Question

An FDA regulation controlling the contents of packaged food items states that no more than 5 percent of the items produced and sold can contain less than 95 percent of the stated/labeled weight. Assuming that the standard deviation of the process, when in control or is operating as expected, is 0.90, determine if Siders Breakfast Foods, Inc., is in compliance or not in compliance with the FDA regulation given these parameters, i.e. process mean of 25 ounces and standard deviation of 0.90. Explain and show evidence supporting your conclusion. (10 pts). What should Siders Breakfast do if they discover their process to be in violation of the Federal regulation? (5 pts)

(Assume that the content weight follows the normal distribution).

Answer 1

As, Given that as per FDA Regulation, contents of packaged food items states that only up to 5 percent of the items could be less than 95 percent of the stated/labeled weight. As, standard deviation makes dispersion of the process and content weight already follows normal distribution, and p value is already less than 0.05 or alpha level, hence, next thing we will create control chart, that could be I –MR or X bar R Chart, here, we will see that whether process is in control or out of control, we also can check capability of the process, that can tell that whether actual process mean is shifted from target process mean or not, whether process is capable to produce the result or not, in case after checking control chart, if we receive assignable cause, then we will make Root cause analysis for the sample that having assignable cause, hence, if we found any violation of the federal regulation, here, we will make root cause analysis and check what are the possible root causes are making such process deviation, and in capability analysis, we also can check sigma level of the process and if process is performing at 3 or more than 3 sigma, then process can be accepted and doing as with the regulatory practices of FDA,