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Quality by Design (QbD) Risk Assessment
SamGardner
Level VII

Note:  Revised add-in uploaded on 03 Jan 2023, fixed minor bugs.

 

This add-in allows you to create a risk assessment for a process, where you can rank the importance that each process factor has on product quality.  This add-in follows a typical risk assessment methodology used in Quality by Design (QbD) for pharmaceutical process development, applying a RPN score approach.  This methodology could also be used in other applications where new process are being developed for a product, and it is described in this companion blog post.  When you run the add-in, you can choose Help from the red triangle menu and it will open a document that describes how to use the add-in.  

 

Kudos to @brady_brady for doing all of the coding and @Chandramouli_R and @mia_stephens for collaborating on the development of this addin.  

 

We hope this add-in is helpful and we welcome feedback on it's value or if you find issues that need to be addressed.  

Comments
pslee

훌륭합니다.

QbD Works의 QbD Risk Assessment와 유사한 방식인 것 같습니다.

RA와 DoE를 각각 다른 프로그램을 사용해서 불편한 점이 있었는데

이제 JMP에서 RA와 DoE를 함께 할 수 있게 되었습니다.

감사합니다. 

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