ML23062A707
| ML23062A707 | |
| Person / Time | |
|---|---|
| Issue date: | 10/02/2000 |
| From: | Charlton M, Emery R, Hernandez M, Orders A Office of Nuclear Material Safety and Safeguards, Univ of Texas |
| To: | |
| Shared Package | |
| ML23062A719 | List: |
| References | |
| Download: ML23062A707 (25) | |
Text
Getting to the Root Causes ofGetting to the Root Causes of Non-Compliance:Non-Compliance:
A Prescription for PreventionA Prescription for Prevention
Robert Emery, Dr.P.H., CHP, CIH, CSP, RBPRobert Emery, Dr.P.H., CHP, CIH, CSP, RBP University of Texas-Houston Health Science CenterUniversity of Texas-Houston Health Science Center
Michael Charlton, MS, MPH, CHP, CHMMMichael Charlton, MS, MPH, CHP, CHMM University of Texas Health Science Center-San AntonioUniversity of Texas Health Science Center-San Antonio
Amy Orders, MS, RTAmyOrders, MS, RT University of Texas-Houston Health Science CenterUniversity of Texas-Houston Health Science Center
Mike Hernandez, Graduate Biometry StudentMike Hernandez, Graduate Biometry Student University of Texas-Houston School of Public Health University of Texas-Houston School of Public Health Objectives Objectives
To emphasize how stakeholders reallyreally To emphasize how stakeholders evaluate radiation safety programs and the evaluate radiation safety programs and the important role compliance plays in this important role compliance plays in this assessment assessment
ToTo objectivelyobjectively identify the commonidentify the common violations issued to permit holders in Texas violations issued to permit holders in Texas
Show how this data can be put to use forShow how this data can be put to use for prevention by identifying the root causes ofpreventionby identifying the root causes of non-compliance non-compliance
Make you an offer youMake you an offer you cantcant refuse!refuse!
Health and Safety OutcomeHealth and Safety Outcome MeasuresMeasures
SystemicSystemic : ultimate program outcomes: ultimate program outcomes
number of injuries, illnesses, fatalitiesnumber of injuries, illnesses, fatalities
OSHA 200 log or equivalentOSHA 200 log or equivalent
OrganicOrganic: indicators of program design and: indicators of program design and implementation implementation
numbers of unsafe conditions, practices,numbers of unsafe conditions, practices, behaviors, attitudes behaviors, attitudes
regulatory complianceregulatory compliance A Word About Inspections A Word About Inspections (to the regulated community) (to the regulated community)
The public and the radiation safety The public and the radiation safety profession benefit from the compliance profession benefit from the compliance inspection process.inspection process.
These works are intended to make permitThese works are intended to make permit
holders aware of the common deficiencies, holders aware of the common deficiencies, so they can be avoided. so they can be avoided.
This should not be done to the exclusion ofThis should not be done to the exclusion of
other important safety tasks!
other important safety tasks!
Licensees: Top Ten ViolationsLicensees: Top Ten Violations 1988-1997 1988-1997
Procedures 11%11% InventoriesInventories 6%6%
Procedures
Absent surveys 10%Absent surveys10% Transfer recordsTransfer records 6%6%
Leak testing 8%Leak testing8% Disposal recordsDisposal records 4%4%
Personnel monitoring 7%Personnel monitoring 7% Main programMain program 4%4%
Instrument calibration 7% Training Instrument calibration 7% Training 2%2%
TotalTotal 65%65%
Annual Top Ten Varied from 55% to 75% of all NOVsAnnual Top Ten Varied from 55% to 75% of all NOVs Licensee: Top Ten Violations By YearLicensee: Top Ten Violations By Year 1988-1997 1988-1997
25.0%
20.0%
Percent of All 15.0%
Violations Issued 10.0%
5.0% 1991 1988
0.0% 1994 Year
1997 Licensee NOVs by RegulatoryLicensee NOVs by Regulatory Citation: 25 TAC 289Citation: 25 TAC 289
202(e) Radiation protection programRadiation protection program 17%17%
202(e)
201(g) Sealed source leak testSealed source leak test 16%16%
201(g)
202(p)202(p) Surveys and monitoringSurveys and monitoring 11%11%
201(o)201(o) General public dose limitsGeneral public dose limits 8%8%
201(d)201(d) Receipt, transfer,disposal recordsReceipt, transfer,disposal records 8%8%
Top five account for 60% of total, based on Top five account for 60% of total, based on 1999 data. 1999 data.
Licensee ViolationsLicensee Violations Severity Level DistributionSeverity Level Distribution 1988-19971988-1997
Severity Level I Severity Level II Severity Level V 2% 1%
4%
Educational Value Educational Value
Figure 2: Summary of overexposure and total incidents reported to the Texas Department of Health, Bureau of Radiation Control from 1988 to 1997.
300 264 279 250 256 267 1994 - Revision of regulations (10CFR20).
200 201 206 190 168 164 Overexposure 150 Total Incidents 131
100 100 101 73 78 83 78
50 39
16 10 15 0
1986 1988 1990 1992 1994 1996 1998
Year Educational Value Educational Value Educational Value Educational Value Educational Value Educational Value What Does All This Cost? What Does All This Cost?
Estimating the administrative cost to the Estimating the administrative cost to the BRC associated with the issuance of BRC associated with the issuance of violations: violations:
baseline cost of inspection processbaseline cost of inspection process
some added cost to issue and resolve NOVssome added cost to issue and resolve NOVs
if this added cost could be estimated, thenif this added cost could be estimated, then reductions through education could be reductions through education could be quantified quantified
Cost to the permit holders not included, butCost to the permit holders not included, but
equally important equally important Estimating the Cost Estimating the Cost
$100,000.00 R2 = 0.8014
$90,000.00
$80,000.00
$70,000.00
$60,000.00
$50,000.00 Registrants
$40,000.00
$30,000.00
$20,000.00
$10,000.00 Licensees
$0.00 0 2000 4000 6000 8000 10000 12000 14000 16000
Number of Violations The EU (Emery Unit)!The EU (Emery Unit)!
Administrative dollars per NOV saved, at STPAdministrative dollars per NOV saved, at STP The Next Step: Root Cause Analysis The Next Step: Root Cause Analysis Ex: Sealed Source Leak Test NOV Ex: Sealed Source Leak Test NOV
Problem Problem Root CauseRoot Cause
Done or not doneDone or not done Failure to executeFailure to execute
Ever? Or not atEver? Or not at proscribed frequency? proscribed frequency? FrequencyFrequency
Time frame based onTime frame based on Violation of regulationViolation of regulation permit condition or or permit conditionpermit condition oror permit condition regulation? regulation?
DocumentationDocumentation CompletenessCompleteness incomplete? incomplete?
Found leaking, but notFound leaking, but not reported? reported? Inappropriate actionsInappropriate actions Fault Tree Analysis:Fault Tree Analysis:
Sealed Source Leak Test NOVSealed Source Leak Test NOV
SEALED SOURCE LEAK TEST NOTICE OF VIOLATION
VIOLATION OF VIOLATION OF PERMIT REGULATION CONDITION
OR OR
FAILURE TO EXECUTE DOCUMENTATION FREQUENCY ACTIONS FAILURE TO EXECUTE DOCUMENTATION FREQUENCY ACTIONS
PERFORMED BUT NOT FULLY PERFORMED PERFORMED LEAKING:NOT FOUND FOUND PERFORMED BUT NOT FULLY PERFORMED PERFORMED LEAKING:NOT FOUND FOUND TASK NOT BUT NOT DOCUMENTED/ BUT NOT AT POSTED OR LEAKING: TASK NOT BUT NOT DOCUMENTED/ BUT NOT AT POSTED OR LEAKING:
PERFORMED DOCUMENTED INCORRECTLY FREQUENCY REQUIRED TAKEN OUT OF NOT NOTIFIED AUTHORITIES PERFORMED DOCUMENTED INCORRECTLY FREQUENCY REQUIRED TAKEN OUT OF NOT NOTIFIED AUTHORITIES DOCUMENTED SERVICE DOCUMENTED SERVICE Fault Tree Analysis:Fault Tree Analysis:
Sealed Source Leak Test NOVSealed Source Leak Test NOV
VIOLATION OF REGULATION
FAILURE TO EXECUTE DOCUMENTATION FREQUENCY ACTIONS
OR OR
PERFORMED PERFORMED FOUND FOUND TASK NOT PERFORMED BUT NOT FULLY BUT NOT AT LEAKING:NOT LEAKING:
PERFORMED BUT NOT DOCUMENTED/ REQUIRED POSTED OR AUTHORITIES DOCUMENTED INCORRECTLY FREQUENCY TAKEN OUT OF NOT NOTIFIED DOCUMENTED SERVICE Results of Analysis Results of Analysis
INAPPROPRIATE OTHER ONLY ACTIONS ONLY 2% 5%
FAILURE TO EXECUTE FAILURE TO AND INAPPROPRIATE EXECUTE AND ACTIONS OTHER 7%
FAILURE TO EXECUTE AND COMPLETENESS 7%
FAILURE TO EXECUTE 34%
FAILURE TO EXECUTE FAILURE TO AND FREQUENCY EXECUTE 43% TOTAL 93% TOTAL 93%
Implications Implications
Consider the findings within the context of Consider the findings within the context of the regulators common plea: read your the regulators common plea: read your permit! permit!
Do the permit holders really know what theyDo the permit holders really know what they are supposed to do? are supposed to do?
What can be done to improve compliance?
What can be done to improve compliance?
create summaries of requirements inherent tocreate summaries of requirements inherent to permits and their identified regulations? permits and their identified regulations?
modify the way RSOs are trained?modify the way RSOs are trained?
re-structure permit inspection process?re-structure permit inspection process?
What About Other States? What About Other States?
Are the trends shown here consistent?
Are the trends shown here consistent?
Are the root causes consistent?Are the root causes consistent?
Could there be some basic, simpleCould there be some basic, simple
interventions? interventions?
Proposal to OAS Proposal to OAS
To facilitate comparisons, heres the deal ::
To facilitate comparisons, heres the deal
identify number of licensees and averageidentify number of licensees and average number of NOVs per permit inspection number of NOVs per permit inspection
well calculate an appropriate sample size andwell calculate an appropriate sample size and sampling strategy sampling strategy
you get the coding forms completedyou get the coding forms completed
we (grad student) will summarize andwe (grad student) will summarize and analyze as their research project analyze as their research project
findings provided to you and OASfindings provided to you and OAS We Need to Stress That Were AllWe Need to Stress That Were All in the Same Pool!in the Same Pool!
By any measure, theBy any measure, the radiation safety record is radiation safety record is excellent!
excellent!
This success is due in partThis success is due in part to the inspection process:
to the inspection process:
hate it or love it, it benefits hate it or love it, it benefits all.
all.
NOV outcome data can beNOV outcome data can be valuable for prevention valuable for prevention
Emphasize theEmphasize the commoncommon goal and work together to goal and work together to achieve it!
achieve it!
ReferencesReferences
Emery, R.J., Johnston, T.P., Sprau, D.D., "Simple Physical, Chemical, and Emery, R.J., Johnston, T.P., Sprau, D.D., "Simple Physical, Chemical, and Biological Safety Assessments as Part of a Routine Institutional Radiation Biological Safety Assessments as Part of a Routine Institutional Radiation Safety Survey Program" Health PhysicsSafety Survey Program"Health Physics, Vol. 69, No. 2, pp. 278-280, 1995., Vol. 69, No. 2, pp. 278-280, 1995.
Emery, R.J., Sawyer, R.L., Sprau, D.D., "Assessing the Service ProvidedEmery, R.J., Sawyer, R.L., Sprau, D.D., "Assessing the Service Provided by an Institutional Radiation Safety Survey Program" Health Physicsby an Institutional Radiation Safety Survey Program"Health Physics, Vol., Vol.
70, No. 5, pp. 741-743, 1996. 70, No. 5, pp. 741-743, 1996.
Emery, R.J., Savely, S., "The Benefits of Actively Soliciting WorkerEmery, R.J., Savely, S., "The Benefits of Actively Soliciting Worker Concerns During Routine Safety Inspections" Professional SafetyConcerns During Routine Safety Inspections"Professional Safety, Vol. 42,, Vol. 42, No. 7, 36-38, 1997. No. 7, 36-38, 1997.
Emery, R.J., Pollock, J., Charlton, M., "Notices of Violation Issued toEmery, R.J., Pollock, J., Charlton, M., "Notices of Violation Issued to Texas Radioactive Material Licensees Inspected in 1995", Health PhysicsTexas Radioactive Material Licensees Inspected in 1995",Health Physics,,
Vol. 73, No. 4, 706-709, 1997. Vol. 73, No. 4, 706-709, 1997.
References (cont)References (cont)
Emery, R.J., "Adding Value to Your Radiation Protection Program", chapter Emery, R.J., "Adding Value to Your Radiation Protection Program", chapter in Management and Administration of Radiation Safety ProgramsinManagement and Administration of Radiation Safety Programs, Medical, Medical Physics Publishing, Madison, WI. 1998. Physics Publishing, Madison, WI. 1998.
Emery, R.J., Charlton, M.A., Assessing the Results of Receipt MonitoringEmery, R.J., Charlton, M.A., Assessing the Results of Receipt Monitoring Programs for Packages Containing Radioactive Materials OperationalPrograms for Packages Containing Radioactive MaterialsOperational Radiation Safety, Vol. 77, (Radiation Safety, Vol. 77, ( Health PhysicsHealth Physics Supplement 1) S5-S9, 1999.Supplement 1) S5-S9, 1999.
Emery, R.J., Charlton, M.A., Goodman, G.R., Texas Radiation SafetyEmery, R.J., Charlton, M.A., Goodman, G.R., Texas Radiation Safety Program Outcomes as Indicated by Regulatory Compliance Activities from Program Outcomes as Indicated by Regulatory Compliance Activities from 1988 to 1997 Health Physics1988 to 1997Health Physics, Vol. 78, No. 3, 335-342, 2000., Vol. 78, No. 3, 335-342, 2000.
Emery, R.J., Charlton, M.A., Mathis, J.L, "Estimating the AdministrativeEmery, R.J., Charlton, M.A., Mathis, J.L, "Estimating the Administrative Cost of Regulatory Noncompliance: A Pilot Method for Quantifying the Cost of Regulatory Noncompliance: A Pilot Method for Quantifying the Value of Prevention", Operational Radiation SafetyValue of Prevention",Operational Radiation Safety, Vol. 78 (, Vol. 78 ( HealthHealth Physics Supplement 2)S40-S47; 2000.PhysicsSupplement 2)S40-S47; 2000.