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American Association for Laboratory Accreditation
Document Revised:
C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and December 20, 2011
DoD Gray Box Requirements
Page 1 of 10
The following pages present the criteria from the NELAC Appendix C and the current DoD QSM Gray Box requirements in a checklist format as they relate to
the demonstration of capability. The laboratory’s policies and procedures must meet these requirements. Management system documentation and supporting
records must be available for the assessor’s review.
To the best of my knowledge, all laboratory document references below as well as actual laboratory practice have been assessed for compliance with the relevant
clauses of ISO/IEC 17025, the A2LA Environmental Program Requirements, the DoD QSM Gray Box Requirements and the A2LA General Requirements for
Accreditation of Laboratories. I hereby attest that all ‘Yes’ marked compliance clauses, whether initialed or not, meet the aforementioned requirements. Any
areas of noncompliance have been fully described in the Assessor Deficiency Report.
CAB Name:
Address:
Contact:
Phone: Email:
Master Code: Assessment ID:
Certificate(s): Conformity Standard:
Assessment Dates: Assessment Type:
Assessor(s): Assessor Signature(s):
AcO:
L:\Checklists\C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and DoD Gray Box Requirements
American Association for Laboratory Accreditation
Document Revised:
C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and December 20, 2011
DoD Gray Box Requirements
Page 2 of 10
{RESERVED FOR ASSESSORS ONLY}
Requirement Reference Compliance
Comments
Y N NA
C.1 Procedure for Demonstration of Capability
A demonstration of capability (DOC) must be made prior to
using any test method, and at any time there is a change in
instrument type, personnel or test method (see 5.4.2.2).
All demonstrations shall be documented through the use of
the form found in Appendix C (final page of this checklist).
All data applicable to the demonstration need not be
attached to the form, but must be retained and available.
The following steps shall be performed if required by
mandatory test method or regulation. It is the responsibility
of the laboratory to document that other approaches to DOC
are adequate, this shall be documented in the laboratory’s
Quality Manual, e.g., for Whole Effluent Toxicity Testing
see section D.2.1.a.1.
a) A quality control sample shall be obtained from an
outside source. If not available, the QC sample may be
prepared by the laboratory using stock standards that are
prepared independently from those used in instrument
calibration.
b) The analyte(s) shall be diluted in a volume of clean
quality system matrix sufficient to prepare four aliquots at
L:\Checklists\C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and DoD Gray Box Requirements
American Association for Laboratory Accreditation
Document Revised:
C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and December 20, 2011
DoD Gray Box Requirements
Page 3 of 10
{RESERVED FOR ASSESSORS ONLY}
Requirement Reference Compliance
Comments
Y N NA
the concentration specified, or if unspecified, to a
concentration of 1–4 times the Limit of Quantitation.
c) At least four aliquots shall be prepared and analyzed
according to the test method either concurrently or over a
period of days.
d) Using all of the results, calculate the mean recovery in
the appropriate reporting units and the standard deviations
of the population sample (n-1) (in the same units) for each
parameter of interest. When it is not possible to determine
mean and standard deviations, such as for presence/absence
and logarithmic values, the laboratory must assess
performance against established and documented criteria.
e) Compare the information from (d) above to the
corresponding acceptance criteria for precision and accuracy
in the test method (if applicable) or in laboratory-generated
acceptance criteria (if there are not established mandatory
criteria). If all parameters meet the acceptance criteria, the
analysis of actual samples may begin. If any one of the
parameters does not meet the acceptance criteria, the
performance is unacceptable for that parameter
f) When one or more of the tested parameters fail at least
one of the acceptance criteria, the analyst must proceed
according to 1) or 2) below.
1) Locate and correct the source of the problem and
repeat the test for all parameters of interest
L:\Checklists\C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and DoD Gray Box Requirements
American Association for Laboratory Accreditation
Document Revised:
C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and December 20, 2011
DoD Gray Box Requirements
Page 4 of 10
{RESERVED FOR ASSESSORS ONLY}
Requirement Reference Compliance
Comments
Y N NA
beginning with c) above.
2) Beginning with c) above, repeat the test for all parameters
that failed to meet criteria. Repeated failure, however,
confirms a general problem with the measurement system.
If this occurs, locate and correct the source of the problem
and repeat the test for all compounds of interest beginning
with c).
DoD C-1 Certificate Statement: Demonstration of
Capability (Requirement) All attempts to demonstrate
capability shall be documented and available for review.
C.3 Initial Test Method Evaluation
For all test methods other than toxicity and microbiology the
requirements of C.3.1 and C.3.2 apply. For Toxicity testing,
and Microbiology testing, the initial test method evaluation
requirements are contained at Appendix D.2 and D.3,
respectively. For the evaluation of precision and bias
(C.3.3), the requirements of C.3.3(a) apply to standard
methods. The requirements of C.3.3(b) apply to the
methods referenced therein.
DoD C-2 Initial Test Method Evaluation: QC Requirements
for Non-Standard Methods (Requirement)
The laboratory must evaluate non-standard methods
(including laboratory-developed methods) using quality
L:\Checklists\C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and DoD Gray Box Requirements
American Association for Laboratory Accreditation
Document Revised:
C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and December 20, 2011
DoD Gray Box Requirements
Page 5 of 10
{RESERVED FOR ASSESSORS ONLY}
Requirement Reference Compliance
Comments
Y N NA
control procedures and acceptance criteria that are
consistent with those similar standard methods or
technology. At a minimum, quality control procedures must
address:
Calibration;
Interferences/contamination;
Analyte identification;
Selectivity;
Precision; and
Bias.
The use of any non-standard method requires approval by
DoD Personnel.
C3.1 Limit of Detection (LOD)
a) The laboratory shall determine the LOD for the method
for each target analyte of concern in the quality system
matrices. All sample-processing steps of the analytical
method shall be included in the determination of the LOD
b) The validity of the LOD shall be confirmed by qualitative
L:\Checklists\C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and DoD Gray Box Requirements
American Association for Laboratory Accreditation
Document Revised:
C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and December 20, 2011
DoD Gray Box Requirements
Page 6 of 10
{RESERVED FOR ASSESSORS ONLY}
Requirement Reference Compliance
Comments
Y N NA
identification of the analyte(s) in a QC sample in each
quality system matrix containing the analyte at no more than
2–3X the LOD for single analyte tests and 1–4X the LOD
for multiple analyte tests. This verification must be
performed on every instrument that is to be used for analysis
of samples and reporting of data.
c) An LOD study is not required for any component for
which spiking solutions or quality control samples are not
available such as temperature, or, when test results are not
to be reported to the LOD (versus the Limit of Quantitation
or working range of instrument calibration), according to
Appendices D.1.2, D.4.5, D.5.4, and D.6.6. Where an LOD
study is not performed, the laboratory may not report a
value below the Limit of Quantitation.
DoD C-3 Limit of Detection (LOD): Determination and
Verification of LOD (Requirement) Refer to Box D-13 for
DoD requirements pertaining to the LOD.
C.3.2 Limit of Quantitation (LOQ)
a) The laboratory shall determine the LOQ for each analyte
of concern according to a defined, documented procedure.
b) The LOQ study is not required for any component or
property for which spiking solutions or quality control
samples are not commercially available or otherwise
inappropriate (e.g., pH).
L:\Checklists\C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and DoD Gray Box Requirements
American Association for Laboratory Accreditation
Document Revised:
C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and December 20, 2011
DoD Gray Box Requirements
Page 7 of 10
{RESERVED FOR ASSESSORS ONLY}
Requirement Reference Compliance
Comments
Y N NA
c) The validity of the LOQ shall be confirmed by successful
analysis of a QC sample containing the analytes of concern
in each quality system matrix 1–2 times the claimed LOQ.
A successful analysis is one where the recovery of each
analyte is within the established test method acceptance
criteria or client data quality objectives for accuracy. This
single analysis is not required if the bias and precision of the
measurement system is evaluated at the LOQ.
DoD C-4 Limit of Quantitation (LOQ): Determination and
Verification of LOQ (Requirement) Refer to box D-14 for
DoD Requirements pertaining to LOQ.
C3.3 Evaluation of Precision and Bias
a) Standard methods – The laboratory shall evaluate the
precision and bias of a standard method for each
analyte of concern for each quality system matrix
according to the single-concentration four-replicate
recovery study procedures in Appendix C.1 above (or
alternate procedure documented in the quality manual
when the analyte cannot be spiked into the sample
matrix and QC samples are not commercially
available).
b) Non-standard methods – For laboratory-developed test
methods or non-standard test methods as defined at 5.4.3
and 5.4.4 that were not in use by the laboratory before July
2003, the laboratory must have a documented procedure to
evaluate precision and bias. The laboratory must also
L:\Checklists\C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and DoD Gray Box Requirements
American Association for Laboratory Accreditation
Document Revised:
C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and December 20, 2011
DoD Gray Box Requirements
Page 8 of 10
{RESERVED FOR ASSESSORS ONLY}
Requirement Reference Compliance
Comments
Y N NA
compare results of the precision and bias measurements
with criteria established by the client, by criteria given in the
reference method or criteria established by the laboratory.
Precision and bias measurements must evaluate the method
across the analytical calibration range of the method. The
laboratory must evaluate precision and bias in the relevant
quality system matrices and must process the samples
through the entire measurement system for each analyte of
interest.
C.4 Evaluation of Selectivity
The laboratory shall evaluate selectivity by following the
checks established within the method, which may include
mass spectral tuning, second column confirmation, ICP
inter-element interference checks, chromatography retention
time windows, sample blanks, spectrochemical absorption
or fluorescence profiles, co-precipitation evaluations, and
electrode response factors.
L:\Checklists\C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and DoD Gray Box Requirements
American Association for Laboratory Accreditation
Document Revised:
C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and December 20, 2011
DoD Gray Box Requirements
Page 9 of 10
Demonstration of Capability
Certification Statement
Date: Page __ of __
Laboratory Name:
Laboratory Address:
Analyst(s) Name(s):
Matrix:
(examples: laboratory pure
water, soil, air, solid, biological
tissue)
Method number, SOP#, Rev#, and
Analyte, or Class of Analytes or
Measured Parameters
(examples: barium by 200.7, trace
metals by 6010, benzene by 8021,
etc.)
We, the undersigned, CERTIFY that:
1. The analysts identified above, using the cited test method(s), which is in use at this facility for the analyses of samples under the
_________________ Program, have met the Demonstration of Capability.
2. The test method(s) was performed by the analyst(s) identified on this certification.
3. A copy of the test method(s) and the laboratory-specific SOPs are available for all personnel on-site.
4. The data associated with the demonstration of capability are true, accurate, complete and self-explanatory (1).
5. All raw data (including a copy of this certification form) necessary to reconstruct and validate these analyses have been retained at the facility,
and that the associated information is well organized and available for review by authorized assessors.
L:\Checklists\C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and DoD Gray Box Requirements
American Association for Laboratory Accreditation
Document Revised:
C220 – Specific Checklist: Demonstration of Capability with NELAC Appendix C and December 20, 2011
DoD Gray Box Requirements
Page 10 of 10
_________________________________________ __________________________ ___________
Technical Director’s Name and Title Signature Date
_________________________________________ __________________________ ___________
Quality Assurance Officer’s Name Signature Date
This certification form must be completed each time a demonstration of capability study is completed.
True: Consistent with supporting data.
Accurate: Based on good laboratory practices consistent with sound scientific principles/practices.
Complete: Includes the results of all supporting performance testing.
Self-Explanatory: Data properly labeled and stored so that the results are clear and require no additional
explanation.
Document Revision History
Date Description
12/20/2011 Added CAB Information Block
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