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This fact sheet lists the general standards that must be present in the quality assurance/quality control plan for all mobile laboratories submitting data to the Minnesota Pollution Control Agency and the Minnesota Department of Agriculture’s (MDA) Pesticide & Fertilizer Management Division.
The MDA project manager/project team must determine the scope of the project and the data quality objectives for the project prior to deciding to use a mobile laboratory on a specific site. The level of Quality Assurance documentation (e.g. standard operating procedures, quality control plan) must, at a minimum, be complete enough to give the project staff data of a quality that meets the data quality objectives (DQO) for the site. For some screening analyses somewhat less stringent quality assurance may be acceptable, whereas for some very involved analyses even more stringent quality assurance may be required. Generally, the QA/QC plan submitted for approval should contain the following sections:
All information provided to the MDA will be public information unless clearly marked as a trade secret under Minn. Statutes, Section 13.37, Subd. 1(b).
This section should give a general introduction to the laboratory and the different kinds of analyses performed on the premises.
This section should introduce the reader to the different key personnel in the Laboratory
This section should completely describe the procedure from the receipt of the samples until the samples are disposed of (cradle to grave). (Note: Standard Operating Procedures (SOPs) may be referenced where applicable.)
This section shall describe the procedures used by the lab to calibrate instrumentation and equipment, including balances, in the lab. SOPs may be referred to (where appropriate). All applicable analyses to the site must be discussed.
The mobile laboratory shall describe in detail all Quality Assurance/Quality Control (QA/QC) practices that are used in the laboratory. It is recommended that a flow chart showing from sample receipt to report generation, be included to give a visual picture of the path taken by a sample and the QA/QC association with the sample. The items listed below describe some of the parameters associated with the Internal Quality in a laboratory. This list is not intended to be conclusive as to all the QA/QC a laboratory performs.
The limits associated with specific parameters and how they are developed must be described by the laboratory. Control Charting and any other method of tracking the limits must also be included.
The laboratory will describe, in detail, the in-house data reduction and validation procedures. It is strongly recommended that someone besides the analyst review all raw data and final reports that are generated in the analytical process. Any SOPs associated with these procedures should be referenced. The review process taken by an analyst/field chemist to report data must include:
The laboratory should have a policy of internal audits to verify the QA/QC plan is being followed. The audit should include an examination of the sample receipt documentation, sample log-in, sample storage, chain of custody procedures, sample preparation and analysis, instrument operating records, etc. External audits performed on the mobile laboratory should be discussed as to who performs them, who has performed them, what will be and has been audited, and the results of these audits. Blind QC samples should be submitted to the lab to verify system performance.
The laboratory will describe routine preventative maintenance program used to minimize equipment failure and breakdown. Trained staff should be on the premises to repair equipment and/or a contract be in place with a vendor to do so in a timely manner. All maintenance performed on the equipment shall be recorded in individual books that are kept with the instrument. The lab shall submit a table of its instrumentation and all preventive maintenance regularly performed.
The procedures that are used by the laboratory to assess data shall be annotated.
Corrective action may be required for instruments or in the analytical process. The laboratory must list common problems associated with corrective action and corresponding actions taken by the analysts to correct the situation. If the corrective action of the analyst can not correct the problem there must be a procedure in place for informing management and the QA/QC Officer. The procedures that management will take must be listed. All corrective action taken must be documented on appropriate forms and in the maintenance book for the specific instrument (when applicable).
On long term projects, the laboratory will normally submit quality assurance reports to the Contractor’s Project Manager (and to the state liaison, upon request). The report should include:
This section shall describe the procedures used by the laboratory to file data for immediate and long term storage. Discussion of longevity of files and data, Laboratory Information Management System (LIMS) backups, and any other items applicable can be included.
Analytical Standard Operating ProceduresUse the standard operating procedures (SOPs) format recommended by the USEPA. Include all steps done to perform the analytical method. Do not make a reference or submit a copy of an Instrument Manual, SW-846, or Standard Methods in lieu of an SOP. The SOPs are to show, in detail, how the mobile laboratory is actually performing the methods.
ResumesItems minimally required include: education, experience, current area of assignment, and responsibilities of personnel.
Incident Response Program 651-201-6061 • Fax: 651-201-6112Pesticide & Fertilizer Management Division