Our client is a specialty food brand that typically uses co-manufacturing to produce their products. Their product was a specialty confection they produced in multiple co-manufacturing sites with great success. However, they started detecting irregularities with the product from one site. They came to us looking for assistance to identify the root cause of the inconsistencies.
Partnering with co-manufacturers can be very beneficial for brands. It typically allows them to go to market much faster because they don’t have to heavily invest in manufacturing equipment and infrastructure. By partnering with manufacturing facilities that produce similar products, they can also leverage the experience of the co-manufacturer’s staff for ingredient handling, equipment operation and product quality indicators.
However, with every manufacturing process there is potential for “quality drift.” Manufacturing processes are validated to produce a high-quality product with less than a 5% error rate. Quality drift occurs when a greater percentage of products fail to meet specifications.
After a brief background session with the client, we agreed that the best course of action was to begin with conducting a comprehensive quality audit. The quality audit would identify any areas for improvement at the facility, especially as related to:
● Training and knowledge base for key personnel
● Compliance with cGMP standards
● Equipment maintenance
● Ingredient handling
● General facility workflow
● Daily process flow
● Process adherence
We also observed multiple production runs to compare the audit results with different crews, adjacent operations, and environmental conditions such as general facility air temperature and relative humidity.
Step 1: Plan and procedures review
The audit process began with a review of documents and procedures. First, we looked at the plan documents to understand how the product is intended to be produced. We then compared the brand’s production plan against the facilities. It’s not unusual for the brand or the facility to intentionally modify the plan, but any changes must be fully communicated to each other and signed off by both parties. Document control and process hand-off policies should guarantee this, but it is always worth confirming that both parties agree on how the product should be produced.
In addition to the brand’s specific production plan, we also looked at the facility’s prerequisite programs. This ensures there isn’t anything inherent to how the facility is operated or maintained that would cause production challenges for the brand’s product. We also reviewed any other product HACCP plans the facility was able to share with us. We operate under strict non-disclosure agreements, however some facilities service multiple clients who may not approve for their HACCP plans to be reviewed.
Step 2: Records review
After reviewing all the policies, Standard Operating Procedures (SOPs), and other plan documents we moved on to the records review. At this step we looked for evidence that the facility operates in accordance with the established plan. We look for indications that the production crews are following and documenting the standard processes and noting when they deviate from that process and why.
Every facility will occasionally need to deviate from the standard process. A lack of documentation on deviations can be a red flag that those “in the moment” decisions are not being tracked to ensure they are effective.
Step 3: On-site validation
After a deep dive in the documentation, we then turn to the production floor to validate that the story put forward in the records matches the daily operations.
The baseline for the quality audit is to observe the full production process from start to finish at least once. Depending on the production schedule this may need to take place in multiple visits. For this client, since we had already decided to observe multiple production runs over the course of two weeks, we attended production on four separate days. We observed three complete production runs from ingredient staging through packaging and interviewed three crews covering cooking, cutting, and packaging.
All in all, the crews were very adherent to the written process and were very diligent about documenting any deviations. However, there were differences in the batch outcomes across the three production runs we observed. We dug into the fine details to find minor issues that could be having major impacts.
We identified 3 potential areas for further investigation:
Degree of precision in ingredient weights.
The formulation called out a tolerance of +/- 0.5% for ingredient weights, however certain ingredients such as granulated sugar were used in “whole bag” quantities, which were not individually weighed. Potentially, the per bag variances compound to greater than 0.5%
Temperature of the cook batch.
The cook batch was 2.5x the maximum deposit and the batches were held above their setting temperature between deposits. There is a potential that the difference in total evaporation between deposits impacts the final set.
Interference with the curing process.
The confections were cut based on the availability of the cutting equipment once the set had cured a minimum of 12 hours. However, the facility also ran production processes that generated large amounts of steam. It was plausible that the batches cured during high steam production, which required a longer curing time to complete the set.
The client opted to investigate all three potential sources of variation. They were able to use the findings to fine tune their co-manufacturing agreements going forward and reestablish consistency in their product.