OMB Winter Mtg.-February 5-6, 2015

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Draft 6. Note: This document is a draft suggestion only and is not an approved document. Please do not distribute to laboratory staff for use. The phrase “working on” means the analyst performs the analysis of customer samples independently with the intention of reporting the results. Whenever a trainee is performing tasks on customer samples, the trainee must do so under the supervision of a trained analyst and it is the trained analyst who takes responsibility for these tasks. The laboratory must ensure that the trainee performing the tasks does not impact the analysis. An example where a trainee may perform a task on customer samples is the simple task of pureeing plant material such as lettuce; the task has a distinct endpoint that the trained analyst can observe and ensure the trainee has performed correctly. Another example is entering sample sets into a computer. The trained analyst can verify the information is correct and entered correctly before the analysis takes place. Data demonstrating the initial and ongoing competency of all personnel shall be retained along with, or be referenced in the training records. Records shall include verification that the effectiveness of the training action has been evaluated. A review of the completeness of training records, ongoing analytical performance (e.g. results of internal and external quality controls such as proficiency testing, control charts, etc.) and training requirements shall be performed periodically. The need for competency re-verification shall be assessed and, if needed, implemented for those individuals who have not performed a particular analysis for a prolonged period of time. Personnel working in teams or work groups shall be qualified as a team or work group. Alternatively, a staff member can be qualified on only a portion of a procedure. In these cases, the training records shall reflect the appropriate training authorizations. Each person engaged in the process shall have training and experience that is appropriate to their assigned functions. Sufficient supervisory resources shall be provided to ensure appropriate supervision and oversight of all personnel. The number of personnel reporting to supervisors and managers shall be based on the complexity and diversity of the testing work within the organization. 5.2.2 Laboratory management shall retain records that demonstrate that each individual has the required knowledge, skills, and abilities to adequately perform their assigned tasks. All personnel operating under this document shall have training, at pre-determined intervals, on their roles and responsibilities in the management system and in its proper maintenance. 5.3 Accommodation and Environmental Conditions 5.3.2 Environmental monitoring requirements shall be planned and results shall be recorded. Monitoring shall be consistent with the industry standard for the field of testing on the scope of accreditation. The environmental monitoring shall meet the requirements of the test methods listed on the scope of the accreditation. Additionally, monitoring shall include the requirements necessary to operate instrumentation properly. Examples of microbiological monitoring are laboratory swabbing, hand swabbing, air plates, water testing, and PCR amplicon swabbing. Examples of chemistry monitoring are instrument room temperatures and water testing. The grade of any reagent or reference material used (including water) that affects the quality of tests should be stated in the method together with guidance on any particular precautions that should be observed in its preparation or use. Samples, reagents, measurement standards and reference materials must be stored so as to ensure their integrity. In particular, consideration should be given to avoiding the potential for cross-contamination when storing samples. The laboratory should guard against their deterioration, contamination, and loss of identity. Reagents, reagent solutions, media, and sample solutions shall not be used past their expiry date without verification that they are still suitable for use. The laboratory must define the use of the water and ensure the water is fit for that use. There are various documents that state specifications for water, such as USP, EP, the Standard Methods for the Examination of Water and Waste Water (SMEWW), and ASTM Standard D1193-06 Standard Specifications for Water.