Quality Control & SOPs
Quality Management Framework
SENO's quality system operates on three levels:
| Level | Scope | Responsibility | Frequency |
|---|
| Level 1 — Daily QC | Every PCR run: controls, extraction blanks, replicate testing | Shift lead technician | Every run |
| Level 2 — Periodic QC | Proficiency panels, instrument calibration, reagent lot validation | QC manager | Weekly / per lot |
| Level 3 — System QC | Internal audit, management review, corrective action follow-up | Quality director | Monthly / quarterly |
Key Quality Metrics
| Metric | Target | Monitoring Method |
|---|
| DNA sexing accuracy | ≥ 99% | Periodic blind sample panel (200+ samples) |
| NTC contamination rate | < 1% | Quarterly run audit |
| Sample failure rate (re-extraction) | < 5% | Monthly tracking |
| Report turnaround (standard) | 1–2 working days | Daily log review |
| Proficiency testing score | ≥ 95% agreement | Semi-annual external PT |
| Customer dispute rate | < 0.5% | Per-batch QC review |
Document Directory
| Document | Type | Description |
|---|
| Laboratory QC Protocols | Procedure | Daily QC steps, positive control management, run acceptance criteria |
| DNA Extraction SOP | SOP | Standardized protocol for genomic DNA extraction from avian feather, blood, and swab samples |
| CHD PCR Protocol | SOP | PCR amplification parameters for CHD-W/CHD-Z sex determination |
| PBFD qPCR Validation | Report | Full analytical validation per CLSI EP guidelines: LOD, precision, accuracy |
| PCR Troubleshooting Guide | Reference | 50+ diagnostic entries — amplification failure, contamination, artifacts |
| Lab Workflow | Procedure | End-to-end process: sample reception through report generation |
| Proficiency Testing | Program | Internal and external proficiency testing protocols |
| Accuracy Validation | Procedure | Ongoing accuracy monitoring, method comparison, bias assessment |
Quality Control Personnel
| Role | Staff Count | Key Responsibilities |
|---|
| Senior QC Manager | 1 | System-level QC, audit, certification maintenance |
| Lead Technician (shift) | 3 | Run-level QC, control verification, troubleshooting |
| Validation Specialist | 2 | Method validation, lot-to-lot reagent qualification |
| Data Reviewer | 2 | Report QC, discrepancy investigation, CAPA tracking |
Cross-References
SENO operates a multi-tier quality control framework that governs every stage of the avian genetic testing workflow — from sample reception through DNA extraction, PCR amplification, result interpretation, and final report issuance. This framework is aligned with our ISO 9001:2015 and ISO 13485:2016 certified quality management systems and follows CLSI EP guidelines for assay validation.
QC Architecture
| QC Tier | Scope | Frequency | Responsible Team |
|---|
| Level 1 — Per-Batch Controls | Every analytical run (extraction + PCR) | Each batch | Laboratory Technician |
| Level 2 — Daily QC | Equipment, reagents, lab environment | Every working day | Shift Lead |
| Level 3 — Periodic QC | Calibration, proficiency testing, audits | Quarterly / Semi-annual / Annual | Quality Manager |
| Level 4 — Management Review | Quality objectives, CAPA, trends | Semi-annual | Senior Management |
Standard Operating Procedures
All laboratory procedures are documented as controlled SOPs with version history in SENO's document management system. SOPs are reviewed annually and updated whenever a method change or CAPA necessitates revision.
| Document | Description | Last Reviewed |
|---|
| DNA Extraction SOP | Genomic DNA extraction from feather follicles — step-by-step protocol with troubleshooting | 2026-Q1 |
| CHD PCR Protocol | PCR amplification for avian sex determination — setup, cycling, gel analysis, troubleshooting | 2026-Q1 |
| PBFD qPCR Validation | Analytical validation report for BFDV qPCR assay — LOD, specificity, precision, diagnostic accuracy | 2025-Q4 |
| PCR Troubleshooting | Comprehensive guide to resolving PCR failures, contamination, ambiguous sexing, and qPCR issues | 2026-Q1 |
| Lab Workflow | End-to-end laboratory process: sample reception → registration → extraction → PCR → interpretation → reporting | 2026-Q1 |
Validation & Accuracy
All testing methods must pass a standardized validation process before clinical use. Validation data is maintained in a dedicated validation file per method.
| Test Type | Validation Approach | Key Metric | Reference |
|---|
| DNA Sexing (CHD PCR) | Known-sex birds (50+ species) | ≥ 99% concordance | Accuracy Validation |
| Disease qPCR (PBFD, APV, AIV) | Clinical samples × sequencing confirmation | ROC-AUC ≥ 0.95 | PBFD qPCR Validation |
| DNA Fingerprinting | Population allele frequency | DP > 0.9999 | Application Records |
| Performance Genes | Population association study (2,500 pigeons) | Significant p < 0.01 | Application Records |
Proficiency & External Quality Assessment
SENO participates in annual proficiency testing (PT) through accredited external providers and conducts internal proficiency assessments to ensure ongoing accuracy.
Quality Metrics Dashboard
SENO tracks the following key quality indicators on a monthly basis. Targets are reviewed annually during management review.
| Metric | 2026 Target | 2025 Actual | 2024 Actual |
|---|
| Report accuracy | ≥ 99.5% | 99.7% | 99.6% |
| On-time delivery (within TAT) | ≥ 95% | 96.2% | 95.8% |
| Proficiency test pass rate | 100% | 100% | 100% |
| Client satisfaction score | ≥ 4.5 / 5.0 | 4.7 | 4.6 |
| Retest rate | < 2% | 1.3% | 1.5% |
| Client discrepancy rate | < 0.5% | 0.2% | 0.3% |
| Instrument calibration compliance | 100% | 100% | 100% |
Key Documents
This document is maintained by SENO's Quality Management team. All SOPs and protocols are controlled documents and should not be reproduced without authorization. For questions, contact [email protected].