Quality System of the Secondary Standard Dosimetry Laboratory (SSDL)

of Cuba

Center for Radiation Protection and Hygiene

(CPHR)

The Center for Radiation Protection and Hygiene The Center for Radiation Protection and Hygiene (CPHR) it is a Scientific, Investigation, Technological (CPHR) it is a Scientific, Investigation, Technological Innovation, Productions and Specialized Services Innovation, Productions and Specialized Services institution. The specialization level and excellence institution. The specialization level and excellence that demand this services, imply that are also that demand this services, imply that are also carried out development - investigation projects.carried out development - investigation projects. The CPHR is subordinated to the Nuclear Energy The CPHR is subordinated to the Nuclear Energy Agency that is subordinated to the Ministry Of Agency that is subordinated to the Ministry Of Science, Technology And Environment (CITMA). Science, Technology And Environment (CITMA).

Ministry of Science and Ministry of Science and Technology (CITMA)Technology (CITMA)

Nuclear Energy AgencyNuclear Energy Agency

CPHRCPHR

GENERAL STRUCTUREGENERAL STRUCTURE

Q U A LITY

A SSU R A N C EPR IN C IPA LPH YSIC IA N

D IVIS IO N O FIN VESTIG A TIO N A N D

D EVELO PM EN T

C O M M ER C IA L D IV IS IO NA N D O F SPEC IA LIZED

SER VIC ES

D IVIS IO N O FIN TER N A L SER VIC ES

D IR EC TIO NO F EC O N O M Y

D IR EC TIO N O FH U M A N R ESO U R C ES

G EN ER A LD IR EC TO R

CPHR’S CPHR’S STRUCTURESTRUCTURE

SSDLSSDL

Since 1996 the Laboratory has carrying out its work with the Since 1996 the Laboratory has carrying out its work with the parallel action of a Quality Assurance System. In its beginning parallel action of a Quality Assurance System. In its beginning that system had a simple structure that was able to assure an that system had a simple structure that was able to assure an acceptable quality in the execution of scientific - technical acceptable quality in the execution of scientific - technical services. In 1997, with the accumulated experience of a year of services. In 1997, with the accumulated experience of a year of work this system was improved with the objective of achieving work this system was improved with the objective of achieving long term competition levels comparable to those shown by long term competition levels comparable to those shown by the most noted SSDL in the International Network IAEA/WHO. the most noted SSDL in the International Network IAEA/WHO. It was necessary for this process a total implementation of It was necessary for this process a total implementation of Guide ISO/IEC 25 “General requirements for the competence Guide ISO/IEC 25 “General requirements for the competence of testing and calibration laboratories". With the of testing and calibration laboratories". With the implementation of these requirements was granted to the implementation of these requirements was granted to the laboratory the condition of ACCREDITED LABORATORY (Reg. laboratory the condition of ACCREDITED LABORATORY (Reg. No. 014) for the realization of test and calibrations by the No. 014) for the realization of test and calibrations by the National Accreditation Office of the Republic of Cuba in May of National Accreditation Office of the Republic of Cuba in May of the same year. This office is applying as full member of the the same year. This office is applying as full member of the International Laboratory Accreditation Cooperation (ILAC). In International Laboratory Accreditation Cooperation (ILAC). In the year 2001 the laboratory was reaccredited for meeting the year 2001 the laboratory was reaccredited for meeting requirements of ISO/IEC 17025: “General requirements for the requirements of ISO/IEC 17025: “General requirements for the competence of testing and calibration laboratories".competence of testing and calibration laboratories".

The responsibilities of SSDL include:The responsibilities of SSDL include:

•Maintaining of Cuban reference standards for dosimetry in Maintaining of Cuban reference standards for dosimetry in agreement with the international measurement system.agreement with the international measurement system.

•Performing calibrations of radiation measurement equipment Performing calibrations of radiation measurement equipment and issuing calibration certificates with all necessary and issuing calibration certificates with all necessary information, including the estimated uncertainties.information, including the estimated uncertainties.

•Organizing dose comparisons for radiation therapy for Organizing dose comparisons for radiation therapy for institutions within the country or region, and participating in institutions within the country or region, and participating in measurement comparisons within the IAEA/WHO SSDL measurement comparisons within the IAEA/WHO SSDL Network, and with other standardizing laboratories.Network, and with other standardizing laboratories.

•Co-operating with the IAEA/WHO Network and with other Co-operating with the IAEA/WHO Network and with other metrological laboratories in the exchange of information and metrological laboratories in the exchange of information and improvement of measurement instruments and techniques.improvement of measurement instruments and techniques.

•Documenting and preserving records of all procedures and the Documenting and preserving records of all procedures and the results of calibrations.results of calibrations.

•Keeping up to date on progress in radiation measurements Keeping up to date on progress in radiation measurements techniques, so as to improve calibration techniques as required, techniques, so as to improve calibration techniques as required, and thereby provide a better service to the users of radiation.and thereby provide a better service to the users of radiation.

•Providing training in radiation measurements and calibration Providing training in radiation measurements and calibration techniques and in the use and maintenance of the relevant techniques and in the use and maintenance of the relevant instrumentation, appropriate to the users of radiation served by instrumentation, appropriate to the users of radiation served by the SSDL.the SSDL.

•Performing Performing legal verification of dosimetrics instruments legal verification of dosimetrics instruments

•Reporting , at least annually, on the status of its secondary Reporting , at least annually, on the status of its secondary standards, radiation sources, calibrations performed and standards, radiation sources, calibrations performed and related activities.related activities.

Quality Assurance SystemQuality Assurance System

Main dataMain dataThe Secondary Standard Dosimetry Laboratory (SSDL) of the The Secondary Standard Dosimetry Laboratory (SSDL) of the Center for Radiation Protection and Hygiene (CPHR) has a Center for Radiation Protection and Hygiene (CPHR) has a total of 5 workers, of them, 4 specialists and 1 technician. total of 5 workers, of them, 4 specialists and 1 technician. In the year 2003, a total of 100 Verification Certificates, 18 In the year 2003, a total of 100 Verification Certificates, 18 Irradiation Certificates and 42 Calibration Certificates have Irradiation Certificates and 42 Calibration Certificates have been emitted. been emitted.

Quality Policy: Quality Policy: General policies related to personnel responsibilities, General policies related to personnel responsibilities, measuring standards, and calibration and testing services. measuring standards, and calibration and testing services. A list of those policies comprises :A list of those policies comprises :

Quality Policy: Quality Policy: SSDL’s Head is maximum responsible for well SSDL’s Head is maximum responsible for well implementation of Quality System (QS), its maintenance implementation of Quality System (QS), its maintenance and System improvementand System improvement..

Policies, documented quality requirements and Policies, documented quality requirements and procedures are expected to be followed by every staff , procedures are expected to be followed by every staff , visitors and trainee of the SSDLvisitors and trainee of the SSDL

A high ethic and discretion concerning calibration and A high ethic and discretion concerning calibration and testing results are expected from every SSDL staff testing results are expected from every SSDL staff

Every activity related to calibration and testing services Every activity related to calibration and testing services should be carried out following a valid method and should be carried out following a valid method and documented proceduredocumented procedure

Quality PolicyQuality PolicyEach SSDL reference standard should be Each SSDL reference standard should be supervised by designated a person that is its supervised by designated a person that is its responsible. Supervision comprises storage, responsible. Supervision comprises storage, maintenance and use of standard. As a general maintenance and use of standard. As a general practice transport of standard outside laboratory practice transport of standard outside laboratory areas should be authorized by SSDL’s Head. areas should be authorized by SSDL’s Head.

Laboratory should keep abreast of recent technical Laboratory should keep abreast of recent technical advance and published information in the field of advance and published information in the field of metrology and dosimetry of ionizing radiationmetrology and dosimetry of ionizing radiation

Instruments used in calibration processes have to be Instruments used in calibration processes have to be periodically calibrated and kept under a quality periodically calibrated and kept under a quality control programcontrol program

Quality PolicyQuality PolicyParticipation of SSDL in national or international Participation of SSDL in national or international dosimetric intercomparison is encouraged.dosimetric intercomparison is encouraged.

Calibration services which end in calibration Calibration services which end in calibration certificate should only be carried out by qualified certificate should only be carried out by qualified SSDL permanent staff .SSDL permanent staff .

All calibration and testing data, records and All calibration and testing data, records and certificates have to be maintained at least for two certificates have to be maintained at least for two years years A high attention to user claims and suggestions is A high attention to user claims and suggestions is expected from the Head and all staff of SSDL.expected from the Head and all staff of SSDL.

SSDL structure SSDL structure

• Location.Location.The LSCD is located in areas of the Center for The LSCD is located in areas of the Center for Radiation Protection and Hygiene that is in Radiation Protection and Hygiene that is in Carretera de la Cantera Victoria II Km. 3½ Carretera de la Cantera Victoria II Km. 3½ Guanabacoa, Ciudad de la Habana. Guanabacoa, Ciudad de la Habana.

• Organizational structure. Organizational structure. The organizational structure of the SSDL is The organizational structure of the SSDL is presentedpresented

Organizational structure of SSDLOrganizational structure of SSDL

SSDL’s Head

Head Substitute

Quality Supervisor

Personnel

Quality System structureQuality System structure

• Organization and Responsibilities Organization and Responsibilities The guarantee of the quality of the SSDL works rests in The guarantee of the quality of the SSDL works rests in the Organizational Structure of the same one. the Organizational Structure of the same one.

• Administration Administration

SSDL’s HeadSSDL’s Head

•Establish quality policies and objectivesEstablish quality policies and objectives•Promote the introduction of scientific and technical advancesPromote the introduction of scientific and technical advances•Approve new servicesApprove new services•Give proper attention to training needs of SSDL staffGive proper attention to training needs of SSDL staff•Organize with established periodicity revision of the Quality Organize with established periodicity revision of the Quality ProgramProgram

Quality SupervisorQuality Supervisor

•Keep Quality Manual versions and its distribution updatedKeep Quality Manual versions and its distribution updated•Supervise good order of laboratory ambient conditionsSupervise good order of laboratory ambient conditions•Keep trace of non compliance detected and the Keep trace of non compliance detected and the implementation of corrective actionsimplementation of corrective actions•Organize and participate in internal quality revisions Organize and participate in internal quality revisions

Technical departmentsTechnical departments

The Laboratory complies the IAEA design criteria for The Laboratory complies the IAEA design criteria for establishing an SSDL. It has three calibration rooms, in one of establishing an SSDL. It has three calibration rooms, in one of those are carried out the calibration at radiation protection those are carried out the calibration at radiation protection levels with a gamma irradiator and a X rays equipment and in levels with a gamma irradiator and a X rays equipment and in the other one the calibration at radiotherapy levels using a Co-the other one the calibration at radiotherapy levels using a Co-60 unit. 60 unit.

Laboratory administration description. Laboratory administration description.

The responsibilities in Quality Assurance System of the The responsibilities in Quality Assurance System of the SSDL’s Head, of their Substitute and of Quality Supervisor. SSDL’s Head, of their Substitute and of Quality Supervisor.

As for Laboratory operations, equipment and sources, the same As for Laboratory operations, equipment and sources, the same ones are: ones are: SSDL’s Head: has responsibilities and authorization for working SSDL’s Head: has responsibilities and authorization for working in all SSDL services, equipment, reference standards, working in all SSDL services, equipment, reference standards, working standards and calibration sources.standards and calibration sources.Other specialists: have access to some services and to Other specialists: have access to some services and to equipment, sources and working standards linked to the same equipment, sources and working standards linked to the same ones. ones.

Functional structureFunctional structure

The SSDL functional structure coincides with its organizational The SSDL functional structure coincides with its organizational structure. structure.

Quality Assurance System documentationQuality Assurance System documentation

Structure of Quality Assurance System Documentation Structure of Quality Assurance System Documentation

The documentation of the System of Quality consists of: The documentation of the System of Quality consists of:

Quality ManualQuality Manual: contains the policies and objectives of quality and : contains the policies and objectives of quality and describes the organization, procedures, requirements anddescribes the organization, procedures, requirements and

System has been designed to satisfy the requirements of System has been designed to satisfy the requirements of Standard ISO/IEC 17025:2000 “General requirements for Standard ISO/IEC 17025:2000 “General requirements for the competence of testing and calibration laboratories". the competence of testing and calibration laboratories".

Procedure ManualProcedure Manual: contains the Administration Quality : contains the Administration Quality Procedures and Technical Procedures of the Laboratory. Procedures and Technical Procedures of the Laboratory.

Records ManualsRecords Manuals: contain the quality and technical records. : contain the quality and technical records.

The hierarchical structure of Quality System of the Laboratory The hierarchical structure of Quality System of the Laboratory has three levels, the Level I includes the Quality Manual, the has three levels, the Level I includes the Quality Manual, the Level II includes the Procedure Manual and the Level III Level II includes the Procedure Manual and the Level III contains the rest of the documentation (all records manuals). contains the rest of the documentation (all records manuals).

Distribution and Control Distribution and Control

Generally, the documentation of Quality System stays in Generally, the documentation of Quality System stays in areas of Laboratory. In case that it is necessary the areas of Laboratory. In case that it is necessary the distribution of copies, the same one are controlled through distribution of copies, the same one are controlled through a record. a record.

Emphasis should be made in register for Control of Softwares, Emphasis should be made in register for Control of Softwares, that includes its validation and controls of its use depending on that includes its validation and controls of its use depending on service to which is dedicated. service to which is dedicated.

Quality Manual content.Quality Manual content.The Quality Manual of Laboratory contains 8 chapters, The Quality Manual of Laboratory contains 8 chapters, which are: which are: Special dispositions. Special dispositions.

Terms and definitions. Terms and definitions. Introduction Introduction

SummarySummary Objective Objective Scope Scope

Commitment the Quality. Commitment the Quality. Management Requirements. Management Requirements.

Organization and AdministrationOrganization and Administration Quality system Quality system Documents Control Documents Control Review of requests, tenders and contracts. Review of requests, tenders and contracts. Subcontracting of tests and calibrations. Subcontracting of tests and calibrations. Purchasing services and supplies. Purchasing services and supplies. Service to the customer. Service to the customer. Complaints. Complaints. Control of nonconforming work. Control of nonconforming work.

Corrective actionCorrective action. . Preventive action. Preventive action. Records. Records. Internal audits. Internal audits. Managements reviews. Managements reviews.

Technical requirements. Technical requirements. PersonnelPersonnel. .

Accommodation and environmental conditions. Accommodation and environmental conditions. Test methods. Test methods. Equipment. Equipment. Traceability. Traceability. Sampling. Sampling. Handling of calibration items. Handling of calibration items. Assuring the quality of calibration results. Assuring the quality of calibration results. Reporting the results. Reporting the results.

Bibliography. Bibliography. Annexes Annexes

List of administrative documents and normative. List of administrative documents and normative. Quality Manual.Quality Manual.

Quality Procedures: Quality Procedures: Documental Administration. Documental Administration. Control and Record of Data. Control and Record of Data. Treatment of Non Compliances and taking of corrective and Treatment of Non Compliances and taking of corrective and preventive actions. preventive actions. Treatment of complaints and customer feedback. Treatment of complaints and customer feedback. Subcontracting of Services. Subcontracting of Services. Elaboration and control of certificates and reports. Elaboration and control of certificates and reports. Control of customer items. Control of customer items. Control of equipment, the standard, reference samples and Control of equipment, the standard, reference samples and facilities. facilities. Control of Software. Control of Software. Participation in intercomparison exercises. Participation in intercomparison exercises. For the file and conservation of Quality Documentation of For the file and conservation of Quality Documentation of Laboratory and control of reference data. Laboratory and control of reference data.

Internal Quality Control of equipment and calibration Internal Quality Control of equipment and calibration processes. processes.

Control of Certificates. Control of Certificates. Control of external supplies and services. Control of external supplies and services. Physical control and control of documentation Physical control and control of documentation Control of the environmental conditions. Control of the environmental conditions. List of normative and technical documents. List of normative and technical documents.

Technical Procedures:Technical Procedures:Calibration of area dosemeters and ratedosementers at Calibration of area dosemeters and ratedosementers at radiation protection levels. radiation protection levels.

Calibration of working standard at radiation protection levelCalibration of working standard at radiation protection levelCalibration of brachytherapy sources. Calibration of brachytherapy sources. Calibration of ionization chambers at radioprotection levelsCalibration of ionization chambers at radioprotection levels.

Irradiation of Integral Dosimeters using Cs-137 source. Irradiation of Integral Dosimeters using Cs-137 source. Calibration of dosimetric installations. Calibration of dosimetric installations. Operation of X rays installation. Operation of X rays installation. Irradiation of Integral Dosimeters using X rays beams. Irradiation of Integral Dosimeters using X rays beams. Air Kerma Calibration of radiotherapy dosimeters in Cobalt-60 Air Kerma Calibration of radiotherapy dosimeters in Cobalt-60 beam (PHOENIX-20). beam (PHOENIX-20). Air Kerma Calibration of radiotherapy dosimeters at X rays Air Kerma Calibration of radiotherapy dosimeters at X rays beams (PANTAK-160C). beams (PANTAK-160C). Calibration of radiodiagnosis dosimeters at conventional X rays Calibration of radiodiagnosis dosimeters at conventional X rays beams. beams. Calibration using Cs-137 source of stationary area dosimeters Calibration using Cs-137 source of stationary area dosimeters under operation conditions. under operation conditions. Calibration of radiotherapy dosimeters in terms of Absorbed Calibration of radiotherapy dosimeters in terms of Absorbed Dose to Water at Cobalt-60 beam (PHOENIX-20).Dose to Water at Cobalt-60 beam (PHOENIX-20).

Normative documents.Normative documents.

ISO/IEC 17025 General requirements for the competence ISO/IEC 17025 General requirements for the competence of testing and calibration laboratoriesof testing and calibration laboratories

““Guide to the Expression of Uncertainty in Measurement”. Guide to the Expression of Uncertainty in Measurement”. BIPM/IEC/IFCC/ISO/IUPAC/IUPAP/OIML 1995BIPM/IEC/IFCC/ISO/IUPAC/IUPAP/OIML 1995ISO 4037 Parts 1, 2 y 3. X and gamma reference radiation for ISO 4037 Parts 1, 2 y 3. X and gamma reference radiation for calibrating dosimeters and doserate meters and for determining calibrating dosimeters and doserate meters and for determining their response as a function of photon energy. 1996.their response as a function of photon energy. 1996.Calibration of Dosimeters used in Radiotherapy.TRS-374. IAEA, Calibration of Dosimeters used in Radiotherapy.TRS-374. IAEA, Vienna, 1994.Vienna, 1994.Calibration of radiation protection monitoring instruments. Safety Calibration of radiation protection monitoring instruments. Safety Reports series n° 16. IAEA, Vienna 2000.Reports series n° 16. IAEA, Vienna 2000.Calibration of photon and beta ray sources used in brachytherapy: Calibration of photon and beta ray sources used in brachytherapy: Guidelines on standardized procedures at Secondary Standards Guidelines on standardized procedures at Secondary Standards Dosimetry Laboratories (SSDLs) and hospitals. TECDOC-1274. Dosimetry Laboratories (SSDLs) and hospitals. TECDOC-1274. IAEA, Vienna 2002.IAEA, Vienna 2002.

Complaints Complaints

The Quality Manual of Laboratory includes a chapter dedicated to The Quality Manual of Laboratory includes a chapter dedicated to the treatment of complaints of customers. In same one is made the treatment of complaints of customers. In same one is made reference to procedure that describes this process and its record.reference to procedure that describes this process and its record. Corrective actions. Corrective actions.

The Quality Manual of Laboratory contains a chapter in which the The Quality Manual of Laboratory contains a chapter in which the established dispositions are described for the process of taking of established dispositions are described for the process of taking of corrective actions guided to guarantee a non repetition of those corrective actions guided to guarantee a non repetition of those associate non compliance. associate non compliance. The control includes all the actions related with the correction of The control includes all the actions related with the correction of all non compliance registered in Laboratory. all non compliance registered in Laboratory. In this paragraph is made reference to the procedures that are In this paragraph is made reference to the procedures that are used in the taking of these actions as well as to its record. used in the taking of these actions as well as to its record.

Internal control.Internal control.

The SSDL has a Quality Assurance Programme which includes The SSDL has a Quality Assurance Programme which includes Internal Quality Assurance including redundancy checks on the Internal Quality Assurance including redundancy checks on the reference and working instrumentation and its documentation and reference and working instrumentation and its documentation and record keeping.record keeping.

Reviews Reviews

The Quality Manual contains a paragraph where are described the The Quality Manual contains a paragraph where are described the dispositions relating to management review process, which will be dispositions relating to management review process, which will be directed to guarantee the continuous adaptation, effectiveness directed to guarantee the continuous adaptation, effectiveness and improves of implanted Quality System. The reviews will and improves of implanted Quality System. The reviews will include any aspect of the quality system and services. include any aspect of the quality system and services.

Accreditation certificate issued in the year 2001Accreditation certificate issued in the year 2001

Important remarksImportant remarks

•Accreditation in 1997 by ISO guide 25. First SSDL in the network Accreditation in 1997 by ISO guide 25. First SSDL in the network that has been accredited by a national accreditation body.that has been accredited by a national accreditation body.

•Organization in 1999 of IAEA interregional training course on Organization in 1999 of IAEA interregional training course on calibration procedures and quality assurance in SSDLs.calibration procedures and quality assurance in SSDLs.

•Accreditation in 2001 by ISO/IEC 17025.Accreditation in 2001 by ISO/IEC 17025.

•Visit to laboratory of ILAC/IAAC experts in the year 2003.Visit to laboratory of ILAC/IAAC experts in the year 2003.

Advantages of implementation of quality systemAdvantages of implementation of quality system

•More organization and coordination of the work More organization and coordination of the work •More satisfaction of the clients More satisfaction of the clients •Work according international recommendations Work according international recommendations •More knowledge of the internal needs and of the clients. More knowledge of the internal needs and of the clients. Disadvantages Disadvantages •Hard works with documents and registers.Hard works with documents and registers.•Cost involved Cost involved in accreditation procedurein accreditation procedure Principal problemPrincipal problem

All services are included in the quality assurance system but not All services are included in the quality assurance system but not all are accredited. In the near future the SSDL plan to involve in all are accredited. In the near future the SSDL plan to involve in the accreditation other services. the accreditation other services.