source manufacturer accreditation

[Lester.Slaback@nist.gov]

The HPS Laboratory Accreditation Policy Committee is considering a
proposal to accredit organizations producing radioactive sources in
accordance with ANSI N42.22 (Traceability of Radioactive Sources to NIST). 
The proposal is from a consortium of source manufacturers but the
accreditation would be open to any interested organization.  Prior to
submitting this proposal to the HPS Board of Directors we would like to
elicit comments from the HP community. A few specific questions follow
which are of particular interest to the committee.  Any other comments are
welcomed*.  [Note: some general discussion is provided below.]

1. Do you currently require purchased radioactive standards to be NIST
'traceable'?

2. Is accreditation of sufficient value that it would be a
required specification in the purchase of selected reference
standards?

3. Would the existence of an accreditation program impact current
activities within your operations relating to the production of sources,
e.g., for Q.A. uses? That is, would your management require your program
to be accreditated or require sources to be acquired from an accreditated
organization?

4. While N42.22 is intended for sources that are to be used as reference
standards would you anticipate your organization or oversight body
applying the standard to sources intended for other purposes, e.g., Q.A.
activities?

5. For federal and state organizations: If an HPS accreditation program
were established is there any reason that you could not participate if you
so desired?  As a related point would you
anticipate requesting a similar program under NVLAP for use by government
source manufacturers?

6. For federal and state organizations: Would you anticipate any legal
difficulties in requiring the use of an accreditation from a
non-government organization in the purchase of sources by a government
organization?  [Any DoE expert responder?]

7. Would there be any non-U.S. organizations that would request
accreditation?  If so, what added complications to the process would that
organization anticipate (besides travel expense and possibly language),
e.g., regulatory conflicts?

8. Have you had any experiences (difficulties, source problems) that an
accreditation process would have prevented or minimized?

9. Would an HPS accreditation process relieve you of any auditing or other
assessment requirements that you currently perform?  That is, would it
save you money?

* Early BoD discussions will be held in April and committee
discussions in July so your prompt consideration and comment
would be appreciated.

               ***************************
Some general background:
Accreditation is a process by which manufacturers are audited for
compliance with a standard. In this case the standard is ANSI N42.22,
which establishes the process by which a source
manufacturer can establish traceability to the National Institute of
Standards and Technology (NIST).  The accreditation process involves an
application in which the requirements of the standard are documented, an
audit to verify this compliance, and
successful performance in pertinent NIST Measurement Assurance Programs
(MAPs).  The accreditation process (and the standard) requires, among
other things,
 - lab procedures adequate to produce acceptable standards
 - quality assurance procedures to demonstrate this continuing ability,
and related required records.
 - specifications on how the source activity and accuracy are documented,
how the source is traceable to NIST, and other
pertinent details.
 - qualified staff and adequate resources to produce acceptable standards
 - a definition of the scope of standards subject to the
accreditation program
 - regular audits (other than that of the accreditating
organization)
 - procedures on how disagreements with the customer are to be handled

Note that simply possessing a source purchased from NIST, or
participation in a MAP related to the measurements or the
standard of interest, does not constitute 'traceability'.  These items are
simply components of a defined program that, when taken as a whole,
demonstrate traceability.  But, as was once said, the devil is in the
details.  NIST does not provide standards for every radionuclides, nor for
every matrix and sample geometry, nor for every measurement process. What
does traceability mean when the offered standard is not one for which NIST
has a closely related MAP, e.g., a soil standard?  How does the
accreditation process address this?  Basically that is the kind of issue
that the administrative process of accreditation is intended to solve so
the source buyer knows what is being purchased.

Comments may be sent to Les Slaback, Bldg 235 HP, NIST,
Gaithersburg, MD 20899, or via email to Lester.Slaback@NIST.GOV.  Note
that this will not be a NIST program.  My affiliation is simply
coincidental to this activity.


-- 
the above are the personal musing of the author,
and do not represent any past, current, or future
position of NIST, the U.S. Government, or anyone else
who might think that they are in a position of authority.
NBSR Health Physics
NIST
Gaithersburg, MD 20899
301 975-5810
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Lester.Slaback@nist.gov
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