II.
CONTINUAL IMPROVEMENT GOAL-
Method modification process
(cont).
Modified Method Submission
1.
Applicant submits the final modified method (with any supporting documentation)
2.
To assist the OMB review , the CSO reviews the submission and prepares a packet to
submit to the OMB, which may include:
a.
Summary of data
b.
Copy of the modified method (with the changes from the current method tracked)
c.
Notation of any deficiencies form the modification response
3.
CSO package is sent to the OMB for review
a.
All OMB members will review the method modification package.
b.
The OMB chair will typically appoint at least 2 OMB members to lead the discussion
of the modification. These members will have experience with the
method/technology and will perform an in-depth review.
c.
At this point, the OMB may also decide to consult with additional SMEs.
4.
Based on the review and discussion, the OMB comes to a consensus:
a.
The OMB may accept the method modification as submitted.
b.
The OMB may not accept the method modification as submitted. The reasons for
not accepting must be clearly defined. The reasons and any recommendations will
be forwarded to the applicant
5.
If/when the method modification is approved
a.
The proposed modification will be posted for comment (60-90 days)
b.
After the comment period, OMA will be changed
III. OTHER DECISIONS AND ACTIONS OF THE AOAC OMB
OMB Meetings and Teleconferences
•
30 July- July 1st 2014: in-person meeting (Chicago*/Gaithersburg)*
**Thank you to Sillikar Laboratories for hosting this meeting at their corporate headquarters
in Chicago
•
7 August 2013: Teleconference
•
21 August 2013: Teleconference
•
The next in-person OMB meeting is September 11, 2014 (Boca Raton)
Method Modifications
•
AOAC 2009.01 and AOAC 2011.25 –
OMB recommends that an ERP be established to determine if/what additional work is
needed for Final action consideration.
Official Methods Pathway
ERPs approved- PAH, Pesticides and Dietary Starch
Stakeholder Voting Panels were approved (for the 2014 annual meeting)- SPDS, SPIFAN,
ISPAM, SPSFAM
Erin Crowley approved as Chair of ISPAM
The appointed volunteer role of Study Director has transitioned into the unappointed
volunteer role of Method Author. OMB reached consensus that Method Author is more
consistent with the direction of AOAC and method conformity.
