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EFCOG Best Practice #63
(12/17/08)
PDF
Version
Title:
Qualification of Suppliers/Distributors for
Safety Related SSCs
Facility:
Los Alamos National Laboratory, West Valley Demonstration
Project
Point of Contact:
Tim J. McEvoy, 505-667-8172,
mcevoytj@lanl.gov; or Bob Carter, 509-377-3220,
bob.carter@wch-rcc.com
Brief Description of Best Practice:
Successful efforts to prevent use of
unqualified suppliers or items include:
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Develop and implement a commercial grade
item dedication (CGID) process to dedicate items
obtained from unqualified sources. This process relies
heavily on the responsible engineer’s or Subject Matter
Expert’s (SME) knowledge of the function(s) and failure
modes of the item, the associated critical
characteristics, and the manufacture’s ability to
provide item traceability.
-
Qualify distributors that have
comprehensive sub tier supplier qualification programs.
-
Meet the intent of DOE G 414.1-2A, G
414.1-3 and DOE G 414.1-1B by assuring that audits or
surveillances are performed through every layer of the
supplier chain including foreign manufacturers. Ensure
the latest requirements of ASME NQA-1 parts I and II
including addenda’s are consulted when considering CGID.
There have been many improvements made in this area of
NQA-1 over the years.
-
Utilize the supplier joint audit
procedure and process developed by the EFCOG Supply
Chain Team.
Why the best practice was used:
Since the decline of the commercial nuclear
industry, suppliers have not kept up their rigorous NQA-1
type programs. In addition, a large portion of the raw and
manufactured products (steel, pipe, reinforcing steel, etc.)
have migrated to foreign sources.
This presents a major problem as the majority
of key products are being purchased from distributors who
obtain these items from often complex supply chains and have
no direct contact with the manufacturers. DOE guide orders;
such as, DOE G 414.1-3 2A, and 1-1B make it clear that
certain conditions and controls must be included in the
process of obtaining qualified material, parts, and
components:
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Certified Material Test Reports (CMTRs) -
A written and signed document that is approved by a
qualified party and contains data and information that
attests to the actual chemical and physical properties
of an item and the actual results of all required tests.
The burden falls on the purchaser to assure the
integrity of CMTRs through independent test/inspections.
-
When the supply chain involves multiple
suppliers, each step in the supply chain process should
be validated by audit, source inspection, or other
methods as appropriate.
-
contractors should be cautious about
accepting items based solely on supplier-generated
documentation or part-number verification, unless the
supplier’s quality system for generating the
documentation and maintaining part number configuration
control has been previously verified through requirement
and performance-based evaluations.
-
Items intended for use in safety systems
and mission critical facilities should be procured from
suppliers whose quality assurance programs have been
evaluated by the purchaser, other DOE contractors, or
third party certification agencies.
What are the benefits of the best practice:
Confirming your Design, Procurement and QA
programs have the necessary processes in place to ensure a
high level of confidence that what is being procured will
meet or exceed the expectations of the requirements imposed
on the contractor, suppliers and service providers.
What problems/issues were associated with the
best practice:
The challenge is
especially difficult because many of the actual
manufacturers are foreign and many supplier qualification
programs do not actually validate throughout the sub-tier
supply chain to the manufacturers. Additional problems
include:
-
For smaller projects, facilities, and/or
maintenance, being able to meet schedules with the lead
time necessary to have the supplier quality group
evaluate suppliers.
-
Supplier qualifications can include
distributors and not manufacturers.
-
Supplier quality typically does not
provide a list of those suppliers or distributors that
have been rejected.
How the
success of the Best Practice was measured:
Knowing which suppliers are available that
can meet the necessary requirements and more importantly
those that can not.
Description of process experience using the
Best Practice:
Realizing how the decrease in nuclear quality
suppliers over the years has affected the DOE and other
nuclear industry material needs especially with safety
related or significant items and services. This alone should
raise awareness to know without question what is being
procured and from whom. |