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HomeMy WebLinkAbout#5199_2022_0329_TLH_FINAL NC Department of Environmental Quality | Division of Water Resources | Laboratory Certification Branch 4405 Reedy Creek Road | 1623 Mail Service Center | Raleigh, North Carolina 27699-1623 919-733-3908 May 12, 2022 5199 Mr. Brian M. Conner Avoca LLC P.O. Box 129 Merry Hill, NC 27957 Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Conner: Enclosed is a report for the inspection performed on March 29, 2022 by Thomas Halvosa. I apologize for the delay in getting this report to you. Where Finding(s) are cited in this report, a response is required. Within thirty days, please supply this office with a written item for item description of how these Finding(s) were corrected. Please describe the steps taken to prevent recurrence and include an implementation date for each corrective action. If the Finding(s) cited in the enclosed report are not corrected, enforcement actions may be recommended. For Certification maintenance, your laboratory must continue to carry out the requirements set forth in 15A NCAC 02H .0800. A copy of the laboratory’s Certified Parameter List at the time of the audit is attached. This list will reflect any changes made during the audit. Copies of the checklists completed during the inspection may be requested from this office. Thank you for your cooperation during the inspection. If you have questions or need additional information, please contact me at (919) 733- 3908 Ext. 259. Sincerely, Beth Swanson Technical Assistance & Compliance Specialist Division of Water Resources Attachment cc: Thomas Halvosa, Todd Crawford, #5199 On-Site Inspection Report LABORATORY NAME: Avoca LLC WATER QUALITY PERMIT #: WQ0005910 NC GENERAL PERMIT #: NCG500046 NC STORMWATER PERMIT #: NCS000134 ADDRESS: 841 Avoca Farm Rd. Merry Hill, NC 27957 CERTIFICATE #: 5199 DATE OF INSPECTION: March 29, 2022 TYPE OF INSPECTION: Field Industrial Maintenance AUDITOR: Tom Halvosa LOCAL PERSON(S) CONTACTED: Brian Conner, Bobby Byrum I. INTRODUCTION: This laboratory was inspected by a representative of the North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) to verify its compliance with the requirements of 15A NCAC 02H .0800 for the analysis of compliance monitoring samples. II. GENERAL COMMENTS: The facility is neat and well organized and has all the equipment necessary to perform the analyses. Staff were forthcoming and responded well to suggestions from the auditor. All required Proficiency Testing (PT) Samples for the 2022 PT Calendar Year have not yet been analyzed. The laboratory is reminded that results must be received by this office directly from the vendor by September 30, 2022 The laboratory did not have Quality Assurance (QA) and/or Standard Operating Procedure (SOP) document(s) in place for all currently certified parameters. These documents must be submitted for review as specified in Finding E. The laboratory is reminded that any time changes are made to laboratory procedures, QA/SOP document(s) must be updated and relevant staff retrained. Staff must acknowledge that they have read and understand the changes as part of the documented training program. The same requirements apply when changes are made in response to Findings, Recommendations or Comments listed in this report, to ensure the methods are being performed as stated, references to methods are accurate, and the QA and/or SOP document(s) is in agreement with each approved practice, test, analysis, measurement, Page 2 #5199 Avoca LLC monitoring procedure or regulatory requirement being used in the laboratory. In some instances, the laboratory may need to create an SOP to document how new functions or policies will be implemented. The laboratory is also reminded that SOPs are required to be reviewed at least every two years and are intended to describe procedures exactly as they are to be performed. Use of the word “should” is not appropriate when describing requirements (e.g., Quality Control (QC) frequency, acceptance criteria, etc.). Evaluate all SOPs for the proper use of the word “should”. Contracted analyses are performed by Environment 1, Inc. (Certification # 10). Approved Procedure documents for the analysis of the facility’s currently certified Field Parameters were provided at the time of the inspection. III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS: Documentation: A. Finding: The laboratory is not documenting traceability information for purchased materials, reagents and standards. Cited previously on March 15, 2010. Requirement: 15A NCAC 02H .0805 (a)(7)(K) and (g)(7) requires laboratories to have a documented system of traceability for the purchase, preparation, and use of all chemicals, reagents, standards, and consumables. That system must include documentation of the following information: 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: NC WW/GW LCB Traceability Documentation Requirements for Chemicals, Reagents, Standards and Consumables Policy. Comment: The laboratory does not have a traceability log. They are transferring pH buffers from 4-liter containers in the Avoca’s product QA laboratory to 250 mL wide-mouth plastic containers for use in the wastewater laboratory. They are writing the Buffer Standard Unit values, lot numbers and expiration dates on these bottles, however, the 4.0 S.U. and 10.0 S.U. buffers had incorrect information for lot numbers and expiration dates. An example receipt log was provided to the laboratory at the time of inspection. B. Finding: Error corrections are not properly performed. Cited previously on March 15, 2010. Requirement: All documentation errors shall be corrected by drawing a single line through the error so that the original entry remains legible. Entries shall not be obliterated by erasures or markings. Wite-Out®, correction tape, or similar products designed to obliterate documentation are not to be used; instead the correction shall be written adjacent to the error. The correction shall be initialed by the responsible individual and the date of change documented. Ref: 15A NCAC 02H .0805 (g) (1). Comment: The laboratory does not write the date with the error correction. Page 3 #5199 Avoca LLC C. Finding: The laboratory benchsheets for pH are lacking required documentation: the method or Standard Operating Procedure reference, the laboratory identification, the proper units of measure and the quality control assessments. Requirement: All laboratories shall use printable laboratory benchsheets. Certified Data shall be traceable to the associated sample analyses and shall consist of: the method or Standard Operating Procedure; the laboratory identification, the proper units of measure, the quality control assessments. Each item shall be recorded each time samples are analyzed. Analyses shall conform to methodologies found in Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (2) (A), (B), (L) and (O). Comment: The laboratory has two separate benchsheets for pH. One is for the calibration the other is for compliance sample results. Both benchsheets lack units and method descriptions. The calibration benchsheet lacks the acceptance criterion for the check standard buffer (±0.1 S.U.). The compliance sample benchsheet lacks laboratory identification. Proficiency Testing D. Finding: The laboratory is not documenting PT Sample analyses in the same manner as routine Compliance Samples. Requirement: All PT Sample analyses must be recorded in the daily analysis records as for any Compliance Sample. This serves as the permanent laboratory record. Ref: Proficiency Testing Requirements, February 19, 2020, Revision 5, Section 3.6. Requirement: The laboratory shall retain all records necessary to facilitate historical reconstruction of the analysis and reporting of analytical results for PT Samples. This means the laboratory must have available and retain for five years [pursuant to 15A NCAC 02H .0805 (a) (7) (E) and (g) (1)] all of the raw data, including benchsheets, instrument printouts and calibration data, for all PT Sample analyses and the associated QC analyses conducted by all parameter methods. Ref: Proficiency Testing Requirements, February 19, 2020, Revision 5, Section 4.0. Requirement: The analysis of Proficiency Testing (PT) Samples is designed to evaluate the entire process used to routinely analyze and report Compliance Sample results. PT Samples must be analyzed the same as Compliance Samples. Also, documentation must be made on the same benchsheets used for Compliance Samples. Ref: NC WW/GW LCB Proficiency Testing Samples Analyzed and Documented Same as Compliance Samples Policy. Quality Control E. Finding: SOPs have not been developed for all the methods included on the laboratory’s Certified Parameters Listing (CPL). Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. A copy of each analytical method or Approved Procedure and Standard Operating Procedure shall be available to each analyst and available for review upon request by the State Laboratory. Standard Operating Procedure documentation shall state the effective date of the document and shall be reviewed every two years and updated if changes in procedures are made. Each laboratory shall have a formal process to track and document review dates and any revisions made in all Standard Operating Procedure documents. Supporting Records shall be maintained as evidence that these practices are implemented. Ref: 15A NCAC 02H .0805 (g) (4). Page 4 #5199 Avoca LLC Comment: The laboratory must submit to this office a QA/SOP document for each parameter method included on their CPL by October 31, 2022. SOP templates have been developed and were provided to the laboratory prior to the inspection. A written response is required. F. Finding: The laboratory is lacking a documented training program. Requirement: Each laboratory shall develop and implement a documented training program that includes the following: that staff have the education, training, experience, or demonstrated skills needed to generate quality control results within method-specified limits and that meet the requirements of these Rules; that staff have read the laboratory quality assurance manual or applicable Standard Operating Procedures; that staff have obtained acceptable results on Proficiency Testing Samples pursuant to Rule .0803(1) of this Section or other demonstrations of proficiency (e.g., side-by-side comparison with a trained analyst, acceptable results on a single-blind performance evaluation sample, an initial demonstration of capability study prescribed by the reference method). Ref: 15A NCAC 02H .0805 (g) (5). Comment: The laboratory can include training in the pH SOP if it the SOP includes a section that describes the training and includes an attachment to the SOP for documenting when new employees have satisfactorily completed the training. pH – Standard Methods, 4500 H+ B-2011 (Aqueous) G. Finding: The pH meter is not calibrated prior to analysis of samples each day compliance monitoring is performed. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: Instruments are to be calibrated according to the manufacturer’s calibration procedure prior to analysis of samples each day compliance monitoring is performed. Calibration must include at least two buffers. The meter calibration must be verified with a third standard buffer solution (i.e., check buffer) prior to sample analysis. The calibration and check standard buffers must bracket the range of the samples being analyzed. Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. Comment: The laboratory performs a calibration at the start of each week but not every day compliance samples are analyzed. H. Finding: Instances were observed where the pH calibration check standard did not read within ± 0.1 S.U. of the true value and no corrective action was taken. Requirement: Laboratory procedures shall comply with Subparagraph (a) (1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: All check standard buffers must read within ±0.1 S.U. to be acceptable. If the meter verification does not read within ±0.1 S.U., corrective actions must be taken before any samples are analyzed. Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. Comment: The calibration check standard readings on November 21, 2021 and on December 27, 2021 were greater than ±0.1 S.U. of the true value. Refer to the troubleshooting section of the AP for dealing with unacceptable check buffer results. I. Finding: Values were reported that exceed the method specified accuracy of 0.1 units. Page 5 #5199 Avoca LLC Requirement: By careful use of a laboratory pH meter with good electrodes, a precision of ±0.02 unit and an accuracy of ±0.05 unit can be achieved. However, ± 0.1 pH unit represents the limit of accuracy under normal conditions, especially for measurement of water and poorly buffered solutions. For this reason, report pH values to the nearest 0.1 pH unit. Ref: Standard Methods, 4500 H+ B-2011. (6). Comment: Per PT Vendor instructions, the PT Sample results should be reported to two decimal places, which is an exception to the requirement for compliance samples. IV. PAPER TRAIL INVESTIGATION: The paper trail consisted of comparing original records (e.g., laboratory benchsheets, logbooks, etc.) and contract laboratory reports to Discharge Monitoring Reports (DMRs) submitted to the North Carolina Division of Water Resources. Data were reviewed for Avoca LLC (Water Quality permit # WQ0005910, NC General Permit # NCG500046 and NC Stormwater Permit # NCS000134) for March, August and December 2021. No transcription errors were observed. The facility appears to be doing a good job of accurately transcribing data. V. CONCLUSIONS: Correcting the above-cited Findings will help this laboratory to produce quality data and meet Certification requirements. The inspector would like to thank the staff for their assistance during the inspection and data review process. Please respond to all Findings and include supporting documentation, implementation dates and steps taken to prevent recurrence for each corrective action. Report prepared by: Tom Halvosa Date: April 1, 2022 Report reviewed by: Tonja Springer Date: April 11, 2022 Certificate Number:5199 Effective Date:1/1/2022 Expiration Date:12/31/2022 Lab Name:Avoca LLC Address:841 Avoca Farm Rd. Merry Hill, NC 27957 North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:3/1/2022 The above named laboratory, having duly met the requirements of 15A NCAC 2H.0800, is hereby certified for the measurement of the parameters listed below. CERTIFIED PARAMETERS INORGANIC pH SM 4500 H+B-2011 (Aqueous) This certification requires maintance of an acceptable quality assurance program, use of approved methodology, and satisfactory performance on evaluation samples. Laboratories are subject to civil penalties and/or decertification for infractions as set forth in 15A NCAC 2H.0807.