Quality Manual for SJCUEL

Transcription

1 St. Johns County Board of County Commissioners St. Johns County Utility Environmental Laboratory P.O. Drawer 3006 St. Augustine, FL Technical Director, & QA Officer: Stacy Kowlsen 860 West 16 th Street St. Augustine, FL Phone: (904) Fax: (904) Quality Manual for SJCUEL Prepared by Stacy Kowlsen Quality Manual for TNI Volume 1, Module 2 Revision #1 July 6, 2011 This Quality Assurance Plan written for the use of the St. Johns County Utility Department and all other documents are approved by the Technical Director and the Quality Assurance Officer prior to issuing. All Quality Assurance Plans written before TNI Volume 1, Module 2 Revision number #1 are now obsolete but will be retained for at least 5 years. TNI Standard Volume 1 Module QA Officer 07/06/2011 Date Technical Director 07/06/2011 Date Page 1 of 208

2 TNI Standard Volume 1 Module e: The identification of the laboratory s approved signatures Approved Signatories The following persons are authorized to sign documents for the St. Johns County Environmental Laboratory: Initials Print Signature Date 1.HLK 2.AMG 3.MPC Heather Kronz Amy Glidewell Marisa Clark 07/06/ /06/ /06/ SLK 5.JAS Stacy Kowlsen 07/06/2011 Jerome Sachs 07/06/2011 Page 2 of 208

3 VOLUME 1 MANAGEMENT AND TECHNICAL REQUIREMENTS FOR LABORATORIES PERFORMING ENVIRONMENTAL ANALYSIS Module 2: Quality Systems General Requirements TNI Standard Page 3 of 208

4 VOLUME 1, MODULE 2 Quality Systems General Requirements Table of Contents 1.0 INTRODUCTION, SCOPE AND APPLICABILITY 1.1 Introduction Scope NORMATIVE REFERENCES Cover Page TERMS AND DEFINITIONS 3.1 Additional Terms and Definitions Sources...NA 3.3 Exclusions and Exceptions...NA 4.0 MANAGEMENT REQUIREMENTS 4.1 Organization Management Document Control Review of Request, Tenders and Contracts Subcontracting of Environmental Tests Purchasing Services and Supplies Service to the Client Complaints Control of Nonconforming Environmental Testing Work Improvement Corrective Action Preventive Action Control of Records Internal Audits Management Reviews Data Integrity Investigations TECHNICAL REQUIREMENTS 5.1 General Personnel Accommodation and Environmental Conditions Environmental Methods and Method Validation Calibration Requirements Measurement Traceability Collection of Samples Handling Samples and Test Items Quality Assurance for Environmental Testing Reporting the Results Appendices Appendix A Qualifiers Appendix B Calculations 205 Appendix C Acronyms Appendix D Revision History. 209 Page 4 of 208

5 This page left Intentionally Blank Page 5 of 208

6 TNI Volume 1, Module 2 General Systems General Requirements Section 1 Introduction, Scope and Applicability Section one contains a detailed introduction and the scope Page 6 of 208

7 Section 1.0 Introduction, Scope, and Applicability Section 1.1 Each Laboratory shall have a Quality System. The laboratory s quality system is the means by which an organization ensures the quality of the products or services it provides and includes a variety of management, technical, and administrative elements such as: Policies and objectives, Procedures and practices, Organizational authority, Responsibilities, and Performance measures. Introduction St. Johns County Environmental Laboratory (SJCUEL) operates as a division of the St. Johns County Utility Department and has its own operating budget approved by the St. Johns County Board of County Commissioners. The SJCUEL s quality system provides the framework for planning, implementing, assessing, and improving work performed by the laboratory for the water and wastewater plants owned and operated by the St. Johns County Utility Department (SJCUD). All sections of the quality system are documented in the quality assurance plan including all quality control procedures. The purpose of the SJCUEL s Quality Assurance Program is to operate under standardized QA procedures, to provide guidance to all personnel and it is designed to continually monitor the reliability of test results, ensuring that they fall within acceptable limits, and provide guidelines for the implementation of corrective action when necessary. This Quality Assurance Manual is a summary document that outlines the policies and operational procedures and the laboratory management system associated with work carried out at its permanent facility in St. Augustine, Florida. It is intended to ensure the high quality of analytical services that the Laboratory is committed to provide to the other divisions within the St. Johns County Utility Department and other St. Johns County Departments. This Manual contains Page 7 of 208

8 references to other supporting documents also related to the Quality Assurance System, such as SOPs, QC acceptance limits, MDL studies, Performance Evaluation Results, and Policy documents. The QA Manual and its supporting documents are reviewed annually to ensure that they reflect current laboratory practices and are in agreement with current regulations. The Quality Assurance System is constantly monitored, reviewed and evaluated. The Quality Assurance Officer is the primary person in charge of updating, revising and distributing this QAP. The Laboratory Director and Technical Directors also have input in the upgrade of the plan. The revision process takes place when needed if there is a change in some of the processes described, and it is also reviewed and re-approved yearly, if no changes are needed. After the revision is completed, the manual is approved for release by the QA Officer and by the Management. After it is submitted, some time is allowed for training of the personnel in the changes introduced if any. The Dates of submittal and the effective date are in the cover page of the document. All policies and procedures have been structured in accordance with the TNI standards, the ISO/IEC 17025:2005 standards and applicable requirements, regulations, guidance, and technical standards from the USEPA and State regulatory agencies. If more stringent standards or requirements than are specified in this Manual are included in a mandated test method or by regulation, such requirements must be met. If it is not clear which requirements are more stringent, the standard from the method or regulation is to be followed. Page 8 of 208

9 Section 1.2 The requirements in this document give the basis for a laboratory s quality system in order to carry out environmental tests. It covers testing performed using reference methods, non-reference methods, and laboratorydeveloped methods. This document contains the essential elements required to establish a quality system that produces data of known and documented quality, and demonstrates proficiency through the use of proficiency testing and employee training. The general requirements in this document give the basis for a laboratory s quality system in order to carry out environmental tests, regardless of the number of personnel or the degree of environmental testing activities. When the use of the data requires compliance with the Standards, these Standards shall be followed. This document is for use by laboratories, clients, regulatory authorities, and accreditation bodies to ensure the laboratory has appropriate management and technical quality systems to perform environmental testing. This document specifies technical, managerial, and documentation requirements needed for assessment by organizations or accreditation bodies to grant approval. This document provides the requirement needed for laboratory accreditation. If the requirements of this document are met, the laboratory operates a quality system in conformance with the applicable clauses of ISO/IEC 17025:2005 (E). Scope The SJCUEL s quality system covers the tests listed in the table below and has accreditation for microbiology, nutrients, wet chemistry, and metals for drinking and non-potable water. All chemists perform the appropriate procedures and test methods according to the Florida Department of Health (FDOH), Florida Department of Environmental protection (FDEP), United States Environmental Protection Agency (USEPA), and the TNI standards. Before an analyst may perform one of the fields of study listed below, they must pass the initial demonstration capability and there after must pass a demonstration of capability on an annual basis. All data is reviewed by the analyst running the samples, by a peer in the laboratory, and then by the quality assurance officer before results are finalized into a report and furnished to the client. Method Analyte Matrix EPA EPA and DER SOP 10/3/83 Alkalinity, Total, Carbonate and Bicarbonate Unionized Ammonia Drinking & Non-Potable Water Non-Potable Water Page 9 of 208

10 Method Analyte Matrix EPA 325.2, SM 4500 Cl-E EPA SM 2120C EPA Chloride Total Residual Chlorine Color Specific Conductivity Drinking & Non-Potable Water Drinking & Non-Potable Water EPA Chemical Oxygen Demand Non-Potable Water SM 5210B Biochemical Oxygen Demand Non-Potable Water SM 5210B SM 2340B Carbonaceous Biochemical Oxygen Demand Total Hardness Non-Potable Water Drinking& Non-Potable Water EPA Ammonia Nitrogen Non-Potable Water EPA Total Kjeldahl Nitrogen Non-Potable Water EPA Nitrate, Nitrite and Nitrate + Nitrite, Nitrogen Drinking& Non-Potable Water EPA and SM O-G Dissolved Oxygen Ground and Surface Waters EPA ph Drinking SM 4500-H+-B ph Non-Potable Water EPA Ortho Phosphate Non-Potable Water EPA Total Phosphorous Non-Potable Water SM 2540D EPA EPA SM 2540C Non-filterable Residue, (Total Suspended Solids) (TSS) Non-filterable Residue, (Mixed Liquor Suspended Solids) (MLSS) Filterable Residue, (Total Dissolved Solids) (TDS) Filterable Residue (Total Dissolved Solids) (TDS) Non-Potable Water Non-Potable Water Drinking Non-Potable Water EPA Sulfate Drinking Page 10 of 208

11 Method Analyte Matrix ASTM D Sulfate Non-Potable Water SM 4500 SO4-E Sulfate Non-Potable Water EPA Temperature EPA Turbidity Non-Potable Water EPA Aluminum (Al) Drinking & Non-Potable Water EPA Antimony (Sb) Non-Potable Water EPA Antimony (Sb) Drinking EPA Arsenic (As) Non-Potable Water EPA Barium (Ba) Drinking& Non-Potable Water EPA Beryllium (Be) Non-Potable Water EPA EPA EPA Cadmium (Cd) Calcium (Ca) Chromium (Cr) Drinking& Non-Potable Water Drinking& Non-Potable Water Drinking& Non-Potable Water EPA Cobalt (Co) Non-Potable Water EPA EPA Copper (Cu) Iron (Fe) Drinking& Non-Potable Water Drinking& Non-Potable Water EPA Lead (Pb) Non-Potable Water EPA Lead (Pb) Drinking EPA Magnesium (Mg) Drinking EPA Manganese (Mn) Drinking& Non-Potable Water EPA Molybdenum (Mo) Non-Potable Water EPA Nickel (Ni) Drinking& Non-Potable Water Page 11 of 208

12 Method Analyte Matrix EPA Potassium (K) Drinking& Non-Potable Water EPA Selenium (Se) Non-Potable Water EPA Selenium (Se) Drinking EPA Silver (Ag) Drinking& Non-Potable Water EPA Sodium (Na) Drinking EPA Thallium (Tl) Non-Potable Water EPA Thallium (Tl) Drinking EPA Vanadium (V) Non-Potable Water EPA Zinc (Zn) Drinking& Non-Potable Water SM 9223B Total Coliform (TC) Drinking SM 9222D Fecal Coliform (FC) Non-Potable Water SM 9223B Escherichia coli (EC) Drinking SM 9215B Heterotrophic Plate Count (HPC) Page 12 of 208

13 TNI Volume 1, Module 2 Normative References Section 2 Page 13 of 208

14 TNI Volume 1, Module 2 Terms and Definitions Section 3 Section three contains the terms and definitions and sources. Section 3.1 Additional Terms and Definitions Acceptance Criteria: specified limits placed on characteristics of an item, process, or service defined in requirement documents. Page 14 of 208

15 Accreditation: the process by which an agency or organization evaluates and recognizes a laboratory as meeting certain predetermined qualifications or standards, thereby accrediting the laboratory. Accuracy: the degree of agreement between an observed value and an accepted reference value. Accuracy includes a combination of random error (precision) and systematic error (bias) components that are due to sampling and analytical operations. It is a data quality indicator. Calculate percent accuracy by dividing the observed value by the reference value and multiplying by 100. Analyst: the designated individual who performs the hands on analytical methods and associated techniques and who is the one responsible for applying required laboratory practices and other pertinent quality controls to meet the required level of quality. Analytical Uncertainty: A subset of Measurement Uncertainty that includes all laboratory activities performed as part of the analysis. Assessment: the evaluation process used to measure or establish the performance, effectiveness, and conformance of an organization and/or its systems to defined criteria. Audit: a systematic and independent examination of facilities, equipment, personnel, training, procedures, record-keeping, data validation, data management, and reporting aspects of a system to determine whether QA/QC and technical activities are being conducted as planned and whether these activities will effectively achieve quality objectives. Batch: environmental samples that are prepared and/or analyzed together with the same process and personnel, using the same lot(s) of reagents. A preparation batch is composed of one to twenty environmental samples of the same quality systems matrix, meeting the above-mentioned criteria and with a maximum time between the start of processing of the first and last sample in the batch of 24 hours. An analytical batch is composed of prepared environmental samples (extracts, digestates, or concentrates), which are analyzed together as a group. An analytical batch can include prepared samples originating from various environmental matrices and can exceed 20 samples. Bias: The systematic or persistent distortion of a measured process, which causes errors in one direction (i.e., the expected sample measurement is different from the sample s true value). Blank: a sample that has not been exposed to the analyzed sample stream in order to monitor contamination during sampling, transport, storage or analysis. The blank is subjected to the usual analytical and measurement process to establish a zero baseline or background value and is sometimes used to adjust or correct routine analytical results. Blanks include: Page 15 of 208

16 Method Blank: A sample of a matrix similar to the batch of associated samples (when available) that is free from the analytes of interest and is processed simultaneously with and under the same conditions as samples through all steps of the analytical procedures, and in which no target analytes or interferences are present at concentrations that impact the analytical results for sample analyses. Calibration: a set of operations that establish, under specified conditions, the relationship between values of quantities indicated by measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards. In calibration of support equipment the values realized by standards are established through the use of reference standards that are traceable to the International System of Units (SI). In calibration according to methods, the values realized by standards are typically established through the use of Reference Materials that are either purchased by the laboratory with a certificate of analysis or purity, or prepared by the laboratory using support equipment that has been calibrated or verified to meet specifications. Calibration Curve: the mathematical relationship between the known values, such as concentrations, of a series of calibration standards and their response. Calibration Standard: a substance or reference material used for calibration Certified Reference Material: reference material accompanied by a certificate, having a value, measurement uncertainty, and stated metrological traceability chain to a national metrology institute Chain of Custody Form: Record that documents the possession of the samples from the time of collection to receipt in the laboratory. This record generally includes; the number and types of containers; the mode of collection; the collector; time of collection; preservation; and requested analysis. Chemical Oxygen Demand: is measured by heating the sample in a strongly acid solution with a known excess amount of potassium dichromate. The potassium dichromate oxidizes the organic waste in the sample. This results in a change of chromium from the hexavalent state to the trivalent state. Both of these chromium species are colored and absorb in the visible region of the spectrum. The samples are read on a spectrophotometer. Chloride: is measured by titration with mercuric nitrate until a purple complex is formed. It is one of the major inorganic anions in water and wastewater. It is a requirement for drinking water and for cation/anion balances. Page 16 of 208

17 Color: is measured by a visual comparison between the sample and a platinumcobalt standard. It is useful for measuring color of water derived from naturally occurring materials, i.e., vegetable residues such as leaves, bark, roots, humus, and peat. Compromised Samples: those samples, which are improperly sampled, insufficiently documented, improperly preserved, collected in improper containers, or exceeding holding times when delivered to a laboratory. Under normal conditions compromised samples are not analyzed. If emergency situations require analysis, the results must be appropriately qualified. Conductivity: electric current. k is a measure of the ability of an aqueous solution to carry an Confirmation: verification of the identity of a component through the use of an approach with a different scientific principle from the original method. These may include but are not limited to: Second column confirmation, Alternate wavelength, Derivatization, Mass spectral interpretation, Alternative detectors, or Additional cleanup procedures. Data Reduction: the process of transforming the number of data by arithmetic or statistical calculations, standard curves, and concentration factors, and collating them into a more useable form. Demonstration of Capability: a procedure to establish the ability of the analyst to generate analytical results of acceptable accuracy and precision. Duplicate Analysis: the analyses or measurements of the variable of interest performed identically on two sub-samples of the same sample. The results from duplicate analyses are used to evaluate analytical or measurement precision but not the precision of sampling, preservation or storage internal to the laboratory. Equipment Blank: a sample of analyte-free media, which has been used to rinse common sampling equipment to check effectiveness of decontamination procedures. Field Blank: blank prepared in the field by filling a clean container with pure deionized water and appropriate preservative, if any, for the specific sampling activity being undertaken. Field of Accreditation: Those matrix, technology/method, and analyte combinations for which the accreditation body offers accreditation. Finding: an assessment conclusion referenced to a laboratory accreditation standard and supported by objective evidence that identifies a deviation from a laboratory accreditation standard requirement. Formazin Polymer Standards: these standards are used to check the calibration of the turbidity meter. Page 17 of 208

18 Holding Times: the maximum time that can elapse between two specified activities Internal Standard: a known amount of standard added to a test portion of a sample as a reference for evaluating and controlling the precision and bias of the applied analytical method. Instrument Blank: A clean sample processed through the instrumental steps of the measurement process; used to determine instrument contamination. Internal Standard: a known amount of standard added to a test portion of a sample as a reference for evaluating and controlling the precision and bias of the applied analytical method. Laboratory Control Sample: (however named, such as laboratory fortified blank, spiked blank, or QC check sample) A sample matrix, free from the analytes of interest, spiked with verified known amounts of analytes or a material containing known and verified amounts of analytes and taken through all sample preparation and analytical steps of the procedure unless otherwise noted in a reference method. It is generally used to establish intra-laboratory or analyst specific precision and bias or to assess the performance of all or a portion of the measurement system. Laboratory Duplicate: aliquots of a sample taken from the same container under laboratory conditions and processed and analyzed independently. Legal Chain of Custody Protocols: Procedures employed to record the possession of samples from the time of sampling through the retention time specified by the client or program. These procedures are performed at the special request of the client and include the use of a Chain of Custody form that documents the collection, transport, and receipt of compliance samples by the laboratory. In addition, these protocols document all handling of the samples within the laboratory. Linear Dynamic Range: The concentration range over which the analytical curve remains linear. Limit of Detection (LOD): a laboratory s estimate of the minimum amount of an analyte in a given matrix that an analytical process can reliably detect in their facility. Limit of Quantitation (LOQ): the minimum levels, concentrations, or quantities of a target variable (e.g., target analyte) that can be reported with a specified degree of confidence. Matrix: the substrate of a test sample. Matrix Duplicate: A replicate matrix prepared in the laboratory and analyzed to obtain a measure of precision. Page 18 of 208

19 Matrix Spike (spiked sample or fortified sample): a sample prepared, taken through all sample preparation and analytical steps of a procedure unless otherwise noted in a reference method, by adding a known amount of target analyte to a specified amount of sample for which an independent test result of target analyte concentration is available. Matrix spikes are used, for example, to determine the effect of the matrix on a method s recovery efficiency. Matrix Spike Duplicate (spiked sample or fortified sample duplicate): a replicate matrix spike prepared in the laboratory and analyzed to obtain a measure of the precision of the recovery for each analyte. Measurement System: a method, as implemented at a particular laboratory, and which includes the equipment used to perform the test and the operator(s). Method: a body of procedures and techniques for performing an activity (e.g., sampling, chemical analysis, quantification), systematically presented in the order in which they are to be executed. Mobile Laboratory: a portable enclosed structure with necessary and appropriate accommodation and environmental conditions for a laboratory, within which testing is performed by analysts. Examples include but are not limited to trailers, vans, and skid-mounted structures configured to house testing equipment and personnel. National Institute of Standards and Technology (NIST): a federal agency of the US Department of Commerce s Technology Administration that is designed as the United States national metrology institute (NMI). Negative Control: measures taken to ensure that a test, its components, or the environment do not cause undesired effects, or produce incorrect test results. Nephelometric Turbidity Units (NTU): the units that turbidity is measured. Performance Audit: the routine comparison of independently obtained qualitative and quantitative measurement system data with routinely obtained data in order to evaluate the proficiency of an analyst or laboratory. Positive Control: measures taken to ensure that a test and/or its components are working properly and producing correct or expected results from positive test subjects. Precision: the degree to which a set of observations or measurements of the same property, obtained under similar conditions, conform to themselves; a data quality indicator. Precision is usually expressed as standard deviation, variance or range, in either absolute or relative terms. Preservation: any conditions under which a sample must be kept in order to maintain chemical and/or biological integrity prior to analysis. Page 19 of 208

20 Procedure: a specified way to carry out an activity or process. Procedures can be documented or not. Proficiency Testing: a means of evaluating a laboratory s performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an external source. Proficiency Testing Program: the aggregate of providing rigorously controlled and standardized environmental samples to a laboratory for analysis, reporting of results, statistical evaluation of the results and the collective demographics and results summary of all participating laboratories. Proficiency Test Sample: a sample, the composition of which is unknown to the laboratory and is provided to test whether the laboratory can produce analytical results within specified acceptance criteria. Protocol: a detailed written procedure for field and/or laboratory operation (e.g., sampling, analysis) which must be strictly followed. Pure Reagent Water: shall be water (defined by national or international standard) in which no target analytes or interferences are detected as required by the analytical method. Quality Assurance: an integrated system of activities involving planning, implementation, assessment, reporting and quality improvement to ensure that a process, item or service is of the type and quality needed and expected by the client. Quality Control: the overall system of technical activities that measures the attributes and performance of a process, item, or service against defined standards to verify that they meet the stated requirements established by the customer; operational techniques and activities that are used to fulfill requirements for quality; also the system of activities and checks used to ensure that measurement systems are maintained within prescribed limits, providing protection against :out of control conditions and ensuring that the results are of acceptable quality. Quality Control Sample (QCS): a sample used to assess the performance of all or a portion of the measurement system. One of any number of samples, such as Certified Reference Materials, a quality system matrix fortified by spiking, or actual samples fortified by spiking, intended to demonstrate that a measurement system or activity is in control. Quality Manual: a document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability, and implementation of an agency, organization, or laboratory, to ensure the quality of its product and the utility of its product to the users. Page 20 of 208

21 Quality System: is the means by which an organization ensures the quality of the products or services it provides and includes a variety of management, technical and administrative elements such as; policies and objectives, procedures and practices, organized authority, responsibilities, and performance measures. Quality System Matrix: These matrix definitions are to be used for purposes of batch quality control requirements: Air and Emissions: whole gas or vapor samples including those contained in flexible or rigid wall containers and the extracted concentrated analytes of interest from a gas or vapor that are collected with a sorbent tube, impinger solution, filter, or other devise. Aqueous: any aqueous sample excluded from the definition of Drinking Water or Saline/Estuarine. Includes surface water, groundwater effluents, and TCLP or other extracts. Biological Tissue: any sample of a biological origin such as fish tissue, shellfish, or plant material. Such samples shall be grouped according to origin. Chemical Waste: a product or by-product of an industrial process that results in a matrix not previously defined. Drinking Water: any aqueous sample that has been designated a potable or potential potable water source. Non-Aqueous Liquid- any organic liquid with <15% settleable solids. Saline/Estuarine: any aqueous sample from an ocean or estuary, or salt water sources such as the Great Salt Lake. Solids: includes soils, sediments, sludges, and other matrices with >15% settleable solids. Raw Data: the documentation generated during sampling and analysis. This documentation includes, but is not limited to, field notes, electronic data, magnetic tapes, un-tabulated sample results, QC sample results, print outs of chromatograms, instrument outputs, and handwritten records. Reference Material: material or substance one or more whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials. Reference Standard: standard used for the calibration of working measurement standards in a given organization or at a given location. Page 21 of 208

22 Resource Conservation and Recovery Act (RCRA): the enabling legislation under 42 USC 321 et seq. (1976), that gives EPA the authority to control hazardous waste from the cradle-to-grave, including its generation, transportation, treatment, storage, and disposal. Safe Drinking Water Act (SDWA): the enabling legislation, 42 USC 300f et seq. (1974), (public Law ), that requires the EPA to protect the quality of drinking water in the U.S. by setting maximum allowable contaminant levels, monitoring, and enforcing violations. Sampling: activity related to obtaining a representative sample of the object of conformity assessment, according to a procedure. Selectivity: the ability to analyze, distinguish, and determine a specific analyte or parameter from another component that may be a potential Interferent or that may behave similarly to the target analyte or parameter within the measurement system. Sensitivity: the capability of a method or instrument to discriminate between measurement responses representing different levels (e.g., concentrations) of a variable of interest. Spike: a known mass of target analyte added to a blank sample or subsample; used to determine recovery efficiency or for other quality control purposes. Standard: the document describing the elements of laboratory accreditation that has been developed and established within the consensus principles of standard setting and meets the approval requirements of standard adoption organizations procedures and policies. Standard Operating Procedures (SOP): a written document that details the method for an operation, analysis or action with thoroughly prescribed techniques and steps. SOP s are officially approved as the methods for performing certain routine or repetitive tasks. Sulfate: the sulfate ion (SO 4 2- ) is precipitated in an acetic acid medium with barium chloride to form barium sulfate crystals, which are white in color. The sample is measured by a photometer and the sulfate ion concentration is determined by a comparison of the reading with a standard curve. Determining the turbidity of each of the known sulfate standards creates the standard curve. Technology: a specific arrangement of analytical instruments, detection systems and/or preparation techniques. Traceability: the ability to trace history, application, or location of an entity by means of recorded identifications. In a calibration sense, traceability relates measuring equipment to national or international standards, primary standards, Page 22 of 208

23 basic physical constants or properties, or reference materials. In a data collection sense, it relates calculations and data generated throughout the project back to the requirements for the quality of the project. Turbidity: is determined by a comparison between the intensity of the light scattered by the sample and by a standard reference suspension. United States Environmental Protection Agency (EPA): the federal governmental agency with responsibility for protecting public health and safeguarding and improving the natural environment (i.e., the air, water, and land) upon which human life depends. Verification: confirmation by examination and objective evidence that specified requirements have been met. Note: In connection with the management of measuring equipment, verification provides a means for checking that the deviations between values indicated by a measuring instrument and corresponding known values of a measured quantity are consistently smaller than the maximum allowable error defined in a standard, regulation or specification peculiar to the management of the equipment. The result of verification leads to a decision either to restore in service, to perform adjustment, to repair, to downgrade, or to declare obsolete. In all cases, it is required that a written trace of the verification performed shall be kept on the measuring instrument s individual record. Page 23 of 208

24 Volume 1, Module 2 Quality Systems General Requirements Section 4.0 Management Requirements Page 24 of 208

25 Section 4.1: Organization (ISO/IEC 17025:2005 (E), Clause 4.1 Organization Board of County Commissioners Directory of the Utility Department Operations Manager Administration Manager Operations Superintendent Technical Director, QA Officer Chemist Chemist Chemist Lab Technician Section 4.1.1: Does the laboratory or the organization of which it is a part an entity that can be held legally responsible? SJCUEL works beneath the umbrella of the St. Johns County Utility Department, which is under the authority of the St. Johns County Board of County Commissioners that can be held legally responsible. Section 4.1.2: Does the laboratory uphold its responsibility to carry out its testing and calibration activities in such a way as to meet the requirements of this standard? Does the laboratory carry out its testing and calibration activities in such a way as to meet the requirements of the customer, the regulatory authorities or organizations providing recognition? Page 25 of 208

26 The laboratory staff performs their testing and calibration activities to meet the requirements of the customer, the regulatory authorities or organizations providing recognition. Section 4.1.3: Does the management system cover work carried out in the laboratory s permanent facilities, or in associated temporary or mobile facilities? The management system covers work carried out in the laboratory s permanent facility located at 860 West 16 th Street, St. Augustine, Florida Section 4.1.4: If the laboratory is part of an organization performing activities other than testing and/or calibration, are the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities defined in order to identify potential conflicts of interest? The director of the utility department is in charge of the entire utility department and works directly under the county administrator. The administrative manager handles the budget for all the divisions in the utility department. This person along with the finance department approves the money used to buy new laboratory equipment, repair old equipment, hire employees, purchase standards, reagents, and all other necessary items to operate a laboratory efficiently. The operations superintendent reports to the Operations Manager, and is responsible for the day to day operations of the five divisions, which are the laboratory/ pretreatment, wastewater, water, transmission and distribution, and lift station maintenance. The technical director reports directly to this person regarding all major decisions affecting the laboratory. Section 4.1.5a: Does the laboratory managerial and technical personnel with the authority and resources needed to perform their duties, identify departures from the management system or from the procedures for performing tests and/or calibrations, initiate actions to prevent or minimize such departures, implement, maintain, and improve the management system irrespective of other responsibilities? The lab is staffed with adequate technical personnel with the authority to perform their duties, identify departure from the management system or from the procedures for performing tests and/or calibrations, initiate actions to prevent or minimize such departures, implement, maintain, and improve the management system irrespective of other responsibilities. Section 4.1.5b: Does the laboratory have arrangements to ensure that its management & personnel are free from any undue internal and external commercial, financial, and other pressures that may adversely affect the quality of their work? The organizational structure and the management staff above the chemists and lab technician ensure that the analysts are free from any undue internal and Page 26 of 208

27 external commercial, financial and other pressures that may adversely affect the quality of their work. Section 4.1.5c: Does the laboratory have policy and procedures to ensure the protection of its customers confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results? The laboratory must follow the sunshine laws and therefore all records are public. No reports are transmitted electronically because they are stored on an intranet web site available only to designated St. Johns County Utility Department employees. Section 4.1.5d: Does the laboratory have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgment or operational integrity? It is the goal of SJCUEL to perform its testing and calibration activities to meet the requirements of the customer and the regulating authorities to the best of their ability by avoiding involvement in any activities that would diminish confidence in its competence, impartiality, judgment, or operational integrity. Section 4.1.5e: Does the laboratory define the organization and management structure of the laboratory, its place in any parent organization, and its relationships between quality management, technical operations, and support services? The St. Johns County Utility Environmental Laboratory is a division of the St. Johns County Utility Department. The laboratory only performs work for the utility department or other departments of St. Johns County. The management staff consists of the utility manager, utility superintendent, and the director of the utilities. The technical director handles all day to day operations including quality management, technical operations, and support services. Section 4.1.5f: Does the laboratory specify the responsibility, authority, and interrelation of all personnel who manage, perform or verify work affecting the quality of tests and/or calibrations? The technical director is responsible for the final review of all data, laboratory reporting, non conformity reports, and calibration records. Before the data reaches the technical director, it has been reviewed by the analyst, and by another peer, to ensure that the data reported is accurate. Section 4.1.5g: Does the laboratory provide adequate supervision of testing and calibration staff, including trainees, by persons familiar with methods and procedures, the purpose of each test and/or calibration and the assessment of results? Page 27 of 208

28 The technical director and senior chemist provide adequate supervision of testing and calibration staff, including trainees, because they are familiar with methods and procedures, and the assessment of results. Section 4.1.5h: Does the laboratory have technical management with overall responsibility for the technical operations and the provision of resources needed to ensure the required quality of laboratory operations? The technical director has overall responsibility for the technical operations and the provision of resources needed to ensure the required quality of laboratory operations. Section 4.1.5i: Does the laboratory appoint a member of staff as quality manager? Does this quality manager have defined responsibility and authority for ensuring that the management system is implemented and followed at all times? Does the quality manager have direct access to the highest level of management at which decisions are made on laboratory policy or resources? The technical director/ QA officer is responsible for ensuring that the management system is implemented and followed at all times and has direct access to the highest level of management. If the technical director is on vacation or is absent from the laboratory, the senior chemist assumes the role of technical director and the chemists assumes the role of QA officer by peer reviewing each other s work. If both the technical director and the senior chemist are absent from work, the chemists will resume the role of technical director and QA officers until one of them returns to work. Section 4.1.5j: personnel? Does the laboratory appoint deputies for key managerial Not applicable Section 4.1.5k: Does the laboratory ensure that personnel are aware of the relevance and importance of their activities and how they contribute to overall management system goals? Each year, the analysts attend the data integrity training to stress the importance of quality data and to ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the overall management system goals. Section 4.1.6: Does top management ensure that communication processes are established and that communication regarding the effectiveness of the management system takes place? Page 28 of 208

29 SJCUEL employees have several forms of communication available to discuss pertinent information that affects the laboratory. All laboratory staff has access to , daytime phone, and an emergency on call cell phone. Notification Policy for possible exceedences for Reclaimed Water total suspended solids (TSS) and fecal coliform (FC) samples the environmental coordinator, lead operator, wastewater superintendent, and the operations superintendent if the samples collected to meet reclaimed water are above a five (5) ppm TSS or there is a count for FC #/100ml. Make sure that you write a possible exceedence. It is up to the lead operator to determine if it is an exceedence. Notification Policy for Total Coliform Results Compliance Total Coliforms If there is a sample that is positive for total coliform, call the operator immediately after the results are final. If there is a sample that is positive for both total coliform and e-coli, then call the operator and the appropriate state department immediately after the results is final. Main Clearance and Boil Water Notice Total Coliform Results If the samples were collected for boil water notices, call or the collector and the compliance officer for either positive or negative results. If the samples were collected for main clearances, only notify the collector for either positive or negative results. Process Control Samples or Spill Samples the environmental coordinator, lead operator, wastewater superintendent, and the operations superintendent for both process control and spill samples. Section a-h: Quality Manager and/or his/her designee shall: Serve as the focal point for the QA/QC and be responsible for the oversight and/or review of quality control data. Have functions independent from laboratory operations for which they have quality assurance oversight. Be able to evaluate data objectively and perform assessments without any outside influence. Page 29 of 208

30 Have documented training and/or experience in QA/QC procedures and the laboratory s quality system. Have a general knowledge of the analytical tests methods for which data review is performed. Arrange for or conduct internal audits as per section 4.14 annually. Notify laboratory management of deficiencies in the quality system. Monitor corrective actions. Note: SJCUEL s QA officer is also the technical director. Section a-f: shall: The laboratory s technical manager(s) and/or his/her designee(s) Be a member of the staff of an environmental laboratory who exercises actual day-to-day supervision of laboratory operations for the appropriate fields of accreditation and reporting results. Have duties that include; o Monitor standards of performance in quality control and quality assurance. o Monitor the validity of analyses performed and data generated in the laboratory to assure reliable data. Not be the technical manager(s) of more than one accredited environmental laboratory without authorization from the primary Accreditation Body. Circumstances to be considered in the decision to grant such authorization shall include: o The extent to which operating hours of the laboratories to be directed overlap. o Adequacy of supervision in each laboratory o The availability if environmental laboratory services in the area served If absent for a period of time exceeding fifteen (15) consecutive calendar days shall designate another full-time staff member meeting the qualifications of the technical manager(s) to temporarily perform this Page 30 of 208

31 function. If this absence exceeds thirty-five (35) consecutive calendar days, the primary accreditation body shall be notified in writing. Meet qualification requirements as specified in Section Page 31 of 208

32 Section 4.2: Management (ISO/IEC 17025:2005 (E), Clause 4.2 Management System Section 4.2.1: Appropriate to the scope of its activities, has the laboratory established, implemented, and maintained a management system? The St. Johns County Utility Department Environmental Laboratory has established, implemented, and maintained a management system that includes policies, systems, programs, procedures, and instructions to assure that the quality of the tests and calibrations are accurate. The system is communicated through , and the computer. All pertinent files are located on the T drive for laboratory personnel only. Section 4.2.2a: Are the lab s management system policies and objectives defined in a quality manual (however named)? Are the policies, systems, programs, procedures and instructions of this system documented to the extent necessary to assure the quality of the test and/or calibration results? Is the system documentation communicated to, understood by, available to, and implemented by the appropriate personnel? The policies and objectives are defined in the one (1) quality assurance manual All the policies, systems, programs, procedures and instructions of the management system policy are documented well and all staff are trained on the policies to assure good quality on the test and/or calibration results The system documentation is understood by all and implemented to all staff. SJCUEL Quality Policy Statement This Quality Manual summarizes the laboratory policies and operational procedures associated with St. Johns County Utility Environmental Laboratory (SJCUEL) located at 860 West 16 th Street in St. Augustine, Florida. This plan, structured in accordance with the TNI standards adopted in July 2011, ISO/IEC 17025:2005(E), and applicable EPA requirements, regulations, guidance, and technical standards, describes specific protocols for sample handling and storage, chain-of-custody, and laboratory analyses, data reduction, corrective action, and reporting. All policies and procedures have been documented in this quality manual by the technical director and are available for review and implementation by all personnel. It is a requirement that tests and/or calibrations shall be performed in accordance with stated methods and customers requirements. Further details on these policies and procedures are contained in Page 32 of 208

33 SOPs and related documents. This Quality Manual, SOPs, and related documentation describe the quality system for SJCUEL. The laboratory performs chemical analyses and microbiology analyses for inorganic constituents in surface, ground, lab D.I. water, potable and waste waters. It is the commitment of the laboratory staff and the management to provide a good professional practice along with quality testing and calibrations to provide good customer service and quality data. All personnel concerned with environmental testing and calibration activities within the laboratory familiarize themselves with the quality documentation and implement the policies and procedures in their work. The management team, consisting of the Director of the Utility Department, Operations Manager and the, Operations Superintendent is committed to good professional practices and to the quality of its environmental testing in servicing its clients. The managers and the chief executives standard of service is defined as good quality, reproducible, and defensible data produced in a timely manner as to comply with TNI standards, ISO regulations, and FDEP and EPA regulations. Section 4.2.3: Has top management provided evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness? The top management provides funding to hire an outside consultant to perform the required annual manager s review. The manager review reports provide excellent feedback on meeting all required standards while producing a high quality of data to the customers. Each year, the laboratory improves its systems and procedures which improve the service to the customers. Section 4.2.4: Has top management communicated to the organization the importance of meeting customer, statutory and regulatory requirements? See section 4.2.2a-e Section 4.2.5: Does the quality manual include or make reference to supporting and technical procedures and does it outline the structure of the documentation used in the management system? The quality manual includes or makes reference to supporting and technical procedures and outlines the structure of the documentation used in the management system in Section 4.3 of this manual. Section 4.2.6: Does the quality manual define the roles and responsibilities of the technical and quality managers, including the roles which ensure compliance with this standard? Page 33 of 208