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HomeMy WebLinkAbout#5755_2022_0216_TS_FINAL March 17, 2022 5755 Mr. Jeremy Keltner Novo Nordisk DAPI US 3611 Powhatan Rd. Clayton, NC 27527 Subject: North Carolina Wastewater/Groundwater Laboratory Certification Branch (NC WW/GW LCB) Maintenance Inspection Dear Mr. Keltner: Enclosed is a report for the inspection performed on February 16, 2022 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 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: Todd Crawford, Tonja Springer, #5755 On-Site Inspection Report LABORATORY NAME: Novo Nordisk DAPI US NC GENERAL PERMIT #: NCG060000 (Stormwater) NC INDUSTRIAL USER PERMIT #: IUP0005-02 ADDRESS: 3611 Powhatan Rd. Clayton, NC 27527 CERTIFICATE #: 5755 DATE OF INSPECTION: February 16, 2022 TYPE OF INSPECTION: Field Industrial Initial AUDITOR(S): Tonja Springer LOCAL PERSON(S) CONTACTED: Jessica Darby 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 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, 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 September 1, 2022. Page 2 #5755 Novo Nordisk DAPI US 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 Comment: The incorrect certification number #5737 is documented on the benchsheets instead of #5755. 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 noted of error corrections lacking the date and initials of the analyst. B. Finding: The laboratory benchsheet is lacking required documentation: the method reference. 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. 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). Comment: Benchsheets lack the method reference for Temperature. C. Finding: The laboratory benchsheet is lacking required documentation: meter calibration time. 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: Meter calibration and meter calibration time(s). Ref: NC WW/GW LCB Approved Procedure for the Analysis of pH. Comment: The pH meter calibration time is not always documented in the space provided on the benchsheet. Page 3 #5755 Novo Nordisk DAPI US D. Finding: The laboratory is not documenting all traceability information for purchased pH buffers. 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 pH buffer Lot # and expiration date are documented on the benchsheet. 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: 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 on a separate day. This would be considered part of the corrective action plan. Reporting F. 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 4 #5755 Novo Nordisk DAPI US 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. IV. PAPER TRAIL INVESTIGATION: The paper trail consisted of comparing original records (e.g., laboratory benchsheets, logbooks, etc.) and contract laboratory reports to Industrial User Pretreatment Permit (IUP #0005-02) submitted to the Town of Clayton. Data were reviewed for October 2021, November 2021 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: Tonja Springer Date: March 10, 2022 Report reviewed by: Jill Puff Date: March 11, 2022 Certificate Number:5755 Effective Date:1/1/2022 Expiration Date:12/31/2022 Lab Name:Novo Nordisk DAPI US Address:3611 Powhatan Rd. Clayton, NC 27527 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.