zilongwang/ReadingBank huggingface dataset:
parent term digits), Level 3 terms using digits 5 to 6 – again maintaining the level 1 and 2 parent term digits. Each code thus reflects the relationship to the parent / child term and the body of nomenclature it belongs to. Having two digits per level allows for changes in the future (deletion of terms / introduction of terms), which requires assignment of new codes so as to allow backward compatibility with existing terms/codes from previous reporting and as compiled in data bases. 1: Overview of the four terminologies comprising the complete terminology for adverse event reporting. Nr. Name of terminology Description Annex Coding system 1 Medical device problem Terms/codes for describing problems (malfunction, deterioration of function, failure) of medical devices that have occurred in pre- or contexts (e.g. clinical studies, clinical evaluation or post-market surveillance) A A|00[00][00] 2 Cause investigation Terms/codes for describing the investigation and cause of the device involved in the reported event. There are three sections. Section1: Type of Investigation, Section 2: Investigation Findings and Section 3: Investigation Conclusion. Section 2 and 3 have a hierarchical structure. B Type of Investigation B1|00 Investigation Findings B2|00[00][00] Investigation Conclusion B3|00[00] 3 Patient Problem under development C – to be developed C|… (to be defined) 4 Component under development D – to be developed D|… (to be defined) Figure 4: The Adverse Event Reporting terminology is composed of four sets of terminologies: (1) Medical device problem terminology, (2) components terminology, (3) cause investigation terminology and (4) patient problem terminology. Note that for an effective monitoring of adverse events, means of effectively identifying devices as well as the category they belong to (e.g. GMDN) are important.
OUTCOME STATEMENT of the IMDRF-8 MANAGEMENT COMMITTEE 15 to 17 September 2015 The eighth meeting of the Management Committee (MC) of the International Medical Device Regulators Forum (IMDRF) took place in Kyoto (Japan), from 15 to 17 September 2015. The meeting was chaired by Japan. The MC consists of regulators from Australia, Brazil, Canada, China, the European Union, Japan, the Russian Federation, and the United States of America. Representatives of the World Health Organization (WHO) and Asia-Pacific Economic Cooperation (APEC) as an Official Observer and Asian Harmonization Working Party (AHWP) and Pan American Health Organization (PAHO) as an Affiliate Organization also participated. On the first day, the MC discussed the progress achieved on the current work items: Medical Device Single Audit Program (MDSAP) National Competent Authority Report (NCAR) Regulated Product Submission (RPS) Software as a Medical Device (SaMD) Medical Device Patient Registries Medical Device Adverse Event Terminology Use of Standards Two New Work Item Proposals (NWIPs) were also presented to the MC: Software as a Medical Device (SaMD): Clinical Evaluation Good Regulatory Review Practice – Competence and Training Requirement for Pre-market Reviewers and Product Specialist The MC invited IEC to make a presentation on the proposed collaboration between IMDRF and IEC. The MC also discussed IMDRF strategic plan to identify its direction for the coming years to better coordinate its activities and allocate its limited resources. The MC invited Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Association (DITTA) based on their request to make a presentation on standards. Brief statements were provided by the WHO and the APEC as an Official Observer, as well as the following Invited Observers: AHWP PAHO Global Medical Technology Alliance (GMTA) DITTA
Japan Ministry of Health, Labour and Welfare (MHLW) Pharmaceuticals and Medical Devices Agency (PMDA) All medical devices are required to satisfy the EPs that align with those defined in GHTF/SG1/N68:2012 Essential Principles of Safety and Performance of Medical Devices. ISO 10993-1:2009 can be used for its purpose, which is clearly referred to in checklist of EPs or certification/approval standards for each medical device. Russia Russian Ministry of Health Roszdravnadzor In current regulation using of standards is voluntary in premarket MD evaluation. And Regulator does not recognize any standard which could provide presumption of conformity. But when on the market, some types of MD have to be certified for particular mandatory standards (list of mandatory standards and types of MD is available on Regulator’s web site). It should be noted, that this regulation is to be canceled on 01/01/2016. The United States of America US Food and Drug Administration (US FDA) ISO 10993:2009 is recognized by the US FDA medical device program as a consensus standard for which a person may submit a declaration of conformity in order to meet a premarket submission requirement or other requirements to which a standard is applicable. US FDA by recognizing ISO 10993:2009 and ISO 10993-1:2013 believes these standards can successfully serve to address many of the issues associated with the biocompatibility evaluation of medical device. The standard is used by CDRH to identify the types of issues relevant to a biocompatibility risk assessment, and to determine if the currently available information (e.g., formulation, manufacturing, previously collected data, literature information) is sufficient, or if additional testing might be needed (per other parts of the 10993 standard).
(including outline of issues to be addressed and opportunities for regulatory convergence) Issues to be addressed Opportunities for regulatory convergence General Work Plan and Timelines Proposed Working Group Chair Proposed sources of necessary expertise Relevant existing documents at IMDRF or GHTF and national level, as well as in international bodies. IMDRF Template: September 2014 C Cover Page for Final IMDRF Documents Final Document Title: Authoring Date: [Signature], IMDRF Chair
D IMDRF Membership Criteria and Roles MC Member Official Observer Invited Observer Regional Harmonization Initiatives (RHIs) Criteria Must be a Regulatory Authority A regional influence Must have been an Official Observer for at least the last three (3) consecutive years prior to the application for membership Must have participated in all IMDRF MC meetings (including teleconferences) for the last 3 consecutive years Must have participated in in a majority of WGs as an Official Observer, providing active contribution for the last 3 consecutive years. Must be a Regulatory Authority Regulatory Authority should operate a mature system for medical device regulation should include: Established laws and regulations for medical devices building substantially on GHTF and IMDRF foundations and principles Proper competencies for effective implementation and enforcement of the established laws and regulation A system for conformity assessment of devices building on GHTF and IMDRF guidance documents Must be a regulatory authority or global industry or stakeholder association Perceived contribution or value to IMDRF meetings A regulatory authority should have a mature or maturing system for medical device regulation or contribution to medical device regulation Must be associations/initiatives comprising medical device regulatory authorities representing the majority of countries in a certain region/area of the world Must have mandate of regional harmonization amongst its members Must have a demonstrated interest in medical device regulatory activities that are directly related to the common of fostering global regulatory convergence, leveraging resources and making available safe and effective medical devices globally
Sufficient resources and regulatory expertise to perform its duties Contribution to scientific or regulatory innovation in the field of medical devices as demonstrated by development of guidance(s) in emerging technical and regulatory issues A capacity to contribute resources and expertise to the objectives of IMDRF A recognized commitment to the objectives of IMDRF demonstrated by implementation of IMDRF documents (work items) Roles Participates and provides oversight in the decision making process and strategic direction of IMDRF activities Attends all “open” and “closed” sessions of the MC meetings including MC teleconferences Does not participate in the decision making process of IMDRF Attends all “open” and “closed” sessions of the MC meetings Participates in IMDRF Working Groups Does not participate in the decision making process of Only attends “open” MC meetings Invited on a meeting by meeting basis Does not participate in the decision making process of Only attends “open” MC meetings May attend certain portions of the “closed” sessions of the MC meetings by invitation of the MC
The functions covered by a Regulatory Authority, within the of this document, and the independence of the roles assigned are described in Table 1. Functions Assessment Decision Making Conduct a review of the assessment application to determine assessment team competence requirements, select assessment team members, and determine assessment duration n/a Program Administrator Assessment of a the Auditing Organization’s management system Lead Assessor / Assessor n/a Assessment of the Auditing Organization’s competence (IMDRF MDSAP WG N4) Lead Assessor / Assessor n/a Assessment of the conformity of the Auditing Organization with regulatory requirements (IMDRF MDSAP WG N3) Lead Assessor / Assessor n/a Approval of Assessment Results n/a Recognition Manager Table 1: Regulatory Authority Functions and Roles Reference(s) IMDRF MDSAP N3 - Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition IMDRF MDSAP N4 - Competence and Training Requirements for Auditing Organizations IMDRF MDSAP N5 - Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations GHTF/SG1/N78:2012 - Principles of Conformity Assessment for Medical Device ISO 9000:2005 - Quality management systems — Fundamentals and vocabulary ISO/IEC 17000:2004 – Conformity assessment – Vocabulary and general principles ISO/IEC 17021:2011 - Conformity Assessment – Requirements for bodies providing audit and certification of management system. Definitions
Review the manufacturer’s application to determine audit team competence required, select the audit team members, and determine audit duration n/a Program Administrator Evaluation of quality management system Lead Auditor / Auditor n/a Evaluation of product/process related technologies Technical Expert n/a Evaluation of Technical Documentation Technical Expert n/a Evaluation of Regulations Lead Auditor / Auditor / Technical Expert n/a Approval of Results n/a Final Reviewer Table 1: Auditing Organization Functions and Roles Reference(s) Normative Reference: International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC) ISO/IEC 17021:2011 - Conformity Assessment – Requirements for bodies providing audit and certification of management system. GHTF/SG3/N19:2012 - Quality management system – Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange General References: GHTF/SG1/N78:2012 - Principles of Conformity Assessment for Medical Device. GHTF/SG1/N46:2008 - Principles of Conformity Assessment of In Vitro Diagnostic (IVD) Medical Devices. GHTF/SG1/N71:2012 - Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device.' ISO/IEC – Conformity assessment – Vocabulary and general principles Definitions Audit: A systematic, independent, and documented process for obtaining records, statements of fact or other relevant information and assessing them objectively to determine the extent to which specified requirements are fulfilled. (ISO 17000:2004)
7.5.2 (IMDRF-N3) AO requires competence to verify appropriateness and validity of evidence provided by subcontractor X 7.5.3 (IMDRF-N3) Contractual arrangements between the AO and the subcontractor, including clause for witnessed audits by RA. X 7.5.4 (IMDRF-N3) Auditing Organization responsible for ensuring that all individuals within an outsourced organization that are involved in a regulatory audit are directly assessed by the Auditing Organization to ensure consistency with the IMDRF MDSAP WG N3 and N4 requirements. X 8.0 Information requirements 8.1 Publicly accessible information 8.1.1 Publicly accessible information X 8.1.2 Information provided by AO (including advertising) not misleading X 8.1.3 Publicly accessible information certificates granted, suspended or withdrawn X 8.1.4 to confirm validity of certification X 8.2 Certification documents 8.2.1 Means to provide certification documents to certified clients X 8.2.2 Effective date shall not be before the date of certification decision X 8.2.3 Details of certification document content X 8.2.1 (IMDRF-N3) Audit reports and certificates conform to RA requirements X 8.2.2 (IMDRF-N3) Certificate must reflect the scope of the audit, including regulations covered. Certificate shall not exclude part of processes, products or services from scope of certification X 8.3 Directory of certified clients. X 8.3.1 (IMDRF-N3) AO compliance with RA requirements related to publicly accessible information X 8.4 Reference to certification and use of marks (title only) 8.4.1 AO policy governing any mark it authorizes certified clients to use. X 8.4.2 AO shall not permit its marks to be applied to laboratory test, calibration or inspection reports. X 8.4.3 AO’s requirements of the client medical device manufacturer regarding reference to certification. X 8.4.4 AO ownership of marks and reports and control of use and references. X 8.5 Confidentiality 8.5.1 Policy and arrangements to safeguard confidentiality X 8.5.2 Inform clients in advance of information to be placed in public domain X 8.5.3 Written consent to release information X
Introduction This document was developed by the IMDRF National Competent Authority report (NCAR) Exchange Program Working Group as an update to the original document (N79) authored by Study Group 2 of the Global Harmonization Task Force (GHTF) in relation to the GHTF Exchange Program. This document concerns a two way communication system involving confidential information for serious public health issues. This document will provide guidance, procedures and for exchange of reports between IMDRF members. Other forms of information exchange may be addressed in the future. 1. Scope This document provides guidance on: the criteria to be used for deciding when to exchange information, the procedures to follow when exchanging information, the forms to use for exchanging information, the requirements for members participation in the NCAR Exchange Program. 2. References The latest revision of GHTF SG2 N57 Medical Devices Post Market Surveillance: Content of Field Safety Notices. 3. Definitions NCAR Secretariat The organization which facilitates and monitors the exchange of NCARs between reporting National Competent Authorities (NCAs) and other NCAR participants in accordance with this guidance. The NCAR Secretariat is the recipient and repository of all NCARs. The NCAR Secretariat monitors the quality and consistency of the NCAR Exchange Program and circulates NCARs in line with the provisions of section 6.1 of this guidance. The NCAR Secretariat produces and publishes statistical analysis /reports regarding participation and report exchange on a periodic basis. The NCAR Secretariat also maintains an updated list of participants in the NCAR Exchange Program and keeps this list publicly available on the IMDRF website. The NCAR Secretariat does not assess or propose action on the NCARs received; this is the responsibility of the originator and recipients of the NCAR. Field Safety Corrective Action - FSCA
Name and Model: Device also marketed as (trade name), if known: If Applicable, UDI #: Software version (If Applicable): Serial number(s): Lot / number(s): Regulated Parties Manufacturer: Entity legally representing the manufacturer: If Applicable, CAB / Notified Body #: Country: Country: Full Address: Full Address: Contact: Contact: Telephone: Telephone: Email: Email: BACKGROUND INFORMATION AND REASON FOR THIS REPORT <background of query / notification of lead CA> Is the Investigation of the report Complete : Yes No Attachments : Yes No (… include info re manufacturer/assembly location) QUESTIONS AND RESPONSES (If Applicable)
Deadline For Response: <date of deadline for response - dd/mm/yyyy> Question Answer Rationale / Remarks ADDITIONAL RATIONALE AND REMARKS DETAILS OF RESPONDING NCA Responding NCA: <name of CA> Contact Person: <name of contact person> Telephone: <telephone number> E-mail: <email address> Fax: <fax number> SUMMARY / COMMENTS ANNEX 2: IMDRF MEDICAL SPECIALITY AREAS in relation to field 12 of the NCAR Form of Annex 1. Anaesthesia Cardiovascular Chemistry Dental Ear, nose and throat
The assessment method specific to a particular medical device regulatory scheme may take into account additional requirements from the jurisdictions addressed in the scheme. References – Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition – Competence and Training Requirements for Auditing Organizations – Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations – Regulatory Authority Assessor Competence and Training Requirements – MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization 24 – Medical Device Single Program (MDSAP): Medical Device Regulatory Audit Reports IMDRF/MDSAP WG/N29 – Clarification of the Term “Legal Entity” for MDSAP Recognition Purposes ISO/IEC 17000:2004 – Conformity assessment – Vocabulary and general principles ISO/IEC 17021:2011 – Conformity Assessment – Requirements for bodies providing audit and certification of management system. – Principles of Conformity Assessment for Medical Device – Quality management system – Medical devices – Nonconformity Grading System for Regulatory Purposes and Information Exchange Definitions 3.1 Audit: A systematic, independent, and documented process for obtaining records, statements of fact or other relevant information and assessing them objectively to determine the extent to which specified requirements are fulfilled. (ISO 17000:2004) 3.2 Auditing Organization: An organization that audits a medical device manufacturer for conformity with quality management system requirements and other medical device regulatory requirements. Auditing Organizations may be an independent organization or a Regulatory Authority which perform regulatory audits. 3.3 Regulatory Authority: A government body or entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and that may take
Annex B: Cause Investigation – Type of Investigation Terms and Codes Annex C: Cause Investigation – Investigation Findings Terms and Codes Annex D: Cause Investigation – Investigation Conclusion Terms and Codes Annex E: Patient Problem Terms and Codes Annex F: Component Terms and Codes N are placeholders for Arabic numbers uniquely identifying the term with Level 1 terms populating digits 1-2 only, Level 2 terms populating digits 3 to 4 (maintaining the Level 1 parent term digits), Level 3 terms using digits 5 to 6 – again maintaining the level 1 and 2 parent term digits. Each code thus reflects the relationship to the parent / child term and the body of nomenclature it belongs to. Having two digits per level allows for changes in the future (deletion of terms / introduction of terms), which requires assignment of new codes so as to allow backward compatibility with existing terms/codes from previous reporting and as compiled in databases. Table 1: Overview of the four sets of terminologies comprising the complete terminology for adverse event reporting. No. Name of terminology Description Annex Coding system 1 Medical device problem Terms/codes for describing problems (malfunction, deterioration of function, failure) of medical devices that have occurred in pre- or contexts (e.g. clinical studies, clinical evaluation or post-market surveillance) A A|00[00][00] 2 Cause investigation Type of Investigation Terms/codes for describing the type of investigation of the device involved in the reported event. B B|00 Cause investigation Investigation Findings Terms/codes for describing the findings of the device involved in the reported event. C C|00[00][00] Cause investigation Investigation Conclusion Terms/codes for describing the conclusion of the device involved in the reported event. D D|00[00] 3 Patient Problem under development E – to be developed E|… (to be defined) 4 Component under development F – to be developed F|… (to be defined)
This section uses simple steps to help SaMD manufacturers through the approach to generating evidence for the clinical evaluation of a SaMD and provides links to techniques, definitions and sources that are available to help a SaMD manufacturer generate appropriate evidence. Note: The examples used are not intended to be comprehensive. All data sources and statistical methods should be tailored to the specific SaMD and its intended use. Clinical Evaluation ① Valid Clinical Association ② Analytical Validation ③ Clinical Validation Is a valid clinical association between your SaMD output and your SaMD’s targeted clinical condition? Does your SaMD correctly process data to generate accurate, reliable, and precise output data? Does use of your SaMD’s accurate, reliable, and precise output data achieve your intended purpose in your target population in the context of clinical care? Figure 12 - Clinical Evaluation Examples of existing evidence Literature searches Original clinical research Professional society guidelines Examples of generating new evidence Secondary data analysis Perform clinical trials ① Clinical Association: Is there a valid clinical association between your SaMD output, based on the inputs and algorithms selected, and your SaMD’s targeted clinical condition? Step 1: Verify that the association between the SaMD output and the targeted clinical condition is supported by evidence. Note: All SaMD should demonstrate a valid clinical association. Question: How do I “generate evidence”? You can verify by using existing evidence or you can verify by generating new evidence. Verification – confirmation through provision of objective evidence that specified requirements have been fulfilled. Source: [6] Section 2.7 Validation – confirmation through provision of objective evidence that the requirements for a specific intended use or application have been fulfilled. Source: [6] Section 2.8 ② Analytical Validation: Does your SaMD meet technical requirements? Step 1: Generate evidence that shows that the output of your SaMD is technically what you expected. Note: All SaMD should demonstrate analytical validation. Question: How do I “generate evidence”?
The remaining sections of this guidance outline recommendations for standards development and participation that are based upon these general principles, and which will foster the development of standards that are optimized for regulatory use. Recommendations for Standards Development This section offers specific suggestions for improving standards for regulatory use and for achieving harmonization. Optimizing standards content Standards must contain objective and specific requirements that clearly indicate how conformity can be achieved and conveyed. Adherence to the following will improve standards’ content and suitability for regulatory purposes: The standard should clearly identify to a stakeholder considering its use whether and which IMDRF EP(s) are addressed. Where possible, standards should include terms and definitions that are identical to or aligned with existing terms and definitions established and accepted in other standards (see ISO/IEC Directives Part 2). Standards should have a rationale explaining the basis for the requirements in the standard that may assist in interpreting the meaning and/or purpose of the standard. The rationale should identify and explain test methods and/or other means of demonstrating compliance. In addition, the rationale should explain how conformity to the standard achieves its goal of satisfying the associated IMDRF EP(s). Scope and residual risk: the standard’s scope should clearly identify when a reasonably foreseeable risk, hazard or hazardous situation is determined to be out of the standard’s scope. When a standard identifies a hazard or a hazardous situation without giving a specific requirement for its mitigation, the standard should provide direction on how to address the resulting risk as appropriate. Standards for specific products should include specific requirements for mitigation of a hazard or hazardous situation. Standards requirements should be associated with acceptance criteria, quantitative where applicable, including instances in which clinical performance is a normative requirement. Where such criteria are absent, other ways to demonstrate conformity should be indicated. Acceptance criteria should be based on generally accepted science and technology, and where this is absent, be validated as relevant for meeting safety and performance requirements. A rationale section can provide information on the validation methods used.
Medical Device Primary Identity Information Medical Device Name or Common name) Catalog/Reference (REF) Catalog/Reference (REF) Description Version (Software or Firmware) Unique Device Identifier (UDI) Device Identifier (DI) Production Identifier (PI) Serial Number Lot or Batch Number Manufacturing Date Expiration Date The value of the data elements are assigned by the Regulated Entity for the purposes of identifying and tracking the medical device throughout its life cycle. Regulated Entity Name Address Identifier Type These data elements as specified by the Regulatory Authority and the values provided by the Regulated Entity are for the purposes of identifying the legal party involved in a regulatory activity. Kit These data elements provide an indicator used to differentiate the grouping of different medical devices and/or accessories for the purpose of placing it on the market. Medical Device System Contains Biological Materials This data element provides an indicator for the existence of specific biologic materials in the medical device for safety purposes. Medical Device Single Use Device Reusable - Single Patient Use Device Reusable - Multi-Patient Use Device The values of the data elements are determined by the Regulated Entity for the purposes of managing risks associated with multiple use of the medical device. Sterilization Information Supplied Sterile Needs Sterilization before use Method of Sterilization The values of the data elements are determined by the Regulated Entity for the purposes of managing risks associated with sterilization. Regulatory Information Medical Device Type Medical Device Risk Classification Submission Number Regulatory Authorization or Marketing Number Regulatory Authorization or Marketing Status The values of the data elements are assigned by the Regulatory Authority for the purposes of identifying and tracking regulatory activities for a medical device through its life cycle. Note: The values assigned to the data elements may change at any point in time and may require reporting to the Regulatory Authority.
limitations and are requested to keep filenames and pathnames in submissions as short as possible. The IMDRF folder templates and file naming specifications have been established in an effort to ensure submissions can be received and stored by regulators without reaching the operating system limits. It is recommended that applicants examine the length of the entire pathname (i.e. all nested folders and file name and file extension) prior to transmission to verify the path length is 200 characters or less. File and Submission Size Limitations No individual PDF file in the submission shall exceed 100 MB. The entire submission should not exceed 4GB to ensure acceptance by all participating regions. Document Security Files should not have any security settings, specifically: Files must not have password protection preventing the file from opening. Files should be set to allow printing, selecting text and graphics, and adding or changing notes and form fields. Applicants should use secure upload facilities or reputable couriers to protect the transmission to the regulators. Bookmarking in PDF Files It is also important that PDF files be properly structured, with a properly bookmarked internal table of contents. The following are recommended as good structuring practices: Documents of ten pages or more should have their own internal table of contents. When creating bookmarks, the magnification setting should be set to Inherit Zoom so that the destination page displays at the same magnification level that the reviewer is using for the rest of the document. Sections, subsections, tables, figures and appendices should all be bookmarked. Attachments to PDF files should be avoided. Too many levels of bookmarks are inefficient. In most instances, three levels of bookmarks should be sufficient: 1 Heading 1.1 Subheading 1.1.1 Sub-subheading. It is recognized that bookmarks are generated automatically from document headings; nevertheless, it is recommended that they be kept concise.
One of the following is the largest of nine consecutive positive integers whose sum is a perfect square. Which one is it? A 118 B 128 C 138 D 148 E 158 What is the largest power of 2 that divides ? A B C D E If and are all positive integers, which of the following is least? A B C D E If the pattern shown is continued, what number will appear directly below 400? A 438 B 439 C 440 D 441 E 442
Courtney Walker Program Spec./State Evaluator Florida Department of Educ. 325 West Gaines Street Tallahassee, FL 32399 850-245-9946 Brad Whitman* Supervisor of School Improvement Services The Northwest Tri-County Intermediate Unit 252 Waterford Street Edinboro, PA 16412 814-734-8449 Nancy Wiehe Senior Project Associate Interstate Migrant Education Council, One Massachusetts Avenue, NW, Suite 700 Washington, DC 20001-1431 202-336-7078 John Wight State Director, MEP and Refugee Programs Georgia Dept. of Education 1854 Twin Towers East 205 Jesse Hill Jr. Dr. SE Atlanta, GA 30334 404-463-1857 __________________________ *IMEC Member Sonja Williams Program Administrator Program Monitoring Section North Carolina Department of Public Instruction 6351 Mail Service Center Raleigh, NC 27699 919-807-3958 Ian Yaffe Senior Education Specialist ESCORT Portland, ME 207-619-2822 This page left blank intentionally
0306-07 REFERENCES IMC 0040, “Preparing, Revising, and Issuing Documents for the NRC Inspection Manual” IMC 0305, “Operating Reactor Assessment Program” IMC 0307, Appendix B, “ROP Baseline Inspection Procedure Reviews” IMC 0310, “Aspects Within Cross-Cutting Areas” IMC 0612, “Power Reactor Inspection Reports” IMC 0612, Appendix B, Screening” IMC 2201, Appendix A, “Security Baseline Inspection Program” IMC 2515, “Light Water Reactor Inspection Program” 5 USC 552a, “Records Maintained on Individuals” 10 CFR Part 9, “Public Records” NEI 99-02, “Regulatory Assessment Performance Indicator Guideline”
Attachment 1 – Revision History for IMC 0308, Attachment 3, Appendix M Commitment Tracking Number Accession Number Issue Date Change Notice Description of Change Training Required and Completion Date Comment and Feedback Resolution Accession Number N/A ML13070A253 06/11/14 CN 14-012 Initial Issuance. N/A ML13263A300
in general, people have the same version as others around them. Paying Attention Participate in an activity to highlight the challenges to paying attention to details while still keeping the big picture in mind. 10–30 minutes (depending on activity selected) Slides 20–23 Facilitators may choose whether to use the activity on slide 20 or 21 to discuss attention. Slide 20 will take 5-10 minutes and Slide 21 will take 10-20 minutes. For 21: need speakers For Slide 22: see “The Wright Family Directions” for details on how to facilitate the activity. You will need One playing card, penny, pen, paper clip, or some other small item for each person in the group Creating Norms Participants create a set of shared norms to be used throughout the review process. 10–20 minutes Slides 24–27 Distribute cards to participants for Slide 26. Have chart paper ready to write the agreed-upon group norms. Additional Considerations for facilitators N/A Slides 28–35 These slides are not meant to be delivered to participants. They provide more ideas that facilitators may want to consider as they prepare their review teams.
Signed: Training Incumbent Signed: Curate D. Personality and Character Formational Criteria for ALL curates Additional Formational Criteria for those selected for potential post of responsibility Ordained ministers show insight, resilience, maturity and integrity in the pressure and change entailed in public ministry. They Incumbents … are able to balance appropriate care of self with the care of others by developing sustainable patterns of life and work, and effective support networks in the context of public ministry. encourage and enable colleagues to balance appropriate care of self with care of others Ordained ministers are growing in self-knowledge and commitment to Christ within the roles and expectations of ordained ministry. They … Incumbents personify an integration and integrity of authority and obedience, leadership and service. They … are able to approach the sacrificial impact of ordained ministry on the whole of life with wisdom and discernment. engage with others to reflect with insight on their style of leadership, its strengths and weaknesses in context, and demonstrate appropriate development are able to reflect with insight and humility on personal strengths, weaknesses, failures, gifts and vulnerability in response to a new context of public ministry. D. Personality and Character
Examples of poor skills Examples of better skills not listening to various cues, signals listening carefully, taking up cues butting in, interrupting allowing space, and some pauses making assumptions, ‘knowing’ or assuming answers seeking the individual’s answers; extending the of the interview by offering possible links trying to influence, or providing own solution, manipulative shaping the interview, but encouraging the person to come to their own solution asking leading or closed questions, and asking two questions at one time asking open questions, questions which draw out more information, avoiding questions with yes/no answers being threatening, heavy handed, devaluing and defensive; officious, pressurising, sarcastic and sexist being friendly, gentle, sincere, encouraging, genuinely interested showing lack of empathy, unable to acknowledge true feelings showing strong empathy and compassion
and master classes at the Palazzo Pucci, the headquarters of the IME in Italy, as well as at LVMH Maison ateliers. “This partnership is an important initiative for Polimoda, confirming the school’s competitiveness on an international and recognizing the success of our educational methods for fashion design and business professionals. It is also a major development for our region, recognizing it as a center of competencies and expertise and affirming the worldwide reputation of ‘Made in Italy’ excellence,” commented Danilo Venturi, Director of Polimoda. “The LVMH Institut des Métiers d’Excellence plays a vital role in perpetuating the excellence of our Maisons and in ensuring the perpetuation of these métiers. I am delighted to see the launch of this new program with Polimoda in Italy, an exemplary country regarding creativity, talent and fundamental savoir-faire that are essential to the LVMH Group,” said Chantal Gaemperle, LVMH Group Executive Vice President Human Resources & Synergies. About Polimoda Polimoda is known worldwide for its independence in thinking and action by combining business and design across all departments. Considered by the Business of Fashion as the best fashion institute in Italy, and amongst the top ten in the world, Polimoda balances the of Italian design and production with an international vision. The undergraduate, master’s and short courses offered at Polimoda connect the legacy of the past, with new research and creativity. Professors offer experience-based learning, adapting courses to the changes in the industry as they happen, which is nurtured inside the Renaissance-style building of Villa Favard and in the state-of-the-art Design Lab. With 70% of students from countries outside Italy, Polimoda is a cultural force in the heart of Florence. www.polimoda.com Polimoda Media Contacts Worldwide Gianpaolo D’Amico / Tessa Pisani Polimoda +39 055 2750675 About LVMH
0.171 1.34 Calculate the molarity of a solution of magnesium chloride with a concentration of 22.7 mg/mL. 0.477 M 0.238 M 0.119 M 4.19 M 0.380 M of the following favors the solubility of an ionic solid in a liquid solvent? a large magnitude of the solvation energy of the ions a small magnitude of the lattice energy of the solute a large polarity of the solvent all of the above none of the above A solution is prepared from 76.4 g of a nonvolatile, nondissociating solute and 85.0 g of water. The vapor pressure of the solution at 60°C is 132 torr. The vapor pressure of water at 60°C is 150. torr. What is the molar mass of the solute? 86.8 g/mol 16.2 g/mol 49.1 g/mol 208 g/mol 119 g/mol Use the following to answer questions T - V: For each of the following solutions, describe the deviation with respect to Raoult's Law. hexane (C6H14) and chloroform (CHCl3) relatively ideal positive deviation negative deviation more information needed none of these acetone (C3H6O) and water relatively ideal positive deviation negative deviation more information needed none of these . hexane (C6H14) and octane (C8H18) relatively ideal positive deviation negative deviation more information needed none of these
OE approval is required if more than a minor violation is involved and the staff determines not to pursue an enforcement action (i.e., notice of violation or a non-cited violation). The enforcement action shall reference the NOED number. When the root cause of a licensee’s need for a NOED was a violation, OE will issue an enforcement action (EA) number regardless of the severity level or whether the violation will ultimately be dispositioned as a notice of violation (NOV) or a non-cited violation (NCV). However, the NOED shall not include the enforcement action number. OE will post the NOED granting or denial letter on the NRC external Web page. 0410-10 DISTRIBUTION Copies of any NOED-related letters to the licensee are distributed according to established regional, NRR and OE procedures and shall include the following as a minimum: Regional Coordinator, OEDO Regional Administrator NRR Reactor Safety Programs Deputy Director NRR/DORL Division Director Office of Enforcement Director DRP, Region [X], Director Public NRR/DORL Technical Assistant Online documents: electronic copy (Word file) to OE Internet Web master, e-mail: OEWEB Resource (file MUST be the FINAL agency document). Applicable BCs (Region and NRR) Applicable NRR plant PM Applicable SRI Further, the issuing region shall ensure the licensee's written request is profiled into ADAMS as “publicly available” in accordance with agency policy. Electronic copies of NOEDs should also be prepared. OE will post the region’s NOED granting or denial letter on the NRC external Web page. 0410-11 TRACKING NOEDs
Attachment 3 Revision History Commitment Tracking Number Accession Number Date Change Notice Description of Change Description of Training Required and Completion Date Comment and Feedback Resolution Accession Number ML120810084 03/05/2013 CN13-007 First issuance. This is a complete revision to IMC Part 9900: Technical Guidance for NOEDs and change to IMC 0410. NRC staff required to review the new document. ML12215A287 ML13071A487 03/13/2013 CN13-009 Corrected formatting issues. None N/A
Commitment Tracking Number Accession Number Issue Date Change Notice Description of Change Description of Training Required and Completion Date Comment and Feedback Resolution Accession Number (Pre-Decisional, N/A ML101400488 06/08/11 CN 11-010 This revision updates the hyperlink to the OE Web page. It adds use of SAPHIRE version 8 and updates the participants and members of the SERP. The IMC has been better aligned with IMC0609 – SDP to remove redundancy. Clarification was for the deadline that licensees have to submit additional information. The term ‘caucus’ was changed to ‘post-conference review’. Clarification was added for findings in which the review determines the significance of a finding should be changed as a result of new data provided by the licensee, then the finding will be reviewed at a final SERP. The material covered at the final SERP should focus on those areas affected by the Regulatory Conference and that changed the original SERP outcome. A review of related documents will be completed to ensure conforming changes to other related areas in IMC0609, including those governing the scope and content of the final SERP package, are reflected as well (ROPFF 0609.01-1481). N/A ML103490479 ML14153A568 04/29/15 CN 15-008 Several significant changes to the guidance were made based on recommendations from the SDP Business Process Improvement (BPI) Report (ML14318A512) and the ROP Independent Assessment Report (ML14035A571). Incorporated recommendations from ROPFF 0609.01-1759, 1908, 1910. N/A ML15072A302 ML14099A265 ML14099A277 ML14099A285
Commitment Tracking Number Accession Number Issue Date Change Notice Description of Change Description of Training Required and Completion Date Comment and Feedback Resolution Accession Number (Pre-Decisional, C2 ML16288A119 12/08/16 CN 16-032 Revised to clarify the expected need for flexibility in performing SDP evaluations. This item is a commitment related to a recommendation made in response to No training is needed. ML16291A560
findings and will not be the SDP. onditions performance are not may need to be addressed by other NRC processes (e.g., , Generic Safety Issue, rule-making). 03.0 Nothing in this guidance relieves any licensee from fully complying with Technical Specifications, licensing basis commitments, or other applicable regulatory requirements. Continued compliance with regulatory requirements maintains the requisite defense-in-depth and safety margins necessary to achieve adequate protection of public health and safety. 03.0 The significance of reactor events caused or complicated by equipment malfunction or operator error assessed by NRC in accordance with IMC 0309, “Reactive Inspection Decision Basis for Reactors” MD 8.3, “NRC Incident Investigation Program.” Although the product of this risk evaluation may provide useful risk insights to for event response or follow-up, it was not designed to determine the safety significance of . the SDP is used to estimate the significance of , including those that manifest themselves during events, associated with a reactor event should be 0609-04 DEFINITIONS 04.01 Applicable definitions are located in IMC 0612, “Power Reactor Inspection Reports” 04.02 Inspection findings are assigned a color representing the significance of the finding. The following definitions (04.02.a thru 04.02.d) include the quantitative and qualitative for each color and need to be applied appropriately to each SDP appendix listed at the end of this document. A graphical representation of the quantitative significance of findings is displayed in Exhibit 1.
Attachment 1 Revision History - IMC 0609 Commitment Tracking Number Accession Number Issue Date Change Notice Description of Change Description of Training Required and Completion Date Comment and Feedback Resolution Accession Number (Pre-Decisional, N/A 10/13/2006 Revision history reviewed for the last four years N/A N/A N/A 04/21/2000 CN 00-007 This manual chapter supports the New Reactor Oversight Program for significant determination of findings. The significance determination process detailed in the manual chapter is designed to characterize the significance of inspection findings for the NRC licensee performance assessment process using risk insights, as appropriate. N/A N/A N/A 02/27/2001 CN 01-005 0609 has been revised to correct minor errors and inconsistencies, and to clarify the overall SDP description. N/A N/A N/A 08/16/2001 CN 01-015 0609 has been revised to correct the title of Attachment 2 (0609.02) as listed in the attachments to this manual chapter. N/A N/A N/A 04/30/2002 CN 02-022 0609 has been revised to reflect revisions to Attachments 1 and 2, and changes to the recently issued Appendix A to IMC 0609. N/A N/A N/A 05/19/2005 CN 05-014 0609 is revised to add Appendix K, “Maintenance Rule Risk Assessment and Risk Management” as an attachment. N/A N/A
3 – Traditional Enforcement Violation [05.01a – Title] Cornerstone Severity Cross-cutting Aspect Report Section Not Applicable [05.01c2 – Severity and Tracking] Not Applicable [05.01e - Section] [05.01f – Introduction and Identification] Description: [05.02a - Description] Corrective Action(s): [05.02b - Corrective Action(s)] Corrective Action Reference(s): [05.02c - Corrective Action Reference(s)] Performance Assessment: [05.03e – Traditional Enforcement Assessment] Enforcement: Severity: [05.04a - Severity] Violation: [05.04b - Violation] Enforcement Action(s): [05.04c - Enforcement Action(s)] [05.05 - Unresolved Item Closure] The following table shall be used to document findings with associated TE violations documented together in the same report. Findings with associated TE violations are those findings and violation sharing a common performance deficiency or closely related by cause and effect, or both. Table 4 – Finding with Traditional Enforcement Violation [05.01a - Title] Cornerstone Significance/Severity Aspect Report Section [05.01b [05.01c3 - Synopsis] [05.01d - Aspect] [05.01e - Section] [05.01f – Introduction and Identification]
Attachment 1 – Revision History for IMC 0611 Commitment Tracking Number Accession Number Date Change Notice Description of Change Description of Training Required and Completion Date Comment Resolution and Closed Feedback Form Accession Number (Pre-Decisional, Information) 05/03/17 CN 17-009 Initial issue of IMC 0611. This IMC has been created to separate power reactor inspection reports from issue screening, and is consistent with the inspection report documentation guidance that was formerly in IMC 0612. n/a ML17150A030 12/13/17 CN 17-029 Revised to reflect new streamlined report format. This is a complete rewrite. Completed non-concurrence package can be found in ML17345A041. 0612-2269 ML17348A017 See non-concurrence package ML17345A041
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