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HomeMy WebLinkAbout#5703_2023_1019_TS_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 December 4, 2023 5703 Mr. Randy Clark Sanderson Farms Inc. St. Pauls Processing 2076 NC Hwy 20W St. Pauls, NC 28384 Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Clark: Enclosed is a report for the inspection performed on October 19, 2023 by Tonja Springer. 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 not 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: Todd Crawford, Tonja Springer, #5703 On-Site Inspection Report LABORATORY NAME: Sanderson Farms Inc. St. Pauls Processing WATER QUALITY PERMIT #: WQ0037772 ADDRESS: 2076 NC Hwy 20W St. Pauls, NC 28384 CERTIFICATE #: 5703 DATE OF INSPECTION: October 19, 2023 TYPE OF INSPECTION: Field Initial AUDITOR: Tonja Springer LOCAL PERSON(S) CONTACTED: Randy Clark 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 analyst was forthcoming and responded well to suggestions from the auditor. All required Proficiency Testing (PT) Samples have been analyzed and the laboratory has fulfilled its PT requirements for the 2023 PT Calendar Year. Any time changes are made to laboratory procedures, Quality Assurance (QA) and/or Standard Operating Procedure (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, 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. Revisions to the SOPs, based on the Findings, Comments and Recommendations within this report must be submitted to this office by January 31, 2024. The laboratory is reminded that SOPs 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 Environmental Chemists, Inc. (Certification # 94). Page 2 #5703 Sanderson Farms Inc. St. Pauls Processing 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 Comment: Chemical containers are not dated when opened. North Carolina Administrative Code, 15A NCAC 02H .0805 (g) (7) states: Chemical containers shall be dated when received and when opened. Acceptable corrective action was taken at the time of the inspection (i.e., the date opened, found on the laboratory’s reagent log, was documented on the reagent containers currently in use). No further response is necessary for this Corrected Finding. Recommendation: It is recommended that the laboratory replace the term “Final” with “001 Effluent” for clarity on the laboratory benchsheet for the sample identification. A. Finding: Error corrections are not always properly performed. 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: There were instances of write-overs and no dates of changes or initials of the responsible individual on the reagent logs that were submitted prior to the inspection. B. Finding: The laboratory benchsheet is lacking required documentation: the method or Standard Operation Procedure reference, the instrument identification, the signature or initials of the analyst, proper units of measure and the quality control assessment for the pH check buffer. 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 instrument identification, the signature or initials of the analyst, the proper units of measure and all 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), (C), (E), (L) and (O). Comment: The acceptance criterion for the 7.0 S.U. buffer used as the daily QC check in pH analyses is ± 0.1 S.U., but this is missing from the benchsheet. A checkbox on the benchsheet to indicate whether the criterion has been met would satisfy the requirement. No data were observed where the QC results were outside the acceptance criterion. Comment: The laboratory benchsheet does not clearly identify that the sample collector and analyst are the same. Only the sample collector is documented on the benchsheet. Comment: Proper units of measure for pH (i.e., S.U.) are not documented on the benchsheet. C. 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 Page 3 #5703 Sanderson Farms Inc. St. Pauls Processing 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’s training program may be outlined in the pH SOP. The NC WW/GW LCB SOP Template includes an Employee Training section. The documented training program must be submitted no later than January 31, 2024. 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 same daily analysis records (e.g., benchsheets) as for any Compliance Sample. This serves as the permanent laboratory record. Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, 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, January 1, 2023, Revision 6, Section 4.0. Comment: Current laboratory practice is to record the results of PT analyses solely on the reporting form and PT vendor preparation sheet that accompanies the PT Sample. Calibration information is documented on the PT vendor preparation sheet. E. Finding: PT Samples are not analyzed in the same manner as routine Compliance Samples. Requirement: Laboratories are required to analyze an appropriate PT Sample by each Parameter Method and in each associated matrix on the laboratory’s CPL. The same PT Sample may be analyzed by one or more methods. Laboratories shall conduct the analyses in accordance with their routine testing, calibration and reporting procedures, unless otherwise specified in the instructions supplied by the Accredited PT Sample Provider. This means that they are to be logged in and analyzed using the same staff, sample tracking systems, standard operating procedures including the same equipment, reagents, calibration techniques, analytical methods, preparatory techniques (e.g., digestions, distillations and extractions) and the same quality control acceptance criteria. PT Samples shall not be analyzed with additional quality control. They are not to be replicated beyond what is routine for Compliance Sample analysis. Although, it may be routine to spike Compliance Samples, it is neither required, nor recommended, for PT Samples. PT sample results from multiple analyses (when this is the routine procedure) must be calculated in the same manner as routine Compliance Samples. Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 3.6. Comment: The laboratory is currently analyzing PT Samples multiple times and reporting the first value, which is not how Compliance Samples are treated. Sample duplicates are not required for Field Parameters. Page 4 #5703 Sanderson Farms Inc. St. Pauls Processing F. Finding: The laboratory does not have a documented plan for PT procedures. Requirement: Laboratory Procedures. 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). Requirement: Laboratories must have a documented plan [this is usually detailed in the laboratory’s Quality Assurance Manual or may be a separate Standard Operating Procedure (SOP)] of how they intend to cover the applicable program requirements for Proficiency Testing per their scope of accreditation. This plan shall cover any commercially available PT Samples and any inter-laboratory organized studies, as applicable. The plan must also address the laboratory’s process for submission of PT Sample results and related Corrective Action Reports (CARs). Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 3.0. Comment: The NC WW/GW LCB pH SOP template was provided to the laboratory during the inspection which includes the PT requirements. Quality Assurance/Quality Control (QA/QC) G. Finding: SOPs have not been updated 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). Comment: An SOP describes the method in such detail that an experienced analyst unfamiliar with the method can obtain acceptable results and meet documentation requirements. SOPs must describe in detail how a method is performed. Comment: The laboratory does have an SOP for pH but it only includes procedural steps for the calibration and sample analysis. The laboratory must have updated QC/SOP document for the parameter included on their CPL by January 31, 2024. It must be submitted for review upon completion. pH – Standard Methods, 4500 H+B-2011 (Aqueous) H. Finding: Values were reported that exceed the method specified accuracy of 0.1 units. 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 Page 5 #5703 Sanderson Farms Inc. St. Pauls Processing 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. Recommendation: The laboratory currently reports pH sample results to two decimal places. It is recommended that the laboratory continue to measure and document sample results on the benchsheet to two decimal places, and to round to the nearest 0.1 S.U. when reporting results on the Non-Discharge Monitoring Report (NDMR). I. Finding: The laboratory benchsheet does not clearly label which buffer is used to check the meter calibration. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H 0805 (g) (4). Requirement: The following must be documented in indelible ink whenever sample analysis is performed: True value for the check standard buffer. Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. Comment: The 7.0 S.U. check buffer result is documented on the outside margin of the benchsheet but it is not labelled as the check buffer. Temperature – Standard Methods, 2550 B-2010 (Aqueous) Comment: The laboratory does not report results of all tests on the characteristics of the effluent on their NDMR. North Carolina Administrative Code, 15A NCAC 02B .0506 (b) (3) (J) states: The results of all tests on the characteristics of the effluent, including but not limited to NPDES Permit Monitoring Requirements, shall be reported on monthly report forms. Acceptable corrective action was taken at the time of the inspection (i.e., the laboratory stated Temperature measurements have been discontinued and an Amendment Application was completed to request the deletion of Temperature from their Certified Parameter Listing (CPL) effective October 19, 2023). No further response is necessary for this Corrected Finding. Reporting J. Finding: Data qualifiers from the contract laboratory reports are not being transferred to the NDMR. Requirement: Each certified Field Laboratory shall be in accordance with Paragraph (e) of this Rule. Ref: 15A NCAC 02H .0805 (g) (17). Requirement: Reported data associated with quality control failures, improper sample collection, holding time exceedances, or improper preservation shall be qualified as such. Ref: 15A NCAC 02H .0805 (e) (5). K. Finding: The laboratory does not report results of all tests on the characteristics of the effluent on their NDMR. Requirement: The results of all tests on the characteristics of the effluent, including but not limited to NPDES Permit Monitoring Requirements, shall be reported on monthly report forms. Ref: 15A NCAC 02B .0506 (b) (3) (J). Page 6 #5703 Sanderson Farms Inc. St. Pauls Processing Requirement: Reporting shall be in accordance with 15A NCAC 02B .0506 except as otherwise provided by applicable rules in this Subchapter. Ref: 15A NCAC 02T .0105 (l). Comment: A pH sample is pulled with the composite samples that are being analyzed by the contract laboratory. The pH results are qualified as out of holding time on the client report but the sample results are not reported on the NDMR. An email was received on October 23, 2023 stating that the contract laboratory (i.e., Environmental Chemists) has been contacted and will discontinue reporting pH as a Parameter on the client report. IV. CONCLUSIONS: Correcting the above-cited Findings and implementing the Recommendations 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: Tonja Springer Date: November 2, 2023 Report reviewed by: Tom Halvosa Date: November 3, 2023 Certificate Number:5703 Effective Date:1/1/2023 Expiration Date:12/31/2023 Lab Name:Sanderson Farms Inc. St. Pauls Processing Address:2076 NC Hwy 20W St. Pauls, NC 28384 North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:10/19/2023 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.