Customized Proficiency Testing Request System
The Customized Proficiency Testing Request System is a corporate application and program-design infrastructure that provides laboratories with a demand-driven, configurable, and fully traceable proficiency testing (PT) process for needs not adequately covered by the market (e.g., rare analytes, unique matrices, specific concentration ranges, limited participant numbers). Its purpose is to ensure—through a structured request workflow—that the PT scheme aligns with the laboratory’s routine operations and accreditation requirements, rather than forcing the laboratory to fit into a pre-existing program.
Why the Customized Proficiency Testing Request System?
Standard PT programs may not always meet the following needs:
- Niche analytes / rare matrices (process-specific samples, waste streams, special compositions)
- Specific concentration levels (verification near LOQ, levels close to regulatory limits)
- Limited participation (internal comparisons with a small number of laboratories)
- Scope extension / new method validation (need for evidence prior to audits)
- Multi-site structures (demonstrating alignment between branches using the same method)
The system closes this gap by technically clarifying the request and converting it into a measurable, fit-for-purpose PT program.
How Does the System Work? (End-to-End Workflow)
1) Create a Request (Structured Application)
The laboratory defines its request in the system using technical fields. Example fields include:
- Analyte(s), matrix/matrices, target concentration range
- Method/instrument information, reporting units, LOQ/LOD expectations
- Target measurement uncertainty, acceptance criteria, and any regulatory limits
- Number of participants (single-organization internal / multi-organization), locations
- Sample storage/transport conditions (cold chain, stability window)
- Hazard class, SDS/transport restrictions, customs requirements
- Target round date (aligned with audits, internal audits, and management review)
2) Feasibility Assessment & Technical Clarification
After the request is received, the technical team evaluates:
- Material producibility and stability risks
- Assigned value approach (reference value / formulation / consensus)
- Statistical evaluation model (z, z′, zeta, Eₙ)
- Logistics and timeline plan
and requests any additional information required.
3) Quotation & Approval of Program Design
The following are clearly presented to the laboratory:
- Program scope (analyte–matrix–level)
- Number of rounds/frequency
- Sample set design
- Report format and performance criteria
- Timeline and logistics plan
- Confidentiality model and participant coding structure
Once approved, the program plan is “locked” and moved into implementation.
4) Sample Production & Quality Assurance
Customized program samples are prepared to represent routine samples. Where applicable:
- Homogeneity and stability studies are performed in line with the ISO 13528 approach
- Batches are documented through critical quality controls
- Risks of deviations caused by sample nonconformity are minimized
5) Round Management: Shipment – Results – Documentation
The program includes sample shipment, receipt confirmation, result entry, and—when required—raw data/document upload. The process is managed with traceability at the participant level.
6) Evaluation, Reporting & Action Support
Once evaluation is complete:
- Performance indicators (according to the selected model) are issued
- Comparisons are provided by method/instrument groups
- For warning/action signals, technical feedback is provided to support root cause analysis and corrective action planning (CAPA)
7) Continuity & Trend Monitoring
In programs with multiple rounds, the laboratory’s:
- Bias trends
- Precision/repeatability trends
- Round-to-round performance changes
are monitored to support a sustainable improvement framework.
Outputs (Evidence & Documentation Provided to the Laboratory)
- A program plan and scope definition suitable for accreditation and audits
- Round-based evaluation and final report
- Traceable records: application, sample, results, documents, revision history
- Technical interpretation and guidance for CAPA where needed
- Cross-site performance overview for internal benchmarking
Security, Impartiality & Confidentiality Approach
Within the system:
- Each participant is identified with a coded identity
- Results are shared only with the relevant participant
- Program delivery is designed to be documentable and aligned with ISO/IEC 17043 principles
- Data and document flow is controlled and fully recorded
Who Is It Particularly Suitable For?
- QC laboratories working with unique product/production matrices
- Organizations needing internal comparisons with a limited number of laboratories
- Accredited laboratories requiring demonstrable performance evidence for rare parameters
- Teams expanding scope, validating new methods, or preparing for accreditation/audits