“AOAC International Guidelines “ 2015” Do training records include verification that effectiveness of the training action(s) have been evaluated? “AOAC International Guidelines “ April 2015” Is there evidence of periodic reviews of completeness of training records, ongoing analytical performance (e.g.results of internal & external quality control records, such as proficiency testing, control charts, etc.) and training requirements? “AOAC International Guidelines “ 2015” Whenever a trainee is performing tasks on customer samples, is the trainee under the supervision of a trained analyst and does the trained analyst take responsibility for these tasks? “AOAC International Guidelines “ April 2015 Does the laboratory ensure that the trainee performing the tasks does not impact the analysis? “AOAC International Guidelines “ April 2015 Do training/authorization records reflect when/if staff is trained on only a portion of a procedure? “AOAC International Guidelines “ 2015 At that time, is the need for re- verification of competency assessed and, if needed, is a re-verification performed and recorded? “AOAC International Guidelines “April” Are personnel working in teams or work groups qualified as a team or work group, and are records of competency for the team placed in the individual personnel's training records?
5.7.2 Where the customer requires deviations, additions or exclusions from the documented sampling procedure, are these recorded in detail with the appropriate sampling data? Are these included in all documents containing test and/or calibration results? Are these communicated to the appropriate personnel? 5.7.3 Does the laboratory have procedures for recording relevant data and operations relating to sampling that part of the testing or calibration done? 5.7.3 Do records include: - the sampling procedure used? - the identification of the sampler? - environmental conditions (if relevant)? - diagrams or other equivalent means to identify the sampling locations as necessary? - if appropriate, the statistics the sampling procedures are based upon? 5.8 Handling of Test and Calibration Items 5.8.1 Does the laboratory have procedures for the following regarding test and/or calibration including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and customer: - transportation? - receipt? - handling? - protection? - storage? - retention and/or disposal?
“AOAC International Guidelines “ April 2015” Are staff associated with administration of the sample handling system properly trained, competent, & authorized? “AOAC International Guidelines “April 2015” Are minimum sample retention periods and storage conditions documented in the management system and communicated to customers so that all parties are aware of how long the sample will be available for retesting or retrieval? 5.9 Assuring the Quality of Test and Calibration Results 5.9.1 Does the laboratory have quality control procedures for monitoring the validity of tests and calibrations undertaken? 5.9.1 Is the resulting data recorded in such a way that trends are detectable, and where practicable, statistical techniques applied to the reviewing of the results? 5.9.1 Is this monitoring planned and reviewed? Quality Control Samples “AOAC International Guidelines 2015” Are quality control procedures defined for both quantitative and qualitative methods? “AOAC International Guidelines “April 2015” Do the procedures include the use of quality control samples (QCS) with each batch of samples? “AOAC International Guidelines 2015” Is the term “Batch” defined unambiguously for the laboratory?
“AOAC International Guidelines “ April 2015” In absence of a Certified Reference Material (CRM) for any analysis, is an appropriate Reference Material determined that can provide a measure of accuracy? Is its suitability justified and documented? Proficiency Testing “AOAC International Guidelines “ March 2010” Proficiency Testing “AOAC International Guidelines “ April 2015” Does the laboratory have a documented proficiency testing plan for all test methods technology on the scope of accreditation? NOTE: FDA scope of accreditation is based upon technology; not method “AOAC International Guidelines “ 2015” Is proficiency testing rotated among qualified analysts? “AOAC International Guidelines “ April 2015” When a relevant external PT is not available, is there an alternative means of evaluation used? “AOAC International Guidelines “ 2015” Does the Laboratory have at least one PT event annually for each technology on the scope of accreditation? 5.9.2 Does the Laboratory have pre-defined acceptability criteria for quality control data? “AOAC International Guidelines April 2015 2015” Is the laboratory’s SPC data reviewed on a regular basis to ensure it is reporting reliable data?