43 z5403 Checklist
43 z5403 Checklist
43 z5403 Checklist
ASSESSOR NAME:
DATE
ANSI/NCSL Z540.3:2006 CHECKLIST
Include specific references to records or written procedures witnessed for areas identified by bold type.
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Assessment
Compliant
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Assessment
Compliant
Does the laboratory ensure that the scope of calibration capability is consistent with
the calibration requirements of the customer contracting the service?
5.3Q2
Requirements
Does the laboratory ensure the levels of measurement decision risk are acceptable to
both the customer contracting the service and the laboratory?
Note: In many measurements associated with calibrations, a tolerance is given to define what is considered an acceptable
performance range. This tolerance itself is one form of decision criteria that is applied to the result of a measurement that may
define further actions. As the measurement quantity being calibrated is drawn from some large population with a distribution of
values and the calibration process exhibits a degree of measurement uncertainty, the decision itself is subject to error.
For example, if the measured value exceeds the tolerance limits and is declared out-of-tolerance, there is some chance that
this decision is actually wrong. This type of incorrect decision is called a false reject. The risk (or probability) of making this
type of incorrect decision is called false reject risk. Additionally, if the measured value is within the tolerance limits and is
declared in-tolerance, there is some chance that this decision is also wrong. This alternative type of incorrect decision is
called a false accept. The risk (or probability) of making this type of incorrect decision is called false accept risk. When
viewed as a population, the proportion of the total wrong test decisions to the total number of tests conducted may be
considered the measurement decision risk. Typical analyses focus on only part of the risk, such as false accept risk or false
reject risk. Each of these are simply the proportion of wrong decisions in the categories of accept or reject decisions,
respectively, of the total tested. Sub-clause 5.3 applies the overall measurement decision risk to the scope of a calibration
capability. Sub-clause 5.3 b applies this concept to limiting the probability that incorrect acceptance decisions (false accept)
will result from calibration tests to 2 %.
5.3Q3
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Requirements
Assessment
Compliant
In cases where the customer requests measured values be reported, does the
laboratory ensure that the measurement uncertainty is acceptable to the customer
and is the acceptance documented?
ASSESSOR NOTE: Acceptance by the customer of the certificate of calibration with data and uncertainties will suffice for this
requirement. If uncertainties are not listed on the certificate at customer request, other documentation must be provided to the assessor
for verification of acceptance.
ACLASS Form 43
1 February 2011
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE
5.3Q4
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Requirements
Assessment
Compliant
In cases where the customer requests verification that measurement quantities are
within specified tolerances (statement of compliance), does the laboratory ensure
that the probability that incorrect acceptance decisions are made (Probability of
False Accept) (PFA) does not exceed 2% and has the laboratory documented this?
ASSESSOR please specify method used or attach documentation with report.
ASSESSOR NOTE: The Handbook for the Application of ANSI/NCSL Z540.3-2006 Requirements for the Calibration of
Measuring and Test Equipment contains several methods for calculating estimated PFA. These are not all-inclusive and other methods
encountered by assessors will require analysis for suitability.
Note: Achieving these requirements may involve adjustment and management of calibration system parameters such as:
measurement reliability, calibration intervals, measurement uncertainty, calibration tolerances, and/or guard bands.
5.3Q7
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Assessment
Compliant
In cases where it is not practicable to estimate PFA, does the laboratory ensure that
the Test Uncertainty Ratio (TUR) is equal to or greater than 4:1?
TUR is calculated as follows (UUT = unit under test):
UUT upper tolerance limit UUT lower tolerance limit
2 (95% expanded uncertainty of measurement process)
For example, a 0 to 100 psi pressure gage has a tolerance of +/- 1 psi and the applied value is 50 psi. The 95% expanded uncertainty of the
measurement process is calculated to be 0.5% of applied value. After ensuring all inputs to the formula are in the same units of measure
(0.5 % of 50 psi = 0.25 psi), the TUR is calculated as follows:
51 - 49 =
2
=
4
2 (0.25)
0.5
1
However, at an applied value of 100 psi, since the uncertainty is 0.5 % of 100 psi or 0.5 psi, the TUR is:
101 - 99
=
2
2 (0.5)
1
5.3Q8
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Requirements
Assessment
Compliant
Is all measuring and test equipment (M&TE) included in the laboratorys calibration
system including measuring systems, calibration equipment, reference standards and
material, and other inspection and monitoring equipment, calibrated prior to use and
recalibrated at predetermined intervals to ensure acceptable measurement
uncertainty, traceability, and reliability? Intervals may be based on usage or time
since last calibration.
ASSESSOR NOTE: In order to meet this requirement, the laboratory should have specified measurement uncertainty, traceability,
and reliability goals in place and be able to demonstrate to the assessor how these goals will be achieved. Laboratories experiencing
their initial accreditation assessment to this Standard may not yet have the history needed to set intervals or time limits to meet these
goals but should be able to explain how this will be done.
5.3Q9
ACLASS Form 43
1 February 2011
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE
Requirements
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Assessment
Compliant
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Assessment
Compliant
When there is doubt as to the suitability of an item for calibration, when an item
does not conform to the description provided, or the calibration required is not
specified in sufficient detail by the customer, does the laboratory consult with the
customer for further instructions before proceeding and is there a record of the
discussion?
5.3.1
Requirements
5.3.1.2
ACLASS Form 43
1 February 2011
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE
Requirements
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Assessment
Compliant
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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
Document
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Assessment
Compliant
Are controls adjusted when the results of previous measurements indicate that such
action is appropriate to maintain acceptable measurement uncertainty or reliability?
Measurement assurance controls may be based on the use of calibrated check
standards, usage, and/or time since the last performance.
5.3.2d
Requirements
Are the measurement assurance procedure and any associated M&TE documented
as a calibration procedure in accordance with section 5.3.1 of this Standard?
5.3.3
Requirements
5.3.3.1
ACLASS Form 43
1 February 2011
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE
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Requirements
Does the laboratory have a documented procedure for estimating and expressing
the uncertainty of measurement for all calibrations? Does the procedure
address/contain:
Sources of measurement uncertainty?
Assessment
Compliant
*
5.3.3.2a
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Compliant
*
Requirements
Assessment
Compliant
When traceability to SI units is not available through NIST or any other acceptable
NMI, or SI units are not established, does the laboratory apply a consensus standard
including a reference standard and related calibration procedures, which are clearly
specified and mutually agreed upon by all parties concerned?
ASSESSOR NOTE: A consensus standard is an artifact and process that is sufficiently characterized and stable that it can be used as
an interim standard until sufficient measurement traceability through an NMI to the SI units of measurement can be established.
ACLASS will determine on a case-by-case basis whether the use of a consensus standard is acceptable. Assessors should provide all
available objective evidence with this checklist for ACLASS evaluation.
Note: Section 5.3.3.3 does not exist in the National Standard.
5.3.3.4a
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Compliant
Are all M&TE required for the correct performance of calibrations and related
measurements, including calibration and reference standards and reference material,
available to the laboratory?
5.3.3.4b
ACLASS Form 43
1 February 2011
CUSTOMER NAME/LOCATION:
ASSESSOR NAME:
DATE
Requirements
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Assessment
Compliant
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Assessment
Compliant
In those cases where the laboratory needs to use equipment outside its permanent
control, does it ensure that the requirements of this National Standard are met?
5.3.3.4c
Requirements
Does the laboratory ensure M&TE that may affect the results of calibrations is itself
calibrated and is included in a calibration system meeting the requirements of this
National Standard?
Note: Sections 5.3.4 through 5.3.8 are equivalent to ISO/IEC 17025:2005 requirements and are assessed in that checklist.
5.3.9Q1
Requirements
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Assessment
Compliant
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Assessment
Compliant
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Assessment
Compliant
Are records maintained of each item of equipment and software where its use
contributes to the results of the calibrations performed? Do these records include:
5.3.9Q2
Requirements
Are specific laboratory personnel authorized to generate, amend, issue, and delete
records?
5.3.9Q3
Requirements
Does the laboratory document the reasons for amendments or deletion of records?
ACLASS Form 43
1 February 2011