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Manufacturing

Blog posts and articles about using data analysis and statistics in quality improvement initiatives in manufacturing.

Suppose that you plan to source a substantial amount of parts or subcomponents from a new supplier. To ensure that their quality level is acceptable to you, you might want to assess the capability levels (Ppk and Cpk indices) of their manufacturing processes and check whether their critical process parameters are fully under control (using control charts). If you are not sure about the efficiency... Continue Reading
Last week I was fielding questions on social media about Minitab 18, the latest version of our statistical software. Almost as soon as the new release was announced, we received a question that comes up often from people in pharmaceutical and medical device companies: "Is Minitab 18 FDA-validated?" How Software Gets Validated That's a great question. To satisfy U.S. Food and Drug Administration (FDA)... Continue Reading

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by Dan Wolfe, guest blogger How would you measure a hole that was allowed to vary one tenth the size of a human hair? What if the warmth from holding the part in your hand could take the measurement from good to bad? These are the types of problems that must be dealt with when measuring at the micron level. As a Six Sigma professional, that was the challenge I was given when Tenneco entered into... Continue Reading
In the mid 1940s, Taiichi Ohno established the Toyota Production System, which is primarily based on eliminating non-value-added waste. He discovered that by reducing waste and inventory levels, problems get exposed and that forces employees to address these problems. To engage the workers and therefore improve processes, Ohno developed many exercises. One of his most popular exercises, “Stand in a... Continue Reading
Choosing the right type of subgroup in a control chart is crucial. In a rational subgroup, the variability within a subgroup should encompass common causes, random, short-term variability and represent “normal,” “typical,” natural process variations, whereas differences between subgroups are useful to detect drifts in variability over time (due to “special” or “assignable” causes). Variation within... Continue Reading
In Parts 1 and 2 of Gauging Gage we looked at the numbers of parts, operators, and replicates used in a Gage R&R Study and how accurately we could estimate %Contribution based on the choice for each.  In doing so, I hoped to provide you with valuable and interesting information, but mostly I hoped to make you like me.  I mean like me so much that if I told you that you were doing... Continue Reading
You run a capability analysis and your Cpk is bad. Now what? First, let’s start by defining what “bad” is. In simple terms, the smaller the Cpk, the more defects you have. So the larger your Cpk is, the better. Many practitioners use a Cpk of 1.33 as the gold standard, so we’ll treat that as the gold standard here, too. Suppose we collect some data and run a capability analysis using Minitab Statisti... Continue Reading
In Part 1 of Gauging Gage, I looked at how adequate a sampling of 10 parts is for a Gage R&R Study and providing some advice based on the results. Now I want to turn my attention to the other two factors in the standard Gage experiment: 3 operators and 2 replicates.  Specifically, what if instead of increasing the number of parts in the experiment (my previous post demonstrated you would need... Continue Reading
"You take 10 parts and have 3 operators measure each 2 times." This standard approach to a Gage R&R experiment is so common, so accepted, so ubiquitous that few people ever question whether it is effective.  Obviously one could look at whether 3 is an adequate number of operators or 2 an adequate number of replicates, but in this first of a series of posts about "Gauging Gage," I want to look at... Continue Reading
In its industry guidance to companies that manufacture drugs and biological products for people and animals, the Food and Drug Administration (FDA) recommends three stages for process validation: Process Design, Process Qualification, and Continued Process Verification. In this post, we we will focus on that third stage. Stage 3: Continued Process Verification Per the FDA guidelines, the goal of... Continue Reading
To make objective decisions about the processes that are critical to your organization, you often need to examine categorical data. You may know how to use a t-test or ANOVA when you’re comparing measurement data (like weight, length, revenue, and so on), but do you know how to compare attribute or counts data? It easy to do with statistical software like Minitab.  One person may look at this bar... Continue Reading
People frequently have different opinions. Usually that's fine—if everybody thought the same way, life would be pretty boring—but many business decisions are based on opinion. And when different people in an organization reach different conclusions about the same business situation, problems follow.  Inconsistency and poor quality result when people being asked to make yes / no, pass / fail, and... Continue Reading
The line plot is an incredibly agile but frequently overlooked tool in the quest to better understand your processes. In any process, whether it's baking a cake or processing loan forms, many factors have the potential to affect the outcome. Changing the source of raw materials could affect the strength of plywood a factory produces. Similarly, one method of gluing this plywood might be better... Continue Reading
The ultimate goal of most quality improvement projects is clear: reducing the number of defects, improving a response, or making a change that benefits your customers. We often want to jump right in and start gathering and analyzing data so we can solve the problems. Checking your measurement systems first, with methods like attribute agreement analysis or Gage R&R, may seem like a needless waste... Continue Reading
We’ve got a plethora of case studies showing how businesses from different industries solve problems and implement solutions with data analysis. Take a look for ideas about how you can use data analysis to ensure excellence at your business! Boston Scientific, one of the world’s leading developers of medical devices, is just one organization who has shared their story. A team at their Heredia,... Continue Reading
There may be huge potential benefits waiting in the data in your servers. These data may be used for many different purposes. Better data allows better decisions, of course. Banks, insurance firms, and telecom companies already own a large amount of data about their customers. These resources are useful for building a more personal relationship with each customer. Some organizations already use... Continue Reading
I thought 3 posts would capture all the thoughts I had about B10 Life. That is, until this question appeared on the Minitab LinkedIn group: In case you missed it, my first post, How to Calculate B10 Life with Statistical Software, explains what B10 life is and how Minitab calculates this value. My second post, How to Calculate BX Life, Part 2, shows how to compute any BX life in Minitab. But... Continue Reading
This is an era of massive data. A huge amount of data is being generated from the web and from customer relations records, not to mention also from sensors used in the manufacturing industry (semiconductor, pharmaceutical, petrochemical companies and many other industries). Univariate Control Charts In the manufacturing industry, critical product characteristics get routinely collected to ensure... Continue Reading
In my last post, I discussed how a DOE was chosen to optimize a chemical-mechanical polishing process in the microelectronics industry. This important process improved the plant's final manufacturing yields. We selected an experimental design that let us study the effects of six process parameters in 16 runs. Analyzing the Design Now we'll examine the analysis of the DOE results after the actual... Continue Reading
I used to work in the manufacturing industry. Some processes were so complex that even a very experienced and competent engineer would not necessarily know how to identify the best settings for the manufacturing equipment. You could make a guess using a general idea of what should be done regarding the optimal settings, but that was not sufficient. You need very precise indications of the correct... Continue Reading