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HomeMy WebLinkAbout#5453_2021_0603_TLH_FINAL July 1, 2021 5453 Mr. Kent D. Cutler Patheon Manufacturing Services LLC - Thermo Fisher Scientific 5900 Martin Luther King Jr Hwy Greenville, NC 27834 Subject: North Carolina Wastewater/Groundwater Laboratory Certification (NC WW/GW LC) Maintenance Inspection Dear Mr. Cutler: 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 Paramete r 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, Tom Halvosa, file #5 453 On-Site Inspection Report LABORATORY NAME: Patheon Manufacturing Services LLC - Thermo Fisher Scientific NPDES PERMIT #: NC0001058 ADDRESS: 5900 Martin Luther King Jr Hwy Greenville, NC 27834 CERTIFICATE #: 5453 DATE OF INSPECTION: June 3, 2021 TYPE OF INSPECTION: Field Industrial Maintenance AUDITOR: Tom Halvosa LOCAL PERSON(S) CONTACTED: Kent Cutler and Natalie Brown 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 Environment 1, Inc. (Certification #10 ) and Eurofins Lancaster Laboratories Environmental LLC (Certification #521). 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: The laboratory benchsheet for pH and Temperature is lac king required documentation: the method or Standard Operating Procedure and units of measure. 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 Page 2 #5453 Patheon Manufacturing Services LLC - Thermo Fisher Scientific Standard Operating Procedure, 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) and (L). Comment: The method description was missing for Temperature and the method description for pH did not include the revision year. Proficiency Testing B. 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 daily analysis records as for any Compliance 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 printouts 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. C. 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, February 19, 2020, Revision 5, Section 3.6. Comment: Dating and initialing the instruction sheet for each prepared PT Sample would satisfy the documentation requirement. Quality Control D. Finding: SOPs have not been developed for the methods included on the laboratory’s Certified Parameters Listing (CPL). Requirement: Laboratory procedures shall comply with S ubparagraph (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 document ation 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: Field Parameter SOP templates were provided to the laboratory prior to the inspection. Page 3 #5453 Patheon Manufacturing Services LLC - Thermo Fisher Scientific Temperature – Standard Methods, 2550 B -2010 (Aqueous) E. Finding: The Reference Temperature-Measuring Device does not have a stated accuracy of ± 0.5 °C and is not able to distinguish temperature changes of 0.1 °C . Requirement: A Reference Temperature-Measuring Device is an NIST traceable temperature-measuring device used only to verify the calibration of other temperature- measuring devices. It must have a stated accuracy of ± 0.5 °C, be able to distinguish temperature changes of 0.1 °C and equilibrate rapidly. Ref: NC WW/GW LC Approved Procedure for the Analysis of Temperature. Comment: The laboratory is using a NIST traceable liquid thermometer with a stated accuracy of only 1 °C and it is not able to distinguish temperature changes of 0.1 °C. After the inspection, the laboratory was provided with a link showing an example of an acceptable Reference Temperature-Measuring Device. F. Finding: The annual temperature-measuring device check procedure is not performed correctly. Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: To check a compliance temperature-measuring device, compare readings at two temperatures that bracket the range of compliance samples routinely analyzed again st a National Institute of Standards and Technology (NIST) traceable temperature-measuring device and record all four readings. The readings from both devices must agree within 0.5 ºC. Ref: NC WW/GW LC Approved Procedure for the Analysis of Temperature. Comment: The laboratory is performing the annual temperature-measuring device check procedure at only one temperature (ambient). Chlorine, Total Residual – Hach 10014 ULR (Aqueous) G. Finding: The laboratory is not analyzing a Reagent Blank . Requirement: Laboratory procedures shall comply with Subparagraph (a)(1) of this Rule. Ref: 15A NCAC 02H .0805 (g) (4). Requirement: Reagent Blank: Deionized or Distilled water, from the same source used to make calibration and calibration verification standards, to which 1.0 mL of Blanking Reagent is added. The Blanking Reagent removes chlorine and chloramines from the water. It is then analyzed like a sample (i.e., with DPD/buffer added). The concentration of the reagent blank must not exceed 5 μg/L. Ref: NC WW/GW LC Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by Hach 10014 ULR). Requirement: The Reagent Blank value must be determined each analysis day and must be < 5 μg/L. The Reagent Blank value must be subtracted from the Met hod Blank and all sample and standard results. Ref: NC WW/GW LC Approved Procedure for the Analysis of Total Residual Chlorine (DPD Colorimetric by Hach 1 0014 ULR). Comment: After the inspection, the laboratory requested to delete the Hach 10014 ULR (Aqueous) method and add the Standard Methods, 4500 Cl G -2011 (Aqueous) method , which does not require a Reagent Blank. Page 4 #5453 Patheon Manufacturing Services LLC - Thermo Fisher Scientific IV. PAPER TRAIL INVESTIGATION: The paper trail consisted of comparing original records (e.g., laboratory benchsheets, logbooks, etc.) and contract laboratory reports to Discharge Monitoring Reports (DMRs) submitted to the North Carolina Division of Water Resources. Data were reviewed for Patheon Manufacturing Services LLC - Thermo Fisher Scientific (NPDES Permit # NC0001058) for September 2020 , January 2 021 and April 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 Cer tification 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 15, 2021 Report reviewed by: Jason Smith Date: June 17, 2021 Certificate Number:5453 Effective Date:1/1/2021 Expiration Date:12/31/2021 Lab Name:Patheon Manufacturing Services LLC - Thermo Fisher Scientific Address:5900 Martin Luther King Jr Hwy Greenville, NC 27834 North Carolina Wastewater/Groundwater Laboratory Certification Certified Parameters Listing Date of Last Amendment:1/1/2021 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 Hach 10014 ULR (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.