Assessment of External Laboratories

Éidín Christie

Office of Environmental Assessment,Environmental Protection Agency,

Inniscarra,Cork

EPA Licence Condition

“Where analysis is subcontracted it shall be

to a competent laboratory”

Assessing competence

Option 1 :

Use of Formal External Recognition

Option 2 :

Assessment of external laboratories competence by licensee

Formal External Recognition

Accreditation

Accreditation to ISO17025 is defined as formal recognition that a laboratory is

competent to carry out specific tests or specific types of tests.

Accreditation to ISO17025

Need to consider:

n Scope of Accreditationn Parameter, units of measurementn Matrixn Method usedn Limit of quantitationn Uncertainty of Measurementn Fitness for Purposen Sampling/sample integrity

Scope of Accreditation

Scope of Accreditation

Assessing Laboratories

Laboratory Management and Staff

n Qualified and experienced Laboratory manager and deputy

n Adequate qualified and trained staffn Training procedures in place for staffn Training records in place for staffn Assessment of staff competencen Training Records up to date

Assessing Laboratories

Commitment to Quality

n Are laboratory facilities appropriate for carrying out tests.n Documented Quality Manual in placen Quality manager/co-ordinator appointedn Quality Control procedures in placen Regular audits carried out to assess compliance

Assessing Laboratories

Equipment and Calibration

n Documented calibration programme in place

n Are calibration records current

n Has traceability of Calibrations been established

n Is equipment maintained according to manufacturers

recommendations and recognised practices.

Assessing Laboratories

Analytical Methods

n Are documented SOPs in place for all relevant methodsn Are procedures based on reference standard methodsn Are procedures in place for method validationsn Has method validation been carried outn Has method performance been establishedn Have the relevant matrices been assessedn Is it ‘fit for purpose’ i.e LOQ, Accuracy, Precision,

Uncertainty of Measurement.

Assessing Laboratories

Analytical Quality Control

n Documented AQC procedure in place.n All relevant tests subject to AQCsn Are AQCs evaluatedn Are Controls on AQC ‘fit for purpose’n Are failures dealt with appropriatelyn Are External/independent checks carried outn Are results obtained satisfactoryn Are failures acted on appropriately