qa online training tutorial by quontra solutionss

8/12/2019 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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qa online training tutorial by quontra solutionss

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