Tips and Techniques for Statistics and Quality Improvement

Blog posts and articles about using Minitab software in quality improvement projects, research, and more.

Process validation is vital to the success of companies that manufacture pharmaceutical drugs, vaccines, test kits and a variety of other biological products for people and animals. According to FDA guidelines, process validation is “the collection and evaluation of data, from the process design state through commercial production, which establishes scientific evidence that a process is capable of consistently...

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Confidence intervals show the range of values we can be fairly, well, confident, that our true value lies in, and they are very important to any quality practitioner. I could be 95% confident the volume of a can of soup will be 390-410 ml. I could be 99% confident under 2% of the products in my batch are defective.

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If you have a process that isn’t meeting specifications, using the Monte Carlo simulation and optimization tools in Companion by Minitab can help. Here’s how you, as an engineer in the medical device industry, could use Companion to improve a packaging process and help ensure patient safety. You can also check out our webinar recording, Seeing the Unknown: Identifying Risk and Quantifying Probability with Monte Carlo...

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Dramatic cost savings. Lead time and inventory reductions. Improved transactional processes.

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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 of the supplier...

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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:

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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 something flat-out wrong and had been...

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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.

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"You take 10 parts and have 3 operators measure each 2 times."

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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 will focus on that third stage.

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