1. How to Implement the TNI Standard in a Small Lab
Marlene Moore
Advanced Systems, Inc.
June 15, 2010

2. Objective
Laboratories with a staff of less than 15 people often ask how to implement the TNI standard?  Many of the requirements of the standards seem to be geared to large laboratories.  
The presentation includes various ways that a small laboratory may implement the TNI standard.  
Elements to be reviewed include: internal audits, management review, corrective action, data review, contract review, subcontracting, purchasing, document control, plus others.

3. Outline Quality Manual updated Documents updated Records changed
Proficiency testing reviewed
Training and implementation
By - July 1, 2011
NELAC 2003 replaced!
Troubling sections for small labs

4. Standards Acquired (Step 1)
TNI = The NELAC Institute
Left column “Standards”
Pending TNI standards
Purchase with ISO language for complete copy

5. TNI LABORATORY 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: Toxicological Testing
Volume 2 Accreditation Body Requirements
Module 1 – General Requirements
Module 3 – On-Site Assessment
Module 2: Proficiency Testing
Volume 3 Proficiency Testing Provider Requirements
Volume 4 Proficiency Testing Oversight

6. Volume 1: Laboratory Requirements
Uses current version of ISO 17025
Increased clarity.
Everything in one place:
Proficiency testing,
Quality systems, and
Personnel.
Discipline specific quality control modules greatly improved.
Very few new requirements.
Greater flexibility

7. Read the Standard (Step 2)
V1M1
V1M2
If applicable
Chemistry - V1M4
Microbiology – V1M5

8. Note Standard Changes As you read - note anything you did not know
Many people are seeing new requirements
May have been overlooked
Looks different since in different section
Intent not changed
Some specific language deleted
Redundant language

9. Quality Manual updated (Step 3)
Glossary
Table of Contents
Other Sections of note
You must review!

10. GLOBAL CHANGES ISO/IEC 17025
Quality System changed to Management System
Client changed to Customer

11. OTHER CHANGES ISO/IEC 17025 Many, many editorial changes
New sections on laboratory management responsibilities
New section on quality improvement
New language on evaluating QC results
Not just doing QC, but also evaluating the QC
Not a new concept, but now a requirement in case you were doing QC, but not evaluating it.

12. Added Definitions
Analytical Uncertainty: A subset of Measurement Uncertainty that includes all laboratory activities performed as part of the analysis.
Bias: The systematic or persistent distortion of a measurement process, which causes errors in one direction (i.e., the expected sample measurement is different from the sample’s true value).

13. Added Definitions
Matrix Duplicate: A replicate matrix prepared in the laboratory and analyzed to obtain a measure of precision
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.

14. Added Definitions
Quality Assurance [Project] Plan (QAPP): a formal document describing the detailed quality control procedures by which the quality requirements defined for the data and decisions pertaining to a specific project are to be achieved. (EPA- QAD)

15. Added Definitions
Sampling: Activity related to obtaining a representative sample of the object of conformity assessment, according to a procedure
Have you reviewed your glossary in your QM to be sure these are added and that others are removed?

16. Quality Manual 4.2.8.3 The quality manual shall contain:
Document title;
Plus 8 other items
The quality manual shall contain or reference:
All maintenance, calibration and verification procedures used by the laboratory in conducting tests
Plus 19 other items
Note: Requirements for contents of Title Page removed!

17. Organization
4.1.5 (k) ensure personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system. 
4.1.6 ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system.

18. 5.2.6 Personnel
Technical Director requirements from NELAC Chapter 4

19. Management System
Implementation of the management system and to continually improving its effectiveness.
Importance of meeting customer requirements as well as statutory and regulatory requirements.
Ensure the integrity of the management system is maintained when changes to the management system are planned and implemented.

20. Service to Customer Customer feedback required How do you do this?
Recommended in older version of 17025
Not in 2003 NELAC
How do you do this?

21. Improvement (New)
The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
HOW!

22. Corrective Action Required changes to be documented and implemented.
Really a clarification to Corrective Action Process

23. Internal Audits
Follow-up required to verify corrective actions implemented
Be sure to add to your internal audit process

24. Accommodations NELAC 5.5.3.6 unencumbered work area language deleted
ISO/IEC and keep the requirement
5.3.4 Access to lab
Circumstances define the controls needed
5.3.5 Good housekeeping
Special procedures if needed

25. Reporting Results Not required to be included Units of measurement;
Failures identified;
For Whole Effluent Toxicity, the statistical package used to provide data
Date of issue
Name or number of subcontractor on the report, (subcontract results must be identified)

26. Documents updated (Step 4)
Review your SOPs

27. Methods and SOPS
NELAC and reformatted into TNI section 2.8.5, under records.
Improved clarity and consistency
Removal of “methods manual”
Use of LOD instead of detection limit

28. Comparison of Sample Handling Requirements
NELAC
TNI
All records pertaining to:
a) sample preservation including appropriateness of sample container and compliance with holding time requirement;
b) sample identification, receipt, acceptance or rejection and log-in;
c) sample storage and tracking including shipping receipts, sample transmittal forms, (chain of custody form); and
d) documented procedures for the receipt and retention of samples, including all provisions necessary to protect the integrity of samples.
The laboratory shall establish a record keeping system that allows the history of the sample and associated data to be readily understood through the documentation. This system shall produce unequivocal, accurate records that document all laboratory activities such as sample receipt, sample preparation, or data verification, and inter-laboratory transfers of samples and/or extracts.

29. Support Equipment
Daily check to NIST traceable reference removed; daily check still required

30. Record forms changed (Step 5)
Equipment
Personnel
Performance - DOC

31. 5.5.5 Equipment Records
Removed requirements for date received, placed in service and condition when received!!!
This was never in ISO/IEC

32. 5.6.4 Standards and Reagents
Expiration dates for original containers not required unless provided by manufacturer!!!
Expiration dates for prepared reagents and standards must be on container
NELAC allowed to be documented in quality manual or SOP
Reagents and standards cannot be used after expiration date
Surprisingly, this was not in NELAC

33. Analytical Records
NELAC and combined into one subsection listing information needed to reconstruct the analytical data
Some items from NELAC not specifically listed (e.g., archived SOPs), but still covered under the phrase “all information necessary.”

34. Personnel Requirements
Detailed NELAC requirements relating to personnel requirements deleted, but ISO appropriate education, training, experience and/or demonstrated skills maintains requirement

35. Personnel: Demonstration of Capability
NELAC and Appendix C
Not in Module 2
DOC is contained in Modules 3-7 and varies based on the scientific discipline
Note: Work Cells eliminated entirely

36. Personnel: Data Integrity
NELAC
TNI
Data Integrity Procedures
Data Integrity Training
Management requirements
4.16 Data Integrity Investigations
5.2.7 Data Integrity Training
Comparable language with equal intent

37. Method Performance TNI Section 1.6 – Technical modules
Prior to acceptance and institution of any method for which data will be reported, a satisfactory initial DOC is required.
Thereafter, ongoing DOC, such as laboratory control samples is required.

38. General
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.

39. Method DOC
The laboratory shall have records on file to demonstrate that a DOC is not required.
For the initial DOC, appropriate records as shall be completed.
An initial DOC shall be completed each time there is a change in instrument type, personnel, or method.

40. General All demonstrations shall be documented.
All data applicable to the demonstration shall be retained and readily available at the laboratory.

41. Initial DOC Prior to using method
Change in instrument type, personnel or method
If not performed by an analyst within 12 months

42. 1.6 On-going DOC Procedure needed
Analyst(s) demonstrates on-going capability
Meets QC requirements
Document other approaches to DOC if not per method, lab SOP, regulation, client specifications

43. M4 1.4 Method Selection
Allows the adding of analytes to reference method
Method must be identified as modified

44. M4 1.5 Method Validation Evaluation of Required for all methods:
LOD, if reporting to LOD
LOQ
Precision and bias
Selectivity (not required for reference methods)
Required for all methods:
Reference methods, non-reference methods, laboratory-developed methods, reference methods used outside their published scope, and amplifications and modifications of reference methods

45. M4 1.5.2 Limit of Detection Combination of NELAC C.3.1 and D.1.2.1
No changes to requirements
Determine using any procedure if data reported to LOD
Verify by analysis of QC sample
Verify annually or change in method

46. M4 1.5.2 Limit of Quantitation
Combination of NELAC C.3.2 and D.1.2.2
No changes to requirements
Determine using any documented procedure
Verify by analysis of QC sample
Verify annually or change in method
LOQ must be greater than LOD
Removed: “must have procedures to relate LOD to LOQ”

47. M4 1.6 Demonstration of Capability
4 replicates is one option, but not required
Form in NELAC Appendix C deleted, but requirements for documentation remain:
analyst(s);
b) matrix;
c) analyte(s);
d) identification of method(s) performed;
e) identification of laboratory-specific SOP;
f) date(s) of analysis; and
g) summary of analyses
Not required to be in personnel file

48. M4 1.6 On-going DOC Options from NELAC 5.5.2.6 still allowed:
Single-blind sample
Initial DOC
4 LCS
Another option added:
a documented process of analyst review using QC samples. QC samples can be reviewed to identify patterns for individuals or groups of analysts and determine if corrective action or retraining is necessary

49. M4 1.7 Calibration Initial Calibration Continuing Calibration
Comparable to NELAC
Low standard must be at or below LOQ
Minimum number of points changed to 3, but 0 appears to be allowed as a point
Continuing Calibration
Virtually identical to NELAC

50. M4 1.7 Quality Control Method Blank LCS MS/MSD MD Surrogates
No change from NELAC Appendix D.1
Reorganized with evaluation criteria as a separate section

51. Removed NELAC D.1.6 b Glassware cleaning and storage procedure
Cleaned to meet test sensitivity

52. M SAMPLE PRESERVATION
Thermal preservation not required if analysis begins within 15 minutes of collection or samples refrigerated within 15 minutes
Chlorine residual check requirement revised
Increased clarity and inten

53. M5 Chlorine Check
Samples from known chlorinated sources (such as wastewater effluent), unknown sources where chlorine usage is suspected (such a new client or a new source) and all potable water sources (including source water) shall be checked for absence of chlorine residual. Laboratories that receive samples from potable water sources (including source water) that have a demonstrated history of acceptable preservation may check a sample from each source at a frequency of once per month if:
the laboratory can show that the received sample containers are from their laboratory;
sufficient sodium thiosulfate was in each container before sample collection to neutralize at minimum 5 mg/l of chlorine for drinking water and 15 mg/l of chlorine forwastewater samples;
one container from each batch of laboratory prepared containers or lot of purchased ready-to-use containers is checked to ensure efficacy of the sodium thiosulfate to 5 mg/l chlorine or 15 mg/l chlorine as appropriate and the check is documented;
chlorine residual is checked in the field and actual concentration is documented with sample submission.

54. Proficiency Testing (Step 6)
Selection
Provider
Analytes
Process
Passing
Corrective Action

55. Selecting a PT Provider
Compare scope of provider’s accreditation to the PT samples you need in your laboratory
Select as you would any other vendor (Remember V1M2 – Section 4.6)
Are they accredited for all samples you require?
Does their schedule meet your need?
Are their reports adequate to meet your need?

56. Approved Providers www.A2LA.org
Absolute Standards
Environmental Resource Associates (ERA)
NYS DOH (New York accredited labs only)
NSI Solutions
Resource Technology Corporation (RTC)
Wibby Environmental

57. PT Program Requirements
Two PT samples per year per Field of Proficiency Testing (FoPT)
Six months apart
Not to exceed seven months apart
PTs by Matrix - Technology/Method - Analyte
Potable water (also called drinking water, WS)
Non-potable water (also called WP)
Solid and Chemical Materials (also called RCRA- Solid)
Uniform acceptance criteria
Pass two out of last three

58. Process
Labs contract directly with approved PT sample provider of their choice
Samples sent to lab
Results to PT Provider
Final report to State and to lab
Two PT samples per year/field of testing

59. Fields of Proficiency Testing
Established by TNI PT Board and adopted by NELAP Board
Matrices, analytes, concentration ranges, and acceptance limits
PT Reporting Limits (PTRLs)
Footnotes – read the footnotes they are important!
Published on TNI website

60. Organization of NELAC PT Tables
Drinking water
Wastewater
Solids
Radiochemistry
Whole Effluent Toxicity
If you run ANY analytes on these tables you must run two PT per year for each Field of Testing
Coming Soon:
Air and Emissions

61. Example of PT Sample Selection
Anaytes in Lab Scope
Lead
Mercury
Methylmercury
Benzene
Trifluralin
TCLP pH
Analytes in FoPT Tables
Lead
Mercury
Benzene pH
You do not need to PT test for methylmercury, trifluralin and TCLP!

62. Matrix - Technology/Method - Analyte
GFAA / – lead
ICPAES / – lead
ICPMS / – lead
GFAA / 7421 – lead
ICPMS / 6020 – lead
You may use one PT sample for multiple methods
How many PTs do you need for this scope?

63. Concentration Range
True Value of PT sample must be within the range specified
Multi-analyte organic samples may not contain all analytes:
<10: All analytes
10-20: At least 10, or 80%
>20: At least 16, or 60%
Important Note: Analytes not spiked have an assigned value of < PTRL!

64. 4.2 – Continued Accreditation
2 TNI compliant PTs per year
At least 5 and no more than 7 months apart
Corrective Action PTs must be analyzed at least 15 days apart.
Successfully analyze 2 of the last 3
Provision to obtain from non-accredited provider
Highly unlikely this will ever be used
Provision for experimental PTs

65. 5.2 Sample Reporting
Laboratories will report PT data based on their documented Limit of Quantitation (LOQ).
LOQ definition
Calibration curve: LOQ = low calibration point
Otherwise, LOQ = lab LOQ

66. LOQ REPORTING
This allows the laboratories to analyze and report the PT samples in the same manner as their normal samples.
Removes issue of reporting to the PTRL.
Report before closing date
Lab authorization to report data directly to primary AB
If the laboratory reports a < LOQ and the LOQ value is greater than the lower acceptance limit, the reported < LOQ is evaluated as ‘Acceptable”
Look for more guidance on this issue in 2010

67. EXAMPLE Assigned Value = 10 Acceptance limits = 5-10 Report
5 = Acceptable
4 = Not Acceptable
11 = Not Acceptable
< 7 = Acceptable
< 4.99 = Not Acceptable

68. Evaluating Results Analytes omitted are considered to be < PTRL.
False positives are graded as unacceptable if they are reported above the PTRL.
Only applicable for samples with 10 or more analytes (e.g., VOAs, Semivolatiles, Pesticides and Herbicides)
Some analytes may have other analytes as impurities
Example: Xylene may have 1% benzene
If xylene is at 100 ug/L, benzene would be 1 ug/L
Drinking water PTRL for benzene is 3 ug/L
PT Provider required to verify that benzene is not present above 3 ug/L
If benzene is detected by lab at 4 ug/L and reported, it would be a false positive and scored as “Not Acceptable”.
If benzene is detected by lab at 2 ug/L and reported, it would be scored as “Acceptable”, since it is less than the PTRL.

69. Analyses of PT Samples Must be analyzed like routine samples
Scheduled as normal samples
Diluted or prepared according to instructions
Analysis by “normal” chemist
No additional QC
No extra analyses
No sharing of data
Document any exceptions
Test only per technology not method, except drinking water
No sharing of PT samples between labs

70. Corrective Action Supplemental studies may be done
Must be different sample ID
Assigned value may not be 0. When ordering specify the analytes required.
At least 15 days apart from end of first study to shipment date for second study

71. Some states do not require a separate DMR QA sample.
NOT PART OF NELAP!
Same acceptance criteria
Once per year based on EPA schedule
Limited suite of analytes
NELAP studies usually DMRQA compliant
DMRQA studies may not be NELAP compliant
Some states do not require a separate DMR QA sample.

72. Training - Implementation (Step 7)
Review changes to TNI standard
Review changes made to documents/records
Don’t forget….
Annual ethics training
If needed
perform new DOC due to QC changes
Isn’t there always 7 ?

73. Troubling Sections Internal Audits Management Review
Corrective Action, Preventive Action
Data Review
Contract Review
Subcontracting
Purchasing
Document Control

74. Internal Audits Are you doing what you say you do?
How can we fill in the whole checklist – it takes too long?
Don’t do it all at once
Put together a schedule to cover it all
Problem areas first
Do a sampling and process review
Review SOPs and records – independent!
Don’t wait till the assessor tells you
Manage your own business

75. Management Review Do you have a business meeting?
Add quality to the the meeting and review the items in the standard.
Takes ½ day but must be done by management – or provider of the resources
Need to add improvement!

76. Actions Corrective and Preventive Why is this difficult?
How do you address problems?
How do you manage change? Or do you just let change happen?
Documenting how you solve problems demonstrates the technical competence of the organization and management’s commitment to quality.

77. Data Review Integrity Complete Correct to method Correct to client
How is this done efficiently, effectively?
How do you determine that your data review is acceptable?

78. Contract Review How do you know the method?
How do you handle changes to requests?
Does not require extreme process, but does require a record to ensure client has provided the needed information.

79. Subcontracting
Do you subcontract any work on your scope of accreditation?
Then you need process for:
Notifying client
Handling samples and data
Reporting results

80. Purchasing
How do you ensure the quality of the supplies and materials you purchase?
Where do you specify the quality?
How do you decide what to order?
How do you decide which vendor to select?

81. Document Control How do you manage your documents?
How to you communicate changes?
How do you ensure they are implemented?
Does staff understand importance?
If not, then staff will not implement
Keep process simple and easy to update
You will need to update –
Electronic systems simpliest

82. Management System Is management involved?
Does your laboratory react or prevent problems?
Does you laboratory control change or does change just happen?
What type of environment do you work in?

83. Questions ? ? ? ? ? ? ? ? ? ?