HomeMy WebLinkAbout#5458_2016_0412_TS_FINALTo be attached to all inspection reports in-house only.
Laboratory Cert. #:
5458
Laboratory Name:
CPI USA North Carolina, LLC
Inspection Type:
Field Maintenance
Inspector Name(s):
Tonia Springer
Inspection Date:
April 12, 2016
Date Report Completed:
May 23, 2016
Date Forwarded to Reviewer:
Mav 23, 2016
Reviewed by:
Anna Ostendorff
Date Review Completed:
May 25, 2016
Cover Letter to use:
❑ Insp. Initial ❑ Insp. Reg.
❑ Insp. No Finding ❑ Insp. CP
❑ Corrected ® Insp. Reg. Delay
Unit Supervisor/Chemist III:
Todd Crawford
Date Received:
May 25, 2016
Date Forwarded to Admin.:
June 10, 2016
Date Mailed:
June 14, 2016
Special Mailing Instructions:
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Water Resources
ENVIRONMENTAL QUALITY
June 14, 2016
5458
Mr. Wright Whitlow
CPI USA North Carolina, LLC
PO Box 1153
Roxboro, NC 27573-1153
PAT MCCRORY
DONALD R. VAN DER VAART
S. JAY ZIMMERMAN
Subject: North Carolina Wastewater/Groundwater Laboratory Certification (NC WW/GW LC)
Maintenance Inspection
Dear Mr. Whitlow:
Enclosed is a report for the inspection performed on April 12, 2016 by Tonja Springer. 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.
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 (919) 733-3908 ext. 251.
Sincerely,
Todd Crawford
Technical Assistance & Compliance Specialist
NC WW/GW Laboratory Certification Branch
Attachment
cc: Dana Satterwhite, Tonja Springer, Master File
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LABORATORY NAME:
NPDES PERMIT #:
ADDRESS:
CERTIFICATE #:
DATE OF INSPECTION:
TYPE OF INSPECTION:
AUDITOR(S):
LOCAL PERSON(S) CONTACTED:
I. INTRODUCTION:
CPI USA North Carolina, LLC
NCO065081
PO Box 1153
Roxboro, NC 27573
5458
April 12, 2016
Field Maintenance
Tonja Springer
Wright Whitlow and Ginny Grace
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 2H .0800 for the analysis of environmental samples.
II. GENERAL COMMENTS:
The facility has all the equipment necessary to perform the analyses. The laboratory has
undergone personnel changes since the last inspection. The laboratory supervisor, Edward Kell
left the facility in November 2015, and was replaced in December 2015 by Wright Whitlow. The
current staff were forthcoming and seemed eager to adopt necessary changes.
All Proficiency Testing (PT) samples for the 2016 proficiency testing calendar year have not been
analyzed. The laboratory is reminded that these results must be submitted to this office directly
from the vendor by September 30, 2016.
Contracted analyses are performed by Meritech, Inc. (Certification #165).
Current Quality Assurance Policies for Field Laboratories and Approved Procedure documents for
the analysis of the facility's currently certified parameters were provided at the time of the
inspection.
III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS:
Documentation
A. Finding: The laboratory needs to increase the documentation of purchased reagents.
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. A system (e.g., traceable identifiers)
must be in place that links standard/reagent preparation information to analytical batches
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#5458 CPI USA North Carolina, LLC
in which the solutions are used. This information as well as the vendor and/or
manufacturer, lot number, and expiration date must be retained for chemicals, reagents,
standards and consumables used for a period of five years. Consumable materials such
as pH buffers and lots of pre -made standards are included in this requirement. Ref: The
Quality Assurance Policies for Field Laboratories.
Comment: Date opened (in use) and the Vendor was not being documented for Total
Residual Chlorine (TRC) reagents and pH buffers.
Chlorine, Total Residual — Standard Methods, 4500 Cl G-2000 (Aqueous)
Chlorine, Free Available — Standard Methods, 4500 CI G-2000 (Aqueous)
Comment: The laboratory's NPDES permit states to monitor chlorine only if chlorine is used by
the facility and only on those days when chlorination occurs. There is no chlorine being used at
the facility and no compliance samples are being analyzed and reported.
Chlorine, Free Available — Standard Methods, 4500 Cl G-2000 (Aqueous)
Comment: The laboratory is currently not certified for this parameter. The analysis must be done
by a certified lab whether that be a contract laboratory or CPI USA North Carolina, LLC. The
laboratory must have a backup plan in place in case chlorine is ever used in plant.
Chlorine, Total Residual — Standard Methods, 4500 Cl G-2000 (Aqueous)
B. Finding: Manufacturer's expiration dates are exceeded for the TRC reagents.
Requirement: Adherence to manufacturer expiration dates is required. Chemicals,
reagents, standards, 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: Quality Assurance Policies for Field
Laboratories.
Comment: The DPD liquid indicator and liquid buffer solution expired on 9/2011.
C. Finding: The laboratory is not verifying the instrument's factory set curve every 12
months.
Requirement: Analyze a calibration blank to zero the instrument and then analyze a
series of five standards (do not use gel or sealed liquid standards for this purpose). The
curve verification must check 5 concentrations (not counting the blank) that bracket the
range of the sample concentrations to be analyzed. This type of standard curve
verification must be performed at least every 12 months. The values obtained must not
vary by more than 10% of the known value for standard concentrations greater than or
equal to 50 µg/L and must not vary by more than 25% of the known value for standard
concentrations less than 50 µg/L. The overall correlation coefficient of the curve must be
>_0.995. Ref: Approved Procedure for the Analysis of Total Residual Chlorine. Please
submit a copy of the calibration curve verification with the report reply.
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#5458 CPI USA North Carolina, LLC
Requirement: Each day that prepared standards are analyzed, a reagent blank must
be analyzed to determine if method analytes or other interferences are present in the
laboratory, environment, the reagents or the apparatus. This includes annual standard
curve verification as well as daily prepared standards. Ref: Approved Procedure for the
Analysis of Total Residual Chlorine.
Comment: The same line of reasoning applies to the analysis of PT samples. When a
PT sample has to be prepared with deionized (DI) water, a reagent blank must be
analyzed to demonstrate that the reagents are not contributing to the analyte
concentration.
Comment: A reagent blank is an aliquot of reagent water or other blank matrices that
are treated exactly as a sample including exposure to all glassware, equipment and
reagents (e.g., DPD) that are used with other samples. The concentration of reagent
blanks must not exceed 50% of the reporting limit, unless otherwise specified by the
reference method, or corrective action must be taken.
Comment: The last documented calibration curve verification was performed on
3/21 /2011.
Recommendation: It is recommended that the annual calibration curve verification
standards have the following concentrations: 10 (or 15), 30, 50, 200 and 400 pg/L. This
will verify the analytical range used to measure the permitted discharge limit (i.e., 17
pg/L:), Proficiency Testing (PT) samples, standards and compliance samples, if needed.
D. Finding: The laboratory is not verifying the Gel® Standard every 12 months.
Requirement: Purchased "Gel -type" or sealed liquid ampoule standards may be used for
daily standard curve verification only. These standards must be verified initially and every
12 months thereafter, with the standard curve. When this is done, these standards may be
used after the manufacturer's expiration date. Ref: Approved Procedure for the Analysis
of Total Residual Chlorine. Please submit a copy of the gel verification with the
report reply.
Comment: It is only necessary to verify the gel or sealed liquid standard which falls within
the concentration range of the curve used to measure sample concentrations. For
example, if you are measuring samples against a low range curve, a 200 µg/L standard
would be verified, and not the 800 µg/L standard since the 800 µg/L standard would be
measured using a high range curve.
Comment: The value of the Gel® standard obtained at the time of the 5-standard
calibration curve verification will be the "true value" used throughout the year and until a
new curve is verified and the Gel® standard concentration is reassigned.
Comment: The gel/liquid standard verification must be performed for each instrument
on which they are to be used. If multiple instruments and/or standard sets are used,
each must have assigned values specific for the instrument and standard set.
Documentation must link the gel standard identification to the meter with which the
assigned value was determined.
Comment: There was no documentation since 2011 of the gel verification being done.
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#5458 CPI USA North Carolina, LLC
Temperature — Standard Methods, 2550 B-2000 (Aqueous)
Recommendation: It is recommended that the sample site include a more detailed descriptor
(e.g., Outfall 003). The sample site is currently documented as "003".
IV. PAPER TRAIL INVESTIGATION:
The paper trail consisted of comparing original records (e.g., laboratory benchsheets, logbooks,
etc.) and contract lab reports to Discharge Monitoring Reports (DMRs) submitted to the North
Carolina Division of Water Resources. Data were reviewed for NPDES permit #NC0065081 for
January and February 2016. No transcription errors were detected. The facility appears to be
doing a good job of accurately transcribing data.
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: Tonja Springer Date: May 23, 2016
Report reviewed by: Anna Ostendorff Date: May 23, 2016