1. New TNI Consensus Standards Changes for the Environmental Laboratory

2. The 2003 NELAC Standard Strengths
Uses ISO 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.

3. 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 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Muddled and outdated version of ISO 17025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

4. 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

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

6. 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Removal of outdated NELAC language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!!!

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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)

17. 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 to here
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.

18. 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

19. 4.2.8.4 The Quality Manual shall contain:
Changes to NELAC 2003
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.

20. 4.2.8.4 The Quality Manual shall contain or reference:
Changes to NELAC 2003
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;

21. 4.2.8.4 The Quality Manual shall contain or reference:
Changes to NELAC 2003
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.

22. 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

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

24. 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 (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.

25. Modules 3 to 7 – Example Section
1.6 Demonstration of Capability (DOC)
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 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.

26. 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.

27. Demonstration of Capability
Changes to NELAC 2003
Demonstration of Capability
1.6.3 Ongoing DOC
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.

28. 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

29. 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

30. The ISO Issue
Some TNI Standards contain copyright protected language from either ISO or ISO
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.

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

32. 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

33. Thank You! Questions?