What to Do When Your Test Results Don’t Match Expectations
In the world of dietary supplements and food testing, unexpected results can be unsettling, but they’re not uncommon. Whether it’s a failed specification, an out-of-spec (OOS) result, or a surprising contaminant detection, the key is to approach the situation with a structured, collaborative mindset.
Here’s how to navigate the process when results don’t align with expectations:
Step 1: Run Parallel Investigations
Unexpected results don’t always point to an analytical error. In fact, there are often multiple contributing factors. That’s why two investigations should happen simultaneously:
- Analytical Review: Partner with a reputable lab to confirm the accuracy of the test result. Confidence in the data is foundational.
- Operational Review: Examine batch records, raw materials, and manufacturing processes. If you're working with a contract manufacturer (co-man), share the data and ensure they understand what the results indicate.
Step 2: Validate the Lab’s Process
Your testing partner has a responsibility to rule out any analytical error. Internal investigations should focus on method integrity, equipment performance, and sample handling.
To uncover the root cause, key questions should be answered by the lab including:
- Do the analysis batch records support the product claims?
- Do ingredient test results align with expectations?
- What is the age of the product?
- What unit and form are the specification based on?
- What is the product’s stability profile?
- How was it stored and shipped?
These insights often reveal whether the issue is isolated or systemic.
Step 3: Assess the Scope
Is the issue limited to a single lot, or could it affect multiple batches or products? Understanding the scale helps determine next steps—from targeted recalls to broader supply chain reviews.
Step 4: Be Prepared with a Contingency Plan
Not everything will go as planned. That’s why it’s critical to have a documented response strategy:
- SOPs and work instructions for handling OOS results
- A clear internal investigation process
- Qualified co-manufacturers with regular audits and oversight
- A trusted lab partner with validated, fit-for-purpose methods
Remember: Trust but verify. Even the best partners need accountability.
Unexpected results are not the end of the road. They’re an opportunity to strengthen your processes, protect your brand, and ensure consumer safety. With the right approach and the right lab partner, you can turn uncertainty into clarity.
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