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Acceptance Criteria

The Acceptance Criteria page defines, for each method–element combination, the acceptable limits, the measurement uncertainty and the rule by which a statement of conformity is reached (EN ISO/IEC 17025:2017 §7.6, §7.7, §7.8.6).

Found under: Quality Control → Acceptance Criteria.

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Fields

FieldDescription
Document No.Unique criteria code (for example AC-YYYY-0001). Leave blank for auto-numbering.
Lab MethodThe analysis method to which the criteria apply
ElementThe chemical element or parameter being evaluated
Lower LimitThe minimum acceptable measurement value
Upper LimitThe maximum acceptable measurement value
UncertaintyThe expanded measurement uncertainty (±U)
Calculation FormulaMathematical formula (optional, hidden column); a preview of the result shows below the field
Decision RuleThe rule behind the statement of conformity — see below
Decision Rule NotesRounding, averaging of replicates, outlier handling (Eurachem MUC §3)
Specification / standard§7.8.6.2(b) — where the limits come from; printed beside the conformity statement
NotesAdditional remarks or instructions

Decision rules

RuleWhen
Simple AcceptanceThe value is judged as it stands; needs an uncertainty pre-condition, see below
Guard BandsThe limit is shifted by a guard band so the risk of false acceptance is contained
ILAC-G8The rule from the ILAC-G8 guidance
Customer SpecifiedThe rule agreed on the order or in the standing terms
Qualitative Match§7.8.2 — for examinations with no numeric result

The simple-acceptance pre-condition

Simple acceptance is not "no rule". A value landing exactly on the limit carries a 50 % false-decision risk unless we know how narrow the uncertainty is relative to the specification interval. So the criterion accepts two bounds, either or both:

FieldMeaning
Min. capability index C95C95 = (TU − TL) / (2·U95) — how many times the uncertainty "fits" into the specification interval
Max. expanded uncertainty UmaxAn absolute cap on U. Target per Eurachem STMU §5.1.2: (upper − lower limit) / 8, or the proficiency-testing scheme's σ

The guard band

Under the guard-bands rule, the band comes from two fields:

FieldMeaning
Coverage factor kThe k of the stored expanded U (§7.6)
Max. false-acceptance probability PFAmax (%)How much false-acceptance risk you accept

The band becomes w = kw·u, with u = U/k and kw from the standard normal distribution for PFAmax (UKAS LAB 48 App C). Leave PFAmax empty and the band becomes w = U95 — the typical band, at roughly 2.5 % false acceptance.

Provenance of the uncertainty (§7.6)

A U value with no provenance is not a record. The criterion holds four fields for it:

FieldDescription
Uncertainty BasisType A — statistical (e.g. QC) · Type B — literature/certificates · From method validation · Not estimable
Uncertainty ScaleLinear (± in the unit) or Logarithmic log10 — see below
U Evaluated OnWhen it was evaluated
U includes sampling§7.6.1 — whether sampling uncertainty is inside U
U Derivation Record§7.6.3 — sources, data, combined u and k. The full worksheet can be attached to the method validation

Above the derivation field there is a collapsible box listing the minimum contributors a complete uncertainty budget must name under §7.6.3. Open it the first time you write a derivation.

The Uncertainty field shows, where one exists, a Type A suggestion from the most recent locked QC series for the same method–element pair. It is an indication only: it never fills the field by itself.

Logarithmic scale for counts

For microbiological counts (ISO 19036) the uncertainty is not symmetric around the value. With Logarithmic log10, U is expressed in log10 units, the interval becomes asymmetric, and the guard band is computed on the log scale.

Qualitative match (§7.8.6)

When the examination yields no number, the "specification" is not an interval but the expected verdict, and the limits above do not apply. Choosing the Qualitative Match rule reveals an Expected Result field with the four verdicts: Detected, Not detected, Presumptive positive, Invalid examination.

With no expected result the rule judges nothing. The criterion says so on the spot, rather than leaving the lab wondering why nothing is being evaluated.


See also

Connects to

Points at — this page does not stand without these:

If this is missing

  • With no criterion for a method-element pair, the measurement gets no conformity verdict. No

error appears; there is simply no ✓ or ✗. The report goes out with a number and no judgement.

  • 🔴 A simple-acceptance criterion with no capability pre-condition is the subtlest gap: a value

sitting exactly on the limit is called "in" with a 50 % chance of a wrong decision. That is

why the criterion accepts either a C95 capability index or a maximum-uncertainty cap — fill one in.

  • An indeterminate verdict is not an omission but a brake: the approval guard blocks approval

until a person decides.