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• 2.7.1 Performance Evaluation Performance evaluation studies are used to measure the performance of the laboratory on unknown samples. Performance evaluation samples are typically submitted to the laboratory as blind samples by an independent outside source. The results are compared to predetermined acceptance limits. Performance evaluation samples can also be submitted to the laboratory as part of the QA function during internal assessment of laboratory performance. Records of all performance evaluation studies should be maintained by the laboratory. Problems identified through participation in performance evaluation studies should be immediately investigated and corrected. 2.7.2 Internal Assessment by QA Function Personnel performing field and laboratory activities are responsible for continually monitoring individual compliance with the QAPjP. The QA function should review procedures, results and calculations to determine compliance with the QAPjP. The results of this internal assessment should be reported to management with requirements for a plan to correct observed deficiencies. 2.7.3 External Assessment The field and laboratory activities may be reviewed by personnel external to the organization. Such an assessment is an extremely valuable method for identifying overlooked problems. The results of the external assessment should be submitted to management with requirements for a plan to correct observed deficiencies. 2.7.4 On-Site Evaluation On-site evaluations may be conducted as part of both internal and external assessments. The focus of an on-site evaluation is to evaluate the degree of conformance of project activities with the applicable QAPjP. On-site evaluations may include, but are not limited to, a complete review of facilities, staff, training, instrumentation, procedures, methods, sample collection, analyses, QA policies and procedures related to the generation of environmental data. Records of each evaluation should include the date of the evaluation, location, the areas reviewed, the person performing the evaluation, findings and problems, and actions recommended and taken to resolve problems. Any problems identified that are likely to affect data integrity should be brought immediately to the attention of management. 2.7.4.1 Field Activities The review of field activities should be conducted by one or more persons knowledgeable in the activities being reviewed and include evaluating, at a minimum, the following subjects: Completeness of Field Reports -- This review determines whether all requirements for field activities in the QAPjP have been fulfilled, that complete records exist for each field activity, and that the procedures ONE - 5 Revision 1 July 1992