1. ROLE OF SAMPLE MANAGEMENT AND CRMs IN ISO/IEC 17025
- Why sample management and CRMs matter: legal defensibility, data comparability, accreditation, trade implications, common audit non‑conformities
- Relevant ISO/IEC 17025 clauses: handling of test items, metrological traceability, control of technical records, assurance of validity of results
- (Online clause‑to‑practice mapping)
2. LABORATORY SAMPLE MANAGEMENT SYSTEMS
Sample lifecycle
- Request → receipt → storage → preparation → analysis → disposal – responsibility at each stage, risks and control points
Sample receipt and registration
- Verification against submission forms, unique sample ID (barcoding), condition assessment, acceptance/rejection criteria
Chain of custody
- Definition, purpose, documentation requirements, digital vs paper systems, legal implications
- (Virtual chain‑of‑custody exercise)
3. SAMPLE HANDLING, STORAGE, AND PRESERVATION
- Storage conditions: temperature‑controlled, light protection, humidity control, segregation
- Stability and holding times: matrix‑dependent holding times, degradation mechanisms, stability studies
- Sub‑sampling and aliquoting: representativeness, cross‑contamination prevention, traceability
4. SAMPLE TRACKING AND TRACEABILITY
- Manual vs electronic sample management (LIMS), data integrity, audit trail requirements
- Traceability requirements (ISO 17025): linking samples to methods, instruments, analysts, reference materials
- Sample retention and disposal: retention periods, safe disposal, documentation
5. INTRODUCTION TO REFERENCE MATERIALS
- Definitions: Reference Material (RM), Certified Reference Material (CRM), primary vs secondary standards, matrix‑matched CRMs
- Role of CRMs in measurement traceability: SI traceability, comparability between laboratories, regulatory acceptance
6. SELECTION AND PROCUREMENT OF CRMs
- Criteria for selecting CRMs: relevance to analyte/matrix, concentration range, measurement uncertainty, certification body credibility
- Accredited CRM producers (ISO 17034), examples of international producers, required documentation
- (Online CRM selection scenario)
7. HANDLING AND STORAGE OF CRMs
- CRM receipt and verification: Certificate of Analysis (CoA) review, lot number, expiry and validity
- Storage conditions: temperature/light requirements, segregation from samples, inventory control
- Stability and shelf life: open‑bottle stability, in‑use tracking, re‑certification considerations
8. PREPARATION AND USE OF CALIBRATION STANDARDS
- CRM to working standard: dilution schemes, gravimetric vs volumetric, documentation and labeling
- Internal standards and surrogates: purpose, selection, traceability considerations
- Verification of working standards: comparison with fresh CRM, drift and degradation checks
- (Virtual calibration standard preparation exercise)
9. QUALITY CONTROL USING CRMs
- CRMs in method validation: accuracy, trueness, bias estimation
- CRMs in routine analysis: ongoing performance verification, control charts, proficiency testing
- Use of in‑house reference materials: when acceptable, characterization, documentation, limitations under ISO 17025
10. DOCUMENTATION AND RECORD KEEPING (ISO 17025)
- Required records: sample receipt logs, storage records, CRM inventory/usage logs, preparation worksheets
- Data integrity (ALCOA+): attributable, traceable, controlled access, error correction practices
11. COMMON NON‑CONFORMITIES AND AUDIT FINDINGS
- Sample management‑related: unlabeled samples, missing chain of custody, improper storage
- CRM‑related: expired CRMs, missing CoAs, untraceable working standards
- (Interactive audit finding simulation)
12. ONLINE PRACTICAL COMPONENT
- Virtual sample receipt and rejection decision cases
- CRM selection and CoA interpretation
- Standard preparation and traceability mapping
- Audit‑style review of sample and CRM records