| HACCP System |
Codex Alimentarius, General Principles of Food Hygiene, CXC 1-1969, revised 2020 |
Establish a documented food-safety system based on the seven HACCP principles, including hazard analysis, CCP determination, monitoring, corrective action, verification, and record keeping. |
Documented rationale for determining whether foreign-body detection is a Critical Control Point or another control measure. |
Approved HACCP plan, process-flow diagram, hazard analysis, CCP decision-tree records, and management review. |
Required by HACCP system |
| Hazard Analysis |
Codex CXC 1-1969; U.S. FDA 21 CFR Part 117, Subpart C |
Food hazards must be identified and evaluated using the product, process, intended use, and reasonably foreseeable hazards as the basis for preventive controls. |
Risk assessment covering glass, stone, mineral fragments, metal, dense plastic, and other foreign materials relevant to the product and process. |
Written hazard analysis, supplier and process records, historical complaint data, and documented justification for selected detection technology. |
Required where applicable |
| Critical Control Point |
Codex CXC 1-1969, Principle 2 |
A CCP is a step at which control can be applied and is essential to prevent, eliminate, or reduce a food-safety hazard to an acceptable level. |
Defined inspection location, product condition, operating speed, detection capability, reject method, and response to a failed test. |
CCP determination record, approved operating procedure, line-layout drawing, and documented acceptance criteria. |
Site-defined through HACCP |
| CCP Monitoring |
Codex CXC 1-1969, Principle 4; FDA 21 CFR 117.145 |
Monitoring procedures must be written and performed at a frequency sufficient to confirm that preventive controls remain effective and within established limits. |
Test-piece challenge checks at start-up, after product or setting changes, after interruptions, and at the frequency specified in the validated HACCP plan. |
Signed or electronic test logs showing date, time, product, line speed, test standard, result, operator, and corrective action when required. |
Monitoring required |
| Detection Sensitivity |
Equipment capability and site validation; no single universal value is set by HACCP, FDA, or EU food-hygiene rules |
Detection capability must be suitable for the product, package, orientation, density, temperature, line speed, and identified hazard. |
Minimum detectable test-piece size by contaminant type, product SKU, package format, and operating condition. |
Validated challenge-pack results under worst-case conditions, including the densest product, fastest approved speed, and most difficult package orientation. |
Validated by site and product |
| Test Standards |
Food-industry validation practice; equipment manufacturer instructions |
Challenge devices should be identifiable, controlled, and suitable for the intended inspection application. Regulations generally do not prescribe one universal test-piece size. |
Unique identification, contaminant type, nominal size, certificate or calibration information, condition, and storage control. |
Test-piece register, certificates where applicable, periodic condition checks, replacement records, and traceability to each validation test. |
Site-defined control |
| Reject-System Validation |
Codex verification principle; FDA 21 CFR 117.150 and 117.165 |
Corrective actions and verification must address deviations and confirm that the preventive control is implemented and effective. |
Confirmed automatic rejection, secure reject-bin status, fail-safe response, reject confirmation, and line-stop or hold action when the reject system fails. |
Challenge-test records, reject confirmation tests, alarm history, locked reject-bin inspection, and documented disposition of affected product. |
Required when part of the control |
| Corrective Action |
Codex CXC 1-1969, Principle 5; FDA 21 CFR 117.150 |
Deviations require documented correction, evaluation of affected food, root-cause review, and action to prevent recurrence. |
Automatic hold or controlled isolation of product produced since the last acceptable check, followed by investigation and re-inspection where justified. |
Deviation report, product-hold record, root-cause analysis, re-inspection results, release authorization, and preventive-action record. |
Required for deviations |
| Verification and Validation |
Codex CXC 1-1969, Principles 6 and 7; FDA 21 CFR 117.155 and 117.165 |
Procedures must verify that the HACCP or preventive-control system operates as intended and that controls are scientifically or technically effective. |
Initial commissioning, product change validation, periodic review, software or recipe-change review, and documented revalidation after significant process changes. |
Validation protocol, approved test results, trend analysis, internal audit findings, calibration or service records, and review approval. |
Required system activity |
| FDA Preventive Controls |
U.S. FDA, 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls |
Covered facilities must implement a written food-safety plan with hazard analysis, preventive controls, monitoring, corrective actions, verification, and records, subject to applicable exemptions. |
Documented foreign-material preventive control when the hazard analysis identifies a reasonably foreseeable hazard that requires control. |
Food-safety plan, monitoring and verification records, corrective-action records, training records, and qualified-individual review. |
Required where applicable |
| EU HACCP Rules |
Regulation (EC) No 852/2004 on the hygiene of foodstuffs, Article 5 |
Food business operators must put in place, implement, and maintain permanent procedures based on HACCP principles, subject to the regulation’s scope and provisions. |
Foreign-body control must be integrated into the documented HACCP-based procedure when identified as a significant hazard. |
HACCP documentation, CCP monitoring records, verification activities, deviation records, and evidence of corrective action. |
Required where applicable |
| EU Traceability |
Regulation (EC) No 178/2002, Article 18 |
Food businesses must be able to identify suppliers and the businesses supplied, enabling traceability through relevant stages of production, processing, and distribution. |
Link x-ray inspection results, alarms, holds, and release decisions to product code, batch or lot, production time, and line. |
Electronic or paper batch records, inspection logs, product-hold records, and one-step-back/one-step-forward traceability tests. |
Required for covered food operations |
| EU Official Controls |
Regulation (EU) 2017/625 on official controls and other official activities |
Competent authorities use risk-based official controls to verify compliance with food and feed law, including applicable hygiene and safety requirements. |
Availability, integrity, and retrievability of inspection, maintenance, calibration, verification, alarm, and corrective-action records. |
Audit-ready records, data-integrity controls, access permissions, retention procedure, and documented response to authority requests. |
Records must support verification |
| EU Equipment Materials |
Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food |
Food-contact materials must not transfer constituents to food in quantities that could endanger health, cause unacceptable changes, or deteriorate organoleptic characteristics. |
Assessment of product-contact belts, guides, seals, covers, and other materials used around the inspection point. |
Supplier declarations, material specifications, intended-use assessment, cleaning compatibility records, and change-control documentation. |
Required for applicable food-contact materials |
| Radiation Safety |
Applicable national legislation implementing Council Directive 2013/59/Euratom; local occupational-safety requirements |
Ionising-radiation equipment is subject to applicable safety, shielding, inspection, warning, maintenance, and worker-protection requirements in the jurisdiction of use. |
Radiation-leakage survey results, safety-interlock tests, warning-label checks, operator training, and service documentation. |
Installation acceptance record, radiation survey report, interlock test log, maintenance history, and local compliance documentation. |
Jurisdiction-dependent legal requirement |
| Audit Metrics |
HACCP, FDA preventive-controls, and EU food-hygiene verification principles |
Records must demonstrate that controls are implemented, monitored, verified, and corrected when deviations occur. |
Test completion rate, failed-test rate, corrective-action closure time, reject confirmation rate, product-hold traceability, and repeat-deviation rate. |
Monthly or quarterly trend reports, internal-audit findings, management-review minutes, and documented improvement actions. |
Defined by the food business |