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Home My WebLink About#554-final INSPECTION REPORT ROUTING SHEET To be attached to all inspection reports in-house only. Laboratory Cert. #: 554 Laboratory Name: Fortron Industries Inspection Type: Industrial Maintenance Inspector Name(s): Todd Crawford Inspection Date: August 24, 2011 Date Report Completed: September 1, 2011 Date Forwarded to Reviewer: September 1, 2011 Reviewed by: Tonja Springer Date Review Completed: September 19, 2011 Cover Letter to use: ___ Insp. Initial X Insp. Reg. Insp. No Finding Insp. CP __ Corrected Unit Supervisor: Dana Satterwhite Date Received: September 19, 2011 Date Forwarded to Alberta: September 27, 2011 Date Mailed: September 28, 2011 _____________________________________________________________________ On-Site Inspection Report LABORATORY NAME: Fortron Industries ADDRESS: P.O. Box 327 Wilmington, NC 28402-0327 CERTIFICATE #: 554 DATE OF INSPECTION: August 24, 2011 TYPE OF INSPECTION: Industrial Maintenance AUDITOR(S): Todd Crawford LOCAL PERSON(S) CONTACTED: Jonathan Corbett, Dale Moore, Gary Nixon and James Roberts I. INTRODUCTION: This laboratory was inspected to verify its compliance with the requirements of 15A NCAC 2H .0800 for the analysis of environmental samples. II. GENERAL COMMENTS: The laboratory was clean and well organized. The facility has all the equipment necessary to perform the analyses. The requirements associated with Findings B, D, E, H, I and J are new policies that have been implemented by our program since the last inspection. III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS: Documentation Comment: For several analyses, the laboratory stores calibration and quality control (QC) results on a computer and sample results on a paper benchsheet. The fact that the calibration and QC data are not with the analytical results makes data validation cumbersome and time consuming. Recommendation: It is recommended that benchsheets be designed to allow the documentation of both standards and samples in the order that they are analyzed. The sheet must also state the concentration acceptance ranges for standards or the percent recovery acceptance range and space to show the percent recoveries of the QC standards. Comment: The documentation of the temperature sensor verifications do not include the serial numbers (or other traceable identifier) of the meters that are being checked. Recommendation: It is recommended that the temperature sensor verification documentation include the serial number (or other traceable identifier) of the NIST traceable thermometer used for the verification and the manufacturer, model and serial number of the meter being checked. A. Finding: Standard Operating Procedures (SOPs) have not been reviewed and/or updated since 2001. Requirement: Each laboratory shall develop and maintain a document outlining the analytical quality control practices used for the parameters included in their certification. Supporting records shall be maintained as evidence that these practices are being effectively carried out. The quality control document shall be available for inspection by the State Laboratory. Ref: 15A NCAC 2H .0805 (a) (7). Submit the updated SOPs for review by December 31, 2011. A written response is required. Page 2 #554 Fortron Industries General Quality Control B. Finding: The use of purchased and prepared standards and reagents are not documented in such a way as to provide a traceable history from analysis to manufacturer. Requirement: All chemicals, reagents, standards and consumables used by the laboratory must have the following information documented: Date received, Date Opened (in use), Vendor, Lot Number, and Expiration Date (where specified). A system (e.g., traceable identifiers) must be in place that links standard/reagent preparation information to analytical batches in which the solutions are used. Documentation of solution preparation must include the analyst’s initials, date of preparation, the volume or weight of standard(s) used, the solvent and final volume of the solution. This information as well as the vendor and/or manufacturer, lot number, and expiration date must be retained for primary standards, chemicals, reagents, and materials used for a period of five years. Consumable materials such as pH buffers, lots of pre-made standards and/or media, solids and bacteria filters, etc. are included in this requirement. Ref: North Carolina Wastewater/Groundwater Laboratory Certification Policy. C. Finding: The analytical balance is not being checked with one class S, or equivalent, standard weight each day used and at least three standard weights quarterly. Requirement: The analytical balance must be checked with one class S, or equivalent, standard weight each day used and at least three standard weights quarterly. The values obtained must be recorded in a log and initialed by the analyst. Ref: 15A NCAC 2H .0805 (a) (7) (K). Residue, Suspended – Standard Methods, 18th Edition, 2540 D Comment: The desiccator used for solids had an electronic dehumidifier but its operation could not be verified and the owner manual could not be located. The humidity gauge indicated that the air was dry but the moisture indicating desiccating granules indicated that it was not. The amount of moisture indicating desiccant (a ¾ full 100 ml beaker) alone is not enough to absorb the moisture from cooling samples. If you want to use granular desiccant as a color indicating backup, it must be replaced or recharged regularly. The color indicating desiccant turns pink when exhausted. Regenerate to the original blue color by heating in an oven at 218°C (425°F) for 1 hour or by following the manufacturer's instructions. When the color indicating material no longer returns to the original blue color, the desiccating capacity of the material also becomes questionable. Desiccant must be replaced when this occurs. D. Finding: Filters are not weighed to constant weight prior to sample analysis, nor is a dry filter blank analyzed with each set of samples. Requirement: If pre-prepared filters are not used, the method requires that filters must be weighed to a constant weight after washing. Repeat cycle of drying, cooling, desiccating, and weighing until a constant weight is obtained or until weight change is less than 4% of the previous weighing or 0.5 mg, whichever is less. In lieu of this process, it is acceptable to analyze a single daily dry filter blank to fulfill the method requirement of drying all filters to a constant weight prior to analysis. Ref: North Carolina Wastewater/Groundwater Laboratory Certification Policy based upon Standard Methods 20th Edition 2540 D. (3) (a). E. Finding: The samples are not weighed to constant weight, nor is an annual multiple weighing study to verify the adequacy of the drying time performed. Requirement: Constant weights must be documented. The approved methods require the following: “Repeat the cycle of drying, cooling, desiccating, and weighing until a constant weight is obtained or until the weight change is less than 4% of the previous weight or 0.5 mg, whichever is less.” In lieu of this, an annual study documenting the time required to dry representative samples to a constant weight may be performed. Verify minimum daily drying time is greater than or equal to the time used for the initial verification study drying cycle. Drying cycles must be a minimum 1 hour for verification. Ref: North Carolina Wastewater/Groundwater Laboratory Certification Policy based on Standard Methods 20th Edition, 2540 D. (3) (c), 2540 B. (3) (b), and 2540 C. (3) (d). Page 3 #554 Fortron Industries Comment: North Carolina allows for an annual drying study in lieu of the requirement above to repeat the drying cycle for every sample. A random full set of samples should be used f or the drying study. The repeated drying time in the oven should be at least 1 hour long. The time used for the annual drying study is the minimum time that samples are to be dried until a new drying study is performed. F. Finding: A quarterly check standard is not being analyzed. Requirement: Excluding Oil and Grease, all residue parameters, leachate extractions, residual chlorine, and coliform, analyze one known standard in addition to calibration standards each day samples are analyzed to document accuracy. Analyze one suspended residue, one dissolved residue, one residual chlorine and one oil and grease standard quarterly. For residual chlorine, all calibration standards required by the approved procedure in use and by EPA must be analyzed. Ref: 15A NCAC 2H .0805 (a) (7) (B). Ammonia Nitrogen – Standard Methods, 18th Edition, 4500 NH3 F G. Finding: The laboratory’s mechanism for recording quality control standards does not adequately reflect that the calibration blank and calibration verification standard are analyzed at the appropriate intervals. Requirement: The calibration blank and calibration verification standard (mid-range) must be analyzed initially (i.e., prior to sample analysis), after every tenth sample and at the end of each sample g roup to check for carry over and calibration drift. If either fall outside established quality control acceptance criteria, corrective action must be taken (e.g., repeating sample determinations since the last acceptable calibration verification, repeating the initial calibration, etc.). Ref: North Carolina Wastewater/Groundwater Laboratory Certification Policy based upon Standard Methods, 20th Edition, 1020 B. (10) (c), 3020 B. (2) (b), and 4020 B. (2). Requirement: All analytical data pertinent to each certified analysis must be filed in an orderly manner so as to be readily available for inspection upon request. Ref: 15A NCAC 2H .0805 (a) (7) (A). Comment: The laboratory is documenting quality control data but it is entered directly into a computer spreadsheet. This manner of record-keeping does not adequately demonstrate that the requirement associated with Finding G is being met. Documentation of quality control samples with environmental sample data in a manner that allows for sequential reconstruction is considered pertinent information. H. Finding: A calibration blank and calibration verification standard (mid-range) are not analyzed at the end of the sample group. Requirement: The calibration blank and calibration verification standard (mid-range) must be analyzed initially (i.e., prior to sample analysis), after every tenth sample and at the end of each sample group to check for carry over and calibration drift. If either fall outside established quality control acceptance criteria, corrective action must be taken (e.g., repeating sample determinations since the last acceptable calibration verification, repeating the initial calibration, etc.). Ref: North Carolina Wastewater/Groundwater Laboratory Certification Policy based upon Standard Methods, 20th Edition, 1020 B. (10) (c), 3020 B. (2) (b), and 4020 B. (2). Comment: The calibration verification standard is prepared from the calibration stock standard solution. I. Finding: The laboratory is not analyzing matrix spikes. Requirement: Unless the referenced method states a greater frequency, spike 5% of samples on a monthly basis. Laboratories analyzing less than 20 samples per month must analyze at least one matrix spike each month samples are analyzed. Prepare the matrix spike from a referenc e source different from that used for calibration unless otherwise stated in the method. If matrix spike results are out of control, the results must be qualified or the laboratory must take corrective action to rectify the effect, use another method, or employ the method of standard additions. When the method of choice specifies matrix spike performance acceptance criteria for accuracy, and the laboratory chooses to develop statistically valid, laboratory-specific limits, the laboratory-generated limits cannot be less stringent than the criteria stated in the approved method. Ref: North Carolina Wastewater/Groundwater Laboratory Certification Policy. Page 4 #554 Fortron Industries J. Finding: Composite samples are not being preserved to a pH <2 within 15 minutes of the addition of the last aliquot. Requirement: For a composite sample collected with an automated sampler (e.g., using a 24-hour composite sampler; see 40 CFR 122.21 (g) (7) (i) or 40 CFR Part 403, Appendix E), refrigerate the sample at ≤6 °C during collection unless specified otherwise in this Table II or in the method(s). For a composite sample to be split into separate aliquots for preservation and/or analysis, maintain the sample at ≤6 °C, unless specified otherwise in this Table II or in the method(s), until collection, splitting, and preservation is completed. Add the preservative to the sample container prior to sample collection when the preservative will not compromise the integrity of a grab sample, a composite sample, or an aliquot split from a composite sample; otherwise, preserve the grab sample, composite sample, or aliquot split from a composite sample within 15 minutes of collection. Ref: Code of Federal Regulations, Title 40, Part 136; Federal Register Vol. 72, No. 47, March 12, 2007; Table II. K. Finding: Samples are not allowed to come to room temperature before analysis. Requirement: Maintain the same stirring rate and a temperature of about 25°C throughout calibration and testing procedures. Ref: Standard Methods, 18th Edition, 4500 NH3 F. (4) (b). L. Finding: Laboratory reagent blank concentrations are not being documented. Requirement: For analyses requiring a calibration curve, the concentration of method and reagent blanks must not exceed 50% of the reporting limit, unless otherwise specified by the reference method. Ref: North Carolina Wastewater/Groundwater Laboratory Certification Policy. Requirement: Any time quality control results indicate an analytical problem, the problem must be resolved and any samples involved must be rerun if the holding time has not expired. Ref: 15A NCAC 2H .0805 (a) (7) (F). Comment: Only the “absorbance” reading of the blank is being documented. Only the concentrations of the standards are being documented. Without similar units of measure, there is no way to determine from the documented information whether or not the blank concentration is less than half that of the lowest calibration standard and whether corrective actions need to be taken. pH – Standard Methods, 18th Edition, 4500 H+ B Comment: The QC limits for the pH 7 check buffer on the benchsheet, and in the SOP, are incorrectly stated as 7 ± 0.7 pH units. The correct limit is ± 0.1 pH units. No exeedances of the limit were observed. M. Finding: The pH 10 buffer solution expired in July, 2011. Requirement: Adherence to manufacturer expiration dates is required. Chemicals/reagents/ consumables exceeding the expiration date can no longer be considered reliable. If the expiration is only listed as a month and year (with no specific day of the month), the last day of the month will be considered the actual date of expiration. Monitor materials for changes in appearance or consistency. Any changes may indicate potential contamination and the item should be discarded, even if the expiration date is not exceeded. If no expiration date is given, the laboratory must have a policy for assigning an expiration date. If no date received or expiration date can be determined, the item should be discarded. Ref: North Carolina Wastewater/Groundwater Laboratory Certif ication Policy based upon Standard Methods, 18th Edition, 1070 C. (3) (c). Comment: Be mindful that the pH 10 buffer usually has a shorter shelf life than the pH 4 and pH 7 buffer solutions. Dissolved Oxygen – Standard Methods, 18th Edition, 4500 O G Comment: It was mentioned by Mr. Corbett, during the inspection, that the facility was considering replacing their current meter with a Luminescent Dissolved Oxygen meter. Please be reminded that North Carolina Administrative Code 15A NCAC 2H .0805 (c) (7) states: A certified laboratory must submit a written amendment to Page 5 #554 Fortron Industries the certification application each time that changes occur in methodology, reporting limits, and major equipment. The amendment must be received within 30 days of such changes. N. Finding: The temperature sensor on the D.O. meter has not been verified annually against a National Institute of Standards and Technology (NIST) traceable thermometer. Requirement: All thermometers must meet National Institute of Standards and Technology (NIST) specifications for accuracy or be checked, at a minimum annually, against a NIST traceable thermometer and proper corrections made. Ref: 15A NCAC 2H .0805 (a) (7) (O). Comment: This meter is used for regulatory measuring of the effluent temperature. O. Finding: The time that meter is calibrated is not being documented. This is considered pertinent information. Requirement: All analytical data pertinent to each certified analysis must be filed in an orderly manner so as to be readily available for inspection upon request. Ref: 15A NCAC 2H .0805 (a) (7) (A). IV. PAPER TRAIL INVESTIGATION: No paper trail performed. V. CONCLUSIONS: Correcting the above-cited findings and implementing the recommendations will help this lab to produce quality data and meet certification requirements. The inspector would like to thank the staff for its assistance during the inspection and data review process. Please respond to all findings. Report prepared by: Todd Crawford Date: August 24, 2011 Report reviewed by: Tonja Springer Date: September 19, 2011