Blog Post: Shipping Delay Root Cause Analysis


#1

Earlier this week, we announced an issue in fulfillment that resulted in delayed shipments of Soylent 2.0. Out of the more than 400,000 bottles shipped thus far, we have been made aware of 11 isolated incidents of mold growth on the external part of the bottle, which is well within the industry standard rate of one in 10,000 defects in low acid aseptic packaging. Using the utmost caution, we immediately halted shipments until we could conduct a thorough investigation of the reports.

At Soylent, our top priority is the health and well-being of our customers. We want to assure you that the processes and procedures we implement in our state-of-the-art facilities ensure that our products are produced in environments that strictly adhere to federally-regulated current Good Manufacturing Practices (cGMP). Any report regarding the quality of our products is taken very seriously and carefully investigated.

Our investigation involved an exhaustive review of manufacturing records and comprehensive product inspections at our distribution center. Our records indicate that all manufacturing procedures were in place and followed properly. Additionally, all microbiological records for in-process and finished product were satisfactory.

During our record review process we did, however, discover that the conveyor guardrail settings were not optimized, causing some bottles to move erratically on the conveyor, which resulted in small splashes on the external surface of the bottle, thereby allowing mold from the environment to grow on the bottle. To verify that these findings were indeed isolated, we conducted physical and visual inspections, along with microbial tests, of 2,000 bottles in our distribution center and found only two bottles with the same defect. We have since optimized the line settings to minimize any recurrence of this issue.

Given that all manufacturing records and product sterility tests during manufacturing were satisfactory, and with verification that the findings were truly isolated, we are confident in the safety of our product and have decided to resume shipments of Soylent 2.0 as soon as our logistics team and distribution partner are online again. Our conservative estimate for shipping commencement is Thursday, October 8, 2015.

Although it is not ideal, in any manufacturing practice, from hardware to consumer products, there is an inherent defect rate. In the event that you receive a bottle exhibiting this defect, we urge you to please dispose of that bottle, and let us know so we can send you replacement product and a full refund.

Nothing matters more to us than ensuring our customers receive the perfect product, and we appreciate your feedback to inform us when that is not the case. Please rest assured that the product remains entirely safe, but if you have any questions or concerns at all, feel free to reach out to our Customer Support Team at info@soylent.com. Your health and safety are always our first priority, and your constant support is appreciated more than you know.

Source: http://blog.soylent.com/post/130348210172/shipping-delay-root-cause-analysis

I’m curious if the conveyor belt referred to is shown in this video:

What are your thoughts on how the Soylent team handled the situation?

I’m impressed with the level of detail they provided in this update. Ultimately, the fact that they poured so much effort into finding a root cause means that the quality level of future batches will be improved.


#2

I’m satisfied with their response.

“Out of the more than 400,000 bottles shipped thus far, we have been made aware of 11 isolated incidents of mold growth on the external part of the bottle, which is well within the industry standard rate of one in 10,000 defects in low acid aseptic packaging.”

They got enough reports that they felt the need to do more checking.

“microbial tests, of 2,000 bottles in our distribution center and found only two bottles with the same defect”

And discovered that while the customer reported defects were below the 1 in 10,000 industry standard rate in actuality they were actually having defects ten times as common as the industry standard rate. 1 in 1,000 vs. the industry standard of 1 in 10,000.

They found the suspected cause and have fixed it and will be shipping again soon.

Good enough for me. I do wonder if the first bottle of 2.0 I had suffered from mold, the second bottle tasted better. But that could have just be in my head.