Inspections by the Swedish Radiation Protection Authority Torsten Cederlund, Peter Hofvander and Carl-Göran Stålnacke Department of Occupational and Medical Exposure Mr.. European ALARA Network 8th Workshop Uppsala, Sweden 22-24 September 2004

Swedish Radiation Protection Authority SSI employs 110 professionals with a broad and varied expertise: Engineers, physicists, chemists, lawyers and press officers. WE have a budget of about 10 million EURO per year, financed by taxes and fees. SSI is headed by a government-appointed director general and has a board of governors. SSI are divided in 5 different departments and I will describe the inspections activities performed by the Department of Occupational and Medical Exposures. Of the 110 employs approximately 20 are involved with supervision of occupational exposure.

Use of ionising radiation in Sweden Nuclear power 4 NPP´s, research reactor, fuel factory &facilities for waste/spent fuel More then 1000 non nuclear industries with licensed equipment Research facilities 11 major sites and 760 licenses 232 hospitals X-ray, nuclear medicine, radiation therapy, research Dentists, 12000 (general licenses) Veterinaries 264 licenses The use of ionising radiation in Sweden is quit comprehensive.

Swedish Radiation Protection Act Is a framework from 1988 Requires licence for all work with ionising radiation Is giving general radiation protection obligations The base in our legal framework is the “Swedish Radiation Protection Act” from 1988. It regulates all activities with radiation and is a basic law, which means that the law contains of general issues but have to be complemented with regulations. The law requires licence for all work with ionising radiation and it is giving general radiation protection obligations. It also assigns SSI as the competent authority with the task of: -Issuing regulations -Grant licences -Perform supervision and inspections -Promoting research

Authority SSI has the authority to: issue prescriptions and prohibition issue decision under penalty of a fine withdraw a licence. WE have the legal authority to decide what action should be taken by the licence holder in order to improve radiation protection by issuing prescriptions and prohibitions. We can also prescribe a penalty for non-compliance or withdraw a licence.

The base for all inspection activities is our regulations: SSI has issued a number of regulations according to BSS, 96/29 Euratom. You will find our regulations on SSI´s web site: www.ssi.se According to the European Basic Safety Standard SSI has issued a number of regulations. We have high demands, in the regulations, on the users to have quality assurance of all activities involving ionising radiation. At the inspections we usually don’t do any measurements we just check that the user have all documents, procedures and equipment that they need according to the regulations. You will find our regulations on SSI´s web site: www.ssi.se

Inspection Policy with Strategy and Guidelines for Inspection The policy describes the approach to and overall goals for SSI’s inspection activities. The strategy specifies how SSI should work in order to attain its policy goals. The guidelines provide sound guidance for everyone working with inspections at SSI. The guidelines are of a general nature and are to be applied within all activity areas at SSI. In recent years, SSI has improved its policy for inspections in order to create an updated and uniform programme for all areas and activities which SSI has to supervise. The inspection policy describes the approach to and goals for SSI:s inspection activities. -Inspection is a main task for SSI. -Inspections can be conducted in all areas involving radiation. - Inspections are to be conducted where they accomplish the most benefit. -Inspections are to be conducted with the right level of quality and in accordance with the adopted steering documents. -Inspections are to be characterised by integrity and professional behaviour. The strategy specifies how SSI should work in order to attain policy goals. -Inspection is a high-priority method of supervision. -Severe accidents and incidents should be immediately followed by an inspection. -The inspections are to be based on SSI’s priorities.

High-priority facilities for supervision according to the policy are: Those that result in or can result in high radiation doses Those where there is a considerable risk that many can receive minor but not negligible radiation doses Those about which SSI needs to have more knowledge. 1 Fore example workers at nuclear power plants, site radiography and interventional radiography in medicine 2 3 Fore example the resent development in x-ray diagnostic were film is replaced by digital imaging receptors

inspections per year Number of objects Part inspected Dentists 0 12000 0 % Industry 30 1500 2 % Veterinarian 5 264 2 % Medicine 30 300 10 % Nuclear instal 40 6 600 % The inspection frequency wary a lot between different areas:

The inspection process Selection and planning Preparation and planning Evaluation Follow-up Inspection Our inspection activity is a continuous process where the inspection experience of previous years is used as the basis for planning the inspection work of subsequent years. The inspection process is divided into six stages, illustrated in the figure. Post inspection work

Selection and planning Where? Who? When? When we have decided who to inspect and when, we confirm the date with the licensee at least 2 weeks in advance, unannounced inspections are seldom performed. We also confirm that all persons that we want to interview will be present. Finally we check all documents concerning the licence that we have in our archives and we prepare a protocol with questions.

Inspection ID Regulations Protocols No equipment ID showing we are a public servant

Post inspection work Report Licensee checks report before it is sent Date Inspectors Persons interviewed Regulations Comments (both good and bad) Licensee checks report before it is sent After the inspection a report is written. The report should contain of: Date for the inspection Name of inspectors Name of persons interviewed Comments, both good and bad The licensee also gets the opportunity to check the report before any final decisions are taken.

After the authorities decision The licence holder have to respond in writing Time limit depending on the issues Usually – SSI is satisfied with the actions Some cases – exceeded time limits Rarely – new decision under penalty of a fine

Discrepancies found Inadequate education and training in particular concerning cardiologists and orthopaedist Inadequate organisation of radiation protection lack of qualified expert, The most frequent findings are inadequate education and training, in particular concerning cardiologists and orthopaedist And Inadequate organisation of radiation protection, lack of qualified expert.

Feedback SSI Reports Annual meetings with radiation protection managers at NPP:s Biannual meetings with qualified experts Biannual meetings with the medical physicists SSI active at national meetings In addition to decisions SSI gives feedback to the lichens holders by Reports and guidelines. We also arrange: Annual meetings with.. Biannual meetings… And we are also active at national meetings for exampel: The annual meeting of the Swedish Society of Medicine

Conclusions SSI has high demands on the users to have a quality assurance programme for all activities involving ionising radiation SSI works continuously to improve the quality of the supervision SSI have high demands on the users to have a formal quality assurance of all activities. Including: Self assessment Audit Education and training and we works continuously to improve the quality of our own supervision

We believe that our inspections are justified but not yet optimised Conclusions We believe that our inspections are justified but not yet optimised Finely we believe that our inspections are justified but not yet optimised! Thank you for listening