Quality Systems Expert Committee

1
The NELAC Institute (TNI) Laboratory Standards
for Quality Systems in Environmental Testing
Laboratories
Robert P. Di Rienzo Quality Assurance Manager ALS
Laboratory Group
Environmental Measurement SymposiumNEMC 2009
2
What is Consensus?
3
Consensus is a decision-making process that not
only seeks the agreement of most participants,
but also to resolve or mitigate the objections of
the minority to achieve the most agreeable
decision.
4
What is a Standard?
5
A standard is an established norm or requirement.
It is usually a formal document that establishes
uniform engineering or technical criteria,
methods, processes and practices.
6
TNI Quality Systems Expert Committee
Accreditation Bodies Aaren Alger, State of
Pennsylvania Laurie Carhart, State of New
York Michelle Potter, State of New Jersey
Accredited Laboratories Robin Cook, City of
Daytona Beach Robert Di Rienzo, DataChem
Laboratories Wilson Hershey, Lancaster
Laboratories Paul Junio, Test America
Other Silky Labie, State of Florida Fred
McLean, DoD Randy Querry, A2LA
7
How does a laboratory know what to do?
8
(No Transcript)
9
Will the laboratory every get it right?
10
(No Transcript)
11
The TNI Standards are based on the concept of
sectors, volumes, and modules.
Environmental Laboratory Sector
Volume 1 Management and Technical Requirements
for Laboratories Performing Environmental Analysis
Module 1 Proficiency TestingModule 2 Quality
Systems General Requirements Module 3 Quality
Systems for Asbestos Testing Module 4 Quality
Systems for Chemical Testing Module 5 Quality
Systems for Microbiological TestingModule 6
Quality Systems for Radiochemical TestingModule
7 Quality Systems for Toxicity Testing
12
The TNI Standards are based on the concept of
sectors, volumes, and modules.
Environmental Laboratory Sector
Volume 1 Management and Technical Requirements
for Laboratories Performing Environmental Analysis
Module 1 Proficiency Testing PT Testing
Requirements for Laboratories Module 2 Quality
Systems General Requirements Module 3
Asbestos Testing Module 4 Chemical Testing
Module 5 Microbiological TestingModule 6
Radiochemical TestingModule 7 Toxicity Testing
13
The TNI Standards are based on the concept of
sectors, volumes, and modules.
Environmental Laboratory Sector
Volume 1 Management and Technical Requirements
for Laboratories Performing Environmental Analysis
Module 2 Quality Systems General
Requirements A Quality System for all
laboratories
14
Volume 1 Environmental Laboratory
Sector Laboratories Requirements
Module 2 - Quality Systems General Requirements

• Format consistent with ISO 170252005

• Additional NELAC 2003 requirements follow
  applicable ISO sections

• Specific technical requirements in Modules 3
  to 7

15
Module 2 - Quality Systems General Requirements
1.0 INTRODUCTION, SCOPE AND APPLICABILITY Introd
uction and Scope 2.0 NORMATIVE
REFERENCES 3.0 TERMS AND DEFINITIONS Additional
Terms and Definitions, Definition Sources, and
Exclusions and Exceptions
16
Module 2 - Quality Systems General Requirements
4.0 MANAGEMENT REQUIREMENTS Organization,
Management, Document Control, Review of
Request, Tenders and Contracts, Subcontracting,
Purchasing Services and Supplies, Service to
the Client, Complaints, Control of
Nonconforming Work, Improvement, Corrective
Action, Preventive Action, Control of Records,
Internal Audits, Management Review, and Data
Integrity Surveillance
17
Module 2 - Quality Systems General Requirements
5.0 TECHNICAL REQUIREMENTS General, Personnel,
Accommodation and Environmental Conditions,
Environmental Test Methods and Method
Validation, Calibration Requirements,
Measurement Traceability, Collection of
Samples, Handling Samples and Test Items,
Quality Assurance for Environmental Testing,
and Reporting the Results
18
Module 2 - Quality Systems General Requirements
Example Section from Module 2 Non ISO version
4.14 Internal Audits (ISO/IEC 170252005(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.
19
Major Changes from NELAC 2003

• ISO 170252005 Changes
• Addition of section on Improvement (4.10)
• Management System Quality System
• Summary of ISO Changes is available.

20
Major Changes from NELAC 2003

• NELAC 2003 Reorganization
• All Technical Requirements moved to Technical
  Modules
• Elements of Quality Manual in section 4.2.8
• Calibration Requirements

21
Major Changes from NELAC 2003 The Quality Manual
4.2.8 Additional Management System
Requirements 4.2.8.3 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
22
Major Changes from NELAC 2003 The Quality Manual
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
23
Major Changes from NELAC 2003 The Quality Manual
g) the objectives of the quality system and
contain or reference the laboratorys policies
and procedures h) the laboratorys official
quality policy statement and managements
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.
24
Major Changes from NELAC 2003 The Quality Manual
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
25
Major Changes from NELAC 2003 The Quality Manual
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
26
Major Changes from NELAC 2003 The Quality Manual
g) job descriptions h) procedures for
traceability i) a list of all test
methods j) procedures for reviews all new
work k) procedures for handling samples
27
Major Changes from NELAC 2003 The Quality Manual
l) procedures for corrective action when
discrepancies are detected, or departures from
documented policies and procedures
occur m) policy for permitting departures
from documented policies and procedures n) pro
cedures for dealing with complaints
28
Major Changes from NELAC 2003 The Quality Manual
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.
29
Major Changes from NELAC 2003 Calibration
Requirements
5.5.13 Additional Requirements and Clarifications
Calibration requirements for analytical
support equipment are included in this Section
while requirements for instrument (testing)
calibration are included in technical modules
(i.e., Asbestos, Chemistry, Microbiology,
Radiochemistry and Toxicology).
30
Major Changes from NELAC 2003

• Additional Requirements
• NONE

• Significant Changes in Requirements
• No Arbitrary Expiration Dates
• Removes NELAC 2003 language and replaces with ISO
  170252005 language, where applicable

31
The TNI Standards are based on the concept of
sectors, volumes, and modules.
Environmental Laboratory Sector
Volume 1 Management and Technical Requirements
for Laboratories Performing Environmental Analysis
Module 1 Proficiency TestingModule 2 Quality
Systems General Requirements Module 3 Quality
Systems for Asbestos Testing Module 4 Quality
Systems for Chemical Testing Module 5 Quality
Systems for Microbiological TestingModule 6
Quality Systems for Radiochemical TestingModule
7 Quality Systems for Toxicity Testing
32
Volume 1 Environmental Laboratory
Sector Laboratories Requirements
Modules 3 to 7 Quality Systems for Asbestos,
Chemical, Microbiological, Radiochemical, and
Toxicological Testing

• Specific to Testing Activity

• Consistent Format and Structure in all
  Technical Modules

33
Major Changes from NELAC 2003

• NELAC 2003 Reorganization
• Combination of Requirements from NELAC 2003,
  Chapter 5 and Appendix C and D
• Format Consistent in all Technical Modules
• All Testing Requirement Related to Technology
• Support Equipment Requirements in Module 2

34
Major Changes from NELAC 2003

• Major Items
• Initial Demonstration of Capability and Ongoing
  Demonstration of Capability
• Technical Requirements include
• Calibration
• Quality Control
• Data Reduction
• Acceptance/Rejection Criteria
• Sample Handling

35
Modules 3 to 7 Quality Systems for Testing
_____________TESTING 1.1 Introduction 1.2
Scope 1.3 Terms and Definitions
36
Modules 3 to 7 Quality Systems for Testing
_____________TESTING 1.4 Method Selection 1.5
Method Validation Validation of Methods, Limit
of Detection and Limit of Quantitation,
Evaluation of Precisions and Bias, and
Evaluation of Selectivity
37
Modules 3 to 7 Quality Systems for Testing
_____________TESTING 1.6 Demonstration of
Capability (DOC) General, Initial DOC, and
Ongoing DOC 1.7 Technical Requirements Initial
Calibration, Continuing Calibration, Quality
Control for Chemistry, Data Reduction, Reagent
Quality, Water Quality and Checks, Data
Acceptance/Rejection Criteria, and Sample
Handling
38
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.
39
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.
40
Major Changes from 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.
41
Major Changes from 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.
42
Questions?
Robert P. Di Rienzo Quality Assurance Manager ALS
Laboratory Group, Environmental Division (Salt
Lake City, UT)
Bob.DiRienzo_at_alsenviro.com [phone]