Information Notice 1991-31, Nonconforming Magnaflux Magnetic Particle (14AM) Prepared Bath: Difference between revisions
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{{#Wiki_filter:UNITED STATES | {{#Wiki_filter:UNITED STATES | ||
COMMISSION | NUCLEAR REGULATORY COMMISSION | ||
OFFICE OF NUCLEAR REACTOR REGULATION | |||
NOTICE NO. 91-31: NONCONFORMING | WASHINGTON, D.C. 20555 May 9, 1991 NRC INFORMATION NOTICE NO. 91-31: NONCONFORMING MAGNAFLUX MAGNETIC PARTICLE | ||
(14AM) PREPARED BATH | |||
==Addressees== | ==Addressees== | ||
: | : | ||
All holders of operating | All holders of operating licenses or construction permits for nuclear power | ||
licenses or construction | |||
reactors. | |||
==Purpose== | ==Purpose== | ||
: This information | : | ||
This information notice is intended to alert addressees of a product recall | |||
notice | notice issued by the Magnaflux division of Illinois Tool Works Inc. | ||
of | (Magnaflux), regarding their aerosol cans of fluorescent magnetic particle | ||
prepared bath (14AM Magnaglo) (Attachment 1). The recall notice has been | |||
transmitted by Magnaflux through its distribution channels; however, all | |||
commercial nuclear and industrial end-users may not receive this information. | |||
It is expected that recipients will review the information for applicability to | |||
their facilities and consider actions, as appropriate, to avoid similar problems. | |||
However, suggestions contained in this information notice do not constitute NRC | |||
requirements; therefore, no specific action or written response is required. | |||
==Description of Circumstances== | |||
: | |||
While under contract by Consumers Power Company, MQS Inspection, Inc. (MQS), | |||
tested some aerosol cans of Magnaflux 14AM Magnaglo in accordance with the | |||
American Society for Mechanical Engineers Boiler and Pressure Vessel Code | |||
(ASME Code), Article 25, Standard SE-709, 1986 edition. MQS found the particle | |||
concentration levels of batches 90F12P and 90HOlK to be out of compliance with | |||
this ASME standard. Subsequently, nondestructive testing personnel of | |||
Consumers Power Company performed a particle concentration check on batch | |||
90F12P and confirmed the conclusion of MQS. | |||
MQS notified Magnaflux of the deviation on February 11, 1991. On the basis of | |||
this information, Magnaflux initiated an investigation on the particle | |||
concentration levels of Magnaflux 14AM Magnaglo and, as part of its corrective | |||
notice | actions, issued the attached recall notice. Additional information on the | ||
Magnaflux recall may be obtained by calling Magnaflux Customer Service at (708) | |||
867-8000. | |||
50 63 ZA | |||
to4 IN 91-31 May 9, 1991 This information notice requires no specific action or written response. If | |||
you have any questions about the information in this notice, please contact one | |||
of the technical contacts listed below or the appropriate NRR project manager. | |||
Qr es E. Ro~ss, i'rec-to | |||
Division of Operational Events Assessment | |||
Office of Nuclear Reactor Regulation | |||
Technical Contacts: Joseph J. Petrosino, NRR | |||
(301) 492-0979 Nancy Campbell, NRR | |||
(301) 492-0836 Attachments: | |||
1. Magnaflux 14AM Aerosol Recall Notice | |||
of | 2. List of Recently Issued NRC Information Notices | ||
Attachment 1 | |||
[4~IJX WAS LUXMayiI.A. | |||
.... IN 91-31 | |||
9, 1991 14AM AEROSOL RECALL NOTICE | |||
Testing has revealed that particle concentration may be out of specification in some aerosol cans | |||
of 14AM in batches 90O11P, 90F12P, and.4OHO1K. Indications are that a very small percentage of | |||
of | cans were affected. However, in order to avoid any possibility of the affected cans being used in | ||
inspections, we are hereby recalling ihe three batches identified above. | |||
===Nature of the Deficiency=== | |||
An intermittent problem occurred in the aerosol canning process. As a result, the particle | |||
concentration may be light' (too few particles) in some cans, and 'heavy' (too many particles) ian | |||
others. This only affected a small numbermf cmns in each batch. The vast majority of cans in these | |||
batches are of the proper concentration. | |||
===Bulk 14AM. 14A Powder. Carrier 11 Are Unaffected=== | |||
These products are not affected. The problem relates only to the aerosol canning process and not to | |||
the materials themselves. | |||
===Corrective Action Has Been Taken=== | |||
The source of the problem has been positively identified. Process changes have already been made | |||
to prevent any recurrence, and appropriate Quality Control checks are in place. The problem has been | |||
corrected in 14AM aerosol batches beginning with 91B03K. This material is in stock and available | |||
for immediate shipment. | |||
Recall Procedures | |||
1. Telephone MAGNAFLUX Customer Service to request a Returned Goods Authorization and | |||
shipping instructions -- (708) 867-8000., | |||
Please identify the number of cans you wish to return, the batch number(s) and where | |||
purchased. | |||
Inform MAGNAFLUX of any Sppcial circumstances, such as an urgent need for an interim | |||
supply, until the replacement shipment arrives. We will make every effort to accommodate | |||
everyone's needs. | |||
2. Return material to MAGNAFLUX, De Witt Plant, freight collect. | |||
3. Replacement material will be shipped to you directly, freight prepaid. | |||
Other Aerosol Prodnct: | |||
Only 14AM aerosol was affected. | |||
Other Batches of 14AM | |||
Because of a similarity in process, we are issuing a WARNING for batches 9DA01K, 90E02P, | |||
90E03P, 90K08K, 91A02P, and 91A03P. No evidence has been found that these batches are | |||
affected. Our investigation continues at this time, however, and in the event any evidence of further | |||
errors is found, you will be informed immediately. No other batches are affected. | |||
Recognition of the Problem in the Field | |||
may | It is likely that an experienced inspector may notice a defective can as being 'light' in color or almost | ||
devoid of particles under black light. Similarly, other cans might exhibit an abnormally high amount | |||
of background. However, depending on field conditions and the type of parts being inspected, the | |||
earor may not be obvious to the eye. The situation could be confirmed by discharging the contents into | |||
a container and using a centrifuge tube to test settling volume--just as for a normal particle bath. | |||
MAGNAFWX. A Division. of linots Tool Works Inc. | |||
7300 West Lawrence Avenue IChicago, llihnois 60656 1 Telephone: 708-867.80001 Telex 277858 MAGX UR IFax 708.867-6833 | |||
VAGk4 tFLUX Page 2 Final Report: 14AM Recall | |||
I. Introduction | |||
A small percentage of cans from recent batches of 14AM aerosol have been found | |||
to have a particle concentration outside MAGNAFLUX acceptance specifications. | |||
This report summarizes the investigation of the problem and outlines the | |||
corrective actions taken. The bulk material is manufactured at the MAGNAFLUX | |||
manufacturing facility in De Witt, Iowa and is canned by two contract fillers, IKI, | |||
of Edgerton, WI, and Plaze, Incorporated of St. Louis, MO. | |||
MAGNAFLUX has recalled the following batches: | |||
90EOIP | |||
90F12P | |||
90HOIK | |||
II. Nature of the Problem | |||
MAGNAFLUX was first notified of a possible problem on February 11, 1991, by | |||
Quality Control | Wilmer Blankenship of MQS Inspection, Inc., who contacted Mathew Plamoottil, Quality Control Manager, De Witt Manufacturing Plant. | ||
Wilmer reported that testing of cans from two batches, 90F12P and 9OHOlK had | |||
produced the following results: | |||
Table 1 MQS Data, Batches 90F12P & 90HOlK | |||
MAGNAFLUX 90F12P 90HOlK | |||
Control Limits | |||
Particle .25-.40 .08 1.03 Concentration .09 1.02 (ml/100 ml bath) 1.50 3.00 | |||
III. Investiga-tion | |||
A. Testing of MAGNAFLUX Retain Samples | |||
The retain samples of both of these batches were checked; all were within | |||
the control limits. Mr. Plamoottil requested that Mr. Blankenship return | |||
the suspect cans for confirmation. | |||
of | MAGNAFWX. A Drvision of Illinois Tool Works Inc. | ||
7300 West Lawrence Avenue I Chicago. Illinois 606561 Telephone: 708-867-80001 Telex: | |||
277858 MAGX UR I Fax: 708-867-6833 | |||
Page 3 | |||
===B. Development of a Standard Test Method=== | |||
A standard testing method was developed to eliminate variables from the | |||
testing procedure. For example, if not properly shaken throughout the | |||
expulsion, an artificially low reading would be attained. If, on the other | |||
hand, a can had been used for some time and had not been well shaken, and | |||
then tested, an artificially high reading would be attained. | |||
Only new cans were tested (verified by inspection of the spray tip and | |||
weight). All material was evacuated from the can into a glass beaker, and | |||
the can was cut open to verify that no particles remained. | |||
===C. First Visit to IKI=== | |||
Since MAGNAFLUX had a scheduled canning run of two totes of 14AM | |||
(5000 cans each), Mr. Plamoottil visited IKI on February 14. The run was | |||
completed with no breaks and assigned batch # 91B03K. | |||
Samples were taken from ungassed cans from the line at the beginning, middle, and end of each tote (Table 2). Mr. Plamoottil provided written | |||
instruction to both canners to perform these tests on all suspended particle | |||
products until further notice (See attached document). | |||
Soon after the batch was delivered to De Witt, a can was pulled from every | |||
and | pallet layer and tested for concentration (Table 3). Beginning with this | ||
batch, IKI stamped each can with a serialized number. | |||
Table 2 Data Taken at IKI During Run of Batch #91K03K | |||
Particle | |||
Concentration | |||
l_ (ml/100 ml bath) | |||
Tote 1 Beginning .30 | |||
Middle .27 End .30 | |||
Tote 2 Beginning .30 | |||
Middle .30 | |||
End .30 | |||
i | |||
Page 4 Table 3 Batch #91B03K--Each Pallet Layer | |||
Serial I Particle Serial I Particle | |||
Concentration Concentration | |||
(mi/100 ml bath) (mnl100 mI bath) | |||
493 .29 3022 .30 | |||
703 .28 3061 .30 | |||
933 .28 3384 .28 | |||
990 .29 3719 .23 | |||
1076 .28 4414 .31 | |||
1581 .30 4379 .31 | |||
1968 .30 4629 .30 | |||
2010 .30 4650 .30 | |||
24131 .29 4836 .30 | |||
2623 .30 5057 .29 | |||
2956 .30 5192 .30 | |||
===D. MOS Visit to Chicago Lab=== | |||
On Tuesday, February 26, Ron Faloon, Executive Vice President of | |||
MQS and Mr. Blankenship visited the Chicago office. We discussed | |||
what steps had been taken so far, and assured them of our | |||
commitment to uncover the cause of the problem and correct it. Cans | |||
the | from the two suspect batches were run, the results of which confirmed | ||
the results earlier obtained by Mr. Blankenship. | |||
Assured that the most recent batch, 91B03K, was a good batch, Mr. | |||
Faloon indicated they would replace all returned material with this | |||
batch. We agreed that when the cause of the problem was determined | |||
and corrected, we would invite them to audit us at De Witt and at | |||
each canning facility. | |||
E. Visit to Plaza | |||
In order to determine the cause of the concentration inconsistency, one-tote runs were scheduled at each canning facility. Plaze was | |||
visited March 5 and 6, by myself, Mr. Plamoottil, and Cheri Zeleznik | |||
and Sei Song from the Chem Lab. The cause of the problem was | |||
traced to inadequate mixing of the filling material during line shut | |||
downs. | |||
- | |||
*6 Page 5 During filling, material is pumped from the bottom of the tote | |||
through a pipe and hose to a hopper. The filling is triggered by a | |||
level sensor in the hopper, and during normal operation occurs every | |||
30-40 seconds. Between tote and filler nozzle, there is a total volume | |||
of 4 gallons, including the hopper (1-2 gallons). | |||
Although material was being mixed constantly in the tote throughout | |||
the run, no mixer was present in the hopper. If the line were to shut | |||
down for an extended period of 30 minutes or more, particles would | |||
settle in the hopper and in the transfer plumbing, causing uneven | |||
particle distribution in the resulting cans. To confirm this, the line | |||
was shut down for 30 minutes with material in the lines and restarted | |||
without mixing. The resulting cans were out of specification. | |||
===F. Visit to IKI=== | |||
IKI was visited March 14 by Mr. Fijalkowski and Ms. Zeleznik. | |||
the | Similar to Plaze, the plumbing between tote and filler nozzle is about | ||
4 gallons. Although a mixer had always been used in the hopper, no | |||
special precautions had been taken during break periods to prevent | |||
particles from settling. | |||
===G. Concluson=== | |||
1. Scope of Problem | |||
Any batch which might have been subject to a 30 minute break or | |||
more during its run might have as many as 80 cans per break | |||
affected. For two breaks in a 10,000 can run, this would amount | |||
to 1.5% of the total. | |||
2. Other Products Affected | |||
Only 14AM, 7CF, and 9CM have fast enough settling rates to have | |||
been affected. 7CF and 9CM, however, are canned from drums | |||
and are run continuously from start to finish without break. | |||
3. Other Batches of 14AM | |||
Records were requested from both canners on the number and | |||
duration of all breaks during from all previous batches of 14AM | |||
(See Appendix 1). Based on these data, batches 9NEOWP, 90E02P, | |||
90E03P, 90F12P, 91A02P, 91A03P, 9OAO1K, 90HO1K, and 90K08K | |||
might have been affected. | |||
To date, based on testing of cans returned from the field, only | |||
cans from batches 90F12P, 9OE01P, and 90HOlK have been | |||
verified to have cans outside MAGNAFLUX control limits (See | |||
. | Page 6 Appendix 2). | ||
Batches prior to those listed in Appendix 1 were either canned | |||
from drums and not subject to long break periods or were canned | |||
by MAGNAFLUX. Batches starting with 91B03K were not | |||
subject to the conditions which caused the problem. | |||
===IV. Corrective Action=== | |||
A. Written Procedures | |||
Both IKI and Plaze have been given the following in writing: | |||
1. Settling Test Procedure | |||
2. Setup Procedure | |||
. Fit tote with double prop mixer blade at bottom of tank. | |||
and | . Mix and recirculate through bottom valve back into tote for 30 | ||
minutes. | |||
. Sample tote for settling test. | |||
. On approval from QC, fill hopper and start mixer. | |||
3. Filling Instructions: | |||
. Mixers shall be on throughout run. | |||
. For any break in line operation, empty transfer plumbing back | |||
into tote. | |||
. For breaks longer than one hour, recirculate for 30 minutes | |||
before restarting. | |||
4. OC Procedure | |||
Sample ungassed cans from the beginning, middle, and end of | |||
each tote. | |||
5. Training | |||
. A request to train all personnel making them sensitive to the | |||
quick settling rate of 14AM, 7CF, and 9CM particles. | |||
B. Training of MAGNAFLUX Personnel | |||
MAGNAFLUX personnel shall be trained to respond to customer | |||
quality complaints by: | |||
Immediately informing the appropriate Product Manager, the Sales | |||
Representative, and Sales Manager. | |||
Page 7 C. Recall/Warning Issued | |||
MAGNAFLUX has recalled the following batches: | |||
9OEOIP | |||
90F12P | |||
90HO1K | |||
Although no evidence has been found, due a similarity in process, MAGNAFLUX has also issued a WARNING for the following | |||
batches: | |||
9OAO1K 90E02P | |||
90E03P 90K08K | |||
91A02P 91A03P | |||
Our investigation continues at this time and in the event any evidence | |||
of further errors is found, you will be informed immediately. | |||
No other batches are affected. | |||
Page 8 Appendi z | |||
14AM Batches Using Totes | |||
===Recall Issued=== | |||
Batch # -Can | |||
90EO1P 10,284 | |||
90F12P 10,711 | |||
90HO1K 10,716 | |||
===Warning Issued=== | |||
90E02P/9OE03P 3,924 | |||
9OAOK 10,465 | |||
90K08K 10,180 | |||
91A02P 3,996 | |||
9IA03P 10,560 | |||
===Not Affected=== | |||
89J04K/89JO5K 8,984 | |||
89L04K 10,564 | |||
90C06K 10,716 | |||
90KO1K(Gov't.) 3,770 | |||
91B03K 10,536 | |||
91COlP 10,560 | |||
91COlK* 2,650 | |||
All subsequent batches are not affected. | |||
K) | |||
Attachment 2 IN 91-31 May 9, 1991 LIST OF RECENTLY ISSUED. | |||
NRC INFORMATION NOTICES | |||
Information Date of | |||
Subject Issuance Issued to | |||
Notice No. | |||
Inadequate Calibration of 04/23/91 All fuel cycle licensees and | |||
91-30 other licensees routinely | |||
Thermoluminescent Dosi- meters Utilized to Monitor handling unshielded uranium | |||
Extremity Dose at Uranium materials. | |||
Processing and Fabrication | |||
Facilities | |||
Recognition of American 04/16/91 All holders of OLs or CPs | |||
86-21, for nuclear power reactors | |||
Supp. 2 Society of Mechanical Engi- neers Accreditation Pro- and all recipients of | |||
gram for N Stamp Holders NUREG-0040, Licensee Con- tractor and Vendor Inspection | |||
Status Report' (White Book). | |||
Deficiencies Identified 04/15/91 All holders of OLs or | |||
91-29 CPs for nuclear power | |||
During Electrical Distri- bution System Functional reactors. | |||
Inspections | |||
Cracking in Feedwater 04/15/91 All holders of OLs or | |||
91-28 CPs for pressurized water | |||
System Piping | |||
reactors (PWRs). | |||
Incorrect Rotation of 04/10/91 All holders of OLs or | |||
91-27 CPs for nuclear power | |||
Positive Displacement Pump | |||
reactors. | |||
Pressurizer Safety Valve 04/10/91 All holders of OLs or | |||
89-90, CPs for nuclear power | |||
Supp. 1 Lift Setpoint Shift | |||
reactors. | |||
Potential Nonconservative 04/02/91 All fuel cycle licensees | |||
91-26 and other licensees, in- Errors in the Working Format | |||
Hansen-Roach Cross-Section cluding all holders of | |||
Set Provided with The Keno operating licenses for | |||
and Scale Codes nuclear power reactors, who use physics codes to | |||
support criticality | |||
safety in the use of | |||
fissile material. | |||
OL = Operating License | |||
Cp = Construction Permit | |||
IN 91-31 May 9, 1991 This information notice requires no specific action or written response. If | |||
you have any questions about the information in this notice, please contact one | |||
of the technical contacts listed below or the appropriate NRR project manager. | |||
Charles E. Rossi, Director | |||
Division of Operational Events Assessment | |||
Office of Nuclear Reactor Regulation | |||
Technical Contacts: Joseph J. Petrosino, NRR | |||
(301) 492-0979 Nancy Campbell, NRR | |||
(301) 492-0836 Attachments: | |||
1. Magnaflux 14AM Aerosol Recall Notice | |||
2. List of Recently Issued NRC Information Notices | |||
*SEE PREVIOUS CONCliRANCE%, | |||
XOE*3NP F ' *C/OGCB:DOEA:NRR *RPB:ADM *MQS Inspection | |||
Ceiffosft' CHBerlinger TechEd JFaloon | |||
05/7/91 05/01/91 04/24/91 04/26/91 | |||
*OGCB:DOEA:NRR*RVIB:DRIS:NRR *C/RVIB:DRIS:NRR *D/DRIS:NRR *Magnaflux Corp. | |||
NCampbell JJPetrosino GCwalina BKGrimes JChase | |||
04/25/91 04/25/91 04/26/91 04/26/91 04/25/91 OFFICIAL RECORD COPY | |||
Document Name: IN 91-31 | |||
IN 91-XX | |||
April xx, 1991 This information notice requires no specific action or written response. If | |||
in this notice, please contact one | you have any questions about the information in this notice, please contact one | ||
contacts listed below or the appropriate | of the technical contacts listed below or the appropriate NRR project manager. | ||
Charles E. Rossi, Director | |||
Division of Operational Events Assessment | |||
~ Office of Nuclear Reactor Regulation | |||
Contacts: | Technical Contacts:A Petrosino, NRR | ||
(301) 492-0979 Nancy Campbell, NRR | |||
(301) 492-0836 Attachments: | |||
1. Magnaflux Magnetic Particle (14AM) Prepared | |||
Bath Recall Notice | |||
2. List of Recently Issued NRC Information Notices | |||
Document Name: INFO NOTICE - CAMPBELL | |||
*SEE PREVIOUS CONCURRENCES | |||
D/DOEA:NRR C/OG | |||
CERossi CHBerlinger | |||
04/ /91 QK/ 1/91 OGCB:DOEA:NRR RyW :NRR A | |||
//BR 4 :NRR ,8)bRIS:NRR *RPB:ADM | |||
NCampbel iA4 J sino GCwalina (jK~rimes TechEd | |||
04/2r/91 ' sft 04/,Z791 04/A/91 {4/591 04/24/91 Hag 4ux Corporation I 4) S :7r&5w4 e | |||
I | |||
. | |||
XT 1a | |||
A. | |||
J00n-1 | |||
, Exew. 11P by c eo | |||
1.& | |||
. 7-,AV | |||
F70db) 8 47-3. 9' O (0) -9 / .5777 | |||
- a | |||
IN 91-XX | |||
April xx, 1991 Page 2 of | |||
This information notice requires no specific action or written response. If | |||
* 2rtx. | |||
you have any questions about the information in this notice, please contact We | |||
technical contact'listed below or the appropriate NRR project manager. 8 Charles E. Rossi, Director | |||
Division of Operational Events Assessment | |||
Office of Nuclear Reactor Regulation | Office of Nuclear Reactor Regulation | ||
Technical | Technical Contacts: Joe Petrosino, NRR | ||
Contacts: Joe Petrosino, NRR | |||
(301) 492-0979 Nancy Campbell, NRR | |||
(301) 492-0836 Attachments: | |||
1. Magnaflux Magnetic Particle (14AM) Prepared | |||
Bath Recall Notice | |||
2. List of Recently Issued NRC Information Notices | |||
Document Name: INFO NOTICE - CAMPBELL | |||
C/ | D/DOEA:NRR C/OGCB:DOEA:NRR | ||
CERossi CHBerlinger | |||
04/ / | 04/ /91_ 04/ /91 OGCB:DOEA:NRR RVIB:DRIS:NRR C/RVIB:DRIS:NRR D/DRIS:NRR | ||
NCampbell JJPetrosino BKGrimes TechEi | |||
04/ /91 | 04/ /91 04/ /91 04/ /91 04/ /91 04 P7/91}} | ||
{{Information notice-Nav}} | {{Information notice-Nav}} |
Latest revision as of 03:25, 24 November 2019
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR REACTOR REGULATION
WASHINGTON, D.C. 20555 May 9, 1991 NRC INFORMATION NOTICE NO. 91-31: NONCONFORMING MAGNAFLUX MAGNETIC PARTICLE
(14AM) PREPARED BATH
Addressees
All holders of operating licenses or construction permits for nuclear power
reactors.
Purpose
This information notice is intended to alert addressees of a product recall
notice issued by the Magnaflux division of Illinois Tool Works Inc.
(Magnaflux), regarding their aerosol cans of fluorescent magnetic particle
prepared bath (14AM Magnaglo) (Attachment 1). The recall notice has been
transmitted by Magnaflux through its distribution channels; however, all
commercial nuclear and industrial end-users may not receive this information.
It is expected that recipients will review the information for applicability to
their facilities and consider actions, as appropriate, to avoid similar problems.
However, suggestions contained in this information notice do not constitute NRC
requirements; therefore, no specific action or written response is required.
Description of Circumstances
While under contract by Consumers Power Company, MQS Inspection, Inc. (MQS),
tested some aerosol cans of Magnaflux 14AM Magnaglo in accordance with the
American Society for Mechanical Engineers Boiler and Pressure Vessel Code
(ASME Code), Article 25, Standard SE-709, 1986 edition. MQS found the particle
concentration levels of batches 90F12P and 90HOlK to be out of compliance with
this ASME standard. Subsequently, nondestructive testing personnel of
Consumers Power Company performed a particle concentration check on batch
90F12P and confirmed the conclusion of MQS.
MQS notified Magnaflux of the deviation on February 11, 1991. On the basis of
this information, Magnaflux initiated an investigation on the particle
concentration levels of Magnaflux 14AM Magnaglo and, as part of its corrective
actions, issued the attached recall notice. Additional information on the
Magnaflux recall may be obtained by calling Magnaflux Customer Service at (708)
867-8000.
50 63 ZA
to4 IN 91-31 May 9, 1991 This information notice requires no specific action or written response. If
you have any questions about the information in this notice, please contact one
of the technical contacts listed below or the appropriate NRR project manager.
Qr es E. Ro~ss, i'rec-to
Division of Operational Events Assessment
Office of Nuclear Reactor Regulation
Technical Contacts: Joseph J. Petrosino, NRR
(301) 492-0979 Nancy Campbell, NRR
(301) 492-0836 Attachments:
1. Magnaflux 14AM Aerosol Recall Notice
2. List of Recently Issued NRC Information Notices
Attachment 1
[4~IJX WAS LUXMayiI.A.
.... IN 91-31
9, 1991 14AM AEROSOL RECALL NOTICE
Testing has revealed that particle concentration may be out of specification in some aerosol cans
of 14AM in batches 90O11P, 90F12P, and.4OHO1K. Indications are that a very small percentage of
cans were affected. However, in order to avoid any possibility of the affected cans being used in
inspections, we are hereby recalling ihe three batches identified above.
Nature of the Deficiency
An intermittent problem occurred in the aerosol canning process. As a result, the particle
concentration may be light' (too few particles) in some cans, and 'heavy' (too many particles) ian
others. This only affected a small numbermf cmns in each batch. The vast majority of cans in these
batches are of the proper concentration.
Bulk 14AM. 14A Powder. Carrier 11 Are Unaffected
These products are not affected. The problem relates only to the aerosol canning process and not to
the materials themselves.
Corrective Action Has Been Taken
The source of the problem has been positively identified. Process changes have already been made
to prevent any recurrence, and appropriate Quality Control checks are in place. The problem has been
corrected in 14AM aerosol batches beginning with 91B03K. This material is in stock and available
for immediate shipment.
Recall Procedures
1. Telephone MAGNAFLUX Customer Service to request a Returned Goods Authorization and
shipping instructions -- (708) 867-8000.,
Please identify the number of cans you wish to return, the batch number(s) and where
purchased.
Inform MAGNAFLUX of any Sppcial circumstances, such as an urgent need for an interim
supply, until the replacement shipment arrives. We will make every effort to accommodate
everyone's needs.
2. Return material to MAGNAFLUX, De Witt Plant, freight collect.
3. Replacement material will be shipped to you directly, freight prepaid.
Other Aerosol Prodnct:
Only 14AM aerosol was affected.
Other Batches of 14AM
Because of a similarity in process, we are issuing a WARNING for batches 9DA01K, 90E02P,
90E03P, 90K08K, 91A02P, and 91A03P. No evidence has been found that these batches are
affected. Our investigation continues at this time, however, and in the event any evidence of further
errors is found, you will be informed immediately. No other batches are affected.
Recognition of the Problem in the Field
It is likely that an experienced inspector may notice a defective can as being 'light' in color or almost
devoid of particles under black light. Similarly, other cans might exhibit an abnormally high amount
of background. However, depending on field conditions and the type of parts being inspected, the
earor may not be obvious to the eye. The situation could be confirmed by discharging the contents into
a container and using a centrifuge tube to test settling volume--just as for a normal particle bath.
MAGNAFWX. A Division. of linots Tool Works Inc.
7300 West Lawrence Avenue IChicago, llihnois 60656 1 Telephone: 708-867.80001 Telex 277858 MAGX UR IFax 708.867-6833
VAGk4 tFLUX Page 2 Final Report: 14AM Recall
I. Introduction
A small percentage of cans from recent batches of 14AM aerosol have been found
to have a particle concentration outside MAGNAFLUX acceptance specifications.
This report summarizes the investigation of the problem and outlines the
corrective actions taken. The bulk material is manufactured at the MAGNAFLUX
manufacturing facility in De Witt, Iowa and is canned by two contract fillers, IKI,
of Edgerton, WI, and Plaze, Incorporated of St. Louis, MO.
MAGNAFLUX has recalled the following batches:
90EOIP
90F12P
90HOIK
II. Nature of the Problem
MAGNAFLUX was first notified of a possible problem on February 11, 1991, by
Wilmer Blankenship of MQS Inspection, Inc., who contacted Mathew Plamoottil, Quality Control Manager, De Witt Manufacturing Plant.
Wilmer reported that testing of cans from two batches, 90F12P and 9OHOlK had
produced the following results:
Table 1 MQS Data, Batches 90F12P & 90HOlK
MAGNAFLUX 90F12P 90HOlK
Control Limits
Particle .25-.40 .08 1.03 Concentration .09 1.02 (ml/100 ml bath) 1.50 3.00
III. Investiga-tion
A. Testing of MAGNAFLUX Retain Samples
The retain samples of both of these batches were checked; all were within
the control limits. Mr. Plamoottil requested that Mr. Blankenship return
the suspect cans for confirmation.
MAGNAFWX. A Drvision of Illinois Tool Works Inc.
7300 West Lawrence Avenue I Chicago. Illinois 606561 Telephone: 708-867-80001 Telex:
277858 MAGX UR I Fax: 708-867-6833
Page 3
B. Development of a Standard Test Method
A standard testing method was developed to eliminate variables from the
testing procedure. For example, if not properly shaken throughout the
expulsion, an artificially low reading would be attained. If, on the other
hand, a can had been used for some time and had not been well shaken, and
then tested, an artificially high reading would be attained.
Only new cans were tested (verified by inspection of the spray tip and
weight). All material was evacuated from the can into a glass beaker, and
the can was cut open to verify that no particles remained.
C. First Visit to IKI
Since MAGNAFLUX had a scheduled canning run of two totes of 14AM
(5000 cans each), Mr. Plamoottil visited IKI on February 14. The run was
completed with no breaks and assigned batch # 91B03K.
Samples were taken from ungassed cans from the line at the beginning, middle, and end of each tote (Table 2). Mr. Plamoottil provided written
instruction to both canners to perform these tests on all suspended particle
products until further notice (See attached document).
Soon after the batch was delivered to De Witt, a can was pulled from every
pallet layer and tested for concentration (Table 3). Beginning with this
batch, IKI stamped each can with a serialized number.
Table 2 Data Taken at IKI During Run of Batch #91K03K
Particle
Concentration
l_ (ml/100 ml bath)
Tote 1 Beginning .30
Middle .27 End .30
Tote 2 Beginning .30
Middle .30
End .30
i
Page 4 Table 3 Batch #91B03K--Each Pallet Layer
Serial I Particle Serial I Particle
Concentration Concentration
(mi/100 ml bath) (mnl100 mI bath)
493 .29 3022 .30
703 .28 3061 .30
933 .28 3384 .28
990 .29 3719 .23
1076 .28 4414 .31
1581 .30 4379 .31
1968 .30 4629 .30
2010 .30 4650 .30
24131 .29 4836 .30
2623 .30 5057 .29
2956 .30 5192 .30
D. MOS Visit to Chicago Lab
On Tuesday, February 26, Ron Faloon, Executive Vice President of
MQS and Mr. Blankenship visited the Chicago office. We discussed
what steps had been taken so far, and assured them of our
commitment to uncover the cause of the problem and correct it. Cans
from the two suspect batches were run, the results of which confirmed
the results earlier obtained by Mr. Blankenship.
Assured that the most recent batch, 91B03K, was a good batch, Mr.
Faloon indicated they would replace all returned material with this
batch. We agreed that when the cause of the problem was determined
and corrected, we would invite them to audit us at De Witt and at
each canning facility.
E. Visit to Plaza
In order to determine the cause of the concentration inconsistency, one-tote runs were scheduled at each canning facility. Plaze was
visited March 5 and 6, by myself, Mr. Plamoottil, and Cheri Zeleznik
and Sei Song from the Chem Lab. The cause of the problem was
traced to inadequate mixing of the filling material during line shut
downs.
-
- 6 Page 5 During filling, material is pumped from the bottom of the tote
through a pipe and hose to a hopper. The filling is triggered by a
level sensor in the hopper, and during normal operation occurs every
30-40 seconds. Between tote and filler nozzle, there is a total volume
of 4 gallons, including the hopper (1-2 gallons).
Although material was being mixed constantly in the tote throughout
the run, no mixer was present in the hopper. If the line were to shut
down for an extended period of 30 minutes or more, particles would
settle in the hopper and in the transfer plumbing, causing uneven
particle distribution in the resulting cans. To confirm this, the line
was shut down for 30 minutes with material in the lines and restarted
without mixing. The resulting cans were out of specification.
F. Visit to IKI
IKI was visited March 14 by Mr. Fijalkowski and Ms. Zeleznik.
Similar to Plaze, the plumbing between tote and filler nozzle is about
4 gallons. Although a mixer had always been used in the hopper, no
special precautions had been taken during break periods to prevent
particles from settling.
G. Concluson
1. Scope of Problem
Any batch which might have been subject to a 30 minute break or
more during its run might have as many as 80 cans per break
affected. For two breaks in a 10,000 can run, this would amount
to 1.5% of the total.
2. Other Products Affected
Only 14AM, 7CF, and 9CM have fast enough settling rates to have
been affected. 7CF and 9CM, however, are canned from drums
and are run continuously from start to finish without break.
3. Other Batches of 14AM
Records were requested from both canners on the number and
duration of all breaks during from all previous batches of 14AM
(See Appendix 1). Based on these data, batches 9NEOWP, 90E02P,
90E03P, 90F12P, 91A02P, 91A03P, 9OAO1K, 90HO1K, and 90K08K
might have been affected.
To date, based on testing of cans returned from the field, only
cans from batches 90F12P, 9OE01P, and 90HOlK have been
verified to have cans outside MAGNAFLUX control limits (See
Page 6 Appendix 2).
Batches prior to those listed in Appendix 1 were either canned
from drums and not subject to long break periods or were canned
by MAGNAFLUX. Batches starting with 91B03K were not
subject to the conditions which caused the problem.
IV. Corrective Action
A. Written Procedures
Both IKI and Plaze have been given the following in writing:
1. Settling Test Procedure
2. Setup Procedure
. Fit tote with double prop mixer blade at bottom of tank.
. Mix and recirculate through bottom valve back into tote for 30
minutes.
. Sample tote for settling test.
. On approval from QC, fill hopper and start mixer.
3. Filling Instructions:
. Mixers shall be on throughout run.
. For any break in line operation, empty transfer plumbing back
into tote.
. For breaks longer than one hour, recirculate for 30 minutes
before restarting.
4. OC Procedure
Sample ungassed cans from the beginning, middle, and end of
each tote.
5. Training
. A request to train all personnel making them sensitive to the
quick settling rate of 14AM, 7CF, and 9CM particles.
B. Training of MAGNAFLUX Personnel
MAGNAFLUX personnel shall be trained to respond to customer
quality complaints by:
Immediately informing the appropriate Product Manager, the Sales
Representative, and Sales Manager.
Page 7 C. Recall/Warning Issued
MAGNAFLUX has recalled the following batches:
9OEOIP
90F12P
90HO1K
Although no evidence has been found, due a similarity in process, MAGNAFLUX has also issued a WARNING for the following
batches:
9OAO1K 90E02P
90E03P 90K08K
91A02P 91A03P
Our investigation continues at this time and in the event any evidence
of further errors is found, you will be informed immediately.
No other batches are affected.
Page 8 Appendi z
14AM Batches Using Totes
Recall Issued
Batch # -Can
90EO1P 10,284
90F12P 10,711
90HO1K 10,716
Warning Issued
90E02P/9OE03P 3,924
9OAOK 10,465
90K08K 10,180
91A02P 3,996
9IA03P 10,560
Not Affected
89J04K/89JO5K 8,984
89L04K 10,564
90C06K 10,716
90KO1K(Gov't.) 3,770
91B03K 10,536
91COlP 10,560
91COlK* 2,650
All subsequent batches are not affected.
K)
Attachment 2 IN 91-31 May 9, 1991 LIST OF RECENTLY ISSUED.
NRC INFORMATION NOTICES
Information Date of
Subject Issuance Issued to
Notice No.
Inadequate Calibration of 04/23/91 All fuel cycle licensees and
91-30 other licensees routinely
Thermoluminescent Dosi- meters Utilized to Monitor handling unshielded uranium
Extremity Dose at Uranium materials.
Processing and Fabrication
Facilities
Recognition of American 04/16/91 All holders of OLs or CPs
86-21, for nuclear power reactors
Supp. 2 Society of Mechanical Engi- neers Accreditation Pro- and all recipients of
gram for N Stamp Holders NUREG-0040, Licensee Con- tractor and Vendor Inspection
Status Report' (White Book).
Deficiencies Identified 04/15/91 All holders of OLs or
91-29 CPs for nuclear power
During Electrical Distri- bution System Functional reactors.
Inspections
Cracking in Feedwater 04/15/91 All holders of OLs or
91-28 CPs for pressurized water
System Piping
reactors (PWRs).
Incorrect Rotation of 04/10/91 All holders of OLs or
91-27 CPs for nuclear power
Positive Displacement Pump
reactors.
Pressurizer Safety Valve 04/10/91 All holders of OLs or
89-90, CPs for nuclear power
Supp. 1 Lift Setpoint Shift
reactors.
Potential Nonconservative 04/02/91 All fuel cycle licensees
91-26 and other licensees, in- Errors in the Working Format
Hansen-Roach Cross-Section cluding all holders of
Set Provided with The Keno operating licenses for
and Scale Codes nuclear power reactors, who use physics codes to
support criticality
safety in the use of
fissile material.
OL = Operating License
Cp = Construction Permit
IN 91-31 May 9, 1991 This information notice requires no specific action or written response. If
you have any questions about the information in this notice, please contact one
of the technical contacts listed below or the appropriate NRR project manager.
Charles E. Rossi, Director
Division of Operational Events Assessment
Office of Nuclear Reactor Regulation
Technical Contacts: Joseph J. Petrosino, NRR
(301) 492-0979 Nancy Campbell, NRR
(301) 492-0836 Attachments:
1. Magnaflux 14AM Aerosol Recall Notice
2. List of Recently Issued NRC Information Notices
- SEE PREVIOUS CONCliRANCE%,
XOE*3NP F ' *C/OGCB:DOEA:NRR *RPB:ADM *MQS Inspection
Ceiffosft' CHBerlinger TechEd JFaloon
05/7/91 05/01/91 04/24/91 04/26/91
- OGCB:DOEA:NRR*RVIB:DRIS:NRR *C/RVIB:DRIS:NRR *D/DRIS:NRR *Magnaflux Corp.
NCampbell JJPetrosino GCwalina BKGrimes JChase
04/25/91 04/25/91 04/26/91 04/26/91 04/25/91 OFFICIAL RECORD COPY
Document Name: IN 91-31
IN 91-XX
April xx, 1991 This information notice requires no specific action or written response. If
you have any questions about the information in this notice, please contact one
of the technical contacts listed below or the appropriate NRR project manager.
Charles E. Rossi, Director
Division of Operational Events Assessment
~ Office of Nuclear Reactor Regulation
Technical Contacts:A Petrosino, NRR
(301) 492-0979 Nancy Campbell, NRR
(301) 492-0836 Attachments:
1. Magnaflux Magnetic Particle (14AM) Prepared
Bath Recall Notice
2. List of Recently Issued NRC Information Notices
Document Name: INFO NOTICE - CAMPBELL
- SEE PREVIOUS CONCURRENCES
D/DOEA:NRR C/OG
CERossi CHBerlinger
04/ /91 QK/ 1/91 OGCB:DOEA:NRR RyW :NRR A
//BR 4 :NRR ,8)bRIS:NRR *RPB:ADM
NCampbel iA4 J sino GCwalina (jK~rimes TechEd
04/2r/91 ' sft 04/,Z791 04/A/91 {4/591 04/24/91 Hag 4ux Corporation I 4) S :7r&5w4 e
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A.
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IN 91-XX
April xx, 1991 Page 2 of
This information notice requires no specific action or written response. If
- 2rtx.
you have any questions about the information in this notice, please contact We
technical contact'listed below or the appropriate NRR project manager. 8 Charles E. Rossi, Director
Division of Operational Events Assessment
Office of Nuclear Reactor Regulation
Technical Contacts: Joe Petrosino, NRR
(301) 492-0979 Nancy Campbell, NRR
(301) 492-0836 Attachments:
1. Magnaflux Magnetic Particle (14AM) Prepared
Bath Recall Notice
2. List of Recently Issued NRC Information Notices
Document Name: INFO NOTICE - CAMPBELL
D/DOEA:NRR C/OGCB:DOEA:NRR
CERossi CHBerlinger
04/ /91_ 04/ /91 OGCB:DOEA:NRR RVIB:DRIS:NRR C/RVIB:DRIS:NRR D/DRIS:NRR
NCampbell JJPetrosino BKGrimes TechEi
04/ /91 04/ /91 04/ /91 04/ /91 04 P7/91