L17 qa for industrial practices

1. 5th BAERA Training Course on Radiation Protection for
Radiation Control Officers (RCOs) of Industrial Practices
Bangladesh Atomic Energy Regulatory Authority
Agargaon, Dhaka
06-09 November 2017
Lecture-17: QA for Industrial Practices

2. 2
Quality assurance programs
Quality Assurance: (QA) refers to administrative and procedural
activities implemented in a quality system so that requirements
and goals for a product, service or activity will be fulfilled. It is the
systematic measurement, comparison with a standard, monitoring
of processes and an associated feedback loop that confers error
prevention.
 Quality Assurance measures the quality of the processes
being utilized to produce quality products.
 QA cannot absolutely guarantee the production
of quality products.
 Management shall develop, implement and maintain a quality
Assurance Program
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

3. Quality assurance programs
The quality assurance program shall include –
 Organizational structure,
 Functional responsibilities,
 Levels of authority
 Interfaces for those managing, performing and assessing the
adequacy of work
 Management measures, including planning, scheduling and
resource considerations.
 Interdisciplinary approach involving many organizational
components; and
 shall not be regarded as the sole domain of any single group.
QA lecture by Zoardar (SSO, NSRCD) 3

4.  The quality assurance program shall demonstrate three
principles-
1. Managers provide planning, direction, resources and
support to achieve the organization's objectives
2. staff performing the work achieve quality; and
3. staff performing assessments evaluate the effectiveness of
management processes and work performance.
 The quality assurance program shall be binding on everybody
 The person in the most senior management position within
the organization is responsible for establishing the QA
program.
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

5.  Radiation Protection & safety shall be the fundamental
consideration in the identification of the items, services and
processes to which the quality assurance program applies
 A graded approach based on the relative importance to
radiation safety of each item, service or process shall be
used
 The graded approach shall reflect a planned and
recognized difference in the applications of specific quality
assurance requirements
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

6. Basic Requirements:
 QUALITY POLICY
 PLANNING
 TRAINING AND QUALIFICATION
 NON-CONFORMANCE CONTROL AND CORRECTIVE ACTIONS
 DOCUMENT CONTROL AND RECORDS
 INTERFACE ARRANGEMENTS
 WORK
 DESIGN
 PROCUREMENT
 INSPECTION AND TESTING FOR ACCEPTANCE
 MANAGEMENT SELF-ASSESSMENT
 INDEPENDENT ASSESSMENT
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

7. QUALITY POLICY: The quality policy should;-
 Specify the organization’s mission and objectives
 Set management’s expectations for organizational and individual
employee performance
 Create an environment that promotes quality and the improvement of
quality throughout the entire organization
 Ensure employees have the necessary responsibility and authority to
carry out their work as it has the greatest effect on item, service and
process quality
 Establish management’s responsibility for ensuring that employees
understand and accept their respective roles and obligations in
carrying out the quality policy.
 Define the key documents which govern the levels of performance,
such as:
1. National codes and standards, 2. Statutes and regulations etc.
Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

8. PLANNING
 Management should prepare a plan to achieve full implementation
of the QA program. Plan should be approved and monitored by the
appropriate management level
 Provisions for selecting, training and assigning adequate numbers of
personnel consistent with schedules for implementation and work
loading
 Work plans, schedules, instructions, technical instructions and
drawings which are needed to define the specific actions to perform
work should be developed and used to accord with the management
processes described in the QA program description
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

9. TRAINING AND QUALIFICATION
 Personnel shall be trained and qualified so that they are competent
to perform their assigned work and understand the safety
consequences of their activities
 The organization’s overall objectives regarding item quality,
personnel and public safety and their direct relation to the quality
policy and the QA program shall be explained in the initial and
continuing training of all personnel who are managing, performing
and assessing work
 Training shall provide for the progressive improvement of personnel,
and should not be limited to initial job qualification and proficiency
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

10. JOB DESCRIPTIONS:
 A typical job description should contain the following
information-
 Job title
 Purpose of job
 Organization (Organizational structure for that post,
Position in the organization, Lines of reporting),
 Duties (Key tasks and responsibilities, Authority,
Accountability)
 Qualifications (Knowledge and expertise, Education,
Training, Experience, Medical fitness)
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

11. NON-CONFORMANCE CONTROL:
 NON-CONFORMANCE IDENTIFICATION: Conditions and events to be
handled by the non-conformance control process could include-
 Physical characteristics outside specified limits, such as
dimensional and/or material parameters, installation errors and
item/system performance deficiencies
 Deviations from approved process parameters or procedures
 Failure of personnel to implement work, inspection or test
instructions
 Inadequate documentation, containing incorrect or incomplete
information
 Inadequate training of personnel to perform safety related tasks
for which they have been given responsibility
 Incidents, malfunctions and failures
Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

12. NON-CONFORMANCE CONTROL:
 REPORTING: A formal report of a non-conformance should-
 Identify who is reporting the non-conformance, when it was
found and to whom it was reported
 Identify the non-conforming item, service or process and state
the location, the method used to physically mark, label,
segregate or otherwise control the item and the service or
process to prevent its inadvertent use
 Include a description of the non-conformance
 Describe the immediate action taken by the originator, or known
to be taken by others, to minimize adverse effects of the non-
conformance
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

13. NON-CONFORMANCE CONTROL:
 CORRECTIVE ACTIONS : Non-conformances could be designated in
one of the following ways-
 Reject, Repair, Rework, Accept with condition, Accept without
modification
 Preventive Actions
 Changes to designs, specifications, procedures, etc
 Enforcement of the requirements of procedures, work
instructions, etc
 Modification of current procedures or issue of new procedures
 Withdrawal of defective equipment for maintenance or calibration
 Retraining and requalification of personnel involved
 Improvement to the QA programme
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

14. DOCUMENT CONTROL
 Documents such as procedures, instructions, specifications and
drawings, or other media, which describe processes, specify
requirements or establish design, shall be prepared, reviewed,
approved, issued, distributed, authorized, revised and, as required,
validated
 Procedures for the preparation, review, approval, issue, modification
and control of documents should be established
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

15. 15
POLICY AND
OBJECTIVES
MANAGEMENT
CONTROL
Work Implementation
Quality assurance programs
DOCUMENTATION STRUCTURE OF THE QUALITY ASSURANCE PROGRAMME
Level 1: QA Program Description
Quality policy statement
Mission and objectives
Organizational structure
Functional responsibilities
Level 2: Management documents
Management procedures
Job descriptions
Interface arrangements
Department manuals
Level 3: Detailed working documents
Work instructions
Technical instructions
Drawings
Plans and schedules
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

16. RECORDS :
 Records relating to personnel and records that describe the status,
configuration and characteristics of items and services, describe the
performance of processes and represent objective evidence of
quality shall be specified, prepared, reviewed, approved and
maintained
 All records shall be legible, complete and identifiable
 An appropriate records system shall be established and
implemented by the responsible organization
 The responsibilities for maintaining and operating the records
system should be clearly defined and documented
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

17.  The records system should ensure that records are-
 Categorized
 registered upon receipt
 readily retrievable
 indexed and placed in their proper location within the
record facility files with the retention time clearly
identified
 stored in a controlled environment
 corrected or supplemented to reflect the actual plant
status
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

18. INTERFACE ARRANGEMENTS:
 There needs to be a clear understanding of the division of responsibilities
between all organizational units participating in a QA program
 In the preparation of these interface among the divisions or units the
following points should be addressed-
 The participating units should be identified and included on the
circulation/control list
 The prime responsibilities, authority and accountability for the activity
should be clear
 Responsibilities for review and comment, approval of technical issues,
implementation, reporting, verification and audit, where appropriate,
should be defined
 Key positions within each unit to act as focal points for communication
should be identified
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

19. WORK
 During all stages in the life of the radiological facility, work shall be
planned and performed in accordance with established codes,
standards, specifications, practices and administrative controls
 Equipment used for process monitoring, data collection, and
inspections and tests shall be of the proper range, type, accuracy and
precision
DESIGN
 Design, including subsequent changes, shall be carried out in
accordance with established engineering codes and standards, and
shall incorporate applicable requirements and design bases
 The adequacy of design, including design tools and design inputs and
outputs shall be verified
Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

20. PROCUREMENT
 Procured items and services shall meet established requirements
and perform as specified
 Suppliers shall be evaluated and selected on the basis of specified
criteria
 Requirements necessary to ensure the quality of items and services
shall be developed and specified in the procurement documents
 Evidence that purchased items and services meet procurement
requirements shall be available before they are used
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

21. INSPECTION AND TESTING FOR ACCEPTANCE:
 Inspection and testing of specified items, services and processes shall be
conducted using established acceptance and performance criteria
 Inspection and testing, whether performed by the responsible organization or
by a supplier, take place at three identifiable stages. These are-
 Receiving inspection and testing, prior to commencement of work
 In-process inspection/monitoring, during performance of the work
 Final inspection and acceptance testing, upon completion of the work
 Tests may include
prototype qualification tests pre-operational tests
production tests operational tests
proof tests prior to installation
construction tests
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QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)
Quality assurance programs

22. MANAGEMENT SELF-ASSESSMENT
 Management at all levels shall regularly assess the processes for
which it is responsible
 Management shall determine its effectiveness in establishing,
promoting and achieving radiation safety objectives
An effective management self-assessment evaluates issues such as:
 mission of the organization
 whether employees understand the mission
 what is expected of the organization
 whether the expectations are being met
 opportunities for improving quality and enhancing radiological
safety
 how to make better use of human resources
Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

23. INDEPENDENT ASSESSMENT
 Independent assessments shall be conducted on behalf of
management to measure the effectiveness of management
processes and the adequacy of work performance, to monitor
item and service quality and to promote improvement
Independent Assessment shall be performed through the following
Procedures:
 INTERNAL AUDITS
 EXTERNAL AUDITS
 SURVEILLANCE
 PEER EVALUATION
 TECHNICAL REVIEW
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Quality assurance programs
QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

24. 24
CONCLUSION
Quality assurance, is the systematic monitoring and evaluation
of the various aspects of a project, service or facility to maximize
the probability that the minimum standards of quality are being
attained by the production process.
QA cannot absolutely guarantee the production
of quality products.
Quality is determined by the product users, clients or customers,
not by society in general.
It is not the same as 'expensive' or 'high quality'.
Low priced products can be considered as having high quality if
the product users determine them as such.
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QA – A K M Raushan Kabir Zoardar (PSO, BAEC & BAERA)

25. References:
 www.iaea.org
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Thank you