Common Findings. Lynn Boysen MN-ELAP. Presented at MWOA Annual Training June 10, 2010

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1 Common Findings Lynn Boysen MN-ELAP Presented at MWOA Annual Training June 10, 2010 The Minnesota Environmental Laboratory Accreditation Program (MN-ELAP) presented common findings specific to the 2003 NELAC Standard and the Biological Oxygen Demand methodologies (BOD). The findings were presented at the MWOA Summer Workshop on June 10, 2010.

common findings specific to the 2003 NELAC Standard and the Biological Oxygen Demand

2 Most Common Findings Quality Manual and SOP Do not contain all required items Do not accurately reflect the current lab practices Client and contract review No procedure Proficiency Test sample not treated the same as an environmental sample Traceability Standards, reagents, media Historical reconstruction of data Lot numbers of reagents, standard, media not recorded on bench sheet The first part of the presentation briefly reviewed the common findings and observations noted since the adoption of the 2003 NELAC standard in July 2009: The quality manuals do not contain all the required items. The quality manual requirements are specified NELAC standard. The NELAC Institute (TNI) website has templates available to ensure labs include all required items in their manuals. The templates can be located at the following web address: In some cases, the quality manuals do not accurately reflect the current lab practices. The NELAC standard does allow the laboratory to amend documents by hand, pending the re-issue, and if the laboratory s documentation control systems allows it. Labs must have a procedure for reviewing client contracts. For example, when a new permit is issued the lab must make sure it is a accredited for and have the staff and equipment to fulfill the tests requirements for compliance purposes. If the lab is going to subcontract the samples, the work must go to another accredited lab and the client needs to be notified the specific tests will be subcontracted. Many labs do not log the proficiency testing (PT) sample into the sample receipt logbook. A laboratory cannot run more quality control with a PT or run it more frequently than one would a regular sample. The laboratory does not always have the records to allow traceability of reagents, standards, and media. To aid in traceability, data integrity and historical reconstructions, laboratories must maintain documentation such as vendor, certificate of analysis, the date of receipt (preparation date, if prepared in lab) and expiration date. Another common finding is that the lab does not record the necessary data, such as the ph of samples, lot numbers of reagents, standards, and media used. For example, labs will perform positive and negative control on their media (e.g. MFC, Colilert and etc.), but will not record the lot number of the media. Therefore, the laboratory does not really have the documentation to prove that the lab actually did the required quality control checks. The goal is to have well documented and legally defensible data.

part of the presentation briefly reviewed the common findings and observations noted since the adoption of the 2003 NELAC standard in July 2009: The quality manuals do not contain all the required

3 Most Common Findings Training files Missing required documentation Document control No written procedure or non existent Internal audits and management reviews Not performed Maintenance logs Not kept or incomplete Corrective/Preventative Action No written procedure or non existent Final report Results not qualified Many labs do not keep training files that include the initial demonstration of capabilities and documentation of annual continued proficiency, documentation that the analyst has read, and understands and is using the most current version of the SOP Document control The lab needs to address and maintain a procedure for how documents in the lab are controlled. Specifically, the lab needs a master list of documents available to preclude the use of invalid/obsolete documents, determine how obsolete documents are retained, approved, issued and changed. The laboratory shall establish and maintain procedures to control all documents that form part of its quality system (internally generated or from external sources). Labs must do internal audits at a minimum of once per year. The quality manager must plan and organize internal audits at least annually. The scope of the audits must ensure the laboratory staff reviews all tasks performed. They are done to find flaws in the lab s quality system. Maintenance logs must be kept on each piece of equipment. They can be very beneficial to a lab in troubleshooting problems with an instrument. For example, if a lab is having a problem with the spectrophotometer, one can review the log to determine if something done recently may be causing the problem, or if someone had a similar problem in the past. Complete and accurate maintenance logs will allow review of the steps and actions to taken to solve the previous problem, and may decrease time spent troubleshooting. Section of the standard requires the laboratory to have a procedure for corrective action. Corrective action is defined as the action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent recurrence. The lab needs to determine the root cause, identify potential corrective actions and select the action most likely to eliminate the problem and prevent recurrence, and monitor the results to ensure the actions taken are effective. For example, if a lab receives an Not acceptable proficiency test score the laboratory must use its corrective action procedures (e.g. corrective action forms, root cause analysis, re-order PT samples and etc.) to determine cause and document return to control. The laboratory s test report must include all information on specific test conditions that may have affected the quality of the results (i.e. exceed hold time). The lab s report to the client must be qualified if samples are subcontracted, or if the lab reports our a result it is not accredited for.

capabilities and documentation of annual continued proficiency, documentation that the analyst has read, and understands and is using the most current version of the SOP Document control The lab

4 Common BOD and CBOD findings Dilutions Averaging results of dilutions that don t meet criteria (i.e. minimum residual DO and minimum DO depletion) Not doing enough dilutions to get valid data Dilution Water Blank Results high (exceed 0.20 mg/l) Seed Preparation Not documented in SOP The next items are common finding that we see at laboratories analyzing samples for biological oxygen demand (BOD or CBOD): -Labs will often include in the average reported results dilutions that don t meet the method acceptance criteria. The purpose of doing dilutions is to ensure valid data, and one way to assure that the data is valid is use only results that meet the depletion and residual criteria (depletion: 2 mg/l, residual: 1 mg/l). -High Blanks can come from a variety of reasons, but often times stems from one s source water -The lab should include in their standard operating procedure where they obtain their seed, (i.e. plant influent, primary effluent, purchase) and how the seed is prepared.

the average reported results dilutions that don t meet the method acceptance criteria.

5 Common BOD and CBOD findings ph not checked/ not recorded/ not adjusted Luminescence Dissolved Oxygen (LDO) Using without being accredited GGA Not evaluating the results Test Report Not qualified -The ph of samples must be checked and recorded to be between 6.0 and 8.0 and adjusted to if not within range. The analyst must seed all ph adjusted samples. -The use of the luminescent dissolved oxygen (LDO) probe is approved by Minnesota and is available for accreditation; however, a laboratory must apply for the HACH method. The lab must pass 2 proficiency testing (PT) samples and submit an standard operating procedure, an application, and the applicable fees. The lab can not just switch from a membrane electrode to an LDO probe without MN- ELAP approval. -Labs will analyze the GGA quality control sample, but sometimes are not aware of the acceptable range. The GGA is a laboratory control sample with a known acceptable range of 198 ± 30.5 mg/l ( ). -The laboratory s test report must include all information on specific test conditions that may have affected the quality of the results. Per Standard Methods procedure 5210 B, lab s must qualify reported results if any of the following occur: -dilution water blank exceeds 0.20 mg/l, -GGA fails, -test replicates show more than 30% difference between high and low values, -seed control samples show more than 30% difference between high and low values in all dilutions, or -minimum dissolved oxygen (DO) is less than 1.0 mg/l.

-The use of the luminescent dissolved oxygen (LDO) probe is approved by Minnesota and is available for accreditation; however, a laboratory must apply for the HACH 10360 method.

6 Contact Us Environmental Lab Accreditation Program (MN-ELAP) Minnesota Department of Health 601 Robert Street North Saint Paul, Minnesota Website: Susan Wyatt, Program Manager Lynn Boysen, Laboratory Assessor Stephanie Drier, Laboratory Assessor and QSO Cheryl Scholten, Laboratory Assessor Denise Schumacher, Laboratory Assessor

Read all instructions carefully before completing the application. Applications must be typewritten.

Read all instructions carefully before completing the application. Applications must be typewritten. Appendix A Tier 2 Application A This application is designed for use by laboratories seeking accreditation for samples analyzed for compliance with a National Pollution Discharge Elimination System (NPDES)