Quick Guide for an Out-of-Specification Micro Result
Well-managed or not, any food company may occasionally experience a laboratory test result that is out-of-specification (OOS). An OOS data point occurs when the value does not meet a predetermined level (specification), suggesting that a process is out of control or you are inheriting a supplier problem.
This OOS Response Guide breaks down best practices for preparation before an OOS result is received, environmental monitoring program OOS actions, product OOS actions, and follow-up actions to prevent the reoccurrence of contamination.
Pre-OOS Preparation and Best Practices
- Establish a response team. Select diverse team members including QA/QC, sanitation, production, and maintenance personnel. Consider legal and/or outside consultants in food safety and public relations.
- Build a written OOS response plan. Outline the actions to be taken in the event of an OOS sample, product or facility. Consider who is responsible for data control, conducting root cause analysis and corrective action investigation, and communicating to management, shareholders, regulators, media, and the public.
EMP (Environmental Monitoring Program) OOS Actions
- Limit access to the hot spot area.
- Completely disassemble and inspect nearby equipment for obvious harborage locations, difficult to clean areas, and support legs.
- Thoroughly clean and sanitize all equipment parts, surfaces, and tools in the contaminated area.
- Resample equipment and surfaces to determine if contamination is localized or widespread.
- Monitor area around the hot spot with vector sampling.
- Re-clean, re-sanitize, resample as needed; do not restart operations until all tests are in-spec.
- After remediation, increase sample frequency to determine efficacy of corrective actions.
- Once contamination site has been remediated, return that location to routine sampling frequency after three successive negatives from samples taken on three successive dates; test and hold.
Product OOS Actions
- Review all GMP verification data for compliance.
- Review all process control verification data to ensure control was maintained.
- Review all EMP verification data to ensure sanitation control was maintained.
- Review all ingredient verification data to ensure you are not inheriting a supplier problem.
- Retest multiple samples from suspect lot, preceding lot, and succeeding lot.
- Test all ingredient lots used in suspect product lot.
- Determine product disposition: test/hold, reprocess if kill step is used, destroy, or divert implicated product to another use.
- Increase monitoring sample volumes to help define risk.
Post-remediation Actions
- Record root cause, corrective actions in a CAPA document.
- Consider drafting/revising SOPs to prevent the reoccurrence of contamination.
- Consider removing, replacing, or redesigning process equipment or features
Questions on how this information is applicable to your food process?
Additional Resources
OMG I have an out-of-spec micro sample, what should I do? Webinar
Microbiological Specifications in Food Operations
Ask An Expert with David Legan - Absence, Negative, and Not Detected
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