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Date Printed:_________________________ Verifier:__________________________
PURPOSE This procedure describes the ORNL corrective
action program (including reporting, tracking, and
trending) for conditions determined to be adverse to
safety, health, operations, quality, security, or the
environment.
APPLIES TO This procedure applies to all ORNL Sites and
Organizations. This procedure is written to
allow for direct implementation.
It applies to corrective actions generated in response
to external assessments, site/division/program
assessments, and reportable occurrences
(Category 1 - 3).
It is not applicable to divisional self-assessments,
and nonconformances unless specified by Site
Management.
Classified audit findings. Unclassified Controlled
Nuclear Information (UCNI) and Classified information
will not be entered on documents generated by this
procedure. Questions regarding the classification of
information must be reviewed by an Authorized
Derivative Classifier PRIOR to entry in the Energy
Systems Action Management System (ESAMS) or on
corrective action documentation.
It does not apply to Occupational Safety and Health
Administration (OSHA) noncompliances.
This procedure is effective 30 days after approval and
applies to all existing open issues and those
identified after the effective date of this procedure.
The requirements of this procedure are not retroactive
to actions closed prior to the effective date of this
procedure.
OTHER o X-AD-7, ORNL Records Management
DOCUMENTS
NEEDED o ORNL Guide ESS-MS-131, Integrated Resource
Management Systems
o OP-301, Occurrence Reporting and Notification
o ESP-QA-16.2, Root Cause Analysis
o ESP-QA-16.3, Lessons Learned and Alerts System
o ESS-QA-16.4, Energy Systems Action Management
System (ESAMS)
WHAT TO DO NOTE 1: Appendix A, Corrective Action Process
flowdown provides graphical representation of this
process.
NOTE 2: Assignment of responsibilities for
occurrences is made in accordance with OP-301,
Occurrence Reporting and Notification.
A. Initial Assignment of Responsibility
Assessments 1. Receives audit reports and other assessment
Manager documentation from auditing/assessing
organizations.
2. Coordinates review of assessment documentation to
identify and incorporate factual accuracy comments,
if applicable.
3. Determines the preliminary assignment of
responsibility for the issue, i.e., Responsible
Manager.
4. Coordinates the review of issues for risk priority
in accordance with ESS-MS-131, Integrated
Resource Management System, and site specific
criteria.
5. Forwards the assessment documentation,
risk/priority analysis, and the preliminary
assignment of responsibility, to the
Corrective Action Support Staff.
B. Notification of Assignment
Corrective 1. Enters the assessment and issue information into
Action Support the Energy Systems Action Management System
(ESAMS).
Staff
2. Initiates a request for the Responsible Manager to
perform an initial review of the issue.
C. Initial Review of Issue
Responsible 1. Performs an initial review of the issue including
Manager the following:
a. Confirms the factual accuracy of the issue by
concurring that the issue describes a condition
which requires corrective action.
b. Accepts responsibility for implementing or
coordinating the implementation of corrective
actions.
c. Assigns a responsible person to develop a
corrective action plan response, as
appropriate.
d. Identifies any issues corrected during the
audit or assessment.
2. Responds to the Corrective Action Support Staff
(normally within 7 calendar days) to either concur
with the initial assignment or to provide written
justification for nonconcurrence with the
assignment of responsibility or the factual
accuracy of the issue.
3. If factual accuracy of the issue is disputed,
then
requests reevaluation of the issue by the lead
auditor,
or
the person conducting the surveillance.
4. If the preliminary assignment of responsibility
is disputed, then
requests reevaluation of the assignment of
responsibility.
Corrective 5. Closes any issues corrected during the audit or
Action Support assessment.
Staff
6. If the Responsible Manager does not respond,
then
considers the assignment of responsibility made by
the Assessments Manager to be accurate.
D. Nonconcurrence With Assignment or Factual
Accuracy
Corrective 1. If the Responsible Manager does not concur with
Action Support the factual accuracy or the assignment of
Staff responsiblity, then
notifies the Assessments Manager.
Assessments 2. Coordinates reevaluation of the assignment or the
Manager factual accuracy.
Assessments 3. If reevaluation does not result in satisfactory
Manager/ resolutions, then
Responsible escalates the disputed issue to the ORNL Quality
Manager Director.
Quality 4. Evaluates the escalated quality issue and provides
Director a documented decision within 15 working days.
Quality 5. If resolution cannot be reached, then
Manager/ escalates the disputed issue, in writing, to the
Responsible Associate Director, Operations, Environment,
Manager Safety and Health.
Associate 6. Resolves the issue and provides a written decision
Director within 15 working days.
Assessments 7. Assigns responsibility based on the resolution.
Manager
E. Opening Issues
Corrective 1. Opens the issue in ESAMS.
Action Support
Staff 2. Generates an ESAMS Corrective Action Plan action for
the issue.
This directs the Responsible Individual to analyze
the issue and to develop a corrective action plan
response (normally within 30 calendar days).
F. Analysis of Issue
Responsible 1. Performs review of the issue including the
Person following:
a. Conducts a review to identify similar,
previously identified issues and the current
status of these issues.
b. Identifies the functional category of the
issue in accordance with Appendix G,
Functional Category Codes.
c. Evaluates the risk/priority of the issue, in
accordance with ESS-MS-131.
2. Evaluates the issue for significance based on the
criteria given in Appendix B, Definitions.
3. Determines the direct cause and contributing
causes.
The direct cause is the action or action sequence
that caused the deviation from expected behavior
or performance.
4. If the issue is significant, then
identifies the root cause, in accordance wtih
ESP-QA-16.2, Root Cause Analysis.
Root cause is the most basic causal factor or
factors that, if corrected or removed, would have
prevented the direct cause from developing and
the issue from occurring.
5. Determines the extent and the potential
applicability of the issue for Lessons Learned.
a. If the issue includes examples, then
defines the population that contains the
cited examples,
and
ensures that the corrective action addresses
the scope of the issue.
b. If the issue potentially applies to
operations in other organizations or at other
facilities, then
develops a Lessons Learned or an Alert, in
accordance with ESP-QA-16.3, Lessons
Learned and Alerts System.
6. Identifies what actions will correct both the
effects and the direct cause of the issue.
a. If corrective actions cannot be promptly
implemented, then
determines the immediate mitigation actions
to temporarily control the issue and prevent
further deviations or hazardous conditions.
b. Uses pre-existing actions, currently in
progress to correct similar issues, as a
means of correcting the issue for which the
plan is being developed.
7. If root cause analysis is performed, then
determines the preventive actions that will
correct the root cause.
8. Designates any issue meeting the following criteria
as a Quick Fix
o Corrected during the audit or assessment.
o Can be corrected within 30 calendar days from
the date of notification using existing
resources.
9. Designates any issue for which resources are not
available or which has a low risk/priority as
On-Hold; provides justification for placing the
issue On-Hold.
10. Considers the calendar date for closure of
corrective actions based on priorities and
resources.
G. Quick Fix Issues
NOTE 1: This section is not applicable to
Reportable Occurrences.
NOTE 2: Quick Fix issues do not require a formal
Corrective Action Plan.
Responsible 1. Ensures entry of a summary of the Quick Fix
Person activity into ESAMS.
2. Ensures the results of Lessons Learned, Generic
Implications and Root Cause reviews are entered
in ESAMS.
3. If the completion of the Quick Fix activities
occur within the 30 calendar days, then
a. Prepares the evidence package for the issue.
b. Ensures the entry of completion status (CO)
for the issue into ESAMS.
c. Go To Section N.3 for verification and
closure of the issue.
4. If Quick Fix activities cannot be completed
within 30 calendar days of notification of
responsibility, then
Go To Section I of this procedure, to develop a
detailed Corrective Action Plan.
H. On-Hold Status
NOTE: This section is not applicable to Reportable
Occurrences.
Responsible 1. Ensures the entry of justification for placing the
Person issue On-Hold in the ESAMS Status Comments for
Open status.
2. Ensures the generation of the report. See
Appendix C, Energy Systems Action Management
System Corrective Action Plan (CP) Report.
3. Obtains validation for placing on-hold as per the
following guidelines:
o High priority issues will be validated by a
representative of the responsible organization
and by a designated representative of the
Quality organization.
o Medium and low priority issues will be
validated by an independent designee
identified by the Responsible Manager.
4. Forwards the signed/approved ESAMS CP Report to
the Corrective Action Support Staff.
5. Reviews On-Hold issues/actions annually and
disposition as follows:
a. Restores to active status.
b. Retains in On-Hold status.
c. Evaluates for cancellation after 2 years in
On-Hold status.
6. Restores On-Hold issues to active status using
Appendix E, Energy Systems Action Management
System (ESAMS) Change Request.
7. Cancels On-Hold issues using Appendix E.
I. Developing a Corrective Action Plan
Responsible 1. Lists all actions along with the responsible
Person individual and the scheduled date for closure.
2. Considers the document or evidence requirements for
each action.
3. Coordinates the responsibilities with the
responsible individuals.
4. If supporting actions by another organization
or division are needed, then
obtains documented acceptance of responsibility.
5. If coordination of responsiblity for supporting
actions cannot be resolved, then
escalates as per Section D of this procedure.
6. Ensures entry of the actions into ESAMS with
"Partial" status.
7. Ensures entry of the results of Lessons Learned,
Generic Concerns, and Root Cause reviews into
ESAMS, where applicable.
8. Coordinates an independent validation of the plan
with technical experts and/or Quality organization
personnel utilizing the following guidelines or as
specified by site criteria:
o High priority issues and category 1 and 2
occurrences will be validated by a
representative of the responsible organization
and by a designated representative of the
Quality organization.
o Medium and low priority issues and category 3
occurrences will be validated by an
independent designee identified by the
Responsible Manager.
Validator 9. Validates the proposed corrective actions for the
and/or following:
Technical
Expert o Interim actions are adequate, where required.
o Actions are appropriate to correct and prevent
recurrence of the issue.
o Actions specifically address the system,
feature, or program element cited in the issue.
o All applicable requirements; root cause, generic
concerns, and lessons learned reviews, are
addressed.
o Actions are achievable, closeable, and can be
documented.
o The corrective action plan is correctly
processed, including attachments, correct
numbering, cross-references, and signatures.
Responsible 10. Ensures the generation of ESAMS CP Report or
Person Final Occurrence Report as appropriate.
11. Forwards the signed/approved ESAMS CP Report or the
Final Occurrence Report to the Corrective Action
Support Staff.
12. If the issue is an occurrence, then
forwards the signed/approved Final Occurrence
Report to the Occurrence Reporting Staff/Facility
Manager.
Occurrence 13. Transmits the final report of corrective actions
Reporting for occurrences to the Occurrence Reporting and
Staff/Facility Processing System (ORPS).
Manager
J. Opening Actions
Corrective 1. Closes the ESAMS Corrective Action Plan action,
Action Support upon receipt of the approved action plan.
Staff
2. Opens the corrective actions in ESAMS, or places
On-Hold, as appropriate.
3. If external review or appproval is required,
then
initiates a request for the auditing or assessing
organization to approve the Corrective Action
Plan(s).
K. Corrective Action Implementation
Responsible 1. Monitors the implementation of the corrective
Person actions to ensure that the actions are implemented
according to the plan and the schedule is
maintained.
2. If corrective actions are not implemented
according to schedule, then
prepares an ESAMS Change Request to do one of the
following:
o revise the schedule
o revise the action description
o reassign responsibility for the action.
3. If responsibility is reassigned to another
organization, then
obtains documented acceptance of responsibility from
the assignee.
4. If the action is to be placed On-Hold, canceled,
or restored to active status after being placed
On-Hold, then
prepares an ESAMS Change Request to change the
status of the action.
5. Provides justification for the status change.
6. Obtains validation and approval for changes at the
same level as for the original plan.
7. Forwards the signed ESAMS Change Request to the
Corrective Action Support Staff.
L. Corrective Action Completion
Responsible 1. Prepares the evidence package for each action,
Person using the guidelines in Appendix F, Guidelines for
Evidence Package Compilation.
2. Ensures entry of the completion status (CO) for
the action into ESAMS.
3. Obtains verification for the action.
Verifier 4. Performs verification of the action using a graded
approach with the following as the recommended
minimum requirement:
o Low Priority - line organization review of
evidence package.
o Medium Priority and Category 3 Occurrences -
independent line organization verification of
evidence package.
o High Priority and Category 1 & 2 Occurrences -
independent quality field verification.
5. Signs the report as shown in Appendix D, Energy
Systems Action Management System Corrective
Action (CA) Report, indicating completion of
verification activities.
Responsible 6. Forwards the signed ESAMS CA Report and the Evidence
Person Package to the Corrective Action Support Staff.
M. Corrective Action Closure
Corrective 1. Closes each action upon receipt of the Evidence
Action Support Package for the action.
Staff
2. If the action is in response to a reportable
occurrence, then authorizes closure of the
action in ORPS.
3. Forwards the Evidence Package to file.
N. Issue Review and Verification
NOTE: The purpose of reviewing and verifying the
issue is to ensure that the individual actions remain
valid to collectively resolve the issue after the
interval from the time the plan was issued until the
last action was closed.
Corrective 1. When the last action is closed, then
Action Support requests the Responsible Manager to review the
Staff completed Evidence Package for the issue.
Responsible 2. Ensures that the action plan, as completed, is
Manager verified as being effective in correcting and
preventing recurrence of the issue.
Verifier 3. Verifies the issue using a graded approach with the
following as the recommended minimum requirement:
o Low Priority - line organization review of
evidence package.
o Medium Priority and Category 3 Occurrences -
independent line organization verification of
evidence package.
o High Priority and Category 1 & 2 Occurrences and
Quick Fixes - independent quality field
verification.
4. Signs the ESAMS CP Report indicating verification.
Responsible 5. Provides a signed ESAMS CP Report to the Corrective
Manager Action Support Staff.
Corrective 6. Closes the issue in ESAMS upon receipt of the signed
Action Support ESAMS CP Report.
Staff
7. If external verification is required, then
initiates a request for external verification.
8. If external verification fails, then
notifies the Responsible Manager,
and
reopens the issue and corrective actions.
O. Corrective Action Status Reporting and Trending
Corrective 1. Prepares monthly reports upon request, showing the
Action Support status of corrective actions.
Staff
2. Reviews corrective action status to identify trends
and similar root causes and notifies management of
any identified trends.
3. Provides corrective action and root cause
performance indicator data upon request.
RECORDS NOTE: All records required to document the
identification, validation, implementation, completion,
verification and closure of corrective actions will be
maintained in the corrective action Evidence Package.
These records shall be maintained in accordance with
approved records inventory and disposition schedules.
Responsible 1. Prepares documentation to be included in Evidence
Person Packages in accordance with IO-101, Records
Management, and the following:
a. Ensures that all information is legible.
b. Marks or highlights applicable sections of
documents.
c. Includes approved and/or issued copies only.
Drafts are unacceptable unless specifically
identified as drafts in the action step.
d. Ensures ESAMS CA Reports, ESAMS CP Reports, and
ESAMS Corrective Action Change Requests are
signed and dated.
e. Includes the cover page, signature page, the
applicable sections of the document, and the
transmittal letter, as appropriate.
APPENDIXES
Appendix A. Corrective Action Process
Appendix B. Definitions
Appendix C. Energy Systems Action Management System
(ESAMS) Corrective Action Plan (CP) Report
Appendix D. Energy Systems Action Management System
(ESAMS) Corrective Action (CA) Report
Appendix E. Energy Systems Action Management System
(ESAMS) Corrective Action Change Request
Appendix F. Guidelines for Evidence Package
Compilation
Appendix G. Functional Category Codes
APPENDIX B
DEFINITIONS
ESAMS Corrective Action Report (CA) - A report which summarizes the
ESAMS action status.
ESAMS Corrective Action Closure (CL) - The status of an action when
the Corrective Action Support Staff receives objective evidence that the
action is complete and has been verified.
ESAMS Corrective Action Completion (CO) - The status of an action when
all specified work has been performed and documented and the action is
ready for verification.
ESAMS Corrective Action Plan Report (CP) - A report which summarizes
the status of all actions in an action plan.
Evidence Package - Documentation that the work specified by the action
has been completed and was effective in correcting and preventing
recurrence of the problem.
Issue - Generic term for problems, deficiencies, findings, concerns,
alerts, observations, and other conditions requiring evaluation for
corrective action. These terms are identified as different ESAMS Action
Item Types. Issues are classified as internal: i.e., those identified by
Energy Systems and its organizational subdivisions, and external; i.e.,
those identified by organizations external to Energy Systems, including
Martin Marietta Corporate, the Department of Energy and the State of
Tennessee.
Quick Fix - Issues which can be completed and closed within 30
calendar days using existing resources and with no impact on schedules.
Risk/Priority - The evaluation of the consequences and the probability
of occurrence of a problem based on the Energy Systems risk and priority
methodology. The following Risk/Priority category designations will be
used:
Risk Rank Score Occurrences
High >100 Category 1 & 2
Medium 50-100 Category 3
Low <50
Significance - Significant deficiencies are those meeting one of the
following criteria:
o Any item with a high Risk/Priority.
o Any item which is reportable under DOE Order O232.1.
o Any condition which merits increased management attention.
o Programmatic breakdowns identified by adverse trends or other
means.
o Repetitive or deliberate violations of procedure or falsification
of documentation.
o A problem which has recurred after being corrected with a formal
Corrective Action Plan.
Validation - An independent review performed to ensure that planned
corrective actions address causes of issues, will prevent recurrence of
issues, and can be accomplished and documented as scheduled.
Verification - An evaluation to determine that an action or action
plan was actually completed and was effective in correcting a problem.
APPENDIX F
GUIDELINES FOR EVIDENCE PACKAGE COMPILATION
Evidence Packages are compiled for each corrective action which is
specified in the Corrective Action Plan response, as well as for issues
placed on-hold or addressed via Quick Fix activities. Collection of
objective evidence should begin as soon as the action is identified as one
which will correct or mitigate the issue. The contents of the Evidence
Package are considered QA records. The following guidelines should be
used when compiling evidence.
Evidence associated with the Issue:
1. Copy of the initial issue description and any associated response
documentation.
2. Initial signed and dated ESAMS Corrective Action Plan Report or Final
Occurrence Report.
3. Signed and dated ESAMS Change Requests for changes or revisions to
the action plan.
4. Root Cause analysis documentation, if performed.
5. Signed and dated ESAMS Corrective Action Plan Report indicating closure
and verification for all corrective actions performed to address the
issue.
6. Supporting evidence to document the closure of a Quick Fix issue.
7. Documentation to justify canceling or placing an issue On-Hold.
8. Table of contents for information contained in the Evidence Package.
Evidence associated with each Corrective Action:
1. Copy of the signed and dated ESAMS Corrective Action Reports(s) which
document the action(s).
2. Signed and dated ESAMS Change Requests for changes to the
corrective action schedule, status, or content.
3. Signed and dated ESAMS Corrective Action Plan Report indicating closure
and verification of the corrective action.
4. Supporting evidence to document closure of the corrective action:
Examples: a. Revisions or changes to a procedure will include:
o Procedure cover page showing revision date and
revision level
o Signature page, signed and dated
o Pages with pertinent paragraphs highlighted. For
comparison purposes, include comparable pages prior to
the revision.
b. If training was performed, include:
o Attendee roster including date of training,
instructor, and title of training,
o Lesson information or official course identification.
c. Development of a functional charter will include a signed
and dated copy of the charter.
d. Documentation of staffing increases will include:
o Position descriptions or charters
o Old and new organization charts
o Signed and dated approved staffing requisition
o Pertinent correspondence related to actual staff
assignment.
e. Physical changes in equipment or facilities will include,
as applicable:
o Photographs
o Approved drawings
o Procurement records
o Associated correspondence.
f. Documented test results.
g. Surveillance results to indicate results of monitoring
performed on on-going activities.
5. Documentation to justify canceling or placing a corrective action
On-Hold.
6. Table of contents for information contained in the Evidence Package.
APPENDIX G
FUNCTIONAL CATEGORY CODES
AQ Air
AS Aviation Safety
AX Auxiliary Systems
BI Biota
CO Communications
CS Criticality Safety
DP Directive Process
EA Experimental Activities
EM Environmental Monitoring
EN Environmental
EP Emergency Preparedness
ES Explosive Safety
FP Fire Protection
FR Facility Safety
FS Firearms Safety
GW Groundwater
HM Hazardous Materials
HS Health & Safety
IH Industrial Hygiene
IR Incident Reporting Trend Analysis
IW Inactive Waste Sites
MA Maintenance
MG Management
MI Management Information Systems
MN Mission
MS Medical Services
NE NEPA Implementation
NS Nuclear Safety
OA Organization and Administration
OP Operations
OS Occupational Safety
OV Oversight
PB Planning & Budgeting
PO Policy & Procedures
PP Personnel Protection
PT Packaging and Transportation
PU Public Protection
QA Quality Assurance
RE Resources
RM Radioactive Materials
RP Radiological Protection
SA Self-Assessment/Correction Action
SE Sediment
SO Soil
SS Security/Safety Interface
ST Special Topics
SW Surface Water
TC Training and Certification
TS Technical Support
WM Waste Management
WS Worker Safety
Approved by: [J. H. Swanks]
Associate Director
Operations, Environment, Safety, and Health
Oak Ridge National Laboratory
PIC - A. J. Denton
FPM - P. B. Hoke
Directives Coordinator
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Updated:Wednesday, 12-Feb-97 13:00:07 EST(npn)