Technical Assessment Guide- Licensee management of records

Issue Date:

20/08/2009

Review Date:

20/08/2012

Open Government Status:

Fully Open

Approved By:

A Hall

Contents

• Purpose and scope
• Relationship to licence and other relevant legislation
• Relationship to Safety Assessment Principles, WENRA reference levels and IAEA safety standards
• Advice to inspectors
  • Establishing a records process
  • Categorisation of records Administration of records
  • Receipt of records
  • Retrieval and accessibility
  • Storage requirements
  • Disposal
  • Summary
• Annex 1 - Electronic record management system
• Annex 2 - Media for record storage
• Annex 3 - Document and record storage facilities
• Annex 4 - Record retention and storage
• Annex 5 - Compendium of relevant standards

1. Purpose and scope

1.1  The purpose of this Technical Assessment Guide (TAG) is to provide generic guidance to advise and inform ND inspectors in the exercise of their professional regulatory judgment when considering the adequacy of a licensee’s records management arrangements made under Licence Condition (LC) 6. It also adds detailed guidance to the Site Inspection and Enforcement Guide for LC6 (T/INS/006).

1.2  Management of records is an important topic which has a huge array of information available in the form of standards and guidance. There are also rapidly developing technologies which can be applied to records generation, retention and storage. This TAG does not attempt to repeat all of this detail.  Instead, it confines itself to the basic principles which could be expected of any records system. It is for the licensee to justify the arrangements that it puts in place to satisfy the requirements of LC6.

1.3  The main scope of the guide covers the establishment and administration of a records management process, the physical nature of records and the conditions of storage. It does not deal with which records should be made and retained to satisfy the requirements under LC6. It should, however, always be borne in mind that certain records e.g. relating to 'as built' plant and radioactive waste, may be required for considerably longer than 30 years after the record is made or ceases to be a live record. In such cases the arrangements are not considered adequate unless an appropriate period is given and long term storage arrangements specified. NII may wish to 'approve' those parts of the arrangements.

1.4  The TAG describes the general management arrangements required for an effective records management system. It also provides a series of Annexes which provide supporting detail on particular aspects of the system.

2. Relationship to licence and other relevant legislation

2.1  The legal framework relating to management of records is made up of numerous pieces of legislation; however the principal legislation applicable is NIA65, RSA93 and IRR99. Legislation which gives access to records includes the Public Records Act 58 (PRA58) and the Freedom of Information Act (FOI2000). Other safety related legislation requiring records includes Management of Health and Safety at Work Regulations 1999, Lifting Operations and Lifting Equipment Regulations 1998 etc. However, the guidance in this TAG is specific to records relating to nuclear safety and licensees should manage other records in relation to their business risks.

2.2  LC6 - Documents, Records, Authorities and Certificates - requires that the licensee makes adequate records to demonstrate compliance with the Conditions attached to the Licence and that there are adequate arrangements to preserve records for a period of 30 years or such other periods as the Executive may approve. It should be noted that LC5(3) includes a specific requirement for a retention period of 50 years.

2.3  There are a number of Licence Conditions that require the generation of records which should be subject to the controls developed under LC6.

2.4  LC17 requires that adequate Quality Assurance arrangements are developed and implemented by the Licensee. An essential part of these arrangements is the development of procedures which detail the generation and control of records. These procedures should, as a minimum, detail:

• responsibilities for the identification (normally through record schedules) and control of records
• methods, conditions and monitoring of storage/retention commensurate with the nature of the record and the media used
• means of retrieval and update
• levels of security to protect from corruption, unauthorised access, loss or damage
• duration of storage
• arrangements for the review and disposition of records
• arrangements for the periodic auditing of the control and storage of records.

2.5  Where licensees wish to change their record keeping arrangements, particularly when this involves significant changes in media type and management, this should be discussed with the NII site inspector and a formal modification considered.

2.6  The distinction between active (where records are incomplete and/or still in use) and inactive (where records are complete and ready for disposition) records needs to be appreciated when making judgments on the suitability of controls and storage arrangements, recognising that active records need appropriate levels of security commensurate with ease of access, retrieval and updating.

2.7  Civil nuclear security arrangements should be considered against the requirements of Nuclear Industries Security Regulations 2003 and other related guidance. Additionally Licensees must comply with National Security requirements.

3. Relationship to Safety Assessment Principles, WENRA reference levels and IAEA safety standards

3.1  The Safety Assessment Principles for Nuclear Facilities (SAPs) provides a framework to guide regulatory decision-making in the nuclear permissioning process. It is supported by Technical Assessment Guides (TAGs) which further aid the decision-making process.  This TAG provides supporting information to SAP MS.2 paragraph 60.

3.2  WENRA reference levels do not reference records directly; however there are requirements to maintain records of the activities undertaken.

3.3  The applicable IAEA standard is safety requirements document GS-R-3, ‘The Management System for Facilities and Activities’ and the supporting safety guide GS-G-3.1, ‘Application of the Management System for Facilities and Activities’. The guidance presented in this TAG is consistent with GS-G-3.1.

3.4  There are a number of codes and standards which provide advice and guidance on records systems, however there are three British Standards which provide core information for a records system:

• BS15489  Information and documentation – Records management Part 1 General

• BS15489  Information and documentation – Records management Part 2 Guidelines

• BS5454  Recommendation for the storage and exhibition of archival documents

3.5  BS15489 Parts 1 and 2 are suitable for records kept up to 30 years, beyond this BS5454 should be used. BS5454, and its associated guide PD0024:2001, requires environmental controls to be put in place to preserve records.

3.6  A comprehensive listing of relevant standards is provided in Annex 5.

4. Advice to inspectors

Establishing a records process

4.1  Licensee arrangements should reflect a clear commitment from senior management and from staff at all levels to records management. The licensee should have a clear appreciation of the totality of the organisation’s key records and how they are managed especially during periods of organisational change.

4.2  A record provides objective evidence of an activity performed or results achieved and can be a document or a physical item. Records are of strategic importance to a licensee and are an asset that needs to be properly managed. Records should enable a licensee to demonstrate how it has acted and how it has complied with the requirements of the licence condition and other regulatory requirements.

4.3  An effective record system is dependent on having an adequately resourced infrastructure with an adequate number of suitably qualified and experienced personnel available at all times to manage, maintain and operate it. The licensee should have mechanisms in place to check that arrangements are being effectively implemented. The licensee will need to consider appropriate and adequate records management arrangements for the organisation which may include a central processing resource with interfaces to the facilities that are generating the records. These arrangements will need to consider the physical assets [building, machinery, location] that will be used for processing the records prior to archiving and whether they are fit for purpose. The organisation should provide effective training in records management where appropriate.

4.5  The licensee should have a process, described by a documented procedure, for dealing with records management which covers responsibilities, generation, indexing, media type (this will be dependent on retention period allocated), number of copies and archiving arrangements.

4.6  The licensee should have a Records Retention Schedule which details the type of records to be kept and their retention and review periods. The Records Retention Schedule should be used by facility managers to draw up a facility specific Record Schedule which itemises the records that are being generated by their facility. The Record Schedules should provide the licensee with the means to determine the extent of its records and a means of controlling those records. 

4.7  The Record Retention Schedule should identify the legislation requiring records to be retained, however two key pieces of legislation are the Health and Safety at Work Act 1974 and the Nuclear Installations Act 1965 (as amended).

4.8  Contracts awarded to suppliers of plant and equipment or services should state the records to be provided. An appropriate monitoring regime should be put in place to check that contractors are retaining the records in accordance with the contract and are supplying the records required by the customer. This can create particular concerns when different organisations are involved during the different lifecycle phases of the facility. The key points to consider are the ownership and the need for adequate management arrangements for the long term integrity and stewardship of the records.

4.9  There may be occasions when an organisation is updating its record management arrangements or undergoing organisational changes including change of ownership. When this situation arises an effective and robust link is required between the new arrangements and the records that have been generated under previous arrangements. A transition plan should be put in place to cover any organisational change affecting records in support of LC36 submissions.

4.10  The licensee’s procedures should explain what records are required; the relationship with the record keeping process and how long records should be kept.

4.11  The requirements for the management and retention of records, such as statutory obligations, codes and standards, and customer expectations, should be identified and understood, to ensure that they are addressed by the licensee’s management processes.

4.12  Responsibilities for maintaining and operating the records’ process and the facilities for the storage of records should be clearly defined and documented. Responsibilities for records should be assigned to personnel who have the knowledge and authority to review and sentence them.

4.13  The legal ownership of records and the responsibilities for managing them for all lifecycle phases should be clearly established. The organisation that operates a record storage facility has a responsibility to ensure that appropriate records for all lifecycle phases  are available. Where there are a number of different parts of the same organisation or where external organisations are involved, adequate interfaces must be developed to ensure, amongst other things, that records are adequately managed.

4.14  The records’ process should ensure that records are specified, prepared, authenticated and maintained as required by the applicable codes, standards and specifications.

4.15  The records’ process should also ensure that records:

• are categorised (see below and Annex 4);

• are registered upon receipt;

• are readily retrievable;

• are indexed and placed in their proper locations relevant to their use which maybe at a number of locations with the retention times clearly specified;

• are stored in a controlled and secure environment;

• are stored in appropriate storage media (Annex 2);

• remain unchanged under normal circumstances.

4.16  If it becomes necessary to correct errors, any revisions to records should be adequately controlled and tracked.

4.17  Storage facilities for records should be maintained to prevent damage from causes such as fire, water, air, rodents, insects, earthquakes and the actions of visitors without admission rights. The licensee should consider contingency plans and back up.

4.18  Storage facilities may be operated by the licensee, or the licensee may choose to contract the archive storage to a specialist service provider. The interface between the licensee and the service provider will need to ensure that storage and retrieval arrangements are adequate. Adequate arrangements also need to be put in place for storage of duplicate sets of records noting that this might not be a complete set. Records which are important to the licensee may be duplicated and located at a different and equivalent store at a different location.

4.19  Records that need special processing and control, such as computer codes and software, and information stored on high density media or optical disks, should be maintained and controlled to ensure that they are readily retrievable and usable, recognising changes in technology.

4.20  The facilities for control of emergencies should hold appropriate information and records [or have secure access to them] for responding to an emergency.

Categorisation of records

4.21  Records should be categorised according to the needs of the licensee and the necessary retention period of the records. Annex 4 provides guidance on retention periods.

4.22  The organisation should establish appropriate criteria to enable it to draw up a Record Retention Schedule to identify the type and category of records it will be keeping. Record Schedules will identify the particular records to be retained. The process developed by the licensee will identify the strategy for each category of record including copying and archiving and how it will be stored i.e. a combination of hard copy, microfiche and electronic media. How important the records are to the organisation will influence the level of control including the retention period, the amount of copying, the media type and the number of locations used to retain them.

Administration of records

4.23  All records should be readable, complete and identifiable with the product or process involved.

4.24  To prevent the deterioration of records during the retention period, it may be necessary to transfer records to a different medium. The transfer process should include control, and verification that the information has been transferred accurately. If any copying is necessary to maintain image quality during the retention period, this should also be controlled and verified.

4.25  Records should be logged and listed in an index prior to receipt into storage. The methods of logging and indexing to be used should be established before the receipt of records. The index should provide sufficient information to identify both the products and the relevant records and should for example indicate:

• the title or unique identification of the record and the item, service or process it is related to;

• the organisation or person generating the record;

• the retention time of the record;

• the location of the record in the storage facility;

• revision dates and the persons approving the revisions.

4.26  The administration of records, from capture in the facilities, through to central processing and output as a delivery to the archive can be regarded as the records management process. This process will require adequate human and physical resources for all elements of the process. There are benefits from having a means of measuring the effectiveness and efficiency of the process and its implementation so that areas for improvement can be identified. This is normally achieved through self-assessment, auditing and review processes.

4.27  The licensee should have a due process for correcting or supplementing records. This process should be of the same standard as that used for the approval of the original record.

4.28  The correction or supplement should include the date and the identification of the person making the correction or supplement.

4.29  Consideration should be given to refreshing electronic media used to manage and store records such as databases. There needs to be an appropriate IT strategy in place to cover the need to refresh databases.

Receipt of records

4.30  The receipt control of records should ensure that the records are complete, legible and in a form suitable for storage.

Retrieval and accessibility

4.31  The licensee should ensure that records are indexed, filed, stored and maintained in facilities that allow their retrieval when necessary. The records should be accessible at all times during the specified retention periods. Access to locations where records are retained should be controlled. Consideration should be given to storing documents that may be necessary in emergency conditions at a location away from the facility.

4.32  Records need to be properly identified to facilitate future knowledge of what they are.

4.33  Management arrangements need to provide for adequate access and retrieval of records from service providers and for the safe return of the record to the archive if it is removed.

Storage requirements

4.34  The licensee should establish a suitable storage facility for the maintenance, preservation and protection of records and associated test materials and specimens from the time of their receipt until the time of their disposal. Annex 4 provides supplementary guidance.

4.35  If the necessary storage conditions are unattainable, consideration should be given to the provision of a duplicate set of records stored in a separate facility.  In such cases, the location and construction features of both facilities should be such that the probability of the simultaneous destruction, loss or deterioration of both sites for records is sufficiently low.

4.36  Records shall be stored in such a manner as to prevent deterioration. Examples of storage methods for different storage media are given in Annex 3.

4.37  Consideration should be given to segregating records in the storage facility  associated with different facilities or projects to facilitate ease of ‘batch transfer’ at some future date.

4.38  Electronic storage media should be robust and future proof as far as is possible. Resources need to be devoted to refreshing electronic storage media to take account of advancements in technology which can rapidly make systems obsolete.

4.39  The record store must be able to cope with the type and nature of the records being sent to it. If the licensee decides to outsource the storage of records to a specialist service provider the service provider should be vetted to ensure that it is capable of handling the records that are to be sent to it including retrievability and security requirements and handling processes for hazardous material. A robust specification needs to be placed on the specialist service provider and periodic checks, by both the service provider and the licensee, made to ensure that key parameters of the storage service are being adhered to.

4.40  Record storage facilities must take into account the potential contamination of records with hazardous substances, including radioactive contamination.

4.41  Some records may be physical samples which will require different considerations for storage from paper or electronic records and there is a potential contamination issue to consider.

4.42  Records belonging to different organisations which are stored in the same record storage facility need to be clearly identified.

Disposal

4.43  The licensee should identify who is responsible for the transfer or disposal of records. Records should be categorised and retained for the retention period specified by the licensee. The records system should be designed to provide adequate prompts to identify when a record reaches its review point prior to consideration for disposal. There should be adequate arrangements in place for reviewing records that have reached the end of their retention period. Before final disposal an appropriate review should be undertaken and approval for destruction or continued retention given by the licensee.  Arrangements will need to reflect the involvement of contractors where they are used to store the records.

Summary

4.44  The following summary points should be considered:

• The management of records of any organisation will not succeed without senior management involvement and commitment.
• There needs to be an adequate system which is properly resourced and has effective management arrangements with responsibilities clearly identified.
• The records system must comply with appropriate legislation.
• When more than one organisation is involved in record keeping during the various lifecycle phases of a facility the responsibilities and interfaces should be clearly defined.
• The system should be designed such that it is a relatively straightforward task for managers to be able to sort and sentence records.
• The ownership of the records should be clearly identified at all stages of the storage.
• Due consideration should be given to storage location.
• Human Factors should be considered carefully when designing a records system for effectiveness and ease of use.
• The system should identify what records should be kept and for how long.
• Consideration should be given to storing records on a project/facility basis to facilitate easier retrieval. An adequate description should be provided of what the record is.
• Record keeping arrangements are subject to the vagaries of time i.e. changes in technology/organisation; the record keeping package should be as robust and resistant to the effects of these changes as reasonably practical.
• Consideration should be given to the management of records generated electronically as part of an operational activity (e.g. data logger)

• Annex 1 - Electronic record management system
• Annex 2 - Media for record storage
• Annex 3 - Document and record storage facilities
• Annex 4 - Record retention and storage
• Annex 5 - Compendium of relevant standards

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