ML20149J820
| ML20149J820 | |
| Person / Time | |
|---|---|
| Site: | 07100102 |
| Issue date: | 07/21/1997 |
| From: | Dicharry D, Frizell M, Weber P SOURCE PRODUCTION & EQUIPMENT CO., INC. |
| To: | |
| Shared Package | |
| ML20149J226 | List: |
| References | |
| NUDOCS 9707290113 | |
| Download: ML20149J820 (18) | |
Text
._
l SPEC Quality Assurance Program - NRC Certificate of Compliance No. 0102 3
INTERNAL AUDIT REPORT Revision (1), July 21,1997 4
Audit date:
July 7,1997 Report date:
July 12,1997 Report Revised; July 21[1997,to; add cross references of all Phase I Corrective Actions with the corresponding completion record listed in the Matrix of Assignments and Correc.t.ive A_ctionsjRey (5), dated _ July 21,1997. Revision (1) contains no : revisio_ns to any information in the, Internal Audi_t 1(eport, Rev (0).1 Revision (1) was made only to facilitate the NRC's review of the corrective actions completed in Phase I,.which are reported in the above
~
Matrix.: All text revisions are boldface and redlined.
i Report by:
Pete Weber, General Manager Fil:name:
AUDIT 97.(1)
Executive Post-audit Summary:
l The one-day audit did not indicate any lack of quality or safety of Type B packagings. The significant margin of safety in the design i
of SPEC packages remained evident. However, the audit revealed the general lack of a " quality culture" at SPEC. This was directly caused by a lack of senior management participation in the QA system. This in turn resulted in a widespread lack of QA program ownership at all levels wititin the organization. Aldough the quality culture problem is a significant root cause of many of the audit findings it will not be included as the specific cause in this report. The quality culture concern will be addressed in a global manner in conjunction with a comprehensive independent audit, root cause analysis, and a corrective action plan. In order to improve the reli2bility and effectiveness of the QA system and to assure that quality is built into each package, a comprehensive corrective action plan will be implemented immediately. All Phase I corrective actions are indicated by redline.
Audit Method:
The audit encompassed the QA Program, Implementing Procedures and Records related to Fabrication activities, and related Design Control, Inspection and Procurement activities, for Type B Packages. The audit plan was based on ANSI /ASQC Ql-1986 " Generic Guidelines for Auditing of Quality Systems."
During the opening meeting, three Type B packages of current design, a SPEC C-1, a SPEC 2-T and a SPEC-150, were chosen essentially at random. Serial numbers were generated by audit team members providing individual digits within the serial number range. A package was assigned to each auditor with instructions to begin with the final inspection document and work backward as far as possible, with the inspection expanding outward to include such items as fabrication documentation, equipment calibration, personnel qualifications, etc. Inspectors were given QA Internal Audit Record forms to record observations.
Audit Team:
Team leader:
Pete Weber SPEC General Manager Auditors:
Kenny Carrington SPEC Special Projects Manager Joe Fryer SPEC Engineering Manager Pete Weber SPEC General Manager Assistants:
Donny Dicharry SPEC President Mike Frizell SPEC QA Manager Steve Punch SPEC Assistant RSO Tommie Ruiz SPEC QA Inspector Michael Williams SPEC QA Inspector Assignments:
SPEC-150 Serial number 458 Joe Fryer SPEC 2 T Serial number 1137 Pete Weber SPEC C-1 Serial number 274 Kenny Carrington Ir.ternal Audit Report SPEC Quality Assurance Program Revision (1) July 21, IM Pagei NRC Certificate of Compliance No. 0102 9707290113 970721 PDR ADOCK 07100102 C
i Audit Findines And Corrective Actions:
1.
SPEC procedure 7.23, para 7.1.2.3 requires drawing number and revision forjigs and fixtures. He working copy of the calibration log does not provide this.
What happened? %e working copy of the calibration log was not developed in accordance with SPEC procedure 7.23 Cause? The author of the list did not comply with the written procedure, ne creation of the document was not reviewed or approved as required by the QA manual.
What will be done to correct the problem? The problem does not impact the quality or safety of SPEC products. No
{
corrective action is necessary. Para 7.1.2.3 is unnecessary. He calibration log is not used to determine which jig or fixture j
to use with a particular part; this information is contained in the traveler. Procedure 7.23 rev(1) will be revised to delete para 7.1.2.3. He list will be reviewed and approved by the President.
What will be done to prevent the condition from recurring? All QA personnel will be retrained in procedure 7.23 and QA manual chapter 6.0.
2.
SPEC procedure 7.23 para 7.1.2.4 is not complied with.
What happened? The procedure requires that the fixture, jig, and gauge list contain inspection and/or calibration instructions, and critical dimensions with tolerances. The list does not contain these. Hey are present in the folder as a calibration / inspection report for fixtures, jigs, and gauges, but this report is not associated with the list. Also, the reports are not completely filled out.
Cause? The author of the list did not comply with the written procedure. He creation of the document was not reviewed or approved as required by the QA manual.
What will be done to correct the problem? A folder will be created for each fixture and jig. The folder will contain a calibration sheet for that particular fixture orjig. A calibration sheet will be filled out and dated at each calibration and i
placed in the folder. The fixture, jig, and gauge list will be kept in a separate folder and will serve as the master list.
Procedure 7.23 will be revised to incorporate these changes. Calibration records for All fixtures and jigs will be reviewed.
Re-calibrations will be performed as needed.
What will be done to prevent the condition from recurring? All QA personnel will be retrained in procedure 7.23 and QA manual chapter 6.0. %is item will be added to the next audit checklist.
3.
SPEC procedure 7.23, para 7.1.2.5 requires recording of measured critical dimensions. He working copy of the calibration log does not provide this.
What happened? The critical dimensions were not recorded on the calibration list.
Cause? He author of the list did not provide a means to record the measured critical dimensions. The list was not reviewed and approved prior to implementation. The procedure was not consulted prior to performing calibrations.
What will be done to correct the problem? See item 2 What will be done to prevent the condition from recurring? See item 2 4.
QAM 12.0, control of measuring and test equipment, requires listing caliper serial number and cal date on forms QA 10.3 and QA 10.4. Form 10.3 complies, form 10.4 does not have an area to record this information.
What happened? He required information was not recorded.
Cause? He author of the form did not include the required provision for recording caliper information.
What will be done to correct the problem?
This information is not necessary on either form. QAM will be revised 12.0 to delete the last sentence.
What will be done to prevent the condition from recurring? QA personnel will be retrained in QA program chapter 12.0 and QA manual chapter 10.4.
5.
A survey instrument calibration certificate is used to record the results of an instrument " check" performed before each tot of DU castings is inspected. The form should only be used for true calibrations.
What happened? An actual calibration form was used to record the results of a" check" calibration. This form is not readily distinguishable from a true calibration certificate. QA manual 12.1.c.8 requires the serial numbers of the items Internal Audit Report SPEC Quality Assurance Program Revision (1), July 21.1997 Page 2 NRC Cenificate of Compliance No. 0102
t surveyed to be recorded on a copy of the last calibration form. Instead, a new calibration form was used to verify calibration and to record the serial numbers.
4 Cause? Conflicting QA documentation. QA procedure 7.49 conflicts with QA manual 12.1.c.8 The inspector followed QA procedure 7.49.
)
1 What will be done to correct the problem? He two QA procedures will be reviewed and modified as necessary to reconcile. A new form will be created for verifying calibration of survey meters. QA personnel will be retrained. Package i
safety is not affected so remedial action is unnecessary.
What will be done to prevent the condition from recurring? As part of the scheduled independent audit, we will review the overall QA program and impicmenting procedures.
6.
In general, travelers do not list the revision letters or offer blanks to fill in revision letters for referenced documents.
i What happened? The travelers were created without provision to record associated drawing revision letters. Whereas this does not violate the QA manual, it makes it difficult to audit the documentation used to fabricate a particular package.
J Cause? Lack of consideration of the " big picture" when creating travelers. Insufficient management review. Absence of a link between travelers and engineering drawings. Travelers created by QA instead of production or engineering.
]
What will be done to correct the problem? Revise travelers to include a blank for a revision letter for each referenced l
drawing.
What will be done to prevent the condition from recurring? Assign the creation of travelers to Engineering. Audit travelers periodically.
4 1
r 7.
The Certificate of Compliance for the SPEC 2-T lists the S-tube material as Zircalloy, we use Titanium. Not a finding per i
discussion between Donny and Ross Chapel (NRC).
8.
He serial numbers of the items (DU castings) surveyed following the survey meter accuracy verification were not i
documented on QA form 12.1.1 as required by section 12.1.c.8. See item 5 of this report.
9.
The supplier evaluation records were not on file for all suppliers of C-1,2-T, and SPEC-150 components.
What happened? QAM 4.0 Section D7 was not complied with. The QA Manager (Mike Frizell) was aware of the requirement. Mike Frizell made a vendor list and felt like we could evaluate vendor's performance based on accepvreject rates. (In fact, some vendors have been deleted from the Accepted Vendor's List due to this method of evaluation). Mike had intentions of sending Form 4.3 to the "new vendors" that remained on the list, primarily the SPEC-ISO component suppliers (if documentation of the supplier evaluation did not already exist). This was not considered a high priority item by Mike Frizell.
/
Paul Guess (purchasing), Mike Williams (QA) and Tommy Ruiz (QA) were unaware that the document existed. Tommy commented that he was trained as a "part inspector" and less focused on the details of the sections of the QAM that did not pertain to inspection instructions.
Cause? Not considered high enough priority in comparison with other outstanding QA tasks.
What will be done to correct the problem?
1)
Review the vendor files, determine what vendors have not been evaluated and perform the evaluation in accordance with QAM 4.0 Section D.7.
What will be done to prevent reoccurrence?
!)
Train or (re-train) all QA personnel in all aspects of the QAP and QAM.
2)
Evaluate the " complexity and critical nature"(described in QAM 4.0, Section D.7) of each cart of the Type B packages based on safety concerns (i.e. source lock verses source tag screw).
3)
Determine the level of the " evaluation" required based on safety concerns. (For example, depleted Uranium suppliers would require a closer evaluation than the vendor that supplies quick disconnects for safety plugs).
4)
Consider modifying QAM 4.0 to require the evaluation to apply only to those vendors that supply Q-A and Q-B items, not necessarily all sucoliers.
Intemal Audit Report SPEC Quality Assurance Program
)
Revision (1), July 21.1997 Page 3 NRC Certificate of Compliance No. 0102 l
j l
5)
Plan an extensive evaluation of depleted Uranium shield suppliers (possibly a visit. This is based on comments by Tom Matula).
6) 6 month re-evaluation of vendors and component lists to ensure that each vendor of a Type B package component has been evaluated as applicable. Put on QA maintenance calendar.
7)
Establish a requirement and method that prevents a Q-A or Q-B vendor to be used before the evaluation is completed.
10.
SPEC C-1 final radiation survey, the form does not have a form nuniber or a place for manager approval.
What happened? There was an additional radiation survey (form) included with the Final Inspection report for the package (C-1). He form did not include appropriate locations for QA Manager signature, Non conforming material reporting, etc.
which is inconsistent with QA report practices. However, the form is not intended to be a QA document. The information on the report is intended to be supplemental information for in-house use only. He radiation profile is not required for Type B radiation acceptance. In addition, the form is placed in a yellow sheet cover in the manual designating a Non QA item in accordance with QAM 6.0, Section C.4 Cause? N/A What will be done to correct the problem? No remedial action is required.
What will be done to present the condition from recurring? No action required.
I 1.
Survey meter calibration certificates are not approved by the QA manager.
What happened? His is not a true finding since the document does not provide a specific blank for QA Manager signature nor is QA Manager signature required by QAM. He document is currently being used for both customer survey meter calibrations and survey meters for internal use. We have an internal requirement to calibrate to
+-10%, regulation is +-20%. This observation was noted to emphasize the control of the +-10% range (internal i
requirement).
Cause? N/A i
What will be done to correct the problem? No remedial action required since this is not a finding.
What will be done to prevent the condition from recurring? Generate a separate meter calibration record for internal use.
Include the pertinent requirements of 10%, verification immediately prior to use, etc. See QAM 12.1 Section C. 8 and incorporate this into Procedure 7.49. Note: Procedure 6.10, Survey Meter Calibration already requires 10% accuracy (not 20% as allowed by regulation). We may want to reconsider this for customer meter calibrations. Compare Procedure 6.10 to the QAM 12.0 for inconsistencies and resolve.
12.
SPEC C-1 drum fabrication / tracking and inspection log a.
Form does not have a form number.
b.
Several completed drums were not inspected.
c.
No drawings are referenced.
d.
Not recorded on form 10.1i e.
No qualifications for Tim Perrin.
What happened? Violation of QAM 10.0; Form QA 10.1I was not used to record the inspection of 2T and C-1 drums.
Cause? The log that was used to record the inspection was created by Jake Kennedy (Procedure 4.16). The Form QA 10.11 (from the QAM) was not included in that procedure. Individuals were instructed to use the procedure for the manufacturing and the log for documenting the inspection. Tommy Ruiz and Mike Frizell were aware that Form QA 10.11 existed.
Tommy did not question Jake's inspection instructions (to use the log in Procedure 4.16). Mike Frizell didn't relate the Form QA 10.11 to drum manufacturing since it doesn't state " Shipping Drum"(or something similar). Mike Williams was unaware that the form existed. There were drums that were not inspected since they were not brought to QA's attention for inspection (per Tommy).
Note: One of the findings was that the log used in Procedure 4.16 does not have a form number. This may not be a finding since that log is part of the approved procedure and the procedure is an extension of the manual. Another finding is that there are no drawings or inspection criteria referenced on the log. He inspection criteria is included in the procedure as Internal Audit Report SPEC Quality Assurance Prograrn Revision (1). July 21.1997 Page 4 NRC Certificate of Compliance No. 0102
i-well, so this may not be a true finding.
What will be done to correct the problem?
Corrective action: Retrain fabrication and QA workers to comply with procedure 4.16 para 7.1.9. Revise procedure 4.16 to delete para 9.1. Revise QA manual 4.0 to require distribution of drawings to fabrication workers with shop orders, and the distribution of drawings to vendors with purchase orders. Create a shop order form and procedure. Qualify Tim perrin per procedure 4.16.
What will be done to prevent the condition from recurring?
1)
Training in all aspects of QAP and QAM.
~
2)
Compare Procedure 4.16 to QAM 10.0 for inconsistencies and resolve.
3)
Non QA: Determine ifit is advantageous to continue the log (sales info primarily).
l 13.
SPEC C-1 housing plates receiving records, Purchase order i1250 No inspection records for 20 ea:
Top door, Sides / Bottom, Front door, Inner panels and Back Panels.
l What happened? Violation of QAM 7.0, Form QA 7.2. He material was not documented as being received or inspected aller receipt.
Note: His may not be a 'inding. The retention of Form 7.2 is only two years. The material was purchased around 10/14/91.
Cause? Uncertain. Either the receiving inspection was not performed or the inspection report was misplaced. (There are plates in stock that appear to have been inspected since they are marked green).
i What will be done to correct the problem?
1)
' The C-1 plates in stock (that are painted green) but do not have documentation available, will be re-inspected to current drawings and inspection documentation will be generated before use of any of the material.
}
What will be done to prevent the condition from recurring?
1)
Re-train. Receiving Inspections will be performed in accordance with QAM 7.0., etc.
i Note: The plates are currently not in a controlled area. His observation is addressed in a separate audit report.
2)
Procedure 1.14 and QAM 7.0 have conflicting forms for Receiving Inspection Reports. Rese documents will be reviewed and reconciled.
,i 14.
SPEC C-1 component procurement Purchase order i1580, outlet nipple boss, part was ordered without an approved drawing a.
What happened? There was a Violation of QAM 4,0 Section D.3. The approved drawing shows the part (C-1 outlet boss) i to be %" in length (drawing dated 10/20/89). When the part was ordered a copy of the approved drawing was marked i
showing a length of.380" +.005". De marked up drawing was identified as," Production Drawing Only. Not a QA Document" and the drawing number was scratched out. That unapproved and marked up drawing was the one attached to the purchase order and packing slip. It was observed that the mating pan (the outlet nipple for the C-1) has a thread length of
.385" +.015", indicating that the.380" length boss is the correct length. In addition, some of the 200 series C-l's bosses were measured and confirmed to be approximately 3/8". The approved drawing shows the length dimension at %" +.000, -
.125". Although the part is at the low end of the tolerance, it remains in tolerance when the part is.380" +.005" as ordered from the marked up drawing.
Cause? The drawing did not go through an ECR and revision process prior to ordering the component.
What will be done to correct the problem?
1) ne drawing will go through the ECR process before re-ordering the component.
2)
Any remaining components in-house will be re-inspected and documented using the revised (and approved) drawing.
Corrective action: Revise procedure 3.01 to require purchase orders for SPEC designed parts to include a copy of the current, approved engineering drawing.
What will be done to prevent the condition from recurring? See. foe Fryer's document control corrective action recommendation for similar findings regarding drawing and procurement control. We have already identified other corrective actions regarding purchasing (i.e. drawing attachments, approvals, etc.).
Intemal Audit Report SPEC Quality Assurance Program Revision (1) July 21,1997 Page5 NRC Certificate of Compliance No. 0102 L-
t 15.
Deleted (formatting error).
16.
SPEC C-1 U-tubes, Show inspecting 34 U-tubes, no material or fabrication inspections.
What happened? Violation of QAM 4.0. Form QA 4.1. No procurement information was available.
Note:
Dis may not be a finding. Retention of Form 4.1 is three years. The inspection reports on the u-tubes were all in 1992.
Cause? Uncertain. Either the purchasing documentation (P.O.) was not generated.or it was misplaced after completion.
What will be done to correct the problem? No remedial action rei uired. He u-tubes are now in C-1 shields. Any l
l markings that may have been on the tubes, indicating supplier, material grade, etc. that may have offered an avenue to 1
investigate further is now cast in depleted Uranium and unaccessible.
What will be done to prevent the condition from recurring? Retrain Purchasing and QA departments on QA Mam.al chapter 4.0. Establish a recording method that ties purchasing information of materials (rod, plate, bar, etc.) to the Receiving l
Inspection Report when SPEC is the supplier. (For example: We purchase titanium tube to make s-tubes. Then we cut the material and make the s-tubes. Then we inspect the s-tubes but there is no P.O. #, Packing Slip, etc. since that type of j
information is not applicable. Therefore, the purchasing information of the raw material that was used is not is not able to be retraced.
Note:
QAM 4.0 requires three year document retention for QA Form 4.1.
Form 17.1 only requires two years retention.
Resolve this conflict.
J 17.
SPEC C-1 drawing 62190(2), door bracket drawing 322002(0), nameplate does not have QA classification in accorcance with QA manual 3.0 E.1.
What happened? Violation of QAM 3.0, Section E.1. The QA classification was not added to the drawings. The door bracket drawing was revised on 7/15/92. The nameplate drawing was created on 1/27/97. The QAM 3.0 Section E.1 l
requires that, "All drawings initiated or revised after 1/1/92 will include classification on the drawing".
Cause? Unknown. Likely an oversight.
What will be done to correct the problem? In addition to the two drawings noted above, all C-1 drawings will be evaluated and assigned a QA Classification designation. Currently, none of the C-1 drawings have been QA classified (all are dated prior to 1/1/92).
What will be done to prevent the condition from recurring? See Joe Fryer's drawing control corrective action.
18.
Design activity record form QA 3.3, Design activity records are not available for C-1.
What happened? QAM 3.0 requires the use of Form QA 3.3, Design Activity Record for package designs to verify conformance to 10 CFR Part 71. There are no Design Activity Records available for the C-1. However, this is not a true finding since the C-1 was designed before the requirement was established.
j Cause? N/A. Not a finding.
What will be tione to correct the problem? N/A. Not a finding.
What will be done to prevent the condition from recurring? Future design activity will be recorded in accordance with SPEC's QA manual. The QA manager will be trained in QA Manual chapter 3.0.
19.
Tungsten electrodes and Titanium tiller rod and Argon, receiving inspection reports and purchase order form QA 4.1 Receiving reports not approved by QA manager.
a.
What happened? There was a violation of QAM 7.0, Form QA 7.2., SPEC Receiving Inspection Report.
Cause? QA inspectors were instructed by the previous QA manager (Jake Kennedy) to file the document after the receiving inspection was performed and not to pass the document to him for the QA Manager's review. Although this was contrary to previous instructions (by Jim Moore), the inspectors conducted the inspection as instructed by Jake. Additionally, QAM 7.0 is not clear that the QA Manager must sign the Receiving Inspection Report. Section C.1 only states,"The receiving inspection shall give carefut consideration to... and cornolete documentation." Also, Section C.ll states that the reports ~
"shall be filed and maintained by the QA manager", not actually signed. Also, Procedure 7.36, Section 7.2.24 states that the QA Manager shall sign the report after reviewing.
Internal Audit Report SPEC Quality Assurance Program j
Revision (1). July 21,1997 Page 6 NRC Cenificate of Compliance No. 0102
i
'l Note:
The inspection form in the procedure is identified as SPEC Form 1.12A (which is identical to Form QA 7.2)
What will be done to correct the problem? The QA manager will review and sign past receiving inspection reports.
Findings resulting from his review will be addressed.
Corrective action: Retrain and require records to be reviewed for completeness and approved before filing.
What will be done to prevent the condition from recurring?
I)
Re-train QA staffin QA Manual 7.0.
2)
All documentation will be reviewed by the QA manager and signed off before filing.
3)
Procedure 7.36 and the QAM 7.0 will be reviewed for inconsistencies and revised appropriately.
20.
SPEC-150 DU shield, drawing 15B008 rev 2, drawing 150008 rev 2, traveler 15008 rev 1, ICL-149 in process survey inspection, receiving inspection reports.
No ECE (QA form 5.1) for rev 2 of Dwg 15B008 a.
b.
No DCE (QA form 5.2) for n v I of traveler Original drawing in folder not signed by president (there is a copy with his signature) c.
d.
Traveler references non-approved sketch.
The form ICL-149 is not a controlled QA document. ICL-149 rejects casting, but there is no Non-conforming c.
material report. The ICL is not approved, and no casting weight is reccrded.
f.
In process survey not approved.
g.
Unapproved drawing (150008 2) sent to vendor for sleeve.
h.
No certificate of compliance from vendor for casting.
20 a.
What happened? There are two drawings, proprietary and non-proprietary for certain items that require a drawing for a package application. The non-proprietary drawing is denoted by the letter B in the drawing number. A revision was made to the non-proprietary drawing that did not affect the proprietary drawing so no ECE was originated.
Cause? Originals of non-proprietary drawing for package applications are filed in a different location than proprietary drawings.
What will be done to correct the problem? No problem to resolve.
What will be done to prevent the condition from recurring? File non-proprietary drawings adjacent to proprietary drawings. Mandate when revisions are made to one drawing the other drawing must be revised simultaneously.
20 b.
What happened? Travelers for the SCEC-150 were not considered as QA documents by the QA manager at the time the document was revised. Instead of completing a DCE (QA form 5.2) the manager created a revision history on the back of a
" master copy do not remove" cover sheet.
Cause? Ignorance of the QA Manual.
What will be done to correct the problem? No problem to resolve.
What will be done to prevent the condition from recurring? Revise the drawing controlprocedure to make each traveler part of the. assembly instructions for a specific drawing. Mandate that whenever a drawing or traveler is revised the complementary document. be revised at the same time. Subject trav_elers to the same change authorization procedures as drawings. Control the distribution of travelers in the same manner as drawings.
[See Phase 1 CA Report, Rev (5), item # ISA and 17A ],
20 c.
What happened? The signed original non-proprietary drawing for the package application was filed with the application Cause?
What will be done to correct the problem? No problem to resolve.
What will be done to prevent the condition from recurring? See 20 a Internal Audit Report SPEC Quality Assurance Program Revision (1), July 21,1997 Page 7 NRC Ceniticate of Cornpliance No. 0102
20 d.
What flappened? During development of the SPEC-ISO sketches were made to guide manufacturing in certain operations or clarify steps in the assembly process. These sketches were incorporated into travelers.
Cause? Indeterminate.
What will be done to correct the problem? Compare alliexisting sketches against the_ drawings that control t.he configuration. Revise the drawings if necessary._ Remove the reference to the sk_ etch _on the traveler and reference the drawing. [See Phase 1 CA Report /Rev (5), Item #.~20A j What will be done to prevent the condition from recurring? Ske'tchesyvillbe eliminated from SPEC. Controlled drawings will replace sketches; [See Phase 1 CA Report, ReyJ5), Item,#120A ]
20 e.
What happened? Receiving inspection reports for shields differ from other purchase items because of the Q-A requirement.
The QA manual has a separate QA form for receiving shields (QA form 7.4). When the SPEC-ISO was developed the QA manager developed his own form for the SPEC-ISO shield without consulting the QA manual. The form was not approved because the weights were not recorded and the dimension reject box was checked off.
Cause? Ignorance of QA manual.
What will be done to correct the problem? Rename form ICL-149 to QA 7.8. Revise the form to correct problems.
What will be done to prevent the condition from recurring? Rename form ICL-J49,to QA 7.8 Revise the, form to correct s
problems; [See Phase.l,CA Report, Rev_ (5), Item #'21 A ]
20 f.
What happened? QA inspectors were instructed by the QA manager at that time to file the in process survey forms after the survey was complete. He assumed his approval was not necessary.
Cause? Ignorance of the QA manual.
What will be done to correct the problem? No problun to resolve. He safety of the completed packages is assured during the final package survey.
What will be done to prevent the condition from recurring? Retrain.the QA' instructors to forward the in process survey report.(QA form 11.3) to the QA manager after conducting the survey.;ne survey is.not. complete until the survey is j
approved.' This step may be added to traveler 150008 to. insure compliance.5.[See, Phase.1lCA Report, Rev (5), Item # 22 A l
j 1
20 g.
What happened? Drawing 150008-2 contained an error in the intemal diameter dimension for the sleeve. This problem was noted by rnaking a red line drawing change. He red line change was not incorporated into the drawing and the red Ime j
drawing has existed on the shop floor for two years. As additional copies of the redline change drawing were needed the origina! drawing was copied and the redline change added to it. The QA managers signature on the original red line drawing approving the change was lost.
Cause? Non conformance with Drawing Control Prccedure 1.10 What will be done to correct the problem? Revise the_ original drawing.; Collect and destroy all existing redline change drawings 150008-2. [See Phase 1 CA Report, Rev (5), Item #,,26Al What will be done to prevent the condition from recurring? Reevaluate the drawing congol procedure to determine its adequacy in controlling red line changes. Rewrite the procedure as necessary, Investigate the possibility of eliminating red line changes. [See Phase 1 CA Report, Rev (5), Item #. 26A]
20 h. THIS MAY NOT BE A FINDING. THE COC WAS EVENTUALLY FOUND What happened? The purchase order (PO 59590) for the SPEC-150 shield (150008) is written as a blanket PO covering the purchase of approx 1000 shields. The purchase order has the statement requiring a certificate of compliance from the vendor as required in Section 4.0 of the QAM. Here is a problem with the PO in that there is no part number referencing the item being purchased specifically part no 150008. The description list only " SPEC-150 UNITS". The purchase order Internal Audit Report SPEC Quality Assurance Program Revision (1). July 21.1997 Page 8 NRC Certificate ofCompliance No. 0102
specifies delivery shall be 120 units per month. The delivery of the shields occurs on a continuous basis with shields being received in quantities of approximately 25 per month. Manufacturing Sciences Corp (MSC) provides a one certificate of comp!iance for each shipment that list the serial numbers of the castings being delivered. A traveler was developed to route the casting through the receiving inspection, tube cutting operation and in process survey steps. The traveler and the reports for each of these operations are filed in a master folder for each Type B package that SPEC fabricates. The situation occurs where the certificate of compliance for a shipment of castings is filed in one of approximately 25 different folders.
Cause? Development of a traveler that does not cover all the steps necessary to complete the required task.
l What will be done to correct the problem? Searchiall files to loca'te_the certificates ofco.mpliance Either create a file specifically for certificates.of compliance or make copies of each applicable certificate of compliance and file it.with each package's master file;[See Phase I~ CA; Report, Rev (5)f Item #f27Al What will be done to prevent the condition from recurring? Revise traveler l_50008 to. include a step specifying what is to be done with the certificate of compliance. [See Phase.1 CA; Report, Rev (5)iltem # 27AJ 21.
SPEC-150 lock end plate, drawing 150203, traveler 150203, drawing 150104, receiving inspecA1 reports a.
No record of drawing distribution on ECE (QA Form 5.1).
b.
Fixture not specified on traveler No way to verify engraved plate dimensions are correct (no link to un-engraved plate p/n 150104).
1 c.
d.
Receiving inspection report (QA form 7.2) not approved (150201).
21 a.
What happened? The method of distributing drawing has changed as the organizatioc has grown. As each new QA manager has taken over the resposibility of distributing drawings he has implemented his own drawing distribution system.
The QAM forms 5.1 & 5.2 were not revised to reflect changes made by the different QA managers.
Cause? Turnover in the QA management position. No written procedure defining drawing & document distribution.
What will be done to correct the problem? Inspection of all controlled drawing books to verify that the current drawing is presents [See Phase 1 CA Report, Rev (5), item # 28A]
. What will be done to prevent the condition frorn recurring? Create a document distribution procedure.
[See Phase I CA' Report, Rev (5), item #.28Al 21 b.
What happened? The traveler for this item does not reflect the current method of manufacture. Step i requires the worker
)
to position a part in a particular orientation.' A fixture was developed to perform this operation. The traveler was not revised to include the new fixture. The traveler form used is generic in that there is a blank forjigs and fitures even if they are not used.
Cause? Revision to travelers have not been controlled.
What will be done to correct the problem? Review all_ existing travelers by production and engineering to verify they construct the current revesion level for that item. [See Phase 1 CA Report, Rev (5), Item # 16Al What will be done to prevent the condition from recurring? Revise the drawing control procedure to make each traveler part of the assembly instructions for a specific drawing. Mandate that whenever a drawing or travelar is revised the complemetary document be revised at the same timeu Subject travelers to the same change authorin 1.,n procedures as drawings. Control the distribution of travelers in the same manner as drawings (see 21a). [See Phase I CA Report, Rev (!),
item R17Al 21 c.
(This may not be a finding)
What happened? The current receiving inspection procedure and purchasing procedures have no provisions for determining what parts are sent to vendors to have additional operations performed on them.
Cause? Oversight.
What will be done to correct the problem? Inspect existing parts with engraving against the, drawing for parts prior to i
engraving. [See Phase 1.CA Report, Rev (5), Item # 32A]
Internal Audit Report SPEC Qua3ty Assurance Program Revision (1). July 21,1997 Page 9 NRC Certificate of Cornpliance No. 0102 L
What will be done to prevent the condition from recurring? Record the tot number of parts sent to sent to vendors for additional operations on the purchase order for the additional operation.
21 d.
See 19 22.
SPEC-150 Inner Bulkhead Assembly, drawing 150304, traveler 150304, receiving inspection reports No record of drawing distribution on ECE (QA Form 5.1).
a.
b.
No DCE (QA form 5.2) for rev I of traveler c.
Missing receiving inspection reports (QA form 7.2) for 150301,150300 22 a.
See 21 a.
22 b.
See 20 b.
22 c.
See 13 23.
SPEC-150 outlet end plate, drawing 150400, traveler 150400, receiving inspection reports, drawing 150002-4, drawing control procedure 1.10 Manufacturing sketch in traveler not approved per drawing control procedure 1.10. Sketch contradicts drawing a.
150002-4 instructions b.
No DCE (QA form 5.2) for rev I of traveler.
Receiving inspection reports (QA form 7.2) not approved c.
23 a See 20 d.
23 b.
See 20 b.
23 c.
See 19 24.
SPEC-150 outlet panel assy, drawing 150406, traveler 150406, receiving inspection reports.
a.
No DCE (QA form 5.2) for traveler rev 2.
b.
Traveler includes non-approved redline Missing receiving inspection (QA form 7.2) report for nipple (dwg 150405) c.
d.
Receiving inspection report (QA form 7.2) not app oved (150800).
24 a.
See 20 b.
24 b.
See 20 d.
24 c.
See 13 24 d.
See 19 25.
SPEC 150 handle assembly, drawing 151104, traveler 151104, receiving inspecticn reports.
a.
No record of drawing distribution on ECE (QA Form 5.1).
b.
Missing receiving inspection reports (QA form 7.2) for 151100.151103 i
Receiving inspection reports (QA form 7.2) not approved.
c.
l 25 a.
See 21 a.
25 b.
See 13 25 c.
See 19 1
26.
SPEC-150 lock cap assembly, drawing 150916, traveler 150910, receiving inspection reports.
a.
Drawing is approved but ECE (QA form 5.1) for rev 1 is not.
b.
Traveler # references obsolete part c.
No DCE (QA form 5.2) for traveler rev 1 & 2 Intemal Audit Report SPEC Quality Assurance Program Revision (1), July 21,1997 Page 10 NRC Certificate of Compliance No. 0102
- ~ - = - -. -
d l
}
d.
Receiving inspection reports (QA form 7.2) not approved for parts 150913,150914,150917 i
26 a.
j What happened? During the development of the SPEC 150 a substantial number of drawings were produced. Prior to i
application approval development drawings were signed for approved without completing the ECE (QA from 5.1). When the application was approved ECE (QA from 5.1) was completed for the drawings. The drawing approval signature line on the form is one line away from the change authorization signature line. It appears some forms were signed on the wrong line j
or the whole form was accidentally skipped.
Cause? Oversight What will be done to correct the problem? Procedural problem to be corrected.
What will be done to prevent the condition from recurring? Revise the ECE (QA form 5.1) to eliminate the approval signature line. The ECE should be done before a revision is made and approval granted to make the change (change authorization). The drawing is approved by signing the drawing not the ECE.
J 26 b.
See 21 b.
26 c.
See 20 b.
26 d.
See 19 27.
SPEC-150 safety plug, drawing 150805, traveler 150805, receiving inspection re port Drawing distributed not approved - original on file is approved.
a.
b.
No record of drawing distribution on ECE (QA Form 5.1).
c.
Receiving inspection reports (QA form 7.2) not approved (150800).
d.
Traveler specifies cable part # 150803, part # 151205 used instead.
27 a.
What happened? De QA manager was distributing a number of drawings. His involves making approximately 10 copies, going to 10 books spread across 2 buildings, removing 10 drawings, and inserting 10 new drawings, and doing the same with 10 new indexes. When tiling the drawings after completing distribution he observed the approval block on one original had not been signed. The original was returned for approval but the signed original was not re-distributed.
Cause? Oversight What will be done to correct the problem? Audit all existing drawing boo.ks against the originals on file for similar I
occurrences.]See Phase I CA, Report, Rey (5), item # 29A]
What will be done to prevent the condition from recurring? Investigate and implement a new drawing distribution procedure. See 21]u [See Phase 1 CA Report, Rev (5), item.#' 29A]
l 27 b.
See 21 a.
27 c.
See 19 27 d.
See 21 b.
28.
' Spec-150 package assembly, drawing 15B0024, traveler 150 a.
No ECE (QA form 5.1) found for rev 3 dwg 15B002A.
b.
Package as manufactured does not match drawing (old lock cap shown).
c.
No DCE (QA form 5.2) for traveler rev 3.
d.-
Traveler 150 rev 3 was used since shields were inspected 11/95. Traveler was revised to rev 412/4/95.
Receiving inspection reports (QA form 7.2) not approved.
c.
f.
ECE (QA form 5.1) exists for all drawings on parts list, however no distribution information is recorded.
.g.
Individual detail drawings of parts used in sub-assemblies all parts with revision histories in QA form 5.1 distribution not signed as complete. The following drawings did not have ECE (QA form 5.1) to record change
- authorization or the form was missing the information shown:
Internal Audit Report SPEC Quality Assurance Program Revision (I), July 21.1997 Page 11 NRC Certificate of Compliance No. 0102 1
1 l
Y 4.
150300 support cup 5.
150301 shim 6.
150302 sleeve 7.
150106 end plate (incomplete data) 8.
150409 doublerplate 9.
150900 lock cap plate (no approval)
' 10.
150800 quick disconnect (no approval) i 1, 150801 pipe plug (no approval) 12.
150802 plug stem (no approval) '
13.
151103 lumdle connecting rod (no approval) 28 a.
See 20 a.
28 b.
See 20 a.
28c.
See 20 b.
23 d.
What happened? When a shipment of shields is received from MSC two travelers are initiated one for the shield (T150008 and one for the housing (T150). The housing traveler is initiated only to record the serial number of the shield assigned to that package. There was a two month delay between when the shields were inspected and work on the actual housing The initiated housing traveler (T150 rev 3) was filed away during the delay. The housing traveler (T150 rev 3) was revised during the two month delay to rev 4. When work resumed on the housing it continued to the rev 3 version of the traveler.
Cause? Prematur.: initiation of a traveler.
What w'81 be drne to correct the problem? No problem to resolve. Revision 4 of the traveler was to incorporate red line changes being made to rev 3 traveler.
What will be done to prevent the condition from recurring?;In,i_tlate travelers only when actual work on the particular item (begins.'l Remove all existing travelers from the shop floort Mandate the production manager is the only individual to initiate trayelers and only after QA approval.;See 20 b. [See Phase 1.CA ReportfRev (5), Rev (5), Item # ~18A]
28 c.
See 19.
I 28 f.
See 21 a.
l 28 g.
See 21 a and 26 a.
Annrovals:
7hY!7[
QA Manager x
m, //
Date:
Team Leader
/
Date:
/
9/
7 8/27 President d4d4/'
Date:
/
Intemal Audit Report SPEC Quality Assurance Program Revision (1), July 21,1997 Page 12 NRC Certificate of Compliance No. 0102
SPEC Quality Assurance Progearu - NRC Certificate of Compliance No. 0102 NRC Observations from June 16-19.1997 Insnection and SPEC Corrective Actions Report Revision 11)[ July 21[1997 Report By:
Pete Weber Report Date:
July 11,1997 Repo.rt; Revised; July.21; 1997 to add cross references of all Phase I_Cprrective Actions with the corresponding completion record 1.isted in_the Matrix of Assignments and Correc_tive Actions, Rev (5), dated: July 21,1997. Revision (1) contains, no yevisio_ns to any information in the InternaljAud_it_ Report, Rey (0)(Revision (1) was made only to facilitate _the NRC's review of.the_ corrective actions completed in Phase I which are reported in the above Matrix. Al1 text revisions are boldface and edlined; f
Filename:
AUDITNRC.(1)
Preface:
On June 16,1997, NRC inspectors visited SPEC and evaluated our hypothetical accident condition testing of Type B Packages.
Additiona!!y, the inspectors evaluated certain areas of SPEC's QA program. This document lists the concerns voiced by the inspectors and SPEC's corrective action response. The inspectors stressed that these findings are preliminary and will be evaluated and formalized by NRC management, and included in a formal report. Phase I Corrective Actions are redlined in this report.
Preliminary findines and corrective actions:
1.
Surveys / survey instrument - No calibration procedure What Happened? A survey meter calibration procedure did exist, but the Inspector found insufficient detail in the actual calibratica process. De inspector also found that arattenuator used as part of SPEC's survey instrument calibration procedure was not controlled by the QA department and was not calibrated.
Cause: A Basic misunderstand'ng of the purpose of a procedure, coupled with a failure to understand the degree of control necessary. The individual calibrating the meters is the one who wrote the procedure and didn't feel there was a need to be more specific.
What will be done to correct the problem? The attenuator has been calibrated and will be logged into the QA program.
An analysis revealed that the attenuator, which is basically a lead block, did not deviate from the specified dimensions and compromise survey meter calibrations, so remedial action is unnecessary. The procedure,has beer. revised and will be reviewed furtherprior to the next survey ofType B Packages..[See Phase I CA Report, item # 25A]
What will be done to prevent the condition from recurring? SPEC will perform internal and independent audits per our QA program. SPEC employees will be re-trained in the purpose and scope of procedures. ([See Phase I.CA Report, Item #
06A and,30Al 2.
Qualification of personnel What happened? He inspector found no records to indicate that Mr. Bob Lawrason was certified to perform survey meter calibrations. Also, his training file was practically empty.
Cause? QA manual section 2.1 is not explicit in the control and administration of employee training. Procedure 2.1 overlaps and conflicts with QA manual section 2.1. Administration and records of training have been informal.
What will be done to correct the problem? SPEC will institute a.standadown for the purpose of retraining all QA, fabrication, and fabrication-related employees. [See Phase I CA Report, Item #.06A a.nd 30Aj. The Quality Assurance Manager has certified those persons involved in receiving, in-process inspections, final inspections, surveys, calibration of survey meters, welding, and welding instruction. He has updated the listing of persons qualified in these areas.
What will be done to prevent the condition from recurring? A training coordinator will be appointed. Duties to include the mr.intenance of a training matrix, scheduling of training, and periodic review of training records for each employee.
NRC Inspection Observations SPEC Quality Assurance Prograrn Exit Meeting, June 19.1997 NRC Cenificate ofCompliance No. 0102 Report Revision (1), July 21,1997 PageIof3
3.
SPEC-150 pmtotype inspected to unapproved drawings, Lack of QA procedures for prototype.
What happened? The pre-production SPEC-150 prototypes used for testing were not built to a complete package of approved drawings. Preliminary drawings were used for many parts. These drawings were later approved, but in many cases there were no formal change control documents associated with the conversion from preliminary to production draw status.
Cause? The situation was caused by an attitude that pre-production prototype units need not be documented to the same level of detail as production units.
What will be done to correct the problem? Type B package tests (vere re-conducted using well documented production specimens, ne QA manager will review the preliminary drawings used to fabricate the early prototypes and create a rep documenting any differences from the equivalent approved drawing'.s What will be done to prevent the condition from recurring? Thejob descriptions for purchasing agent, machinist, and QA inspector are being revised to include statements not to purchase, fabricate, or inspect to unapproved drawings. A control will be placed on orders for parts manufactured in: house requiring taignature by a Quality Assurance Inspector prior to fabrication.; By signing; the Quality Assurance Inspector certifies that t! c draging is approved and current. [See Phase I CA Report, Item _#;31 A]
4.
No record of final inspection, minimum record ofin process inspection (welds only).
What happened? The pre production SPEC-150 prototypes used for testing were wellinspected, but the inspections were not well documented.
Cause? The inspections were made prior to the finalization of the production travelers.
What will be done to correct the problem? The items cannot be reinspected, but production models were re-tested. When the SPEC-150 package went into production, a final inspection report, in-process inspection reports, and fabrication travelers were finalized or created. No corrective action.
What will be done to prevent the condition from recurring? Reyise the,QA Manual to,specify that prototype package drawings will be created in accordance with the sam.e procedures that apply,to production _ drawings. [See Phase I CA Report, Item # 36A]
5.
QA signoffs, missing signatures. Materials Receiving Reports not signed off or signed by same individual.
What happened? The inspector found missing final signatures on QA documents. The final signatures indicate the QA manager has reviewed the documents for completeness. The inspector also found cases where the same individual signed as inspector and reviewer.
Cause? There was not a good hand-off during recent changes in QA managers. During the current QA manager's administration, QA inspectors got out of the habit of bringing documents to the QA manager to sign, and the QA manager did not seek out the documents to sign.
What will be done to correct the problem? The Quality Assurance manager will review all receiving inspection reports, traveler packages for SPEC-150 and SPEC 2 T, and all other QA documents requiring his review and signature dated January,1994 to present and sign with current date for review of form.
What will be done to prevent the condition from recurring? The_QAl manual will be reyised to require the QA manager's approval signature to assure completeness of all package fabrication and inspection records prior to filing; Create 7 hold area for records pending approval signature. [See Phase I CA Reportiltem # 33A]. Periodically audit to verify compliance.
6.
No apparent process whereby " preliminary" status is removed from drawings?
What happened? An inspector found versions of SPEC drawings marked " preliminary" and versions of the same drawings with the preliminary marking removed. There appeared to be no process used to remove this marking. Procedure 1.10, Drawing Control allows the use of preliminary drawings, which by definition are not approved. The procedure states that preliminary drawings will not be used for fabrication or QA. The preliminary drawings in this case were used for both of these purposes.
Cause? See item 3 of this report.
NRC Inspection Observations SPEC Quality Assurance Program Exit Meeting, June 19,1997 NRC Certincate of Compliance No. 0102 Report Revision (I). July 2!,1997 Page 2 of 3
What will be done to correct the problem? No remedial action is required.
What will be done to prevent the condition from recurring? See item 3 of this report. Also;c9mplete the in progress Misions to. the Engineering Change Request and Engineering Change Notice proceduresj [See Phase I_CA; Report / Item #
23A) All changes in drawing configuration will be controlled by this system. A change review board will monitor all changes to drawings and component configuration.
End 4
NRC Inspection Observations SPEC Quality Assurance Program Exit Meeting, June 19,1997 NRC Certificate of Compliance No. 0102 Repon Revision (1), July 21,1997 Page 3 of 3 a
l 1
SPEC Quality Assurance Program - NRC Certificate of Cor;gliance No. 0102 NRC Observations from July 9-10.1997 Insr ection and SPEC Corrective Actions EePyr@ @ M g,1g Report By:
Pete Weber Report Date:
July 11,1997 Report Revisedt [uly;21i 1997 to add eross references orallRhete1 Corrective: Attiens with the corresponding. completion record listed in the_Matrir_ of Assignmes_tsJadlCerrtetive:ActionsiRev [5Mted; July 2111997tRepion (1) contains agevisions 19 any informatipo irthsInternalAudit Report; Rer(0XRevision (1) was made only to feeliitate theNRC's rev,lew of the correctityactionsynapleted;infhasejryhich are reportedja the,above Matrity All text revisions are boldface _mn_diredlined!
Fil:name:
AUDITNR2.(l)
Preface:
On July 10,1997 a closeout meeting was held at SPEC to discuss the NRC's observations during a two day inspection by Tom Matula and Bill Ward conducted July 9-10,1997. These observations are preliminary and subject to NRC matagement review prior to inclusion in the official inspection report. SPEC senior management now realizes that our QA system has a systemic weakness; we will treat each of the observations as a finding. Phase ! Corrective Actions are milmeij in this report.
NRC observations:
1.
SPEC-150 Some travelers include line-outs, line-outs are not reviewed to determine if the traveler should be revised, Parts list on Travelers, Changes not implemented, Engineering is not synchronized with the revision of the travelers. These observations
)
are addressed on other audit documents.
2.
SPEC C-1 What happened?
ne outlet nipple boss is listed as 1/2" on the certificate of compliance.
The part actually is 0.380".
The part is within the minus 1/8" tolerance, but the part was ordered using a drawing that did not specify 1/2". SPEC should check with Ross Chapel to determine if a drawing revision is required.
Cause? SPEC maintains drawings for Application and drawings for fabrication. The two sets ofdrawings are not linked.
What will be done to correct the problem? A link will be established between the two sets of drawings. The drawings will be reviewed and synchronized. Mr. Ross Chapel of NRC will be contacted to discuss further remedial action.
What will be done to prevent the condition from recurring? Type B Application drawings will be linked to fabrication drawings. A procedure for application drawings will be created. Engineering, and QA will be trained.
3.
Calibration:
What happened?
He caliper tracking list is not up to date.
Here is no procedure to remove calipers from use.
One caliper had an " acceptable" tag after it was taken out of service.
There was a consistent error in one caliper by 0.006".
Class I calipers were calibrated improperly.
One caliper was out of cahbration by 0.005"?
Here is no apparent safety significance to the calibration problems except perhaps for the effect on jigs and fixtures. (We need to evaluate the safety significance of the calibration errors on jigs and fixtures).
Dere is no procedure to calibrate the calibration standard (Block).
NRC Inspection Observations SPEC Quality Assurance Program Exit Meeting. July 10,1997 Page1of3 NRC Certificate of Compliance No. 0102 Report Revision (I), July 21.1997
.v Cause? It.1 proper understanding and use of the calibration proctdure.
What will be done to correct the problem? The caliper calibration procedure yill be reviewed 1mdyvised as needed."'All calipersfill be removed from service until provert that they,are in proper calibration andjnarkedjecordinglyJ Fixtures, and MPMil.l_be re-calibratedj. See_ Phase I CA'Reportptem #_24A]
What will be done to prevent the condition from recurring?[QA, personnel willbe retrained. [See Phase I CA, Report, j
Item # 06A] Periodic audits will assure compliance with the calibration procedure.
4.
Welding traveler Process:
What happened?
ne process is burdensome.
I Some records have open blanks.(We should re-evaluate the process)
Cause? ne travelers were not drafted by the department fabricating parts in accordance with them. This resulted in a lack
{
ofownership.
What will be done to correct the problem? Production.. department representatives wiu review and revise each traveler as needed to ensure each traveler is relevant and up to datej [See_ Phase I CA Report, Jtem # 19A] _
What will be done to prevent the condition from recurring? Drafting of travelers will be assigned to the Production department.t Travelers wi1,l_be checked by Engineering and QAj [See Phase I CA Report, Item # 19A] Travelers will be approved by the General Manager. Travelers will be filed and dist:ibuted by QA.
5.
QA Classification System:
A graded approach is needed.
Response: Spec has a graded classification system procedure as part of QA manual 3.0, Design Control. The classification system will be reviewed and supplemented to clearly define the grading system.
6.
Non-Conforming Material Control:
What happened?
Non-conforming material is not controlled.
Some parts are not red tagged or not segregated.
Control areas should be locked.
Some non-conforming material is mingled with conforming material.
i NCR Documentation is not current.
I The non-conforming material tracking report is not able to determine close out status (no open/close dates on the report).
Many NCR's should be updated or completed.
i There are multiple copies of the same Non-Conforming material report at various stages of completion.
A procedure is needed to control non-conforming material.
Add "open and closed" columns NCR tracking report. Add date and time.
Report forms need to be controlled. Making copies can cause problems.
Cause? These are symptoms of the systemic problem with SPEC's QA system and the corresponding lack of ownership of the NCR system.
J What will be done to correct the problem? Non conform _ing material will be separated in a QA controlled, locked area.-
All in-process work will be reviewe_d and tagged properlyq [See Phase I CA Report, Item # 34A] NCR documentation will be completed and filed. Open and closeout dates will be added to the NCR status report.
What will be done to prevent the condition from recurring? His is an arca where the independent audit will be focused to perform a root cause analysis.
7.
Document Control, QA 5.1 and 5.2:
What happened?
Not available between revision and others incomplete.
Sketches are used but are not referenced in QAM and are not controlled.
Some documents are red-lined. The red-lines are uncontrolled and should be eliminated. Red-lines are ok on a temporary basis in an emergency but there needs to be a controlling procedure.
NRC Inspection Observations SPEC Quality Assurance Prograrn Exit Meeting. July 10,1997 Page 2 of 3 NRC Certificate ofCompliance No. 0102 Report Revision (I), July 21,1997
-. = -.-..
2 Response:LThese observations are addressed' on other audit documents.
L' Audits:.
What happened? -
There is currently no audit scheduled for 1997.
he last internal audit was in 1993.
MSC has not been audited.
An audit should be performed for vendors of all Q-A items.
Cause? Lack of upper management support for the QA program.,
What will be done to correct the problem? An in-house audit lias been performed and corrective actions are in work now.
. NRC has conducted two inspections and the observations are being. addressed. An independent audit is scheduled.' A root cause analysis is scheduled.
. What will be done to prevent the condition from recurring? The root cause analysis will ra doubt provide additional ^
measures to prevent the condition from recurring, but the change in quality culture that has already begun will cause SPEC to focus on audits as the single most important means of communicating the importance of maintaining and working in accordance with written procedures. AllimplementationTeamme(tbygildEgdkig$lglgeylthnetions an1 random basisJhmighput the normal course e.f_businessg:yie.sudit obsergspoenuG111eWeser$edrNgocedure will,be; established, andge_t audit, record pads.used for," walk-through" spot,,sugtg RMMj_temJ 35AJ 9.
Procurement:..
What happened?
The last approved vendors list is 1993.
The current list is not dated.
The depleted Uranium shield vendor is not on the list.
The purchasing department does not have a copy of the list.
He purchasing dept. Is not tied into the QA system.
The purchase requisition form is not controlled by QA.
Traceability of DU shields. Lack of certificates of compliance. Existing certificates are not maintained by QA.
Response: These observations are addressed on other audit documents.
10.
Training:
What happened?
(
No formal means to track training.
A matrix should be created to track training more easily.
- He 1997 schedule does not include some required training.-
Revise schedule to train specifically in all 18 chapters once or twice per year.
Response: These observations are addressed on other audit documents.
l I
NRC Inspection Observations SPEC Quality Assurance Program Exit Meeting. July 10.1997 Page 3 of 3 NRC Certificate of Compliance No. 0102 R; port Revision (1). July 21,1997
'