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Method Modifications Proposal
Page
1
of
4
Immediately below is the process currently on the books. It relies on a single person/body
to make decisions affecting the analytical communities and the Association. A change to
the flowchart is proposed as shown on the next page to reflect the Board’s new Working
Group initiated process approved 12/9/2014. Draft major/minor modification definitions
are included for clarification.
Modification Workflow Concepts:
Any community member may submit a request for a method modification. Modification
submissions go to the Chief Scientific Officer and must include the following paperwork.
Editorial Modification:
A written explanation of the reason(s) for the modification is required.
Typos or editorial corrections or clarifications are forwarded to the OMB for approval then to the
editorial board or OMA editor as appropriate. Methods that have undergone an editorial
modification will retain the same number. A list of the methods with editorial modifications will
be published in
Inside Laboratory Management
and on the Website.
Method Modifications:
Require the submission of data to justify the requested modification. All Method Modifications
go to a Working Group. The Working Group will review the modification proposal. If the WG
determines that a method modification is needed, they will draft the appropriate Standard
Method Performance Requirements to reflect the needs of the community.
1.) Minor Modification, no change or a simple modification of the current SMPRs might
suffice. There is no significant effect to the results; i.e. new results are within (1 or 2
σ)
as
defined by original study and the needs of the community. Regulatory limits should inform the
decision as well. For example, if the compliance limit is +/- 20% and the replicates for the new
method are within about half that range (<10%), then it would probably pass regulatory approval.
2.) Major Modification will require drafting new SMPRs. There is a significant effect on the
results and/or a significant change to the technology. For example, if the modification requires
retraining of technical personnel; or purchase of significantly more expensive equipment; or
significant change in sample prep; or changing the chemistry of any step in the process (e.g.a
different catalyst, pH change, temperature change) all indicate significant changes to technology.
OMB review of
CSO’s
recommendation
CSO
recommendation
revised with OMB
consensus input
Final version of
recommendation
to be sent to
applicant
No addi’l
OMB input?
Final version of
recommendation
to be sent to
applicant
With Addi’l
OMB input
Applicant
requests a
method
modification
CSO
Recommendation
and level
assignment
Forwarded to
CSO
Forwarded to
OMB
Figure 1