AOAC Official Methods of AnalysisSM

144 Pages·2012·9.39 MB·English

AOAC Official Methods of
AnalysisSM
Darryl Sullivan, Covance Laboratories and Past President, AOAC INTERNATIONAL
On March 28, 2011, the AOAC INTERNATIONAL
Board of Directors approved an alternative path to
achieve an Official Method (Official First Action status)
for methods selected and reviewed using the AOAC
volunteer consensus standards development
processes.

How this change came about…
Rationale for Change
AOAC’s ability to validate fully collaboratively
•
studied methods has been steadily on the decline,
approving only three in 2010.
AOAC was repeatedly disappointing customers
•
and communities who needed methods to solve
problems.
AOAC already had a reputation of being slow and
•
old with cumbersome processes – was potentially
facing decline in the confidence of our brand.
Rationale for Change
AOAC has evolved and now acts as a problem solver
•
through a broader process of consensus building and
standards development.

AOAC is trying to meet community/customer needs
•
by gathering the world’s authorities to articulate and
evaluate methods needs through expertise and
judgment.
Rationale for Change
AOAC decided to find a way to give proper weight to
•
the confidence we have in the judgment and collective
knowledge of our experts.

AOAC decided to align our brand and method output
•
closer to our proven standards development processes

The “new” or “alternate” path…
How it Works – At a Glance
Funded Stakeholder Panel
Working Groups to establish Standard
Method Performance Requirements
(SMPRs)
Expert Review Panels to adopt
methods as Official First Action based
upon performance against SMPRs
How it Works: The Details
Expert Review Panels
Must be supported by relevant stakeholder body


Membership is carefully managed and properly vetted by

the AOAC Official Methods Board

Holds transparent public meetings only


Remains in force to monitor methods as long as method is

in First Action Status.
How it Works: The Details
Official First Action Status Decision

Method adopted by ERP must perform adequately against

the SMPR set forth by the stakeholders

Method becomes Official First Action on date when ERP

decision is made.
How it Works: The Details
Official First Action Status Decision

Methods to be drafted into AOAC format by a

knowledgeable AOAC staff member or designee in
collaboration with the ERP and method author.

Report of decision complete with ERP report regarding

decision including scientific background (references etc) to
be published concurrently with method in traditional
AOAC publication venues
How it Works: The Details
Transition to Final Action Status

ERP will monitor performance and data submitted for two

years

Further data indicative of adequate method reproducibility

performance to be collected. Data may be collected via a
collaborative study or by proficiency or other testing data
of similar magnitude