NRL Matters No. 10

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NRL Matters No. 10

Revised June 2008

Licensee Responsibilities and Compliance Monitoring

Principal licensee

Any use of radiation typically involves a facility where it is used, a person or company that owns the facility and/or the radiation sources, and people who use the radiation.

There is no provision in the Radiation Protection Act 1965 for the licensing or registering of a radiation facility. Instead the Act requires individuals to be licensed to use radiation for a particular purpose. In addition, the Radiation Protection Regulations 1982 require owners of radiation sources to provide all necessary safety features and ensure that there is a suitably licensed person for the “safe care” of the radiation sources. That licensed person is in turn responsible for obtaining from the owner whatever is needed for safety. This ambiguity in responsibility is exacerbated when there are several licensees using the same facility. Furthermore the owner of the radiation facility may not own the radiation sources, and indeed there may be several owners of radiation sources. This is a further cause of ambiguity.

In order to clarify this, NRL requires that the owner of any facility where radiation sources are used (as an intrinsic part of the business of the facility) take the overall role of owner and designate one of the licensees as principal licensee. The principal licensee then has the responsibility for organising radiation safety at the facility. This means being the principal advisor to the owner on issues of radiation safety, and being responsible for developing and maintaining safe procedures.

Many of the NRL Codes of Safe Practice have requirements for written rules and safety procedures, along with other facility requirements. It is the responsibility of the principal licensee to advise the owner of these facility requirements, and to produce the written material. In order to ensure organisation-wide commitment to radiation safety, the principal licensee should involve all stakeholders in the development of procedures and local rules. However it should be pointed out that the principal licensee is not responsible for the actions of the owner or of other licensed users.

In summary:

The owner of the facility is responsible for:

appointing a principal licensee
providing the safety equipment, shielding, etc, as advised by the principal licensee. (Note that this includes the carrying out of any maintenance and quality assurance of all equipment that may cause a radiation hazard.)

The principal licensee is responsible for:

advising the owner of requirements for radiation safety
producing (or facilitating production of) safety procedures and local rules to be followed by anyone working in the facility

All licensees are responsible for:

the safety of their own work
following the safety procedures and local rules for the facility
the training and safety of anyone working without a licence under their supervision or instructions

Compliance monitoring

The National Radiation Laboratory, as New Zealand’s Regulatory Authority, is empowered to carry out compliance monitoring audits of facilities where ionising radiation is used. These compliance monitoring audits occur at frequencies determined by NRL in order to verify that the use of radiation at the facility is in compliance with the Radiation Protection Act 1965, the Radiation Protection Regulations 1982 and the relevant NRL Code of Safe Practice.

Advance notification of an impending visit by an NRL auditor is normally given, in the first instance, to the principal licensee of a facility where radiation is used, because of the primary role that person takes in the radiation safety management of a facility. The notification also specifies the documentation that will need to be available during the audit. In some cases a request will be made for copies of particular reports to be sent to NRL prior to the visit.

The audit usually commences with an entrance interview between the auditor and the principal licensee, plus any other person the principal licensee wishes to have present. Such additional persons might include those with particular responsibilities in the radiation protection quality assurance programme. At the entrance interview the facility’s radiation protection documentation, as requested in the visit notification letter, should be available. This is reviewed by the auditor who will check for compliance with the Act, Regulations and Code. A site inspection then takes place and in some cases particular radiation measurements or other spot checks may be performed. Observation of the use of radiation may also take place.

The auditor then completes a written report and the compliance monitoring audit concludes with an exit interview at which the results are presented and discussed with the principal licensee. Any items of concern will be explained and for those items of actual non-compliance, appropriate courses of action will be discussed, including a time-frame for compliance.

The compliance monitoring audit cycle for a given radiation facility remains open in cases of non-compliance until such time as the principal licensee has notified NRL in writing that the agreed corrective actions have been implemented. At this stage, or if in the first instance there were no non-compliance items, the compliance monitoring audit cycle is closed, and the facility is given confirmation in writing of full compliance.

Responsibility for remedying an item of non-compliance corresponds to the respective responsibilities outlined in the previous section on principal licensees. For example:

Non-compliance item	Person responsible
Lack of appropriate written procedures	Principal licensee
Equipment that does not comply with a Code of Safe Practice	Owner, acting on the advice of the principal licensee
Person at the facility who should hold a licence	The individual in question
Records not kept up to date by licensed users	The principal licensee must ensure there is a workable record-keeping system; individual licensees are responsible for following the system

COMPLIANCE TERMS USED IN NRL AUDIT REPORTS

Prohibition notice:

Issued in cases where a particular piece of equipment or radiation use is judged to be of a very serious nature and/or presenting an unacceptable level of risk. A prohibition notice will be posted either on the equipment or in the area of use.

The notice will state that any further use represents a serious breach of the relevant Code of Safe Practice (or other legislation) and will result in cancellation of the licence of the offender and/or initiation of prosecution proceedings.

A prohibition notice will remain in effect until rescinded in writing by NRL.

Non-compliance notice:

Issued in cases where a non-compliance issue is considered to be of a major nature. A non-compliance notice is a direct instruction that specified actions must be completed within a specified time scale.

This will be served on the person responsible at the exit interview if possible, so that the requirements can be made clear, and a realistic time scale determined. This will be open to reasonable negotiation.

No enforcement action will be taken as long as written confirmation and proof that any required actions have been completed are supplied to NRL within the agreed time period.

Corrective actions notice:

Used for items of non-compliance that are judged to require corrective action but are of a relatively minor nature. A period of no more than 3 months would usually be allowed for correction.

NRL will not actively pursue confirmation of completion of corrective actions until the next compliance monitoring audit. However notification of such confirmation is strongly encouraged as it allows the audit cycle to be closed. Many accreditation bodies require evidence of compliance with the radiation protection legislation, and this will not be available while items of non-compliance are still unresolved.

Improvements and preventive actions notice:

Used to detail actions that, although not regulatory requirements, are generally held to be good practice, and need to be given careful consideration for the optimisation of radiation safety. While not mandatory, any reasons for choosing not to act on any of the recommendations will normally be discussed at the next audit.