L17 qa in industrial practices

1. 5th BAERA Training Course on Radiation Protection
for Radiation Control Officers (RCO) of Industrial
Practices
06-9 November 2017
L17: QA for Industrial Practices
Md Mustafijur Rahman
Principal Engineer
Bangladesh Atomic Energy Regulatory Authority

2. What is a QA/QC program?
• A Quality Assurance program is a set of processes that
help to ensure a desirable outcome by reducing defects
and non-conformance. The program starts at the design
phase and includes the specification, procurement,
manufacturing, fabrication, installation, and
commissioning of materials and/or equipment.
• Quality Control is a component of the Quality Assurance
program, and involves inspections and testing to identify
defects and non-conforming items. Quality Control also
provides a valuable feedback loop to improve the Quality
Assurance process
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3. What is a QA/QC program?
• “All those planned and systematic actions necessary to
provide confidence that a product or service will satisfy
given requirements for quality.” (ISO 9000)
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4. Legal basis for QA
• Rule-19.1 of NSRC Rules-1997
• “ A Licensee shall establish an appropriate
Quality assurance (QA) programme following
standard, code and guide in order to ensure
the implementation of all nuclear safety and
radiation protection requirement.
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5. Purpose of QA
To provide:
• A quality product or quality services for
customer satisfaction
• Reduce radiation exposure to workers to a
level As Low As Reasonably Achievable
(ALARA).
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6. Principles and Criteria for good practice
• Mission and vision of the radiation facility
• Quality management system
• Structure of the facility
• Equipment
• Documentation control
• Consumer feedback and complaints
• Communication
• The audit programme
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7. A Comprehensive QA Program typically
comprises of
• Quality Assurance Committee
• Policies and Procedures Manual
• Quality Assurance team
• Quality audit
• Resources
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8. Benefits of an Effective QA/QC Program
• Reduced defects & rework
• Assurance payments are in lock-step with work
• Quicker holdback release (bill more confidently; pay
more confidently)
• Better insurance and performance security terms
• Lower asset lifecycle costs
• Enhanced reputation and improved client and
subcontractor relations
• Greater certainty of project success
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9. Designing a Best-in-Class QA/QC Program
• Identifying and documenting best practices
• Implementation and Operation
• Continuous improvement (feedback loops)
• Evidence of compliance (audits)
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10. Elements of Quality Management system
• Control of documents and records
• Purchasing
• Traceability
• Calibration
• Maintenance
• Non-conforming product
• Internal audit
• Personnel
• Responsibilities and the irradiation contract
(IAEA Radiation Technology series-4, 2013)
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11. Standards, Code and Guides
• IAEA Safety Series No. 50-C/SG-Q
• The International Atomic Energy Agency (IAEA) Code
and Safety Guides contained in the Safety Series No.
50-C/SG-Q define basic quality assurance requirements,
which must be considered to ensure safety, and provides
recommendations on how to fulfill these basic
requirements.
• The IAEA 50-C/SG-Q standard reflects the performance
based approach to quality assurance covering all
aspects of plant safety, economics and efficiency
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12. • The International Organization for Standardization (ISO)
International Standard ISO 9001:1994 specifies quality
system requirements for use where any supplier’s
capability to design and supply a conforming product
needs to be demonstrated.
• The requirements specified are aimed primarily at
achieving customer satisfaction by preventing
nonconformity at all stages from design through to
servicing
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13. The comparison of the following publications
• IAEA Safety Series No. 50-C/SG-Q (1996), Quality
Assurance for Safety in Nuclear Power Plants and other
Nuclear Installations, Code and Safety Guides Q1–Q14
• ISO 9001:1994, Quality Systems — Model for Quality
Assurance in Design, Development, Production,
Installation and Servicing
• ISO 9002:1994, Quality Systems — Model for Quality
Assurance in Production, Installation and Servicing
• ISO 9003:1994, Quality Systems — Model for Quality
Assurance in Final Inspection and Test
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14. IAEA The quality assurance Code 50-C-Q consists of 10
basic requirements (BR);
1. Management
• BR 1: Quality Assurance Programme
• BR 2: Training and Qualification
• BR 3: Non-Conformance Control and Corrective Actions
• BR 4: Document Control and Records
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15. 2. Performance
• BR 5: Work
• BR 6: Design
• BR 7: Procurement
• BR 8: Inspection and Testing for Acceptance
3. Assessment
• BR 9: Management Self-Assessment
• BR 10: Independent Assessment
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16. Quality System Standard ISO 9001:1994
The clauses of ISO 9001:1994 are:
• 4.1 Management Responsibility
• 4.2 Quality System
• 4.3 Contract Review
• 4.4 Design Control
• 4.5 Document and Data Control
• 4.6 Purchasing
• 4.7 Control of Customer-Supplied Product
• 4.8 Product Identification and Traceability
• 4.9 Process Control
• 4.10 Inspection and Testing
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17. • 4.11 Control of Inspection, Measuring and Test Equipment
• 4.12 Inspection and Test Status
• 4.13 Control of Nonconforming Product
• 4.14 Corrective and Preventive Action
• 4.15 Handling, Storage, Packaging, Preservation and
Delivery
• 4.16 Control of Quality Records
• 4.17 Internal Quality Audits
• 4.18 Training
• 4.19 Servicing
• 4.20 Statistical Techniques
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