ML20086Q121
| ML20086Q121 | |
| Person / Time | |
|---|---|
| Site: | Point Beach  |
| Issue date: | 12/16/1991 |
| From: | Doolittle W, Johansen K, Pusztai A WISCONSIN ELECTRIC POWER CO. |
| To: | |
| Shared Package | |
| ML20086Q120 | List: |
| References | |
| A-V-89-02, A-V-89-2, NUDOCS 9112300006 | |
| Download: ML20086Q121 (13) | |
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$,. b i1f[ V mt Audit Report No. A-V-89-02 QUALITY ASSURANCE AUDIT REPORT TELEDYNE 150TOFE5 MIDWEST LABORATORY NORTHBROOK, ILLINDIS FEBRUARY 8-9, 1989~
I.
Purpose and Scope The audit was conducted to reevaluate Teledyne Isotopes Midwest Laboratory (TIML) as a qualified environmental lab for performing analyses for the PBNP Radiological Environmental Monitoring Program (REMP) and to continue to maintain TIML on Wisconsin Electric's PBNP QualifIedSuppliersList(QSL).
The basis for the audit was the TIML 1
Quality Control Program (TIML-QCP-L Revision 10) and compliance to thePBNPStudyPlan,ProjectNo.8066, Revision 1,whichincludes applicable requirements of 10CFR50, Anendix B.
The audit was conducted at the new location in Nortur4, Illinois.
II.
The audit team consisted of:
A 2. Pusztai (L) - Project Specialist, Quality Assurance K. A. Johansen, Ph.D. - Radiological Engineer iNPERS), Technical Advisor W. W. Doolittle - Specialist - Nuclear Health Physics (PBNP),
Technical Advisor III.
Perscr.s Contacted The following TIML personnel were contacted during the audit:
- L. G. Huebner - General Manager
- B. Grob - Lab Supervisor
- H. Sharifi - Q.C.-- Officer G. McGlauchlin - Technician, Sample Preparation T. Coorlim - Technician, Counting Room A. Faymen - Lab Technician TLDs A. Passman - Lab Technician,,ian 1-131 Analysis S. Blitt - Receiving Technic II
- Denotes those present at the exit meeting.
IV.
Summary of Audited Areas As a result of the audit, a total of nine Audit Finding Reports (AFRs) were issued.
Three were classified as findings, and the i
balance were observations.
Deficient areas included procedural discrepancies, compliance with Reg Guide 4.13, previously identified problems with TLD Transportation Control, lack of participation-in.
crosscheck programs, not adhering to good lab practices,-and recording of sample collection times.
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Page 2 recommended corrective action (s) are provided in AFRs A-V-89 02 008 through -016 which are attached to this report and require TIML response.
The results are summarized below:
AFR#A-V-89-02008(Finding)
The calibration methodology in use for the gamma detection instrumentation (intrinsic ermanium & GeLi) ion Procedure foris not in compliance C 9.1, "Calibrat i
with calibration procedure Determination of Absolute E ficiency."
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AFR#A-V-89-02-009(Finding) 4 Actual practice in performing 1-131 analysis (Batch Method) of milk samples does not match the analytical procedure in two instances.
The changes do not affect the results obtained and are, in fact, improvements.
AFR$ A-V-89-02-010 (Finding)
There is no documentation to verify-compliance with Reg. Guide 4.13.
Aho, problems exist with transportation control TLDs.
AFR#A-V-89-02-011(Observation)
There is no evidence at TIML of International Intercomparison of Environmental Dosimeters Program participation since 1986.
AFR# A-V;89-02-012 (Observation)
Low level radioactive standards for calibrating gamma spectrometers for various geometries were not labeled as radioactive.
Spikes also had no radioactive stickers.
There is no specific re these levels but it would follow good lab practices. quirement at AFR# A-V-89-02-013 (Observation)
Standards for " spiking"'were still in cabinets even though expiration date(s) had been exceeded.
This was also identified as a lack of good lab practice.
AFR#A-V-89-02-014(Observation)
NBS Crosscheck Program is referenced in TIML QC Program, but no evidence of recent participation was found.
AFR#A-V-89-02-015(Observation)
Samples Receiving Log c)ntains incorrect instruction (note) which can tt used if PBNP does not include time of collection on milk sample
. labels.
This informatio1 does not adversely affect the results obtained. -Corrective Action is-required by both TIML and PBNP.
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l AFR# A V-89 02-016 (Observation)
The PBNP Study Plan Revision 2 has not been reviewed in the past i
threeyearsasrequIredbyTIML'sQAprogramtoensureinformationis kept up to-date.
Various other comments and recommendations were made during the audit and will be covered later in Section VI of this report.
V.
Discussion of Audited Areas The audit began with a brief entrance meeting to discuss the scope and schedule of the audit.
Following this meeting, a short tour of the facility was made.
Areas of the tour and audit included the i
sample receiving and storage area $, sample ) reparation, counting room, TLD room, hot lab, and the general la) oratory where environmental analyses are performed.
A review of count room activities was perfonned and a problem was noted with the humidity controls in the new facility.
Mr. Huebner expressed some concern and is following up with an HVAC vendor.
Couni room records were reviewed.
Control charts were'in order for gamma detection equipment and beta counters.
They were up-to-date with control levels noted.
Detector history files contained the results of these twice weekly checks including observed FWHM and detector maintenance history.- All calibration stickers were up-to date.
No calibrations were scheduled during the audit; however, calibration methodology was discussed.
It was apparent that the currently approved procedure has not been kept up-to-date.
A-V-89-02-008 was issued because the gamma detection equipment and calibration methodology have changed and.are not contained in the procedure.
Calibration standards are NBS traceable-and marked with adequate identification to allow users to establish their origin.
Records of standard preparation and spiked sample preparation were reviewed and
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found satisfactory.
Computer program verification was reviewed for alpha / beta and 7LD calculations.
The verifications included a comparison with hand-computations which appeared adequate.
Problems have been encountered with high results for the transportation controls for the environmental TLDs.
This, together with the increased variability in TLD results since 1984,ide 4.13 for resulted in a scrutiny of the TLD program for compliance with Reg. Gu environmental TLDs.
No records of testing required by this Reg.
Guide were found.
WE will cooperate with-TIML to determine the.
possible cause of the discrepancy in the transporation TLDs..
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Page 4 TIML must perform the required tests to determine the degree of in house contribution to the observed results.
An audit firiding was issued to ensure proper corrective action.
Radioactive liquid standards used for " spikes" are stored in a laboratory cabinet at TIML.
These standards have labels indicating preparation and expiration dates.
Several were in the cabinet beyond their expiration date and one had no expiration date.
As a result, audit finding report #A-V-89-02-013 was issued.
The TIML QC Program refers to participation in various crosscheck l
programs including NBS crosscheck program.
If TIML no longer i
participates in tais program, the manual should be changed accordingly.- See AFR #A-V-89-02-014 for details.
The Samples Receiving Le book was checked while investigating the handling of milk and veptation samples.- There is a note in the book that all PBNP milk samples should be given a collection time of 6 p.m. if no collection time is given on the sample tap.
If PBNP should neglect to put a collection time on the tag, the TIML procedure would lead to a lower than actual value when correcting the milk I-131 for decay.
The difference is small - about 3% - but should be corrected.
(See AFR #A-V-89-02-015 for details.) PBNP typically collects milk about 9-12 in the morning.
PBNP 1r.bels for milk have a space for collection time to be indicaterf.
The appropriate caution will be forwarded to PBNP to remind collectors to enter the correct collection time on the sample label.
Sample 1 reparation was observed during the audit for powdered milk and fisi samples.
The precautions taken during sample preparation were adequate to prevent sample cross-contamination.
Sample sheets-provided data on sample identification and sample weights.be dried or ashed are m Sam There was no DOE sponsored environmental TLD program at EML in 1988 as had been scheduled. TIML will participate in this program when it-is run.
However, until then, TIML snould initiate an in-house program to provide an outside verification of its TLD capabilities.
This could be accomplished by sending a. series of TLDs to NIST,-
Bate 11e Northwest Labs or some other facility for irradiation and thenchecktheircapcbllitybycomparingtheirreadoutoftheseTLDs to the known exposure.
To resolve this matter, AFR #A-V-89-02-011 us - issued.
The low level radioactive standards of various geometries used in gamma spectrometer calibration had no radioactive material labels on them.
Even though these standards may be exempt quantities from a federal _ regulatory perspettive, good lab practice O dates that the standards be labeled radioactive so as-to ensure that the proper care is taken when handling these" sources and as a reminder that any F _E COPY
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deleterious change in the standards' physical integrity could comprise the results of environmental radioactivity measurements.
(See AFR #A-V-89-02-012 fordetails.)
1 1
The qualification and training files were reviewed for various TIML t
personnel.
The persons performing assigned tasks were found qualified and their training records. reflected this.
Other records including work sheets,-progress reports, and computer calculations were reviewed and available as requested for activities related to thePBNPproject.
Long term storage of records were verified for at least the last five years.
Annual internal audits by the Corporate office of Teledyne Isotopes of Westwood, New Jersey are performed.
The previous two audits of 1987 and 1988 were reviewed, including the TIML responses to deficiencies, and final closeout based on TIML's corrective action.
This area has improved since WE's last audit of 1986.
Sample retention, both short and long term storage, were checked and found acceptaH e.
Other than having a problem locating a recent fish sample, all others were readily available.- The approach used for this audit was primarily performance-based, and included as much observation of work in process and questioning of technicians to verify they understand their procedures.
Recently, milk-samples were received from PBNP for I-131 analysis.
The processing and analysis for I-131 was observed during the two days beginning with the mixing of the samples with-resin culminating with the final preparation for the counting room._ Except for two minor discrepancies, the procedure was followed very well.
The two differences were discussed with lab supervision and found to be an improvement to the procedure.
In order to get this reflected in the procedure, AFR #A-V-89 was issued.
After the_ completion of the audit, an exit meeting was held with TIML management personnel to discuss the audit results.
Specific details of the audit can be found in the completed audit 6
team's checklists which were based on the_ TIML QC program and the PBNP Study Plan.
l VI.
Assessment of Audited Areas Based on the a rit' results,.it was determined that-TIML,'except for the three audit findings and six observations, is complying to their-
-QC program and the PBNP Study Plan. _The problems generally do not affect the results'of the lab analyses performed.. With proper corrective action and closure of the Audit Finding Reports, TIML can be.taintained on WE's Qualified Suppliers List.
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audit results further indicate that both PBNP and NPERS are properly performing the required activities necessary to assure compliance with regulations.
During the course of the audit, several comments, concerns and/or recommendations were_noted and discussed with responsible individuals.
While these items are not
-deficiencies ~in the administration and implementation of the program, they should be.addressedLin order:to either-correct minor deficiencies or to make_possible program enhancements.
They will not be followed up through'this audit, but should_rather be considersd in the next audit of the REMP.
Therefore, no-documented, formal response-is required.. These items'are summarized--belows-1.
The review and evaluation _ performed by the NPERS -
-Radiological 2EngineerLof the Monthly-Progress Reports' received from Teledyne, should be better documented (i.e.,Ldocumentation-that the-Radiological Engineer has performed a review should be maintained:in file, as-opposed to informally maintaining worksheets'and signoff-with non-file copies of reports).
(NPERS Responsibility) 2-Clarification =is required:in_the Section 2.2.6'of_-
the Environmental Manual, concerning the inclusion of deviations / problems in-the obtainment of_ samples in-the Semiannual Report.- The manual; requires that-
-_ henever:PBNP logs and conveys a-formally written.
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-problem to NPERS using:a_ form fromLtheinanual, the description of the sampling problem must be included in;the Semiannual Report. This is.notothe intent, as some problems' identified do not involve a true-deviation from th'e required sampling schedule as L
required'by. Technical Specifications.- The procedure-should be revised.to indicate that only some.of the problems _that PBNP formally conveys _to NPERS need-be' L
included _in-the SemiannualLReport.
(NPERS Responsibility) 3.
.The. inclusion of NRC recommendations from the May 1990 inspection into the procedure;for leak testing:
-the-air samplers should-be; completed.' lThe 4
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Audit No. A-P-90-15 1
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recommendations are being followed in practice, but the procedure reflecting the practice has not yet been revised.
(PBNP Responsibility.
Note that this item is being tracked internally _by HP as Item No. HP90037 in their Health Physics Status Report.)
l 4.
Teledyne Isotopes Midwest Laboratory's (TIML) Study
-Plan (contractor procedure) needs to be updated to change distribution of the monthly progress-report, from J. J.'Zach to G. J. Maxfluid.
(NPERS Responsibility to contact TIML) 5.
The copy'of the TIML QA-Program Manual maintained by NQAD was found:as not being current and should be updated accordingly..
[NQAD Responsibility)
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