Investigating Consumer Complaints

A full investigation and report could include any, most, or all of the following: 

• Does the Batch Record have any deviations or anomalies documented? Is it consistent with the prior and subsequent batch records?

• Does the retained product sample meet all the established specifications? Retained samples may have to be tested and analyzed to confirm compliance with specifications. Are the test results consistent with previous and subsequent batches?

• If the possible cause could be related to raw materials, pull all retained samples of every raw material and test or verify compliance. Do all raw materials meet specifications and are they consistent with results for previous and subsequent lots?

• If the possible cause could be related to a packaging component, pull all retained samples of the components used for the lot number being investigated and samples of previous and subsequent lots. Verify compliance of all packaging components. This could also include verifying that all labeling is correct for directions, ingredients, and warnings. 

• If the possible cause could be related to operator error, review training records, documentation, and interview operators for their knowledge of the specific procedures involved. 

The investigation report should include the rationale for the investigation based on a review of all investigational steps and findings along with all test results for the investigational lot of the product, raw materials, and components as well as for previous and subsequent batches. A conclusion should be supported by the evidence and corrective actions suggested. Corrective action steps should be verified after the close of the investigation after both a short time interval and again at a longer time interval to determine if corrective actions are being followed and are producing the desired results.  

The Case of the Chipped Tablets 

During the course of a couple of months, a number of consumer complaints were received regarding chipped tablets. Initially, no red flags were raised because the complaints were not for the same tablet product or lot number. Only after QA received the fourth compliant was it clear that this might be a bigger problem than a single chipped tablet in a bottle or blister package. 

Retained samples of each lot of tablets in this size range over the previous two months were retrieved along with the manufacturing batch records. A few of the batch records mentioned chipped tablets. A single bottle of tablets was opened for each lot within the defined timeframe and examined for chipped tablets. Almost half of the 90 count bottles contained a chipped tablet or about 2% of the tablets were chipped. A broader review of retained samples showed that only some lots contained chipped tablets and others had no chipped tablets at all. 

The occurrence of the chips was correlated to only one of the two tablet presses used. Manufacturing records for the tablet press that appeared to be responsible for the chipped tablets were examined and retained samples of the tablet lots checked for chips. Virtually all recent tablet bottles sampled showed a chipped tablet. The maintenance logs showed that the press had received a maintenance review prior to the earliest date of the complaints about chipped tablets. The maintenance department had checked the press, feed frames and de-duster, and had adjusted the guides to prevent loss of tablets and consistent tablet flow. A screw on the exit ramp from the press table to the de-duster had been replaced. The screw used had a larger head than the previous screw. This larger screw head stuck out slightly at the end of the shoot as tablets entered the de-duster from the exit on the feed frame. It was observed that tablets hitting the raised screw head at exit velocity chipped at the rate of less than one tablet per revolution or less than 0.5%. 

The screw was replaced with a flat head screw that would lay flush with the exiting frame, and the number of chipped tablets fell to virtually zero. Tablet operators were reminded to always notify Quality and Maintenance if they observe anything different in the operation of a press or with the equipment. Maintenance was instructed to use identical parts when making replacements on any piece of equipment. Additional flat headed screws were ordered from the maker of the de-dusting unit. 

Corrective actions included: 1) Maintenance SOPs for procurement were updated to specify the need to replace parts with manufacturer approved and identical parts. 2) Maintenance personnel received review training for assembly of the tablet feed shoots for the de-dusters and the change to the parts procurement SOP. 3) And tablet press operators reviewed SOPs on the assembly of the feed frames, de-duster and the screw incident and training documented in their training files. 

About the Author: Mary Beth Watkins served as Director of Product Development at Nutraceutical Corporation staring in 2007. Prior she was the Director of Scientific Affiars at Botanical Laboratories for 16 years. Her article originally appeared in the August 2012 hardcopy-only edition of the AAHP Network News. AAHP honored Ms. Watkins as an emeritus AAHP board member upon her retirement due to her years of dedicated volunteerism at the association.