Analysis of 'Value Added' System & Process Steps - Inspection

v9991

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#1
by definition of VAs, process/system has to add to product feature/functionality,.

From pharma perspective, being a critical operation, there are more unit operations relying on inspection, quality control. and some instances, inspection is mandated by regulations and standards.

so, should the inspection be really categorized as NVA?

Inspection takes many forms in pharma: visual analysis, record review, audits, and walkarounds, and yet Six Sigma
regards inspection as fundamentally unproductive and “non-value added.” In addition to the fact a process should be
improved to make inspection less prevalent, it is clear that the cost and time required to inspect and fix problems is beyond
what most customers would pay, if given the choice.
 
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lokeky1

#3
The reason inspection is categorized as NVA is to change paradign. If the upstream processes are out of control, inspection is definitely needed. But inspections are always too late! To my understanding, it is defined as NVA so that we think about how we can avoid inspection by making the product right first time.

Even though "inspection" can never be eliminated (similar to Energy), it actually can change form!. Inspection can be built into the product at design stage (QbD), into the process via Poka Yoke and Jidoka or into production via Standard Work.

FDA and ICH are recommending upstream real time monitoring. http://www.fda.gov/downloads/Drugs/Guidances/ucm073507.pdf
 
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