Routine production checks
QSA Global uses a four-part quality assurance system to ensure radiation sources meet the highest integrity levels in the industry, meeting or exceeding statutory and international regulatory requirements.
Quality Assurance
Radiation sources are manufactured in accordance with a strict quality assurance program, details of which can be retained on request
Leakage and Contamination Tests
Stringent tests for leakage are essential features of radioactive sources production. Our tests are based on ISO 9978. Some standard methods used for testing radiation sources are listed below.
- Wipe Test I - The source is wiped with a swab or tissue, moistened with ethanol or water, and the activity removed is measured.
- Limit: 200Bq
- (Limit USA: 5nCi)
- Immersion Test II - The source is immersed in a suitable liquid at 50°C for at least 4 hours. The activity removed is then measured.
- Limit: 200Bq
- (Limit USA: 5nCi)
- Bubble Test III - The source is immersed in water or a suitable liquid, and the pressure in the vessel reduced to 13kPa (100mm Hg). No bubbles must be observed.
- Krypton Emanation Test V - The source is held under reduced pressure for 24 hours. The content of the chamber is analyzed for Krypton-85 by scintillation counting.
- Krypton Emanation Test VI - The source is held under reduced pressure for 24 hours. The content of the chamber is analyzed for Krypton-85 by scintillation counting. The test is repeated after at least 7 days.
Special Safety Performance Tests on Prototypes
A radiation source must provide the highest possible integrity, together with minimum attenuation of the required radiation by the encapsulation materials. A compromise is sometimes made, particularly for alpha, beta, and low energy photon sources.
Safety must always be the prime consideration. Standards for sealed radioactive source testing have been specified by ISO.2919 and ISO.9978.
- ISO.2919 'Sealed radioactive sources – Classification'
- ISO.9978 'Sealed radioactive sources – leak test methods'
This classification system is modeled on USA standard US ANSI N43.6-1997 which also gives a number of comparable leak test methods.
Measurements
Each source or batch of sources is checked to ensure that the strengths of the sources supplied are within the limits specified. Wherever possible, the results of these checks are indicated on the rest report.
Test Reports
A test report is supplied with each source or batch of sources. The following information is supplied where applicable:
- Product code
- Product description
- Capsule type
- ISO classification
- Special form certificate
- Serial number of source
- Measurement check
- Leakage check
- Contamination check
ISO.9001 International Management System Standard
In addition to our routine quality control procedures, QSA Global Inc. is approved to the Internal Quality Management System Standard ISO 9001:2000.
This Quality Management System defines Quality Policy, describes the necessary organization in place to carry out the policy, and describes the procedures in place which are necessary to carry out and maintain the system.
The system involved the thorough training of all staff, documentation of procedures, maintenance of records, and the assessment & recertification of non-conformities.
Regular surveillance audits are made by Lloyd's Register Quality Assurance Ltd.*, to ensure that the high standards demanded by ISO.9901 are maintained by QSA Global Inc. to all stages of the source production process from establishing the source specifications, through design, manufacture, test and measurement to dispatch and after sales service.
* Lloyd's Register Quality Assurance Ltd. (LRQA) is accredited by the National Accreditation Council for Certification Bodies.