ML20127A538

Discusses QC Concerns W/Mine Safety Appliances Co Full Face Negative Pressure Respirators (Ultra View & Ultra Twin) W/Potential 10CFR21 Implications

ML20127A538
Person / Time
Site:	Trojan File:Portland General Electric icon.png
Issue date:	01/07/1993
From:	Liza Cunningham Office of Nuclear Reactor Regulation
To:	Cooper R, Norelius C, Stohr J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
Shared Package
ML20127A542	List: ML20127A538 ML20127A544 ML20127A549
References
NUDOCS 9301110323
Download: ML20127A538 (2)

Text

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,. S ~[J - N f JAN 0 71993

.M MEMORANDUM FOR: Richard W. Cooper, Director, DRSS, Region I

/'" J. Philip Stohr, Director, DRSS, Region II 2 Charles E. Norelius, Director, DRSS, Region III L. Joseph Callan, Director, DRSS, . Region IV c_ _

Ross A. Scarano, Director, DRSS, Region V M- LeMoine J. Cunningham, Chief Radiation Protection Branch x Division of Radiation Safety n and Safeguards p Office of the Nuclear Reactor Regulation

( 4.CT: FOLLOW-UP ON A REFJRT OF RESPIRATOR DEFECT Trohn Nuclear Power Plant staff submitted information to us concerning-quality control cence.,as with Mine Safety Appliances Co. (MSA) full face negative pressure respirators (Ultra View and Ultra Twin) with potential 10 ..

i CFR Part 21 implications. We have contacted the National Institute of pJ Occupational Safety and Health (NIOSH) and MSA concerning this matter and_ are providing the following for your information. This is not an official .<

radiation protection branch (PRPB) Part 21 closecut, as the consequences of 3 the raspirator defects do not neet the thrchold requirements of Part 21 (they do not create r 'tantial safety hazard' PRPB contacted NIOSH informing them of Trojan's report of defects (see enclo ure 1). NIOSH then contacted MSA and followed up on the vendor response (see enclosures 2 & 3). MSA responded to NIOSH (see enclosure 4) by >

characterizing the problem as an isolated incident unique to their special order process and not a generic issue. NIOSH concluded that MSA had made satisfactc~ progress toward the resolution of this problem (enclosure 5).

PRPB wanted t3 pursue the special order issue further and after conferring with NIOSH contacted MSA directly to ask what actions were taken to prevent _

any reoccurrence with other special orders. MSA responded.(enclosure 6) that .

it has reviewed its inspection procedures with its production personnel and' have taken steps necessary to prevent occurrences of this type in the future.

Since the vendor's corrective actions appear to be appropriate, PRPB plans no further action in this matter. If you have any questions contact Dan Carter - -

v at (301)504-1848.

Original signed by LeMoine J. Cunningham LeMoine J. Cunningham, Chief 11002-3 Radiation Protection Branch Division of Radiation Safety Q f QOS$ $0f>O344 PDR and Safeguards S

Office of Nuclear Reactor Regulations

Enclosures:

As stated plSTRIBUTION: See next page OFC PRPB:DRSS

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NAME DCARTERDL

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~* I DAQl/7/93 b 01/7/93 01/7/93 Of ficial Record Copy' Document Name: :.sa21 1

DISTRIBUTION:

B. Murray, RIV F. Congel E. Butcher

-L. Cunningham

. Central l File,: P1.37 -

F. Combs, 6H3 J. Wigginton PRPB R/F R. Anderson, TTC T. Essig PDR, LL6 L. Norrholm, 904 J. Joyner, RI W. Cline, RII

. C. Pederson, RIII J. Reese, RIV J. Catshall, MSA R. Metzler, NIOSH G. Huey, Trojan L. Kokajko, 13E16

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Enclosure 1 f3 UNITED STATES

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.. i NUCLEAR REGULATORY COMMISSION WASHINoToN D.C. 20666 k~/ muw L

Mr. Richard W. Metzler, Chief Certification and Quality Control Branch National Institute of Occupational Safety and Health Division of Safety Research Room S-105 944 Chestnut Ridge Road j Morgantown, West Virginia 26505-2888 1

SUBJECT:

PROB!. EMS WITH MSA RESPIRATORS i

L Dear Mr. Metzler-I ihis letter is to bring to your attention an issue identified to us by one of j J

our power reactor licensees. This issue (see enclosure)= focuses on quality i control concerns with Mine Safety _ Associates (MSA) full face negative pressure i

respirators (Ultra View and Ultra Twin). These concerns range from-respirator! l microphones being installed upside down, filter gaskets installed. upside down,- J L a missing inhalation valve disc and improperly installed lens ring:: causing.

L distortion of rubber around the lens covers. These deficiencies were-identified by the licensee as part of their incoming quclity control (QC) checks on all new respirato_rs- prior to field use.-

The licensee notified MSA of these problems-and' a-vendor representative was-sent to the reactor site to investigate the matter. The MSA representative p inspected 20 respirators identified as having problems and confirmed that 11 i

had rubber distortion of some matter in the face piece area; the remaining'9 were able to be repaired on site. The 11 respirators with distorted rubber were returned to MSA for evaluation. Two of the 11_respirat' ors' returned failed the vendor DOP testing criteria.

MSA claimed that they did not know how these problems occurred and'said-that) their QC was "as good as always." MSA representatives informed our licensee- 'i I that they did n'ot feel it was necessary to' alert other MSA customerst of these problems unless other customers expressed similar.protlems. If MSA is waiting 3 for feedback from their customers, then we should point out that not many of the thousands of NRC licensees (aside from the 100 cr so power reastor-licensees) have comprehensive, sophisticated-incoaing QA/QC programs which-test 100 percent of the negative pressure respirators. prior to use. We suspect that the vast number of respiratory protection programs across-the country for not. have-formal aggressive incoming QC programs.

Is L

I would like to talk with you about MSA's apparent lack'of wiliingness to '

inform their customers of possible generic problems with their products.

L While this is not a serious worker safety issue at nuclear power reactor

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' facilities, because there respirators are used only in areas of relatively low:

concentrations of radioactive materials,-we are considering issuing ant z

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,' Mr. Richard W. Metzler  ;

information notice to the nucisar industry. The purpose of this industry

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notice would be to inform our-licensees of this issue so that they might consider expanding the scope of their own QC programs. Please contact me at (301) 504-1007 or Jim Wigginton at (301) 504-1059.

Sincerely, Original signed by LeMoine J. Cunnine^m

. LeMoine J. Cunningham, Chief Radiation Protection Branch _

Division of Radiation Protection and Emergency Preparedness Office of Nuclear Reactor Regulation

Enclosure:

As stated

. Distribution:

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CORRECTIVE ACTION REQUEST (CAR)

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INITIATION / .

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A new shipment of small and large respirators were received at the plant and purchased by Joan and Margaret from the '

varehouse (10 large, lo small). While preparing these '

respirators for use, they noticed the first respirator to have its micretSone upside down and repaired it. Further inspection showed that all 10 of the large and 7 of the small respiraters had problems. The following is a list of the M indications.

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- Upside down microphones,

- Inproperly installed lens rings. Some were pinching the i) rubber between the mating portions which caused the rubber to bulge out. One had the lens not eve.n seated in the "

rubbor portion at the bottom of the face piece holder.

Some rings were not lined up with the center lines

• indicated at the top a,nd bottom of the respirator.

- Microphones found installed at the 5 and 8 o' clock {'

positions which were pressing into the rubber. pM m

- Upside down filter gaskets. -7

- Missing inhalatiot, valve disc.

- Gap between the speaker assemblies and the rubber.

- oposition.

rings on the sp5aker assemblies rotated to the wrong .

Joan and Margaret called Dallas somerville to inform him of these problems. Dallas asked thet they bring the respirators from the assembly room to the conference room and he would ca. A MSA. Bob Rucinski of MSA was notified and arrived at the plant at 1200. He inspected all of the 20 respirators and confirmed that all 10 large and i small had the rubber distorted in some manner in the face piece area. The remaining 9 small :espirators were able to be rapaired.

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A complete inspection of all respirators in-stock at the warehouse was performed with Bob Rueinski.. No problems were found.. A detailed inspection of all respirators purchased since December of 1991 and already in service in cabinets and emergency lockers was also performed, and no problems identified. .

NOTE: 1. Problems with microphones being installed upside down was in both ultra twin and ultra view

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respirators.

,2. Rubber distortion and missing pieces were isolated to ultra twins only. -

Another meeting will be conducted with representatives from MSA er _ E[

along with Dallas Somerville, ;Toan Thackery, Margaret Brady, 4.

Spike Ford of the compliance group, and myself at the plant on j,

.. April 14, 1992. Items to be discussed will be the lack of  ;

quality workmanship recently indicated with the MSA respirators, .

what MSA's results of investigating the problems were, and -

potential reporting issues. .

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.-[ DEPARTMENT OF HEALTH A HUM AN SERVICES Public Health Service

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NIOSH

Reference:

TN-06205 / Qnters for Disease Control National Institute for Occupational Safety and Health - ALOSH 944 Chestnut Ridge Road Morgantown, WV 26505-2838 August 20, 1992 Mr. LeMoine J. Cunningham United States Nuclear Regulatory Commission Was!.ington, D. C. 20555 i

Dear Mr. Cunningham:

The National Institute for Occupational Safety and Health (NIOSH) has received your letter of August 12, 1992, concerning nonconformances with Mine Safety Appliances Company (MSA) Ultraview and Ultratwin negative-pressure facepieces.

The investigation of these reperted nonconformances has been assigned NIOSH Task Number TN-06205. Mr. Jeffrey L. Gutshall of MSA has been contacted, and NIOSH awaits the manufacturer's report of investigation concerning this matter. You will be kept informed of the developments concerning this investigation.

If NIOSH can be of further assistance, feel free to contact this office.

Sincerely yours, O**

Richard W. Metzler, Chief certification and Quality Assurance Branch Division of Safety Research i

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Enclosure 3 1

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DEPARTMENT Of HEALTH & HUM AN SERVICES Public Health Service

'O'*** NIOSH

Reference:

TN-06205 i Centers fot Diseau controt I

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v National Institute for Occupational EWfety and Healm - ALOSH 944 Chestnut Ridge Road Morgantown, WV 26505-2888 August 31, 1992 Mr. Jeffrey L. Gutshall Mine Safety Appliances Company P.O. Box 439 Pittsburgh, Pennsylvania 15230

Dear Mr. Gutshall:

The National Institute for Occupational Safety and Health (NIOSH) has received a report of nonconformances with the MSA Ultraview and Ultratwin negative pressure facepieces. These nonconformances reportedly involve microphones and filter gasket; heing instal-led.

upside down, a missing inhalation valve disc, and improperly .

installed lens rings.

These nonconformances have been reported to NIOSH-by Mr. LeMoine J. Cunningham of the U.S. Nuclear Regulatory Commission.. A copy of the letter initiating this investigation is enclosed.

The investigation and ultimate resolution of this nonconformance investigation have been assigned NIOSH Task Number TN-06205. The MSA report of investigation and proposed corrective action, if cny, should be submitted by September 18, 1992. Special consideration should be given to Mr. Cunningham's concern about notifying other users of the need to closely inspect their own respirators for similar nonconformances.

Please provide this office with a list of all model and certification numbers involved in this investigation.

Sincerely yours,

/ ichard W. Metzler, Chief Certification and Quality Assurance Branch Division of Safety Research Enclosure l cc:

L. Cunningham (NRC)

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I' Ehclosure 4

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A Mine Safety Appliances Company + Safety Products Engineenng

• P.O. Box 439 + Pittsburgh, PA 15230 Telephone:(412) 776 7700 wm asom aom.o-(412) 776-7740 September 17, 1992 Mr. Richard MetzJer Certification Branch NIOSH 944 Chestnut Ridge Road Morgantown, WV 26505 RE: Reported MSA Facepiece Problems TN-06205 MSA REF: NP92-48

Dear Mr. Metzler:

This is in response to your letter dated August 31,1992.

MSA was 'nade aware of this problem through our field representative. A subsequent investigation confirmed that these respirators were not representative of the quality our customers have come to expect from MSA. The subject respirators were repaired and returned to the customer.

These respirators are not stocked equipped with a communications package. This is usually added by the user through the use of a kit. In this instance, a number of respirators were supplied so equipped through a gecial order.

The positioning of the microphone can be changed by the user to suit preference. -If, however, -

the microphone is in the lower quadrant of the facepiece, it can interfere with our DOP test fixturing. This is why it is shown in the 12:00 position on the drawing. Any other position is user determined and is cosmetic.

Gur information confirms this problem is isolated to this special order. It is conceivable that some of these escaped normal Q.C. inspection. , __ _

The lens ring assembly procedures, as well as the valve, gasketing and other installations are monitored by each worker in the work cell. Furthermore, each facepiece is normally 100% DOP inspected and random post production samples are removed and inspected. Q.C. has been alerted to this problem and has reviewed Ge inspection procedures with production personnel.

LOCM'.0a. Waldo Road Cranberry Twp.

• Mars, PA 16046 ~

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1 MSA sold'over 50,000 Ultra-Twin respirators in 1991. Thousands havc been sold to commercial nuclear users. A greater number were purchased by the D.O.E. No other problems have been reported. This confirms the finding at Trojan that a 100% inspection of their stock found no other defective respirators.

MSA is convinced thtt this is not a generic problem with our products. Our internal review, the customer review, as well as a review of field experience confirm this as an isolated incident.

If you have any questions, picase contact me.

Sincerely,

/ .

Jeffrey L. Outshall Design Engineer, Government Relations Safety Products Division JLG:Ib b

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