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The problem that Ross is having is the caps are not always a uniform shape. If the shape is off by just a little bit then they will get stuck in the cap-shoot and cause the line to go down. This affects the production deadlines and affects the on-time delivery of the product. This also creates a problem with the cap size that was validated by the FDA and any change in size has to be approved by the FDA using a Validation Change Request. Since the cap size is not the same as the ones that were validated then the whole process is in jeopardy of being shutdown by the FDA. This also would have a tremendous affect on the on-time delivery of the product to the customers...
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