to the user experience as there is with browser based applications.  The application runs on a server, which can be hosted on the company network, or over the Internet when being hosted like an Internet based application.
 
The bottom line?  The best of both worlds and the flexibility to choose your own hosting strategy 
(in-house vs outsourced) depending on cost and security issues.
 
RASS is used to give TLM Enterprise the flexibility to be used as a network and/or Internet based application, and improves performance by keeping all of the processing on the sever. 
 
The other advantage is that once installed, you can also set up other applications for multiple or remote user access as well.
 
Want to see it in action? Click here to log into our TLM Enterprise demo via RASS.
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Based on a poll from our website, most companies (over 70%) view corrective and preventive actions (CAPAs) within their quality system as a negative event.  But wait, isn't the CAPA system the meat and potatoes of section 8.5 of ISO 9001 - titled Improvement?  It sounds like we are saying improvement is a bad thing.  That can't be right.
 
In Mike Rother's new book, "Toyota Kata," it appears that compared to Toyota, most companies are falling behind in terms of management methodologies that support continuous improvement.  It's not that they don't want to improve, it's that the need to improve is often identified with a problem, and problems usually cause someone to worry about being blamed, or we don't know how to figure out root causes, or we don't know when to figure out root causes.
 
In this issue we take the expertise from three separate leaders in the quality field and focus on the CAPA system in order to eliminate the obstacles that are preventing companies from getting much more out of their CAPA systems.  All three of our experts agree, most companies could get a lot more return on their CAPA system efforts.
 
The Lean Machine has integrated CAPA with document control, and other areas of the quality management system so that a company's quality management system can be effectively used to manage and drive continuous improvement, regardless of the methodologies used to improve. (Six Sigma, Lean, etc).
"No Problem is BIG Problem"
This is the motto at Toyota.  In contrast to most companies who view CAPA's as kind of a bad thing, Toyota will call an all hands meeting and remind their employees that it is their job to find problems if the number of problems discovered per month falls below their standard.
 
Wait a second, they actually have a metric for a minimum number of problems? What can you say about a company that accepts that problems are a part of doing business and openly admits it and actively looks for them? (I'll leave that as a rhetorical question.)
 
Can you imagine a company policy that every major process should have an open CAPA in order to find and manage the next change to make this process even better?  Would Auditors have a problem with that?  Would your boss have a problem with that?  That's basically what Toyota does with their A3 process. 
 
Mike Rother spent six years researching Toyota and discovered that underneath all the Lean techniques we have been trying to copy lies the root cause of their success, a better way of managing that resulted in their employees developing the Lean techniques that spawned an entirely new way to look at how we do business.
 
The conclusion of his new book, "Toyota Kata," is that while the LeanToyota Kata Techniques are great, companies have struggled with implementing and maintaining the change because they are missing the foundation that supports those techniques, which is how Toyota manages the improvement process and prevents slippage due to the inevitable forces of entropy.
 
To summarize how Toyota manages improvement, one could say that they use a short cycle PDCA process which focuses on deeply understanding the current situation (i.e. good root cause analysis) and then only changing one variable before repeating the cycle as soon as possible.  This fundamental cycle is taught to every employee in a hands-on, one-on-one, mentor - mentee training process and practiced continuously.  The Japanese term that describes a routine practiced over and over until it is natural, is Kata, and Mike has coined this aspect of their management style as the Improvement Kata.  (I would read the book and digest all the details yourself, though.)
 
The Lean Machine has been updated to accommodate the Improvement Kata, which is managed by the CAPA module with links to the documents that represent the process being changed, as well as other modules where the records can be found that relate to the investigation of the problem's root causes.
 
 
CAPA Flow Chart
 
 
In order to demonstrate TLM's ability to accommodate the Improvement Kata, we recreated the example case study in Chapter 8 of Toyota Kata, which is now the product overview demo on our home page as well as the database for our 30 day free demo.
Lean ISO
 Lean ISO 9001In our last newsletter we introduced Mike Micklewright's new book, "Lean ISO 9001," and showed how we incorporated his recommendation that the CAPA form should have a field to identify the "Requirement actually or potentially not being met."   This aligns perfectly with Denise Robitaille's, The Corrective Action Handbook, in the next article.
 
This month we showcase another example of how The Lean Machine can help you develop and maintain a lean quality system by identifying which documents are actually being used, which is another recommendation Mike Micklewright makes in Lean ISO 9001.
 
In most quality systems, and especially a paper based system, this decision would likely be based on the Quality Manager's experience, and the experience of several people involved in the process.  Of course the quality manager would have to find and ask those people how often they reference this document.  Even if those people are waiting by their phones, which they aren't, we are at least talking several minutes under the most ideal conditions to find this out.
 
We put together a 10 second Animated Demo to show how this same information in The Lean Machine can be accessed less than 10 seconds, since each document has a usage log that tracks the total time a user has the document open.
 
This information also supports the training process, since the usage log will show who has likely read a procedure after it is released.  This visibility helps to motivate users to actually read and follow the procedure, which is that critical first step to stabilize a process enough to establish a baseline of performance.  Without this baseline, it is much harder to identify root causes and the next improvement step as part of the Improvement Kata.
 
The goal behind The Lean Machine is to develop tools that take good theory, like Lean ISO 9001, and Toyota's Improvement Kata, and incorporate that theory into the details needed to execute on a day-to-day basis. 
 
You can see for yourself with an on-line tutorial or full featured trail version at www.TheLeanMachine.com.
 
Or feel free to contact us at: [email protected] to arrange a free on-line consultation.
The Corrective Action Handbook
CAPA HandbookIn Denise Robitaille's newest edition of The Corrective Action Handbook, she does a beautiful job of explaining the CAPA system for non quality employees, and providing insight to the issues that need to be considered for each corrective action.
 
While she doesn't specifically mention an intention to create a "Lean" CAPA System, we couldn't help noticing that the forms and fields she chose for her example forms were in fact a very lean approach and only contained what was truly needed.
 
Another contribution she makes towards a lean CAPA system was her insights for when to initiate a corrective or preventive action, and when not to.
 
In a nutshell, she distinguishes between a "correction" and a "corrective action."  She warns against using "correction" as a way to avoid a new CAPA, but this distinction is an important tool in preventing clogging up the CAPA system with problems that are low risk, one-time anomalies, or otherwise don't suggest there's any point in marshalling company resources to discover root causes and develop actions to prevent reoccurrence.
 
She also adds value to root cause analysis and action plan development by outlining a methodology for analyzing the dynamics that effect a situation. We incorporated these methodologies as options in The Lean Machine so that The Corrective Action Handbook can be used as a training tool for a CAPA system that can then be implemented with The Lean Machine software.
 
Watch the new animated CAPA demo to get an idea of how this would work.
Template Procedures - Corrective/Preventive Actions
Open OfficeLast month we introduced our effort to update our template procedures in Open Office using some of Mike Micklewright's Lean ISO ideas and document formatting.  Since this month seems to be focused on Corrective and Preventive Actions (CAPA) and Continuous improvement, our CAPA template is the featured template document this month.
 
We used the procedure format from Lean ISO 9001 and included a definitions section.  Since The Lean Machine has a built in module for terms and definitions, you can simply enter these in The Lean Machine, make any adjustments for your company, and then shorten this section in the document to simply refer to this module in the The Lean Machine software.  Using the terms and definitions module ensures searchable access for everyone, and saves all the time writing and editing this section in all your other procedures, since all your terms and definitions are only defined in one place. 
 
(watch the 10 second demo on the Terms and Definitions module)
 
One of the common issues with CAPA systems is the on-time completion rate as CAPA assignments get pushed to the back of peoples "to-do" list until forgotten.  This causes significant waste in the form of waiting, as well as waste associated with the problems that aren't fixed.
 
The CAPA Procedure addresses this issue in two ways, based on the most common root causes for CAPA delays, poor visibility by management, and low priority given by those assigned to the corrective or preventive action.
 
Visibility for both managers and process owners is addressed by taking advantage of several key date assignments that feed the Dashboard feature in The Lean Machine so that users see their CAPA responsibilities as soon as they log in.  All dates can be exported to your MS Outlook calendar if you need reminders about pending due dates.  Managers also have reporting options to focus on CAPAs that seem to be bogged down.
 
(Watch the 10 second demo on Finding Overdue CAPA Actions.)
 
This months template procedure helps keep CAPAs a high priority on everyone's to-do list by encouraging the assignment of the CAPA Manager as the supervisor of the person who owns the process being addressed by the CAPA.  This sets up the person closest to the process to do most of the work in terms of root cause analysis and establishing the action plan, but they are doing it for their boss who is ultimately responsible for the CAPA timeline, approval, and completion.  This also creates a Mentor/Mentee dynamic for coaching root cause analysis, which is fundamental to the Improvement Kata mentioned in the article above used by Toyota.
 
The result is a CAPA system with more positive motivation for completion than one where CAPAs are assigned by an internal auditor from some other department that your boss really isn't aware of that you have to do all alone.  Plus the Mentor/Mentee dynamic can be used to address any other obstacles that might slow down the process.  Regardless of the skill levels, just having two people tackle a CAPA together will foster more responsibility and more brainstorming.  After all, "two heads are better than one," and "misery loves company," right?
 
Click here  to download our new Corrective and Preventive Action template procedure. (OpenOffice .odt format)
 
Download the latest version of Open Office to view this template.
The Developer's Corner
The Developer
David
How exciting is your quality system?  Can you ever imagine using 'exciting' and 'quality system' in the same sentence?
 
We are excited about the untapped potential of most companies quality systems and our ability to help them squeeze much more value from that investment in time and resources.
 
In addition to the CAPA improvements mentioned above, this section highlights a recent improvement to The Lean Machine that was a direct result of someone thinking about what would work better.  After all, making things work better, faster or cheaper is pretty exciting, right? If you are using some other software and realize something could be better, can you call the developer with your idea?  Probably not.
 
This month's improvement highlight was based on a request to get more visibility into who had overdue DCOs (Document Change Orders).
 
While we already had some reporting available for this, we made some improvements that included exporting the data to Excel and grouping the report based on Due and Overdue status.
 
That way a manager could scan the graph to see who needs a little encouragement, print out those pages for those people, drop by with the list and hand it to them with some friendly comments to show this has their attention, and then go to lunch.
 
By the time they get back, that list will be at least cut in half. :-)
 
Click here to watch a 20 second demo of these reports and where they are located.
Update News
All of our update files are current at revision 4.89.2.056.
 
Existing users can update their installations from the update page on our web site.
 
New in the Latest Version
 
  •  Training Needed on the DCO is being removed.
 
The need for training is really driven by the user.  A new user may need to train on a document that an existing user does not, so the need for training is simply represented by whether or not the user is on the Training List/Record.
 
  •  Document numbers are now optional.
 
If you want to dispense with those pesky document numbers, there is now a system setting that will essentially hide them.  They are all still there, but new documents will simply inherit the unique record ID number assigned by the database.
 
Some of the development projects on the near horizon include:
 
  • Better scheduling features for the work order module.  
  • Training Gap Tool - Before you run a work order, are all the operator training records current?  This tool will help you figure this out quickly and take appropriate action if needed.
Our goal with this newsletter is to highlight the latest quality and lean expertise from multiple sources along with demonstrations of how this expertise has been incorporated into the features available in The Lean Machine software.
 
Even if your aren't currently using The Lean Machine, we hope some of the ideas, links to resources, or template procedures might prove useful to you.
 
If we found you in error, however, please accept our apologies and use the link below to remove your e-mail address from our database.
 
If you would like to see a specific issue addressed, let us know what that is and we will try to include it in a future newsletter.  The Lean Machine has been delivering quality and material management solutions for a while now, so it's likely we've seen that issue before.
Sincerely,
 

David Smithstein, CEO
Lean & Mean Business Systems, Inc.