We use cookies to enhance your browsing experience, serve personalized ads or content, and analyze our traffic. By clicking "Accept All", you consent to our use of cookies.
Customize Consent Preferences
We use cookies to help you navigate efficiently and perform certain functions. You will find detailed information about all cookies under each consent category below.
The cookies that are categorized as "Necessary" are stored on your browser as they are essential for enabling the basic functionalities of the site. ...
Always Active
Necessary cookies are required to enable the basic features of this site, such as providing secure log-in or adjusting your consent preferences. These cookies do not store any personally identifiable data.
No cookies to display.
Functional cookies help perform certain functionalities like sharing the content of the website on social media platforms, collecting feedback, and other third-party features.
No cookies to display.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics such as the number of visitors, bounce rate, traffic source, etc.
No cookies to display.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
No cookies to display.
Advertisement cookies are used to provide visitors with customized advertisements based on the pages you visited previously and to analyze the effectiveness of the ad campaigns.
FDA Warning Letter Summary In Warning Letter 320-25-22 after an FDA inspection, the FDA cited the following significant deviations from Current Good Manufacturing Practices (CGMP): What does the FDA want the manufacturer to do? The letter says: “Correct any deviations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved deviations may also prevent other Federal agencies from awarding contracts.” One Suggested Action All pharmaceutical manufacturers need a superior program to: all significant deviations from Current Good Manufacturing Practices. What do we recommend? TapRooT® […]
Cause of a Quality Issue – Human Error I saw a letter from the FDA to a drug manufacturer. The FDA stated that the manufacturer had performed an insufficient analysis of a manufacturing quality problem. Why was the analysis insufficient? The analysis stated that “human error” was the root cause of the issue. This isn’t the first time I’ve seen someone use human error as a root cause. I have written about it before. Perhaps this is my favorite article: But why does the FDA say that human error is an insufficient cause? Because “human error” can’t be fixed. To […]
Article Says Bad Root Cause Analysis Is a Common Problem An article about a drug manufacturer’s quality problem said: “Root cause analysis isn’t new, but it is one of the most often misunderstood quality processes drugmakers must master. In fact, inadequate root cause analysis is one of the FDA’s most common findings during an inspection.“ The article says the publisher can send you a booklet to learn how to perform root cause analysis. A booklet? You must be kidding. Would you depend on a booklet for something as important as pharmaceutical quality root cause analysis? Learn the Best Advanced Root […]
Yes, I had an AT&T Outage on Thursday Morning This morning, I was trying to call my wife. The call wouldn’t go through. I looked at my phone, and instead of the normal display of bars, it said – SOS. SOS? Was something wrong with the world? Was someone trying to tell me something? When I got to work, I asked someone if their phone said SOS. They said no, but they had Verizon service. However, they had heard that AT&T was having an outage. I turned on calling with WiFi. Later in the day, my service came back on. […]
How To Make a Risk-Based Decision Are your regulators asking for “risk-based decisions?” For example, the FDA requires a Quality Risk Management System. Do you know how to build the latest risk assessment/management techniques into risk-based decisions? If you need to learn more about the latest risk assessment/management techniques and how to make (and document) risk-based decisions, then you should consider attending this pre-Summit course: Risk Assessment and Management Best Practices that is being taught by Australian risk management expert Jim Whiting. When is the course being held? April 29-30. Where is the course being held? At the beautiful […]
Benna and Alex Discuss RCA for Quality Issues Advanced root cause analysis works better for solving quality issues by guiding the problem solver to the true, fixable causes of quality issues. Watch what Benna Hughes and Alex Paradies have to say about using advanced root cause analysis to solve quality issues. Learn from Past Videos We are bringing back some of our classic TapRooT® TV videos from the past two, three, or four years that you might have missed or might be applicable today (when it wasn’t applicable for you years ago). This video from three years ago is about […]
Benna and Alex Discuss Lean and How to Improve Your Lean Implementation Here is a video from 2020 about ways you might improve your Lean implementation… Learn from Past Videos We are bringing back some of our classic TapRooT® TV videos from the past two, three, or four years that you might have missed or might be applicable today (when it wasn’t for you years ago). This video from three years ago is just as applicable for improving Lean implementation as it was three years ago. TapRooT® RCA Training Do you need to invest in better root cause analysis? TapRooT® […]
Think About Next Year’s Performance Improvement Initiatives Does your organization need to improve: Then, you should be thinking of your goals and initiatives for 2024. But where can you get new ideas to take your improvement initiatives to the next level? We will provide several suggestions below… Performance Improvement Success Stories Sometimes, you can get ideas from others’ success. Here are links to several TapRooT® User Success Stories that might give you some great ideas… I hope that those successes gave you some ideas. To see all the TapRooT® User Success Stories, CLICK HERE. Past Summit Suggestions for Performance Improvement […]
Equipment Reliability or Design or Safety or Quality? CTV News reported on a problem with the commuter train service in Ottawa, Canada. HERE is a link to the article. The notice above is from the OC Transpo website about a partial return to service of the affected line. The article says OC Transpo is performing a root cause analysis on the failure of a bearing on a train car hub. The failed bearing was discovered during a routine maintenance inspection. A failed bearing makes this an equipment reliability type of incident … right? But it seems that the equipment reliability […]
Join TapRooT® experts Alex Paradies and Benna Hughes for the discussion, Do Lean Transformations Need Advanced Root Cause Analysis? You’re guaranteed an interesting discussion when you tune in to Benna Hughes and Alex Paradies as they discuss “Do Lean Transformations Need Advanced Root Cause Analysis?” Be sure to read Alex’s insightful article by the same title, “Do Lean Transformations Need Advanced Root Cause Analysis?” either before or after you enjoy the video. And explore the advantage for you and your team of 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Training. Alex tells us that, “One important Lean […]
