Why is this happening?
Using your quality audit to solve production mysteries
Our client is a specialty food brand that typically uses co-manufacturing to produce their products. This allows them to go to market quickly because they don’t have to heavily invest in manufacturing infrastructure and equipment. They typically look for a manufacturing partner that already produces a similar product in order to leverage the collective experience of the co-man’s staff when it comes to ingredient handling, equipment operation and product quality indicators. This typically shortens the time to market significantly and allows the brand to feel confident trusting their product manufacturing to a third party. However, with every manufacturing process there is potential for “quality drift.” This is when a manufacturing process is validated to correctly produce a high quality product with less than 5% error rate, but currently is seeing a greater percentage of product failing to meet specifications.
In this case, our client’s product is a specialty confection that they produce with multiple co-manufacturing sites with great success, but had recently been detecting irregularities with the product from one site. They came to us looking for assistance with identifying the root cause of these irregularities.
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
General facility workflow
Daily process flow
Specifically, we would also observe multiple production runs to compare the audit results with different crews, different adjacent operations, and other differences in environmental conditions such as general facility air temperature and relative humidity.
The audit process begins with a review of documents and procedures. We look first at the plan documents to understand how the product is intended to be produced. We take this opportunity to compare the brand’s production plan against the facility’s. It’s not unheard of for either the brand or the facility to make intentional modifications of the plan, but for those changes not to be fully communicated to each other and to be signed off by both parties. Document control and process hand-off policies should prevent this, but it is always worth confirming that there is agreement on how the product should be produced.
In addition to the brand specific production plan, we also look at the facility’s prerequisite programs to make sure that 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 review any other product HACCP plans that the facility is 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.
After reviewing all of the policies, Standard Operating Procedures (SOPs), and other plan documents we move on to the records review. At this step we are looking 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 have to deviate from that process and why. Every facility will occasionally need to deviate from the standard process, so a lack of documentation in this area can be a red flag that those “in the moment” decisions are not being tracked to ensure they are effective.
After a deep dive in the documentation, we then turn to the production floor to validate that the story that is put forward in the records matches the reality of the day to day. The baseline for the quality audit is to observe the full end to end 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 4 separate days. We observed 3 complete production runs from ingredient staging through packaging and interviewed 3 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 across the three production runs observed - there were differences in the batch outcomes. At this point we really dug into potentially 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. There is a potential that the per bag variances compound to greater than 0.5%
The cook batch is 2.5x the maximum deposit. The batches are held above their setting temperature between deposits. There is a potential that the difference in total evaporation between deposits impacts the final set.
The confections were cut based primarily on the availability of the cutting equipment once the set had cured a minimum of 12 hours. However, the facility also runs production processes which generate large amounts of steam. There is a potential that batches cured while high steam production is occurring require a longer curing time to complete the set.
The client opted to investigate all three potential sources of variation and was able to use their findings to fine tune their co-manufacturing agreements going forward.