Laboratory Audits Clause Samples
The Laboratory Audits clause grants a party the right to inspect and review the operations, records, and compliance of a laboratory involved in the agreement. Typically, this clause outlines the procedures for scheduling audits, the scope of information that can be reviewed, and any advance notice requirements. By enabling regular or ad hoc audits, the clause ensures that the laboratory adheres to agreed-upon standards and regulatory requirements, thereby promoting transparency and mitigating risks related to non-compliance or quality issues.
Laboratory Audits. Each laboratory working on the ▇▇▇▇▇ project is required to participate in an annual on-site laboratory audit carried out by the EPA through the QATS contract. These audits are performed by EPA personnel (and their contractors), that are external to and independent of, the ▇▇▇▇▇ laboratory team members. These audits ensure that each analytical laboratory meets the basic capability and quality standards associated with analytical methods for asbestos used at the ▇▇▇▇▇ site. They also provide information on the availability of sufficient laboratory capacity to meet potential testing needs associated with the Site. Audits consist of several days of technical and evidentiary review of each laboratory. The technical portion of the audit involves an evaluation of laboratory practices and procedures associated with the preparation and analysis of samples for the identification of asbestos. The evidentiary portion of the audit involves an evaluation of data packages, record keeping, SOPs, and the laboratory QA Management Plan. A checklist of method-specific requirements for the commonly used methods for asbestos analysis is prepared by the auditor prior to the audit, and used during the on-site laboratory evaluation. Evaluation of the capability for a laboratory to analyze a sample by a specific method is made by observing analysts performing actual sample analyses and interviewing each analyst responsible for the analyses. Observations and responses to questions concerning items on each method-specific checklist are noted. The determination as to whether the laboratory has the capability to analyze a sample by a specific method depends on how well the analysts follow the protocols detailed in the formal method, how well the analysts follow the laboratory- specific method SOPs, and how the analysts respond to method-specific questions. Evaluation of the laboratory to be sufficient in the evidentiary aspect of the audit is made by reviewing laboratory documentation and interviewing laboratory personnel responsible for maintaining laboratory documentation. This includes personnel responsible for sample check- in, data review, QA procedures, document control, and record archiving. Certain analysts responsible for method quality control, instrument calibration, and document control are also interviewed in this aspect of the audit. Determination as to the capability to be sufficient in this aspect is made based on staff responses to questions and a review of archived d...
Laboratory Audits. Laboratory audits include both onsite technical and offsite systems evaluations. Laboratory audits may be requested by facilities or by RWQCB or USEPA . The audit requirements shall be documented in the site -specific work plan. will be covered in a technical systems audit of the laboratory include : Certification and training records . Calibration procedures an d documentation . Treatment and handling of standards . Completeness of data forms, notebooks, and other reporting requirements . Data review and verification procedures . Data storage, filing, and recordkeeping procedures . Sample custody procedures . Quality c ontrol procedures, tolerances, and documentation . Operating conditions of facilities and equipment . Documentation of staff training and instrument maintenance activities . Systems and operations overview . A written audit report will then be sent to the labo ratory within a specified time. A copy of the audit report will be sent to the project -specific Project Manager . A copy will be retained in the project files. The need for follow -up action will be determined based on the laboratory ’s responses. If an audit identifies an unacceptable condition or unacceptable data, the auditor will be responsible for developing and initiating corrective action. The Project Manager will be notified if the non -conformance impacts the project and requires resources not normally available to the project team. In such cases, the Project Manager will decide whether resources to pursue corrective action will be made available. Disposition may include: Reanalysis of samples if holding time has not expired . Resampling and analysis . Amending analytical procedures . Acceptance of suspect data acknowledging the limits on usability .