qa online training tutorial by quontra solutionss
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QUALITY ASSURANCE(QA)
BY
QUONTRA SOLUTIONS
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Recap
What is testing?
Who does testing?
Why do we do testing?
Software testing process?
Software Testing
Levels of testing
Methods/techniques of testing
Test cases
Writing effective test cases
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Activities of Quality Assurance Dept.
Technology transfer
Validation
DocumentationAssuring quality of products
Quality improvement plans.
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Technology Transfer:
Technology Transfer Receipt of product
design documents from research centre
Distribution of documents received from
research centre
Checking and approval of documents
generated based on research centre
documents i.e. batch manufacturing record
Scale-up and validation of product
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Validation
Validation Preparation of validation plans for
facility, equipments/process including
cleaning
Approval of protocol for validation of
facility/equipment/product/process
Team member for execution of validation of
facility/equipment/product/process
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Documentation Control
Documentation Control Controlle distribution
and archiving of documents
Control of changes made by proper
Change control procedure Approval of all
documentS
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Assuring Quality of Products
cGMP training
SOP compliance
Audit of facility for compliance
Line clearance
In-process counter checks
Critical sampling
Record verification
Release of batch for marketing Investigation of market complaints
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Quality Improvement Plans:
Feedback received from the compliance team
Proposals for corrective and preventive actions
Annual Products review
Trend analysis of various quality parameters for
products, environment and water
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Elements of S/W Quality Assurance
Standards
Reviews and audits
Testing
Error/defect collection and analysis
Change management
Education
Vendor management
Security management Safety
Risk management
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SQA tasks
Prepares an SQA plan for a project
Participates in the development of the projects softwareprocess description
Reviews software engineering activities to verify
compliance with the defined software processAudits designated software work products to verify
compliance with those defined as part of the softwareprocess
Ensures that deviations in software work and work
products are documented and handled according to adocumented procedure
Records and noncompliance and reports to seniormanagement
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ISO 9000 Quality Standards
ISO 9000 describes QA elements in generic terms Elements include organizational structure, procedures,
processes and resources. It treats an enterprise as a network of interconnected processes. To be ISO-complaint processes should adhere to the standards
described.
Ensures quality planning, quality control, quality assurance andquality improvement.
From S/W engineering view point: An international standardwhich provides broad guidance to software developers on how toImplement, maintain and improve a quality software systemcapable of ensuring high quality software
Consists of 20 requirements... Differs from country to country..
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Statistical SQACategories of errors
Incomplete or erroneous specification (IES)
Misinterpretation of customer comm (MCC)
Intentional deviation from specification (IDS)
Violation of programming standards (VPS)
Error in data representation (EDR)
Inconsistent module interface (IMI) Error in design logic (EDL)
Incomplete or erroneous testing (IET)
Inaccurate or incomplete documentation (IID)
Error in programming lang. Translation (PLT)
Ambiguous or inconsistent human-computer interface (HCI) Miscellaneous (MIS)
Most often IES, MCC and EDR are the vital few causes for majority oferrors.
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Management responsibility
Quality system
Contract review
Design Control
Document and data control
Purchasing
Control of customer suppliedproduct
Product identification andtraceability
Process control
Inspection and testing
Control of inspection, measuringand test equipment
Inspection and test status Control of non-confirming
product Corrective and preventive action
Handling, storage, packaging,preservation and delivery Control of quality records Internal quality audits Training Servicing
Statistical techniques
ISO 9001 requirements
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www.quontrasolutions.com
Quontra solutionsEmail: info@quontrasolutions comhttp://www quontrasolutions com
Call : (404) 900-9988
mailto:[email protected]:[email protected]