PIC - G. E. Chitwood
FPM - P. B. Hoke
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I. PURPOSE
This procedure prescribes qualifications for Auditors and Lead
Auditors participating in Oak Ridge National Laboratory,
technical audits. It also establishes lead auditor certification
requirements.
II. REQUIREMENT REFERENCES
A. DOE Order 5700.6C, Quality Assurance
B. Y/QD-15, "LMES Quality Program Description"
C. X-QA-1, "Quality Assurance Program"
D. X-AD-7, "ORNL Records Management"
E. QA-18.1, "Independent Assessments"
III. SCOPE/LIMITATIONS
This procedure applies to all ORNL organizations
performing technical audits in accordance with QA-18.1,
"Independent Assessments"
IV. DEFINITIONS
A. Audit - A planned and documented activity performed to
determine by investigation, examination, or evaluation of
objective evidence the adequacy of and compliance with
established procedures, instructions, drawings, and other
applicable documents and the effectiveness of implementation.
NOTE: An audit should not be confused with surveillance or
inspection activities performed for the sole purpose
of process control or product acceptance.
B. Auditor - a qualified individual who performs any portion
of an audit, including lead auditors, technical specialists,
and others such as management representatives and auditor-in-
training.
C. Auditor Examiner - an individual appointed by the ORNL
Quality Director to administer the requirements of
qualification of lead technical audit personnel. The auditor
examiner is responsible for certifying and recertifying
personnel who lead technical audits within ORNL.
D. Lead Auditor - an individual qualified to organize and
direct an audit, report audit findings and observations, and
evaluate corrective action.
V. REQUIREMENTS
A. Auditor qualifications shall include
1. quality experience or training commensurate with the
scope, complexity, or special nature of the activities to
be audited as well as a working knowledge of applicable
quality assurance procedures for implementing the audit
and reporting results;
2. training and/or orientation in the
a. quality assurance requirements, fundamentals,
characteristics, objectives, organization,
performance, and reporting of results of technical
auditing;
b. methods of examining, questioning, and evaluating, and
documenting audit findings;
c. methods of evaluating corrective actions and closing
out findings; and
3. on-the-job training, guidance, and counseling under the
direct supervision of the Lead Auditor; practical training
includes training in audit planning, performing,
reporting, and corrective action follow-up.
NOTE: The Lead Auditor shall ensure audit team
members' qualifications.
B. Lead Auditor qualifications shall include verifiable evidence
that a minimum of ten credits have been accumulated under the
following scoring system:
1. Education (four credits maximum)
a. associate's degree in engineering, physical and life
sciences, business management, mathematics, or quality
assurance = two credits; or
b. associate's degree in other field = one credit; or
c. bachelor's degree in engineering, physical and life
sciences, business management, mathematics, or quality
assurance = three credits; and
d. bachelor's degree in other field = two credits; or
e. postgraduate degree in engineering, physical and life
sciences, business management, mathematics, or quality
assurance = one additional credit.
NOTE: Physical sciences includes degrees in
Environmental, Safety, and Health fields.
2. Experience (nine credits maximum)
a. technical or management experience in engineering,
manufacturing, construction, operation, or
maintenance = one credit for each full year with a
maximum of five credits for this aspect of experience;
and
b. two years of this experience in the nuclear field =
one additional credit; or
c. two years of this experience in quality assurance,
environmental, safety, or health = two additional
credits; or
d. two years of this experience in auditing = three
additional credits; or
e. two years of this experience in nuclear quality
assurance, environmental, safety, or health = three
additional credits; or
f. two years of this experience in nuclear quality
assurance, environmental, safety, or health auditing =
four additional credits.
3. Other professional credentials (two credits maximum)
Certification of competency in engineering, science, or
quality assurance specialties issued and approved by a
state agency or a national professional or technical
society.
4. Rights of management (two credits maximum)
NOTE: The lead auditor's organizational management may
grant up to two credits for other performance
factors applicable to auditing that may not be
described explicitly in this procedure.
Examples of the factors are leadership, sound
judgment, maturity, analytical ability,
tenacity, and past performance.
5. Lead auditor communication skills
The ability to communicate effectively, both in writing
and orally, shall be attested to in writing by the
applicant's supervisor or manager.
6. Lead auditor audit participation
A minimum of five technical-related audits shall be
performed within three years preceding the date of
qualification. One of the audits shall be a technical
audit of a nuclear facility and shall be performed within
one year preceding qualification.
7. Lead auditor examination
Prospective lead auditors shall be tested and shall pass
as appropriate, a written, oral, or practical examination
that evaluates the comprehension of knowledge received in
training. Lead auditor examinations administered, passed,
and documented by ORNL not more than two years
prior to application are acceptable to meet the
examination requirement for certification. Other
previously passed lead auditor examinations may be
acceptable at the discretion of the auditor examiner.
8. Lead Auditor maintenance of qualifications
a. Lead auditor maintenance of qualifications shall
include one or more of the following:
(1) participation in the audit process; or
(2) documented review and study of codes, standards,
procedures, etc., related to quality assurance
programs and/or program auditing as directed by
the ORNL Auditor Examiner; or
(3) participation in training programs; and
(4) annual assessment of the lead auditor's
performance (assessments shall be documented).
b. Requalification as a lead auditor is required if
qualifications are not maintained for a period of two
years. These cases may, at the discretion of the
ORNL Quality Director, require
(1) retraining in accordance with Sect. V.D. of this
procedure;
(2) retesting in accordance with to Sect. V.C.7. of
this procedure; and
(3) participation as an auditor in at least one
nuclear quality assurance audit.
C. Audit training courses
Training courses should include the following based on the
needs of each prospective auditor or lead auditor:
1. knowledge and understanding of environmental, safety,
health, and quality applicable codes, standards,
regulations, and regulatory guides;
2. structure and implementation of ORNL quality
assurance programs;
3. applicable ORNL requirements;
4. auditing techniques;
5. audit planning for activities affecting quality, design,
purchasing, fabrication, handling, shipping, storage,
cleaning, erection, installation, inspection, testing,
statistics, nondestructive evaluation, maintenance,
repair, operation, modification of nuclear facilities or
associated components, and safety aspects of the nuclear
facility; and
6. practical training that includes the elements of the audit
activity as described in QA-18.1, "Independent Assessments."
VI. RESPONSIBILITIES
A. ORNL Quality Director
1. establishes the standards to ensure that technical
auditors are suitably knowledgeable in auditing methods
and are suitably proficient in the applicable duties and
responsibilities by overviewing the Auditor and Lead
Auditor Qualification System;
2. appoints an ORNL Auditor Examiner to administer
the requirements for certification of lead auditors and to
approve lead auditor training lesson plans and
certification examinations; and
3. appoints the chairman of the ORNL Quality
Training Review Board to administer the development of
lesson plans and training course examinations (as opposed
to certification examinations) for auditor training and
orientation and lead auditor training.
B. Organization Quality Manager
1. schedules auditor orientation and training;
2. coordinates personnel to take a lead auditor training
course and a lead auditor examination;
3. conducts an annual evaluation of lead auditor records and
makes recommendations for recertification; and
4. maintains the organization's file of auditor and lead
auditor qualifications for Sect. VI.B.1, 2, and 3.
C. ORNL Auditor Examiner
1. administers the requirements of qualification of lead
technical audit personnel;
2. reviews applications for lead auditor certification;
3. certifies and recertifies personnel who lead technical
audits within ORNL;
4. advises the ORNL Quality Training Review Board
on content of auditor and lead auditor training and
training course examinations;
5. reviews and approves lead auditor training lesson plans
and lead auditor examinations recommended by the ORNL
Quality Training Review Board; and
6. maintains a file of lead auditor qualifications and
certifications.
D. Prospective Lead Auditor
provides personal history documentation attesting to
qualification as an auditor or lead auditor and participates
in the training process.
VII. ACTION STEPS
A. Organization Quality Manager
1. completes Sects. 1 through 4 of Form UCN-17679
for each prospective lead auditor,
2. ensures lead auditor training attended by the prospective
lead auditors and submits Form UCN-17679 to the ORNL
auditor examiner,
3. receives lead auditor certifications from the ORNL
Auditor Examiner and maintains a file on the
organization's auditors and certified lead auditors, and
4. evaluates lead auditor qualification and lead auditor
certification on a yearly basis and forwards Form UCN-
17679 with recommendations for any needing recertification
to the Auditor Examiner.
B. Lead Auditor/Prospective Lead Auditor
1. provides backup personal/education history to the
organization quality manager,
2. attends a lead auditor training course,
3. participates in the audit process under the supervision of
a certified lead auditor,
4. completes experience requirements for lead auditor
qualification, and
5. provides update information on experience and
qualifications to the organization quality manager.
C. ORNL Auditor Examiner
1. oversees and administers the lead auditor examinations as
necessary;
2. evaluates certification examination results (as opposed to
training course examinations) to determine each
prospective lead auditor's ability and comprehension to
apply the proper auditing technique or practice;
3. verifies Sect. 3 and completes Sect. 5 of Form UCN-17679
for each prospective lead auditor;
4. certifies the successful lead auditors using Form UCN-
17679 (Sect. 6) and distributes copies to the new lead
auditors and their respective organization quality
managers;
5. receives updated Form UCN-17679 and the recommendation for
recertification, recertifies the lead auditor as
appropriate, and places the Form UCN-17679 (Sects. 6
and 7) in the applicable file; and
6. maintains a file of all organizations' lead auditors.
VIII. REQUIRED RECORDS
Records of personnel qualifications for lead auditors shall be
maintained by the ORNL Auditor Examiner. Examples of
these records are copies of diplomas, resumes, professional
licenses, training certifications, audit plans for audit
participation, auditor certification form, etc., that support the
certification process. These records are quality assurance
records and shall be retained in accordance with approved records
and disposition schedules.
Approved by: [J. H. Swanks]
Associate Director
Operations, Environment, Safety, and Health
Oak Ridge National Laboratory
PIC - G. E. Chitwood
FPM - P. B. Hoke
Directives Coordinator
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Wednesday, 12-Feb-97 13:37:45 EST(npn)