PIC - D. C. Reagan
FPM - P. B. Hoke
Directives Coordinator
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Date Printed:_________________________ Verifier:__________________________
I. PURPOSE
This procedure identifies the requirements for establishing and
implementing a system for controlling purchased items and services
to ensure conformance to specified requirements.
II. REQUIREMENT REFERENCES
A. DOE Order 5700.6C, Quality Assurance
B. Y/QD-15, "LMES Quality Program Description"
C. ESS-QA-4.0, "Procedure Document Control"
D. 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
that purchase and maintain items and services that have critical
applications or are complex items as defined in Sect. IV.
Applicable controls from this standard 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.
V. REQUIREMENTS
A. This document becomes effective 60 days after approval
signature date.
B. Procurement Planning
1. Planning shall be initiated and documented as early as
practicable (e.g., conceptual design phase), but not later
than at the start of those procurement activities that
must be controlled to ensure interface compatibility and a
uniform approach to the procurement process.
2. Planning shall result in the documented identification of
methods to be used in procurement activities and shall
determine what is to be accomplished, how and when it is
to be accomplished, and by whom.
3. Procurement planning shall provide for the integration of
and result in documented methods for
a. preparation, review, and change control of procurement
documents;
b. selection of suppliers;
c. evaluation and award of bids;
d. control of supplier performance (e.g., scheduling,
qualification of personnel, penalty/award contracts);
e. evaluation and verification of supplier activities
(source surveillance, inspection, or audits),
including provisions for the notification of hold and
witness points;
f. control of nonconformances;
g. corrective action;
h. acceptance of items or services; and
i. quality assurance records.
C. Supplier Selection
1. Suppliers shall be selected based on an evaluation of
their capability to provide items or services in
accordance with procurement practices and Department of
Energy (DOE) policies before the award of the contract.
2. The Procurement Organization shall coordinate, with affected
organizations, the determination of a supplier's
capability and the evaluation and selection of suppliers.
3. ORNL's Office of Quality Programs and Inspection (OQP&I)
shall ensure the supplier's quality assurance capability
and the evaluation of the results are documented.
4. Measures for the evaluation and selection of a supplier
shall be documented based on
a. the supplier's current capability and an evaluation of
the supplier's performance history on similar
products;
b. the supplier's current quality records, supported by
documented qualitative and quantitative evidence of
the supplier's performance; or
c. a direct evaluation (by survey) of the supplier's
facilities, equipment, personnel, and implemented
quality assurance program to determine technical and
quality capability.
D. Bid Evaluation
1. shall determine the extent of conformance to procurement
requirements and shall be documented;
2. team members shall be identified and this information
documented;
3. shall be based on any one, or combination of, the
following
a. supplier's technical expertise, manufacturing
capabilities, quality assurance program, availability
and qualifications of personnel, and past performance;
b. supplier's exceptions and proposed alternatives to the
requirements; and
c. a visit to the supplier's facility by a team
consisting of Engineering, Quality, Procurement, and
Auditors (as an example); and
4. quality deficiencies found during the bid evaluation shall
be resolved before awarding the contract.
E. Supplier Performance Evaluation
1. measures shall be established, when needed, to verify the
supplier's performance through
a. establishing an understanding between the purchaser
and supplier of the provisions and specifications of
the procurement documents,
b. requiring the supplier to identify planning techniques
and processes for meeting contractual requirements,
c. reviewing supplier documents as they are generated to
ensure compliance with procurement requirements,
d. identifying and processing necessary change
information,
e. establishing a method of exchanging information
between ORNL and the supplier, and
f. establishing the extent of source surveillance and
inspection activities.
2. Verification activities by ORNL shall be
performed as early as practicable. However, procurement
documents shall contain an annotation to the supplier that
ORNL verification activities do not relieve the
supplier of his responsibility for attaining the required
quality.
a. Extent of activities - to which verification
activities are applied shall be based on the
supplier's past quality performance and the relative
importance, quantity, and complexity of the item or
service procured.
Supplier activities shall be verified, inspected,
audited, or witnessed by qualified personnel.
b. Records - activities performed to verify conformance
to requirements shall be recorded; and the results of
source surveillances, audits, receiving inspections,
nonconformances, dispositions, deviations, waivers,
and corrective actions shall be documented and
controlled as quality assurance records.
Supplier quality-related documentation shall be
evaluated to determine the effectiveness of the
supplier's quality assurance program.
F. Control of Supplier-Generated Documents
Methods shall be established and implemented for
1. controlling and approving supplier-generated documents;
2. identifying in the subcontract the supplier-generated
documents to be submitted to ORNL for review or
approval;
3. reviewing supplier-submitted documents by program/project
personnel and quality, and;
4. establishing measures to acquire, process, and record
evaluations of technical, inspection, and test data
against acceptance criteria.
G. Change Control
Measures to control changes in procurement documents shall be
established, implemented, and documented in accordance with
ORNL requirements for document control.
H. Acceptance of Items and Services
1. The supplier shall verify that the items or services
furnished conform to procurement requirements.
2. When documentation is required by code, regulation, or
contractual requirements, suppliers shall provide to
ORNL documented evidence of an item's
conformance to procurement requirements as stipulated in
the contractual agreement or before the item is installed
or used.
3. Items may be accepted from a supplier in accordance with
one or more of the following methods:
a. Certificate of Conformance - procedures the supplier
must follow in filling out, reviewing, and approving
the certificate shall be described in the supplier's
quality assurance program. The supplier's conformance
and certification system shall be verified either
during the performance of audits or during the
inspection and test of the delivered items.
The minimum criteria for certificates of conformance
shall include the following:
(1) purchased item (e.g., by purchase order number);
(2) procurement requirements met for the purchased
item such as codes, standards, and other
specifications along with approved changes,
waivers, or deviations;
(3) any procurement requirements not met, along with
the method to resolve the nonconformances; and
(4) name and signature of the person responsible for
the quality assurance function, as described in
the supplier's or ORNL quality assurance
program.
b. Source Verification
(1) An item's conformance to requirements shall be
verified at the supplier's location at intervals
consistent with the importance and complexity of
the item or service.
(2) Surveillance plans shall be developed to monitor,
witness, observe, inspect, examine, or test items
at predetermined points.
(3) Documented evidence of source surveillance
acceptance shall be provided to the item-receiving
destination, to ORNL Purchasing, and to
the supplier.
c. Receiving Inspection
(1) procedures or instructions shall be provided to
ensure that delivered items are inspected
according to requirements, taking into account
source verification, audit activities, and
demonstrated quality performance when receiving
inspection is used.
(2) tests shall be performed according to established
procedures and instructions, and the following
features shall be verified:
(a) proper configuration;
(b) item identification;
(c) dimensional, physical, and other
characteristics;
(d) freedom from shipping damage;
(e) cleanliness; and
(3) shall be coordinated with a review of any supplier
documentation that must be furnished before site
inspection and acceptance.
d. Post-Installation Testing (PIT)
The requester (ORNL) and supplier shall mutually establish
the requirements and acceptance documentation when PIT
is used.
4. Services from a supplier shall be accepted by any one or
more of the following:
a. technical verification of the deliverables produced;
b. surveillance or audit of the activity; and
c. review of documents for objective evidence of
conformance to procurement document requirements, such
as those for certifications, stress tests, and
reports.
I. Control of Supplier Nonconformances
1. All nonconforming supplier items submitted for ORNL
acceptance shall be accompanied by a written
"Request for Waiver or Deviation," Form UCN-13816.
ORNL shall evaluate and approve or disapprove the
request.
2. Nonconformance documentation furnished by the supplier
shall include the nonconformance notice Form UCN-13816,
the specific nonconforming characteristic(s) and the
related specification requirement, the supplier's
evaluation and recommended disposition (e.g., use-as-is or
repair) with technical justification, and the proposed
corrective action to prevent recurrences and the
dispositioning authority's signature.
3. Nonconformances that result in an item being scrapped or
reworked shall be documented and internally dispositioned
followed by verification of the implementation of the
disposition.
4. The supplier shall be required to notify ORNL of
nonconformances when any of the following occur:
a. technical or material requirements are violated;
b. requirements in supplier documents approved by ORNL
are violated;
c. nonconformances that cannot be corrected by continuing
the original manufacturing process except by reworking
or repairing the item; or
d. the item does not meet original requirements, even
though it can be restored to a fully functional
condition.
5. Records of supplier-submitted nonconformances shall be
maintained.
J. Commercial Grade Items
1. As an acceptable alternate to other requirements of this
standard, the use of commercial grade items in a design
shall require
a. identification of the commercial grade item in an
approved design output document,
b. verification and documentation that the item is
suitable to perform the intended function as a
replacement,
c. verification and documentation that the item will meet
design requirements applicable to both the replaced
item and its application,
d. source evaluation in accordance with requirements
defined in this document, and
e. identification of the commercial grade item in the
purchase order by supplier's published product
description and catalog number.
2. Receipt inspection of commercial grade items shall verify
that
a. shipping damage did not occur,
b. the item received was the item ordered,
c. the inspection or test is done according to
ORNL requirements to ensure conformance to
published requirements, and
d. applicable documentation was received and is accepted.
VI. RESPONSIBILITIES
A. ORNL Organization Managers
ensure that the requirements of Sect. V. of this document are
being implemented.
B. OQP&I Manager
1. provide guidance and assistance in the implementation of
Sect. V. of this document, and
2. ensure that audits and surveillances are performed to
validate that these requirements have been implemented and
met.
VII. REQUIRED RECORDS
Quality assurance records shall be retained in accordance with
X-AD-7, "Records Management" for approved records
inventory and disposition schedules.
VIII. 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 suppliers 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-4.0, "Procurement Document Control,"
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
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Wednesday, 12-Feb-97 13:06:28 EST(npn)