CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
Asterisks (*) indicate sections where objective evidence is required.
Grey Boxes are unique TNI requirements and not required for accreditation only to ISO/IEC 17043.
TNI Requirements are based on TNI EL-V3-2009 – General Requirements for Environmental Proficiency Testing Providers
& TNI V1M1-2009 - General Requirements for Stationary Source Audit Sample Providers
4. Technical Requirements
4.1 General
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Requirements
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Compliant
Is the development and operation of proficiency testing schemes only
undertaken by proficiency testing providers having competence to conduct
interlaboratory comparisons and with the particular type of proficiency test
items?
Does the proficiency testing provider or subcontractors have competence in
the measurement of the properties being determined?
NOTE: ISO/IEC 17025 or ISO 15189 can be used to demonstrate the competence of a proficiency testing provider's laboratory, or the
laboratory subcontracted to perform tests or measurements related to the proficiency testing schemes.
ISO Guide 34 can be used to demonstrate the competence of producers of reference materials that provide proficiency test items.
4.2 Personnel
4.2.1
Requirements
Document
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Document
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Assessment Compliant
Document
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Assessment Compliant
Does the proficiency testing provider have managerial and technical personnel
with the necessary authority, resources and technical competence required to
perform their duties?
4.2.2
Requirements
Has the proficiency testing provider's management defined the minimum
levels of qualification and experience necessary for the key positions within its
organization and ensure those qualifications are met?
4.2.3
Requirements
Does the proficiency testing provider use personnel who are either employed
by, or under contract to it?
Where contracted and additional technical and key support personnel are used,
does the proficiency testing provider ensure that such personnel are supervised
and competent and that they work in accordance with the management system?
NOTE: Where technical experts are used on an ad-hoc basis or as part of an advisory or steering group (see 4.4.1.4), the existence of
formal agreements through, for example, group terms of reference or other means, can be considered to satisfy this requirement.
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
4.2.4
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Requirements
Assessment Compliant
Does the proficiency testing provider authorize specific personnel to:
a) select appropriate proficiency test items;
b) plan proficiency testing schemes;
c) perform particular types of sampling;
d) operate specific equipment;
e) conduct measurements to determine stability and homogeneity, as well as
assigned values and
associated uncertainties of the measurands of the proficiency test item;
f) prepare, handle and distribute proficiency test items;
g) operate the data processing system;
h) conduct statistical analysis;
i) evaluate the performance of proficiency testing participants;
j) give opinions and interpretations; and
k) authorize the issue of proficiency testing reports?
4.2.5
Requirements
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Assessment Compliant
Document
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Assessment Compliant
Does the proficiency testing provider maintain up-to-date records of the
relevant authorization(s), competence, educational and professional
qualifications, training, skills and experience of all technical personnel,
including contracted personnel?
Is this information readily available and include the date on which competence
to perform their assigned tasks was assessed and confirmed?
4.2.6
Requirements
Does the proficiency testing provider formulate the objectives with respect to
the education, training, and skills for each staff member involved with the
operation of the proficiency testing scheme?
Does the proficiency testing provider have a policy and procedures for
identifying training needs and providing training of personnel?
Is the training program relevant to the present and anticipated needs of the
proficiency testing provider?
NOTE: It is advisable to consider the need to retrain staff periodically. Staff training policies can take account of technological
change, the need to demonstrate ongoing competence and aim at continual skills upgrading.
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
4.2.7
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
Document
Review
Assessment Compliant
Does the proficiency testing provider ensure that the staff receives the
necessary training to ensure competent performance of measurements,
operation of equipment and any other activities which affect the quality of the
proficiency testing scheme?
Is the effectiveness of training activities evaluated?
NOTE: Objective measures can be used to assess the attainment of competence.
4.3 Accommodation and environment
4.3.1
Requirements
Does the proficiency testing provider ensure that there is appropriate
accommodation for the operation of the proficiency testing scheme?
Does this include facilities and equipment for proficiency test item
manufacturing, handling, calibration, testing, storage and dispatch, for data
processing, for communications, and for retrieval of materials and records?
4.3.2
Requirements
Does the proficiency testing provider ensure that the environmental conditions
do not compromise the proficiency testing scheme or the required quality of
operations?
Is particular care taken when operations are undertaken at sites away from the
proficiency testing provider's permanent facilities or are undertaken by
subcontractors?
Are the technical requirements for accommodation and environmental
conditions that can affect the proficiency testing documented?
4.3.3
Requirements
Are access to and use of areas affecting the quality of proficiency testing
schemes controlled?
Does the proficiency testing provider determine the extent of control based on
its particular circumstances?
4.3.4
Requirements
Does the proficiency testing provider identify environmental conditions that
can significantly influence the quality of the proficiency test items and any
testing and calibration carried out, including conditions that are required by
relevant specifications and measurement procedures?
Does the proficiency testing provider control and monitor these conditions,
and record all relevant monitoring activities?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
Are relevant proficiency testing activities stopped when the environmental
conditions jeopardize the quality or the operations of the proficiency testing
scheme?
NOTE: Conditions can include, for example, biological sterility, dust, electromagnetic disturbances, radiation, humidity, electrical
supply, temperature, and sound and vibrations levels, as appropriate to the technical activities concerned.
4.3.5
Requirements
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Document
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Is there effective separation between neighboring areas in which there are
incompatible activities?
Is action taken to prevent cross-contamination?
4.3.6
Requirements
Does the proficiency testing provider ensure that performance characteristics
of laboratory methods and equipment used to confirm the content,
homogeneity and stability of proficiency testing items are appropriately
validated and maintained?
*
4.4 Design of proficiency testing schemes
4.4.1 Planning
4.4.1.1
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Requirements
Assessment Compliant
Does the proficiency testing provider identify and plan those processes which
directly affect the quality of the proficiency testing scheme and ensure that
they are carried out in accordance with prescribed procedures?
NOTE: Stakeholders' interests can be considered in developing a plan and relevant information.
4.4.1.2
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Requirements
Assessment Compliant
Is there evidence that the proficiency test provider does not subcontract the
planning of the proficiency testing scheme (see 5.5.2)?
NOTE: The proficiency testing provider can utilize advice or assistance from any advisors, experts or steering group (see 4.4.1.4).
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
4.4.1.3
Document
Review
Requirements
Does the proficiency testing provider document a plan before commencement of
the proficiency testing scheme that addresses the objectives, purpose and basic
design of the proficiency testing scheme, including the following information
and, where appropriate, reasons for its selection or exclusion:
a) the name and address of the proficiency testing provider;
Assessment Compliant
*
b) the name, address, and affiliation of the coordinator and other personnel
involved in the design and operation of the proficiency testing scheme;
c) the activities to be subcontracted and the names and addresses of
subcontractors involved in the operation of the proficiency testing scheme;
d) criteria to be met for participation;
e) the number and type of expected participants in the proficiency testing scheme;
f) selection of the measurand(s) or characteristic(s) of interest, including
information on what the participants are to identify, measure, or test for in the
specific proficiency testing round;
g) a description of the range of values or characteristics, or both, to be expected
for the proficiency test items;
h) the potential major sources of errors involved in the area of proficiency testing
offered;
i) requirements for the production, quality control, storage and distribution of
proficiency test items;
j) reasonable precautions to prevent collusion between participants or falsification
of results, and procedures to be employed if collusion or falsification of results is
suspected;
k) a description of the information which is to be supplied to participants and the
time schedule for the various phases of the proficiency testing scheme;
l) for continuous proficiency testing schemes, the frequency or dates upon which
proficiency test items are to be distributed to participants, the deadlines for the
return of results by participants and, where appropriate, the dates on which testing
or measurement is to be carried out by participants;
m) any information on methods or procedures which participants need to use to
prepare the test material and perform the tests or measurements;
n) procedures for the test or measurement methods to be used for the
homogeneity and stability testing of proficiency test items and, where applicable,
to determine their biological viability;
o) preparation of any standardized reporting formats to be used by participants;
p) a detailed description of the statistical analysis to be used;
q) the origin, metrological traceability and measurement uncertainty of any
assigned values;
r) criteria for the evaluation of performance of participants;
s) a description of the data, interim reports or information to be returned to
participants;
t) a description of the extent to which participant results, and the conclusions that
will be based on the outcome of the proficiency testing scheme, are to be made
public; and
u) actions to be taken in the case of lost or damaged proficiency test items?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
4.4.1.4
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
Does the proficiency testing provider have access to the necessary technical
expertise and experience in the relevant field of testing, calibration, sampling
or inspection, as well as statistics? Is this achieved by establishing an
advisory group (named as appropriate)?
4.4.1.5
Requirements
Is technical expertise used, as appropriate, to determine matters such as the
following:
a) planning requirements as listed in 4.4.1.3;
b) identification and resolution of any difficulties expected in the preparation
and maintenance of homogeneous proficiency test items, or in the provision of
a stable assigned value for a proficiency test item;
c) preparation of detailed instructions for participants;
d) comments on any technical difficulties or other remarks raised by
participants in previous proficiency testing rounds;
e) provision of advice in evaluating the performance of participants;
f) comments on the results and performance of participants as a whole and,
where appropriate, groups of participants or individual participants;
g) provision of advice for participants (within limits of confidentiality), either
individually or within the report;
h) responding to feedback from participants; and
i) planning or participating in technical meetings with participants?
4.4.2 Preparation of proficiency test items
4.4.2.1
Requirements
Does the proficiency testing provider establish and implement procedures to
ensure that proficiency test items are prepared in accordance with the plan
described in 4.4.1?
*
NOTE: It is advisable that the proficiency testing provider give due consideration to the preparation of sufficient numbers of
proficiency test items, in order to allow for the need to replace any such proficiency test items lost or damaged during distribution, or
intended to be provided for use after the results of the proficiency testing scheme have been evaluated. Such uses can include training
aids for participants or use as a reference material.
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
4.4.2.2
Document
Review
Requirements
Does the proficiency testing provider establish and implement procedures to
ensure appropriate acquisition, collection, preparation, handling, storage and,
where required, disposal of all proficiency test items?
Do the procedures ensure that materials used to manufacture proficiency test
items are obtained in accordance with relevant regulatory and ethical
requirements?
Assessment Compliant
*
4.4.2.3
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Do proficiency test items match in terms of matrix, measurands and
concentrations, as closely as practicable, the type of items or materials
encountered in routine testing or calibration?
4.4.2.4
Requirements
In proficiency testing schemes that require participants to prepare or
manipulate, or both prepare and manipulate, the proficiency test item and
submit it to the proficiency testing provider, does the proficiency testing
provider issue instructions for preparation, packaging and transport of the
proficiency test item?
*
TNI 6.1 Design Review (TNI specific requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
Does the PT provider demonstrate to the satisfaction of the PTPA that their PT
sample designs and manufacturing processes:
a) permit proficient laboratories, conforming to the calibration and quality
control requirements of the analytical method(s) for which the sample was
designed, to generate results that fall within the PT sample acceptance limits
defined in the TNI Fields of Proficiency Testing Tables;
b) provide equivalent challenge to all participant laboratories; and
c) result in laboratory pass/fail rates that are consistent with historical norms?
TNI 6.2 Sample Matrices (TNI specific requirement)
Requirements
TNI 6.2.1 Do matrices of all PT samples, to the extent possible, resemble the
matrices which participant laboratories routinely analyze?
Requirements
TNI 6.2.2 Are matrix for soil PT samples well-characterized natural soil and not
contain greater than 90% sand by mass?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
TNI 6.3 Sample Analytes (TNI specific requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
Document
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Document
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Document
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Document
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Assessment Compliant
6.3.1 Does the PT provider prepare samples that are compliant with the criteria
defined by the PT Board and published in the TNI FoPT Tables on the TNI
website?
Requirements
TNI 6.3.2 When the PT Board makes changes to the PT sample design criteria,
does the PT provider comply with the revised requirements per the PT Board’s
implementation schedule?
Requirements
TNI 6.3.3 For those multi-analyte categories designated in the TNI FoPT tables
as not requiring all analytes to be spiked, does the PT Provider determine the
number of analytes based on the following?
a) PT samples that are to be scored for one (1) to ten (10) analytes shall include
all of the analytes;
b) PT samples that are to be scored for ten (10) to twenty (20) analytes shall
include at least ten (10) analytes or 80% of the total, whichever number is
greater;
c) PT samples that are to be scored for more than twenty (20) analytes shall
include at least sixteen (16) analytes, or 60% of the total analytes, whichever
number is greater;
d) If following TNI 6.3.3.b) or TNI 6.3.3.c) above and the calculated percentage
of the total number of analytes in the PT sample is a fraction, the fraction shall
be rounded up to the next whole number?
Requirements
TNI 6.3.4 Does the PT provider use a random-selection process to determine
which analytes will be spiked and unspiked within any given PT sample?
Requirements
TNI 6.3.4.1 Does the PT provider make modifications to randomly-selected
analyte lists based on technical (i.e. compatibility, interference) issues?
Requirements
TNI 6.3.4.2 Are modifications to randomly-determined analyte lists
documented?
Requirements
TNI 6.3.5 Are the assigned value for unspiked analytes set to <PTRL?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
TNI 6.3.6 If the provider spikes analytes not on the TNI FoPT Tables in their
PT samples, does the PT provider ensure, to the satisfaction of the PTPA, that
these additional analytes do not interfere with laboratory performance for the
required analytes? Does the PT provider ensure additional analytes do not count
toward the minimum analyte requirements of Section 6.3.3?
4.4.3 Homogeneity and stability testing
4.4.3.1
Requirements
Are the criteria for suitable homogeneity and stability established and based on
the effect that inhomogeneity and instability will have on the evaluation of the
participants' performance?
*
NOTE 1: The requirements in this sub clause are intended to ensure that every participant receives comparable proficiency test items,
and that these proficiency test items remain stable throughout the proficiency testing. Careful planning, manufacture and shipping are
necessary to achieve this, and testing is usually needed to confirm it.
NOTE 2: In some cases, it is not feasible for proficiency test items to be subjected to homogeneity and stability testing. Such cases
would include, for example, when limited material is available to prepare proficiency testing items.
NOTE 3: In some cases, materials that are not sufficiently homogeneous or stable are the best available; in such cases, they can still be
useful as proficiency test items, provided that the uncertainties of the assigned values or the evaluation of results take due account of
this (see B.3.1.3 and ISO 13528:2005, Annex B).
NOTE 4: Considerations for homogeneity and stability are further discussed in ISO Guide 34, ISO Guide 35 and ISO 13528.
4.4.3.2
Document
Review
Requirements
Are the procedures for the assessment of homogeneity and stability documented
and conducted, where applicable, in accordance with appropriate statistical
designs?
Where possible, does the proficiency testing provider use a statistically random
selection of a representative number of proficiency test items from the whole
batch of test material in order to assess the homogeneity of the material?
Assessment Compliant
*
NOTE: In some cases, the use of a random stratified or systematic selection of proficiency test items from the whole batch is more
appropriate.
4.4.3.3
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Review
Requirements
Assessment Compliant
Is the assessment of homogeneity normally performed after the proficiency test
items have been packaged in the final form and before distribution to
participants unless, for example, stability studies indicate that they should be
stored in bulk form?
NOTE 1: Homogeneity can be demonstrated prior to packaging where no influence of packaging is reasonably expected.
NOTE 2: On some occasions, homogeneity testing cannot be carried out prior to distribution for practical, technical or logistical
reasons.
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
4.4.3.4
Document
Review
Requirements
Are proficiency test items demonstrated to be sufficiently stable to ensure that
they will not undergo any significant change throughout the conduct of the
proficiency testing, including storage and transport conditions?
Assessment Compliant
*
When this is not possible, is the stability quantified and considered as an
additional component of the measurement uncertainty associated with the
assigned value of the proficiency test item, and/or taken into account in the
evaluation criteria?
4.4.3.5
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
When proficiency test items from previous rounds are retained for future use,
are the property values to be determined in the proficiency testing scheme
confirmed by the proficiency testing provider prior to distribution?
4.4.3.6
Requirements
In circumstances where homogeneity and stability testing is not feasible, does
the proficiency testing provider demonstrate that the procedures used to collect,
produce, package and distribute the proficiency test items are sufficient for the
purpose of the proficiency testing?
TNI 7.2 Homogeneity Testing (TNI specific requirement)
Requirements
TNI 7.2.1 Does the PT provider analytically verify that all analytes in all PT
samples within a packaging event are sufficiently homogenous prior to their use
in a PT study?
Requirements
TNI 7.2.2 Is homogeneity verified using the procedure described in Appendix A
or a procedure with an equivalent ability, as determined by the PTPA, to verify
that differences between samples will not impact the laboratory evaluations?
Requirements
TNI 7.2.3 Is homogeneity testing performed on a representative selection of
samples randomly selected from each final packaged PT sample batch prior to
shipment to participant laboratories?
Requirements
TNI 7.2.4 Are PT samples which fail to meet the requirements of this Section
not be used in a PT study?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
TNI 7.3 Stability Testing (TNI specific requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
TNI 7.3.1 Does the PT provider verify, after the closing date of the PT study but
prior to the issuance of final reports, that all analytes in all PT samples remained
stable during the course of the study?
Requirements
TNI 7.3.2 Does the PT provider retain samples of the original PT study material
until the close of the study for use in post-study analytical verification?
Requirements
TNI 7.3.3 Is the PT sample stability assessments based on analytical data
comparing the mean of a series of random samples analytically tested before the
start of a study to the mean of a series of random samples analytically tested
after the study close date?
If the difference between the two means cannot be shown to affect an
evaluation, is the analyte considered stable for the study period?
Requirements
TNI 7.3.4 Does the PT provider use a stability verification procedure approved
of by the PTPA?
Requirements
TNI 7.3.5 Does post-study stability verification include ensuring that unspiked
analytes are still below one-half the PTRL?
Requirements
TNI 7.3.6 Are PT samples or analytes which fail to meet the criteria of this
Section invalidated in the PT study and described in the study discussion report?
TNI 7.4 Verification, Homogeneity and Stability Testing Reporting (TNI specific requirement)
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Requirements
Assessment Compliant
TNI 7.4.1 Upon request, and only after the issuance of final evaluation reports,
does the PT provider release to a designated participant-laboratory
representative the results of the provider’s assigned value verification,
homogeneity, and stability testing for any PT sample that the laboratory has
reported data for?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
TNI 7.4.2 Upon request, and only after the issuance of final evaluation reports,
does the PT provider release to laboratory accreditation bodies the results of the
provider’s assigned value verification, homogeneity, and stability testing for any
PT sample/analyte for which results were submitted to that laboratory
accreditation body?
Requirements
TNI 7.4.3 Upon request and only after the issuance of final evaluation reports,
does the PT provider release to the PT Board the results of the provider’s
assigned value verification, homogeneity, and stability testing for any PT study
sample/analyte?
Requirements
TNI 7.4.4 Does the PT provider supply to their PTPA the results of the PT
provider’s assigned value verification, homogeneity and stability testing for all
PT samples/analytes included in each PT study?
Requirements
TNI 7.4.5 Does the PT provider follow the format and schedule for submittal of
this data as provided by the PTPA?
Requirements
V3 Appendix A.1 Does the PT Provider, in order to satisfy the requirements for
the repeatability of test methods used to validate PT samples, determine the
repeatability at two or more levels?
4.4.4 Statistical design
4.4.4.1
Requirements
Are statistical designs developed to meet the objectives of the scheme, based on
the nature of the data (quantitative or qualitative, including ordinal and
categorical), statistical assumptions, the nature of errors, and the expected
number of results (see B.3.2.2)?
*
NOTE 1: Statistical design covers the process of planning, collection, analysis and reporting of the proficiency testing scheme data.
Statistical designs are often based on stated objectives for the proficiency testing scheme, such as detection of certain types of errors
with specified power or determination of assigned values with specified measurement uncertainty.
NOTE 2: Data analysis methods could vary from the very simple (e.g. descriptive statistics) to the complex, using statistical models
with probabilistic assumptions or combinations of results for different proficiency test items.
NOTE 3: In cases where the proficiency testing scheme design is mandated by a specification given by, for example, a customer,
regulatory authority or accreditation body, the statistical design and data analysis methods can be taken directly from the specification.
NOTE 4: In the absence of reliable information needed to produce a statistical design, a preliminary interlaboratory comparison can be
used.
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
4.4.4.2
Document
Review
Requirements
Does the proficiency testing provider document the statistical design and data
analysis methods to be used to identify the assigned value and evaluate
participant results, and provide a description of the reasons for their selection
and assumptions upon which they are based?
Is the proficiency testing provider able to demonstrate that statistical
assumptions are reasonable and that statistical analyzes are carried out in
accordance with prescribed procedures?
Assessment Compliant
*
*
4.4.4.3
Document
Review
Requirements
Assessment Compliant
In designing a statistical analysis, does the proficiency testing provider give
careful consideration to the following:
a) the accuracy (trueness and precision) as well as the measurement uncertainty
required or expected for each measurand or characteristic in the proficiency
testing;
b) the minimum number of participants in the proficiency testing scheme
needed to meet the objectives of the statistical design; in cases where there is an
insufficient number of participants to meet these objectives or to produce
statistically meaningful analysis of results, Does the proficiency testing provider
document, and provide to participants, details of the alternative approaches used
to assess participant performance;
c) the relevance of significant figures to the reported result, including the
number of decimal places;
d) the number of proficiency test items to be tested or measured and the number
of repeat tests, calibrations or measurements to be conducted on each
proficiency test item or for each determination;
e) the procedures used to establish the standard deviation for proficiency
assessment or other evaluation criteria;
f) procedures to be used to identify or handle outliers, or both;
*
g) where relevant, the procedures for the evaluation of values excluded from
statistical analysis; and
h) where appropriate, the objectives to be met for the design and the frequency
of proficiency testing rounds?
*
*
*
4.4.5 Assigned values
4.4.5.1
Document
Review
Requirements
Does the proficiency testing provider document the procedure for determining
the assigned values for the measurands or characteristics in a particular
proficiency testing scheme?
Does this procedure take into account the metrological traceability and
measurement uncertainty required to demonstrate that the proficiency testing
scheme is fit for its purpose?
ACLASS Form 38
PT Provider Accreditation Checklist
Assessment Compliant
*
*
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
TNI 5.1.4 Do the testing facilities used to support the verification, homogeneity
and stability testing required in this Standard meet the requirements of ISO
17025 (General Requirements for the Competency of Testing and Calibration
Laboratories)?
NOTE: Metrological traceability is not always possible or appropriate.
4.4.5.2
Requirements
Do proficiency testing schemes in the area of calibration have assigned values
with metrological traceability, including measurement uncertainty?
*
4.4.5.3
Document
Review
Requirements
Assessment Compliant
For proficiency testing schemes in areas other than calibration, are the
relevance, needs and feasibility for metrological traceability and associated
measurement uncertainty of the assigned value determined by taking into
account specified requirements of participants or other interested parties, or by
the design of the proficiency testing scheme?
NOTE: The required metrological traceability chain can differ depending on the type of proficiency test item, the measurand or
characteristic, and the availability of traceable calibrations and reference materials.
4.4.5.4
Document
Review
Requirements
When a consensus value is used as the assigned value (see Annex B), does the
proficiency testing provider document the reason for that selection and estimate
the uncertainty of the assigned value as described in the plan for the proficiency
testing scheme?
Assessment Compliant
*
4.4.5.5
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the proficiency testing provider have a policy regarding the disclosure of
assigned values?
Does the policy ensure that participants cannot gain advantage from early
disclosure?
TNI 6.4 Assigned Values (TNI specific requirement)
Requirements
TNI 6.4.1 Does the PT provider use a random process to determine the target
assigned values for their PT samples?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
Requirements
Document
Review
Assessment Compliant
Document
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Assessment Compliant
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Assessment Compliant
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TNI 6.4.1.1 Does the PT provider make modifications to randomly-selected
assigned values based on technical (i.e., solubility, compatibility, interference)
issues?
Requirements
TNI 6.4.1.2 Are any modifications to randomly-selected assigned values
documented?
Requirements
TNI 6.4.2 Are assigned values for aqueous, non-microbiological analytes that
are measured (chemical concentrations, isotope activities, etc.):
a) equal to the made-to values of the analytes based on gravimetric and
volumetric measurements of a starting material of known concentration, and
b) presented as three (3) significant figures?
Requirements
TNI 6.4.3 Are assigned values for quantitative microbiology analytes:
a) equal to the mean of the assigned value verification and/or homogeneity
testing conducted per Sections 7.1 and 7.2, and
b) presented as a whole number with no more than three (3) significant figures?
Requirements
TNI 6.4.4 Are assigned values for solid and chemical matrix analytes:
a) equal to the natural (background) concentration as analytically determined by
the PT provider, plus the made-to concentrations of any spiked analytes based
on gravimetric and volumetric measurements of a starting material of known
concentration and
b) presented as three significant figures?
Requirements
TNI 6.4.5 Are assigned values for qualitative analytes represented as “Present”
or “Absent”?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
TNI 7.0 PT SAMPLE TESTING
TNI 7.1 Verification of Assigned Value (TNI specific requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
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Assessment Compliant
TNI 7.1.1 Does the PT provider analytically verify the assigned value of all
analytes in all PT samples prior to use in a PT study.
Requirements
TNI 7.1.2 Does the PT provider verify the assigned value by direct analysis
against a calibration standard made from, or traceable to, a primary reference
material (e.g. National Institute of Standards and Technology (NIST), United
States Pharmacopeia (USP), etc) if available?
Requirements
TNI 7.1.3 If a primary reference material is not available, is verification
performed against an independently prepared calibration material?
Requirements
TNI 7.1.4 Does the assigned value verification analytical event also include the
analysis of a second source reference material from a source independent of the
calibration standard and the PT sample being verified?
Requirements
TNI 7.1.5 Does the PT provider have documented criteria for the acceptance of
the results of the second source reference material?
Requirements
TNI 7.1.6 Does the analytical method used by the PT provider for assigned
value verification have a repeatability relative standard deviation of not more
than one-sixth of the acceptance limits for the participant laboratories?
Requirements
TNI 7.1.7 Is the relative standard deviation of the provider’s verification method
established by a method validation study for each method and instrument?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
TNI 7.1.8 For aqueous chemistry analytes, is the assigned value of an analyte
verified if the mean of the provider’s verification analyses is within one-third of
the laboratory acceptance limits, to a maximum of 10%, as calculated per
Section 10.2, of either:
a) the assigned value, if an unbiased verification method is used; or
b) the expected mean value for the analyte, if a biased method is used?
Requirements
TNI 7.1.9 For solid matrix and microbiology analytes, is the assigned value of
an analyte is verified if the mean of the provider’s verification analyses is within
one-half of the laboratory acceptance limits, as calculated per Section 10.2, of
either:
a) the assigned value, if an unbiased verification method is used; or
b) the expected mean value for the analyte, if a biased method is used?
Requirements
TNI 7.1.10 Is the standard deviation of the verification analyses less than one
standard deviation as calculated for the participant laboratories?
Requirements
TNI 7.1.11 Are all unspiked analytes analytically verified to ensure that they are
not present at or above one-half the PTRL?
Requirements
TNI 7.1.12 Is any PT sample that fails to meet the requirements of this Section
not be used in a PT study?
4.5 Choice of method or procedure
4.5.1
Requirements
Are participants normally expected to use the test method, calibration or
measurement procedure of their choice, which should be consistent with their
routine procedures?
Does the proficiency testing provider instruct participants to use a specified
method in accordance with the design of the proficiency testing scheme?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
4.5.2
Requirements
Document
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Where participants are permitted to use a method of their choice, does the
proficiency testing provider:
a) have a policy and follow a procedure regarding comparison of results
obtained by different test or measurement methods;
*
b) be aware of which different test or measurement methods for any measurand
are technically equivalent, and take steps to assess participants' results using
these methods accordingly?
*
4.6 Conduct of proficiency testing schemes
4.6.1 Instructions to participants
4.6.1.1
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the proficiency testing provider give participants sufficient prior notice
before sending proficiency test items, providing the date on which the
proficiency test items are likely to arrive or to be dispatched, unless the design
of the proficiency testing scheme makes it inappropriate to do so?
4.6.1.2
Requirements
Does the proficiency testing provider give detailed documented instructions to
all participants? Do instructions to participants include:
a) the necessity to treat proficiency test items in the same manner as the
majority of routinely tested samples (unless there are particular requirements of
the proficiency testing scheme which require departure from this principle);
b) details of factors which could influence the testing or calibration of the
proficiency test items, e.g. the nature of the proficiency test items, conditions of
storage, whether the proficiency testing scheme is limited to selected test
methods, and the timing of the testing or measurement;
c) detailed procedure for preparing or conditioning, or both preparing and
conditioning, of the proficiency test items before conducting the tests or
calibrations;
d) any appropriate instructions on handling the proficiency test items, including
any safety requirements;
e) any specific environmental conditions for the participant to conduct tests or
calibrations, or both, and, if relevant, any requirement for the participants to
report relevant environmental conditions during the time of the measurement;
f) specific and detailed instructions on the manner of recording and reporting
test or measurement results and associated uncertainties. If the instructions
include reporting of the uncertainty of the reported result or measurement, does
it include the coverage factor and, whenever practicable, the coverage
probability;
g) the latest date for the provider to receive the proficiency testing or
measurement results for analysis;
ACLASS Form 38
PT Provider Accreditation Checklist
*
*
*
*
*
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
h) information on the contact details of the proficiency testing provider for
enquiries; and
i) instructions on return of the proficiency test items, when applicable?
*
NOTE: This instruction usually includes parameters such as the units of measurement, the number of significant figures or decimal
places and reporting basis (e.g. on dry weight, or “as received”).
TNI 8.1 Study Duration (TNI specific requirement)
Requirements
Document
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Document
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Document
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Is the study closing date no more than forty-five (45) calendar days after the
opening date of the study or as specified by the PT Board?
Is the study closing date for the Whole Effluent Toxicity fields of proficiency
testing, for non DMR-QA Studies no more than ninety (90) calendar days after
the opening date of the study?
For DMR-QA Studies, is the laboratory required to meet the time frames as
stated in the Announcement letter?
TNI 8.2 Study Instructions (TNI specific requirement)
Requirements
TNI 8.2.1 Does the PT provider provide instructions to each participant
describing:
a) how to dilute or otherwise prepare the PT samples;
b) how to report their data to the PT provider;
c) the close date of the PT study; and
d) a warning that the TNI standard requires PT samples to be analyzed like
“real” samples utilizing the same analysts, methods, and quality control
procedures?
Requirements
TNI 8.2.2 Does the PT provider not:
a) provide inappropriate assistance to the participant laboratories nor encourage
the non-routine analysis of PT samples;
b) suggest or direct laboratories to use additional quality control samples or
quality control samples designed specifically for a given PT sample, in
conjunction with any PT study;
c) provide excessive volume of any PT sample that may encourage multiple,
non-routine analyses?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
4.6.2 Proficiency test items handling and storage
4.6.2.1
Document
Review
Requirements
Does the proficiency testing provider ensure that proficiency test items are
appropriately identified and segregated and cannot become contaminated or
degraded, from the time of preparation to their distribution to participants?
Assessment Compliant
*
4.6.2.2
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
Does the proficiency testing provider provide secure storage areas or stock
rooms, or both, which prevent damage or deterioration of any proficiency test
item between preparation and distribution?
Are appropriate procedures for authorizing dispatch to, and receipt from, such
areas defined?
4.6.2.3
Requirements
When appropriate, is the condition of stored or stocked proficiency test items,
chemicals and materials assessed at specified intervals during their storage life
in order to detect possible deterioration?
4.6.2.4
Requirements
Where potentially hazardous proficiency test items, chemicals and materials are
used, are facilities available to ensure their safe handling, decontamination and
disposal?
*
4.6.3 Packaging, labeling and distribution of proficiency test items
4.6.3.1
Document
Review
Requirements
Does the proficiency testing provider control packaging and labeling processes
to the extent necessary to ensure conformity with relevant national, regional, or
international safety and transport requirements?
Assessment Compliant
*
NOTE: The proper distribution of proficiency test items can present severe problems for some types of material, e.g. those which
require uninterrupted storage in cold conditions or which should not be exposed to X-rays, shock or vibration. Most types of chemical
materials would benefit from air-tight packaging to avoid contamination by atmospheric contaminants, e.g. fuel vapors or engine
exhaust gases which can be encountered during transport.
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
4.6.2.3
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the proficiency testing provider specify relevant environmental conditions
for the transport of proficiency test items?
Where relevant, does the proficiency testing provider monitor the pertinent
environmental conditions of the proficiency test item during transport and
assess the impact of environmental influences on the proficiency test item?
4.6.3.3
Requirements
In proficiency testing schemes where participants are required to transport the
proficiency test items to other participants, are documented instructions for this
transport supplied?
*
4.6.3.4
Requirements
Document
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Document
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Does the proficiency testing provider ensure that labels are securely attached to
the packaging of individual proficiency test items and are designed to remain
legible and intact throughout the proficiency testing round?
4.6.3.5
Requirements
Does the proficiency testing provider follow a procedure to enable the
confirmation of delivery of the proficiency test items?
*
NOTE: This could be achieved in accordance with 4.6.1.1 by asking participants to inform the proficiency testing provider if
proficiency test items have not been received in line with the schedule of dates provided.
TNI 8.3 Regularly Scheduled PT Studies (TNI specific requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
TNI 8.3.1 Do regularly scheduled PT studies consist of PT sample lots (or
batches) that have not been provided, in any form or by any entity, to actual or
potential participant laboratories prior to the opening date of the study?
Requirements
TNI 8.3.2 Is it assured that the assigned values for regularly scheduled PT
samples are not be released to any entity outside of the PT provider, other than
the provider’s PTPA, prior to the closing date of the PT study?
TNI 8.4 Supplemental PT Studies TNI specific requirement
Requirements
TNI 8.4.1 For supplemental PT samples, does the PT provider:
a) select a batch of PT samples that has been shown to meet all of the
requirements of Sections 6 and 7 of this Volume;
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
b) conduct stability testing at the close of the supplemental PT study or have
data showing, to the satisfaction of the PTPA, that the sample was stable during
the time period of the supplemental study;
c) have documented procedures and systems in place to track all lots and
assigned values of samples received by laboratories that may be used as
supplemental PT samples ;
d) not supply a supplemental PT sample to a laboratory that has received that
sample in a previous PT study, or in any other form, or has had access to the
assigned values for that sample;
e) remove the original lot number, study number, and/or tracking ID number of
each supplemental PT sample and assign a unique identifier?
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
TNI 8.4.2 If the laboratory informs the PT provider that a supplemental PT
sample is being used for corrective action purposes for a specific quantitative
analyte or analytes, does the PT provider supply a supplemental PT sample that
contains the specified analyte(s) spiked into the sample [i.e. the sample does not
have an assigned value of zero or <PTRL for the laboratory-specified
analyte(s)]?
Requirements
TNI 8.4.3 If the laboratory informs the PT provider that a supplemental PT
sample is being used for corrective action purposes for a specific qualitative
presence/absence) test, whether the analyte of interest is spiked into the sample,
is the spiking randomly determined by the PT provider so that the laboratory
will not automatically know that it is present or not?
Requirements
TNI 8.4.4 Is the closing date of a supplemental PT study the date that the
participant(s) has reported study data for the required analytes?
Requirements
TNI 8.4.5 Is the closing date of supplemental PT studies no more than forty-five
(45) days after the opening date of the study?
4.7 Data analysis and evaluation of proficiency testing scheme results
4.7.1 Data analysis and records
4.7.1.1
Requirements
Is all data processing equipment and software validated in accordance with
procedures before being brought into use?
Does computer system maintenance include a back-up process and system
recovery plan?
Are the results of such maintenance and operational checks recorded?
ACLASS Form 38
PT Provider Accreditation Checklist
*
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
4.7.1.2
Document
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Requirements
Are results received from participants recorded and analyzed by appropriate
methods?
Are procedures established and implemented to check the validity of data entry,
data transfer, statistical analysis, and reporting?
4.7.1.3
Requirements
Assessment Compliant
*
*
Document
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Does data analysis generate summary statistics and performance statistics, and
associated information consistent with the statistical design of the proficiency
testing scheme?
4.7.1.4
Requirements
Assessment Compliant
*
Document
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Assessment Compliant
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Is the influence of outliers on summary statistics minimized by the use of robust
statistical methods or appropriate tests to detect statistical outliers?
4.7.1.5
Requirements
Does the proficiency testing provider have documented criteria and procedures
for dealing with test results that may be inappropriate for statistical evaluation,
e.g. miscalculations, transpositions and other gross errors?
4.7.1.6
Requirements
*
Document
Review
Does the proficiency testing provider have documented criteria and procedures
to identify and manage proficiency test items that have been distributed and are
subsequently found to be unsuitable for performance evaluation, e.g. because of
inhomogeneity, instability, damage or contamination?
Assessment Compliant
*
TNI 9.0 System for Reporting by Participants TNI specific requirement
Document
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Requirements
Assessment Compliant
Does the PT provider:
9a) have procedures and systems in place to ensure the accurate, timely and
secure transmission of PT data from participant laboratories to the PT provider;
9b) have a reporting mechanism that ensures that the results received by the PT
provider are consistent with those submitted by the participant laboratory;
9c) ensure that results reported by participant laboratories are not delayed or lost
due to the provider’s reporting mechanism;
9d) ensure that participant laboratory data are kept secure and that they are not
subject to unauthorized dissemination either during or after the data have been
reported to the PT provider?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
4.7.2 Evaluation of performance
4.7.2.1
Requirements
Document
Review
Does the proficiency testing provider use valid methods of evaluation which
meet the purpose of the proficiency testing scheme?
Are the methods documented and do they include a description of the basis for
the evaluation?
Is there objective evidence that the evaluation of performance has not been
subcontracted (see 5.5.2)?
Assessment Compliant
*
4.7.2.2
Requirements
Document
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Assessment Compliant
Where appropriate for the purpose of the proficiency testing scheme, does the
proficiency testing provider provide expert commentary on the performance of
participants with regard to the following:
a) overall performance against prior expectations, taking measurement
uncertainties into account;
b) variation within and between participants, and comparisons with any
previous proficiency testing rounds, similar proficiency testing schemes, or
published precision data;
c) variation between methods or procedures;
d) possible sources of error (with reference to outliers) and suggestions for
improving performance;
e) advice and educational feedback to participants as part of the continual
improvement procedures of participants;
f) situations where unusual factors make evaluation of results and commentary
on performance impossible;
g) any other suggestions, recommendations or general comments; and
h) conclusions?
NOTE: It can be useful to provide individual summary sheets for participants periodically during or after completion of a particular
proficiency testing scheme. These can include updated summaries of performance for individual participants over successive
proficiency testing rounds of a continuous proficiency testing scheme. Such summaries can be further analyzed and trends highlighted,
if required.
TNI 10.0 PT STUDY DATA ANALYSIS
TNI 10.1 Data Review TNI specific requirement
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Requirements
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10.1.1 Does the PT provider review all PT study data sets for bimodal or multimodal distributions and/or situations where results from a given method have
disproportionately large failure rates or reporting anomalies?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
10.1.2 If a multi-modal distribution is found related to analytical method and
acceptance criteria are calculated using robust statistical analysis of participant
data, are results evaluated on a method-specific basis?
Requirements
10.1.3 Does the PT provider review all PT study data sets for disproportionately
high or low failure rates compared to historical norms?
10.2 Acceptance Limit Determination TNI specific requirement
Requirements
10.2.1 Does the PT provider calculate acceptance limits per the requirements
defined in the TNI Fields of Proficiency Testing Tables?
Requirements
10.2.2 Do analyte- or study-specific evaluation criteria defined in the TNI Fields
of Proficiency Testing Tables supersede the criteria in this Section?
Requirements
10.2.3 Are acceptance limits represented following the same significant figure
rules as defined for assigned values in Section 6.4?
Requirements
10.2.4 For acceptance limits calculated using only the PT provider’s assigned
value (i.e. a fixed percentage limit around the assigned value, regression
equation using the assigned value to determine an estimated mean and estimated
standard deviation, etc.), does the PT provider use their assigned value and
calculate the acceptance limits defined in the TNI Fields of Proficiency Testing
Tables?
Requirements
10.2.5 For acceptance limits calculated using the actual study mean, does the PT
provider use the mean as calculated by the following procedures:
a) for samples sizes of twenty (20) or more values: the biweight mean (per
Section 2.1) using fifteen (15) iterations with c=4 and c o=6;
b) for samples sizes of seven (7) to twenty (20) values: the arithmetic mean after
outlier testing using the T test (see ASTM E178) or other PTPA-accepted
outlier testing procedure. No more than 20% of the values in any set may be
treated as outliers;
c) sample sizes of less than seven (7) values shall only be evaluated using a
statistical procedure approved by the PTPA?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
Requirements
Document
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Assessment Compliant
Document
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Document
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10.2.6 For acceptance limits calculated using the actual study standard
deviation, does the PT provider use the standard deviation as calculated by the
following procedures:
a) for samples sizes of twenty (20) or more values: the biweight standard
deviation (per Section 2.1) using fifteen (15) iterations with c=4 and co=6;
b) for samples sizes of seven (7) to twenty (20) values: the standard deviation
after outlier testing with the T test (see ASTM E178) or other PTPA-accepted
outlier testing procedure. No more than 20% of the values in any set may be
treated as outliers;
c) sample sizes of less than seven (7) values shall only be evaluated using a
statistical procedure approved by the PTPA?
Requirements
10.2.7 For acceptance limits calculated using the actual study median, does the
PT provider use the median calculated from all properly reported data points, as
defined by the PT Board, in the data set?
Requirements
10.3.1 Does the PT provider adhere to the following:
If the assigned value is greater than “0” the numerical value reported evaluated
“Acceptable” if it is within the established acceptance limits and evaluated “Not
Acceptable” if the numerical value reported is outside the established
acceptance limits or the numerical value is reported with a less than (<) sign and
the numerical value is less than the lower acceptance limit.
For example, if the Assigned Value is “10.0”, the lower acceptance limit is
“5.00” and the upper acceptance limit is “15.0”.
a) Any reported numeric value between 5.00 and 15.0 shall be evaluated
“Acceptable”
b) Any reported numeric value greater than 15.0 shall be evaluated “Not
Acceptable”.
c) Any reported numeric value less than 5.00 shall be evaluated “Not
Acceptable”.
d) Any numeric value reported with a less than sign (<) shall be evaluated
“Acceptable” if the reported numeric value associated with the less than sign is
equal to or greater than the lower acceptance limit. In this example, a reported
value of ‘< 5.00’ shall be evaluated as “Acceptable” because 5.00 is equal to the
lower acceptance limit.
e) Any numeric value reported with a less than sign (<) shall be evaluated “Not
Acceptable” if the reported numeric values associated with the less than sign is
less than the lower acceptance limit. In this example, a reported value of ‘<
4.99’ shall be evaluated as “Not Acceptable” because 4.99 is less than the lower
acceptance limit?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
Requirements
Document
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Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
Document
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Assessment Compliant
10.3.2 If the Assigned Value is set to the PTRL with a less than sign (<) or set
to “0”, any numeric value reported with a less than sign (<), a reported value of
“0” or a reported numeric value less than the PTRL, is it scored “Acceptable”?
For example, if the assigned value is set to “< 2.50” and 2.50 is the PTRL
associated with a less than sign (<):
a) Any reported numeric value reported with a less than (<) sign shall be
evaluated “Acceptable”.
b) A reported value of zero “0” shall be evaluated “Acceptable”.
c) A reported numeric value between “0” and 2.50 shall be evaluated
“Acceptable”.
d) A reported numeric value greater than 2.50 shall be evaluated “Not
Acceptable”.
Requirements
10.3.3 Are reported values evaluated as “No Evaluation” if it cannot be
evaluated (e.g., alpha characters for a quantitative test)?
Requirements
10.3.4 Are analytes included in a PT sample but not reported by the laboratory
evaluated as “Not Reported”?
Requirements
10.3.5 If the PT Provider invalidates an analyte in a PT study, all evaluations for
data reported for that analyte shall be “No Evaluation” and a discussion of the
situation leading to the invalidation, is it included in the final report to
participant labs and ABs?
4.8 Reports
4.8.1
Requirements
Are proficiency test reports clear and comprehensive and include data covering
the results of all participants, together with an indication of the performance of
individual participants?
Is there evidence that the authorization of the final report is not to be
subcontracted (see 5.5.2)?
*
NOTE: Where all original data cannot be reported to participants, a summary of the results, e.g. in tabulated or graphical form, can be
supplied.
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
4.8.2
Document
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Requirements
Do reports include the following, unless it is not applicable or the proficiency
testing provider has valid reasons for not doing so:
a) name and contact details for the proficiency testing provider;
Assessment Compliant
*
b) name and contact details for the coordinator(s);
c) name(s), function(s), and signature(s) or equivalent identification of person(s)
authorizing the report;
d) indication of which activities are subcontracted by the proficiency testing
provider;
e) date of issue and status (e.g. preliminary, interim, or final) of the report;
f) page numbers and a clear indication of the end of the report;
g) statement of the extent to which results are confidential;
h) report number and clear identification of the proficiency testing scheme;
i) a clear description of the proficiency test items used, including necessary
details of the proficiency test item's preparation and homogeneity and stability
assessment;
j) the participants' results;
k) statistical data and summaries, including assigned values and range of
acceptable results and graphical displays;
l) procedures used to establish any assigned value;
m) details of the metrological traceability and measurement uncertainty of any
assigned value;
n) procedures used to establish the standard deviation for proficiency
assessment, or other criteria for evaluation;
o) assigned values and summary statistics for test methods/procedures used by
each group of participants (if different methods are used by different groups of
participants);
p) comments on participants’ performance by the proficiency testing provider
and technical advisers;
q) information about the design and implementation of the proficiency testing
scheme;
r) procedures used to statistically analyze the data;
s) advice on the interpretation of the statistical analysis; and
t) comments or recommendations, based upon the outcomes of the proficiency
testing round?
NOTE: For continuous proficiency testing schemes, it can be sufficient to have simpler reports, such that many of the elements in this
clause could be excluded from routine reports, but included in proficiency testing scheme protocols or in periodic summary reports
that are available to participants.
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
TNI 11.0 GENERATION OF STUDY REPORTS
TNI 11.1 Schedule TNI specific requirement
Requirements
Document
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Assessment Compliant
Document
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Assessment Compliant
TNI 11.1.1 Are the reports defined in Sections 11.2 and 11.3 submitted to the
required parties no later than twenty-one days after the close of the study?
Requirements
TNI 11.1.2 Are reports submitted to participant laboratories and laboratoryrequested accreditation bodies within the same twenty-four (24) hour period?
TNI 11.2 Final Evaluation Report TNI specific requirement
Assessment Compliant
Requirements
TNI 11.2.1 Does the PT provider submit final evaluation reports to all
participant laboratories?
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
TNI 11.2.2 Does the PT provider submit final evaluation reports to all
laboratory accreditation bodies that have been requested by the laboratories to
receive reports?
Requirements
TNI 11.2.3 Is the following information included in the final evaluation report:
a) PT provider name;
b) PT provider PTPA accreditation number;
c) participant laboratory name;
d) participant laboratory physical address;
e) name, title and telephone number of laboratory point of contact, as provided;
f) participant laboratory’s primary accreditation body ID, as provided;
g) study type and study number;
h) opening and closing dates of the study;
i) date report was prepared;
j) date report was amended, if applicable;
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
k) study discussion including any pertinent information which addresses
unusual details of the study (e.g., need to change an assigned value or delete an
analyte from evaluation)?
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
TNI 11.2.4 Are the following information included for each PT sample/analyte
in the final evaluation report:
a) lot or study number;
b) analyte name;
c) analyte code defined in the TNI FoPT Tables;
d) identification of those analytes included and not included in the PT
provider’s PTPA accreditation;
e) assigned value;
f) acceptance limits;
g) laboratory value, as reported;
h) method description, as reported;
i) analysis dates as reported by the participating laboratory;
j) evaluation per Section 10.3;
k) mean calculated from all study participant data; and
l) standard deviation calculated from all study participant data?
Requirements
TNI 11.2.5 Does each page of the final evaluation report shall include an
indication of the length of the report, presented by either “Page X of Y” or the
total number of pages with each page consecutively numbered?
TNI 11.3 Study Failure Rate Report TNI specific requirement
Requirements
TNI 11.3.1 Upon request by either a participant laboratory or a laboratory
accreditation body, does the PT provider make available a report listing the total
number of participating laboratories and the number of laboratories scoring
“Not Acceptable” for those analytes reported by the laboratory?
Requirements
TNI 11.3.2 Does the PT provider not disclose specific laboratory results or
evaluations to any parties without a written release from the laboratory?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
4.8.3
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Are reports made available to participants within planned timescales? In
sequential proficiency testing schemes, e.g. where the turn-around time may be
very long, and in schemes involving perishable materials, are preliminary or
anticipated results provided before final results are disclosed?
NOTE: This allows for early investigation of possible error.
4.8.4
Requirements
Does the proficiency testing provider have a policy for the use of reports by
individuals and organizations?
4.8.5
Requirements
When it is necessary to issue a new or amended report for a proficiency testing
scheme, does the amended report include the following:
a) a unique identification;
b) a reference to the original report that it replaces or amends; and
c) a statement concerning the reason for the amendment or re-issue?
4.9 Communication with participants
4.9.1
Requirements
Does the proficiency testing provider make detailed information available about
the proficiency testing scheme. Does this include:
a) relevant details of the scope of the proficiency testing scheme;
*
b) any fees for participation;
c) documented eligibility criteria for participation;
d) confidentiality arrangements; and
e) details of how to apply?
4.9.2
Document
Review
Requirements
Assessment Compliant
Are participants advised promptly by the proficiency testing provider of any
changes in proficiency testing scheme design or operation?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
4.9.3
Document
Review
Requirements
Are there documented procedures for enabling participants to appeal against the
evaluation of their performance in a proficiency testing scheme?
Is the availability of this process communicated to proficiency testing scheme
participants?
Assessment Compliant
*
4.9.4
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Are relevant records of communications with participants maintained and
retained, as appropriate?
4.9.5
Requirements
If the proficiency testing provider issues statements of participation or
performance, do the statements contain sufficient information to not be
misleading?
4.10 Confidentiality
4.10.1
Requirements
Are the identities of participants in a proficiency testing scheme confidential
and known only to persons involved in the operation of the proficiency testing
scheme, unless the participant waives confidentiality?
*
4.10.2
Document
Review
Requirements
Assessment Compliant
Is all information supplied by a participant to the proficiency testing provider
treated as confidential?
NOTE: Participants can elect to waive confidentiality within the proficiency testing scheme for the purposes of discussion and mutual
assistance, e.g. to improve performance. Confidentiality can also be waived by the participant for regulatory or recognition purposes.
In most instances, the proficiency testing results can be provided to the relevant authority by the participants themselves.
4.10.3
Document
Review
Requirements
Assessment Compliant
When an interested party requires the proficiency testing results to be directly
provided by the proficiency testing provider, are the participants made aware of
the arrangement in advance of participation?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
4.10.4
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
In exceptional circumstances, when a regulatory authority requires proficiency
testing results to be directly provided to the authority by the proficiency testing
provider, are the affected participants notified of this action in writing?
5 Management Requirements
5.1 Organization
5.1.1 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider’s Quality Management System meet the requirements of ISO
9001 for the design, production, testing and distribution of audit samples, and
the evaluation of audit sample analyses results or measurements?
NOTE: This requirement can be met by demonstrating compliance with the
Management System requirements of a standard that complies with ISO PAS
17005, such as ISO/IEC 17025 or ISO/IEC17043.
5.1.1
Requirements
Is the proficiency testing provider, or the organization of which it is part, an
entity that is legally identifiable and accountable?
5.1.2
Requirements
Does the proficiency testing provider to carry out its proficiency testing
operations in such a way as to meet the requirements of this International
Standard and to satisfy the needs of the participants, regulatory authorities and
organizations providing recognition?
5.1.2 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider’s manufacturing system meet the requirements of ISO Guide
34?
5.1.3
Requirements
Does the management system cover work carried out in the proficiency testing
provider's permanent facilities, at sites away from its permanent facilities, and
in associated temporary facilities?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
5.1.3 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the design and operation of the Providers participation in the SSAS
program meet the relevant requirements of ILAC G-13 (until replaced by
ISO/IEC 17043 when approved)?
5.1.4
Requirements
If the proficiency testing provider is part of an organization performing other
activities, does the proficiency testing provider identify the responsibilities of
key personnel in the organization that have an involvement in or could have
influence on the proficiency test activities, in order to identify potential conflicts
of interest?
If potential conflicts of interest are identified, are procedures put in place to
ensure that all activities of the proficiency testing provider are conducted with
impartiality?
Requirements
*
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
TNI 5.2 a) Does the PT provider seeking to obtain or maintain accreditation:
a) document and certify to the satisfaction of the PTPA that they do not have
any conflict of interest with any laboratory that may participate in their PT
programs;
TNI 5.2 b) inform all internal and contract personnel who perform work on PT
studies of the PT provider’s obligation to report personal and organizational
conflicts of interest to the PTPA;
TNI 5.2 c) have a continuing obligation to identify and report any actual or
potential conflicts of interest arising during the performance of work in support
of PT Programs;
TNI 5.2 d) immediately make a full disclosure to the PTPA of any identified
actual or potential organizational conflict of interest. The disclosure shall
include a description of any action that the provider has taken or proposes to
take after consultation with the PTPA to avoid, mitigate or neutralize the actual
or potential conflict of interest;
TNI 5.2 e) have written procedures to ensure that the confidentiality of data
associated with PT samples and programs is not compromised;
TNI 5.2 f) not release the assigned values or acceptance limits of any PT sample
prior to the conclusion of the study, except to the PTPA;
TNI 5.2 g) only release participant laboratories’ PT study results and/or
evaluations to a designated contact at the laboratory and to laboratory
accreditation bodies and/or other entities as specifically designated by the
laboratory?
5.1.4– TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Do the testing facilities used to support the verification, homogeneity and
stability testing required in the this Standard (volume 1, module 1) meet the
requirements of ISO/IEC 17025?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
5.1.5
Document
Review
Requirements
Assessment Compliant
Does the proficiency testing provider:
a) have managerial and technical personnel who, irrespective of other
responsibilities, have the authority and resources needed to carry out their
duties, including the implementation, maintenance and improvement of the
management system, and to identify the occurrence of departures from the
management system or from the procedures for providing proficiency testing
schemes, and to initiate actions to prevent or minimize such departures;
b) have arrangements to ensure that its management and personnel are free from
any undue internal or external commercial, financial and other pressures that
may adversely affect the quality of their work;
c) have policies and procedures to ensure the protection of its participants'
confidential information and proprietary rights, including procedures for their
protection during electronic storage and transmission;
d) have policies and procedures to avoid involvement in any activities that
might diminish confidence in its competence, impartiality, judgement or
operational integrity;
e) define the organization and management structure, its place in any parent
organization, and the relationships between quality management, technical
operations and support services;
f) specify the responsibility, authority, interrelationships and required
competence of all personnel who manage, perform or verify work affecting the
quality of the operation of proficiency testing
g) ensure that the 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;
h) provide adequate supervision of technical staff, including trainees, by persons
familiar with procedures for each activity;
i) have technical management which has overall responsibility for the technical
operations and the provision of the resources needed to ensure the required
quality of proficiency testing schemes, including access to the necessary
technical expertise and experience in the relevant field of testing, calibration or
inspection, as well as statistics, as indicated in 4.4.1.4;
j) appoint a member of staff as quality manager (named as appropriate) who,
irrespective of other duties and responsibilities, has defined responsibility and
authority for ensuring that the management system is implemented and followed
at all times; does the quality manager have direct access to the highest level of
management at which decisions are taken on the proficiency testing provider's
policies or resources; and
k) appoint deputies for key managerial personnel?
*
*
*
*
*
NOTE: Where proficiency testing providers have a small number of personnel, individuals can have more than one function and it can
be impractical to appoint deputies for all major functions.
5.1.6
Document
Review
Requirements
Assessment Compliant
Does top management ensure that appropriate communication processes are
established within the organization and that communication takes place
regarding the effectiveness of the management system?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
5.1.6 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the Provider maintain all records related to each audit sample
manufacturing lot for a minimum of five (5) years?
5.2 Management system
5.2.1
Requirements
Does the proficiency testing provider establish, implement and maintain a
management system appropriate to its scope of activities, including the type,
range and volume of proficiency testing that it provides?
5.2.2
Requirements
Does the proficiency testing provider define and document its policies,
programs, procedures and instructions to the extent necessary to assure the
quality of all aspects of proficiency testing?
Is the system's documentation communicated to, understood by, available to,
and implemented by the appropriate personnel?
NOTE: These aspects include, but are not limited to, proficiency test item quality (e.g. homogeneity and stability), characterization
(e.g. equipment calibration and method validation), assignment of property values (e.g. use of appropriate statistical procedures),
evaluation of participant performance, distribution of proficiency test items, storage and transport procedures, statistical treatment of
test results, and reporting.
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
5.2.3
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Are the proficiency testing provider's management system policies related to
quality, including a quality policy statement, defined in a quality manual
(named as appropriate)? Are the overall objectives established and reviewed
during management review. Is the quality policy statement issued under the
authority of top management? Does it include at least the following:
a) the management's commitment to the quality of its proficiency testing
services to participants and other customers;
b) the management's statement of the standard of service;
c) the purpose of the management system related to quality;
d) a requirement that all personnel concerned with the proficiency testing
activities familiarize themselves with the quality documentation and implement
the policies and procedures in their work; and
e) the management's commitment to comply with this International Standard
and to continually improve the effectiveness of the management system?
5.2.4
Requirements
Has top management provided evidence of commitment to the development and
implementation of the management system and to continually improving its
effectiveness?
5.2.5
Requirements
Has top management communicated to the organization the importance of
meeting customer requirements, as well as statutory and regulatory
requirements?
5.2.6
Requirements
Does the quality manual include or make reference to the supporting
procedures, including technical procedures? Does it outline the structure of the
documentation used in the management system?
5.2.7
Requirements
Are roles and responsibilities of technical management and the quality manager,
including their responsibility for ensuring compliance with this International
Standard, defined in the quality manual?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
5.2.8
Document
Review
Requirements
Assessment Compliant
Does top management ensure that the integrity of the management system is
maintained when changes to the management system are planned and
implemented?
5.2 – TNI Standard V1M1-2009 (SSAS Requirement)- Provider Conflict of Interest and Confidentiality
Document
Assessment Compliant
Requirements
Review
Does the Provider seeking to obtain or maintain accreditation:
a) Document and certify to the satisfaction to the Provider Accreditor that
they do not have any conflict of interest with any Participant in the
SSAS program?
Note: Such a conflict of interest could take the form of a financial interest or
sharing of personnel, facilities, or equipment with any Participant in the SSAS
Program.
b) Inform all internal and contract personnel who perform work on the
SSAS Program of the Providers obligation to report personal and
organizational conflicts of interest to the Provider Accreditor?
c)
Have a continuing obligation to identify and report any actual or
potential conflicts of interests arising during the performance of work
in support of the SSAS program?
d) Immediately make a full written disclosure to the Provider Accreditor
of any identified actual or potential organizational conflict of interest?
e)
f)
Does the disclosure include a description of any action that the
provider has taken or proposes to take after consultation with the
Provider Accreditor to avoid, mitigate or neutralize the actual or
potential conflict of interest?
Have written procedures to ensure that the confidentially of data
associated with audit samples and the SSAS Program is not
compromised?
Not release the assigned values or acceptance limits of any audit
sample prior to the reporting of the audit sample analyses results?
g) Not disclose specific Facility, Laboratory, or Stationary Source Tester
results or evaluations to any parties other than as specified in Section
11.1.2 without written release from the Facility for Facility data, from
the Laboratory for Laboratory data, or from the Stationary Source
Tester for Stationary Source Tester data?
Note: Providers may release, without permission of participant Laboratories,
summaries of participant Laboratory results that do not identify individual
Laboratories, Stationary Source Testers or Facilities.
5.3 Document control
5.3.1 General
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
Document
Review
Requirements
Does the proficiency testing provider establish and maintain procedures to
control all documents that form part of its management system (internally
generated, or from external sources), such as regulations, standards, other
normative documents, proficiency testing scheme protocols, test or calibration
methods, or both test and calibration methods, as well as drawings, software
specifications, instructions and manuals?
Assessment Compliant
*
5.3.2 Document approval and issue
5.3.2.1
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Are all documents issued as part of the management system reviewed and
approved for use by authorized personnel prior to issue?
Is a master list or equivalent document control procedure identifying the current
revision status and distribution of documents in the management system
established and be readily available, in order to prevent the use of invalid or
obsolete documents, or both?
5.3.2.2
Requirements
Do procedures adopted also ensure that:
a) authorized editions of appropriate documents are available at all locations
where activities essential to the effective operation of proficiency testing
schemes are performed;
b) documents are periodically reviewed and updated, as necessary, to ensure
continuing suitability and compliance with applicable requirements;
c) invalid or obsolete documents are promptly removed from all points of issue
or use, or otherwise assured against unintended use; and
d) obsolete documents retained for either legal or knowledge preservation
purposes are suitably marked?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
5.3.2.3
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Are management system documents generated by the proficiency testing
provider uniquely identified?
Does such identification include the date of issue or revision identification, or
both, page numbering, the total number of pages or a mark to signify the end of
a document, and the issuing authority/authorities?
5.3.3 Document changes
5.3.3.1
Requirements
Are changes to documents reviewed and approved by the same function that
performed the original review and approval, unless specifically designated
otherwise?
Do designated personnel have access to pertinent background information upon
which to base their review and approval?
5.3.3.2
Requirements
Where practicable, is the altered or new text identified in the document or the
appropriate attachments?
5.3.3.3
Requirements
If the proficiency testing provider's document control system allows for the
amendment of documents by hand, pending re-issue of the documents, are the
procedures and authorities for such amendments defined?
Are amendments clearly marked, initialed and dated? Is a revised document
issued as soon as practicable?
5.3.3.4
Requirements
Are procedures established to describe how changes in documents maintained
on computerized systems are made and controlled?
5.3 – TNI Standard V1M1-2009 (SSAS Requirement) - Provider Facilities and Personnel
5.3.1- TNI Standard V1M1-2009 (SSAS Requirement)
Document
Review
Requirements
Assessment Compliant
Does the Provider have appropriate facilities, equipment and analytical
instrumentation in place to produce, analytically verify, distribute and provide
data evaluation and reporting functions for every audit sample for which they
wish to obtain or maintain accreditation?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
5.3.2 - TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the provider employ sufficient technical and support staff to design,
produce, analyze, distribute, and provide data evaluation and reporting functions
for every audit sample for which they wish to obtain or maintain accreditation?
5.3.3 - TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider ensure that no portion of the design, production, testing,
distribution, data collection, data evaluation, or data reporting functions are
outside the direct control of the provider for any particular manufacturing lot.
For the purpose of this Standard (Volume 1, Module 1), “direct control” means
that these function are performed in the Provider’s facilities by the Provider’s
staff or are subcontracted by means of a written agreement with defined
Provider supervision to ensure that all requirements of this Standard are met.
5.3.4 - TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Is any subcontracted function related to the design, production, testing,
distribution, data collection, data evaluation, or data reporting available to be
assessed? Does any subcontracted function meet the applicable requirements of
this Standard?
5.4 Review of requests, tenders and contracts
5.4.1
Requirements
Does the proficiency testing provider establish and maintain policies and
procedures for the review of requests, tenders and contracts. Do these reviews
ensure that:
a) the requirements, including those for test and calibration methods, measuring
equipment and proficiency test items to be used, are adequately defined,
documented and understood;
b) the proficiency testing provider has the capability and resources to meet the
requirements; and
c) the proficiency testing scheme is technically appropriate?
*
NOTE 1: This review is particularly important when a customer requests a proficiency testing scheme to be created for a specific
purpose or for a different level or frequency of participation from that normally offered.
NOTE 2: This review can be simplified when the proficiency test scheme is fully described in a catalogue or other notice, and the
participant is enrolling for a routine shipment.
5.4.2
Document
Review
Requirements
Assessment Compliant
Are records of such reviews, including any changes, maintained? Are records
also maintained of pertinent discussions with a customer relating to the
customer's requirements, or the results of the work during the period of
execution of the contract, or both?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
5.4.3
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the review cover all aspects of the request, including any work that is
subcontracted by the proficiency testing provider?
5.4.4
Requirements
Are the participants and other customers, as appropriate, informed of any
deviation in the contract or agreed proficiency testing scheme design?
5.4.5
Requirements
If a request or contract is amended after the proficiency testing scheme is
underway, is the same review process repeated and any amendments
communicated to all affected personnel?
5.4 – TNI Standard V1M1-2009 (SSAS Requirement) - Complaints Handling
5.4.1– TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider have written procedures for handling both written and verbal
complaints from Participants who receive audit sample reports?
5.4.2 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider record all complaints received concerning the SSAS
Program, including any remedial or corrective actions taken? Is this record
available upon request?
5.4.3 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Is any complaint received by the Provider that remains unresolved after fortyfive (45) days submitted to the Provider Accreditor?
5.5 Subcontracting services
5.5.1
Requirements
When a proficiency testing provider subcontracts work, does the proficiency
testing provider demonstrate that the subcontractors' experience and technical
competence are sufficient for their assigned tasks and that they comply with the
relevant clauses of this International Standard and other appropriate standards?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
TNI 5.3.3 Is it assured that no portion of the design, production, testing,
distribution, data collection, data evaluation, or data reporting functions may be
outside the direct control of the PT provider for any particular study?
For the purposes of this Standard, “direct control” means that these functions
are performed in the PT provider’s facilities by the PT provider’s staff or are
sub-contracted by means of a written agreement with defined PT provider
supervision to ensure that all requirements of this Standard are met.
TNI 5.3.4 Are any subcontracted function related to design, production, testing,
distribution, data collection, data evaluation, or data reporting assessed and meet
the applicable requirements of this Standard?
5.5.2
Requirements
Does the proficiency testing provider not subcontract the planning of the
proficiency test scheme (see 4.4.1.2), the evaluation of performance (see
4.7.2.1) or the authorization of the final report (see 4.8.1)?
NOTE: This does not preclude the proficiency testing provider utilizing advice or assistance from any advisors, experts or steering
group.
5.5.3
Document
Review
Requirements
Assessment Compliant
Does the proficiency testing provider inform participants, in advance and in
writing, of services that are, or may be, subcontracted?
NOTE: This notification can, for example, take the form of a statement in the proficiency testing scheme documentation, such as the
following: “Various aspects of the proficiency testing scheme can from time to time be subcontracted. When subcontracting occurs, it
is placed with a competent subcontractor and the proficiency testing provider is responsible for this work.”
5.5.4
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the proficiency testing provider be responsible to the participants and
other customers for the subcontractor's work, except in the case where a
regulatory authority specifies which subcontractor is to be used?
5.5.5
Requirements
Does the proficiency testing provider maintain a register of all subcontractors
used in the operation of proficiency testing schemes, including the scope of
subcontracting and a record of the competence assessment against relevant parts
of this International Standard and other appropriate standards for the work in
question?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
5.5 – TNI Standard V1M1-2009 (SSAS Requirement) – Notification of Sample Integrity
Document
Requirements
Review
If any audit sample or analyte used in the SSAS Program is found not to meet
any of the requirements of this Standard (Volume 1, Module 1), does the
Provider notify (with full disclosures as to the scope and nature of the
nonconformance) all affected Participants and the Provider’s Provider
Accreditor within seven (7) calendar days of the discovery of the
nonconformance?
Assessment Compliant
Purchasing services and supplies
5.6.1
Document
Review
Requirements
Does the proficiency testing provider have a policy and procedure(s) for the
selection of services and supplies that it uses and that affect the quality of its
proficiency testing schemes?
Do procedures exist for the purchase, reception and storage of reagents,
proficiency test items, reference materials and other consumable materials
relevant for the proficiency testing schemes?
Assessment Compliant
*
*
5.6.2
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the proficiency testing provider ensure that purchased supplies, equipment
and consumable materials that affect the quality of proficiency testing schemes
are not used until they have been inspected or otherwise verified as complying
with specifications or requirements?
Are records of actions taken to check compliance maintained?
5.6.3
Requirements
Are purchasing documents for items affecting the quality of proficiency testing
schemes containing data describing the services and supplies ordered?
Are these purchasing documents reviewed and approved for technical content
prior to release?
5.6.4
Requirements
Does the proficiency testing provider evaluate suppliers of critical supplies and
services which affect the quality of proficiency testing schemes?
Does the proficiency testing provider maintain records of these evaluations, and
list those suppliers that are approved?
*
NOTE: It is understood that some proficiency testing providers can be required to implement their purchasing procedures in
accordance with policies defined by their parent company or a host organization.
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
5.7 Service to the customer
5.7.1
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the proficiency testing provider be willing to cooperate with participants
and other customers in clarifying customers' requests and in monitoring the
proficiency testing provider's performance in relation to the work performed,
provided that the proficiency testing provider assures confidentiality to its
participants?
5.7.2
Requirements
Does the proficiency testing provider seek feedback, both positive and negative,
from its customers?
Is the feedback used and analyzed to improve the management system,
proficiency testing schemes, and customer service?
NOTE: Examples of the types of feedback include customer satisfaction surveys and review of proficiency testing reports with
customers.
5.8 Complaints
5.8 Complaints
Document
Review
Requirements
Does the proficiency testing provider have a policy and follow a procedure for
the resolution of complaints and appeals received from participants, customers
or other parties?
Are records maintained of all complaints, appeals, investigations and
corrective actions taken by the proficiency testing provider?
*
*
Document
Review
Requirements
Assessment Compliant
Assessment Compliant
TNI 5.4.1 Does the PT provider have written procedures for handling both
written and verbal complaints from PT study participants and laboratory
accreditation bodies who receive PT study reports?
TNI 5.4.3 Does any complaint received by a PT provider that remains
unresolved after ninety (90) days get submitted to the PTPA?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
5.9 Control of nonconforming activities
5.9.1
Document
Review
Requirements
Does the proficiency testing provider have a policy and procedure(s) that is
implemented when any aspect of its activities does not conform to its own
procedures or the agreed requirements of its customers? Do the policy and
procedure(s) ensure that:
a) the responsibilities and authorities for the management of nonconforming
work are designated and actions (including halting work of ongoing programs
and withholding reports, as necessary) are defined and taken when
nonconforming work is identified;
b) an evaluation of the significance of the nonconforming work is made;
Assessment Compliant
*
c) a decision on the need for action and timescale is taken immediately, together
with any decision about the acceptability of the nonconforming work;
d) proficiency testing scheme participants and other customers, as appropriate,
are informed and the nonconforming proficiency test items or reports already
sent to participants are recalled or disregarded;
e) the responsibility for authorization of the resumption of work is defined?
NOTE: Identification of nonconforming work or problems with the management system or with technical activities can occur at
various places within the management system and technical operations. Examples are participant complaints, management reviews
and internal or external audits, quality control, preparations of proficiency test items, homogeneity and stability tests, data analysis,
instructions to participants, and materials handling and storage.
5.9.2
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Where the evaluation indicates that nonconforming work could recur or that
there is doubt about the compliance of the proficiency testing provider or
subcontractor with their own policies and procedures, is the corrective action
procedure in 5.11 promptly followed?
Requirements
TNI 5.5 Notification of Sample Integrity
If any sample or analyte used in a PT study is found to not meet any of the
requirements of this Standard, does the PT provider notify all affected
laboratories and their designated accreditation bodies and the provider’s PTPA
within seven (7) calendar days of the discovery of the noncompliance?
5.10 Improvement
5.10 Improvement
Requirements
Does the proficiency testing provider 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?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
5.11 Corrective action
5.11.1 General
Document
Review
Requirements
Does the proficiency testing provider establish a policy and procedure(s) and
designate appropriate personnel for implementing corrective actions when
nonconforming work or departures from the policies and procedures in the
management system or technical operations have been identified?
Assessment Compliant
*
NOTE See 5.9.1, Note.
5.11.2 Root Cause
Document
Review
Requirements
Does the procedure for corrective action start with an investigation to determine
the root cause(s) of the problem?
Assessment Compliant
*
NOTE: Cause analysis is the key and sometimes the most difficult part in the corrective action procedure. Often, the root cause is not
obvious and thus a careful analysis of all potential causes of the problem is required. Potential causes could include customer
requirements, proficiency test items and their specifications, methods and procedures, staff skills and training, consumable supplies,
preparations of proficiency test items, homogeneity and stability tests, statistical design, instructions to participants, and materials
handling and storage.
5.11.3.1
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Where corrective action is needed, does the proficiency testing provider identify
potential corrective actions? Does the proficiency testing provider select and
implement the action(s) most likely to eliminate the problem and to prevent
recurrence?
5.11.3.2
Requirements
Are corrective actions appropriate to the magnitude and risk of the problem?
5.11.3.3
Requirements
Does the proficiency testing provider document and implement any required
changes resulting from corrective action investigations?
5.11.3.4
Requirements
Does the proficiency testing provider monitor the results to ensure that the
corrective actions taken have been effective?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
5.11.3.5
Document
Review
Requirements
Assessment Compliant
Where the identification of nonconforming activities or departures from
authorized procedures cast doubts on the compliance of the proficiency testing
provider with its own policies and procedures, or on its compliance with this
International Standard, Does the proficiency testing provider ensure that the
appropriate areas of activity are audited in accordance with 5.14 as soon as
possible?
NOTE: Such additional audits often follow the implementation of the corrective actions to confirm their effectiveness. An additional
audit can be necessary only when a serious issue or risk to the proficiency testing scheme is identified.
5.12 Preventive action
5.12.1
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Are areas for improvements and potential sources of nonconforming work,
either technical or concerning the management system, identified?
When improvement opportunities are identified, or if preventive action is
required, are action plans developed, implemented and monitored, to reduce the
likelihood of such nonconforming work and to take advantage of the
opportunities for improvement?
5.12.2
Requirements
Does the procedure for preventive action include the initiation of such actions
and application of controls to ensure that they are effective?
*
5.13 Control of records
5.13.1.1 General
Document
Review
Requirements
Does the proficiency testing provider establish and maintain procedures for
identification, collection, indexing, access, filing, storage, maintenance and
disposal of records?
Do quality records include reports from internal audits and management
reviews, as well as records of corrective and preventive actions?
Assessment Compliant
*
5.13.1.2
Document
Review
Requirements
Assessment Compliant
Are all records and stored and retained in such a way that they are readily
retrievable in facilities that provide a suitable environment to prevent damage or
deterioration and to prevent loss?
Are retention times of records established?
NOTE: Records can be in the form of any type of media, such as hard copy or electronic storage media.
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
5.13.1.3
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Are all records kept secure and confidential, and in accordance with relevant
regulatory requirements?
5.13.1.4
Requirements
Does the proficiency testing provider follow procedures to protect and back-up
records stored electronically and to prevent unauthorized access or amendment
of these records?
*
5.13.2 Technical records
5.13.2.1
Document
Review
Requirements
Does the proficiency testing provider retain records of all technical data relating
to each proficiency testing round for a defined period, including, but not
necessarily limited to:
a) results of homogeneity and stability testing;
Assessment Compliant
*
b) instructions to participants;
c) participants' original responses;
d) collated data for statistical analysis;
e) information required for reports (see 4.8); and
f) final reports (summary or individual, or both)?
NOTE 1: It is advisable to retain sufficient information to establish an audit trail for the processing of results from proficiency testing
rounds.
NOTE 2: Technical records are accumulations of data and information which result from carrying out all proficiency testing activities.
They can include forms, contracts, work sheets, work books, check sheets, work notes, sub-contractor reports and participant
feedback.
5.13.2.2
Document
Review
Requirements
Assessment Compliant
Are data entry, checking and calculations recorded at the time they are made
and identifiable to the specific task and to the personnel responsible?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
5.13.2.3
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
When mistakes occur in records and alterations are made, are actions taken to:
a) identify the change and date of alteration;
b) avoid loss of original data; and
c) identify the person making the alteration?
Requirements
TNI 5.1.6 Does the PT providers maintain all records related to each PT study
for a minimum of five (5) years after the close of the PT study?
5.14 Internal audits
5.14.1
Requirements
Does the proficiency testing provider conduct internal audits of its activities
periodically, and in accordance with a predetermined schedule and procedure, in
order to verify that its operations continue to comply with the requirements of
the management system and this International Standard?
Does the internal audit program address all elements of the management system,
including the technical procedures and proficiency test item preparation, storage
and distribution, as well as reporting activities for the operation of a proficiency
testing scheme?
Does the quality manager to plan and organize audits as required by the
schedule and requested by management? Are internal audits carried out by
trained and qualified personnel who are, wherever resources permit,
independent of the activity to be audited?
*
NOTE: It is advisable that the program for internal auditing of the management system be completed every 12 months.
5.14.2
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
When audit findings cast doubt upon the effectiveness of the operations,
including the suitability and correctness of proficiency test items, procedures,
statistical evaluations and data presentation, does the proficiency testing
provider take timely corrective action and notify its customers or participants,
or both, in proficiency testing schemes whose activities may have been
affected?
5.14.3
Requirements
Are the areas of audited activity, the audit findings and any corrective actions
that arise from them recorded?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
5.14.4
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Do follow-up audit activities verify and record the implementation and
effectiveness of any corrective actions taken?
5.15 Management reviews
5.15.1
Requirements
Does the proficiency testing provider's top management periodically, in
accordance with a pre-determined schedule and procedure, conduct a review of
the proficiency testing provider's management system and proficiency testing
activities, in order to ensure their continued suitability and effectiveness and to
introduce any necessary changes or improvements. Does the review take
account of:
a) the suitability of policies and procedures;
*
b) reports from management and supervisory personnel;
c) the outcome of recent internal audits;
d) corrective and preventive actions;
e) assessments by external bodies;
f) changes in the volume and type of work;
g) customer, advisory group or participant feedback;
h) complaints and appeals;
i) recommendations for improvement; and
j) other relevant factors, such as resources and staff training?
NOTE 1: A typical period for conducting a management review is once every 12 months.
NOTE 2: Results can feed into the proficiency testing provider's planning system and can include the objectives and action plans.
NOTE 3: A management review includes consideration of related subjects at regular management meetings.
NOTE 4: Where the proficiency testing provider is part of a larger organization, it can be appropriate to hold a separate review
meeting to cover proficiency testing activities.
5.15.2
Document
Review
Requirements
Assessment Compliant
Are findings from management reviews, and the actions that arise from them,
recorded? Does the management ensure that those actions are discharged within
an appropriate and agreed timescale?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
6.0 – TNI Standard V1M1-2009 (SSAS Requirement) – Audit Sample Design and Manufacture
6.1 – TNI Standard V1M1-2009 (SSAS Requirement) – Design Review
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the Provider demonstrate to the satisfaction of the Provider Accreditor
that their audit sample design and manufacturing processes:
a)
Permit participants, conforming to the calibration and quality control
requirements of the analytical method(s) for which the audit sample
was designed, to generate results that fall within the acceptable limits
defined in the SSAS table?
b) Provide equivalent challenge to all Participants?
c)
Result in Participant acceptable/not acceptable rates that are consistent
with historical norms?
6.2 – TNI Standard V1M1-2009 (SSAS Requirement) – Audit Sample Matrices
Requirements
Do the matrices of all audit samples, to the extent possible, resemble the
matrices which Participants routinely analyze?
6.3 – TNI Standard V1M1-2009 (SSAS Requirement) – Audit Sample Analytes
6.3.1 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider prepare audit samples that are compliant with the criteria
defined by the SSAS Expert Committee and published in the SSAS Table on
the TNI website?
If requested by the Regulatory Agency and/or the Facility, analytes that are not
listed in the SSAS table may be included in an audit sample if the purpose and
technical justification are documented, and if, where appropriate, the
Regulatory Agency and/or facility are notified in advance.
6.3.2 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
When the SSAS Expert Committee makes changes to the audit sample design
criteria, does the Provider comply with the revised requirements per the SSAS
Expert Committee’s implementation schedule?
6.3.3 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider spike the analytes of interest into the audit sample according
to the SSAS Table?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
6.3.4 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the Provider produce audit samples that conform to the method being
tested?
6.3.5 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
If the provider adds interference (not to be reported),normally present in the
matrix being tested, to the audit sample, has this action been approved by the
Provider Accreditor in accordance with the requirements of Section 6.1 of this
Standard ( Volume 1, Module1)?
6.4 – TNI Standard V1M1-2009 (SSAS Requirement) - Audit Sample Concentration Ranges
6.4.1– TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the Provider supply audit samples that reflect the concentration ranges in
the SSAS Table? If requested by the Regulatory Agency and/or the Facility,
ranges that are not listed in the SSAS Table may be included in an audit sample
if the purpose and technical justification are documented, and if, where
appropriate, the Regulatory Agency and/or Facility are notified in advance.
6.4.2– TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Are the assigned values for audit sample analytes that are measured (chemical
concentration, isotope activities, etc):
a)
Equal to the made-to values of the analytes based on gravimetric and
volumetric measurements of a starting material of known
concentration if possible, and if not possible, set to the mean of the
determined measure value?
b) Presented in three (3) significant figures?
7.0– TNI Standard V1M1-2009 (SSAS Requirement) – Audit Sample Testing
7.1– TNI Standard V1M1-2009 (SSAS Requirement) – Verification of Assigned Value
7.1.1 – TNI Standard V1M1-2009 (SSAS Requirement)
Document
Review
Requirements
Assessment Compliant
Does the Provider analytically verify the assigned value of all analytes in all
manufacturing lots of audit samples prior to use?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
7.1.2 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Do Provider’s verify the assigned value by direct analysis against a calibration
standard made from, or traceable to, a primary reference material (e.g. National
Institute of Standards and Technology), if available?
7.1.3 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
If a primary reference material is not available, is verification performed against
an independently prepared calibration material?
Note: An independently prepared calibration material is one prepared from a
raw material source independent of the source used to prepare the audit sample
or one prepared and documented by a source external to the Provider.
7.1.4 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the assigned value verification analytical event also include the analysis
of a second source reference material from a source independent of the
calibration standard and the audit sample being verified?
7.1.5 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider have documented criteria for the acceptance of the results of
the second source reference material?
7.1.6 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the analytical method used by the Provider for assigned value verification
have a repeatability relative standard deviation of not more than one-sixth of the
acceptance limits for the participant Laboratories?
7.1.7 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
For test methods listed in the SSAS Table, where the method performance
precludes the use of the one-sixth limit defined in Section 7.1.6, does the
Provider document the technical justification that the method used to verify the
audit sample assigned value is adequate to ensure that it meets data user
requirements?
Has this been reviewed and approved by the Provider Accreditor?
7.1.8 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Is the relative standard deviation of the Providers verification method
established by a method validation study for each method and instrument?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
7.1.9 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
For analytes in aqueous media, the assigned value of an analyte is verified if the
mean of the Providers verification analyses is within one-third of the
Laboratory acceptance limits as defined in the SSAS table, to a maximum of
10% of either:
The assigned value, if an unbiased verification method is used; or
The expected mean value for the analyte, if a biased method is used.
7.1.10 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
For analytes contained on or in sampling media, the assigned value of an
analyte is verified if the mean of the Providers verification analyses is within
one-half of the Laboratory acceptance limits as defined in the SSAS table, of
either:
The assigned value, if an unbiased verification method is used; or
The expected mean value for the analyte, if a biased method is used.
7.1.11 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Is the standard deviation of the verification analyses less than one standard
deviation, as calculated for the participant Laboratories?
7.1.12 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Is any manufacturing lot that fails to meet the requirements of this Section not
used as an audit sample?
7.2 – TNI Standard V1M1-2009 (SSAS Requirement) – Homogeneity Testing
7.2.1- TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider analytically verify that all analytes in all manufacturing lots
of audit samples are sufficiently homogenous, according to the requirements of
Section 7.2, prior to their use as an audit sample?
7.2.2- TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Is homogeneity verified using a procedure, approved by the Provider
Accreditor, to verify that differences between audit samples will not impact the
evaluation of the stationary source test?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
7.2.3- TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Is homogeneity testing performed on a representative selection of audit samples
randomly selected from each final packaged audit sample batch prior to
shipment?
7.2.4- TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Is any manufacturing lot that fails to meet the requirements of this Section not
used as an audit sample?
7.3- TNI Standard V1M1-2009 (SSAS Requirement) – Stability Testing
7.3.1 - TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider verify the expiration date of the audit sample manufacturing
lot and verify that all analytes in all audit samples remained stable?
7.3.2 - TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider conduct stability testing of each lot of audit sample material
or have data showing, to the satisfaction of the Provider Accreditor, that the
sample was stable during the time period of use in the SSAS program?
7.3.3 - TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
If appropriate according to the sample design, does the Provider retain samples
from each audit sample manufacturing lot for use in confirmation of the lot
assigned values and subsequent analytical verification?
7.3.4 - TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider use a stability verification procedure approved by the
Provider Accreditor?
7.3.5 - TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Are audit samples or analytes that fail to meet the criteria of this Section
invalidated?
Are all sample recipients notified with a detailed discussion report?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
7.4 - TNI Standard V1M1-2009 (SSAS Requirement) – Verification, Homogeneity, and Stability Testing Reporting
7.4.1- TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Upon request, and only after the Provider has released their evaluation of the
audit sample analyses results, does the Provider release, to a designated
Participant, the results of the Providers assigned value verification,
homogeneity, and stability testing for any audit sample/analyte for which the
Participant has reported or received data?
7.4.2- TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Upon request, and only after the Provider has released their evaluation of the
audit sample analyses results, does the Provider release to the PT Executive
Committee the results of the Providers assigned value verification,
homogeneity, and stability testing for any audit sample/analyte?
7.4.3- TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
To protect the blind nature of the audit sample, does the Provider ensure the
manufacturing lot number does not appear on any labels or documentation they
provide to Participants and the PT Executive Committee, for assigned value
verification, homogeneity, or stability testing?
7.5- TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Do Providers label each audit sample with a unique identifier, the SSAS
number?
8.0- TNI Standard V1M1-2009 (SSAS Requirement) - Ordering and Reporting Instructions
8.1 – TNI Standard V1M1-2009 (SSAS Requirement)
Document
Review
Requirements
Assessment Compliant
Does the provider receive an audit sample order from a Facility?
Does the provider contact the appropriate Regulatory Agency to request any
specific requirements (e.g. changes to the audit sample concentration and/or
shipment address) prior to shipment of the audit sample?
The Provider may ship the audit sample if response is not received from the
Regulatory Agency within fifteen (15) calendar days of such request.
a) Does the Provider ensure that the audit sample is sealed such that
opening or tampering will be apparent?
b) Does the Provider ship the audit sample to the Facility, unless the
Regulatory Agency requests that it be shipped, instead to the
Regulatory Agency?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
c)
If the Facility cancels or modifies an audit sample order at any time,
does the Provider notify the Regulatory Agency of such cancellation or
modification within two (2) business days of the receipt of such
notice?
8.2 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the provider provide instructions with each audit sample shipment,
describing :
a)
How to handle, store, dilute, or otherwise prepare the audit sample?
b) How to report the data?
Is the following attestation statement be signed and submitted with the data?
“By affixing my signature below, I attest that the audit sample analyses results
have met the following criteria:
1) I have no prior knowledge of the concentration of target
analyte(s) in the audit sample. No additional information was
solicited or received concerning the assigned values or
acceptance ranges for the audit sample.
2) The audit sample(s) I am reporting was/were analyzed in the
same laboratory under the same calibration, utilizing the
same quality control standards, by the same analysts
following audit sample instructions as the stationary source
test samples.
3) The stationary source test laboratory results and the audit
sample analyses results have been reported to the
appropriate regulatory agency”
c) The expiration date or valid time frame of the audit sample being
provided?
d) A warning that the TNI Standard requires audit samples to be analyzed
at the same time as the stationary source test samples utilizing the
same analysts, methods, and quality control procedures?
e) A warning that the TNI Standard requires audit samples that test the
field stack sampling process (e.g., for EPA Method 25), to be collected
before, during, or after the collection of the field samples, or as
directed by the Regulatory Agency, utilizing the same methods and
quality control procedures?
8.3– TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider not:
a) Provide inappropriate assistance to the Participants, nor encourage the
non-routine analysis of audit samples?
b) Suggest or direct that Laboratories use additional quality control
samples or quality control samples designed specifically for a given
audit sample, in conjunction with any audit sample?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
c)
Provide excessive volume of any audit sample that may encourage
non-routine analyses?
Note: The Provider Accreditor, in consultation with the PT Executive
Committee, will determine what constitutes excessive volume based on method
requirements and common Provider practices within the industry.
d) Provide actual concentration of audit sample to the Facility?
e)
Ship an audit sample past its established expiration date?
f)
Send the same audit sample twice to the same Facility or Laboratory?
9.0 – TNI Standard V1M1-2009 (SSAS Requirement) – System from Reporting
Document
Review
Requirements
Assessment Compliant
Does the provider:
a) Have procedures and systems in place to ensure the accurate, timely,
and secure transmission of audit sample data to the Provider?
b) Have a reporting mechanism that ensures the results received by the
Provider are consistent with those submitted?
c)
Ensure that results reported are not delayed or lost due to the
Provider’s reporting mechanism?
d) Ensure that data are kept secure and that they are not subject to
unauthorized dissemination either during or after data reporting to the
Provider?
e) Evaluate only the analytes of interest for each audit sample as
reported?
10.0 – TNI Standard V1M1-2009 (SSAS Requirement) – Audit Sample Data Analysis
10.1- TNI Standard V1M1-2009 (SSAS Requirement) – Data Review
Document
Review
Requirements
Assessment Compliant
On a periodic basis to be determined by the Provider Accreditor, does the
Provider review the data reported for the following conditions?
10.1.1 Does the Provider review all audit sample data for bimodal or multimodal distribution and/or situations where results from a given method have
disproportionately large failure rates or reporting anomalies?
10.1.2 If a multi-modal distribution is found related to an analytical method, is
this data reported to the SSAS Expert Committee?
10.1.3 Does the Provider review all audit sample data for disproportionately
high or low failure rates compared to historical norms?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
10.2 - TNI Standard V1M1-2009 (SSAS Requirement) – Evaluation of Individual Participant Results
10.2.1 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the Provider evaluate a result as “Acceptable” if it falls within the SSAS
Table-defined acceptance limits?
10.2.2 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider evaluate a result as “Not Acceptable” if it falls outside the
SSAS Table-defined acceptance limits?
10.2.3 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider evaluate a result as “Not Acceptable” if it cannot be
evaluated (e.g. alpha characters for a quantitative test or reported as a less than
or greater than value).
10.2.4 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
If the Provider invalidates an analyte in the audit sample, are all evaluations for
data reported for that analyte reported as “No Evaluation”? Is a discussion of
the situation leading to the invalidation included in the final report to
Participants?
11.0 – TNI Standard V1M1-2009 (SSAS Requirement) – Generation of Reports
11.1- TNI Standard V1M1-2009 (SSAS Requirement) – Schedule
11.1.1 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider submit the evaluation reports defined in Section 11.2 to the
required parties no later than three (3) business days after the reporting of the
audit sample data?
11.1.2 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider submit evaluation reports to Facilities, Facility-requested
Regulatory Agencies, Stationary Source Testers that performed the test and test
method audited, Laboratories that analyzed the audit samples, other parties
requested by the Facility, and to the SSAS Central Database within the same
twenty-four (24) hour period?
Note: Evaluation reports may be submitted in hardcopy of electronic form.
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE:
11.2- TNI Standard V1M1-2009 (SSAS Requirement) – Evaluation Report
11.2.1– TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Document
Review
Assessment Compliant
Does the Provider include the following information in the evaluation report?
a)
Provider Name
b) Provider Accreditation Number
c)
Participant Facility Name
d) Participant Facility physical address
e)
Name, title, and telephone number of Facility point of contact, as
provided
f) Laboratory’s or Stationary Source Tester’s name address, and other
contact information (e.g. telephone, email and fax)
g) Date evaluation report was prepared
h) Date evaluation report was amended, if applicable
i)
Discussion including any pertinent information which addresses
unusual details of the audit sample (e.g. need to change an assigned
value or delete an analyte from evaluation)
11.2.2 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does the Provider include the following information for each audit
sample/analyte in the final evaluation report?
a) SSAS Number
b) Analyte Name
c) Analyte code defined in the SSAS Table
d) Identification of any analytes not included in the Providers
accreditation
e) Assigned value
f) Acceptance limits
g) Laboratory value, as reported
h) Method name or description, as reported
i) Matrix description
j) Analysis dates, as reported by the participating Laboratory
k) Evaluation, per Section 10.2 above
l) Stationary Source Test Start Date
11.2.3 – TNI Standard V1M1-2009 (SSAS Requirement)
Requirements
Does each page of the final evaluation report include an indication of the length
of the report, presented by either “Page X of Y” or the total number of pages
with each page consecutively numbered?
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
CUSTOMER NAME / LOCATION:
ASSESSOR NAME:
DATE:
ACLASS SCOPE / METHOD ASSESSMENT REVIEW
17043 ASSESSMENT REPORT
REVIEW MATRIX
PTP NAME:
ISO/IEC 17043 Section→
Parameter/
Test Name or
Technology
Test
Identification
Depth of
Assessment
*see codes
ASSESSMENT DATE(S):
4.2
4.3
4.4
4.7
Name(s) of
Personnel
Interviewed
Equipment /
Materials
Scheme
Design /
Assigned
Value
Data Analysis
and Evaluation
ASSESSOR NAME:
Sampling;
Handling/
Prep.
Instructions
Page ___ of ___
Quality
Checks
DATE COMPLETED:
NOTES:
ACLASS Form 38
PT Provider Accreditation Checklist
February 1, 2013
5.13
4.8
Records
Report