119 / 164
5
Members of the Committee on Statistics did participate as observers during the discussions on
1
developing general SLV protocol guidance.
2
3
REPRODUCIBILITY/UNCERTAINTY:
4
A.
For quantitative methods, data demonstrating Reproducibility & Uncertainty must be present.
5
Experimental designs to collect this data may vary with the method protocol, available laboratories,
6
and the intended use of the method (i.e., collaborative studies, proficiency testing, etc…)
7
8
The ERP reviewed data statistical sheet
s 12with multi-laboratory testing data for AOAC 2012.16. The data
9
was collected using a general multi-laboratory protocol has been established by the method authors,
10
ERP chair and OMB liaison to SPIFAN ERP. Method authors drafted their own testing protocols and
11
these were forwarded to the ERP chair and the OMB liaison for their input and comments. The multi-
12
laboratory study results were submitted for the ERP’s consideration during their March 2015 meeting.
13
B.
Guidance and support can be obtained from the AOAC Committee on Statistics.
14
15
The OMB liaison served as facilitator by working with both members of the AOAC Committee on
16
Statistics and the method author to ensure a sound study design for the multi-laboratory testing and to
17
ensure the appropriate statistical tools were available to analyze the data. Since this method will be
18
reviewed within ISO and IDF, members of the AOAC Committee on Statistics also reviewed the statistical
19
tool with respect to ISO standards for methods.
20
21
COMPARISON TO SMPR:
22
A.
Document method performance versus SMPR criteria. Note which SMPR criteria are met. For SMPR
23
criteria not met, the ERP documents the reasoning why the method is still acceptable.
24
25
The draft SMPR
13was presented and approved in 2012 by AOAC SPIFAN. The ERP found that the
26
method did meet the SMPR method performance criteria satisfactorily in their collective judgment. The
27
two parameters of AOAC SMPR 2012.009 that were not met by the method at the time it was adopted
28
for First Action OMA status included reproducibility and use of the stated reference material, NIST SRM
29
1849a. The ERP were satisfied that these would be addressed in the multi-laboratory testing for AOAC
30
12
AOAC 2012.16 multi-laboratory testing data summary reports
13
Pan, Shang-Jing,
Approval of SMPR for Pantothenic Acid
(2012) AOAC SPIFAN Meeting – AOAC Annual Meeting, September
29, 2012.