Request Scope Expansions Online Via the TouchStone Customer Portal
A2LA has made it easier for accredited DOD ELAP and DOECAP-AP participant laboratories to request scope expansions. Simply log in to the TouchStone Customer Portal and click the “Scope Expansion Request” tab. As you complete the process, be sure to keep these requirements in mind.
Method Validation
Laboratories must validate non-standard methods, laboratory[1]developed methods, and standard/ reference methods if used outside their intended scope, and for any modifications of standard/reference methods to ensure they are fit for the intended use.
For all methods except reference methods, validation must meet the requirements in the Module 2 section “Selection, Verification and Validation of Methods,” as well as all criteria in the corresponding technical module (modules 3-8).
Proficiency Testing
Laboratories must achieve a history of two successful (acceptable scores) PT studies out of the three most recent attempts for each Field of Accreditation (FoA) for which it seeks accreditation. The two PT studies must be performed no more than 18 months prior to the scope expansion request for acceptance. The opening date of the second study must be at least seven (7) calendar days after the closing date of the first study. The closing date of the most recent successful PT study must be no more than six (6) months prior to the scope expansion request.
SOPs
If manual integrations are performed, the process must be addressed within the associated SOP. Also, raw data records must include a complete audit trail for those manipulations (i.e., the chromatograms obtained before and after the manual integration must be retained to permit reconstruction of the results). This requirement, from the DoD/DOE QSM V6.0, applies to all analytical runs including calibration standards and QC samples.
Traceability
DoD/DOE QSM V6.0 Module 2 Sections 6.4 and 6.5 address the requirements for the calibration of measuring and test equipment. Reference materials must be purchased from accredited ISO/IEC 17034 Reference Material Producers, if available. Reference standards must be traceable to a national standard of measurement.
Outside of a regularly scheduled on-site assessment, there are additional items required for requesting a scope expansion:
- Method Validation Package
- Technical Justification for any Method Modifications
- Limit of Detection (LOD) and Limit of Quantitation (LOQ) Data
- Demonstration of Capability Training Records
- Proficiency Testing (PT) Results
- Standard Operating Procedures (SOP)
- Method Validation/Verification
- Sampling/Handling
- Preparation
- Testing/Analysis
- Reporting
- Evidence of Traceability for:
- Equipment Calibration/Verification
- Reagents
- Standards
- Reference Materials
- Full Data Package
- Control Limits
- Copy of Mass Calibration Data (if applicable)
To learn more, contact your accreditation officer, or reach out to us at info@A2LA.org. Looking to begin the accreditation process? Start here by requesting a quote.