MANAGEMENT SYSTEM DOC. NO.

ELPL/QMSP/22
PROCEDURE
ISSUE. NO.02 Dt. 05.10.2020
DECISION RULE
AMEND. NO. 00 AMEND. Dt

PAGE NO. 1 OF 4

1.0 Objective:
The decision rule applied to conformity assessment with a tolerance interval and
uncertainty.

2.0 Scope:
This procedure is applicable to all the personnel who are involved in testing the samples
and preparation of the test reports.

3.0 Responsibility:
Quality Manager, Technical Manager,

4.0 Reference:
Clauses 7.1.3, & 7.8.3.1 b, 7.8.6of ISO/IEC 17025:2017

1.0 Procedure:
5.1 Conformity assessment is a common activity performed in testing, inspection and
calibration. This has a major impact in the Global Economy because it implies accepting
and rejecting items with direct impact in risk analysis, business decisions and reputational
and financial costs.

5.2 To establish procedures in order to perform conformity assessment in practical

situations (e.g. conformity with metric tolerances) objective criteria are needed in what is
called “decision rules”.

5.3 These are intended to define the limits of conformity assessment “conformance zone”
and, considering a probabilistic approach, the “acceptance zone” (measurement results
including uncertainty that are considered acceptable). The recent development of a
probabilistic approach in measurement, introducing measurement uncertainty as a
parameter to express the variability of measurement, had a significant impact in decision
process, as it implies the need to consider the comparison through a probabilistic view.
5.4 The following figure1 shows three possible situations of measurement results and
their uncertainties within a conformity interval to which a decision rule should be applied.
In Figure 1, we can state that the case A is clearly as “in conformity”, the case C is “out
of conformity”, but in case B we have an undefined situation that needs a formal criteria
based on the confidence interval of the uncertainty measurement ( Considered Gaussian
distribution) expected, to be used to decide about it’s conformity.

MANAGEMENT SYSTEM DOC. NO. ELPL/QMSP/22

PROCEDURE
ISSUE. NO.02 Dt. 05.10.2020
DECISION RULE
AMEND. NO. 00 AMEND. Dt

PAGE NO. 2 OF 4

5.6 A statement of conformity in reporting the result is identified as meeting or exceeding

a specification or standard, is to be mention under clause 7.8.6 to which the decision rule
is applied.

5.7

Decision rule:

A documented rule that describes how measurement uncertainty will be allocated with
regard to accepting or rejecting a product according to its specification and the result of a
measurement.

The definition of a procedure intended to perform conformity assessment can be based on

the following steps:
 a. The specification of a measurand (Y) and the measurement item to be tested.
b. The experimental / analytical results (estimates y of the measurand Y).
c. The measurement standard uncertainty, u(y), for a confidence level,( k=2,at 95%
confidence level).
d. The specification of a single tolerance limit (upper or lower) or tolerance interval
limits.

5.8 Acceptance zone: the set of values of a characteristic, for a specified measurement
process and decision rule, that results in product acceptance when a measurement result is
within this zone.

5.9 Rejection zone: the set of values of a characteristic, for a specified measurement
process and decision rule, that will give noncompliance when a measurement result is
within this zone.

5.10 Uncertainty: the magnitude of the offset from the specification limit to the
acceptance or rejection zone boundary.

MANAGEMENT SYSTEM DOC. NO. ELPL/QMSP/22

PROCEDURE
ISSUE. NO.02 Dt. 05.10.2020
DECISION RULE
AMEND. NO. 00 AMEND. Dt

PAGE NO. 3 OF 4

Figure 2a) Example of areas defined for a tolerance interval

Legend: T U – Tolerance upper limit ; Gu –Acceptance zone upper limit ; T L – Tolerance lower
limit ; G L –Acceptance zone lower limit; U(y) – expanded uncertainty of the measurement.
 Figure 2b) Example of areas defined outside of the tolerance interval
Legend: T U – Tolerance upper limit ; Gu –Acceptance zone upper limit ; T L – Tolerance lower
limit ; G L –Acceptance zone lower limit; U(y) – expanded uncertainty of the measurement.
Figure 2a) and Figure 2b) are the examples of an acceptance and rejection zones
respectively. In the first case the uncertainty bands are within the tolerance zone whereas
outside the tolerance zone in the second case. Thus in figure 2a) the focus is on high
confidence of correct acceptance (guarded acceptance) while in figure 2b) it is on high
confidence of correct rejection (guarded rejection).

MANAGEMENT SYSTEM DOC. NO. ELPL/QMSP/22

PROCEDURE
ISSUE. NO.02 Dt. 05.10.2020
DECISION RULE
AMEND. NO. 00 AMEND. Dt

PAGE NO. 4 OF 4

5.11 Based on the criterion demonstrated in Figure 2a) and 2 b) above the laboratory
follows simple decision rule is to compare the measurement results with the acceptance
zone limits, being considered in compliance (accepted) if the measured value is inside
this zone and non-compliant (rejected) if falls outside the zone.

5.12 As the laboratory decisions rule applied in giving the statement of conformity in
the test report based on the conditions shown in Figures 2a) and 2b) , the probability of
the false accept and false reject is almost negligible and thereby the risk associated with
the decision rule is Nil.

5.13 When the decision rule is prescribed by the customer, regulations or normative
documents, a further consideration of the level of risk is not considered.