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(SOLVED) How Do You Solve Quality Problems?

All too often, life sciences organizations conclude CAPA investigations by determining “human error” was the root cause of an issue 🤓 While human error may be the true root cause, the leg work to determine exactly why needs to happen—was it a failure of SOPs, training, or management? In other cases, there’s even less effort to determine the root 🔥 Organizations may identify the symptom of the true issue instead of the real reason the quality management system broke down. If you don’t get to the root, you risk facing the same issue repeatedly because the cause hasn’t been corrected. Use structured approaches such as Pareto charts and eQMS data to find out the real basis for CAPA. [1]
Problem Solving The process of solving difficult problems by using analytical methods and scientific approaches. The problem must be identified and thoroughly understood before effective problem solving can occur. There are many problem solving tools that can be applied to identify the root cause and then take corrective action to fix it. Repeating problems can be costly and cause damage to the relationship between supplier/customer. It is possible for customers to conclude that your company cannot resolve problems with your products and processes. If used correctly, there are many effective problem-solving tools. Here is a short description and sample of some methods. Aaron Kelly, Nakhon Pathom (Thailand) modified the above list on January 1, 2020 [2]
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Vicente McNamara mastercontrol.comThis article describes james Jardine’s role as a Marketing Content Writer at MasterControl, Inc., which is an industry leader in cloud-based compliance and quality software solutions. MasterControl, Inc. and other industry publications have covered his life sciences and technology stories since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. James was a senior executive in operations, communications and development before joining MasterControl. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager. [3]
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A. Problem Identification through Statistical Quality Control. This is the best way to find problems. According to J.M Juran, in ‘Quality by Design’, Quality control is “the regulatory process through which we measure the actual performance, compare it with standards and act on the difference”. The last part of this definition, Juran has incorporated quality improvement as part of controlChances are that a defective product/unsatisfactory result will occur. It is important to know the likelihood of such an occurrence. The detection of nonconformances in large quantities of products or services is called statistical quality control. Clinical practice uses statistical quality control in the form of Clinical and Medical audit. Last edited by Aurelio Burdick, Dasmarinas (Philippines) 92 days ago [4]
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Refer to the Article

  1. https://www.qualio.com/blog/solving-quality-management-issues
  2. https://quality-one.com/problem-solving/
  3. https://www.mastercontrol.com/gxp-lifeline/quality-problems-beyond-root-causes-to-real-causes/
  4. https://drdollah.com/quality-improvement/problem-solving/
Kelly-Anne Kidston

Written by Kelly-Anne Kidston

I am a writer of many words, from fiction to poetry to reviews. I am an avid reader and a lover of good books. I am currently writing my first novel and would love to find some beta readers who are interested in getting an early look.

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