Laboratory Policy # Lab-01
Revision # A
Last Reviewed/Update Date Nov-25-19
SOP Decision Rules for compliance
Approval E. Matamoros Signature
Name statements
Laboratory Policy
1. Purpose
The new revision of ISO/IEC 17025 produced in 2017 has new requirements for laboratories when customers ask for
statements of conformity associated with their calibration (e.g. pass/fail, in-tolerance/out of tolerance).
2. Scope
Detail of what decision rules are and how much risk is associated with each type
3. References
ISO/IEC 17025:2017 General Requirements For The Competence Of Testing And Calibration Laboratories
JCGM 106:2012 [2] Evaluation of measurement data - The role of measurement uncertainty in conformity assessment.
ILAC-G8:09/2019 Guidelines on Decision Rules and Statements of Conformity
JCGM_106_2012_E Evaluation of measurement data – The role of measurement uncertainty in conformity assessment.
Robert Stern/Jon Harben Keysight Technologies, Decision Rule Reporting to Comply with ISO/IEC 17025
4. Definitions
Tolerance Limit (TL) (Specification Limit): specified upper or lower bound of permissible values of a property
Tolerance Interval (Specification Interval): interval of permissible values of a property
Measured: quantity value representing a measured result
Acceptance Limit (AL): specified upper or lower bound of permissible measured quantity values
Rejection Interval: interval of non-permissible measured quantity values
Guard Band (w): interval between a tolerance limit and a corresponding acceptance limit where length 𝑤=|𝑇𝐿−𝐴𝐿|
Decision Rule: rule that describes how measurement uncertainty is accounted for when stating conformity with a
specified requirement.
Simple Acceptance: a decision rule in which the acceptance limit is the same as the tolerance limit
Indication: quantity provided by a measuring instrument or measuring system
Expanded Measurement Uncertainty (U): The expanded uncertainty U is obtained by multiplying the combined
standard uncertainty uc(y) by a coverage factor k:
U=kuc(y)
Test Uncertainty Ratio (TUR): the ratio of the tolerance, TL, of a measurement quantity, divided by the 95% expanded
measurement uncertainty of the measurement process where 𝑇𝑈𝑅=𝑇𝐿/𝑈
Specific Risk: is the probability that an accepted item is non-conforming, or that a rejected item does conform. This risk
is based on measurements of a single item.
Global Risk: is the average probability that an accepted item is non-conforming, or that a rejected item does conform. It
does not directly address the probability of false accept to any single item, discrete measurement result or individual
workpiece.
In-Tolerance: The measured value is within the Lower and Upper Tolerance Limits, inclusive.
In-Compliance: The measure value is within the Lower and Upper Acceptance Limits, inclusive.
5. Prerequisites
Customer and laboratory must agree at moment of contract review if a compliance statement will be made and what
decision rule will be employed to arrive at such statement.
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Laboratory Policy # Lab-01
Revision # A
Last Reviewed/Update Date Nov-25-19
SOP Decision Rules for compliance
Approval E. Matamoros Signature
Name statements
6. Policy Overview
6.1 DECISION RULE
6.1.1
ISO/IEC 17025:2017 defines a decision rule as:
“rule that describes how measurement uncertainty is accounted for when stating conformity with a specified
requirement”
6.1.2
A decision to accept an item as conforming, or reject it as non-conforming, to specification is based on a measured value
nm of a property of the item in relation to a stated decision rule that specifies the role of measurement uncertainty in
formulating acceptance criteria. An interval of measured values of a property that results in acceptance of the item is
called an acceptance interval.
In basic terms, the “decision rule” is the description of how we decide the acceptability of a statement such as “meets or
does not meet specification”, “pass/fail”, “in/out of tolerance”, etc.
6.1.2
Different decision rules have varying levels of risk that the laboratory can make an incorrect decision for the customer,
calling a good instrument bad or a bad instrument good.
Table1
Decision rule Guard Band Specifik Risk
w
6 sigma 3U < 1 ppm PFA
3 sigma 1.5 U <0.16% PFA
ILAC G8:2009
rule 1U <2.5% PFA
ISO 14253-
1:2017 [5] 0.83 U <5% PFA
Simple
acceptance 0 <50% PFA
Item rejected for measured value grater then AL = TL +
Uncritical -U U <2.5% PFR
Customer % defined by Customers may define arbitrary percentage to have
defined customer applied as guard band
Table 1. PFA = Probability of False Accept and PFR = Probability of False Reject
(Assumes a single sided specification and normal distribution of measurement results)
6.2 ACCEPTANCE MODELS
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Laboratory Policy # Lab-01
Revision # A
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SOP Decision Rules for compliance
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6.2.1
The acceptability of a decision rule comes down to how the laboratory applies it (acceptance model), what and how
much risk is associated with each type of model when making that measurement decision on whether something is
“good” or how “good” it is.
Simple Acceptance Model (zero guard band):
It can also be referred to as the “simple decision rule” (See 8.2.1 of JCGM 106 [1]). The customer agrees that Pass/Fail
decisions are based on tolerance limits chosen based on simple acceptance because Pass is reported whenever the
measured result is in-tolerance and “Fail” is reported when the measured result is out-of-tolerance. The Simple decision
rule is based on mutually agreed testing limits and maximum acceptable expanded uncertainty, usually expressed as
measurement capability index (See 3.3.17 of JCGM 106 [1]) or test uncertainty ratio (TUR) >= 1.
When a measured result is at the tolerance limit See Figure 1 (case C), the specific probability of false accept (PFA) is
50% and the specific probability of false reject (PFR) is also 50% (See 8.3.1.2 of JCGM 106 [1]). For this reason, the
decision rule is also commonly referred to as the “shared risk rule” because at the tolerance limit the consumer(customer)
and producer(laboratory) risks are equal.
Note: The laboratory is not considering the uncertainty in this decision, but in light of the higher level of risk associated
with this model, the laboratory will publish the calibration MU on the results so that the customer can further evaluate
how it may apply to their operation.
Guard Band Acceptance Model (95% guard band)
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Laboratory Policy # Lab-01
Revision # A
Last Reviewed/Update Date Nov-25-19
SOP Decision Rules for compliance
Approval E. Matamoros Signature
Name statements
The laboratory may employ a guard band equal to the 95% expanded uncertainty as per ILAC-G8[9], the use of guard
band can significantly reduce the probability of making an incorrect conformance decision (probability is at most 2.3%).
The guard band is a type of a safety cushion designed to reduce the acceptance limit.
In the guard band model, the decision rule is to compare the measurement results with the acceptance zone limits, being
considered in compliance if the measured value is inside this zone and noncompliant otherwise.
In the previous example (Figure 2) Cases A, B and C are inside the acceptance limit and as a result they are acceptable
but case D is outside therefore it can be determined as In-Tolerance but non-compliant.
Customer defined Acceptance model
If customer has different and specific requirements or acceptance, customer can provide to the laboratory their own
guard band, specifications and/or acceptance requirements by completing form 780.1 (Decision rule-acceptance
requirements), Techmaster will then review and process requirements accordingly in the same manner it does contract
review.
Note: Another option is that the standard method requested such as an ASTM, etc. to use for the calibration has
internally defined what the decision rule is to be applied and thus is already documented in the method, thus you don’t
need any further documentation or a decision rule.
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Laboratory Policy # Lab-01
Revision # A
Last Reviewed/Update Date Nov-25-19
SOP Decision Rules for compliance
Approval E. Matamoros Signature
Name statements
6.3 Customer communication and approval
6.3.1
A conversation between the customer and the laboratory will exist at some point, and the laboratory must communicate
at contract review (quote) these requirements/options to ensure that the specification of the decision rule on how the
laboratory makes a statement of conformity is selected and defined.
Clear communication of the decision rule must be achieved in a manner that it is easily understood by both the laboratory
and the customer and a statement on which decision rule was applied will be stated on the calibration report/certificate.
6.4 Conclusion:
6.4.1
It doesn’t matter who defines the decision rule as long as it is documented, clearly communicated to and acceptable to all
parties and it is reported as part of the calibration results.
Note: the customer may request special compliance requirements either to a published standard, regulatory
requirements or custom specifications in which case the laboratory is not required to determine level of risk or provide
any compliance statement other than to the customer request.
8. Change History
Rev# Change description Authorized Date
A Initial Release E. Matamoros 11-25-2019
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