New TNI Consensus Standards Changes for the Environmental Laboratory http://www.doh.state.fl.us/lab/EnvLabCert/WaterCert.htm http://www.NELAC-Institute.org steve_arms@doh.state.fl.us 904-791-1502

The 2003 NELAC Standard Strengths Uses ISO 17025 quality system approach Adds specificity to improve clarity and help with consistency for environmental testing Allow flexibility in meeting requirements Represents best professional practice Allows for multiple Accreditation Bodies to implement consistently The key slide; as much as it needs improvement, it is the best program.

The 2003 NELAC Standard Weaknesses Refers to an organization that no longer exists Hard to find all the laboratory requirements Written by chemists for chemists Some language could be improved Not a true consensus standard Does not incorporate ISO 17011 for Accreditation Bodies Muddled and outdated version of ISO 17025 This is to begin the transition into the new tNI standards, by showing what is wrong with 2003 NELAC

A New Approach Start with the purpose of an accreditation program Ensure key elements are retained Consider the following goals: Easy to use and understand Easy to grow and expand Easy to revise and implement Applicable to all laboratories

Basis of New Standard International Standards ISO Guide 43 Work of NELAC from 1994 - 2003 Significant input from TNI membership during consensus voting process

Benefits of New Laboratory Standards Removal of outdated NELAC language Incorporation of ISO 17011 Incorporation of current version of ISO 17025 Volume/Modular approach simplifies understanding Improved clarity of Technical Requirements Increased flexibility Very few new requirements True consensus standard!!!

Format of New Standard Sector Volume Module Identifiable accreditation program with unique requirements, e.g., NELAP Volume Key elements of an accreditation program for a particular sector Module Specific requirements combined with other modules to create a volume

2008 TNI Standards Volume 1 Laboratory Requirements Module 1: Proficiency Testing Module 2: Quality Systems General Requirements Module 3: Asbestos Testing Module 4: Chemical Testing Module 5: Microbiological Testing Module 6: Radiochemical Testing Module 7: Toxicity Testing Volume 2 Accreditation Body Requirements Module 1 – General Requirements Module 3 – On-Site Assessment Module 2: Proficiency Testing Volume 3 Proficiency Test Provider Requirements Volume 4 Proficiency Testing Oversight

Proficiency Testing NELAC 2003 Definitions of terms and acronyms not included in Chapter 2. Lacked process flow Sometimes confusing or unclear language TNI STANDARD Each volume and each module includes terms and definitions Maps process flow Concise language & auditable requirements Clarity / Editorial 9

PT Specific to General NELAC STANDARD Laboratory may withdraw from a PT Study if it notifies the AB and PTP before the close date of the study Discipline-specific appendices (Micro, Tox, Rad, Air) TNI STANDARD Withdrawal notification requirement removed Same criteria applied to all disciplines Changed based on guiding principles. NELAC stated “the how to” so ABs could be sure laboratory met semi-annual requirement – TNI is flexible. Labs must still meet the semi-annual schedule to maintain accreditation but participation in any particular study is at their discretion. 10

Proficiency Testing NELAC 2003 PTRL Reporting PT Scheduling calculated on study open/close dates Some program requirements not in standard (Exp. PT) Continued accreditation PT time frame “approximately 6 months apart” TNI 2008 LOQ Reporting PT Scheduling calculated from analysis dates All program requirements included in standard Time frame “at least 5 months apart, and no longer than 7 months apart” Major Technical Changes 11

Proficiency Testing LOQ Reporting for Laboratories Reporting PT data based on the laboratory’s documented Limit of Quantitation (LOQ) Allows laboratories to analyze PT samples in the same manner as routine samples same staff, sample tracking, sample preparation and analysis methods, SOPs, calibration techniques, quality control procedures and acceptance criteria

Proficiency Testing Implementation Guidance Document PT Expert Committee is developing an Implementation Guidance Document This document will go into specifics for the implementation of the standard for each category of stakeholder Accreditation Bodies Laboratories PT Providers

Quality Systems Module 2 contains the General Requirements that apply to all laboratories Much, but not all of NELAC Chapter 5 Updated to 2005 version of 17025 17025 language clearly identified and not modified Personnel requirements from NELAC Chapter 4 Modules 3 though 7 are Technical Requirements for different types of laboratories Method Selection, Validation and DOC Instrument Calibration Quality Control Sample Handling

QS Changes from NELAC 2003 Reorganization Combination of requirements from NELAC 2003, Chapter 5 and Appendices C and D All technical requirements moved from general requirements section to Technical Modules 3-7 Instrument calibration requirements Support equipment requirements still in Module 2 (5.5.13) Terms and definitions included in every module Technical Director qualifications included Reorganization of some sections to improve flow

Changes in ISO 17025 Quality System changed to Management System New sections on laboratory management responsibilities New section on improvement (4.10) New QC language: Quality control data shall be analysed and, where they are found to be outside pre-defined criteria, planned action shall be taken to correct the problem and to prevent incorrect results from being reported. (5.9.2)

Quality Systems General Requirements Example Section from Module 2 – Non ISO version 4.14 Internal Audits (ISO/IEC 17025:2005(E), Clause 4.14) ISO text 4.14.1 to 4.14.4 here 4.14.5 Additional Items a) The laboratory shall have a policy that specifies the time frame for notifying a client of events that cast doubt on the validity of the results. b) The laboratory management shall ensure that these actions are discharged within the agreed time frame. c) The internal audit schedule shall be completed annually.

Changes to NELAC 2003 Technical Director/Manager Qualification Exceptions Drinking water or sewage treatment plant Licensed Operator deemed to meet educational requirements only 2 years testing experience needed Industrial waste treatment plant 2 years supervised testing experience needed Both are limited to the scope of the permit

4.2.8.4 The Quality Manual shall contain: Changes to NELAC 2003 4.2.8.4 The Quality Manual shall contain: a) document title; b) laboratory's full name and address; c) name, address of individual(s) responsible for the laboratory; d) identification of all major organizational units and the effective date of the version; e) identification of the laboratory's approved signatories; f) the signed and dated concurrence of all responsible parties; g) the objectives of the quality system and contain or reference the laboratory’s policies and procedures; h) the laboratory’s official quality policy statement and management’s commitment to ethical laboratory practices and to upholding the requirements of this Standard; and i) a table of contents, and applicable lists of references, glossaries and appendices.

4.2.8.4 The Quality Manual shall contain or reference: Changes to NELAC 2003 4.2.8.4 The Quality Manual shall contain or reference: a) all maintenance, calibration and verification procedures; b) major equipment and reference measurement standards used as well as the facilities and services used by the laboratory in conducting tests; c) verification practices, use of reference materials and internal quality control schemes; d) procedures for reporting analytical results; e) the organization and management structure f) procedures to ensure that all records are retained and procedures for control and maintenance of documentation; g) job descriptions; h) procedures for traceability; i) a list of all test methods;

4.2.8.4 The Quality Manual shall contain or reference: Changes to NELAC 2003 4.2.8.4 The Quality Manual shall contain or reference: j) procedures for reviews of all new work; k) procedures for handling samples; l) procedures for corrective action whenever discrepancies are detected, or departures from documented policies and procedures occur; m) policy for permitting departures from documented policies and procedures; n) procedures for dealing with complaints; o) procedures for protecting confidentiality; p) procedures for audits and data review; q) procedures for personnel experience and needed training; and r) policy addressing the use of unique electronic signatures.

Technical Modules 3-7 Quality Systems for Asbestos, Chemical, Microbiological, Radiochemical, and Toxicity Testing Combination of requirements from NELAC 2003, Chapter 5 and Appendices C and D Format consistent in all Technical Modules All requirements related to the scientific discipline

Technical Modules 3-7 Method Selection and Validation Demonstration of Capability Calibration Quality Control Data Acceptance/Rejection Sample Handling

Modules 3 to 7 – Example Section 1.6 Demonstration of Capability (DOC) 1.6.1 General Prior to acceptance and institution of any method for which data will be reported, a satisfactory initial DOC is required (see Section 1.6.2). Thereafter, ongoing DOC (Section 1.6.3), as per the quality control requirements in Section 1.7.3 (such as laboratory control samples) is required. In cases where a laboratory analyzes samples using a method that has been in use by the laboratory for at least one year prior to applying for accreditation, and there have been no significant changes in instrument type, personnel or method, the ongoing DOC shall be acceptable.

Modules 3 to 7 – Example Section 1.6 Demonstration of Capability (DOC) 1.6.1 General (Continued) The laboratory shall have records on file to demonstrate that a DOC is not required. For the initial DOC, appropriate records as discussed in Section 1.6.2 shall be completed. An initial DOC shall be completed each time there is a change in instrument type, personnel, or method. All demonstrations shall be documented. All data applicable to the demonstration shall be retained and readily available at the laboratory.

Demonstration of Capability Changes to NELAC 2003 Demonstration of Capability 1.6.2 Initial DOC An initial DOC shall be conducted prior to using any test method, and at any time there is a change in instrument type, personnel or test method or any time that a method has not been performed by the laboratory or analyst in a twelve-month period.

Demonstration of Capability Changes to NELAC 2003 Demonstration of Capability 1.6.3 Ongoing DOC 1.6.3.1 The laboratory shall have a documented procedure describing ongoing DOC. The analyst(s) shall demonstrate on-going capability by meeting the quality control requirements of the method, laboratory SOP, client specifications, and/or this Standard. It is the responsibility of the laboratory to document that other approaches to ongoing DOC are adequate.

Other Changes No arbitrary expiration date assignment for original containers Work cells are gone CBI provisions condensed No specific certification statement or form required for DOC Guidance for DOC given in technical modules

A Plan for Implementation January 2008: Review by LASC Summer 2009: Adoption by NELAP Board Fall 2009: Amendments to 64E-1, F.A.C. Spring 2010: Training and outreach Summer 2010: Replace NELAC 2003

The ISO Issue Some TNI Standards contain copyright protected language from either ISO 17025 or ISO 17011. A free version of all Standards without the ISO language is available. TNI must recover the costs of a license agreement with ANSI or ASTM for the integrated documents. As an example, we are charging $50 for a single use version of Volume 1; we must pay ANSI $51.

Summary Major reorganization to simplify understanding Very few new requirements Over a year to prepare Special workshop on August 10 in San Antonio

Recommendations Do not waste your time comparing the new TNI Standard to NELAC 2003 Read the new standard Perform a gap analysis Perform a reverse gap analysis Make any necessary changes

Thank You! Questions?