OMB Meeting Book - January 8, 2015

76

Method Modifications Proposal

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.

Applicant requests a method modification

CSO Recommendation and level assignment

OMB review of CSO’s recommendation

Forwarded to CSO

Forwarded to OMB

With Addi’l OMB input

No addi’l OMB input?

Final version of recommendation to be sent to applicant

CSO recommendation revised with OMB consensus input

Final version of recommendation to be sent to applicant

Figure 1

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 oreditorial 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. AllMethod 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. Authorities: Community – These are members of industry, academia and regulatory bodies that need standards or analytical methods to perform their professional duties. WG – The WG drafts the appropriate Standard Method Performance Requirements. SP- Final decisions on the acceptance of SMPRs remain with the appropriate Stakeholder Panel. ERP- All methods are reviewed and approved for First Action and recommended for approval for Final Action or repeal by the Expert Review Panel. All methods that have undergone a method modification are defined as First Action and receive their unique OMA number. OMB- Final decisions on acceptance of Final Action or Repeal for Official Methods of Analysis remains with the Official Methods Board. All decisions on Official Methods require a minimum2/3 vote of the OMB members. BoD - The Board of Directors reserves all decisions on Policy and Association responsibility to the Board of Directors.

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