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The second step is the measurement process. We must define the defect we are measuring. This will involve analyzing why some our of submissions to the FDA are rejected -- we are making errors at some point in the process. We must then collect data on our current practices. This will give us an indication not just with regard to the type of errors but how often they occur.
Now that we have a data collection in place for the past, we must use that in the future to track our progress. As we implement changes to address the defects in our approval process, we must track how those changes impact the outputs, for example in terms of rejections and in terms of time elapsed before regulatory approval is granted.
Lastly, the measurement process demands that we set a baseline. For example, we understand that there will always be some rejections and delays that are out of our control. The baseline should...
That is, at a point where all controllable errors have been eliminated.
At this point, we have defined the problem, both in terms of deliverables to the customers and to internal stakeholders. We have also determined the process by which we will measure our solutions. We understand what our current performance level is, and what our ideal performance level is as well. Now, we can move on to the next phase of the DMAIC process -- analyzing the root cause of the defect (iSixSigma.com, 2009).
Works Cited:
Chieh, C. (2009). Six sigma basics: DMAIC like normal problem solving. iSixSigma.com. Retrieved October 25, 2009 from http://europe.isixsigma.com/library/content/c070321b.asp iSixSigma.com. (2009). Six sigma DMAIC roadmap. iSixSigma.com. Retrieved October 25, 2009 from http://www.isixsigma.com/library/content/c020617a.asp
Works Cited:
Chieh, C. (2009). Six sigma basics: DMAIC like normal problem solving. iSixSigma.com. Retrieved October 25, 2009 from http://europe.isixsigma.com/library/content/c070321b.asp iSixSigma.com. (2009). Six sigma DMAIC roadmap. iSixSigma.com. Retrieved October 25, 2009 from http://www.isixsigma.com/library/content/c020617a.asp
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