PIC - G. E. Chitwood
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.
Date Printed:_________________________ Verifier:__________________________
PURPOSE This procedure specifies a uniform method by which
ORNL meets the Independent Assessment (Criterion 10)
requirements of DOE Order 5700.6C, "Quality Assurance,"
section 9.b(3)(b), and 10 CFR 830.120, "Quality
Assurance," section (c)(3)(ii).
APPLIES TO This procedure applies to all ORNL organizations that
lead, sponsor or participate in independent audits and
assessments. Independent assessments are conducted to
measure item quality and process effectiveness and to
promote improvement. The organization performing
independent assessments will have sufficient authority
and freedom from the line organization to carry out its
responsibilities. Persons conducting independent
assessments will be technically qualified and
knowledgeable in the areas assessed.
Financial audits are exempt from this procedure.
OTHER o ESP-QA-2.4, "Qualification of Technical Audit
DOCUMENTS Personnel"
NEEDED
o QA-16.1, "Corrective Action Program"
o OP-301, "Occurrence Notification and Reporting"
o UCN-19153, "ORNL Assessment Record"
WHAT TO DO A. Program Management
Quality 1. Provide oversight related to the need,
Director implementation, and conduct of independent
assessments.
NOTE: Assessment Program Manager refers to a
position responsible for leading and
coordinating independent assessment program
activities, such as Manager, Technical
Assessment Group; Section Head, Quality
Assurance; Management Assessment Manager;
Department Head, Quality Assurance; and
Environmental, Safety, & Health Managers.
Assessment 2. Develop and implement an independent assessment
Program Manager program for the organization.
3. Coordinate the identification and prioritization
of needs for independent assessments.
4. Coordinate preparation of the organization's
fiscal-year independent assessment schedule to
be signed by the organization manager and issued
prior to the first day of each fiscal year.
5. Issue and maintain the fiscal-year, ORNL-level
assessment schedule.
6. Coordinate long-term planning (for next 3 years)
of independent assessment needs, and issues
long-term plan prior to the first day of each
fiscal year.
7. Review and approve the assessment plans developed
by the team leaders for each assessment.
8. Provide oversight and support to the organization's
independent assessment teams.
B. Assessment Preparation
NOTE: The team leader will be an ORNL certified lead
auditor in accordance with ESP-QA-2.4,
"Qualification of Technical Audit Personnel."
Team Leader 1. Issue an assessment notification to the assessed
management prior to the assessment.
2. Select the assessment team members.
Each assessment team will be composed of assessors
and technical specialists as needed to properly staff
the team. These team members will be qualified in
accordance with ESP-QA-2.4 and technically
knowledgeable in the areas assessed. The team leader
and team members cannot be responsible for the work
being assessed.
3. Verify and document the qualifications of each
team member.
4. Arrange for team member training when needed.
5. Develop the assessment plan to include:
o Identification of the organization(s)
o Purpose and scope
o Team members
o Scheduled start and completion dates
o Applicable requirement documents such as
Department of Energy (DOE) orders, federal
regulations, and ORNL procedures
6. Forward the assessment plan to the Assessment
Program Manager for review and approval.
Assessment 7. Review and approve the assessment plan.
Program Manager
Team Leader 8. Issue the assessment plan to the assessed
management prior to the assessment.
9. Meet with team members to review the assessment
plan and assignments.
10. Assign team members to prepare specific
checklist(s).
There is no specific format required for a
checklist.
Team Member 11. Develop checklist(s) items for assigned area(s).
Team Leader 12. Approve checklist(s).
13. Make arrangements for facility access and
coordinate required resources with assessed
management.
C. Assessment Performance
Team Leader 1. Manage the assessment team activities and
performance.
2. Conduct a pre-assessment meeting with the team
members and the assessed management to:
o Provide introductions and initiate lines of
communication
o Clarify purpose and scope of the assessment
o Identify documentation needed by the
assessment team
o Identify key personnel that the assessors plan
to interview and areas to which they will need
access
o Specify administrative facilities or services
needed for the assessment team's use
o Present a schedule for conduct of the
assessment
3. Conduct periodic team meetings to review
progress and identify issues, as appropriate.
4. Conduct periodic meetings with the assessed
management to discuss identified issues, as
appropriate.
Assessed 5. Provide the assessment team with reasonable
Management access to facilities, personnel, and records
needed to conduct the assessment.
Team Member 6. Evaluate the assessed management's compliance
level with each checklist(s) item.
7. Record basis of conclusion on the checklist(s)
for compliance and non-compliance assessments.
8. IF a checklist(s) item is not evaluated, THEN
indicate on the checklist(s) that the item was
not evaluated.
NOTE 1: A "finding" is a direct violation of a
requirement. Findings require corrective
action.
NOTE 2: An "observation" is a condition that could
be improved or strengthened. An observation
is not a requirement violation; it is a method
by which opportunities for managerial or
programmatic improvements may be identified.
Observations require documented evaluation or
identification of planned corrective actions.
NOTE 3: Findings and observations will be documented in
the ORNL Issues Management System and handled in
accordance with QA-16.1, "Corrective Action
Program."
NOTE 4: A "proficiency" may be either an exemplary
practice or an area of performance excellence
that the team feels should be brought to the
attention of management. Proficiencies do not
require a response.
NOTE 5: Forms other than UCN-19153, "ORNL Assessment
Record" may be used to document findings,
observations, and proficiencies if the minimum
information in UCN-19153 is recorded on the
form.
9. Document findings, observations, and proficiencies
on Form UCN-19153 in accordance with the Appendix
A, "ORNL Assessment Record - Sample."
10. IF the team member finds that a finding or
observation has previously been entered into
the ORNL Issues Management System
AND
has appropriate progress on an adequate corrective
action plan, then record the corresponding Action
Item Identification Number on the checklist and
do not report this as a new finding or observation.
11. Review UCN-19153 for occurrence criteria that
may be reportable to the DOE and convey this
information to the assessed management as soon
as possible.
Assessed 12. Evaluate and report potential occurrences in
Management accordance with OP-301, "Occurrence Notification
and Reporting."
Team Member 13. Transmit UCN-19153 to the team leader for review
and approval.
Team Leader 14. Review and approve UCN-19153.
15. Transmit UCN-19153 to the assessed management
for review of factual accuracy.
Assessed 16. Review UCN-19153 for factual accuracy.
Management
Team Leader 17. Resolve factual accuracy review comments.
18. If the team leader is unable to resolve
conflicts or professional differences of opinion
between team members and assessed management
concerning finding/observation records, then
escalate the disputed issue to the ORNL Assessment
Program Manager or ORNL Quality Director, as
appropriate.
19. Conduct and lead the post-assessment meeting
between team members and the assessed
management.
The post-assessment meeting contains:
o A summary of top issues with an overview of
areas assessed
o A review of main findings, observations, and
proficiencies
o The schedule for issuance of the assessment
report
20. Ensure all final UCN-19153 forms are signed.
D. Assessment Reporting
Team Leader 1. Prepare an assessment report.
The report includes:
o Executive summary
o Summary of main issues
o Purpose and scope
o List of team members
o List of personnel interviewed or contacted
during the assessment
o UCN-19153 forms
2. Forward the assessment report to the Assessment
Program Manager for approval.
Assessment 3. Approve the assessment report and return to the
Program Manager Team Leader for distribution.
Team Leader 4. Distribute the assessment report to the assessed
management and to the Assessment Program Manager
within 30 days of the post-assessment meeting,
and other organizations, or individuals, as
appropriate.
5. Collect completed checklists from team members
and maintain them with assessment records.
Assessed 6. Document responses to findings and observations
Management in the ORNL Issues Management System
in accordance with QA-16.1, "Corrective Action
Program."
RECORDS
Assessment 1. Create and maintain the following records
Program Manager according to established ORNL records
management practices and approved records
inventory and disposition schedules:
o Assessment notification
o Team member qualification documentation
o Assessment plan
o Assessment report
o Completed assessment checklists
o Transmittal letters, as appropriate.
APPENDIX Instructions for Completing Assessment Record
Approved by: [J. H. Swanks]
Associate Director
Operations, Environment, Safety, and Health
Oak Ridge National Laboratory
APPENDIX A
INSTRUCTIONS FOR COMPLETING ASSESSMENT RECORD
1. Assessment Title - The title of the assessment.
2. Assessment Identification Number - The unique identification of
the assessment "S-104."
3. Assessment Date - The time during which the assessment was
conducted.
4. Subject - The subject of the finding, observation, or
proficiency, such as "Equipment and Pipe Labeling".
5. Assessment Record Number - The assigned identification number for
the finding, observation, or proficiency.
6. Category Identification - Mark as either a finding, observation,
or proficiency.
7. Description of Finding/Observation/Proficiency - A concise
description of the finding, observation, or proficiency.
8. Requirement(s) - The source document(s), including specific
section, where the violated requirement is located.
9. Discussion - Space available for supporting evidence or more
detailed explanation of the finding, observation, or proficiency.
10. Contact(s)/Location(s) - The person(s) interviewed or contacted
and/or the location(s) of the finding, observation, or
proficiency during the assessment.
11. Accepted By - The person appointed by the assessed organization
to accept organizational ownership of the finding, observation or
proficiency, by signing the "ORNL Assessment Record" form.
Acceptance means the responsible organization accepts ownership of
the finding, observation or proficiency. It does not mean the person
signing the form accepts personal responsibility for the applicable
corrective action.
12. Assessed Organization - The assessed unit.
13. Team Member(s)/Team Leader - Name(s) are printed.
14. Team Leader - Name is signed.
15. Date Identified - The date when the finding, observation, or
proficiency was discovered.
PIC - G. E. Chitwood
FPM - P. B. Hoke
Directives Coordinator
Directives Home
ORNL Internal Home
Search the ORNL/LMES Web
http://www-internal.ornl.gov/ORNL/directives/data/506000003151.html
Updated:Wednesday, 12-Feb-97 12:58:09 EST(npn)