In the evolving landscape of food safety, the lines between preventive measures, process controls, and verification activities are becoming more defined—and more scrutinized. One area that continues to generate discussion among manufacturers, auditors, and testing providers is the Operational Prerequisite Program (OPRP).
Although “OPRP certification” is often used colloquially, there is no standalone certification specific to OPRPs. Instead, OPRPs are an integral component within broader food safety management systems (FSMS), such as the ISO 22000 or FSSC 22000, that can be audited and certified. Understanding how OPRPs function—and how contract laboratories can support their validation and monitoring—is key to maintaining compliance and ensuring public health protection.
What Is an OPRP?
An Operational Prerequisite Program (OPRP) is a control measure identified during a facility’s hazard analysis that is pivotal to prevent or minimize food safety hazards to acceptable levels. The concept was formalized in the ISO 22000:2018, which classifies control measures into three categories:
- PRPs (Prerequisite Programs): General hygiene and environmental controls that create a foundation for food safety.
- OPRPs (Operational Prerequisite Programs): Specific actions that help control significant hazards but do not qualify as Critical Control Points (CCPs).
- CCPs (Critical Control Points): Steps at which control is essential to eliminate or reduce a hazard to an acceptable level.
In practical terms, OPRPs serve as intermediate control measures. They are applied to processes or environmental conditions where hazards can be controlled but not entirely eliminated, bridging the gap between the broad PRPs and narrowly defined CCPs.
OPRP Certification and the ISO 22000 Framework
OPRPs are not certified independently but are embedded within an organization’s ISO 22000 or FSSC 22000 certification. These standards require documented procedures for identifying, implementing, and verifying OPRPs as part of a complete food safety management system.
During an ISO 22000 certification audit, the auditor assesses:
- Whether hazards have been correctly identified and analyzed.
- If control measures are properly categorized as PRP, OPRP, or CCP.
- Whether OPRPs are supported by scientific or operational validation data.
- How monitoring, corrective actions, and verification are documented.
An organization’s ability to demonstrate effective OPRP management often determines the success of its certification audit and ongoing compliance with global food safety standards.
Differentiating OPRPs from PRPs and CCPs
| Control Type | Purpose | Examples | Monitoring & Documentation |
|---|---|---|---|
| Prerequisite Program (PRP) | Provides general hygiene and baseline operational conditions | Sanitation, supplier approval, pest control, employee hygiene | Routine observation, general records, internal audits |
| Operational Prerequisite Program (OPRP) | Controls specific hazards not managed by PRPs or CCPs | Metal detection, filter integrity checks, air pressure differentials | Action criteria, monitoring logs, verification of effectiveness |
| Critical Control Point (CCP) | Eliminates or reduces hazards to safe levels | Thermal processing, pH adjustment, pasteurization | Continuous monitoring, critical limits, documented corrective actions |
While PRPs are foundational and CCPs are critical, OPRPs offer a practical means of managing intermediate risks—particularly in complex or multistage processes where control is shared among several preventive steps.
Establishing and Managing OPRPs
Developing an effective OPRP requires a structured approach that integrates risk assessment, validation, and continuous improvement. The ISO 22000 outlines several core steps:
1. Conduct a Comprehensive Hazard Analysis
Each step in the process must be evaluated for potential biological, chemical, and physical hazards. The risk of each hazard, based on severity and likelihood, is used to determine which control measures qualify as OPRPs.
2. Determine Control Measures and Action Criteria
Each OPRP must have defined action criteria (measurable or observable parameters) that trigger corrective actions when deviations occur. For instance, maintaining a metal detector’s sensitivity or ensuring proper filtration pressure are typical OPRP criteria.
3. Validate the Control Measure
Validation involves demonstrating, through scientific data or practical trials, that the OPRP effectively reduces hazard risk. This may include laboratory testing, microbial challenge studies, or statistical process validation.
4. Monitor and Verify Performance
Monitoring ensures that OPRPs consistently operate within defined limits. Verification activities, such as trend analyses or independent testing, confirm that the OPRP remains effective over time.
5. Review and Reassess
Periodic reviews, especially following process changes or nonconformities, ensure the OPRP remains appropriate and scientifically justified.
The Role of Contract Labs in OPRP Validation and Verification
Contract laboratories are uniquely positioned to support manufacturers and food safety teams throughout the OPRP lifecycle. Their technical capabilities, impartiality, and regulatory expertise make them essential partners in demonstrating compliance.
Analytical Testing and Validation
Labs can perform microbiological or chemical tests that confirm the effectiveness of an OPRP. Examples include verifying microbial load reduction, validating cleaning efficacy, or confirming that allergen residues fall below threshold levels.
Environmental and Trend Monitoring
Many OPRPs involve environmental conditions, such as air quality, humidity, or contamination control. Contract labs can provide regular environmental testing, data analytics, and interpretive reports that help identify deviations before they escalate.
Instrument Calibration and Verification
OPRPs often rely on sensors, thermometers, or detectors. Calibration labs play a vital role in ensuring these instruments are accurate, traceable, and compliant with ISO 17025 requirements.
Data Integrity and Documentation
Accurate recordkeeping is critical for certification audits. Contract labs that provide traceable, ISO-accredited reports contribute to audit readiness and strengthen clients’ documentation systems.
Pre-Audit Assessments and Consulting
Through gap analyses and technical consulting, laboratories can help clients align their OPRP documentation and evidence with auditor expectations, minimizing non-conformities during certification reviews.
OPRP Auditing and Common Non-Conformities
When OPRPs are audited as part of ISO 22000 or GFSI-benchmarked certifications, auditors often focus on how control measures are selected and validated. Common non-conformities include:
- Misclassification of a CCP as an OPRP (or vice versa).
- Absence of defined action criteria or documented validation.
- Incomplete records of corrective actions or monitoring results.
- Lack of evidence showing ongoing verification or review.
Proactive testing, data trending, and external verification from accredited laboratories can help prevent such issues and demonstrate that OPRPs are science-based and under control.
Global Trends and Future Developments in OPRP Implementation
Several developments are shaping how organizations implement and verify OPRPs:
- Digital Monitoring and Internet of Things (IoT) Integration:
Real-time sensors and automated quality management systems are improving the accuracy and efficiency of OPRP monitoring. - Data-Driven Risk Management:
Predictive analytics and AI tools are increasingly being used to evaluate OPRP performance and identify potential control weaknesses early. - Regulatory Harmonization:
Ongoing revisions to Codex Alimentarius and GFSI frameworks continue to refine OPRP definitions and harmonize global food safety standards. - Sustainability and Resource Efficiency:
Modern OPRPs are designed to control hazards while minimizing waste and supporting sustainable manufacturing practices. - Expanded Auditor Training:
Certification bodies are enhancing auditor competency requirements to include digital validation methods, statistical reasoning, and laboratory science.
Get OPRP Validation and Verification from Expert Labs
While OPRPs are not a separate certification, they are a cornerstone of any credible food safety management system. Their proper identification, validation, and verification demonstrate a facility’s scientific understanding of hazard control and commitment to continuous improvement.
For third-party testing laboratories, OPRPs present significant collaboration opportunities—from validating process effectiveness to providing ongoing environmental monitoring and data analytics. By aligning testing services with ISO 22000 and GFSI expectations, laboratories can position themselves as trusted partners in safeguarding food integrity across the supply chain.
Need lab support for OPRP validation and ISO 22000 compliance testing? Contract Laboratory can help.
Submit your testing request to connect directly with qualified labs that specialize in your specific process, material, or certification standard. Find the right partner to ensure your OPRPs meet regulatory expectations and deliver consistent, verifiable safety performance.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.