Loading...
HomeMy WebLinkAbout#1_2017_0720_AO_FINALTo be attached to all inspection reports in-house only. Laboratory Cert. #: 1 Laboratory Name: Beacham Labs — Division of Environmental Chemists Inspection Type: Commercial Maintenance Inspector Name(s): Anna Ostendorff, Gary Francies, Beth Swanson Inspection Date: July 20, 2017 Date Forwarded for Initial Review: August 9, 2017 Initial Review by: Jason Smith Date Initial Review Completed: August 9, 2017 Cover Letter to use: ❑ Insp. Initial ❑ Insp. Reg ❑Insp. No Finding ❑Insp. CP ❑Corrected ®Insp. Reg. Delay (to use: rt click, properties, check) Unit Supervisor/Chemist III: Gary Francies Date Received: August 23, 2017 Date Forwarded to Admin.: September 12, 2017 Date Mailed: September 12, 2017 Special Mailing Instructions: u a rr �ruAL rN I f - Water Resources ENVIRONMENTAL- QUALITY September 12, 2017 1 Mr. Ray Porter Beacham Labs - Division of Environmental Chemists 6602 Windmill Way Wilmington, NC 28405 ROY COOPER MICHEAL S. REGAN S. JAY ZIMMERMAN Subject: North Carolina Wastewater/Groundwater Laboratory Certification (NC WW/GW LC) Maintenance Inspection Dear Mr. Porter: Enclosed is a report for the inspection performed on July 20, 2017 by Anna Ostendorff. 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 of receipt, 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 wish to obtain an electronic copy of this report by email or if you have questions or need additional information, please contact me at (828) 296-4677. Sincerely, Dana Satterwhite, Environmental Program Supervisor Division of Water Resources Attachment cc: Anna Ostendorff, Master File #1 Water Sciences Section NC Wastewater/Groundwater Laboratory Certification Branch 1623 Mail Service Center, Raleigh, North Carolina 27699-1623 Location: 4405 Reedy Creek Road, Raleigh, North Carolina 27607 Phone: 919-733-39081, FAX: 919-733-6241 Internet: http:ildeg nc pov/a oouVdivis oonstwate rresources/water-resources• aatalwater•sciences•home•papellaboratoryicertificatiombranch On -Site Inspection Report CERTIFICATE #: DATE OF INSPECTION: TYPE OF INSPECTION: AUDITOR(S): LOCAL PERSON(S) CONTACTED: INTRODUCTION: Beacham Labs — Division of Environmental Chemists 255A Wilmington Highway Jacksonville, NC 28540 July 20, 2017 Commercial Maintenance Anna Ostendorff, Gary Francies and Beth Swanson Rhonda Stokes and Leslie Lewis This laboratory was inspected by representatives of the North Carolina Wastewater/Groundwater Laboratory Certification (NC WW/GW LC) program to verify its compliance with the requirements of 15A NCAC 2H .0800 for the analysis of environmental samples. I1. GENERAL COMMENTS: The laboratory was recently acquired by Environmental Chemists, Inc. (Cert # 94) and has had a change in staffing. Since it was purchased, Environmental Chemists, Inc. was not sure if the location would be used as a store front only, sending samples to Wilmington, or would continue to operate as a certified laboratory. At the time of the inspection, Environmental Chemists intended to keep the Jacksonville laboratory certified and operational. The current staff were forthcoming and seemed eager to adopt the necessary changes. All required Proficiency Testing (PT) samples for the 2017 PT calendar year have not yet been analyzed. Because of the change in ownership and staffing, PT data were not reviewed. A copy of the PT checklist was left with the laboratory staff so an internal audit could be performed. The laboratory is reminded that PT results must be received by this office directly from the vendor by September 30, 2017. The laboratory submitted their Standard Operating Procedures (SOP) documents in advance of the inspection. These documents were reviewed and editorial and substantive revision requirements and recommendations were made by this program outside of this formal report process. Although subsequent revisions were not requested to be submitted, they must be completed within 1 year. 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 instances, the laboratory may need to create an SOP to document how new functions or policies will be implemented. Page 2 #1 Beacham Labs — Division of Environmental Chemists The laboratory is also reminded that SOPs are intended to describe procedures exactl 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". Requirements that reference 15A NCAC 2H .0805 (a) (7) (A), stating "All analytical data pertinent to each certified analysis must be filed in an orderly manner so as to be readily available for inspection upon request", are intended to be a requirement to document information pertinent to reconstructing final results and demonstrating method compliance. Use of this requirement is not intended to imply that existing records are not adequately maintained unless the Finding speaks directly to that. The laboratory receives some samples for analysis for which the Jacksonville location is not certified, and they are transferred to and analyzed by Environmental Chemists, Inc. (Certification # 94) in Wilmington. Current Approved Procedure documents for the analysis of the facility's currently certified Field Parameters were provided at the time of the inspection. The laboratory requested the deletion of Fecal Coliform by Standard Methods, 9222 D-1997 (MF) 24hr 503 (Non -Aqueous) and Color by Standard Methods, 2120 B-2001 (PtCo) (Aqueous) from their Certified Parameter List (CPL) during the audit. III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS: Documentation Recommendation: It is recommended that the "WW Fridge 1" temperature log be updated to label the month by name rather than by number to provide clarity. The temperature log fits one year of daily temperature readings onto one page, and currently identifies the month by number. Recommendation: It is recommended that the method references on all documentation be updated to the current reference format. The method references currently cite the edition of Standard Methods in which the method may be found, rather than the approval year of the method. A. Finding: Error corrections are not properly performed. Requirement: All documentation errors must 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. Write the correction adjacent to the error. The correction must be initialed by the responsible individual and the date of change documented. All data and log entries must be written in indelible ink. Pencil entries are not acceptable. Ref: NC WW/GW LC Policy. Comment: Error corrections are typically made with a single line through the error, but the correction is not initialed or dated. A few instances of write overs, which obliterate the original documentation, were also observed. B. Finding: The laboratory needs to increase the traceability documentation of purchased materials and reagents, as well as documentation of reagents prepared in the laboratory. Page 3 #1 Beacham Labs — Division of Environmental Chemists Requirement: Supporting records shall be maintained as evidence that these practices are being effectively carried out. All analytical records must be available for a period of five years. Ref: 15A NCAC 2H .0805 (a) (7) and (a) (7) (G). Requirement: All analytical data pertinent to each certified analysis must be filed in an orderly manner so as to be readily available for inspection upon request. Ref: 15 NCAC 2H .0805 (a) (7) (A). Requirement: All chemicals, reagents, standards and consumables used by the laboratory must have the following information documented: 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 LC Policy. Comment: All consumables and reagents are received at the Wilmington location and then transferred to the Jacksonville location as needed. The Wilmington location maintains a consumable materials log. Recommendation: It is recommended that copies of the consumable and reagent preparation logs be sent to, and maintained at, the Jacksonville location each time consumables are transferred. Having the consumable and reagent preparation logs readily accessible can be essential to troubleshooting QC failures. C. Finding: The sample condition upon receipt documentation does not adequately demonstrate that analytical quality control practices are being effectively carried out. Requirement: Each laboratory shall develop and maintain a document outlining the analytical quality control practices used for the parameters included in their certification. Supporting records shall be maintained as evidence that these practices are being effectively carried out. Ref: 15A NCAC 2H .0805 (a) (7). Comment: Samples that require acid preservation are checked upon receipt. However, the Laboratory Information Management Systems (LIMS) printout (referred to as the Troll) only includes a blanket statement that states "pH verified by: [analyst initials]" and does not state which samples were checked or what the pH measured. D. Finding: The units of measure are not always documented on the benchsheets. Requirement: All laboratories must use printed laboratory bench worksheets that include a space to enter the signature or initials of the analyst, date of analyses, sample identification, volume of sample analyzed, value from the measurement system, factor and final value to be reported and each item must be recorded each time samples are analyzed. Ref: 15A NCAC 2H .0805 (a) (7) (H). Comment: Units of measure are not documented on the "WW Fridge 1" temperature log for temperature or on the BOD benchsheet for pH of samples. Page 4 #1 Beacham Labs — Division of Environmental Chemists General Laboratory E. Finding: For chemicals/reagents/consumables that do not have an expiration date, the laboratory has not established a policy for assigning expiration dates. Requirement: Adherence to manufacturer expiration dates is required. Chem icals/reagents/consumables exceeding the expiration date can no longer be considered reliable. If the expiration is only listed as a month and year (with no specific day of the month), the last day of the month will be considered the actual date of expiration. Monitor materials for changes in appearance or consistency. Any changes may indicate potential contamination and the item should be discarded, even if the expiration date is not exceeded. If no expiration date is given, the laboratory must have a policy for assigning an expiration date. If no date received or expiration date can be determined, the item should be discarded. Ref: NC WW/GW LC Policy. F. Finding: The laboratory did not have a copy of each approved reference method available. Requirement: Each laboratory requesting certification must contain or be equipped with a copy of each approved analytical procedure being used in the laboratory. Ref. 15A NCAC 2H .0805 (a) (6) (F). Comment: The laboratory has a copy of the 20th edition of Standard Methods, which contains all certified methods except BOD. This does not include the Field Parameters pH and Temperature, which are covered by the NC WW/GW LC Approved Procedures. G. Finding: The refrigerator used to store samples does not consistently maintain an acceptable temperature. Requirement: Cool, :56 'C. Ref: Code of Federal Regulations, Title 40, Part 136; Federal Register Vol. 77, No. 97, May 18, 2012; Table II. Comment: The daily temperature log documented several instances of the temperature reading greater than 6 °C. Temperature readings were very erratic from day to day without any adjustment to the temperature settings. The refrigerator needs to be repaired or replaced. Comment: Failure to maintain thermal preservation until the time of analysis is considered a QC failure and would require affected sample results to be qualified. Recommendation: The Media and Reagent Refrigerator temperature log also demonstrated erratic temperature readings, but only exceeded 6 °C in a few instances since January 2017. It is recommended that the laboratory begin budgeting to repair or replace the Media and Reagent Refrigerator as well. Recommendation: It is recommended that samples be stored in the Media and Reagent Refrigerator until the Sample Refrigerator can be repaired or replaced and that extra diligence be paid to the temperature reading of the Media and Reagent Refrigerator. Quality Control Recommendation: It is recommended that all records of maintenance performed on analytical instrumentation be documented in an individual equipment maintenance log book. All records of Page 5 #1 Beacham Labs — Division of Environmental Chemists corrective action taken or minor troubleshooting and repair performed should also be documented in the equipment maintenance log. The records may include the following, as appropriate: a. The identity of the item of equipment and its software; b. The manufacturer's name, type identification, and serial number or other unique identifier; c. The current location; d. The dates, results and copies of reports and certificates or all calibrations, adjustments, acceptance criteria, and the due date of the next calibration. e. The maintenance plan, where appropriate, and maintenance completed date. f. Documentation of any damage, malfunction, modification, or repair to the equipment. g. Signature or initials of the person performing the maintenance or troubleshooting. These records provide an historical reconstruction of the maintenance performed, a reference for effective troubleshooting in the future, and can also serve as a valuable training tool for new analysts. H. Finding: Data that does not meet all QC requirements is not qualified on the client report. Requirement: When QC failures occur, the laboratory must attempt to determine the source of the problem and must apply corrective action. Part of the corrective action is notification to the end user. If data qualifiers are used to qualify samples not meeting QC requirements, the data may not be useable for the intended purposes. It is the responsibility of the laboratory to provide the client or end -user of the data with sufficient information to determine the usability of the qualified data. Ref: NC WW/GW LC Policy. Comment: Failure to maintain thermal preservation until the time of analysis is considered a QC failure and would require affected sample results to be qualified. Comment: Going through records to identify which samples may have been affected by temperature exceedances in the past may be impractical. An acceptable Corrective Action Response to this Finding would be to qualify sample results whenever thermal preservation is not maintained, effective immediately. Bacteria — Enterococci — IDEXX Enterolert® (MPN) (Aqueous) I. Finding: Duplicate analyses are not analyzed. Requirement: Analyze five percent of all samples in duplicate to document precision. Laboratories analyzing less than 20 samples per month must analyze at least one duplicate each month samples are analyzed. Ref: 15A NCAC 2H .0805 (a) (7) (C). J. Finding: The Quanti-Tray® sealer is not consistently checked each month for leaks. Requirement: If the Quanti-Tray® or Quanti-Tray®/2000 test is used, the sealer must be checked monthly by adding a dye (e.g., bromcresol purple) to a water blank. If dye is observed outside the wells, either perform maintenance or use another sealer. Ref: NC WW/GW LC Policy. Bacteria — Enterococci — IDEXX Enterolert® (MPN) (Aqueous) Bacteria — Coliform Fecal — Standard Methods, 9222 D-1997 (MF) (Aqueous) Recommendation: It is recommended that the autoclave log be updated to clarify which thermometer is used to check the operational temperature of the autoclave. This would distinguish Page 6 #1 Beacham Labs — Division of Environmental Chemists between the temperature gauge on the autoclave and the maximum registering thermometer placed in the chamber. The laboratory currently uses a maximum registering thermometer with each autoclave run and records the temperature from this thermometer. K. Finding: Samples are not consistently checked and documented for the absence of residual chlorine. Requirement: Dechlorinating agents used at the time of sampling must be documented to have been effective upon receipt in the laboratory. A variety of field testing kits are considered to be adequate for most chlorine interference checks and a maximum detection limit of 0.5 mg/L is allowed. Ref: NC WW/GW LC Policy. Bacteria — Conform Fecal — Standard Methods, 9222 D-1997 (MF) (Aqueous) L. Finding: The laboratory is not always analyzing a sample volume that yields a countable plate for the culture positive. Requirement: A culture positive must be analyzed with each batch of prepared media and once per week for purchased ready -to -use media. A sample volume that yields a countable plate must be analyzed so that individual colonies may be verified to have proper morphology (i.e., color, shape, size, surface appearance). Ref: NC WW/GW LC Policy. Comment: The culture positive plates are often too numerous to count. M. Finding: Plate comparison counts are not being conducted. Requirement: For routine performance evaluation, repeat counts on one or more positive samples at least monthly, record results, and compare the counts with those of other analysts testing the same samples. Replicate counts for the same analyst should agree within 5% (within analyst repeatability of counting) and those between analysts should agree within 10% (between analysts reproducibility of counting). If they do not agree, initiate investigation and any necessary corrective action. Ref: Standard Methods, 9020 B-2005. (9) (a). N. Finding: Heat -indicating tape is not used with all materials each sterilization cycle. Requirement: Use heat -indicating tape to identify supplies and materials that have been sterilized. Ref: Standard Methods 9020 B-2005. (4) (h). Comment: Heat -indicating tape is not used with the dilution rinse water, but is used with all other materials. O. Finding: The laboratory is not documenting their use of heat -indicating tape. Requirement: Each laboratory shall develop and maintain a document outlining the analytical quality control practices used for the parameters included in their certification. Supporting records shall be maintained as evidence that these practices are being effectively carried out. Ref: 15A NCAC 2H .0805 (a) (7). Requirement: Use heat -indicating tape to identify supplies and materials that have been sterilized. Ref: Standard Methods 9020 B-2005. (4) (h). Page 7 #1 Beacham Labs — Division of Environmental Chemists P. Finding: The laboratory did not have the documentation on file demonstrating the consumable materials used for the analysis had been tested. Requirement: All analytical data pertinent to each certified analysis must be filed in an orderly manner so as to be readily available for inspection upon request. Ref: 15 NCAC 2H .0805 (a) (7) (A). Requirement: Before a new lot of consumable materials are used for the Fecal Coliform MF method, those materials must be tested and compared to those currently in use to ensure they are reliable. Consumable materials included in this requirement are: membrane filters and/or pads (often packaged together) and media. It is recommended that only one consumable be tested at a time. At a minimum, make single analyses on five positive samples that will yield 20-60 colonies for both the current lot and the new lot. There are two options for determining acceptance of results: Option 1: Follow the acceptance criteria described in Standard Methods 9020 B 5. f 2) a) and b). Option 2: Compare the average colony count of each five -sample set and evaluate against your routine sample duplicate acceptance criterion. Ref: NC WW/GW LC Policy. Please submit the results of this study with your response to this report. Comment: The laboratory staff indicated the consumable materials testing is performed at the Wilmington location before materials are put into use. This practice is acceptable, but a copy of the documentation must be maintained by the Jacksonville laboratory. Q. Finding: The laboratory did not have the documentation on file demonstrating the reagent water used for the Fecal Coliform analysis had been tested. Requirement: All analytical data pertinent to each certified analysis must be filed in an orderly manner so as to be readily available for inspection upon request. Ref: 15 NCAC 2H .0805 (a) (7) (A). Requirement: At a minimum, reagent water used to prepare buffered dilution/rinse water or media must be analyzed at least every twelve months for the following parameters: Specific Conductance, Total Organic Carbon, Cadmium, Chromium, Copper, Nickel, Lead, and Zinc. Maximum Acceptable Limits are: Total Organic Carbon < 1.0 mg/L Specific Conductance < 2 pmhos/cm Heavy Metals, single element < 0.05 mg/L Heavy Metals, Total of cited elements < 0.10 mg/L If the facility is using vendor purchased dilution/rinse water this testing is not required as long as the Certificate of Analysis from the manufacturer meets these requirements and is kept on file. Ref: NC WW/GW LC Policy. Please submit the results of this testing with your response to this report. Page 8 #1 Beacham Labs — Division of Environmental Chemists Comment: The laboratory staff indicated the reagent water testing is performed at the Wilmington location before materials are put into use. This practice is acceptable, but a copy of the documentation must be maintained by the Jacksonville laboratory. BOD — Standard Methods, 5210 B-2001 (Aqueous) Recommendation: It is recommended that the laboratory begin analyzing a seeded blank with each batch. The measured value o� the This serue v es edeas aQC checkof analyst technique blank should approximate ade and of the final seed correction fact homogeneity of seeding material. Recommendation: There were a few instances noted where the final seed correction factor exceeded 1.4 mg/L (e.g., samples analyzed on March 15, 2017 had a final seed correction factor of 1.65 mg/L). It is recommended an upper limit be established (an exceedance of which would require qualification of the data and corrective action). R. Finding: The Dissolved Oxygen (DO) meter is not checked for drift at the end of the analytical series. minate drift in Requirement: If the membrane and final DO dreadings. Ref: Standard Methods,e method is used, take care to 115210 B-2001 calibration between initial (5) (g). Requirement: Immediately after calibration, measure the DO of a BOD bottle of dilution water. Stopper the bottle. Document the concentration on the benchsheet (day one initial drift check). At the end of the sample set reanalyze the drift check bottle and document the concentration (day one final drift check). The laboratory should verify the DO Meter calibration throughout h�Lsae ale set l brat I meterandandReanalyze all samplepeat process on Des since the meter drifts more than g the last drift check. Ref: NC WW/GW LC Policy. S. Finding: Initial DO concentrations of all bottles other than the blank are not always brought to the required range of 7 - 9 mg/L. Requirement: The working range is equal to the difference between the maximum initial DO (7 to 9 mg/L) and minimum DO residual of 1 mg/L corrected for seed, and multiplied by the dilution factor. Ref. Standard Methods, 5210 B-2001. (8) (b). Requirement: Samples supersaturated with DO — Samples containing DO concentrations above saturation at 20 °C may be encountered in cold waters or in water where photosynthesis occurs. To prevent loss of oxygen during incubation of such samples, reduce DO to saturation by bringing sample to about 20 ± 3 °C in partially filled bottle while agitating by vigorous shaking or by aerating with clean, filtered compressed air. Ref: Standard Methods, 5210 B-2001. (4) (b) (4). T. Finding: Extra nutrient, mineral, and buffer solutions are not added to the BOD bottles containing more than 67% (i.e., > 201 mL) sample. Requirement: When a bottle contains more than 67% of the sample after dilution, nutrients may be limited in the diluted sample and, subsequently, reduce biological activity. In such samples, add the ba1erate of 1ral, and mL/L (0.30er solutions mL/300-mL(bottle) or use directly to individual BOD bottles at Page 9 #1 Beacham Labs — Division of Environmental Chemists commercially -prepared solutions designed to dose the appropriate bottle size. Ref: Standard Methods, 5210 B-2001. (5) (c) (2). U. Finding: Three glucose-glutamic acid (GGA) standard solutions are not being analyzed. Requirement: Add sufficient amounts of standard glucose-glutamic acid solution (¶ 3h) to give 3.0 mg glucose/L and 3.0 mg glutamic acid/L in each of three test bottles (20 mL GGA solution/L seeded dilution water or 6.0 mL/300-mL bottle). The resulting average BOD for the three bottles, after correction for dilution and seeding, must fall into the range of 198 ± 30.5 mg/L. Ref: Standard Methods, 5210 B-2001. (6) (b). Comment: The laboratory was analyzing two GGA standard solutions. V. Finding: The sample holding time for BOD analysis was sometimes exceeded. Requirement: Analyze within 48 hours. Ref: Code of Federal Regulations, Title 40, Part 136; Federal Register Vol. 77, No. 97, May 18, 2012; Table II. Comment: Holding times were exceeded only for some samples collected on Mondays. W. Finding: The laboratory is not consistently evaluating precision of duplicate samples on the benchsheet. Requirement: Each laboratory shall develop and maintain a document outlining the analytical quality control practices used for the parameters included in their certification. Supporting records shall be maintained as evidence that these practices are being effectively carried out. Ref: 15A NCAC 2H .0805 (a) (7). X. Finding: The laboratory is not documenting that the initial DO is measured within 30 minutes of preparing dilutions. This is considered pertinent information. Requirement: All analytical data pertinent to each certified analysis must be filed in an orderly manner so as to be readily available for inspection upon request. Ref: 15A NCAC 2H .0805 (a) (7) (A).. Requirement: After preparing dilution, measure initial DO within 30 min. Ref: Standard Methods, 5210 B-2001. (5) (g). pH — Standard Methods, 4500 H+ B-2000 (Aqueous) Y. Finding: The laboratory benchsheet was lacking pertinent data: analysis time. Requirement: All analytical data pertinent to each certified analysis must be filed in an orderly manner so as to be readily available for inspection upon request. Ref: 15A NCAC 2H .0805 (a) (7) (A). Requirement: The following must be documented in indelible ink whenever sample analysis is performed: analysis time. Ref: NC WW/GW LC Approved Procedure for the Analysis of pH. Comment: The time elapsed between sampling and analysis must be documented to determine if hold times are met. Page 10 #1 Beacham Labs — Division of Environmental Chemists Z. Finding: The laboratory benchsheet was lacking pertinent data: meter calibration time. Requirement: All analytical data pertinent to each certified analysis must be filed in an orderly manner so as to be readily available for inspection upon request. Ref: 15A NCAC 2H .0805 (a) (7) (A). Requirement: The following must be documented in indelible ink whenever sample analysis is performed: meter calibration time. Ref: NC WW/GW LC Approved Procedure for the Analysis of pH. AA. Finding: The laboratory benchsheet was lacking pertinent data: instrument identification. Requirement: All analytical data pertinent to each certified analysis must be filed in an orderly manner so as to be readily available for inspection upon request. Ref: 15A NCAC 2H .0805 (a) (7) (A). Requirement: The following must be documented in indelible ink whenever sample analysis is performed: instrument identification. Ref: NC WW/GW LC Approved Procedure for the Analysis of pH. Residue, Suspended — Standard Methods, 2540 D-1997 (Aqueous) 13113. Finding: The samples are not weighed to constant weight, nor is an annual multiple weighing study performed to verify the adequacy of the drying time. Requirement: Constant weights must be documented. The approved methods require the following: "Repeat the cycle of drying, cooling, desiccating, and weighing until a constant weight is obtained or until the weight change is less than 4% of the previous weight or 0.5 mg, whichever is less." In lieu of this, an annual study documenting the time required to dry representative samples to a constant weight may be performed. Verify minimum daily drying time is greater than or equal to the time used for the initial verification study drying cycle. Drying cycles must be a minimum 1 hour for verification. Ref: NC WW/GW LC Policy. CC. Finding: The analytical balance is not checked with a weight each day of use, nor three weights quarterly. Requirement: The analytical balance must be checked with one class S or equivalent standard weight each day used and at least three standard weights quarterly. The values obtained must be recorded in a log and initialed by the analyst. Ref: 15A NCAC 2H .0805 (a) (7) (k). Comment: The laboratory has a spiral bound notebook that documents checking the balance using three weights every month through December 2015. No balance checks have been performed since that time. Recommendation: It is recommended that the balance be checked each day of use with the 100-mg weight to represent the weight of the aluminum weigh pan, which is approximately 110 mg. Page 11 #1 Beacham Labs — Division of Environmental Chemists DD. Finding: The oven temperature is not checked and documented each day of use. Requirement: All analytical data pertinent to each certified analysis must be filed in an orderly manner so as to be readily available for inspection upon request. Ref: 15A NCAC 2H .0805 (a) (7) (A). Requirement: Dry for at least 1 h at 103 to 105°C in an oven, cool in a desiccator to balance temperature, and weigh. Ref: Standard Methods, 2540 D-1997. (3) (c). IV. PAPER TRAIL INVESTIGATION: No paper trail was performed. Client reports are issued from the Wilmington location and were not available for review during the inspection. The laboratory is planning to upgrade their LIMS so that client reports are accessible from any of the Environmental Chemists, Inc. laboratories. V. 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 and implementation dates for each corrective action. Report prepared by: Anna Ostendorff Date: August 9, 2017 Report reviewed by: Jason Smith Date: August 9, 2017 D O J 7 N 7 O 6 � 6 U Q Ov z 0 LL LL 0 2 LU O z O a N a W N W W a,p U w U ❑ Z m m m N 0 7 0 O O 7 o 7 a ❑ o 0 Q W 7 7 a cr g z a a N d r O N m m U) m Q' N 2 ❑ O Imo- m W o " L N to NU') ❑ N d N U) co � U) W U) O