Loading...
HomeMy WebLinkAbout#5485_2023_0919_JMS_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 November 22, 2023 5485 Mr. Paul David Johnson, Jr. The Wilds 1000 Wilds Ridge Road Brevard, NC 28712- Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Johnson: Enclosed is a report for the inspection performed on September 19, 2023 by Jason Smith. 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. 251. Sincerely, Anna Ostendorff Technical Assistance & Compliance Specialist Division of Water Resources Attachment cc: Todd Crawford, Jason Smith, Master File #5485 On-Site Inspection Report LABORATORY NAME: The Wilds NPDES PERMIT #: NC0024376 ADDRESS: 1000 Wilds Ridge Road Brevard, NC 28712 CERTIFICATE #: 5485 DATE OF INSPECTION: September 19, 2023 TYPE OF INSPECTION: Field Maintenance AUDITOR(S): Jason Smith LOCAL PERSON(S) CONTACTED: Paul Johnson 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. The laboratory has all the equipment necessary to perform the analyses. All required Proficiency Testing (PT) Samples have been analyzed for the 2023 PT Calendar Year and the graded results were 100% acceptable. The laboratory does not have Quality Assurance (QA) and/or Standard Operating Procedure (SOP) documents in place for all currently certified parameter methods. These documents must be submitted for review as specified in Finding A. 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 Testing Solutions, Inc. (Certification #600). Approved Procedure documents for the analysis of the facility’s currently certified Field Parameters were provided at the time of the inspection. Page 2 #5485 The Wilds III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS: Documentation A. Finding: The laboratory does not have QA/SOP documents for each certified parameter method nor a documented plan for PT procedures. 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). 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 laboratory submitted a finalized DO SOP, but only submitted unedited SOP templates for pH, TRC and Temperature. Comment: The laboratory’s PT procedure may be outlined in each of the applicable parameter method SOPs. The NC WW/GW LCB SOP Templates include a section for the PT procedure. Comment: These SOPs must be submitted for review upon completion no later than February 1, 2024. B. 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’s training program may be outlined in each of the applicable parameter SOPs. The NC WW/GW LCB SOP templates include an Employee Training section. The documented training program must be submitted no later than February 1, 2024. Page 3 #5485 The Wilds C. Finding: Error corrections are not 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: Error corrections are initialed, but not dated. D. Finding: Chemical containers are not dated when received and when opened. Requirement: Chemical containers shall be dated when received and when opened. Ref: 15A NCAC 02H .0805 (g) (7). E. Finding: The laboratory benchsheet is lacking required documentation: the method or Standard Operating Procedure reference; sample identification. 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; sample identification; 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) and (I). Comment: The sample identification is documented for Temperature, but is not documented for pH, Total Residual Chlorine (TRC) or Dissolved Oxygen (DO). Quality Control F. Finding: The quality control assessments for pH and TRC are not being assessed and documented. Requirement: All laboratories shall use printable laboratory benchsheets. Certified Data shall be traceable to the associated sample analyses and shall consist of: the quality control assessments. Ref: 15A NCAC 02H .0805 (g) (2) (O). Proficiency Testing G. Finding: The laboratory is not documenting the preparation of PT Samples. Requirement: PT Samples received as ampules are diluted according to the Accredited PT Sample Provider’s instructions. It is important to remember to document the preparation of PT Samples in a traceable log or other traceable format. The diluted PT Sample then becomes a routine Compliance Sample and is added to a routine sample batch for analysis. No documentation is needed for whole volume PT Samples which require no preparation, however the instructions must be maintained. Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 3.6. Comment: Dating and initialing the instruction sheet for each prepared PT Sample would satisfy the documentation requirement. Page 4 #5485 The Wilds H. 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: The PT Sample results were being recorded on a sheet of paper that is not used for documenting compliance samples and did not include all required information. I. Finding: PT Samples are not analyzed in the same manner as routine Compliance Samples. Requirement: PT Samples shall not be analyzed with additional quality control. They are not to be replicated beyond what is routine for Compliance Sample analysis. Ref: Proficiency Testing Requirements, January 1, 2023, Revision 6, Section 3.6. Comment: The laboratory is analyzing the PT Sample multiple times and averaging the results, which is not how Compliance Samples are treated. IV. 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: Jason Smith Date: October 3, 2023 Report reviewed by: Tom Halvosa Date: October 5, 2023 Certificate Number:5485 Effective Date:1/1/2023 Expiration Date:12/31/2023 Lab Name:The Wilds Address:1000 Wilds Ridge Road Brevard, NC 28712- North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:1/1/2022 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 CHLORINE, TOTAL RESIDUAL SM 4500 Cl G-2011 (Aqueous) DISSOLVED OXYGEN SM 4500 O H-2016 (Aqueous) 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.