© 2012AOAC INTERNATIONAL
AOACO
FFICIAL
M
ETHODS
OF
A
NALYSIS
(2012)
G
UIDELINES
FOR
S
TANDARD
M
ETHOD
P
ERFORMANCE
R
EQUIREMENTS
Appendix F, p. 5
ANNEXA
Format of a
StandardMethodPerformanceRequirement
AOACSMPRYYYY.XXX
(YYYY=Year; XXX=sequential identificationnumber)
MethodName
: Must include the analyte(s), matrix(es), and
analytical technique [unless the standardmethod performance
requirement (SMPR) is truly intended to be independent of the
analytical technology]. Themethod namemay refer to a “common”
name (e.g., “Kjeldahl”method).
ApprovedBy:
Name of stakeholder panel or expert review panel
Final VersionDate
: Date
EffectiveDate:
Date
1. IntendedUse:
Additional information about themethod and
conditions for use.
2. Applicability:
List matrixes if more than one. Provide
details on matrix such as specific species for biological analytes,
or International Union of Pure and Applied Chemistry (IUPAC)
nomenclature and Chemical Abstracts Service (CAS) registry
number for chemical analytes. Specify the form of thematrix such
as raw, cooked, tablets, powders, etc.
3. Analytical Technique:
Provide a detailed description of the
analytical technique if theSMPR is to apply to a specific analytical
technique; or state that theSMPR applies to anymethod thatmeets
themethod performance requirements.
4. Definitions:
List and define terms used in the performance
parameter table (
see
TableA2 for list of standard terms).
5. MethodPerformanceRequirements:
List the performance
parameters and acceptance criteria appropriate for each method/
analyte/matrix.
See
Table A1 for appropriate performance
requirements.
Ifmore thanone analyte/matrix, and if acceptance criteria differ
for analyte/matrix combinations then organize a table listing each
analyte/matrix combination and its minimum acceptance criteria
for each performance criteria.
6. System Suitability Tests and/or Analytical Quality
Control:
Describeminimum system controls andQC procedures.
7. Reference Material(s):
Identify the appropriate reference
materials if they exist, or state that reference materials are not
available. Refer to
Annex E
(
AOACMethodAccuracy Review
) for
instructions on the use of referencematerials in evaluations.
8. Validation Guidance:
Recommendations for type of
evaluation or validation program such as single-laboratory
validation (SLV),
Official Methods of Analysis
SM
(OMA), or
PerformanceTestedMethods
SM
(PTM).
9. Maximum Time-to-Determination:
Maximum allowable
time to complete an analysis starting from the test portion
preparation tofinal determination ormeasurement.
Annex I: Inclusivity/Selectivity Panel
. Recommended for
qualitative and identificationmethodSMPRs.
Annex II:Exclusivity/Cross-ReactivityPanel
. Recommended
for qualitative and identificationmethodSMPRs.
Annex III: Environmental Materials Panel
. Recommended
for qualitative and identificationmethodSMPRs.
