Microsoft Word - BYLAWS 9_26_10

OMB MEETING MATERIALS

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Straw Man: This document is a starting point for future drafts and is not an approved document. Please do not distribute to laboratory staff for use.

criteria or indicates a trend, the laboratory shall initiate its procedures for processing nonconforming work. The laboratory shall have a procedure for the evaluation of data associated with a quality control material that fails and how to address it. In general, the lab should consider this data suspect. When using multi-analyte test methods, the probability exists that at least one analyte in each run will be out of limits; however, that does not necessarily mean there is an error and assignable cause for the result. The laboratory’s criteria should be balanced: avoiding unproductive corrective actions for statistically random events, yet not so broad as to ignore correctable, non-random errors. The laboratory’s criteria may take into consideration the fact that for some multi-analyte methods, some analytes behave better than others (i.e., exhibiting less variance and/or higher mean recovery) and that an analyte’s variance may increase as the concentration of the analyte decreases. There are several approaches that can be taken to set limits that take into account the probability of an out of control result in multi-analyte methods. Note: Assign the analytes to groups that have similar analytical characteristics or chemical structure. An example of this is low-molecular-weight ketones that tend to be lost in the sample preparation process or organic acids that may be poor performers in certain extraction processes. Then the quality control and control charting procedure can be designed to track a representative analyte of each of these groups. Note: Set limits that take into the account the probability that an out of control result will be encountered, such as the approach set forth for environmental testing laboratories in the TNI (The NELAC Institute) ‘ Management and Technical Requirements for Laboratories Performing Environmental Analysis (2016) .”

Proficiency test sample acceptability

The laboratory shall evaluate PT results when they are received. Most external PT providers issue acceptability limits and criteria; when issued, the laboratory shall use criteria that is at least as stringent as the PT provider’s. If the PT provider does not issue acceptability criteria or the laboratory is performing proficiency testing by alternative means as described above, then they shall have procedures that define the acceptability of the results.

The following information provides guidance to assist the laboratory in evaluating the results. The assigned value can be established by one of the following four options:

  

The SPC ranges for blinded LCSs Fortification value of prepared samples Assigned result from a previous round (set)

 Results obtained from a group of two or more accredited laboratories for that analyte which have demonstrated proficiency in the past

Note: For the majority of laboratories, outliers may be removed for statistical analysis after an error analysis has been shown to be inconclusive , providing that a sufficient number of laboratories participate in a particular round

7.11

Control of data and information management

7.11.2 Procedures, including the use of handwritten and electronic signatures, shall be established to prevent release of unauthorized reports. For dietary supplement and pharmaceutical laboratories, electronic records and signatures must meet the requirements of United States Food and Drug Administration Code of Federal Regulations Title 21, Part 11 Electronic Records; Electronic Signatures . Note : Software such as spreadsheets and databases that contain calculations, “macros”, coding and other functionality for data processing (e.g., a spreadsheet used to calculate moisture results) are part of the laboratory information management system(s) and shall be validated before use.

7.11.3

Note: Software such as spreadsheets and databases that contain calculations, “macros”, coding and other

08/09/2018