Quality Assurance Plan

The purpose of the quality assurance plan is to illustrate the mechanisms and processes that will be used and applied to maintain the quality of cloud-based personal insulin pump.

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Quality Assurance
Cloud-based Personal Insulin Pump (Cloud PIP)
1/1/2019

Quality Assurance
Table of Contents
Quality Assurance Plan.........................................................................................................................3
Introduction.......................................................................................................................................3
Purpose..........................................................................................................................................3
Scope.............................................................................................................................................3
Background...................................................................................................................................3
Project Objectives..........................................................................................................................3
Project Constraints.........................................................................................................................3
Quality Assurance Strategy...............................................................................................................4
Documentation..................................................................................................................................4
QA Goals...........................................................................................................................................4
Reviews & Audits..............................................................................................................................4
Tools & Techniques..........................................................................................................................4
Testing Strategies & Types................................................................................................................5
QA Roles & Responsibilities.............................................................................................................5
Software Quality Model........................................................................................................................5
Functionality......................................................................................................................................5
Reliability..........................................................................................................................................6
Software Quality Management..............................................................................................................6
Issues in Setting up QMS..................................................................................................................6
Recommended QMS..........................................................................................................................7
References.............................................................................................................................................9

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Quality Assurance Plan
Introduction
Purpose
The purpose of the quality assurance plan is to illustrate the mechanisms and processes that
will be used and applied to maintain the quality of cloud-based personal insulin pump.
Scope
The primary audience for the plan is the development team comprising of four requirement
analysts & testers and six trained developers. The plan is also developed for the project
stakeholders and management.
Background
Personal Insulin Pump (PIP) is a cloud-based external device that mimics the function of the
pancreas. There are embedded sensors integrated in the system to keep a track of the blood
sugar level and automate the insulin insertion process as per the need. The hardware
components used in the system include needle assembly, sensor, pump, controller, alarm,
displays, and clock. There are functional, non-functional, and user requirements that shall be
met by the system.
Project Objectives
The objective of the project is to develop an insulin pump for diabetes patients, insulin pump
developers, and physicians to improve the overall health condition.
Project Constraints
There is safety constraints associated with the project with the initial capacity of insulin
reservoir set as 100. The maximum daily dose can be 35, maximum single dose can be 5, and
minimum single dose can be 1. The safety requirements are regulated by the simulator mode
as manual or auto-run (Ieee, 2002).
There are information security constraints that also apply to the project. The patient data and
information must never be exposed to the unauthorized entities.

Quality Assurance
Quality Assurance Strategy
The quality assurance for the project will be maintained as per RAG (red, Amber, Green)
strategy. The risks and factors critical to the project which may hamper the project progress
and deliverables will be marked with red. The moderate-level defects, risks, and issues will
be marked as amber and the project modules and areas without any defects will be marked as
green.
The prioritization of applying quality assurance procedures will be highest for the areas and
issues marked with red followed by amber and green respectively.
Documentation
Quality Assurance and Quality Management plans will be developed in the planning phase of
overall quality management.
Software test scenarios and test cases will be created in the execution phase of quality
management. Software test reports and closure reports will be submitted in the last phase.
QA Goals
 The system shall not have any open defects at the time of final release.
 The cost of quality shall not have negative variance at any point during the project
lifecycle.
 Compliance towards quality, legal, and ethical standards shall be over 99.7%.
Reviews & Audits
Formal reviews and audits will be conducted in every phase of the project as planning,
execution, monitoring, and control.
Informal reviews, such as code walkthroughs will be carried out during the development
activities.
Tools & Techniques
The testing tools that will be used by the team will be HP Quality Centre for test creation and
management, Bugzilla for defect logging and management, and Selenium for automation
testing.

Quality Assurance
Testing Strategies & Types
Unit testing will be done by the development team followed by integration and system testing
by the testers. Regression and sanity testing along with security testing and performance will
also be done by the test team.
The end-users will perform user acceptance testing.
QA Roles & Responsibilities
Role Responsibility
Development Team Unit Testing
Tester 1 Quality management planning and
documentation
Tester 2 Integration & System Testing, Regression
Testing – Logging & tracking of defects, test
reports
Tester 3 Regression Testing – Logging & tracking of
defects, Security testing, test reports
Tester 4 Regression Testing – Logging & tracking of
defects, performance testing, sanity testing,
test reports
Software Quality Model
There are several quality characteristics that are defined under ISO/IEC 9126. Two such
characteristics that must be met by the cloud-based Personal Insulin Pump are functionality
and reliability.
Functionality
The primary goal of the development of the cloud-based personal insulin pump is to assist the
diabetic patients and the medical professionals. The goal of the system can only be achieved
when the functionalities and specifications of the system are included. There are functional,
non-functional, and user requirements that have been defined for the insulin pump that need
to be incorporated.
Functionality is therefore one of the primary characteristics that must be included from the
software quality point of view. The backend cloud platform for the system must have

Quality Assurance
functionality as one of the primary and essential characteristics. For instance, the insulin
delivery and injection will be carried out on the basis of the glucose levels recorded and
registered at the backend of the system (Sqa, 2019). The analysis of the data sets will be
performed on the current and the past values to determine the insulin level to be injected.
Also, there are safety constraints applicable on the system that shall be regulated from the
cloud backend. For example, the initial capacity of insulin reservoir set as 100. The
maximum daily dose can be 35, maximum single dose can be 5, and minimum single dose
can be 1. Also, the simulator mode as manual or auto is controlled by the backend platform.
The measurement of the quality characteristic shall be done on the basis of the defect density
and defect rate at every phase of the project.
Reliability
The data stored at the cloud backend must be reliable as the inadequate or incorrect
information may have fatal impacts on the patient health condition.
Reliability in the case of data sets refers to the accurate update of the information in all the
database instances and repositories. The patients must be able to acquire latest glucose levels
to monitor their health accordingly. Availability is another characteristic that must be met to
make sure that the backend platform is reliable. The system must be available at all times and
must be accessible from every location.
There are certain measures that may be used to monitor these quality characteristics. The
reliability and availability shall be measured on the basis of the downtime of the system and
the mean time to failure associated with the backend.
Software Quality Management
Issues in Setting up QMS
There are several issues that may come up in setting up the Quality Management System
(QMS) for the company.
There are ten resources that are engaged in the development team for the project. These
resources comprise of the requirement analysts, testers, developers, programmers, and
designers. Apart from the development team, there are other departments that are also
involved in the project. There are internal and external stakeholders that have a significant

Quality Assurance
role to play. Communication may be one of the major issues that may crop up in the setting
up the QMS for the company and the project. It is because the quality objectives and goals
may vary from one entity to the other and it may not be easy to come up to consent.
The project belongs to the healthcare domain and there are various regulations and standards
that must be complied with. The healthcare information belongs to the most sensitive and
critical information category and shall be handled with utmost care. There are Health
Insurance Portability & Accountability Act (HIPAA) and other information privacy
regulations that need to be adhered to. The amalgamation and compliance of these
requirements may be an issue during the setting up of QMS.
There may also be too many changes that may come up for the project. It is because there are
a lot of varied components associated with the system. The hardware components used in the
system include needle assembly, sensor, pump, controller, alarm, displays, and clock. There
are software tools and modules involved for the system functionalities. There may be
upgrades or modifications needed in these interfaces and components that may be difficult to
target in the QMS set up.
Recommended QMS
Change Control is one of the quality management systems that must be included in the
project. The QMS will handle all of the changes made to the system and will also handle only
the valid and approved change requests. It will allow the members of the project team to
achieve the quality goals and project objectives as per the defined deadlines for the project.
Policy management is another category of QMS that shall be included to handle the various
parameters and guidelines defined under different regulations and standards. The rules and
protocols defined as per the government policies, healthcare authorities, organizational
policies, etc. will be handled using the QMS (Addey, 2011).
The third type of QMS that shall be included is internal audit. The internal management of
the company shall carry out quality assurance and quality control reviews and audits to meet
the quality objectives. The definition of these goals and characteristics shall be done by the
team of auditors and healthcare experts. The internal audit will ensure that the compliance
towards all of the healthcare standards is maintained and will also synchronize the project
requirements and functionalities.

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The three categories of QMS shall be implemented in the project and the organization to
achieve the quality goals and objectives.

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References
Addey, J. (2011). Quality management system design: A visionary approach. Total Quality
Management, 12(7), 849-854. doi: 10.1080/09544120120095954
Ieee. (2002). IEEE Standard for Software Quality Assurance Plans, (978-0-7381-3286-0).
doi: 10.1109/ieeestd.2002.94130
Sqa. (2019). ISO9126 - Software Quality Characteristics. Retrieved from
http://www.sqa.net/iso9126.html