E-Lesson 2

Step by Step:  the Investigation Section

Looking for Root Cause


You’ve written your problem statement, making sure

you have enough detail, but not too much detail, and avoiding conjecture about what caused it.

Now, it’s time to dig down to root cause to uncover how and why it happened.

 Following through on First Thoughts


You may have an idea about why it happened.  Good!  Follow up on that idea.

But—and this is crucial—

Suppose you’re a reviewer. . .

Based on the criteria we’ve given you, how would you rate the following problem statements? Which problem statements have too little information, which have too much, which ones speculate about the cause (are “contaminated”), and which ones are ok? (Please note that some may fall into more than one category.) Underline your ratings and tell us why.

Your Information:

The calculated batch yield was 62.4% which is below the alert and action limits of 85% and 75%, respectively, according to SOP MFG-23-010 “Reconciliation Limits.”
2. The 12-hydroxyducadone impurity result for finished product Lot 987123 was 12 ppm versus a specification of ≤10 ppm. The 12-hydroxyducadone impurity level in the Active Pharmaceutical Ingredient (API) batch used to manufacture the product was also tested and was higher than normal but within the validation parameters. The batch will be rejected.
USP Purified Water use points #2 and #4 located on the first floor and second floor, respectively, of Building E were sampled on February 4, 2018. Later that day, QC obtained a Total Organic Carbon result of 608 ppb for use point #4 which was greater than the specification of less than 500 ppb. The result for use point #2 met the specification. Facilities locked both use points out of service.
Each lot meets current specifications. However, the R&D group pulled a sample from the downstream process for development work. The material did not perform as expected. Subsequent analysis of the three commercial lots 213798, 412798 and 512798 indicated that the pH of each lot was ≥ 10, 10 and 7, respectively.
Work Order WO 2017-10-XYZ was generated to install set screws on glass washer nozzles that are position specific. After consulting with the vendor, the engineer determined that the set screws were not needed because the vendor had developed a new nozzle design. The new nozzles were purchased and installed on the referenced washers. The work order was not rerouted to approve the modified scope of work as required by the current procedure MFG-13-423. The Responsible Engineer left the company before the work was completed.

Now use the information given below to write a problem statement that meets the criteria we’ve discussed and that doesn’t say too little or too much, and is not contaminated by conjecture about why the problem occurred.