Checklist

Check Sheets “record data on a form that readily allows interpretation of results from the form itself” (Hodgetts 89). As one of Ishikawa’s basic quality tools, Check Sheets are an effective means of gathering data in a helpful, meaningful way.

Kaoru Ishikawa is often credited with “democratizing statistics.” This relates to his desire to spread quality control ideas throughout the workplace. His tools make it easier to comprehend raw data, making quality improvements simpler. Check Sheets are a perfect example of this. Although they can vary a good deal depending on the type of data being collected, the purpose of the check sheet is always the same.



“The Check Sheet is used to facilitate the collection and analysis of data. ‘Garbage in, Garbage out’ is an old cliché, but it is true. Therefore, the purpose for which data is being collected must be clear. Data reflects facts, but only if they are properly collected. The number of defects and where they are found can be recorded and analyzed for causes” (Soin 297).



There are a few steps for constructing a check sheet. Since they are used for “determining the occurrence of events such as non-conformities, including the position in which they appear on the non-conforming item”(Bunney), the first step is to identify what problems, or “non-conforming items” occur often. The next step is to construct the table, which will become the actual sheet. Usually the defects/problems/”non-conforming items” are the titles of the different rows on the left side. The top of the sheet contains columns that usually are the time periods in which the problems may occur. Once all of the rows are ready, the only thing left to do is implement the check sheet in the workplace. This means checking off the type of defect that occurs when it happens. This data can then be analyzed for trends using histograms, Pareto analysis, or in obvious cases just by eye
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This definition closely parallels Dr. Shewhart’s opening statement for his (1939) book Statistical Method from the Viewpoint of Quality Control:
“Broadly speaking there are three steps in a quality control process: the specification of what is wanted, the production of things to satisfy the specification, and the inspection of the things produced to see if they satisfy the specification.”



This idea of an operational definition, which Shewhart and Deming popularized from the work of the philosopher C. I. Lewis, provided the seed for what grew into the Shewhart or PDSA Cycle.

Plan-Do-Study-Act Cycle does form a powerful framework for any improvement effort, it has often been reduced to a checklist to be followed mechanically. This has led to a proliferation of “expanded” PDSA cycles where each of the steps on the checklist are specified in ever increasing detail.
But before we go down this path, I would like to back up and generalize a bit.

In Dr. Deming’s own conversations, when individuals would start telling him about what they or their organization were planning to do, he would invariably have one of two responses for them:
“By what method?” or “How will you know?”
Either one of these questions would generally end the conversation since the individual would have no answer. After discerning this pattern to Dr. Deming’s responses, it finally occurred to me that these two questions corresponded to the last two parts of an operational definition. This realization, in turn, resulted in a generalization of an operational definition to become:

1. What do you want to accomplish?
2. By what method will you accomplish it?
3. How will you know when you have accomplished it?

Whatever you may be doing, until you can answer all three of these questions, you do not have an operational definition but merely a basis for an argument. Shewhart understood this, and in his work he used the concept of an operational definition in the development of the “operation of statistical control.”

Orginal and full text is on SPC Press online

Experiments, Randomization, and Observational Studies

Clearly, process behavior charts were intended for use with observational studies. Since it will generally be much easier to obtain data as a side effect of operations, this alone makes the process behavior chart one of the most important tools in your data analysis tool kit.



However, as is shown in the several of my books, process behavior charts may also be used with experimental data. In fact, they will often be the only analysis technique that will reveal certain aspects of your data (such as a lack of homogeneity where the data should be homogeneous). However, by the very nature of an experiment, experimental data will be collected under two or more conditions. This characteristic of experimental data places restrictions on how the data may be analyzed.

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Checklist

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“The most important factors for success are patience, a focus on long term rather than short-term results, reinvestment in people, product, and plant, and an unforgiving commitment to quality.”

This is a quote from Robert McCurry, former Executive VP of Toyota Motor Sales. It’s a great quote which captures in broad brushstrokes some of the essential characteristics of successful lean companies: long-term thinking, a focus on developing people, and kaizen. At the same time, to companies struggling with short-term challenges, these words can seem like happy talk. Many of us feel like we need to take action now, ideally not at the cost of the long-term, people or quality but to see results today. This is a delicate balance. We need to think long-term, but act each day with urgency.



This has to begin with leadership. From Jeffrey Liker’s book The Toyota Way:

The biggest crisis a company faces is when the leaders believe there is no crisis or do not feel a passionate sense of urgency to continuously improve the way they work.

FC is an in-house lean manufacturing consultant who coordinates the training and implementation. Lean is new to this organization, with most of the focus being on 5S for the past two years, with a recent interest in the other aspects of lean. A few weeks ago FC asked in an e-mail whether we had a checklist to gauge the sense of urgency of the staff. We don’t have such a checklist.



Although by no means a full checklist on a sense of urgency, at a minimum I would ask the following of FC’s leadership:

read full article (by By Jon Miller ) on http://www.gembapantarei.com/

Toyota

Toyota Motor Corporation’s vehicle production system is a way of “making things” that is sometimes referred to as a “lean manufacturing system” or a “Just-in-Time (JIT) system,” and has come to be well known and studied worldwide.
This production control system has been established based on many years of continuous improvements, with the objective of “making the vehicles ordered by customers in the quickest and most efficient way, in order to deliver the vehicles as quickly as possible.”
The Toyota Production System (TPS) was established based on two concepts: The first is called “jidoka“(which can be loosely translated as “automation with a human touch“) which means that when a problem occurs, the equipment stops immediately, preventing defective products from being produced; The second is the concept of “Just-in-Time,” in which each process produces only what is needed by the next process in a continuous flow.



Based on the basic philosophies of jidoka and Just-in-Time, the TPS can efficiently and quickly produce vehicles of sound quality, one at a time, that fully satisfy customer requirements.
Just-in-Time

“Just-in-Time” means making only “what is needed, when it is needed, and in the amount needed.” To efficiently produce a large number of products such as automobiles, which are comprised of some 30,000 parts, it is necessary to create a detailed production plan that includes parts procurement, for example.
Supplying “what is needed, when it is needed, and in the amount needed” according to this production plan can eliminate waste, inconsistencies, and unreasonable requirements, resulting in improved productivity.



Kanban System

In the TPS, a unique production control method called the “kanban system” plays an important role. The kanban system has also been called the “Supermarket method” because the idea behind it was borrowed from supermarkets. Supermarkets and mass merchandizing stores use product control cards on which product-related information, such as product name, product code, and storage location, is entered. Because Toyota employed kanban signs in place of the cards for use in production processes, the method came to be called the “kanban system.” At Toyota, when a process goes to the preceding process to retrieve parts, it uses a kanban to communicate what parts have been used.

Visit toyota.co.jp for more about Toyota production system

Is ISO 9001 relevant to software?

Today, software customers are clearly going global
and are demanding quality.  Given the stakes involved, it is important
for software organizations to understand all the rules for self-improvement
and for doing business in the international marketplace.  The ISO
9001 standard has become a basic part of these rules.

How does ISO 9001 apply to software?

ISO 9001 is an international “quality management system” standard–a standard
used to assess an organization’s management approach regarding quality.

ISO 9001’s focus is directed internally at an organization’s processes
and methods and externally at managing (controlling, assuring,…) the
quality of products and services delivered.

When viewing the key factors affecting the outcome of software development
(shown below in figure 1), ISO 9001’s focus is on all factors except “technology”.



Figure 1: Delivering Quality
Software – macro process (click figure for expanded view)

Scope of ISO 9001:

ISO 9001 is a generic international standard, adopted on a country-by-country
basis, and written for use by the widest possible audience.  As a
result, the standard provides requirements (what needs to be done)
and does not issue specific prescriptive solutions (how to do it).

Being so broadly focused, the ISO 9001 standard does not offer details
about its application to specific domains of expertise.  To assist
in the application of the standard for specific domains, a series of guidelines
are available; e.g., ISO 9000-3 is a guideline for the software development
industry.

Relevance of ISO 9000-3

ISO 9000-3 provides “guidance” on implementing an ISO 9001 compliant set
of processes (collectively referred as a “quality system” or as a “quality
management system”).



ISO 9000-3 is an international guideline.  Guidance is for software
development, supply and maintenance environments.  The guideline is
primarily written for “custom” (contract driven) software markets.
It can easily be adapted for other market needs such as commercial-off-the-shelf
(COTS), internal software development, etc..

ISO 9000-3 virtually mirrors the provision of ISO 9001–it does not
add to, or otherwise change, the requirements of ISO 9001.

ISO 9000-3 is not intended to be used as an internal/external audit
tool.  Its intent is to guide software organizations with their
ISO 9001 implementation and process change efforts: in short, software
organizations are audited against ISO 9001 (not ISO 9000-3).

An example of the type of guidance provided by ISO 9000-3 is shown in
the following table.
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ABC Analysis

Over 100 years ago, Vilfredo Pareto made the statement that twenty percent of the population owned 80 percent of the property in Italy. In 1940, Joseph Juran, a mechanical engineer, reapplied Paretos principle. In doing so, he created Pareto analysis or ABC analysis. Juran said that by using this analysis you could separate the vital few from the trivial many. Managers use this analysis today to prioritize tasks by those that are of most worth.
How To Use ABC Analysis: Sallys Grocery Store
While ABC analysis can be used for many different things, we are going to look at it from an inventory perspective. To better understand this tool, we are going to talk about Sally who owns a grocery store. She is fairly profitable, but would like to focus on the items that create more revenue. As you work this analysis, I will refer back to Sallys grocery store, and how her analysis went.

Proving the Pareto principle, we can see that although you may have a small amount of a certain item, it may create the largest amount of revenue.

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it's all about time

SYSPRO Improves Q/C Time Management 30% at Med. Device Co.

Pragmatic, Yet Visionary Enterprise Software Driving Business Process Efficiencies; 80% Improvements Reported in Month-End Reporting; Lot Traceability Also Key
COSTA MESA, Calif.–(BUSINESS WIRE ) –SYSPRO, a leading, worldwide provider of Enterprise Resource Planning ERP) software, announced today that Acro Associates, a designer of fluid control systems for medical device and bioprocessing companies, is reporting significant business process improvements as a result of its SYSPRO deployment. The Concord, Calif.-based company, which has deployed the newest version of SYSPRO ERP solutions since 2007, is spending 30% less time on quality control and 80% less time on month-end reporting.

Company executives say this is yielding more time for bottom-line decision-making.
“SYSPRO has made a tremendous difference in freeing up our head of Quality to focus on continuing to improve our TQM (Total Quality Management System),” says Russell Ziegler, president of Acro, noting: “SYSPRO is enabling Acro to do more with less.

The software also helps the company to process more orders with fewer man hours.”
Acro also uses SYSPRO’s pragmatic, yet visionary MRP and Lot Traceability modules to drive overall operational productivity. SYSPRO calls this approach “PragmaVision.™” “Because the software is fully integrated, it enables all the departments to communicate and has, in turn, resulted in the efficiency improvements,” Ziegler said. “We used to spend a lot of time communicating key information and activity workflow. SYSPRO is helping us to stay competitive in a challenging economy and use our resources more efficiently.” SYSPRO Power Tailoring Bundle capabilities enable Acro to customize screen views and workflow activity, giving employees the tools to access and act on the specific information they need to maximize efficiency. Additionally, Acro is leveraging these SYSPRO capabilities:

• SYSPRO Executive Dashboard to facilitate management decision-making;
• UniPoint for SYSPRO, a seamless integration of best of class quality
  management software with the SYSPRO ERP system . This streamlines
  critical quality control processes and enhances compliance
  capabilities.

The Medical Device Manufacturing sector is one of four core SYSPRO verticals where SYSPRO boasts industry specific differential functionality, in-depth experience and a large satisfied customer base. Some of the key features of SYSPRO’s medical device solution are: Engineering Change Control; Serial and Lot Traceability; Electronic Funds Transfer; EDI Integration; Real-time Alerts to Deviations; Quality Tracking; Landed Cost Tracking; Forecasting & Inventory Optimization;

Product Configurator; Return Merchandise Authorization; Integrated Bar-Coding; Forecasting; Return to Vendor; Analytics; and Customer Relationship Management. “SYSPRO software is a strong selection for small and medium-sized manufacturing and distribution organizations, such as Acro, that like SYSPRO’s PragmaVision philosophy of providing pragmatic, yet visionary ERP solutions,” said Joey Benadretti, SYSPRO USA president. “Our customers can expand with us as they grow and can also utilize SYSPRO e.net solutions to gain the advantages of Service Oriented
Architectures.”

Read more here

The many different ways of using control charts in both service and manufacturing applications may be summarized under five major headings. These five categories are arranged in order of increasing sophistication below.



The first of these is that of Report Card Charts. Report Card Charts are charts kept for the files. They may be occasionally used for information about how things are going, or for verification that something has or has not occurred, but they are not used in real time for operating or improving the processes and systems present. This is a valid but weak usage of control charts.

The next category consists of Process Adjustment Charts. Some product characteristic may be plotted on a control chart and used in a feedback loop for making process adjustments, or some input characteristic may be tracked and used in a feed-forward loop for the same purpose. In many cases these Process Adjustment Charts will result in substantially more consistent operations than was the case prior to the use of control charts. (This assumes that one will know how to properly adjust the process. In some cases such knowledge can only be gained by some of the following uses of control charts.) However, once this initial improvement has been achieved, Process Adjustment Charts simply strive to preserve the new status quo. The potential for dynamic and continual improvement is missing from this usage of the charts. Unfortunately, this seems to be the only usage considered in most of the articles recently published in the journals.



The third category is Process Trial Charts. These are charts used to analyze the data from simple experiments performed upon the process. This short-term usage of control charts is a simple and easy-to- understand alternative to the use of ANOVA and other statistical techniques. This usage is often found in
conjunction with the next category.

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