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HomeMy WebLinkAbout#5539_2021_0603_TLH_FINAL June 14, 2021 5539 Mr. Ted C. Vandiford, Jr. Alliance One International Inc. - Farmville 8958 West Marlboro Rd Farmville, NC 27828 Subject: North Carolina Wastewater/Groundwater Laboratory Certification (NC WW/GW LC) Maintenance Inspection Dear Mr. Vandiford: Enclosed is a report for the inspection performed on June 3, 2021 by Thomas Halvosa. 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 2H .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, File #5539 On-Site Inspection Report LABORATORY NAME: Alliance One International, Inc. - Farmville NC GENERAL PERMIT #: NCG500201 ADDRESS: 8958 West Marlboro Rd Farmville, NC 27828 CERTIFICATE #: 5539 DATE OF INSPECTION: June 3, 2021 TYPE OF INSPECTION: Field Industrial Maintenance AUDITOR: Tom Halvosa LOCAL PERSON(S) CONTACTED: Ted Vandiford I. INTRODUCTION: This laboratory was inspected by a representative of the North Carolina Wastewater/Groundwater Laboratory Certification (NC WW/GW LC) program 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. The staff were forthcoming and responded well to suggestions from the auditor. All required Proficiency Testing (PT) Samples for the 2021 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, 2021. Contracted analyses are performed by Microbac Laboratories , Inc. (Certification #11 ). The Approved Procedure documents for the analysis of the facility’s currently certified Field Parameter s were provided at the time of the inspection. The laboratory submitted their Standard Operating Procedure (SOP) documents in advance of the inspection. These documents were reviewed and deemed acceptable. The laboratory is reminded that any time changes are made to laboratory procedures, the laboratory must update the Quality Assurance (QA)/SOP document(s) and inform relevant staff. Any changes made in response to the pre-audit review or to Findings, Recommendations or Comments listed in this report must be incorporated to insure the method is 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, monitoring procedure or regulatory requirement being used in the laboratory. In Page 3 #5539 Alliance One International, Inc. - Farmville 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”. III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS: Documentation A. Finding: The laboratory benchsheet is lacking required documentation for pH: the method or Standard Operating Procedure, laboratory identification and units of measure. Requirement: All laboratories shall use pr intable laboratory benchsheets. Certified Data shall be traceable to the associated sample analyses and shall consist of: the method or Standard Operating Procedure, laboratory identificat ion, the proper units of measure. 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) and (L). Comment: The units of measure for pH in the calibration section of the benchsheet must be documented and reported as specified in the permit (S.U.). B. Finding: The laboratory benchsheet is lacking required documentation for Temperature : the method or Standard Operating Procedure. Requirement: All laboratories shall use printable laboratory benchsh ee ts. Certified Data shall be traceable to the associated sample analyses and shall consist of: the method or Standard Operating Procedure. Each item shall be recorded each time samples are analyzed. Analyses shall conform to methodologies found in Subparag raph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (2) (A). C. Finding: The laboratory is not documenting traceability information for purchased materials, reagents and standards. Requirement: 15A NCAC 02H .0805 (a)(7)(K) and (g)(7) requires laboratori es 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 LC Policy. Comment: The laboratory was provided with an example receipt log at the time of the inspection to use for documenting traceability information for purchased materials, reagents and standards. Page 4 #5539 Alliance One International, Inc. - Farmville D. Finding: The laboratory is not documenting PT Sample anal yses. Requirement: All PT Sample analyses must be recorded in the daily analysis records as for any Co mpliance 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 printout s 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. IV. PAPER TRAIL INVESTIGATION: The paper trail consisted of comparing original records (e.g., laboratory benchsheets, logbooks, etc.) and contract laboratory reports to Stormwater Discharge Outfall Monitoring Reports (SDOs) submitted to the North Carolina Division of Water Resources. Data were reviewed for Alliance One International Inc. - Farmville NC (General Permit # NCG500201) for June 2019, November 2019 and May 2020. 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: June 7, 2021 Report reviewed by: Michael Cumbus Date: June 8, 2021 Certificate Number:5539 Effective Date:1/1/2021 Expiration Date:12/31/2021 Lab Name:Alliance One International Inc. - Farmville Address:8958 West Marlboro Rd Farmville, NC 27828 North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment: 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) TEMPERATURE SM 2550 B-2010 (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.