This article explains how to perform a packaging complaint investigation using a case study example of flexible packaging that was found open by a customer. This is part one of a two-part article. The second part will focus on the CAPA Process. Specifically, containment measures, corrections, corrective actions, and preventive actions.
This case study example involves a flexible, peelable pouch made of Tyvek and a clear plastic film. This is one of the most common types of packaging used for sterile medical devices. In parallel with the complaint investigation, containment measures and corrections are implemented immediately to prevent the complaint from becoming a more widespread problem. The investigation process utilizes a “Fishbone Diagram” to identify the root cause of packaging failure. This is just one of several root cause analysis tools that you can use for complaint investigations, but it works particularly well for examples where something has gone wrong in production process controls, but we are not sure which process control has failed.
Once the root cause is identified, for the packaging complaint, then you need to implement corrective actions to prevent a recurrence. Also, FDA Clause 21 CFR 820.100 and ISO 13485, Clause 8.5.3, require that you implement preventive actions to detect situations that might result in a potential packaging failure in the future and implement preventive measures so that similar packaging failures are not able to occur.
A distributor reported the incident that was reported. The distributor told customer service that two pouches in a box containing 24 sterile devices were found to have a seal that appeared to be delaminating. Unfortunately, the distributor was unable to provide a sample of the delaminated pouches or the lot number of the units. Packaging issues and labeling issues are typically two of the most common complaint categories for medical devices. Often the labeling issues are operators errors or a result of labeling mixups, while the packaging errors have may be due to customers that accidentally ordered or opened the wrong size of the product. Therefore they may complain about packaging when there was nothing wrong. It is essential to be diligent in the investigation of each packaging complaint because if there is a legitimate packaging quality issue, then there may be a need or a product recall as part of your corrective action plan.
Reporting of Packaging Complaint Investigation
A lot of clients do not want to report packaging issues as a Medical Device Report or MDR, because they are concerned about potential action by the agency or the negative publicity of the reported adverse event. Even if an injury or death did not occur with a sterile medical device, the quality issue should still be reported as an MDR in accordance with 21 CFR 803 because it could cause an adverse event such as a serious infection that could result in sepsis and death. If you think that this is an extremely conservative approach, you might be surprised to learn that 225 MDRs were reported in just October of 2015 for packaging issues. One random example is this report of a leaking contact lens vial in the following report:
“It was reported that the lens vial was found to have little or no saline storage solution. This was discovered upon receipt, and the product was not used.”
“The lens and lens vial was not returned for evaluation. The lot history record was reviewed, and there were no non-conformities or anomalies related to this complaint. Based on the information currently available, the most likely root cause of the event is related to a leaking lens vial. The type of lens vial associated with this report has been discontinued, and a new (redesigned) vial was implemented.”
Packaging Complaint Investigation when product IS NOT returned
What the narrative above does not elaborate on is what was the specific investigation details for “lot history reviewed.” One of the most useful tools for performing this type of investigation is the “Fishbone Diagram”. There are six parts “6Ms” to this method:
- “mother nature” or environment,
- “manpower” or people, and
Here are a couple of things that could have been done:
- review the complaint log for other complaints with the same lot number and/or from a similar time period, lot of raw materials or packaging machine
- review the device history record for the lot to make sure that the number of units rejected as part of normal in-process and final inspection did not exceed pre-established thresholds for monitoring of the sealing process
- if retains of the lot are available, these might be retested to verify that the testing results after real-time aging remain acceptable
- the maintenance and calibration records of the equipment for manufacture and testing may be reviewed to verify that no repairs were required and no equipment was identified as out-of-calibration
If all of the above fail to identify a potential cause for a packaging failure, then you might have a problem related to people or the environment. People include the people sealing the product package and the users. The environment consists of the temperature and humidity for storage of packaging raw materials, packaged product, sterilization conditions, storage conditions after sterilization, and shipping conditions–including any temporary extremes that might occur during transit.
In our case study, the product was not returned, and we did not have the lot numbers. Therefore, we may need to review distribution records to that distributor and/or the customer to narrow down the possible lots to one or more lots. Then we would need to perform the same type of review of lot history records for each potential lot. In the future, the UDI bar codes that are on products and product labeling will facilitate the identification of lots, because the UDI bar codes will be scanned into each patient’s electronic medical record and the production identifier (PI) portion of the code will tell manufacturers exactly which production lot was involved.
Packaging Complaint Investigation when product IS returned
Sometimes you are fortunate enough to receive returned products. The product should be immediately segregated from your other products to prevent mixups and/or contamination. After it has been determined that the product is safe to handle, the assigned investigator may inspect the product packaging to confirm packaging issues and possibly destructively test the packaging to verify that the packaging returned meets the specifications.
There is an enormous number of articles and studies on the topic of package testing and package design for sterile medical devices. If you have a question, you can probably find a dissertation or two on any obscure aspect of packaging you are interested in. For example, Jordan Montgomery is a packaging engineer/technical fellow with Medtronic. He performed a thorough investigation comparing testing methods for the EN ISO 898-5 with the ASTM F88 method. A dissertation I read also attempted to correlate between burst test results and peel testing results for the same packaging.
If you are interested in learning more about root cause analysis, then you should visit the following articles specifically written about this topic: