January 27, 2022

Lessons Learned from the Art and Science of Forensic Analysis

Despite all the best engineering skills and expertise, packaging non-conformance happens. The phone rings from a manufacturer, or worse, from a hospital where a package failed in the field. Packaging complaints or errors, though rare, put engineers on edge. Most dive for the weeds and feel trapped because the clock is ticking. It can become a big headache if you don’t have a well-structured, solution-focused approach. The risks are significant: recalls, FDA oversight, significant business losses.

Engineers who apply lean manufacturing philosophies and processes to forensic packaging investigations learn a lot along the way, which makes them more effective packaging designers as their careers progress.

Forensic packaging investigations rely on proven analytical techniques to determine the root cause of the problem. I have found that using the 5 Principles of Problem Solving has helped my skills not just for identifying causes, but also for designing better packaging from the start.

Here’s how I use the 5Ps to evaluate a packaging issue:

  1. Purpose. In the first hours after being notified of a packaging issue, we gather as much information as possible. Sometimes this core team is just one person, and sometimes it’s more, depending on the product and complexity of the problem. We ask a lot of questions and mine production data. What product was the packaging for? Where and when did the problem first occur? What was the product lot number? Is this the first time the situation occurred? We pull all types of data threads together and organize the information in a logical manner. This may involve using a “war room” set up with whiteboards, reports, screenshots, etc. pinned on the wall, or it may be a spreadsheet with the data organized digitally and accessible for many team members.
  2. People. Next, we assemble a cross-functional team that includes quality specialists, operations, and professionals unrelated to the product or issue. Our intent is to have many diverse subject matter experts participating in the evaluation as possible, so we don’t miss anything.
  3. Process. We conduct an open-ended, no limits, no judgments brainstorming session to get all the defect factors on the table for our review and discussion. We use mind maps and visuals to identify probable or potential factors.
  4. Platform. We systematically work through each probable cause to affirm or deny the possibility of defect origin. We investigate the likelihood of error using many details and find ourselves digging deep into all types of details. For example, if we notice that a defect occurred under high heat or high humidity, we check National Oceanic and Atmospheric Administration (NOAA) climate records to understand if the weather was an impact. One-by-one, we bring data to the equation through research, test capabilities, and physical properties, and narrow down the causes until we have one, two, or three likely candidates as a defect or error culprits.
  5. Performance. Finally, we recreate the failure. By repeating the actions and conditions that happened in the first place, we learn about the failure factors so we can develop the corrective action plan. This is the first time we actively solve the problem and then monitor our results to develop a better solution for future packaging needs.

This process to investigate issues for post-validated medical devices that are in commercial use is critical. It sets Packaging Compliance Labs apart from other companies that are not as well prepared with a process to evaluate packaging defects. Our process of providing training in a proven problem-solving process and involving different business functions is like having an emergency response team, ready at a moment’s notice to investigate and solve packaging issues.

Personally, going through the 5P process has made me a better design engineer. By unweaving complex problems, I’ve learned more about packaging engineering, supply chain issues, equipment, processes, controls, and downstream handlers. Not only am I gaining knowledge about specific products, but I’m also growing in my skills to design better packaging from the beginning because I know what can happen from design to production to end-user experience.

Contact us to speak with a engineer today if you are experiencing packaging failures.