PIC - D. C. Reagan
FPM - P. B. Hoke
Directives Coordinator
Directives Home
ORNL Internal Home
Search the ORNL/LMES Web
A hard copy of this document is valid only until the document revision number has changed on the Web. The hard copy should be dated and signed the day it is printed. If you continue working from the hard copy, you should verify its accuracy periodically on the Web or add your name to the distribution list for procedure notification any time a document in this Functional Policy Area changes.
Date Printed:_________________________ Verifier:__________________________
I. PURPOSE
This procedure establishes the requirements to ensure that quality,
environmental, safety, health, security, and other technical
requirements are included in ORNL, procurement documents.
Applicable design bases and other requirements necessary
to ensure adequate quality shall be included or referenced
in documents for the procurement of items and services.
II. REQUIREMENT REFERENCES
A. DOE Order 5700.6C, Quality Assurance, 08/21/91
B. Y/QD-15, Rev. 2, "Quality Program Description," May 1995
C. ORNL ESS-QA-7.0, "Control of Purchased Items and Services"
D. ORNL ESS-QA-10.0, "Inspection"
E. ORNL ESS-QA-11.0, "Test Control"
F. ORNL Procedure ESP-PC-151, "Basic
Procurement Procedures"
G. ORNL Procedure X-GP-16, "Procurement of Critical Application/
Safety-Class Items and Services"
III. SCOPE/LIMITATIONS
The provisions of this procedure apply to all ORNL organizations
authorized to procure critical application items and services and
complex items through the use of procurement documents.
Applicable controls from this procedure should also be
considered for items or services of high value or those
associated with milestones.
IV. DEFINITIONS
A. Complex Items - items that have quality
characteristics, not wholly visible in the end item,
for which contractual conformance must be established
progressively through precise measurements, tests, and
controls that are applied to the item individually or
in conjunction with other items during purchasing,
manufacturing, assembly, and functional operation.
B. Critical Application - an application in which the
failure of the item or service could cause personal
injury, harm the environment, or jeopardize security
or a vital ORNL mission.
C. Noncomplex Items - items with quality characteristics
for which simple inspection and testing of the end
product are sufficient to determine conformance to
contractual requirements.
D. Noncritical Application - any application other than a
critical application.
E. Procurement Document - drawings, specifications,
special provisions, or other instructions used to
define requirements of the services, equipment, or
supplies to be procured.
F. Purchase Requisition - the document used to initiate a
procurement action.
G. Quality Reviewer - Quality Assurance Specialist assigned to
divisions.
H. Specification - a document that is a part of or
attached to a requisition and specifies requirements
for the procurement, including as applicable: scope,
design documents, specific codes and standards,
supplier quality assurance program requirements,
personnel qualification and certification, materials,
fabrication, inspection and tests, item
identification, packaging, shipping, handling,
documentation, and records. When the specification is
attached, it shall be referenced in the body of the
Purchase Requisition by unique identification and
revision.
I. Subcontract - the term applied to documents used by
ORNL for the procurement of services or
supplies.
J. Functional Discipline Specialist - a technical
representative (subject matter expert) from
Environmental, Safety, and Health, Engineering,
Safeguards and Security, or another appropriate
technical organization.
K. Division Technical Reviewer (DTR) - a responsible
technical person with specifically delegated authority
from the Division/Program Manager to approve the
organization's procurement packages for technical
adequacy.
V. GENERAL INFORMATION
A. Generators of purchase requisitions and associated
specification documents for critical application or
complex items and services shall ensure that
appropriate technical and quality reviews for adequacy
of requirements are performed as defined in this
standard, in ORNL Procedure ESP-PC-151,
"Basic Procurement Procedures," and in ORNL
Procedure X-GP-16, "Procurement of Critical Application/
Safety-Class Items and Services." Technical reviewers and
quality reviewers shall maintain a record indicating
approval of the requisition and associated procurement
documents for these two categories of items and services.
B. Procurement planning activities (e.g., supplier
selection, offer evaluations, subcontractor
performance monitoring, control of nonconformances,
and acceptance of items and services) shall be
conducted for critical application and complex items
and services in accordance with ORNL
standards ESS-QA-7.0, "Control of Purchased Items and
Services"; ESS-QA-10.0, "Inspection"; and ESS-QA-11.0,
"Test Control." Generators of purchase requisitions
shall ensure that these requirements are evaluated for
applicability to the item or service being procured. A
formal system shall be established to ensure that the
applicability evaluation is performed utilizing
assigned Division Technical Reviewers and Procurement
Quality (or other designated QAS) personnel.
C. All subcontracts for critical application or complex
items and services, including subcontracts for
environmental, safety, health, security, and
analytical laboratory services, shall be monitored for
performance in accordance with the requirements of
ORNL standards ESS-QA-7.0, "Control of
Purchased Items and Services," and ESS-QA-10.0,
"Inspection." Performance monitoring plans shall be
developed to provide instructions for performing
supplier monitoring activities (e.g., receiving
inspection, source surveillance, supplier audits, and
supplier data package evaluations).
D. Only approved critical application and complex items should
be purchased through the Accelerated Vendor Inventory
Delivery (AVID) agreements without the involvement of ORNL
Procurement Quality Engineering and placement of the
supplier and distributor into ORNL Supplier
Evaluation Program.
VI. REQUIREMENTS
A. General
Applicable design bases and the requirements necessary
to ensure adequate provisions for quality,
environmental, safety, health, and security shall be
included or referenced in procurement documents. (See
Appendix)
B. Procurement Document Content Requirements
Procurement documents shall include provisions for
1. Scope of work - include a statement identifying
and defining the scope of work to be performed by
the supplier.
2. Technical Requirements - specify and include all
applicable technical requirements.
a. Specified Requirements - specify requirements
by referencing specific drawings, procedures,
instructions, specifications, and nationally
recognized codes, standards, or regulations
(including the specific section or options to
be applied); indicate the appropriate
revisions describing the items or services to
be furnished.
b. Test, Inspection, and Acceptance Requirements
- identify all tests, inspections, and
acceptance requirements for supplier
performance monitoring and for evaluation by
the purchaser.
c. Special Requirements for Environmental,
Safety, Health, and Security - identify and
specify the applicable environmental, health,
safety, and security requirements and include
these requirements in the technical
specification or as an addendum to it.
3. Procurement documents for critical applications,
items or services and complex items shall have an
independent quality review to determine that all
quality requirements have been included.
4. Procurement documents shall state the requirements
for the supplier or the supplier's subcontractor's
quality assurance program. The supplier's quality
assurance program shall provide the controls
necessary to ensure that the procured item or
service (for all program requirements) will meet
or exceed the specified quality requirements,
which shall also be incorporated into their
subtier procurement documents.
5. Right of Access - Procurement documents shall
provide requirements for ORNL access to
the supplier and, if applicable, to the facilities
of the supplier's subcontractors. Right of access
is accomplished by standard forms (subcontractor
"terms and conditions") used routinely by
Procurement. Procurement documents shall also
specify that records shall be made available or
provided to ORNL for purposes of
performing surveys, audits, surveillances, tests,
inspection reviews, status determinations, and
engineering or contract discussions.
6. Documentation Requirements - identify the supplier
documentation and required data for submitting the
documents for information, review, or approval by
the purchaser at all tiers. Identify the
documentation involving quality assurance records
to be maintained by the supplier, including
retention periods and prescribed disposition
requirements.
7. Nonconformances - purchaser's requirements for
reporting, approving, and dispositioning
nonconformances shall be included in the
procurement documents.
8. Spare and Replacement Parts - procurement
documents shall include specific identifications
and shall specify the technical and quality
assurance data required when spare and replacement
parts, assemblies, or service options are
required.
9. Equipment Operability and Maintainability -
identify and specify the training, maintenance
documentation, and support services needed in the
technical data. These data may also be included as
line items on the requisition.
C. Procurement Document Review and Changes
1. Purchase requisitioners, generators, or the
designated technical reviewers shall review the
procurement documents and their changes before
forwarding to purchasing and shall ensure that the
review is documented. This review is to ensure
that the appropriate technical, quality assurance,
and contractual provisions are included in the
procurement documents so that items and services
will meet the specified requirements. Reviews of
changes in procurement documents shall include
appropriate requirements such as scope of work,
technical requirements, quality assurance program
requirements, right of access, documentation
identification, nonconformances, and spare or
replacement parts. Review consideration also shall
include determination of additional or modified
design criteria and analysis of exceptions or
changes specified by the supplier and the effect
such changes may have on the intent of the
procurement documents or the quality of the item
or service to be furnished. Such reviews shall be
performed by qualified personnel with access to
pertinent information.
2. Procurement document changes shall be subject to
the same depth of review and control as used in
preparing the original document.
VII. RESPONSIBILITIES
A. Procurement Initiator (Requester)
1. establishes the quality assurance parameters
applicable to the procurement documents by
specifying the definition of items or services on
requisitions, including drawings, specifications
test, inspections, and acceptance requirements as
deemed applicable (routine or special inspection
codes should be designated, and on special
inspection codes the appropriate inspection group
shall be identified);
2. specifies, to the extent deemed necessary,
supplier quality assurance program requirements,
nonconformance reporting and approval methods and
documentation required for information, review,
approval, retention, or shipment including
submittal times;
3. ensures that procurement documents receive an
independent quality review for all critical
applications and complex items and services, and
that this activity is documented;
4. ensures that changes in documents are included in
the procurement documents and that the changes are
subjected to the same review as the original
documents; and
5. ensures that spare and replacement parts and
requirements are specified where applicable.
B. Procurement
1. ensures that all specified information involving
the procurement documents is incorporated into the
procurement package transmitted to the supplier;
2. incorporates right of access and inspection coding
into the procurement documents;
3. transmits and receives procurement documentation,
including any changes, to and from the supplier
and the initiator;
4. reviews procurement documents for contractual
clarity; and
5. ensures (as appropriate) suspect/counterfeit parts
information has been included in procurement documents.
VIII. REQUIRED RECORDS
Quality assurance records shall be retained in accordance
with ORNL Procedure X-AD-7, "Records Management" for approved
records and disposition schedules.
IX. APPENDIX
Suspect/Counterfeit Parts Caution
**********************************************************************
APPENDIX
SUSPECT/COUNTERFEIT PARTS CAUTION
Numerous suspect/counterfeit parts are infiltrating the
United States market. Parts suspected of being counterfeit
are fasteners, flanges, piping, circuit breakers, and
numerous other items. Suspect/counterfeit parts are not to
be confused with nonconforming parts. Suspect/counterfeit
parts are parts willfully manufactured or refurbished to
inferior specifications and sold as meeting National or
higher level specifications. Nonconforming parts are parts
which deviate from specified requirements as a result of a
supplier's process being out of control. To prevent
suspect/counterfeit parts from entering ORNL
facilities, special precautions must be taken when ordering
critical application and safety items. The procurement
provisions of this procedure and ESS-QA-7.0, "Control of
Purchased Items and Services," and X-GP-16 should be fully implemented.
Emphasis shall be placed on selecting qualified suppliers,
developing clearly defined technical specifications and
drawings, and utilizing source surveillance and/or receipt
inspection to monitor supplier performance.
Items found to be suspect/counterfeit should be handled as
follows:
1. segregate and retain all suspect/counterfeit items
under lock and key;
2. advise supervision of the discovery;
3. if suspect/counterfeit items are installed in received
product destined for a critical or safety related
application, do not operate the unit until disposition
is made of the suspect/counterfeit items;
4. contact the Site Suspect/Counterfeit Coordinator for
further notification and instructions on reporting;
and
5. initiate a Nonconformance Report and Occurrence Report.
Approved by: [J. H. Swanks]
Associate Director
Operations, Environment, Safety, and Health
Oak Ridge National Laboratory
PIC - D. C. Reagan
FPM - P. B. Hoke
Directives Coordinator
Directives Home
ORNL Internal Home
Search the ORNL/LMES Web
http://www-internal.ornl.gov/ORNL/directives/data/506000001881.html
Updated: Wednesday, 12-Feb-97 13:28:36 EST(npn)