1. Regulatory Control Training Workshop
Module 7 “Regulatory Inspection and Enforcement in Pakistan” Application Set
Regulatory Control Training Workshop
DISCLAIMER This example was prepared by (individual or organization) for this IAEA workshop. The information contained in this example is based on publicly available information and/or personal knowledge; therefore, it does not necessarily represent the institutional position of the organization referred to in the example.

2. CONTENTS PNRA inspection policy
Inspection program for nuclear power plants
Types of inspections
Methods of inspection
Areas of inspection
Inspectors qualification criteria
Inspection reports and findings
PNRA Enforcement Process
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3. PNRA INSPECTION POLICY
Under Section 16(2)(i) of PNRA Ordinance, PNRA is responsible to inspect all nuclear installations and nuclear material to ensure that regulations concerning safety measures are properly followed.
The purpose of the inspections is to make licensee aware of its ultimate responsibility
The management of PNRA is committed to provide necessary resources for the inspections.
The regulatory inspections cover all structures, systems, components and activities important to safety.
The inspections are performed by PNRA authorized inspectors and are conducted as per approved inspection plan.
The results of the inspections are documented in the form of inspection reports which form the basis for any subsequent enforcement action.
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4. POWERS OF INSPECTOR
Under Section 29 of the PNRA Ordinance, an inspector shall have the powers to:
Enter any premises for the purpose of satisfying himself as to whether the provisions of the rules and regulations have been or are being adequately complied with;
Examine designs, drawings, records, reports or documents;
carry out any tests and investigations;
obtain and analyze any samples;
lock and seal any premises, nuclear installation, radiation generator, or any part thereof, where any nuclear substance or radiation generator is being used, stored, operated or maintained
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5. PNRA INSPECTION PROGRAM FOR NUCLEAR POWER PLANTS
PNRA inspection program forms the basis for inspection activities of nuclear power plants.
PNRA performs regulatory inspections to ensure compliance with:
national regulations,
conditions attached to the license and;
commitments made by the applicant/licensee for safety
These inspections, however, do not relieve the licensee of its ultimate responsibility for safety
The inspections of nuclear power plants are performed by respective regional Directorates in coordination with the Licensing Directorate (NSD) responsible for authorization and Licensing (NSD)
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6. PNRA INSPECTION PROGRAM FOR NUCLEAR POWER PLANTS
The inspection of equipment manufacturing is the responsibility of NSD
The Regional Directorates (R-2) and R-3 located at respective nuclear power plant sites Chashma and Karachi are responsible for inspections
The regional Directorate R-1 is located at Headquarters and is responsible for authorization and inspections of radiation facilities.
PNRA authorized inspectors mainly conducts two types of inspections, namely planned inspections and reactive inspections.
Either type of inspection may be announced or unannounced, however, announced inspections are more common.
The planned inspections are conducted as per approved inspection plan and are generally announced to the licensee in advance, however, un-announced inspections may also be performed.
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7. EXTERNAL EXPERT SUPPORT
External expert support was obtained during inspections at equipment manufacturing sites of C-1 and C-2 until indigenous capability was developed at PNRA
In this regard bilateral agreements were made with the Chinese regulatory body NNSA
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8. PLANNED INSPECTIONS
are carried in accordance with a baseline inspection plan
may be linked to licensee’s schedule for performing or completion of certain activities at different stages of the authorization process
differ from reactive inspections in that they are scheduled in advance and are not initiated by unusual or unexpected circumstances,
provide an opportunity for detailed examination of the licensee's activities to identify problems at an early stage.
Include considerations of:
Safety significance of the areas to be inspected;
Licensee's overall performance in the areas to be inspected;
Operational experience and lessons learned from events/problems at other facilities or countries; and
Use of available regulatory inspection resources
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9. REACTIVE INSPECTIONS
initiated in response to an unexpected, unplanned or unusual situation or event to assess its significance and implications and the adequacy of corrective actions.
may be occasioned in response to a generic problem encountered at another plant, or identified during the review and assessment process.
Are conducted by employing maximum resources in case of a serious event
Make use of licensee’s reports of safety related activities or event reports
may comprise of team inspections which may be multidisciplinary according to the need of the situation.
may vary in both scope and complexity
identify underlying causes of problems to determine whether a safety concern represents isolated case or may signify a more serious problem.
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10. ANNOUNCED AND UNANNOUNCED INSPECTIONS
In case of an announced inspection the licensee will be notified in advance by the Regional Directorate
The timing of the announcement may vary according to the circumstances of the inspection.
Inspections are announced when PNRA intends to observe a specific test or activity
The main advantages of such inspections are:
the inspector is able to discuss plans and needs with the licensee in advance,
Assurances may be secured from the licensee that documentation or personnel will be available for inspection or interview
Hence, announced inspections may enhance the efficiency of inspections.
The advantage of unannounced inspections is that these can be carried out at any time to observe the clear/actual picture of the facility or activity
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11. METHODS OF INSPECTION
Discussion and interviews with the licensee's and contractor's personnel
Monitoring and direct observation (e.g. of working practices and equipment)
Examination of procedures, records and other relevant documentation
Tests and measurements (may be performed only in rare cases e.g. environmental radiation monitoring to verify the data of licensee)
The inspectors are free to make their own judgment whether to use one or more of the above methods in a balanced way depending upon the specific situation.
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12. DISCUSSION AND INTERVIEW WITH LICENSEE
The licensee's personnel are kept appropriately informed of inspection activities and the licensee's commitment to respond inspection findings are ensured.
These considerations can be partially satisfied through discussions and interviews.
Discussion with the facility manager and other key management personnel shall be managed to communicate inspection results.
The inspector is required to exercise mature judgment regarding the prerogatives and responsibilities of the facility's management.
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13. MONITORING AND DIRECT OBSERVATION
This method of inspection include direct monitoring of structures, systems and, components, human factors significant to safety
PNRA monitor specific structure, system, component, test or activity as a condition for the licensee to be permitted to proceed to subsequent areas of work for verifying corrective action.
Record', ‘Witness' and ‘Hold' point inspections selected for this stage.
This may be applied for general surveillance of the facility by regulatory inspectors.
These surveillances are for the purpose of gaining an overall impression of the licensee's capabilities and performance
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14. EXAMINATION OF PROCEDURES, RECORDS AND OTHER RELAVANT DOCUMENTS
Inspectors review different documents and records of licensee to ensure compliance with the design and regulatory requirements.
Review of the licensee's documentation serve as means of verification of the licensee's compliance without unduly disrupting work schedules or interfering unduly with the licensee's primary responsibility for the safety
Conduct physical tests and measurements in areas of radiation protection and environmental monitoring etc., however never to t to assume, direct operational control of the facility or any of its systems as the ultimate responsibility for the safety shall still be with the licensee.
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15. AREAS OF INSPECTION
The major inspection areas/activities which are included in the inspection plan are described below:
Siting
Construction Installation and Equipment manufacturing
Commissioning
Testing before fuel loading
Initial fuel loading and criticality
Power ascension testing
Operation
Decommissioning
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16. SITING INSPECTIONS
The inspection plan for siting covers the following areas/activities:
Studies for determining site characteristics;
Excavation and earthwork;
Experiments, if any, to study dispersion models;
Implementation of QAP.
The applicant is required to inform about the work schedules so that PNRA inspectors may perform the inspections.
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17. INSPECTIONS DURING CONSTRUCTION AND INSTALLATION
Objective:
To Verify that Construction, Installation, Manufacturing Activities are carried out in accordance with agreed codes & Standards, National& International and adequate Quality Assurance is maintained as per Quality Assurance Programs (QAP).
Document to be consulted:
PSAR,
50-C/SG-Q-1996
Regulatory Guide
Codes & Standards (ACI, ASME, ASTM, IEEE etc)
Design Specs
Equipment Specs
License Conditions, etc
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18. INSPECTIONS DURING CONSTRUCTION AND INSTALLATION
Control Point Inspections:
Inspection carried out against selected control points from Q- plans
Hold Point (H)
Witness Point (W)
Record Point (R)
General Surveillance:
To observe the working conditions and activities being taken place without any intimation and objectives as in the case of control points inspections
QA Administrative Inspections:
To verify overall quality assurance system of the organization of licensee and its contractors and sub-contractors
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19. CONTROL POINTS INSPECTION ACTIVITIES
Prerequisites mainly include:
Availability of Design specifications and Working Procedure
Availability of Approved Drawings
Personnel Qualification and certification
Material Certification
Equipment Calibration
Civil Works Inspections at site which include:
Welding Inspections
Non Destructive Testing (NDT) and Destructive Testing Inspections
Critical Pipe Bend Inspections
Equipment on site arrival, installation and testing inspections
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20. QA ADMINISTRATIVE INSPECTION
QA Administrative inspection of Owner, Contractor and subcontractors is carried out during construction, installation and manufacturing stages to verify ;
The effectiveness of overall quality management system of relevant manufacturers in compliance with the applicable codes and standards
The effectiveness of QAP of relevant manufacturers
The Manufacturers QAP relevance with OQAP of owner
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21. QA ADMINISTRATIVE INSPECTIONS
Inspections are carried in the following areas;
Organizational structure & job responsibilities
Manpower and training
Non-conformance control and corrective actions
Document control and records
Industrial safety and emergency preparedness
Procurement process and item control
Design control
Inspection and test control
Self & independent assessments
Data collection and analysis
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22. EQUIPMENT MANUFACTURING
Main items/activities to be include:
Processes having an effect on the quality of the equipment such as welding, etc.
Qualification tests (seismic and environmental qualification),
Functional tests.
implementation of QAP
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23. COMMISSIONING
Control Points for inspections are selected from the Commissioning program which include hold points, witness points and record points
Inspection during the commissioning stage should focus on four broad areas:
Testing before fuel loading (e.g hydrostatic testing of reactor coolant system, containment integrity or leak rate testing, testing of ESF etc.)
Initial fuel loading and criticality and low power testing
Power ascension testing (e.g. Main coolant pump trip, loss of off- site power, turbine trip etc.)
Other commissioning activities such as management of commissioning activities, modifications and maintenance, implementation of RP program etc.
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24. OPERATION The areas to be inspected during operation phase include:
Operational limits and conditions
Operating procedures
Control room visits
Radiological protection
Operator training and competence
Effluent and radioactive waste management
Emergency Response Planning and Procedure
Refueling
On-site fuel handling and storage
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25. OPERATION Environmental monitoring Maintenance and surveillance
In-service inspection
Plant modifications
Physical protection
Quality assurance programs
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26. DECOMMISSIONING
Licensee is required to submit the details of decommissioning activities and schedules for the selection of inspection points.
In general, inspection plan for decommissioning include:
Monitoring final fuel removal
Spent fuel and waste management strategy
Draining of coolant and process fluid
Verifying decontamination and dismantling activities of the licensee
Ensuring that the licensee secures the facility against unauthorized
Radiological monitoring and surveillance and public protection plan
Physical security, safeguard and access control
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27. PROVISION OF GUIDANCE TO INSPECTORS
Written procedures which ensure that all nuclear installations are inspected on the basis of a common standard and consistency in the level of safety
Training program of the inspectors emphasizing upon:
legal basis of inspection and the extent of inspector's authority.
applicable regulatory requirements, regulations, guides and industrial standards.
Inspection Program
Policies of PNRA that may affect inspection
Standards of conduct of inspectors
The importance of objectivity and fairness on the part of inspectors and need to respect appropriate facility rules established by the licensee.
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28. INSPECTORS QUALIFICATION CRITERIA
Master degree in Nuclear Engineering / System Engineering/Medical Physics, Physical Sciences or
Bachelor Degree in Engineering and more than six months training course in Medical Physics/health physics/ Radiation Protection or related fields.
Successful completion of:
PNRA level-I & level-II (or equivalent) professional training courses.
Training Course on PNRA Regulations
Training Course on Inspection & Enforcement Techniques.
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29. INSPECTORS QUALIFICATION CRITERIA
1. Nuclear Safety Inspector
Participation in at least two major inspections, under the supervision of a licensed inspector
Participation in at least ten general surveillances inspections under the supervision of a licensed inspector
2. Physical Protection Inspector
Six (06) inspections on physical protection of nuclear power plants or research reactors.
Ten (10) inspections on physical protection of radioactive sources Category 1
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30. PREPARATION FOR AN INSPECTION
Preparation for an inspection includes:
Review of regulatory requirements related to the inspection area.
Knowledge of earlier experience related to the inspection area.
Review of licensee's submissions e.g., PSAR, FSAR, EPP, QAP, etc.
Review of previous inspection findings and corrective actions related to the inspection area.
Review of related correspondence between PNRA and the licensee on the inspection area.
Review of facility's operating and design documentation and operating limits and conditions.
Overview of licensee's management procedures and QA program
Development of inspection procedures, checklists, questionnaire, guidelines, etc. and a list of the documents to be reviewed.
Experience feedback from similar / other power plants.
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31. NECESSARY SUPPORT FROM LICENSEES
As per the Ordinance, the licensees are bound to provide the inspectors with such equipment, assistance and support as may be necessary for carrying out their responsibilities e.g.
on-site working facilities
transport at the site
access to means of communication
facilitation of access to all pertinent information
copies of the relevant documents
meetings with appropriate staff
personal protection equipment
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32. INSPECTION REPORTS AND FINDINGS
The results of the inspections are documented in the form of inspection reports which form the basis for any subsequent enforcement actions.
Report of each regulatory inspection is prepared by the inspector(s) who conducted the regulatory inspection within seven days after the inspection, with the approval of the respective Director.
The approved report is communicated to the respective licensee and circulated to concerned Directorates of PNRA.
Records of all inspection reports are maintained with respect to each nuclear power plant in a retrievable manner.
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33. INSPECTION REPORTS AND FINDINGS
The inspection report shall serve as:
A basis for enforcement action by the regulatory body.
A basis for providing relevant information to other interested or concerned departments and to record the results of all inspection activities related to safety or of regulatory significance.
To record relevant discussions held with facility staff, plant management and other concerned persons and provide a basis for notifying the licensee of the inspection findings and of any regulatory requirements .
To record any findings , recommendations or conclusions reached by inspectors.
A basis for revision of licence requirements, rules or regulations by the regulatory body.
Input for self assessment activities
Input to PNRA HQ personnel responsible for review and assessment
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34. PNRA ENFORCEMENT PROCESS
Under section 44 of PNRA Ordinance, any person who contravenes any provision of the Ordinance and the Regulations issued there under is liable to be prosecuted.
PNRA Enforcement Regulations (PAK/950) provide the mechanism to deal with the violators of the PNRA Ordinance and rules and regulations made there under.
As a general policy of PNRA, the prosecution will be used as a last resort when all the other mechanisms described in the procedure i.e. serving of show cause notice and hearing proceedings do not result in a positive outcome.
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35. ENFORCEMENT STEPS For Licensees For non-licensees
Reporting of Violation
Reporting of Offence
Assessment of Violation
Issuance of Directive or Show Cause Notice
Issuance of Show Cause Notice
Hearing
Issuance of legal notice
Cancellation or suspension of a license or Authorization
Filing of Complaint in the Court of Law for prosecution
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36. PNRA ENFORCEMENT PROCESS
Licensees Non-licensees
Reporting of Violation
Assessment of Violation
Issuance of Warning Notice
Issuance of Show Cause Notice
Conduct of Hearing
Issuance of Legal Notice
Filing of Complaint for Prosecution
Cancellation of Licence
Reporting of Offence
Rectification of Violation or Offence C
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37. THANK YOU
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