State of California Water Resources Control Board …ftp.sccwrp.org/pub/download/DOCUMENTS/ELAP/Background/... · 2017-01-24 · EE. Generating Certificate List for GIS Map SOP

State of CaliforniaWater Resources Control Board

Environmental Laboratory Accreditation Program

Quality Assurance Manual

November 2016

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I. Table of Contents

I. Table of Contents.............................................................................................................. 4

II. Introduction....................................................................................................................... 7

A. Mission and Vision Statement (Draft) .................................................................................... 7

B. Quality Assurance Policy.......................................................................................................... 8

III. Background and Structure of ELAP ................................................................................ 8

A. Background .................................................................................................................................. 8

C. Organizational Structure ........................................................................................................... 9

D. Roles and Responsibilities/Functional Organization Chart .......................................... 10

E. Environmental Laboratory Technical Advisory Committee .......................................... 15

IV. Program Activities That Require Quality Management .................................................16

A. Communications ....................................................................................................................... 16

B. Document Control System ..................................................................................................... 16

C. Accreditation Process ............................................................................................................. 17

D. Notification and Reporting ..................................................................................................... 26

E. Revoking/Suspending/Denying Certification .................................................................... 27

F. Enforcement ............................................................................................................................... 27

G. Staff Training, Consultants, and Resources ...................................................................... 27

V. Quality Management System Elements..........................................................................29

A. Internal Audits ........................................................................................................................... 29

B. Management Reviews .............................................................................................................. 30

C. Preventative Action .................................................................................................................. 31

D. Corrective Actions .................................................................................................................... 32

E. Appeals, Complaints and Disputes ...................................................................................... 32

F. Conflicts of Interest .................................................................................................................. 33

VI. Quality Improvement Process.........................................................................................33

VII. Appendices ......................................................................................................................34

A. Health and Safety Codes and California Code of Regulations ..................................... 34

B. TNI Standard, Volume 2: General Requirements for Accreditation Bodies Accrediting Environmental Laboratories .................................................................................... 34

C. Organizational Chart ................................................................................................................ 34

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D. California State Personnel Board for Classifications ..................................................... 34

E. ELTAC Member Biographies .................................................................................................. 34

F. ELTAC By-Laws ......................................................................................................................... 34

G. Bagley-Keene Open Meeting Act .......................................................................................... 34

H. Procedures Governing ELTAC .............................................................................................. 34

I. Strategic Communications Actions Plan ............................................................................ 34

J. Implementing the Strategic Communications Actions Plan SOP ................................ 34

K. Document Control System SOP ..................................................................................................... 34

L. Standard Operating Procedures Format SOP ............................................................................... 34

M. Electronic Content Management SOP .......................................................................................... 34

N. Laboratory Accreditation Process ................................................................................................. 34

O. ELAP 001 Application .............................................................................................................. 34

P. Receiving and Processing ELAP Applications SOP ....................................................... 34

Q. Renewal Proficiency Testing Review SOP ......................................................................... 34

R. Pending Status Letter or Email Template (in development) .......................................... 34

S. Annual Proficiency Testing Review SOP ............................................................................ 34

T. Temporary Suspension Letter Template (in development) ........................................... 34

U. Assignment of Applications for Certifications SOP ........................................................ 34

V. CA ELAP Assessor Checklist ................................................................................................ 35

W. On-Site Assessment SOP ....................................................................................................... 35

X. On-Site Assessment for Cryptosporidium ......................................................................... 35

Y. On-Site Assessment Report Template ................................................................................ 35

Z. Laboratory Assessment through Off-Site Data Review SOP ........................................ 35

AA. Determining Eligibility for Reciprocity Certification SOP .............................................. 35

BB. Second Review SOP ................................................................................................................. 35

CC. Accreditation Council SOP ..................................................................................................... 35

DD. Generating and Sending Certification Documents SOP ................................................. 35

EE. Generating Certificate List for GIS Map SOP ..................................................................... 35

FF. Change of Ownership, Location, Key Personnel, Major Equipment SOP ................. 35

GG. Revoking/Suspending/Denying Accreditation SOP (in development) ........................ 35

HH. Training for Assessors SOP .................................................................................................. 35

II. Internal Audit SOP .................................................................................................................... 35

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JJ. Management Reviews SOP .................................................................................................... 35

KK. Identification and Management of Nonconformities, Corrective Actions, and Preventative Actions SOP ............................................................................................................... 35

LL. Handling Complaints Process SOP ..................................................................................... 35

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II. Introduction

This Quality Assurance Manual (QAM) has a single purpose. It provides a framework for implementing, documenting, and assessing the Quality Management System (QMS) California Environmental Laboratory Accreditation Program (ELAP) will operate by. This QAM outlines the initiatives, various Standard Operating Procedures (SOPs), and policy of ELAP to fulfill the guidelines and requirements of quality standards for accrediting environmental testing laboratories pursuant to the California Health and Safety Code (HSC) and California Code of Regulations (CCR).

See Appendix A for HSC and CCR.

ELAP is committed to fulfilling its duties to certify, inspect, monitor, and enforce within a QMS that focuses on the quality of accreditation granted and identifies performance metrics for continuous improvement, as well as meeting customer needs. ELAP’s customers are the California regulatory agencies in charge of the State’s drinking water, wastewater, shellfish, food, and hazardous waste programs; and the laboratories that generate the environmental sampling and measurement data used by the State agencies to demonstrate regulatory compliance.

ELAP intends to incorporate all elements of a QMS necessary to be acceptable to other accreditation programs, federal and state regulatory agencies, national and international standards organizations, and the testing laboratories, clients, and the public. ELAP does not intend to be exact in every detail with all other programs and reserves the right to amend its operations to provide improved service to its customers, public and private.

ELAP implements an internal management system voluntarily according to the requirements in The National Environmental Laboratory Accreditation Conference (NELAC) Institute Standard (TNI), Volume 2: General Requirements for Accreditation Bodies Accrediting Environmental Laboratories. By self-imposing these standards, the Program will ensure acceptance as an accrediting body to the laboratory community, other regulatory agencies, and the public.

See Appendix B for TNI Volume 2.

ELAP administers the accreditation process in a nondiscriminatory manner and similarlyencourages accredited laboratories to maintain integrity and impartiality in their testing operations.

A. Mission and Vision Statement (Draft)

MISSION: To implement a sustainable accreditation program that ensures laboratories generate environmental and public health data of known, consistent, and documented quality to meet stakeholder needs.

VISION: Through the effective implementation and continuous improvement, California will produce the highest quality scientific data as a foundation for its environmental and public health programs and decisions.

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B. Quality Assurance Policy

ELAP management considers the reliability and quality of environmental monitoring data to be of paramount importance and issues the following policy.

"ELAP will commit, to the best of its ability, the time and resources necessary to operate a QMS that ensures the quality of accreditation granted by ELAP. The goal is to ensure data generated by environmental testing laboratories that perform testing for regulatory purposes in California is of known quality and therefore, scientifically sound and legally defensible. ELAP also expects all personnel involved with accreditation including program administration staff to assume responsibility to ensure the quality of the program.”

III. Background and Structure of ELAPA. Background

The California Environmental Laboratory Accreditation Act (ELAA) of 1989 established ELAP within the California Department of Public Health (CDPH). Under the Act, accreditation is required for any laboratory that performs analyses on a combination of environmental samples or raw or processed agricultural products for regulatory purposes. Laboratories are required to renew their certification every two years. ELAP technical staff review applications for accreditation, conduct technical assessments, prepare a report identifying any deviations or violations found. The staff also conducts investigations and takes enforcement actions as warranted. Further, ELAP provides technical consultations and regulatory updates to the environmental laboratory community and furnishes information on certified laboratories to government agencies and the public.

California Governor, Jerry Brown, signed Senate Bill 851 and 861, which marked the transition of ELAP from CDPH to the State Water Resources Control Board (SWRCB) effective July 1, 2014. Immediately after, the SWRCB asked the Southern California Coastal Water Research Project Authority (SCCWRP) to convene an Expert Review Panel (ERP) to help chart ELAP's path going forward. SCCWRP convened anindependent, five-member panel to undertake a comprehensive review of ELAP’s accreditation process and released a report in October 2015 containing findings and recommendations to transform and improve ELAP.

The Program Chief, Supervisors, Program Development and Research Unit staff and the Lead Administrative Analyst are charged with planning and implementing all transformative initiatives in response to the ERP report. Full implementation of these initiatives is scheduled for completion by the year 2020 and will broadly impact the entire accreditation process. For more information about the ERP, visit http://www.sccwrp.org/elap

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Delegation of authority was granted to the ELAP Program Chief by the Division of Drinking Water Assistant Deputy Director, Program Management Branch, pursuant to Delegation Order dated July 18, 2016.

B. ELAP Locations Covered by this Quality Assurance Manual

ELAP offices are strategically located throughout California.

1. Sacramento – Headquarters

ELAP headquarters is home to ELAP management and the Program Development, Research, and Enforcement Unit (PDREU). The PDREU is responsible for all program transformative initiatives, technical research, and enforcement cases.

The headquarters office is also the center of all administrative processes and where laboratories submit their formal request for accreditation by submitting applications for certification of environmental testing methods used for regulatory purpose by California regulatory agencies.

Additionally, the office is home to specialty On-Site Assessment staff within the disciplines of Aquatic Toxicity, Bioassay, Shellfish Sanitation, Cryptosporidium and Giardia analytical methods.

2. Glendale – Field Office

The Glendale Field Office is home to ELAP’s On-Site Assessment Unit. This unit is comprised of a group of On-Site Assessment technical staff and is primarily responsible for routine assessments.

Administrative staff are also located within the Glendale Field office to provide administrative support to the field office.

3. Richmond – Field Office

The Richmond Field Office is home to the Proficiency Testing (PT) Unit. The PT Unit is responsible for the evaluation of annual and renewal PT results. The office implements ELAP’s strategy to monitor laboratory performance by reviewing and tracking laboratory PT reports. The office initiates various actions to laboratories for failure to submit PT reports and failure to successfully pass an acceptable range of laboratory performance.

Activities performed across all three ELAP locations will be guided by the procedures and principles of this QAM.

C. Organizational Structure

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ELAP resides within the Division of Drinking Water, Program Management Branch. There are 25 budgeted positions within ELAP. ELAP employees are recruited from State of California Civil Service exam lists of qualified persons who have passed the required examination for the particular classifications. The technical classifications ELAP utilizes are Environmental Program Manager, Staff Chemist, Chemist, Senior Environmental Scientist Supervisor, Environmental Scientist and Specialist. Professional administrative classifications include Staff Services Analyst, Office Technician and Assistant, Management Services Technician, and Laboratory Assistant.

See Appendix C for ELAP Organizational Chart

See Appendix D for California State Personnel Board for Classifications

D. Roles and Responsibilities/Functional Organization Chart

The charts below identify each staff member and their role and responsibility as well as their functional area of responsibility. There are two functional areas of responsibilitywithin ELAP, Planning and Operations. Planning staff lead or assist with transformative initiatives while Operations staff ensure the program is implementing the accreditation workflow process with quality. Certain staff work in both the Planning and Operation arms of ELAP to fulfill programmatic needs.

All staff are State of California employees and must be free from influence from anyone having a commercial interest in the results of accreditation.

Roles and Responsibilities

Position Role/Responsibilities

Program Chief - Develops policies relating to operation of the program.

- Oversees implementation of policies and procedures.

- Has final authority and responsibility for the QMS.

- Manages finances.

- Signs ELAP Certificates and member of the Accreditation Council.

- Makes decisions on contractual arrangements.

- Delegate’s authority to committees or individuals, as required, to undertake

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Position Role/Responsibilities

defined activities on behalf of top management.

- Member of the Executive Management Team of the SWRCB, Division of Drinking Water.

Quality Assurance Officer - Implements and manages the QMS by maintaining documentation and ensures quality control and assurance.

Staff(Administrative and Technical, including On-Site Assessment)

- All staff must be familiar with this QAM and whenever revisions are made, will be requested to review it.

U.S. EPA Safe Drinking Water Act Laboratory Certification Officers for Chemistry, Radiochemistry, and Microbiology including Cryptosporidium and Giardia

- Certified by U.S. EPA to conduct on-site assessment of drinking water laboratories to meet requirements of the U.S. EPA Manual for the Certification of Laboratories Analyzing Drinking Water, Fifth Edition, including Supplement 1 and 2.

State of California Shellfish Sanitation Laboratory Evaluation Officer

- Certified by the Federal Food and Drug Administration to conduct on-site assessments of laboratories conducting analysis of shellfish sanitation methods.

Functional Organizational Chart

Name Functional areas of responsibility

Christine Sotelo - Program Chief

- Planning and Operations

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Jacob Oaxaca - Quality Assurance Officer

- Enforcement Unit Investigator

- Program Development and Research Staff


Maryam Khosravifard

- ELAP Management Team

- Senior Technical Manager

- Enforcement Unit Supervisor

- Program Development and Research Senior Team Manager

- U.S. EPA Safe Drinking Water Act Laboratory Certification Officer,Organic Chemistry


Christopher Ryan, Ph.D


- PT Unit Supervisor

- Program Development and Research Senior Team Member


Angela Anand

- Lead Chemistry Advisor


- U.S. EPA Safe Drinking Water Act Laboratory Certification Officer, Microbiology and Inorganic Chemistry

- On-Site Assessor

- Operations

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Steve Boggs

- ELAP Senior Staff

- Lead Specialty Assessor (Bioassay, Toxicity Testing)

- On-Site Assessor

- Operations

Frank Riley

- ELAP Senior Staff

- On-Site Assessor

- U.S. EPA Safe Drinking Water Act Laboratory Certification Officer, Microbiology

- State of California Shellfish Sanitation Laboratory Evaluation Officer

- Operations

Katelyn McCarthy

- Lead Program Analyst

- Communications Manager


Naeem Ahmad

- U.S. EPA Safe Drinking Water Act Laboratory Certification Officer, Microbiology

- Specialty Assessor (Bioassay, Toxicity Testing)

- Enforcement Unit Investigator


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Maria Friedman


- Southern California On-Site Assessment Unit Supervisor



Elano Galvez

- On-Site Assessor

- U.S. EPA Safe Drinking Water Act Laboratory Certification Officer, Microbiology and Organic Chemistry

- Operations

Karen Hogan- Administrative assistant

- Operations

Manjeet Kaur

- On-Site Assessor

- U.S. EPA Safe Drinking Water Act Laboratory Certification Officer, Microbiology, Organic and Inorganic Chemistry

- Operations

Jane Jensen- PT Unit Review Staff

- Operations

Ruby Lau- Administrative Assistant

- Operations

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Karen Lee

- On-Site Assessor

- U.S. EPA Safe Drinking Water Act Laboratory Certification Officer, Microbiology, Inorganic and Organic Chemistry

- Operations

Mandy Mok- PT Unit Review Staff

- Operations

Dharmendra Rishi

- On-Site Assessor

- Lead Reciprocity Technical Staff

- U.S. EPA Safe Drinking Water Act Laboratory Certification Officer, Inorganic and Organic Chemistry

- Operations

Jane Slaga- PT Unit Administrative Assistant

- Operations

Bill Walker

- On-Site Assessor

- U.S. EPA Safe Drinking Water Act Laboratory Certification Officer, Microbiology, Inorganic and Organic Chemistry

- Operations

E. Environmental Laboratory Technical Advisory Committee

The Environmental Laboratory Technical Advisory Committee (ELTAC) is a formal committee who assists ELAP in technical matters that impact the laboratory community. The committee is composed of approximately eighteen representatives from the laboratory community and data users to speak on behalf of interested parties and certified laboratories. ELTAC’s Mission Statement:

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“ELTAC serves to facilitate transparency, as an inclusive conduit for the fair and balanced exchange of information and dialogue between the laboratory community, California regulatory agencies, data users, and ELAP. ELTAC works to provide support, critical stakeholder review, scientifically valid advice, and unbiased guidance to ELAP on technical issues and the foreseeable effects that ELAP regulatory decisions may have, to ensure public health and environmental protection. ELTAC partners with ELAP to create and maintain a high quality accreditation program to meet the needs of the laboratory community, California regulatory agencies, and data users.”

See Appendix E for ELTAC Member Biographies

See Appendix F for By-Laws

See Appendix G for Bagley-Keene Open Meeting Act

See Appendix H for Procedures Governing ELTAC

IV.Program Activities That Require Quality Management The activities in this section ensure adherence to the program’s QMS. The activities are documented in various SOPs that follow the accreditation workflow process and other program administration activities.

A. Communications

ELAP’s Strategic Communications Action Plan (SCAP) is designed to be a centralized structure for communications. The immediate objective is to communicate critical structural and procedural changes to internal and external stakeholders. ELAP’s long-term objective is to increase regulatory agency partner and laboratory community trust in the efficacy and responsiveness of ELAP. ELAP is committed to frequent and consistent communication that will support a higher level of program operations and allow ELAP to better meet stakeholder needs. The SCAP identifies audiences, key messages, and methods for communications including performance measures to routinely evaluate the program’s progress by setting goals/deadlines and evaluating the ability to meet them. An SOP was developed to ensure quality implementation for the SCAP.

See Appendix I for the SCAP

See Appendix J for Implementing the SCAP SOP

B. Document Control System

A document control system is critical to ensure accountability, traceability, and consistency to the program as a whole. ELAP creates and uses documents to describe policies, standard operating procedures, provide direction, define specifications, and serve a host of other program management needs.

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Documents are representations of ELAP’s intellectual capital that contain information to demonstrate what ELAP knows about implementing its internal management system.Critical information is contained in ELAP documents and is necessary for an effective, functioning internal management system.

The document control system includes how ELAP will control the following: Master List Version Naming convention Effective date Pagination Confidential status Draft vs. Final Document identification Approvals Copyright or Trademark classification Reason for Change Referencing Storage and archiveForms and templates Change history Use of ELAP symbols

See Appendix K for Document Control System SOP

See Appendix L for Standard Operating Procedures Format SOP

See Appendix M for Electronic Content Management (ECM) SOP

C. Accreditation Process

The interpretation of accreditation is critical to understand the importance of quality assurance to ELAP’s accreditation process. The definition is as follows:

Accreditation means the laboratory’s quality system, staff, facilities and equipment, test methods, records, and reports have been evaluated by California ELAP.

The evaluation indicates the laboratory has the capability to provide accurate, defensible data.

Accreditation does not authorize use of a specific method for any specific program or project. It is the responsibility of the laboratory to ensure that methods used to analyze client samples meet the requirements of the program or project for which the data are intended.

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Accreditation does not mean that any specific report or set of data originating in an accredited laboratory is accurate or defensible. To ensure data quality, data users must require laboratories to provide sufficient evidence, usually in the form of results of quality control tests, with each set of data.

See Appendix N for Laboratory Accreditation Process

1. Application Intake

The following items are requested in the ELAP application form:

Type of application, certificate number if applicableLegal name of the laboratoryDivision (if applicable to the laboratory name)Location (full address) of laboratoryCalifornia CountyDescription of laboratory typeLaboratory mailing addressLaboratory billing address, if differentName and phone number of technical director(s), however named andthe lead technical director (if applicable),Name and phone number of the laboratory contactperson Name of owner; address of owner

See Appendix O for ELAP 001 Application

Administrative staff accepts laboratory application packages by electronic mail [email protected] and deem complete or incomplete based on the condition of the application package. The various types of application packages are listed below which include the required documentation and fee necessary to deem complete:

a) Initial and Renewal Application*Signed ELAP 001 ApplicationSigned Fields of Testing form(s) Dated Quality Assurance Manual FOT Worksheet(s) Acceptable Proficiency Testing result(s) for requested methods/analytes from the laboratory’s most recent study Appropriate fee submitted to the Accounting Office

*Renewal Application Packages must be received at least 90-days prior to the date of certificate expiration to avoid lapse in certification.

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See Appendix P for Receiving and Processing ELAP Applications SOP

b) Reciprocity ApplicationSigned ELAP 001 ApplicationSigned Fields of Testing form(s) Dated Quality Assurance Manual FOT Worksheet(s) Acceptable Proficiency Testing result(s) for requested methods/analytes from the laboratory’s most recent study Corrective Action Plans for any Not Acceptable results and previous cycle’s resultsPrimary Certification

o Official Certificate and Scope of Accreditation o Official On-Site Assessment Report and Findings o Applicable Corrective Action Plans

Appropriate fee submitted to the Accounting Office

c) Amendment Application Signed ELAP 001 ApplicationSigned Fields of Testing form(s) Dated Quality Assurance Manual FOT Worksheet(s) Acceptable Proficiency Testing result(s) for requested methods/analytes from the laboratory’s most recent study Appropriate fee submitted to the Accounting Office Initial Demonstration of Capability (IDOC) package

If any documents are missing from each respective application package, the package is returned to the laboratory and deemed incomplete. Only when the laboratory submits a complete application package can administrative staff move the application through the accreditation workflow process.

2. Proficiency Testing Unit Review

Review of Proficiency Testing Reports with Initial and Renewal Laboratory Application Packages

The PT Unit implements ELAP’s strategy to monitor laboratory performance by reviewing and tracking laboratory PT reports and studies from approved providers. Pursuant to CCR Section 64823, ELAP cannot certify a laboratory unless the laboratory has submitted acceptable PT results to ELAP.

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Application packages are moved through the accreditation workflow process to the Proficiency Testing Unit whose charge is to review PT reports to determine “Ready” or “Pending” status.

“Ready” means an application package can be forwarded to the next accreditation work flow process.

“Pending” means the laboratory has either failed to submit PT results or has unacceptable PT results for the method the laboratory is requesting certification.

If the results are acceptable then the Proficiency Testing Unit deems the laboratory “Ready” for assignment for technical staff to conduct a comprehensive review of the laboratory application package.

If results are unacceptable the Proficiency Testing Unit drafts a letter notifying the laboratory of ELAP’s inability to process their application for accreditation for the specific method their seeking accreditation and assigns the laboratory a “Pending” status.

See Appendix Q for Renewal Proficiency Testing Review SOP

See Appendix R Pending Status Letter or Email Template (in development)

Annual Review of Proficiency Testing Results

On the year the laboratory is not seeking renewal of their certification, laboratories are required to submit acceptable PT results to the Program. The Proficiency Testing Unit will review these submittals to ensure all laboratories have submitted acceptable PT results. Laboratories are given two consecutive attempts within six months to pass PT laboratory samples study set(s) and meet acceptable results. If the laboratory is unable to submit passing results after the second attempt, ELAP will suspend accreditation for the methods the laboratory is unable to achieve acceptable PT results. The Proficiency Testing Unit will initiate a temporary suspension action and notify the laboratory in writing ELAP is temporarily suspending certification for the specific method the laboratory failed to receive acceptable results. Temporary Suspension letters are signed and issued by the Program Chief in coordination with the Proficiency Testing Unit Supervisor and SWRCB, Office of Enforcement Attorney.

Suspensions will be lifted only when the laboratory submits acceptable PT results.

See Appendix S for Annual Proficiency Testing Review SOP

See Appendix T for Temporary Suspension Letter Template (in development)

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3. Assigning Technical Assessments

The Assignment Team meets on a weekly basis to assign technical staff application packages for review in the following categories of technical assessments:

On-Site Assessment of the LaboratoryLaboratory Assessment through Off-Site Data Review Reciprocity Review

See Appendix U for Assignment of Applications for Certifications SOP

In general, the following criteria is used to assign technical staff to review assessment categories:

Type of applicationQualifications and experience of the AssessorWorkload of the assessment staffLaboratory's geographic locationLaboratory's Fields of Testing requestLaboratory is in-state or out-of-stateAssessor who performed the previous on-site assessment

After the assignments are delegated to technical staff they must follow the appropriate SOP for the category of technical assessment and move the application package through the accreditation workflow process.

The SOPs for the categories of assessment are the basic steps technical staff must perform. After completion, technical staff will compile the accreditation workflow process documents to create a Recommendation Package that is forwarded to their direct Supervisor for Second Review then to the Accreditation Council who reviews the Recommendation Package and decides on the type of Certification granted.

4. Categories of Technical Assessment

a) On-Site Assessment of Laboratories

1) Prior to conducting an on-site assessment, Assessors prepare their schedules to allow ample time to review the following:

Application FOTs Previous OSAR & CAR Updated laboratory QAM The laboratory QAM shall include the following elements:

o Laboratory Organization and Personnel Responsibilities

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o Quality Assurance Objectives for Measurement Data processes used to identify clients’ Data Quality Objectives

o SOPs that accurately reflect all phases of current laboratory activities with a list of SOPs to ensure that current copies of SOPs are in the laboratory and in the QA Managers files

SOPs must have signature pages and revisions dated o Sampling procedures (when the laboratory performs the sampling) o Chain of Custody, handling, and disposal of samples o Calibration procedures and frequency o Analytical procedures o Acquisition and reduction o Validation and reporting of data o Internal quality control checkso Performance and systems auditso Preventative maintenanceo Assessment of precision and accuracyo Corrective actiono Quality assurance reports o Procedure for transmitting data to state regulatory agency

2) Conducting On-Site Assessment

Conduct the Opening Conference with the Laboratory Director & staff and use the CA ELAP Assessor Checklist.

Review with the Laboratory Director the previous On-Site Assessment Report (OSAR) and Corrective Action Report (CAR) and ensure he/she understands the corrections that should have been addressed from the previous on-site assessment. Review the QAM for compliance with California Code of Regulations.

Laboratory Analysts must know and understand the following:

o All updated laboratory SOPs o The method requesting certification through Initial Demonstration

of Capability (IDC)/Initial Demonstration of Performance (IDP) o Their training history/record

Conduct the Closing Conference with the Laboratory Director & staff and use the CA ELAP Assessor Checklist.

3) Post On-Site Assessment

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An OSAR and an inspection report is drafted within fifteen (15) days from the date of the on-site assessment. The inspection report remains in the laboratory file to document all the relevant facts during the on-site assessment.

If a Laboratory Assessment Team conducted the assessment, the OSAR will include the signature block of the entire team including their direct Supervisors.

OSARs include the name of the method and the deviation and the regulation violations and include the citation from the Health and Safety Code and CCR.

The OSAR contains an itemized list of Corrective Actions the laboratory must perform or address to correct deviations and violations.

The OSAR requires the laboratory make a Statement of Correction for each corrective action.

Laboratories are allowed a maximum of 45-days to correct and submit their CAR.

If a laboratory is able to adequately correct the deviations and/or violations before 45 days, technical staff can expedite the accreditation approval process by forwarding the recommendation package to the Program Chief for final accreditation approval.

See Appendix V for CA ELAP Assessor Checklist

See Appendix W for On-Site Assessment SOP

See Appendix X for On-Site Assessment for Cryptosporidium

See Appendix Y for OSAR Template

b) Laboratory Assessment through Off-Site Data Review

An accredited laboratory seeking additional Fields of Testing for accreditation may receive approval from the Program Chief, to depart from the normal operating procedures to perform an additional on-site assessment, in order to recommend certification. The laboratory will submit analytical data and documents pertinent to instrument calibration, reagent and standard preparation, standard source traceability, test method operating procedures, sample preparation, analysis raw data, calculations, analyst demonstrations

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of accuracy and precision, and detection limit determinations. If submitted data is complete, consistent, and compliant with pertinent reference test methods, and regulatory program requirements, then an additional on-site assessment is determined not to be required and the certification is granted.

This procedure is applicable only to laboratories that are already accredited and in good standing, not to laboratories pending accreditation for the first time. The application package must be deemed complete and proficiency testing must have been acceptably passed.

None of these procedures shall oppose the U.S. EPA Laboratory Certification Manual for analyzing drinking water methods.

See Appendix Z for Laboratory Assessment through Off-Site Data Review SOP

c) Reciprocity Review

Many laboratories outside of the State of California request to become certified in California for environmental testing. ELAP can issue a Reciprocity Certificate to out-of-state laboratories based on that laboratory's certification by another Accreditation Body. In some cases, California based laboratories possess certification from another Accrediting Body and may also apply for Reciprocity certification.

In both cases, an application package must be deemed complete and an Assessor conducts a technical review and forwards a Recommendation Package to their direct Supervisor for review and approval.

The U.S. EPA Manual for Certification of Laboratories Analyzing Drinking Water endorses this procedure and has asserted this as a highly desirable element in any certification program for drinking water laboratories. In the case of drinking water laboratories, only a U.S. Safe Drinking Water Act Laboratory Certification Officer will review Reciprocity application packages and forward to the Program Chief for review and approval of certification.

See Appendix AA for Determining Eligibility for Reciprocity Certification SOP

d) Second Review

Once the technical assessment is complete, the Assessor sends the Recommendation Package to their Supervisor, who performs a second review, consisting of reviewing technical and administrative processes performed by the Assessor or Assessment Team. The second review includes:

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Confirming Assessor has complied with applicable SOPs

A Technical Review of the Assessor’s On-Site Assessment Report and Approved Corrective Actions

Administrative review of laboratory files for required documentation

Administrative review of database for accuracy

Confirmation of receipt of payment in the correct amount

Updating of proposed certificate dates for review by the Accreditation Council

Once the Supervisor has completed their Second Review, they sign and save the Clearance Form and move the application to the Accreditation Council for review and a decision on issuance of certification.

See Appendix BB for Second Review SOP

e) Accreditation Council Review

The final step in the accreditation workflow process is to forward the Recommendation Package to the Accreditation Council (Program Chief,Quality Assurance Officer and Senior Technical Manager) for approval. The Accreditation Council reviews the Recommendation Package for completeness and decides which type of certification the laboratory will be granted. The Accreditation Council will approve the following types of ELAP certification:

Certified - a laboratory that meets the regulatory performance criteria and regulatory requirements.

Not Certified - a laboratory that possesses method deviations and/or regulatory violations and, in the opinion of the Accreditation Councilcannot consistently produce valid data. The laboratory application for accreditation is formally denied.

Interim Certification - interim certification may be granted in certain circumstances when it is impossible or unnecessary to perform an on-site audit. Interim certification status may be granted if, for example, the Accreditation Council determines the laboratory has the appropriate instrumentation, is using the approved methods, has

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adequately trained personnel to perform the analyses, and has satisfactorily analyzed PT samples, if available, for the contaminants in question. On-Site Assessment staff will be assigned to perform an assessment when the Program Chief has adequate resources. In the case of drinking water laboratories, on-site assessments will be conducted no later than every three years.

An example of a situation where this type of certification is warranted is when a drinking water laboratory requests certification for the analysis of additional analytes that involve a method for which italready has certification. The U.S. EPA Laboratory Certification Officer should review the laboratory's quality control data before recommending to the Accreditation Council to grant this type of certification.

Reciprocity Certification – a laboratory meets the Reciprocity criteria to receive certification based on another Accreditation Body certificate.

See Appendix CC for Accreditation Council SOP

f) Generating and Sending Certification Documents

Administrative staff implement the final step in the accreditation workflow process by generating and mailing the Certificate and Certificate List to the certified laboratory.

See Appendix DD for Generating and Sending Certification Documents SOP

g) Geographic Information Systems Map

ELAP created and maintains a Geographic Information Systems (GIS) Map located on the ELAP webpage. The map is a locater tool for stakeholders, the laboratory community, ELAP-certified laboratories, regulatory agencies and the public to locate certified laboratories. Administrative staff update the map on a monthly basis.

See Appendix EE for Generating Certificate List for GIS Map SOP

D. Notification and Reporting

When a change occurs in a laboratory's ownership, location, key personnel, major instrumentation, or other key accreditation criteria, written notification to ELAP is required within 30 calendar days. ELAP must evaluate the significance of a change

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that might alter or impair the laboratory's capability and quality, and indicate to thelaboratory the results of their evaluation in writing. ELAP must retain records toindicate that such an evaluation was conducted.

See Appendix FF for Change of Ownership, Location, Key Personnel, Major Equipment or Location SOP

E. Revoking/Suspending/Denying Certification

In certain circumstances ELAP must engage in actions to revoke, suspend, or deny alaboratories ELAP certification. This procedure must be considered and followed closely because the actions that result can impact the substantial interests of the affected parties.

The SOP for this program activity addresses the revocation, suspension, or denial of laboratory certification by issuing a formal action pursuant to HSC and/or CCR. If the laboratory's actions constitute an immediate threat to public health and the environment, the laboratory's certification may be suspended immediately through an Order. A laboratory's application for certification may be denied if the laboratory does not fulfill the requirements of California Health and Safety Code and CCR.

See Appendix GG for Revoking/Suspending/Denying Accreditation SOP (in development)

F. Enforcement

Within the ELAP organizational structure is the Enforcement Unit charged to conduct investigations in response to appeals by laboratories, complaints from the public or complaint referrals from regulatory agencies that use the data produced from ELAP-accredited laboratories for public and environmental health decisions. The Enforcement Unit is called in to situations where usual on-site assessments by ELAP Assessors cannot be performed. Staff abides by a clear delineated line, which separates functions and responsibility of other ELAP technical staff.

The Program Chief and the SWRCB’s Office of Enforcement manage the activities, investigations, and legal actions initiated by the Enforcement Unit. A dedicated Office of Enforcement Attorney assists the Enforcement Unit to ensure procedures comply with statute and regulations.

Staff are trained in various areas of laboratory fraud, investigation and the regulatory craft.

G. Staff Training, Consultants, and Resources

1. Staff Training

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ELAP currently implements a formal Training Plan that identifies each program position. The Training Plan summarizes each position’s specific role and responsibility and holds Supervisors accountability to conduct annual performance evaluations and development and assist in the implementation of Individual Development Plans as required by the State of California Human Resources Department.

U.S. EPA qualifies On-Site Assessors as Safe Drinking Water Act Laboratory Certification Officers through weeklong training sessions in Microbiology and Chemistry offered through EPA's Office of Research and Development. This certification is required in order to conduct on-site assessment of drinking water laboratories.

To further enhance knowledge skills and abilities, ELAP hosts specific training designed for each category of ELAP On-Site Assessor. The training consists of:

Participation in courses on assessing quality systems and all technical disciplines, which includes technology or combination of method and technology. The Division of Drinking Water’s Principal Laboratory, California Department of Public Health (CDPH), Drinking Water Radiation Laboratory or contracted expert, will host these types of trainings.

Participation in specific analytical method training in the disciplines of Microbiology, Biological, Radiochemistry, Inorganic-Nonmetals/Misc., Inorganic-Metals, Organics, Asbestos, and Field Activities.

Newly hired On-Site Assessors (contract or State of California employee) shadow or accompany other experienced On-Site Assessors on several laboratory on-site assessments as appropriate until the Program Chief andSenior Technical Manager verify adequate competency and experience.

Participation in annual refresher training which includes:

o Technical changes associated with approved methodology and the resulting checklist changes,

o On-Site Assessment skills and techniques,

o New program developments related to drinking water analytical methods, including California specific methods, and

o Annual ELAP Assessor Roundtable meeting designed to refresh Assessors of the top drinking water method ELAP grants certification and new laboratory technologies.

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To ensure Assessor training is conducted on time with clear and complete documentation, the Quality Assurance Officer will take the following steps:

i. Conduct an annual training file review.

ii. Update files with documentation immediately following any in-house training and as soon as documentation is received for externally conducted training.

iii. Continue to ensure that all Assessors sign in at all staff meetings, which serve as on-going training, and keep copies of these sign-in sheets as part of the overall training records.

iv. Use Microsoft Outlook reminders and other available electronic tools to track training needs and accomplishments.

See Appendix HH for Training for Assessors SOP

2. Consultants and Resources

ELAP utilizes consultation from state and federal laboratories including members and representatives of ELTAC. They include staff members of the Division of Drinking Water’s Principal Laboratory, Environmental Chemistry Laboratories (ECL) within the Department of Toxic Substances Control (DTSC), Water Pollution Control Laboratory of the California Department of Fish and Wildlife (CDFW), U.S. EPA Region IX laboratory staff, and the members and California regulatory agency representativeson ELTAC.

The Consultants/Resource Individuals are as follows:

Bruce LaBelle, Chief, ECL Pasadena and Berkeley, DTSCCarol Wortham, QA Officer, ECL Berkeley, DTSCWilliam Draper, Laboratory Director, DWRL Richmond, CDPHJanna Rinderneck, Environmental Program Manager, Water Pollution Control Laboratory Rancho Cordova, CDFWAndy Lincoff, U.S. EPA Region IX Richmond Jack Berges, U.S. EPA Region IX RichmondJennifer Best, U.S. EPA, OGWDW, CincinnatiELTAC California Regulatory Agency representatives

V. Quality Management System Elements

A. Internal Audits

ELAP conducts an internal audit of each aspect of the accreditation program on an annual basis. When planning for the program audit, management will take into

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consideration the importance of the processes and areas to be audited, as well as the results of the previous audits.

ELAP will ensure that:

Internal audits are conducted by personnel different from those who perform the activity to be audited.

Personnel are informed of the outcome of the audit.

Actions are taken in a timely and appropriate manner.

Opportunities for improvement are identified.

See Appendix II for Internal Audit SOP

B. Management Reviews

ELAP management will review the program’s management system annually to ensure continual adequacy and effectiveness in maintaining an effective accreditation program. The focus will be on improvement of the management system and its processes, identification of additional resources, and defining or redefining policies, goals, and objectives. The management review will include current performance and improvement opportunities related to the following:

Results of audits

When errors, deficiencies, or discrepancies are detected as a result of an audit, the responsible person is notified as soon as possible. Corrections are usually made immediately and the person responsible for the error, the person discovering the error, or the Program Chief is authorized to make corrections.

If a discrepancy requires a change in regulation, statute, policy, an SOP, or a document, the Program Chief is notified of the situation. A solution or resolution is usually reached by discussion and consensus of ELAP Management Team and the Quality Assurance Officer. The Program Chief approves any necessary changes to an SOP or document and renders final decisions whenever disputes are unresolved or executive decisions are needed. If SOP revisions are required, the changes are made within 30 days of the deficiencies being detected.

Regulations revisions require completion of administrative rulemaking procedures. Due to the extensive resources consumed, rulemaking is conducted only when policy or procedural changes conflict directly with current rules. The SWRCB Members, the Secretary of the California Environmental Protection Agency and the final approval by California Legislature, must approve statutory

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changes. The SWRCB can sponsor bill language when necessary to authorize ELAP to perform functions not provided for in current statutes. These bills are addressed and voted on during the regular legislative sessions.

Feedback from stakeholders and the public

ELAP welcomes all feedback to help continuously improve the program. To facilitate feedback ELAP created a feedback/comments email box [email protected] at any time, Stakeholders and the public can email ELAP to provide helpful and/or constructive criticism on how ELAP can continually improvement.

During on-site assessment closing conference ELAP Assessor will provide laboratories with the comments email box to submit feedback and comments to ELAP regarding the accreditation process and customer service.

The Program Chief and the Quality Assurance Officer will review feedback and comments. When errors, deficiencies, or discrepancies are detected, the responsible person is notified as soon as possible. Corrections are usually made immediately and the person responsible for the error, the person discovering the error, or the Program Chief is implements and directs corrections.

New areas of accreditation

Trends in non-conformities

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Fulfillment of objectives

Changes that could affect the management system

Analysis of complaints

See Appendix JJ for Management Reviews SOP (in development).

C. Preventative Action

ELAP has established procedures for taking preventative actions to eliminate the causes of potential nonconformities. ELAP will:

Identify potential nonconformities and their causes

Determine and implement the preventative actions needed

Record results of actions taken

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Review the effectiveness of the preventative action taken.

D. Corrective Actions

ELAP has established procedures for the identification and management of nonconformities, and where necessary, preventing recurrence. ELAP will:

Identify nonconformities

Determine the cause of nonconformities

Correcting nonconformities

Ensure nonconformities do not recur

Implement corrective actions

Record the results of actions taken

Reviewing the effectiveness of corrective actions

See Appendix KK for Identification and Management of Nonconformities, Corrective Actions, and Preventative Actions SOP

E. Appeals, Complaints, and Disputes

ELAP has established procedures for dealing with appeals, complaints and disputes.

Appeals, complaints, and disputes are received and reviewed by the Program Chief. These usually arrive by email, but occasionally come by letter or phone call. They typically are complaints from regulatory agencies about non-conformances by certified laboratories, data irregularity and less frequently come from individuals or other laboratories. If complaints are filed against the Program Chief then the complaint is routed directly to the Assistant Deputy Director of the Division of Drinking Water for review and resolution.

The Program Chief reviews the allegations of the appeal, complaint or dispute and any documentation provided to verify the nature and validity and to ascertain the appropriate course of action. ELAP will record all correspondence with the goal of achieving resolution at the early possible date.

In some cases, complaints may take the form of an investigation by the Enforcement Unit or may otherwise become a portion of a regular on-site assessment. Complaints that are verified by documentation may elicit a Notice of Violation to the laboratory with a request for corrective action. Allegations of criminal activity or fraud are referred directly to ELAP’s Enforcement Unit who then partner with the State Water Board’s Office of Enforcement and/or can be referred to the California Attorney General, local District

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Attorney Offices, or the U.S.EPA EPA Laboratory Fraud Investigation Unit or in extreme cases, local law enforcement.

Specific details on administrative hearings, Orders to Correct, and other procedures are defined in CCR and the HSC.

See Appendix LL for Handling Complaints Process SOP.

F. Conflicts of Interest

All ELAP personnel are expected to comply with the confidentiality and no conflict of interest policies of the program.

State employees at the management level are required to file reports to demonstrate there is no conflict of interest each year. These standards ensure that ELAP's management and technical staff are free of any commercial, financial, or other pressures that might influence the results of the accreditation process.

In addition, assessors must complete a conflict of interest form before participation in each assessment.

Questions that arise from laboratories regarding ELAP assessors are handled through the process described in Complaint SOP. Any questions from assessors who are not able to comprehend the State and federal laws on conflicts of interest are discussed individually with the Chief or his/her designee. If an assessor has possible conflicts of interest, then such cases are discussed individually with the Chief or his/her designee and determinations of conflicts of interest are made prior to participation of the assessor in any part of the assessment of the laboratory. If the assessor has been determined to possess even a single conflict of interest, the assessor is prohibited from participating in any part of the assessment. Please note, the State of California does not allow its employees to have any conflict of interest.

VI.Quality Improvement Process

ELAP will incorporate lessons learned through internal audits of the Quality Assurance section of each SOP for quality in its efforts to continuously improve ELAP processes towards a sustainable accreditation program. As ELAP continues to implement the many transformative initiatives, more areas for improvement such as performance metrics and measures will be implemented.

The SWRCB is a performance-based organization and annually releases a Performance Report that provides a mechanism to measure and evaluate both what the agency does and how the environment is responding to agency actions.

The Performance Report presents numerous performance measures for specific outputs and outcomes that are tracked through the state data systems. These performance measures are organized under key functional categories. ELAP resides within the Division of Drinking Water

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regulatory functional category and currently does not participate given the infancy of the program within the State Water Resources Control structure.

VII. Appendices

A. Health and Safety Codes and California Code of Regulations

B. TNI Standard, Volume 2: General Requirements for Accreditation Bodies Accrediting Environmental Laboratories

C. Organizational Chart

D. California State Personnel Board for Classifications

E. ELTAC Member Biographies

F. ELTAC By-Laws

G. Bagley-Keene Open Meeting Act

H. Procedures Governing ELTAC

I. Strategic Communications Actions Plan

J. Implementing the Strategic Communications Actions Plan SOP

K. Document Control System SOP

L. Standard Operating Procedures Format SOP

M. Electronic Content Management SOP

N. Laboratory Accreditation Process

O. ELAP 001 Application

P. Receiving and Processing ELAP Applications SOP

Q. Renewal Proficiency Testing Review SOP

R. Pending Status Letter or Email Template (in development)

S. Annual Proficiency Testing Review SOP

T. Temporary Suspension Letter Template (in development)

U. Assignment of Applications for Certifications SOP

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V. CA ELAP Assessor Checklist

W. On-Site Assessment SOP

X. On-Site Assessment for Cryptosporidium

Y. On-Site Assessment Report Template

Z. Laboratory Assessment through Off-Site Data Review SOP

AA. Determining Eligibility for Reciprocity Certification SOP

BB. Second Review SOP

CC. Accreditation Council SOP

DD. Generating and Sending Certification Documents SOP

EE. Generating Certificate List for GIS Map SOP

FF. Change of Ownership, Location, Key Personnel, Major Equipment SOP

GG. Revoking/Suspending/Denying Accreditation SOP (in development)

HH. Training for Assessors SOP

II. Internal Audit SOP

JJ. Management Reviews SOP

KK. Identification and Management of Nonconformities, Corrective Actions, and Preventative Actions SOP

LL. Handling Complaints Process SOP