Out of Control Events

Sample Receipt Discrepancies

Any discrepancies noted during the sample receiving process are documented on the COC form. Information about discrepancies is provided to the appropriate Project Manager, who is responsible for contacting the client about the problem and documenting the resolution in a phone log. If the client instructs the laboratory to proceed with sample analysis, a Quality Assurance (QA) Notice explaining the problem is included with the data package and the discrepancy is addressed in the SDG Narrative by the Case Reviewer. This process is commonly used when samples are received at higher than required temperatures or have been improperly preserved. If a sample is broken during transport to the laboratory, the Project Manager notifies the client, who, in turn, notifies the field crew to resample if possible. Notification of potentially high concentration samples should be conveyed from the client and entered into the LIMS laboratory instructions field.

Out-of-Control Events at the Bench

Out-of-control events noted and corrected at the bench by technicians or analysts are recorded on sample preparation worksheets, sample analysis worksheets, instrument runlogs, calibration or temperature logbooks, or instrument maintenance logbooks, as applicable. This includes condition codes on analysis worksheets and in the LIMS. Condition codes are used to describe the status of a sample analysis and whether reanalysis is required. The codes can be indicative of trends. A QC failure normally generates a request for re-extraction and reanalysis, but depends on the occurrence or method. For instance, an MS/MSD does not have to be repeated for a surrogate failure when the original unspiked field sample also demonstrates the same failure, confirming sample matrix interference. Other QC failures may prompt the reanalysis of samples and qualifying of results. The analyst makes the determination that corrective action is needed. The type of corrective action needed has been specified in SOPs through approval of the Vice President of QA and Technology. The case reviewer, authorized by the Laboratory management for release of the data, further documents these incidences in the SDG narrative.

Data Report Errors or Omissions

If errors or omissions in data reports are found during any of the review processes, the organics data are corrected online in the ThruPut data management system. The type of correction made and the person who made the correction are documented in the audit trail within ThruPut. A QA notice or laboratory notice may be included with any reported data that does not meet all quality control criteria or which requires explanation. This notice, or the SDG narrative, describes any out-of-control events and corrective actions taken to remedy them. The Case Reviewer, who authorizes release of the data report, writes the SDG narrative.

Client-Identified Discrepancies

Should you who have a question or problem with a data report, you are requested to contact your Project Manager (PM). The PM will complete a Client Inquiry form and direct the issue to the appropriate lab supervisor for resolution. This is all done on-line via internal laboratory servers and copies of the inquiry are e-mailed to all responsible parties that may be necessary to respond and/or resolve the inquiry. Most often these issues are related to poor copy quality, a missing page from the report, or a technical question. Our PM will handle your inquiry and provide a copy of the resolution to QA. Depending on the circumstances, QA may elect to issue a CAR based on the inquiry. Your PM provides QA a response and provides supplemental documentation within an agreed upon time frame.
Where a complaint, or any other circumstance, raises doubt concerning the laboratory's compliance with our own policies or procedures, or with the quality of our tests, the laboratory ensures that those areas of activity and responsibility involved are promptly addressed and audited. Records of the complaint and subsequent actions are maintained for review.