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HomeMy WebLinkAbout#5493_2021_0819_TS_FINAL September 10, 2021 5493 Ms. Robin Housh CREE INC. 4600 Silicon Drive Durham, NC 27703- Subject: North Carolina Wastewater/Groundwater Laboratory Certification (NC WW/GW LC) Maintenance Inspection Dear Ms. Housh: Enclosed is a report for the inspection performed on August 19, 2021 by Tonja Springer. 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: Todd Crawford, Tonja Springer On-Site Inspection Report LABORATORY NAME: CREE INC. NC GENERAL PERMIT #: NCG030433 NCG030541 ADDRESS: 4600 Silicon Drive Durham, NC 27703 CERTIFICATE #: 5493 DATE OF INSPECTION: August 19, 2021 TYPE OF INSPECTION: Field Industrial Maintenance AUDITOR(S): Tonja Springer LOCAL PERSON(S) CONTACTED: Robin Housh 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 inspection was performed remotely due to the coronavirus pandemic. The laboratory submitted the requested documentation and pictures of their reagents and instruments electronically on June 30, 2021 and August 19, 2021. The inspection was performed via WebEx on August 10, 2021 and from a series of emails. Staff was forthcoming and seemed eager to adopt necessary changes. All required Proficiency Testing (PT) Samples for the 2021 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, 2021. The laboratory submitted their Quality Assurance (QA) and/or Standard Operating Procedure (SOP) document(s) 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 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 some Page 2 # 5493 CREE INC. 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 Pace Analytical Services LLC - Eden NC (Certification # 633). 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: 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: Some instances were observed of overwriting and the error corrections were not initialed and dated. B. Finding: The laboratory benchsheet is lacking required documentation: sample identification. Requirement: All laboratories shall use printable laboratory benchsheets. Certified Data shall be traceable to the associated sample analyses and shall consist of: sample identification. 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) (I). Comment: The Finding applies to the benchsheet for the 2020 PT Samples. The laboratory only documented the time of analysis and the results for the initial PT and the remedial PT. C. Finding: The laboratory benchsheet is lacking required documentation: instrument identification. Requirement: All laboratories shall use printable laboratory benchsheets. Certified Data shall be traceable to the associated sample analyses and shall consist of: the instrument identification. 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) (C). Comment: The benchsheet provides a space to document the instrument identification but it is not being utilized. D. Finding: The laboratory benchsheet is lacking required documentation: meter calibration Page 3 # 5493 CREE INC. time. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this R ule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: The following must be documented in indelible ink whenever sample analysis is performed: Meter calibration and meter calibration time(s). Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. Proficiency Testing E. Finding: Additional QC beyond what is routine for Compliance Samples is being analyzed with PT Samples. Requirement: Laboratories are required to analyze an appropriate PT Sample by each parameter method 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, February 19, 2020, Revision 5, Section 3.6. Comment: Standards that are provided with the true values in a sealed envelope, are not considered PT Samples and do not meet the PT requirements outlined in 15A NCAC 02H .0800. Laboratories must not analyze additional standards with known concentrations along with PT Samples with unknown concentrations, as this is not the routine testing protocol for Compliance Samples. This is not to say that they cannot be used for troubleshooting purposes before analyzing a remedial PT Sample. This would be considered part of the corrective action plan. Comment: The laboratory is analyzing a known concentration standard along with an unknown concentration PT Sample. pH – Standard Methods, 4500 H+ B-2011 (Aqueous) F. Finding: The laboratory is not analyzing a post-analysis check standard buffer at the end of the run, when analyses are performed at multiple sample sites in a single day. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: When performing analyses at multiple sample sites, a post-analysis calibration verification using the check standard buffer must be analyzed at the end of the run. It is recommended that a mid-day check standard buffer be analyzed when samples are analyzed over an extended period of time. The post-analysis check standard buffer(s) must read within ±0.1 S.U. or corrective actions must be taken. If recalibration is necessary, all samples analyzed since the last acceptable calibration verification must be reanalyzed, if Page 4 # 5493 CREE INC. possible. If samples cannot be reanalyzed, the data must be qualified. Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. Comment: Analyses are performed at two sample sites. A mid-day check standard buffer is analyzed after the “DUR-1” sample at the first sample site but not after the last sample “RTP-1”. IV. PAPER TRAIL INVESTIGATION: The paper trail consisted of comparing original records (e.g., laboratory benchsheets, logbooks, etc.) and contract laboratory reports to DMRs submitted to the North Carolina Division of Water Resources. Data were reviewed for CREE INC. (Stormwater permit # NCG030541) for March 31, 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: Tonja Springer Date: August 20, 2021 Report reviewed by: Michael Cumbus Date: August 23, 2021 Certificate Number:5493 Effective Date:1/1/2021 Expiration Date:12/31/2021 Lab Name:CREE INC. Address:4600 Silicon Drive Durham, NC 27703- 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) 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.