ML18275A043

Nordion (Canada) Inc. - NRC Form 591S Part 1 and Part 2, Inspection Report 07100703/2018201

ML18275A043
Person / Time
Site:	07100703
Issue date:	08/17/2018
From:	Jeremy Tapp NRC/NMSS/DSFM/IOB
To:	Fulford G Nordion (Canada)
Tapp J
References
IR 2018201
Download: ML18275A043 (13)

Text

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NRC FORM 591S PART 1 r--, U.S. NUCLEAR REGULATORY COMMISSION f.:c:I i OOR,:1 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION

\j 1 CER,IF CA iE/OUAUTY ASSURA:,CE FROGRAV (OAP) HOLDER 2 NRCIREGJONAL Cfi'ICE Nordion (Canada) Inc.

447 March Road Headquarters Ottawa, Ontario, Canada U. S. Nuclear Regulatory Commission K2K IX8 Mail Stop TWFN 48-34

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Washington, DC 20555-0001 REPORT NUM8ER(S) 71-0703/2018-20 I J CERTIFICATE/OAP DOCKET NUMBER(S) 4. INSPECT:ON LOCATION 5 DATE(S) OF INSPECTION 71-0703 Ottawa, Ontario, Canada August 15-17, 2018 CERTIFICATE/QUALITY ASSURANCE PROGRAM HOLDER:

The Inspection was an examination or lhe activities conducted under your OAP as lney relate to compliance with the Nuclear Regulatory Commission (NRC) rules and regulalfons and the conditions of your OAP Approval and/or Cer11ficate(s) of Compliance. The Inspection consisted of selective exam*nations of procedures and representative records, lnlerviews with personnel, and observations by lhe Inspector. The Inspection findings are as follows:

D 1.

Based on lhe inspection findings no violalions were identified.

D 2.

Previous vlolaUon(s) closed.

(Z)3.

The vlolations(s). specifically described to you by lhe inspeclor as non-cited violations, are not being cited because they were self-Identified, non repetitive. and corrective action was or is being taken. and the remaining criteria in lhe NRC Enforcemenl Polley, to exercise discretion, were salisfied.

I Non-cited vlolation(s) was/were discussed involving lhe following requiremenl(s) and Corrective Actions(s)

Title IO CFR 71.111, "Instructions. procedures, and drawings" states, in part, that the licensee shall prescribe activities affecting quality by documented instructions, procedures. or drawings of a type appropriate to the circumstances. The instructions, procedures, and drawings must include appropriate quantilative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.

(Continued on Next Page)

During this inspection, certain of your activities, as described below and/or attached. were In violation or NRC requiremenls and are being cited In accordance with NRC Enforcement Policy This form is a NOTICE OF VIOLATION, which may be subject to posting in accordance with 10 CFR 19.11.

(Violations and Corrective AC1ions)

Statement of Corrective Actions I hereby stale that. within 30 days. the actions described by me to the Inspector will be taken lo correct the violations Identified This slatemenl ol corrective actions is made In accordance with the requirements of 1 O CFR 2.201 (corrective steps already taken. corrective steps which will be taken.

date when lull compliance will be achieved). I understand that no fur1her written response to NRC will be required, unless specincally requested.

TITLE PRINTED NAME ,I SIGNATURE DATE

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CERTIFICATE/OAP Greg Fulford

- - _- v REPRESENTATIVE lbOIO NRCINSPECTOR Jeremy Tapp

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- ,1 r.r/11, BRANCH CHIEF Patricia Silva r"" '>V rx1 I 0/1 (Ir

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NRC FORM 591S PART 2 U.S. NUCLEAR REGULATORY COMMISSION 3

\10-J~~ d201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION

1. CERTIFICATE/QUALITY ASSURANCE PROGRAM (OAP) HOLDER: 2. NRC/REGIONAL OFFICE Nordion (Canada) Inc.

447 March Road Headquarters Ottawa, Ontario, Canada U.S. Nuclear Regulatory Commission K2K IX8 Mail Stop TWFN 4B-34 Washington, DC 20555-000 I REPORT NUMBER($) 7 I-0703/20 I 8-20 I 3 CERTIFICATE/OAP DOCKET NUMBER($) 4. INSPECTION LOCATION 5 DATE(S) OF INSPECTION 71-0703 Ottawa, Ontario, Canada August 15-17, 2018 (Continued)

Contrary to the requirements of IO CFR 7 I. I I I, during an inspection conducted August I 5-17, 2018, the NRC identified that Nordion (Canada), Inc. (Nordion) did not have adequate procedures for maintenance of the F-168 packaging.

Specifically, Nordion failed to include the inspection requirements for the face of the shielding vessel and sealing face of the top plug in the applicable procedure, CO-MD/IT-000 I, Revision I 4. These inspections are required by the packaging specification, IN/OS I 8 I I F 168, Revision 2. In addition, these inspections are not documented as complete in the container management system so no objective evidence could be provided to demonstrate the inspections had been performed. This is a violation of IO CFR 71.1 I I for failure to have adequate procedures to include all required maintenance activities for the F- I 68 packaging.

This violation was entered into Nord ion's corrective action program as CAPA 180804, dated August 21.2018. The inspection team evaluated the violation in accordance with Section 2.3 of the NRC Enforcement Pol icy and dispositioned it as a non-cited Severity Leve l IV violation.

NRG FORM 591S PART 2 (10-2013)

INSPECTOR NOTES COVER SHEET Licensee/Certificate Holder Nordion (Canada), Inc.

(name and address) 447 March Road Ottawa, Ontario, Canada K2K 1X8 Licensee/Certificate Holder Mr. Greg Fulford contact and phone number 613-592-3400 x2658 Docket No. 71-0703 Inspection Report No. 71-0703/2018-201 Inspection Dates( s) August 15-17,2018 Inspection Location(s) Ottawa, Ontario, Canada Inspectors Jeremy Tapp, Team Leader, Safety Inspector Marlene Davis, Senior Safety Inspector Jon Woodfield, Safety Inspector Summary of Findings and On August 15-17, 2018, the U.S. Nuclear Regulatory Actions Commission (NRC) performed an announced inspection of Nordion (Canada), Inc. (Nordion).

The team assessed Nordion's compliance with 10 CFR Parts 21 and 71 . The focus of the inspection was to determine whether Nordion activities were in accordance with their NRC-approved Quality Assurance Program (QAP) and that the foreign packagings they use for transport of radioactive material were being properly used and maintained. The inspection consisted of an examination of selected procedures and representative records, and interviews with personnel.

Overall, the team assessed that Nordion was adequately implementing their QAP.

Based on the results of this inspection, one non-cited Severity Level IV violation was identified and is described in the inspector notes for failure to have adequate procedures to perform all required maintenance activities for the F-168 packaging.

Nordion acknowledged the issue and captured it in their corrective action program.

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Lead Inspector Signature/Date CJ /19 /;p Jeremy Tapp Inspector Notes Approval 10/,/,r

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Branch Chief Signature/Date )L

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-.;:::;r-Patricia Silva Page 1 of 11

Inspection History Nordion (Canada), Inc. (Nordion) holds a limited scope user-only Quality Assurance Program (OAP) approval from the U.S. Nuclear Regulatory Commission (NRC). Nordion also holds a NRC radioactive material license and primarily transports Cobalt-60 to the United States in foreign approved packages under the provisions of 10 CFR 71 .21 . Therefore, the OAP is required to perform these shipments of licensed material to the United States in a foreign approved packaging. It is important to note that Nordion does not currently transport any packagings approved by the NRC for domestic use.

The NRC last inspected Nordion in July 2004 when they previously held a full-scope OAP approval and performed packaging design and fabrication activities (Agencywide Documents Access and Management System (ADAMS) ML042100486). The NRC identified one violation and four nonconformances, in which two of the nonconformances had two examples. The violation was against Part 21 for failure to invoke Part 21 in procurement documents to packaging component suppliers. The nonconformances were related to the areas of design and fabrication controls and are not applicable anymore to the activities allowed to be performed under Nordion's currently approved OAP. The corrective actions for the violation and nonconformances were reviewed by the NRC in 2004 and appeared acceptable, as discussed in a letter to Nord ion dated September 17, 2004.

Inspection Purpose The purpose of the inspection was to assess Nordion's compliance with 10 CFR Parts 21 and 71 . The focus of the inspection was to determine whether Nordion activities were in accordance with their NRC-approved OAP and that the packagings they use for the transportation of radioactive materials were being properly used and maintained. Since Nordion holds a user-only OAP approval, the inspection was limited to management and maintenance controls.

Primary Inspection Procedures/Guidance Documents

• IP-86001, "Design, Fabrication, Testing, and Maintenance of Transportation Packagings"

• NUREG-6314, "Quality Assurance Inspections for Shipping and Storage Containers"

• Regulatory Guide 7.10, "Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material" Page 2 of 11

Inspection Results INSPECTOR NOTES: APPLICABLE SECTIONS FROM IP 86001 WERE PERFORMED DURING THE INSPECTION WITH RESULTS DOCUMENTED BELOW UNDER THE BASIC HEADINGS OUTLINED IN NUREG-6314:

1.0 Management Controls Quality Assurance Policy The NRC inspection team assessed the adequacy of Nordion's NRG-approved OAP implementation. Specifically, the team reviewed the changes made from Nordion's full scope NRG-approved OAP to a limited scope OAP in calendar year 2012. The team review the limited scope OAP, IN/QA 0224 ZOOO, Radioactive Material Transport Package Quality Plan, Revision 12 and various implementing procedures to verify that Nordion conducted activities in accordance with applicable NRC regulations. Additionally, the team reviewed a revised Nordion organization chart and interviewed quality assurance (QA) personnel to assess their organizational independence from cost, schedule, and production activities. The team reviewed a sample of personnel qualifications and indoctrination training records in accordance with implementing procedure OAP AP-47, Training Program and Management System, Revision 7.

The team also reviewed Nordion's overarching Quality Manual QSF-00, Revision 33 and the Sealed Source Quality Plan, IN/QA 0562 AOOO, Revision 5.

Overall, the team assessed that Nordion had programs and procedures in place to conduct activities in accordance with their NRG-approved limited scope QAP, and 10 CFR Part 71 requirements. The team noted that Nordion revised the limited scope OAP to reflect a OAP considering all eighteen description areas of subpart H to 10 CFR Part 71. The team provided Nord ion with an observation that Nord ion did not update the OAP to reflect the status of the current program. Nevertheless, the team assessed that between the main quality manual and the transportation package OAP, Nordion captured the necessary controls to comply with regulatory requirements. The team also assessed that Nordion clearly defined and documented the quality program authorities and responsibilities and that the QA organization functioned as an independent group although Nordion is in the process of an organizational change.

Documentation Controls The team reviewed Nordion's documentation control program to assess the effectiveness of controls established for the approval, issuance, revision and use of quality documents. The team reviewed OAP AP-30, "Management and Control of Corporate Documents in SmartDoc,"

Revision 24 and OAP AP-45, "Change Control Procedure," Revision 27. The team assessed that the procedures provided adequate guidance for the processing of quality document approvals, revisions, and distribution of newly issued documents. For the documents reviewed, the team verified that the quality documents were approved per procedure by appropriate personnel and the most current version was available for use. The team observed Nordion's use of an electronic records management system (SmartDoc) for procedure control and use and Page 3 of 11

noted it was controlled in accordance with the applicable requirements. The team interviewed personnel who used the system regularly to ensure they were knowledgeable of the program requirements and were implementing it as required . The team also verified a sample of controlled documents in the records management system and in the field at controlled locations to ensure that the latest revision was available.

In addition, the team reviewed CPM-7-09, "Quality and EHS Records," Revision 4. The team then discussed with knowledgeable personnel how the applicable regulatory and procedural requirements for quality record control were being implemented by Nordion's QAP to ensure they were being performed as required. Specifically, the team discussed where and how the quality documents were stored and how long they were retained . The team toured the records area to verify the controls in place. The team noted that access to the records area is limited to record and QA staff, records were stored in both fire-proof and steel cabinets, and the room contained a fire sprinkler system. Nordion does not keep duplicate quality records and all quality records are paper, not electronic. Any non-quality electronic records are backed up daily and some paper quality records are stored at an offsite facility. The team also noted that Nordion was not keeping some of its QA related records, specifically, corrective and preventive actions (CAPAs) and internal audit reports and plans, for three years beyond the time when activities cease related to the QAP approval. This was determined to be an observation as it is discussed in Regulatory Guide 7.10, but is not a specific regulatory requirement. The team discussed with Nordion and they acknowledged this observation. Overall, the team determined that Nordion was implementing its document control program, including quality record control, as required by the applicable regulatory and procedural requirements.

Nonconformance and Corrective Action Controls The team reviewed a sample of nonconformance records and interviewed selected personnel to verify that Nordion effectively implemented a nonconformance control program. The team also verified that Nordion completed corrective actions for identified deficiencies and nonconformance in a technically sound and timely manner. Specifically, the team reviewed the following Nordion quality procedures:

• 040701 .SOP, "Handling of Non-Conforming Product and Related Material", Revision 25;

• QAP AP-04, "Corrective and Preventive Action" , Revision 32; and

• QAP AP-62, "Risk Assessment, Root Cause and Corrective Action Guide," Revision 7 The inspectors reviewed nonconformance and CAPAs from the previous five years. The team discussed some of the nonconformance and CAPAs with the Nordion staff. The team also discussed the provisions of 10 CFR Part 21 with Nord ion.

Overall, the team assessed that Nordion had an adequate nonconformance and corrective action program in place to resolve deficiencies. However, the team noted that one of the non-conforming material reports (NCMR #2573) dispositioned as "Accept-as-is" did not document an adequate technical justification. The team assessed that this was an observation because it Page 4 of 11

was only a documentation issue and did not affect the function of the component and there was no adverse consequence associated with the nonconformance. The team discussed with Nordion and they acknowledged this observation . Additionally, the team noted that 10 CFR Part 21 provisions did not apply to the use of foreign approved packages unless Nordion procures material or components from the United States. This was captured in Nordion's implementing quality procedures.

Audit Program The team reviewed Section 4.3, "Procurement," of the Nordion Radioactive Material Transport Package Quality Plan, IN/QA 0224 ZOOO, Revision 12 and Sections 4.6, "Procurement," and 5.3, "Purchasing," of the Nordion Sealed Source Quality Plan, IN/QA 0562 AOOO, Revision 5 as they relate to Nordion's audit program. In addition, the team specifically reviewed the following Nordion procedures associated with the performance of internal and external audits:

• P-310, "Supplier Qualification Program, " Revision 25;

• P-322, "Supplier Reassessment Program," Revision 6;

• QAP AP-41, "Supplier Quality Audits, " Revision 22;

• CPM-7-03, "Internal Audit Program," Revision 12;

• SE-LIC-014, "Process Safety Audits," Revision 5;

• SE-EHS-015, "Management Review," Revision 5; and

• QAG-03, "Management Review Team," Revision 15 For external audits, the team reviewed QAP AP-41 which describes the supplier quality audit program, both for initial evaluations and ongoing supplier re-assessments, which may include an on-site audit or supplier questionnaire. Nordion has several categories of suppliers described in QAP AP-41 . The team focused its review on the category of Approved Supplier as these suppliers would be associated with the supplying of maintenance parts for the F-127 and F-168 transportation packagings. An Approved Supplier must have an initial successful on-site quality audit or complete a supplier questionnaire as required by Nordion QA. Once an Approved Supplier, the supplier is put on an audit frequency as determined by QA. Per the procedure, the type and extent of control applied by Nordion to a supplier is proportionate to the risk associated with the purchased product or service. Transportation packaging (TP) spare parts suppliers would typically have an audit frequency of five years per the procedure. Per the procedure, audit frequency and type may change depending on the ability of the Supplier to meet Nordion's quality standards. The requirement to perform an on-site audit is identified initially during the review of a Supplier Profile Document (supplier questionnaire) that is completed prior to the supplier evaluation , according to procedure P-310. An audit schedule is prepared and maintained by QA and revised on a quarterly basis to ensure that all required audits are performed. QAP AP-41 describes the process for performing supplier on-site audits and performing audit reports based on a supplier's responses to the supplier questionnaire.

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For all suppliers that receive an Approved Supplier classification level, Nordion QA is responsible for determining the level of assessment required. The quality assessment levels are on-site quality audit, on-site visit, or no on-site contact required.

If at the time of assessment a supplier has a current certification to a formal quality system by an accredited registrar, on-site contact may not be required. According to P-310, a formal quality system is defined as having ISO 9001 certification (or recognized equivalent) by an accredited registrar.

The team focused its sampling of external audits on two suppliers of spare parts/maintenance materials for the F-127 and F-168 TPs; Specialty Gasket (SG) and Gould Fasteners Limited (GFL). SG supplies spare plug gaskets and GFL supplies plug assembly spare cap screws for the F-127 and F-168 TPs. Reference Section 4.4.1.4 "Maintenance Materials" for more discussion on these spare parts/maintenance materials.

The team reviewed the original and latest supplier questionnaire filled out by SG and GFL and determined they identified that each company had ISO 9001 certification and therefore Nordion determined that no on-site contact was required based on the risk of each product provided.

The team determined that the Nordion evaluations were adequate and in accordance with its procedures.

Quality procedure OAP AP-41 states that audits shall be performed by individuals who are sufficiently trained or experienced in auditing. Auditors shall have successfully completed a Lead Auditor training course at a recognized institution, possess a Certified Quality Auditor certification by the American Society for Quality or equivalent, or possess a combination of years of experience in a relevant discipline and have completed 3 audits accompanied by a trained auditor.

The team sampled selected qualified lead auditors and requested the auditor qualification records for those individuals. The team determined that all the lead auditors sampled were qualified in accordance with the requirements stated above.

Although Nordion's approach to evaluating its Approved Suppliers could be considered an involved process due to its factoring risk in its evaluation process, the team determined that it was following its procedures. Overall, the team determined that adequate external audits and evaluations were being performed to qualify Nordion's various levels of suppliers with no concerns.

For internal audits, the team reviewed CPM 7-03, which outlines the process for planning, implementing, and documenting internal audits. QA and Environment, Health, and Safety (EHS) are the two groups that perform internal audits. The EHS Committee is responsible for regularly reviewing EHS audit results in accordance with SE-EHS-015. The Management Review Team is responsible for reviewing quality audit summary results at intervals specified by QAG-03.

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Internal audits are scheduled on the basis of the status/importance of the area or process to be audited and performed in sufficient depth to verify that the program or system is being implemented effectively. Audit schedules are prepared annually by the QA and EHS groups and are reviewed at least quarterly. The audit schedule is revised as necessary. The internal audit frequency for the Quality Compliance and EHS Audit schedules are provided in CPM 7-03.

Internal audit schedules are approved by the Audit Program Manager. CPM 7-03 provides auditor minimum qualifications and guidance on audit preparation, conducting the audit, writing the audit report, completing the audit, conducting audit follow-up, and having audits reviewed by management.

The team reviewed Nordion's QA and EHS 2017 and 2018 audit schedules which were broken into quarters. The team selected internal audit reports to review that assessed Nordion's transportation packaging program and areas related to its NRG-approved QAP. The team assessed all the internal audits reviewed to be in compliance with the procedure by containing auditor names, checklists, documents reviewed, findings, CAPAs written, audit conclusions, and approvals. The team verified through meeting records that the internal audits had been reviewed by management in accordance with SE-EHS-015 and QAG-03.

The team specifically reviewed the internal audit, "US NRC QA Program Approval - Package Usage. " The team determined the audit report to follow the procedure, contain checklists, and contain all the proper reviews and approvals. The team assessed the audit to be adequate with one finding for which a CAPA was written.

Quality procedure CPM 7-03 also contains the auditor qualifications required to perform internal audits which are almost identical to those for external auditors. The team sampled qualified lead auditor names from the internal audit documents reviewed and requested the auditor qualification records for those individuals. The team determined that the lead auditors sampled were qualified in accordance with the requirements in CPM 7-03.

Overall, no concerns were identified by the team with the performance of Nordion's internal audits.

2.0 Maintenance Controls Maintenance Activities Nordion primarily uses two foreign approved packages for shipments to and from the United States, which include the F-127 and F-168 packagings. The team reviewed the maintenance requirements for the F-168 packaging described in IN/DS 1811 F168, "Design, Manufacturing and Operating Specification for F-168 and F-168-X Transport Packages," Revision 2, against the applicable Nordion maintenance procedures, which include IN/OP 0019 ZOOO, "Radioactive Material Transport Packaging Inspection and Maintenance Procedure," Revision 14 and CO-MD/IT-0001 , "F-127, F-168, and F-294 Noncontaminated Transport Packaging Inspection and Test Procedure," Revision 14. The team noted that detailed checklists were developed by Page 7 of 11

Nordion for documentation of package maintenance activities performed. The team also noted some instances in which the CO-MD/IT-0001 or IN/OP 0019 ZOOO inspection procedures did not contain certain inspection criteria stated in IN/DS 1811 F168, and were also not documented in the maintenance completion checklist as being performed.

Specifically, for the F-168, IN/DS 1811 F168, Step 5.2.8 states "[t]he top face of the shielding vessel shall be inspected for gouges, corrosion, or any damage that may affect the gasket seal."

In addition, Step 5.2.9 states "[t]he sealing face of the top plug shall be inspected for gouges, corrosion, or any damage that may affect the gasket seal."

Contrary to the above, Nordion failed to incorporate the two maintenance program criteria stated above from the F-168 maintenance requirement document, IN/DS 1811 F168, into the Nordion maintenance procedure CO-MD/IT-0001 . In addition, these maintenance requirements were not documented in the container management system as being completed and therefore, no objective evidence could be provided to the team that they were completed. This is a violation of 10 CFR 71.111, Instructions, procedures, and drawings, for an inadequate procedure. 10 CFR 71.111 requires, in part, that the licensee shall prescribe activities affecting quality by documented instructions, procedures, or drawings of a type appropriate to the circumstances.

The team determined that the violation was more than minor because the failure to have an adequate procedure to perform maintenance could have led to a more significant safety issue during transport of the packaging. The team evaluated the violation in accordance with Section 2.3 of the NRC Enforcement Policy and characterized it as a non-cited Severity Level IV violation . Nordion entered this issue into their corrective action program as CAPA 180804, dated August 21, 2018.

It is important to note that through interviews of Nordion maintenance personnel, the team determined that the top face of the shielding vessel and the sealing face of the top plug were normally inspected even though not specifically required or documented as performed .

At the time of the inspection, no maintenance or repair activities were ongoing for the F-127 or F-168 packagings. Therefore, the team reviewed a sampling of maintenance and repair records associated with the F-168 packaging since 2013. The team also toured the areas where maintenance activities were performed and interviewed Nordion maintenance personnel. The team observed three packagings ready for pressure testing of the cavity and one packaging awaiting cleaning of the internal cavity. The overall condition of each packaging was adequate and the maintenance personnel were found to be knowledgeable of the applicable procedures and processes. The team noted that Nordion was using a controlled copy of the current revision of the applicable maintenance procedure.

Lastly, the team reviewed the training of current maintenance personnel for procedure CO-MD/IT-0001 and all appropriate personnel were trained. In addition , the team reviewed the on-the-job training (OJT) requirements for packaging maintenance personnel including the training records for one individual. The team determined that the individual was adequately trained on Page 8 of 11

the applicable maintenance procedures as required. No concerns were identified with respect to training of Nordion maintenance personnel.

Overall, the team assessed that Nordion adequately implemented its maintenance program, but this was identified as an area for improvement. One non-cited Severity Level IV violation was identified for an inadequate procedure to perform all required maintenance activities for the F-168 packaging .

Maintenance Materials The team reviewed Section 4.3, "Procurement, " of the Nordion Radioactive Material Transport Package Quality Plan, IN/QA 0224 ZOOO, Revision 12 and Sections 4.6, "Procurement, " & 5.3, "Purchasing ," of the Nordion Sealed Source Quality Plan, IN/QA 0562 AOOO, Revision 5. In addition, the team specifically reviewed the following Nordion procedures associated with the procurement of transportation packaging maintenance materials:

• P-310, "Supplier Qualification Program, " Revision 25;

• P-322, "Supplier Reassessment Program," Revision 6;

• 4808, "Item Master Request," Revision 8;

• QAP AP-18, "Inspection and Testing ," Revision 8;

• CO-QC/OP-0012, "Inspection Overview Procedure," Revision 21 ; and

• CO-QC/ID-0016, "Incoming Inspection Sampling Plans, " Revision 8 The team requested from Nordion a spare parts list for the F-127 and F-168 transportation packagings (TPs). The team determined after discussions with Nordion that the plug gaskets and cap screws used to fasten the plugs to the F-127 and F-168 TP main bodies were the most critical and consumed spare parts. The radioactive source holder assembly is placed in the center cavity of the F-127 and F-168 TPs and the plug assembly holds the source holder assembly in place at the center of the TPs. The plug assembly is then fastened to the outside body of the TP using cap screws through its flange cover. The plug gaskets are used under the plug flange cover and between the TP body. The cap screws are critical to ensuring that the radiation sources remain in the TPs during all postulated accidents. Therefore, the team focused its sample assessment of maintenance material quality controls on the F-127 and F-168 plug gaskets and plug flange cover cap screws.

Nordion's program for ensuring the quality of TP maintenance materials was assessed to be comprehensive in that it involves evaluation of the vendor, requirements for certification documentation to be supplied by the vendor, development of critical characteristics for the material/component by Nordion engineering, and verification of the vendor supplied documentation and material/component critical characteristics during receipt inspection.

At the time of the inspection, the suppliers of the plug gaskets and cap screws were SG and GFL, respectively. The team reviewed the process and documentation associated with qualifying these two vendors as Approved Suppliers in accordance with P-310. The team Page 9 of 11

assessed that the two vendors were qualified as Approved Suppliers per P-310 requirements.

Reference the Audit Program section of this IR for more detail on Approved Supplier Evaluations.

Nordion utilizes a computer program to procure any TP spare parts such as the plug gaskets and cap screws. Each TP maintenance material/component has an "Item Master" (data/information for that item) developed for it in accordance with procedure 4808 and then the data is entered into the computer program. Each Item Master contains information such as detailed description, shelf life, initial order and reorder quantity, applicable standards, specifications, associated drawings, associated regulations, inspection requirements such as critical characteristics, and procurement requirements such as vendor certifications. The Item Master is reviewed for input and approval by Nordion QA, engineering, and EHS, before it receives final approval to go live in the system.

Nordion procurement personnel place the initial order and reorders with an approved vendor for a particular material/component utilizing the computer system information. As part of the purchase order, the computer system provides the quantity, specifications, drawings, etc., and required vendor certifications to be part of the purchase order to the vendor. The vendor fulfills the order and the product arrives at Nordion receipt inspection. Receipt inspection is performed in accordance with procedures CO-QC/OP-0012 and OAP AP-18 and any specific Item Master requirements. Receipt inspection personnel can write NCMRs against the product received which are dispositioned by Nordion engineering and tracked against that vendor. The type and number of NCMRs written against the vendor are used in evaluating the vendor for continuation as an Approved Supplier.

Once a product is determined to meet all the requirements for acceptance as specified in the Item Master, it is released for use and stored in the maintenance area. All materials/components released for use have traceability back to the procurement/receipt inspection documentation. Maintenance staff are required to enter into the computer system the number of materials and components used so available inventory can be tracked . As stock is depleted, eventually the minimum product in stock threshold is reached and a notification is sent to the procurement staff to place an order with the vendor for more materials/components.

Nordion stated that with the automatic notification system to reorder, shelf life is not an issue since inventories can be kept small utilizing the actual number in stock.

Since the quality control of TP maintenance materials/components is all electronic within the Nordion computer program, the team requested a demonstration of the system by a Nordion procurement staff member. Using the F-127 and F-168 plug gaskets and plug flange cover cap screws as a sampling, the procurement staff member was able to find the approved supplier qualification for the two vendors, the Item Masters for the gaskets and cap screws with all the purchase order requirements and receipt inspection requirements, the results of the receipt inspections, all the NCMRs written during receipt inspection and their disposition, and release for use documentation. The staff member also demonstrated how the system sent low inventory notifications to procurement and generated a new purchase order to the vendor with Page 10 of 11

all the required specifications, drawings, and vendor certifications. The team assessed that the computer program for controlling the quality of TP maintenance materials/components was effective. In addition, the team assessed that the procurement documentation reviewed for the plug gaskets and cap screw, which included the purchase order, receipt inspections, and release for use documentation, was adequate and complete.

In conclusion, the team determined there were no concerns with Nordion's overall program for ensuring the quality and traceability of maintenance materials and components for its transportation packagings and procurement of the plug gaskets and cap screws, and it was adequate and in accordance with their NRC approved OAP.

Tools and Equipment The team reviewed selected measuring and test equipment (M&TE) including records and procedures to assure that equipment used in activities affecting quality were properly controlled and calibrated. The team reviewed 000021.SOP, "Inspection, Measurement and Test Equipment," Revision 9, and CO-QC/CA-0017, "Calibration Procedure," Revision 23, which prescribe activities and requirements concerning use of M&TE; that calibration occurs to a recognized standard at appropriate intervals; procurement of calibration services; maintenance of records of various tools and equipment used; and actions to take when any piece of equipment is found out of calibration.

The team compared a sampling of M&TE used for recent maintenance and testing activities to the applicable requirements of the two procedures described above, and determined overall compliance to the procedural requirements. The M&TE selected consisted of pressure gauges, a torque wrench, and a contamination probe/meter in which each were found to be in calibration and had current calibration certificates, as applicable.

The team concluded that the M&TE quality procedures being implemented at Nordion provided adequate guidance for M&TE calibration and use, and Nordion had adequately implemented M&TE calibration, tracking, and use requirements.

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