IR 05000263/2016007

NRC Biennial Problem Identification and Resolution Inspection Report 05000263/2016007

ML16323A283
Person / Time
Site:	Monticello
Issue date:	11/18/2016
From:	Kenneth Riemer NRC/RGN-III
To:	Gardner P Northern States Power Co
References
IR 2016007
Download: ML16323A283 (23)

Text

UNITED STATES ber 18, 2016

SUBJECT:

MONTICELLO NUCLEAR GENERATING PLANTNRC BIENNIAL PROBLEM IDENTIFICATION AND RESOLUTION INSPECTION REPORT 05000263/2016007

Dear Mr. Gardner:

On October 7, 2016, the U.S. Nuclear Regulatory Commission (NRC) completed a Problem Identification and Resolution biennial inspection at your Monticello Nuclear Generating Plant. The enclosed inspection report documents the inspection results which were discussed on October 7, 2016, with you and other members of your staff.

This inspection was an examination of activities conducted under your license as they relate to problem identification and resolution and compliance with the Commissions rules and regulations and the conditions of your license. The inspectors reviewed selected procedures and records, observed activities, and interviewed personnel.

Based on the inspection samples, the inspection team determined that your staffs implementation of the corrective action program (CAP) supported nuclear safety. Specifically, the station had a low threshold for identifying problems and entering them into the CAP. Items entered into the CAP were generally screened and prioritized in a timely manner using established criteria; were generally evaluated commensurate with their safety significance; and in most cases, corrective actions were implemented in a timely manner, commensurate with the safety significance.

The team also evaluated other processes your staff used to identify issues for resolution. These included your use of audits and self-assessments to identify latent problems and your incorporation of lessons-learned from industry operating experience into station programs, processes, and procedures. The team determined that your stations performance in each of these areas supported nuclear safety. However, the team was unable to make a complete assessment of your Department Action Request process, as this program was only recently implemented.

Finally, the team determined that your stations management maintains a safety-conscious work environment adequate to support nuclear safety. Based on the teams observations, your employees are willing to raise concerns related to nuclear safety. One NRC-identified finding of very low safety significance (Green) was identified which involved a violation of NRC requirements. However, because of the very low safety significance, and because the issue was entered into your corrective action program, the NRC is treating this issue as a non-cited violation (NCV) in accordance with Section 2.3.2 of the NRC Enforcement Policy.

If you contest the subject or severity of this NCV, you should provide a response within 30 days of the date of this inspection report, with the basis for your denial, to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555-0001, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission - Region III, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-4352; the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; and the Resident Inspector Office at the Monticello Nuclear Generating Plant. In addition, if you disagree with the cross-cutting aspect assigned to the findings in this report, you should provide a response within 30 days of the date of this inspection report, with the basis for your disagreement, to the Regional Administrator, Region III, and the NRC Resident Inspector at the Monticello Nuclear Generating Plant.

In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter and its enclosure, and your response (if any) will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records System (PARS)

component of NRC's Agency wide Documents Access and Management System (ADAMS),

accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (the Public Electronic Reading Room).

Sincerely,

/RA/

Kenneth Riemer, Chief Branch 2 Division of Reactor Projects Docket No. 50-263 License No. DPR-22

Enclosure:

Inspection Report 05000263/2016007

REGION III==

Docket No: 50-263 License No: DPR-22 Report No: 05000263/2016007 Licensee: Northern States Power Company, Minnesota Facility: Monticello Nuclear Generating Plant Location: Monticello, MN Dates: September 19 through October 7, 2016 Inspectors: N. Shah, Project Engineer (Team Lead)

A. Dahbur, Senior Reactor Inspector D. Krause, Resident Inspector J. Park, Reactor Inspector Approved by: K. Riemer, Chief Branch 2 Division of Reactor Projects Enclosure

SUMMARY OF FINDINGS

Inspection Report 05000263/2016007, 09/19/2016-10/7/2016; Monticello Nuclear Generating

Plant; Problem Identification and Resolution.

This inspection was performed by a resident inspector and three NRC regional inspectors. One Green finding was identified by the inspectors. The finding was considered a non-cited violation of NRC regulations. The significance of inspection findings is indicated by their color (i.e.,

greater than Green, or Green, White, Yellow, Red) and determined using Inspection Manual Chapter (IMC) 0609, "Significance Determination Process," dated April 29, 2015. Cross-cutting aspects are determined using IMC 0310, "Aspects within the Cross-Cutting Areas," dated December 4, 2014. All violations of NRC requirements are dispositioned in accordance with the NRCs Enforcement Policy, dated February 4, 2015. The NRC's program for overseeing the safe operation of commercial nuclear power reactors is described in NUREG-1649, "Reactor Oversight Process," Revision 5, dated February 2014.

Problem Identification and Resolution On the basis of the samples selected for review, the team concluded that implementation of the corrective action program (CAP) at the Monticello Nuclear Generating Plant was effective. The licensee had a low threshold for identifying problems and entering them into the CAP. Items entered into the CAP were screened and prioritized in a timely manner using established criteria; were properly evaluated commensurate with their safety significance; and corrective actions were implemented in a timely manner, commensurate with the safety significance.

Operating experience was integrated into daily activities and entered into the CAP and evaluated for applicability to station activities and equipment. Audits and self-assessments were performed at appropriate frequencies and at an appropriate level to identify issues. The assessments reviewed were thorough and effective in identifying site performance deficiencies, programmatic concerns, and improvement opportunities. Based on several interviews conducted by the inspectors, workers at the site expressed freedom to enter safety concerns into the CAP. The inspectors did not identify any impediments to the establishment of a safety conscious work environment at the Monticello Nuclear Generating Plant.

Previously, all issues were handled through the CAP, allowing for a consistent process for screening, prioritizing, and cross-referencing of issues for resolution. However, the licensee recently implemented a non-CAP Action Request process to resolve issues or track work items that do not correct potential conditions adverse to quality. This was done to reduce the CAP burden and allow for more efficient focus on actionable items. The inspectors noted that some of these items may include issues that while not being conditions adverse to quality, may be significant in part, due to their potential impact on plant operation. Additionally, the inspectors noted that this process did not have controls over screening, prioritization and cross-referencing of items similar to the CAP. For example, non-CAP items were not required to be screened by a multi-disciplinary group (as required for CAP items) for disposition; instead, they went directly to the appropriate department(s). There were also no metrics or clear instructions in the audits and self-assessment programs to appropriately evaluate whether non-CAP items were being properly addressed. This introduced a vulnerability in that potentially significant items could be inappropriately handled.

Given the recent implementation, the inspectors could not fully evaluate the effectiveness of the non-CAP process; however, during a selective review of non-CAP issues identified since implementation the inspectors did not find any examples which were inappropriately handled.

Cornerstone: Mitigating Systems

Green.

The inspectors identified a finding of very low safety significance and non-cited violation of Title 10 CFR 50, Appendix B, Criterion V, Instructions, Procedures and Drawings, for the licensees failure to prescribe a procedure appropriate to the circumstances with respect to the identification of a significant condition adverse to quality (SCAQ). Specifically, FP-PA-ARP-01, CAP Action Request Process, provided an overly restrictive definition of what constituted a SCAQ. Consequently, the failure to provide an adequate definition of a SCAQ could result in a failure to identify a SCAQ and therefore, failure to implement corrective actions that preclude repetitive failures of safety-related equipment. The licensee entered this issue into the CAP as action request (AR) 1536735.

The inspectors determined that the licensees failure to prescribe a procedure appropriate to the circumstances under FP-PA-ARP-01 was a performance deficiency. The performance deficiency was determined to be more than minor in accordance with IMC 0612, "Power Reactor Inspection Reports," Appendix B, "Issue Screening," because, if left uncorrected the performance deficiency would have the potential to lead to a more significant safety concern. Although, this issue could potentially affect each of the Reactor Safety Cornerstones, the inspectors elected to evaluate this issue under the Mitigating Systems Cornerstone because inspectors concluded it impacted the availability, reliability, and capability of systems that respond to initiating events to prevent undesirable consequences (i.e., core damage) more than the attributes of the other Cornerstones. The inspectors utilized IMC 0609, Significance Determination Process, Attachment 0609.04, Initial Characterization of Findings, and IMC 0609, Appendix A, The Significance Determination Process for Findings At-Power, and determined that the finding screened as very low safety significance (Green) since the inspectors answered No to each of the questions in Exhibit 2, Section A, Mitigating Systems Screening Questions. The inspectors determined that the performance characteristic of the finding that was the most significant causal factor of the performance deficiency was associated with the cross-cutting aspect of Problem Identification and Resolution, Self-Assessment, and involving the organization routinely conducting self-critical and objective assessments of its programs and practices.

Specifically, the failure to identify the overly restrictive definition of SCAQ during previous audits of the CAP was caused by an insufficiently self-critical audit focus. [P.6] (Section 4OA2.1.b(2))

Licensee-Identified Violations

No violations of significance were identified.

REPORT DETAILS

4OA2 Problem Identification and Resolution

The activities documented in Sections

.1 through .4 constituted one biennial sample of

problem identification and resolution as defined in Inspection Procedure 71152.

.1 Assessment of the Corrective Action Program Effectiveness

a. Inspection Scope

The inspectors reviewed the licensees corrective action program (CAP) implementing procedures and attended CAP meetings to assess the implementation of the CAP by site personnel.

The inspectors reviewed risk and safety significant issues in the licensees CAP since the last U.S. Nuclear Regulatory Commission (NRC) problem identification and resolution inspection in May 2014. The selection of issues ensured an adequate review of issues across NRC cornerstones. The inspectors used issues identified through NRC generic communications, department self-assessments, licensee audits, operating experience reports, and NRC documented findings as sources to select issues.

Additionally, the inspectors reviewed issue reports (IRs) generated as a result of facility personnels performance in daily plant activities. In addition, the inspectors reviewed IRs and a selection of completed investigations from the licensees various investigation methods, which included root cause evaluations, apparent cause evaluations (ACEs),equipment apparent cause evaluations, causal evaluations, and human performance investigations.

In addition, the inspectors performed a 5-year review to assess the licensee staffs efforts in monitoring for system degradation due to aging aspects.

During the reviews, the inspectors determined whether the licensee staffs actions were in compliance with the facilitys CAP and 10 CFR Part 50, Appendix B requirements. Specifically, the inspectors determined if licensee personnel were identifying plant issues at the proper threshold, entering the plant issues into the stations CAP in a timely manner, and assigning the appropriate prioritization for resolution of the issues. The inspectors also determined whether the licensee staff assigned the appropriate investigation method to ensure the proper determination of root, apparent, and contributing causes. The inspectors also evaluated the timeliness and effectiveness of corrective actions for selected IRs. This included completed investigations and NRC findings, including non-cited violations (NCVs).

b. Assessment

(1) Effectiveness of Problem Identification Based on the results of the inspection, the inspectors concluded that problem identification was generally effective. Based on the information reviewed, the inspectors determined that licensee personnel had a low threshold for initiating CAP items; station personnel appropriately screened issues from both the NRC and industry operating experience at an appropriate level and entered them into the CAP when applicable; and identified problems were generally entered into the CAP in a complete, accurate, and timely manner.

The inspectors determined that the station was generally effective at trending low level issues to prevent larger issues from developing. The licensee also used the CAP to document instances where previous corrective actions were ineffective or were inappropriately closed.

The licensee recently implemented a non-CAP Action Request process to resolve issues or track work items that do not correct potential Conditions Adverse to Quality. This was done to reduce the CAP burden and allow for more efficient focus on actionable items.

While most of these issues were low level items (such as procedural change requests or other administrative actions), the inspectors noted that other, potentially more significant items could be included in this process. Some of these items could involve issues affecting plant operation even if not specifically defined as Conditions Adverse to Quality. Because the non-CAP process was less rigorous than the CAP in that it did not have similar controls for screening, prioritizing and cross-referencing, it was possible for these more significant issues to be inappropriately handled. Additionally, the inspectors noted that there were no clear metrics or instructions in the licensee audit or self-assessment programs to evaluate the implementation of the non-CAP process.

Because of its recent implementation, the inspectors could not fully evaluate the effectiveness of the non-CAP process; however, a selective review of recent non-CAP issues did not identify any examples which were inappropriately handled. The licensee documented the inspectors observations as CAP items 1535376 and1535381.

The inspectors identified two examples where potential operability/design issues were identified during cause evaluations, but there was no corresponding CAP item to address them. One of the examples concerned a potential design deficiency in which both trains of residual heat removal could be lost if suction valve indication power was lost; the other concern was the failure to evaluate the effect of temperature rise on the rating for the thermal overload for the emergency diesel generator fuel transfer pumps, after identifying errors in the calculations for maximum room temperatures. The licensee subsequently determined that there was no immediate operability concerns and documented these issues as CAP items 1537040 and 1537019 for further evaluation.

Findings No findings were identified.

(2) Effectiveness of Prioritization and Evaluation of Issues Based on the results of the inspection, the inspectors concluded that identified problems were generally prioritized and evaluated commensurate with their safety significance, including an appropriate consideration of risk. Higher level evaluations, such as root cause evaluations and ACEs were generally technically accurate; of sufficient depth to effectively identify the cause(s); and adequately considered extent of condition, generic implications, and previous occurrences.

The inspectors determined that the CAP screening meetings were generally thorough, that issues were accurately prioritized issues, and that meeting participants were actively engaged and well-prepared. The inspectors also determined that licensee personnel evaluated equipment operability and functionality requirements adequately after a degraded or non-conforming condition was identified, and that appropriate actions were assigned to correct the degraded or non-conforming condition.

Findings Inadequate Procedure for Identification of Significant Conditions Adverse to Quality

Introduction:

The inspectors identified a Green finding and NCV of Title 10 CFR 50, Appendix B, Criterion V, Instructions, Procedures and Drawings, for the licensees failure to prescribe a procedure appropriate to the circumstances with respect to the identification of a SCAQ. Specifically, FP-PA-ARP-01, CAP Action Request Process, provided an overly restrictive definition of what constituted a SCAQ. Consequently, the failure to provide an adequate definition of a SCAQ could result in a failure to identify a SCAQ and therefore, failure to implement corrective actions that preclude repetitive failures of safety-related equipment.

Description:

On October 3, 2016, the inspectors identified that licensee procedure FP-PA-ARP-01, CAP Action Request Process, provided an overly restrictive definition of SCAQ as compared to the definition identified in ASME NQA-1, Quality Assurance Requirements for Nuclear Facility Applications. The inspectors were concerned that failure to provide a procedure, appropriate to the circumstances with respect to identification of a SCAQ could result in the failure to implement corrective actions that preclude repetitive failures of safety-related components.

In the licensees QATR (NSPM-1), Section B.13 Corrective Action, the licensee committed to compliance with the 1994 Edition of NQA-1, Quality Assurance Requirements for Nuclear Facility Applications, in establishing provisions for corrective actions and control of non-conforming items. In NQA-1, a SCAQ was defined as one which, if uncorrected, could have a serious effect on safety or operability. However, in Step 4.31 of FP-PA-ARP-01, the licensee defined a SCAQ as a condition (CAQ) that, if uncorrected, could have a serious effect on safety or operability. That is, the CAQ could reasonably prevent the assurance of the following:

• Integrity of the reactor coolant pressure boundary;

• Capability to shut down the reactor and maintain it in a safe shutdown condition; and

• Capability to prevent or mitigate the consequences of accidents which could result in potential offsite exposures comparable to the guideline exposures of 10 CFR Part 100 or 10 CFR50.67, as applicable.

The inspectors noted that the FP-PA-ARP-01 SCAQ definition added three specific bulleted criteria to the NQA-1 definition which further defined the SCAQ. With these changes, the inspectors concluded that the licensee had created an overly restrictive definition of what constituted a SCAQ at the station. The inspectors did not identify an example where an item was not identified as a SCAQ, if appropriate. The licensee subsequently entered this issue into the CAP as AR 1536735.

Analysis:

The inspectors determined that the licensees failure to prescribe a procedure appropriate to the circumstances with respect to identification of a SCAQ was a performance deficiency. The performance deficiency was determined to be more than minor in accordance with IMC 0612, Power Reactor Inspection Reports, Appendix B, Issue Screening, because, if left uncorrected the performance deficiency would have the potential to lead to a more significant safety concern. Specifically, the failure to provide an adequate definition of a SCAQ could result in a failure to identify a SCAQ and therefore, failure to implement corrective actions that preclude repetitive failures of safety-related equipment. Although, this issue could potentially affect each of the Reactor Safety Cornerstones, the inspectors elected to evaluate this issue under the Mitigating Systems Cornerstone because inspectors concluded it impacted the availability, reliability, and capability of systems that respond to initiating events to prevent undesirable consequences (i.e., core damage) more than the attributes of the other Cornerstones.

Using the Initiating Events Cornerstone, Exhibit 2 of IMC 0609, Appendix A, The SDP for Findings At-Power, Mitigating Systems Screening Questions; the inspectors concluded the finding to have very low safety significance (Green) because all the screening questions were answered No. Specifically, the inspectors did not identify an example where the failure to provide a procedure appropriate to the circumstances with respect to identification of a SCAQ had resulted in repetitive failures of safety-related equipment. The finding was determined to have a cross-cutting aspect in the area of problem identification and resolution, self-assessment component, because the licensee failed to perform sufficiently self-critical assessments of the CAP process. Specifically, the failure to identify the overly restrictive definition of a SCAQ during previous audits of the CAP was caused by an insufficiently self-critical audit focus. [P.6]

Enforcement:

Title 10 CFR 50, Appendix B, Criterion V, Instructions, Procedures and Drawings, requires in part, that activities affecting quality shall be prescribed by documented procedures of a type appropriate to the circumstances.

Contrary to this requirement, prior to October 3, 2016, the licensee had not prescribed a procedure appropriate to the circumstances for identification of a SCAQ. Specifically, the procedure FP-PA-ARP-01, CAP Action Request Process, definition of a SCAQ was not appropriate for the circumstances. Because this violation is of very low safety significance was entered into the corrective action program, this violation is being treated as a non-cited violation consistent with Section 2.3.2 of the NRC Enforcement Policy.

(NCV 05000263/2016007-01; Inadequate Procedure for Identification of Significant Conditions Adverse to Quality)

(3) Effectiveness of Corrective Actions Based on the results of the inspection, overall, the corrective actions reviewed were found to be appropriately focused to correct the identified problem and were generally implemented in a timely manner commensurate with the issues safety significance.

Problems identified through root or apparent cause evaluations were generally resolved in accordance with the CAP procedures and regulatory requirements. Corrective actions intended to prevent recurrence were generally comprehensive, thorough, and timely.

The corrective actions associated with selected NRC documented findings and violations, as well as licensee-identified violations, were generally appropriate to correct the problem and were implemented in a timely manner.

The inspectors identified several examples where items were inappropriately documented in the CAP making it difficult to determine whether issues were being properly addressed. The examples included, but were not limited to, incorrect cross-referencing of CAPs, failure to assign action items and inaccurate/incorrect info.

In most cases, the inspectors eventually determined that the respective issues were properly resolved. However, the inspectors noted one example, involving a condition adverse to quality associated with a potential unanalyzed high energy line break on the reactor core isolation cooling system (AR 1185959), where it was unclear if the issue had been resolved. Although the inspectors eventually concluded that the issue was addressed, the incomplete documentation was partially responsible for the issue remaining open in the CAP since June 2009. The licensee documented the overall concerns as CAP items 1536953 and 1536960. Additionally, separate CAP items were also generated for the individual examples identified by the inspectors. These CAP items are listed in the attached List of Documents Reviewed to this report.

The inspectors also noted that several examples where numerous due date extensions were often granted, often unnecessarily delaying the timely resolution of issues.

Although the extensions were granted in accordance with the CAP procedures, the inspectors questioned whether the extensions were rigorously challenged by the station.

One example concerned CAP 1351259, regarding whether the licensees initial operating licensing training program complied with the Technical Specifications. The inspectors noted that although the licensee determined that the program was compliant, a recommended corrective action to clarify the program requirements remained unimplemented for 4 years due to various extensions. As part of a self-assessment conducted prior to the NRC inspection, the licensee identified the delay and was able to promptly correct the issue within 10 days. The licensee documented the overall issue regarding the adequacy of due date extensions as CAP item 1538798.

Findings No findings were identified.

.2 Assessment of the Use of Operating Experience

a. Inspection Scope

The inspectors reviewed the licensees implementation of the facilitys Operating Experience (OE) program. Specifically, the inspectors reviewed implementing OE program procedures, attended CAP meetings to observe the use of OE information, completed evaluations of OE issues and events, and selected monthly assessments of the OE composite performance indicators. The inspectors review was performed to determine whether the licensee was effectively integrating OE experience into the performance of daily activities, whether evaluations of issues were proper and conducted by qualified personnel, whether the licensees program was sufficient to prevent future occurrences of previous industry events, and whether the licensee effectively used the information in developing departmental assessments and facility audits. The inspectors also assessed if corrective actions, as a result of OE experience, were identified and effectively and timely implemented.

b. Assessment In general, OE was appropriately used at the station. The inspectors observed that OE was discussed as part of the daily station and pre-job briefings. Industry OE was disseminated across the various plant departments. No issues were identified during the inspectors review of licensee OE evaluations. The inspectors also verified that the use of OE in formal CAP products such as root cause evaluations and equipment apparent cause evaluations was appropriate and adequately considered. Generally, OE that was applicable to Monticello was thoroughly evaluated and actions were implemented in a timely manner to address any issues that resulted from the evaluations.

Findings No findings were identified.

.3 Assessment of Self-Assessments and Audits

a. Inspection Scope

The inspectors assessed the licensee staffs ability to identify and enter issues into the CAP program, prioritize and evaluate issues, and implement effective corrective actions, through efforts from departmental assessments and audits.

b. Assessment Based on the results of the inspection, the inspectors did not identify any issues of concern regarding the licensees ability to conduct self-assessments and audits.

Assessments were conducted in accordance with plant procedures, were generally thorough and intrusive, adequately covered the subject area, and were effective at identifying issues and enhancement opportunities at an appropriate threshold. Identified issues were entered into the CAP with an appropriate significance characterization and corrective actions were completed and/or scheduled to be completed in a timely manner commensurate with their safety significance.

Findings No findings were identified.

.4 Assessment of Safety Conscious Work Environment

a. Inspection Scope

The inspectors assessed the licensees safety conscious work environment through the reviews of the facilitys employee concern program implementing procedures, discussions with coordinators of the employee concern program, interviews with personnel from various departments, and reviews of issue reports. In order to assess Monticello safety culture, interviews were conducted with a representative group of station employees over the course of the first and third weeks of the inspection.

Additionally, the sites most recent safety culture assessment was reviewed and the Employee Concerns Program coordinators were interviewed.

b. Assessment Based on the results of the inspection, the inspectors did not identify any issues that suggested conditions were not conducive to the establishment and existence of a safety conscious work environment at Monticello. Information obtained during the interviews indicated that an environment was established where licensee employees felt free to raise nuclear safety issues without fear of retaliation; were aware of and generally familiar with the CAP and other processes, including the Employee Concerns Program and the NRC, through which concerns could be raised; and safety significant issues could be freely communicated to supervision.

The inspectors performed a selective review of issues identified through the Employee Concerns Program since 2014, and did not identify any significant trends or issues.

Findings No findings were identified.

4OA6 Management Meeting

Exit Meeting Summary

On October 7, 2016, the inspectors presented the inspection results to Mr. P. Gardner and other members of the licensee staff. The licensee acknowledged the issues presented. The inspectors confirmed that none of the potential report input discussed was considered proprietary.

ATTACHMENT:

SUPPLEMENTAL INFORMATION

KEY POINTS OF CONTACT

Licensee

Don Bosnic, Business Support Director

Dan Crofoot, Corporate Functional Area Manager

Gene Foote, Performance Improvement Manager

Peter Gardner, Site Vice-President

Harlan Hanson, Plant Manager

Michelle Kelly, Human Performance and Organizational Effectiveness Manager

Mark Lingenfelter, Director of Engineering

Kevin Nyberg, Security Manager

Kent Scott, Director of Site Operations

Rick Stadtlander, System Engineering Manager

Anne Ward, Regulatory Affairs Manager

U.S. Nuclear Regulatory Commission

P. Zurawski, Senior Resident Inspector, Monticello

K. Riemer, Branch Chief

LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED

Opened

05000263/2016007-01; NCV Inadequate Procedure for Identification of Significant Conditions Adverse to Quality (Section 4OA2.1.b (2))

Closed

05000263/2016007-01; NCV Inadequate Procedure for Identification of Significant Conditions Adverse to Quality (Section 4OA2.1.b (2))