Computer Information System Department - New …eac2/Main Files/HMI_FINAL.pdfComputer Information System Department New Jersey Institute of Technology Newark, NJ 07102 Human Machine

Computer Information System Department

New Jersey Institute of Technology Newark, NJ 07102

Human Machine Interface

In Partial Fulfillment of the Course Requirement for: CIS 490 – 001

Proposed to: Prof. Osama Eljabiri

Proposed by: Chang, Evelyn A.

Ding, Daniel Javier, Melissa Kim, Chiyong Pina, Glenys

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TABLE OF CONTENTS

Page i. Title Page

ii. Table of Contents 2

1. Introduction 5

1.1 Project Initiation

1.1.1 Project Abstract 5

1.1.2 History 6

1.2 Project Planning

1.2.1 Background 7

1.2.2 Problem Statement 7

1.2.3 Previous Works 11

1.2.4 Methodologies

1.2.4.1 Waterfall Model 13

1.2.4.2 Spiral Model 15

1.2.4.3 Extreme Programming (XP) – Agile Approach 17

1.2.4.4 WINWIN Spiral Model 19

1.2.4.5 Methodology Selection Matrix 20

1.2.5 Glossary 21

2. Project Management

2.1 Project Team and Roles 27

2.2 Resources Management

2.2.1 Work Breakdown Structure (WBS) 28

2.2.2 Project Milestones 30

2.2.3 Preliminary Project Plan 31

2.2.4 Baseline Plan 32

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2.3 Feasibility Study: Feasibility Study

2.3.1 Economic Feasibility 33

2.3.2 Feasibility Analysis 34

2.3.3 Break-Even Point Analysis 35

2.4 Risk Management 36

3. Project Analysis

3.1 Stakeholder Identification 40

3.2 Gathering Requirements 42

3.2.1 Interviewing 42

3.2.2 USE-CASE Scenarios 43

3.2.3 Brainstorming 50

3.3 Documenting Requirements

3.3.1 Functional Requirements 53

3.3.2 Non-Functional Requirements 55

3.4 Modeling Requirements

3.4.1 USE-CASE Diagram 56

3.4.2 DFD Diagrams 57

3.4.2.1 Grammatical Analysis 59

3.4.2.2 Context Diagram 59

3.4.2.3 General Context Diagram 60

3.4.2.4 Decompositions 61

3.4.3 Data Dictionary 69

4. System Specifications

4.1 Requirement Specification 72

4.1.1 Structured English 72

4.1.2 Decision Trees 74

4.1.3 Decision Tables 75

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4.2 Functional Specification 76

4.3 Design Specification 77

5. Qualifications

5.1 Installation Qualification 78

5.2 Operational Qualification 80

5.3 Performance Qualification 81

6. System Design

6.1 Structured Chart 83

6.2 User Interface Design

6.2.1 AS-IS User Interface Design 84

6.2.2 TO-BE User Interface Design

6.4 Database Design

6.4.1 AS-IS Database Design 87

6.4.2 TO-BE Database Design 89

7. System Architectural Model

7.1 AS-IS System Architectural Model 90

7.2 TO-BE System Architectural Model 91

8. References 92

9. Extra Work 94

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1. Introduction

1.1 Project Initiation

1.1.1 Project Abstract

This project is concerned with the new approach to developing user-interface

applications based on the cognitive aspects of human information processing. Our team

consists of five members whom will assist the engineers of ABC Laboratories in the

development of this Human Machine-Interface (HMI) with ISQL database software.

Our project will provide operators of the facility the ability to monitor and control

equipments from their personal computer platforms. The application interface animates the

manufacturing process on computer displays for engineers to facilitate the monitoring of the

drug production. Equipment operations and functions for manufacturing products are easily

controlled by the “click of a mouse.” Thus, the HMI system should be user-friendly.

This new technology offers engineers the opportunity to increase operating efficiency

and reduce operating costs by allowing the remote monitoring and control of water and

wastewater treatment plants, treatment processes, wells, ground storage tanks, and pumping

stations. Using HMI technology, one person can monitor in real time, multiple facilities located

in geographically dispersed areas. The previous database will be updated to higher version with

better performance and with advance features.

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1.1.2 History

The Human-Machine Interface (HMI) was originated from man-machine interface (MMI)

of the 1950’s, followed by the Programmable Logic Controller (PLC) in the 1970’s. Personal

computer (PC) was developed in the early 1980’s. HMI was created from pixel graphics to

highly graphical object-oriented application. This object-oriented application animates a

production process that provides the look and feel of chart recorders and strip recorders.

The design engineers began creating software-based process visualizations that provide

much more graphical views of production processes. The production process is controlled by

the PLC. This visualization is called HMI. The HMI talks to the PLC and reads its data to

populate the highly graphical screens. The screen provides animation and colors that imitates

the process and showed the real-time data on-screen to provide better feedback to operators.

The architectural concept of HMI development is to normalize plant data into simple tag

data types and abstract graphical user interface (GUI) component. There are available I/O

driver toolkit to support multiple PLCs and provides a unified interface to connect various PLC

drivers. This actually means that HMI became independent of factory-floor devices and was

able to connect to hundreds of different devices.

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1.2 Project Planning

1.2.1 Background

ABC Laboratories is continuously improving its manufacturing practices to meet the

stringent requirements of the FDA. In their engineering department, engineers are trying to

develop a multiple front-end interface system (HMI) and a strong back-end server with

database program (ISQL) to facilitate the manufacturing of drugs and medication. This

program, if successful, would greatly enhanced the manufacturing process by reliably

monitoring the synthesis of medications. Monitoring is an important task that is detrimental in

terms of safely producing a drug.

Dr. J.P. Gray and W.W. Fred founded P Pharma L.P. and The P. Fred Company. They

started the company on Manhattan's Lower East Side on 1892. P Pharma L.P. is one of the

fastest-growing pharmaceutical companies in the world. The company progressed and

expanded their territories to One Stamford Forum, a distinctive, tiered office tower in

Stamford, CT, 13-story, 529,000-square-foot building houses more than 1,000 employees. ABC

Laboratories is a manufacturing division that was established on 1976 in Totowa, NJ. They have

two separate research facilities in the United States that is in Ardsley, NY and Cranbury, NJ.

They have additional headquarters and manufacturing plants that are located in Secaucus, NJ,

Norwalk, CT, Wilson, NC, Garrett Mt, NJ, and Canada. P Pharma L.P., The P Fred Company, and

associated companies are part of an international group of privately held associated companies

- including Mundipharma Vertriebsgesellschaft mbH in Germany and Napp Pharmaceuticals

Limited in the U.K. - employing approximately 5,000 people in pharmaceutical research,

manufacturing, and marketing worldwide.

However, in order for them to maintain their excellent standing, they concentrate their

concerns in their manufacturing division, such as ABC Laboratories. ABC Laboratories

manufactures narcotic and non-narcotic drugs. These products include OxyContin® (oxycodone

HCl controlled-release) Tablets, MS Contin® (morphine sulfate controlled-release) Tablets,

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Uniphyl® (theophylline, anhydrous) Tablets, Chirocaine® (levobupivacaine injection), and the

popular over-the-counter Senokot® Laxatives, Betadine® Microbicides, and Betadine® Brand

Antibiotics. In the process of making these drug products, the trained operators in the facility

has the privilege to interact with the HMI system to control and monitor the cycle of drug

productions in an equipment. The application interface animates the manufacturing process on

computer displays for operators to facilitate the monitoring of the drug production. Instead of

running the equipment manually, which is considered hazardous, the interface system is

programmed to perform an operation with the convenience of touch screen interface.

Nevertheless, the process of controlling gigantic equipment has few issues that the current

system is in deep concerns.

The most common concern is that the built-in interface of the equipment is too complex

for non-technical users. The equipment installed in the facility has its system requirements not

complying with the requirements of the ABC Laboratories. Hence, the interface of the

equipment is not a user-friendly.

Creating batch report is one of the current issues of the engineers in the ABC

Laboratories. The current version of the database, which is Industrial SQL (ISQL) Server 7.1, is

not designed to generate report. The reporting option of a standard database is not available in

the current ISQL because a standard database does not have the ability to handle massive

real-time data in every millisecond. The way the ISQL was designed is for collecting enormous

and rapid incoming data from the PLC. It also has the ability to compress Giga bytes of data in

every ~8 seconds.

The automation of equipments in the facility offers the engineers the opportunity to

increase operating efficiency and reduce operating costs by allowing the remote monitoring and

control of water and wastewater treatment plants, treatment processes, wells, ground storage

tanks, and pumping stations. Using HMI technology, one person can monitor in real-time,

multiple facilities located in geographically dispersed areas.

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1.2.2 Problem Statement

Although the existing HMI system is functional, the current User Interface is too

complex and non-intuitive for non-technical users. These users who operate the systems don’t

understand the technical diagrams and the components in the current system. Furthermore,

they are intimidated to use the system due to this lack of understanding. More intuitive

indicators for parameters or slider bars with warning indicators will help non-technical users

monitor every component of the system and ensure that they know what the appropriate

values for each parameter are.

Current users requested more effective and user-friendly ergonomics. The clients

described that the interface should be intuitive enough even a non-technical person can

operate the system with just enough information about what each parameter should be. In the

case if a regular operator is absent for any reason his or her substitute can easily operate the

system with little training.

For any experienced software developer, the practice of using meaningful and consistent

naming conventions in their code should be second nature. It helps themselves as well as

others to better understand what was written. The current customized code written by the

vendor is too cryptic and lacks proper documentation. The system developers spent a lot of

unnecessary time trying to figure out what was written. If the code was commented properly a

lot of time could be saved for other tasks. For effective and efficient development of the current

project as well as future maintenance and upgrades, the current code has to be made more

concise and understandable. More code comments are required. Although the system is object

oriented. Some classes and modules still need to be optimized and changed in the future to

tailor to the hardware and infrastructure changes. Therefore it is important that the time is

spent right now to optimize and properly document the code so in the future time and money

can be saved when upgrades are necessary.

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There was an instance where a local administrator of a particular HMI module was able

to delete the system administrator of the entire system. Part of the system was rendered

inoperable for that reason. A system restore had to be carried out to return the system to a

previous state. The permissions for each security role in the current system has to be checked

and reapplied carefully so that each user will have only the privileges he or she is supposed to

have.

The physical location of the hardware for the HMI system will also be a concern.

Currently some of the more sensitive hardware such as the terminals is located near potentially

hazardous production areas. Careful Analysis has to be performed to move them to a safer yet

in a strategic location.

One important business process is report generation from historical plant data. The

current HMI system does not have a dedicated reporting module. Microsoft Access is used via

open database connectivity to ISQL and ad hoc reports are then generated within Access.

Microsoft Access was designed as a single user database and does not handle large amounts of

plant data well. It takes up to two days to generate a typical report and that is not acceptable

to the clients. The request is to develop a dedicated reporting module for the HMI system so

report generation is dynamic and relatively fast.

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1.2.3 Previous Works There are many developers of HMI application. Some developers based their application

on pixel graphics and some based on Object-Oriented programming. The graphic application is

tremendously difficult to program pixel drawings and screen diagrams. The developers soon

are trying to establish to design images and diagrams through Object-Oriented designs. In

comparison, all the interface products have similar problems:

The first system is the InTouch® produced by Wonderware Inc., the world's leading HMI

software company. InTouch® provides a single, integrated view of all control and information

resources. It enables engineers, supervisors, managers and operators to view and interact with

the workings of an entire operation through graphical representations of their production

processes. But, the User Interface is too complex and non-intuitive for non-technical users.

Information on the InTouch® may be found at the following URL:

http://www.wonderware.com/products/visualization/intouch/

Second system is the OI-2000® HMI Software produced by Software Horizons Inc. OI-

2000® is powerful, easy to use, yet cost effective HMI available for industrial monitoring and

reporting. It has fast screen creation process through support for OLE (object linking and

embedding), and has TCP/IP Connectivity enables multiple systems to be linked together and

share data. It also has macros and script programming functionalities allow data manipulation

and decision making for user’s application needs.

Information on the OI-2000® may be found at the following URL:

http://www.shorizons.com/

The last system is the Visual Tag System (VTS) produced by Trihedral Engineering. VTS

provides software tools to develop operator interfaces for Original Equipment Manufacturers

(OEMs), Systems Integrators (SIs) and advanced end users across all types of industry. It even

gives users the tools to create new tools to tackle specific situations, and create a custom

operator interface software package with its own personality.

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Information on the VTS® may be found at the following URL:

http://www.trihedral.com/html/about_trihedral/about_trihedral.html

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1.2.4 Methodologies

1.2.4.1 Waterfall Model

The approach we are going to use for the SDLC (Systems Development Life Cycle) of

our system is the classic waterfall model. It involves six major phases each dependant on it’s

predecessor:

Step one involves project identification and selection. Priorities for systems and

projects are identified. An overall architecture for all system components is the result of this

planning phase.

Step two involves project initiation and planning. Detailed steps and work plan for the

project is defined. Specifications for high-level system requirements and features are finalized

here. Resource planning and system justification of the business case is also completed.

Step three is the analysis phase. An overview of the current system is created and the

problem and opportunities are explored. Recommendations are made to replace, repair or

enhance the current system. Justifications are made for the intended alternative.

Step four is the Design phase. The design face itself is divided into two sub-phases.

First, the logical design phase. Functional and detailed specifications of all system components

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are defined. This includes data, processors, inputs, and outputs. Secondly is the physical

design phase. This is where technical, detailed specifications of all system components are

specified. These include programs, files, network, system software, etc.

Step five is the implementation phase. This is the actual development phase where

code, documentation, training procedures, and support capabilities are implemented.

Step six is the maintenance phase. Bug fixes, new versions or releases of software and

associated updates to documentation, training and support are applied in this phase.

Although these major phases cannot be implemented concurrently. Sub-phases within

these major phases can occur concurrently where applicable.

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1.2.4.2 Spiral Model

The idea of the spiral model is evolutionary development intended to help manage risks,

using the waterfall model for each step. The developers usually only define the highest priority

features first rather than the details of the entire system. Once the high priority features are

defined and implemented, feedback from the users or customers are collected. With the

knowledge collected, the developers can go back to the system to define and implement more

features in greater details. In its original form, the spiral model is consisted of four phases.

• Planning (objectives, constraints, alternatives)

• Risk Analysis

• Engineering

• Evaluation

Each phase is represented as a quadrant of the spiral model. Each phase will be

revisited and through the successive iterations of these phases, the project follows the path

of the spiral.

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Initially the project objectives and requirements are defined, and then risk analysis is

performed to determine the volatility and level of uncertainty of the project requirements.

Prototyping is then used in the engineering phase to build a mock up version of the

application. The customer will evaluate this prototype and a more concrete requirement

can be obtained from the feedback of this evaluation.

At the conclusion of each spiral, a decision must be made as to whether it's feasible to

continue the project. If a decision were made to carry on the project, the spiral would

progress through to the next iteration, where the four phases are revisited into a more

detailed system. More and more functionality is built into the application through the

successive builds. A close to complete system should be produced by the time the spiral

has reached its third level.

Strengths of Spiral Model:

• Introduces formal risk management to the software engineering process

• Prototyping controls cost (Sorensen, Acosta), and coveys to the user the look

and feel of a system far more thoroughly than a requirements specification

(Boehm, 1996)

• Evolutionary development allows a product to be released for evaluation early,

and seeks to provide feedback and evaluation for the development team.

Weaknesses of Spiral Model:

• Lack of risk management experience (Charette)

• Lack of milestones (Microsoft, Boehm)

• Management is dubious of the spiral process, its evolutionary nature (May), and

the concept of starting a project without rigidly defined objectives (Sorensen).

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1.2.4.3 Extreme Programming (XP) – Agile Approach

The Agile approach to software development focuses on fast delivery of quality products

through which the project life cycle can be reduced. Agile principles include but are not limited

to a) customer satisfaction through early and continuous delivery of product; b) allow

requirement changes at any stages of the development process for customer advantage; c)

provide customer with frequent working-product delivery allowing testing and viewing how the

product will perform and looks; d) developers and customers ‘must work daily through the

project’; and e) ‘working software is the primary measure of progress’.

Extreme Programming (XP) is an agile methodology which focuses in team work,

customer satisfaction and fast delivery of needed product. “XP improves a software project in

four essential ways: communication, simplicity, feedback and courage”. XP allows changing

customer requirements at any stage of the development life cycle. The product is delivered to

the customer as early as possible, making it easier to implement any changes in requirements.

The team roles in XP are Developers, Customers, and Management.

XP Practices include:

1. Planning Game: there is a close interaction between the programmers and the

customer to estimate the effort needed for implementation (programmers) and

scope and timing of releases (Customer)

2. Frequent Small Releases: release system as often as possible

3. On-site Customer: customer has to be present and available full-time for the

team

4. Testing: test and run system continuously

5. Simple Design: design simplest possible solution that is implemental at the

moment; avoid complexity, extra/duplicate code

6. Re-factoring: improve design of existing code by removing duplication, improving

communication, simplifying and adding flexibility

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7. Pair Programming: two people get to develop all code concentrating on the same

task; one person focuses on the task at hand ‘driving’, and the other focuses on

the big picture ‘navigating’

8. Collective Code Ownership: any team member can change the code

9. Continuous Integration: code is added as soon as it is ready

10. Coding Standards: programmers must follow the coding rules; emphasizes

communication through the code

11. Metaphor: system is defined by a metaphor/set of metaphors between the

customer and programmers, which guide all development by describing how the

system works

12. 40-hour Week: a maximum of 40-hour working week. No two overtime weeks

in a row are allowed

Every development process is different from one another. When using XP methodology,

not all practices have to be selected. Practices should be tailored to suit the needs of the

individual project.

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1.2.4.4 The WINWIN Spiral Model

The WINWIN spiral methodology expands the Boehm-Spiral methodology by adding a

priority-setting step called the WINWIN Process at the beginning of each spiral cycle and by

adding intermediate goals, called anchor points. The WINWIN spiral methodology defines a set

of negotiation activities at the beginning of each pass around the spiral.

These activities include identifying the system or subsystem’s stakeholders, determining

the stakeholders’ “win conditions” and the negotiation of the stakeholders’ win conditions to

convert them into the project’s set of win-win conditions. A ‘win condition’ implies that the

customer wins by getting the system, which satisfied his/her needs, and the developer wins by

finishing the project on time, on target, and on budget.

The three anchor points view the project progress as the project traverses through the

spiral, Life Cycle Objectives (LCO), Life Cycle Architecture (LCA), and Initial Operational

Capability (IOC). LCO, the first anchor point, defines the business case for the entire system.

It establishes the why, what, when, who, where, how, and cost of the system. LCA, the second

anchor point, defines the life cycle architecture. IOC, the third anchor point, defines the

operational capabilities of the system.

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1.2.4.5 Methodology Selection Matrix

MODEL CRITERIA

Waterfall

Spiral

XP

WINWIN

Spiral

20 Project Integration 15 15 10 20 10 Speed 15 20 25 20 15 Quality Management 25 20 25 20 10 Risk Management 15 15 20 20 10 Focus on Avoiding Errors 15 20 20 20 10 Focus on Project Maintenance 25 20 10 20 10 Ability to Manage Change 15 20 20 20 15 Iterative Nature 20 20 25 20 100 145 150 155 160

Methodology Selection

We researched a number of methodologies that we can incorporate into our HMI

Project. After researching four various methodologies, we chose to adopt the WINWIN Spiral

as our project development methodology. We took into consideration other methodologies

including, Waterfall, Spiral, and Extreme Programming. After establishing our project criteria,

we designed a Methodology Selection Matrix system to evaluate the researched methodologies

and obtain the one that best suit our project goal. The Matrix assessed all the different

methodologies against the criteria that we provided, giving WINWIN Spiral the highest points

on the matrix.

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1.2.5 Glossary

CFM - Cubic-foot per Minute

DFD – Data Flow Diagram

ER-D – Entity-relationship Diagram

GUI – Graphical User Interface

HMI – Human Machine Interface

IOC - Initial Operational Capability

I/O - Input/Output

IQ - Installation Qualification

ISQL – Industrial Structured Query Language

LCA - Life Cycle Architecture

LCO - Life Cycle Objectives

MMI – Man Machine Interface

OEMs - Original Equipment Manufacturers

OLE - Object Linking Embedding

OQ - Operational Qualifications

PC – Personal Computer

PLC – Programmable Logic Controller

PQ - Performance Qualification

SDLC – Systems Development Life Cycle

SI - Systems Integrators

TCP/IP – Transmission Control Protocol or Internet Protocol

VTS – Virtual Tag System

XP - Extreme Programming

Abstract - the degree to which a system or component performs only the necessary functions

relevant to a particular purpose.

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Ad hoc - contrived purely for the purpose in hand rather than planned carefully in advance.

Analysis - a set of activities that attempt to understand and model customer needs and

constraints.

Architectural design - the process of defining a collection of hardware and software

components and their interfaces to establish the framework for the development of a

computer system.

Authentication - the verification of the identity of a person or process.

Baseline - a point at which some deliverable produced during the software engineering

process is put under formal change control.

Brainstorming - the unrestrained offering of ideas or suggestions by all members of a

committee, conference, etc. in an effort to find a solution to a problem and generate fresh

ideas

CAT 5 - Short for Category 5, network cabling that consists of four twisted pairs of copper wire

terminated by RJ45 connectors. Cat-5 cabling supports frequencies up to 100 MHz and

speeds up to 1000 Mbps. It can be used for ATM, token ring, 1000Base-T, 100Base-T, and

10Base-T networking.

Compliant - ready to conform or agree to do something.

Components - is an identifiable part of a larger program or construction. Usually, a

component provides a particular function or group of related functions.

Complexity - (Apparent) the degree to which a system or component has a design or

implementation that is difficult to understand and verify.

-(Inherent) the degree of complication of a system or system component, determined by

such factors as the number and intricacy of interfaces, the number and intricacy of

conditional branches, the degree of nesting, and the types of data structures.

Concurrent – happening together: taking place or existing at the same time, or running

parallel.

Constraints - are restrictions or limitations placed on requirements or design.

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Context Diagram – An overview of an organizational system that shows the system

boundaries, external entities that interact, with the system, and the major information

flows between the entities and the system.

Cryptic – Having an ambiguous or hidden meaning.

Data flow diagram (DFD) - a modeling notation that represents a functional decomposition

of a system

Data Dictionary - a database that contains definitions of all data items defined during analysis

Database - a collection of logically related data stored together in one or more computerized

files.

Database Design - the process of developing a database that will meet a user's requirements.

The activity includes three separate but dependent steps: conceptual database design,

logical database design, and physical database design.

Ergonomics – The applied science of equipment design intended to reduce operator fatigue

and discomfort.

Feasibility – the degree to which something can be carried out or achieved. The analysis of a

problem to determine if it can be solved effectively. The operational (will it work?),

economical (costs and benefits) and technical (can it be built?) aspects are part of the

study.

Flexibility - the ease with which a system or component can be modified for use in

applications or environments other than those for which it was specifically designed.

Gantt Chart – A graphical representation of a project that shows each task as a horizontal bar

whose length is proportional to its time for completion.

Graphics – methods and techniques for converting data to or from graphic display via

computers.

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Hardware - the physical, touchable, material parts of a computer or other system

Implementation - is the carrying out, execution, or practice of a plan, a method, or any

design for doing something. Implementation is the action that must follow any preliminary

thinking in order for something to actually happen.

Integration - the specific approach to integration testing

Integration testing - a testing step that constructs the software while testing it

Interface - the point of interaction or communication between a computer and another entity.

Interface design - the activity concerned with the interfaces of the software system

contained in the software requirements and software interface requirements

documentation. Consolidates the interface descriptions into a single interface description of

the software system.

Milestones - a point in time that is used to indicate progress during a project

InTouch - the first object-oriented software based on Windows for the plant floor.

Intuitive –known directly and instinctively, without being discovered or consciously perceived.

Iteration - repetition of a sequence of instructions.

Metaphor - the application of a word or phrase to somebody or something that is not meant

literally but to make a comparison.

Milestones – a point in time that is used to indicate progress during a project

Mind mapping - storing information in a pattern that one understands to separate and use

when necessary.

Mired - a troublesome or oppressive situation or state that is very difficult to escape from.

Module - An independent piece of software, which forms part of one or more larger programs.

Object-Oriented Programming - a unique instance of a data structure defined according to

the template provided by its class. Each object has its own values for the variables

belonging to its class and can respond to the messages defined by its class.

Optimize - to find the best possible solution to a technical problem in which there are a

number of competing or conflicting considerations

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Pert Chart – A diagram that depicts project tasks and their interrelationships; PERT stands for

Program Evaluation Review Technique.

Pixel - the smallest resolvable rectangular area of an image, either on a screen or stored in

memory.

Process – the sequence of states of an executing program.

Project Manager – systems analyst with a diverse set of skills—management, leadership,

technical, conflict management, and customer relationship—which is responsible for

initiating, planning, executing, and closing down a project.

Project Plan - a description of the management approach for a project

Project risks - the set of potential project problems or occurrences that may cause the project

to fail

Project scope - a statement of basic requirements of the software to be built

Proprietary - implies a product imbued with exclusive magic by the unmatched brilliance of

the company's own hardware or software designers.

Prototyping – The creation of a model and the simulation of all aspects of a product.

Reliability - the ability of a system or component to perform its required functions under

stated conditions for a specified period of time.

Security – the ability of a system to manage, protect, and distribute sensitive information.

Specification - A document describing how some system should work.

Software – The instructions executed by a computer, as opposed to the physical device on

which they run.

System – any collection of component elements that work together to perform a task. In

computer science, system is used in a variety of contexts. A computer is hardware system

consisting of a microprocessor and allied chips and circuitry, plus an input device

(keyboard, mouse, disk drive), an output device (monitor, disk drive), and any peripheral

devices (printer, modem).

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Traceability - the degree to which a relationship can be established between two or more

products of the development process, especially products having a predecessor-successor

or master-subordinate relationship to one another

TCP/IP - the connection-oriented protocol built on top of Internet Protocol (IP) and is nearly

always seen in the combination TCP/IP (TCP over IP).

Use Case - is a description of an interaction between an actor and a system.

Volatility - characterized by or prone to sudden change. COMPUTING - losing data when power is

off: used to describe a computer memory that does not store data when the power is

turned off. Random access memory RAM is volatile, while read-only memory ROM is not.

Work breakdown structure (WBS) - the set of work tasks required to build the software;

defined as part of the process model.

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2. Project Management

2.1 Project Team and Roles

Member Name

Role

Responsibilities

Evelyn Chang

Project Manager,

Front-End Designer

Distributing tasks among team members Interview & Communicate with the Sponsor and

system stakeholders Designing the Front End Interface Assisting other members in their assigned tasks

Ding Daniel

Database Designer

Designing/enhancing the AS-IS system database ER-Model Problem Statement Methodologies

Melissa Javier

System Analyst

Working in gathering and modeling requirements Risk Management analysis Use Case Scenario Use Case Diagram

Chiyong Kim (John)

System Analyst

Working together with Melissa in gathering and collecting requirements

Data Flow Diagrams Data Dictionary Requirement Specifications Structured Chart

Glenys Pina

Assistant Project Manager

Assisting Project manager as well as other team members in performing their tasks

Working as a global resource within our group Feasibility Studies Resource Management Gathering and modeling requirements Methodologies

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2.2 Resources Management

2.2.1 Work Breakdown Structure (WBS)

Work Breakdown Structure

Duration

(Days)

Start

Finish

Resources

1. Introduction 15 09/25/02 10/11/02 1.1 Project Initiation 09/25/02 09/28/02 1.1.1 Interview Sponsor 09/25/02 09/25/02 Evelyn Chang 1.1.2 Project Scope 09/25/02 09/27/02 All Members 1.1.3 History 09/25/02 09/28/02 Evelyn Chang 1.2 Project Planning 09/29/02 10/11/02 1.2.1 Background 09/29/02 10/02/02 Evelyn Chang 1.2.2 Problem Statement 09/29/02 10/03/02 Daniel Ding 1.2.3 Previous Works 09/29/02 10/04/02 Chiyong Kim

Melisa Javier 1.2.4 Methodologies 10/03/02 10/10/02 Daniel Ding

Glenys Pina 1.2.4.1 Methodology Method Selection Matrix

10/10/02 10/10/02 Daniel Ding Glenys Pina

1.2.5 Glossary 10/11/02 10/11/02 All Members 2. Project Management 10 10/12/02 10/21/02 2.1 Project Team and Roles 10/12/02 10/13/02 Evelyn Chang

Glenys Pina 2.2 Resources Management 10/13/02 10/16/02

2.2.1 Work Breakdown Structure 10/13/02 10/14/02 Evelyn Chang Glenys Pina

2.2.2 Project Milestones 10/15/02 10/16/02 Glenys Pina 2.2.3 Preliminary Project Plan (GANTT Chart)

10/16/02 10/16/02 Evelyn Chang Glenys Pina

2.2.4 Baseline Plan (PERT Chart) 10/16/02 10/16/02 Glenys Pina 2.3 Feasibility Study 10/17/02 10/19/02 Glenys Pina 2.3.1 Economic Feasibility 10/17/02 10/18/02 Glenys Pina 2.3.2 Feasibility Analysis 10/17/02 10/19/02 Glenys Pina 2.3.3 Break Even Analysis 10/19/02 10/19/02 Glenys Pina 2.4 Risk Management 10/20/02 10/21/02 Evelyn Chang

Melisa Javier 3. Analysis 30 10/22/02 11/28/02 3.1 Stakeholder Identification 10/22/02 10/23/02 Evelyn Chang 3.2 Gathering Requirements 10/24/02 11/08/02 3.2.1 Interviewing 10/24/02 11/08/02 Daniel Ding 3.2.2 USE-CASE Scenarios 10/24/02 11/08/02 Evelyn Chang

Melisa Javier Glenys Pina

3.2.3 Brainstorming 10/24/02 11/08/02 Daniel Ding 3.2.4 Mind Mapping 10/24/02 11/08/02 Daniel Ding

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3.3 Documenting Requirements 11/09/02 11/12/02 3.3.1 Functional Requirements 11/09/02 11/12/02 Evelyn Chang 3.3.2 Non-Functional Requirements 11/09/02 11/12/02 Evelyn Chang 3.4 Modeling Requirements 11/14/02 11/28/02 3.4.1 USE-CASE Diagram

11/14/02

11/21/02

Evelyn Chang Melisa Javier Glenys Pina

3.4.2 DFD Diagram 11/14/02 11/21/02 3.4.2.1 Grammatical Analysis 11/14/02 11/21/02 Chiyong Kim 3.4.2.2 Context Diagram 11/14/02 11/21/02 Chiyong Kim 3.4.2.2.1 AS-IS Context Diagram 11/14/02 11/21/02 Chiyong Kim 3.4.2.2.2 TO-BE Context Diagram 11/14/02 11/21/02 Chiyong Kim 3.4.2.3 General Context Diagram 11/14/02 11/21/02 Chiyong Kim 3.4.2.4 Decompositions 11/14/02 11/21/02 Chiyong Kim 3.4.3 Data Dictionary 11/22/02 11/28/02 Chiyong Kim 4. Requirement Specification 12 11/14/02 11/28/02 4.1 Structured English 11/14/02 11/28/02 Chiyong Kim 4.2 Decision Trees 11/14/02 11/28/02 Chiyong Kim 4.3 Decision Tables 11/14/02 11/28/02 Chiyong Kim 5. Qualification 7 11/21/02 11/28/02 5.1 Performance Qualification 11/21/02 11/28/02 Evelyn Chang 5.2 Operational Qualification 11/21/02 11/28/02 Evelyn Chang 5.3 Installation Qualification 11/21/02 11/28/02 Evelyn Chang 6. System Design 9 11/22/02 12/03/02 6.1 ERM Model 11/22/02 12/03/02 Daniel Ding 6.2 Structured Chart 11/22/02 12/03/02 Chiyong Kim 6.3 User Interface Design 11/22/02 12/03/02 6.3.1 AS-IS User Interface Design 11/22/02 12/03/02 Evelyn Chang

Glenys Pina 6.3.2 TO-BE User Interface Design 11/22/02 12/03/02 Evelyn Chang 6.4 Database Design 11/22/02 12/03/02 6.4.1 AS-IS Database Design 11/22/02 12/03/02 Daniel Ding 6.4.2 TO-BE Database Design 11/22/02 12/03/02 Daniel Ding 7. System Architectural Model 9 11/22/02 12/03/02 7.1 AS-IS Architectural Model 11/22/02 12/03/02 Evelyn Chang 7.2 TO-BE Architectural Model 11/22/02 12/03/02 Evelyn Chang

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2.2.2 Project Milestones

PHASE (DATE) PHASE IMPLEMENTED

START END

ALLOCATED RESOURCES

PHASE DESCRIPTION

PHASE IA– Introduction

09/25/02 09/28/02

Evelyn Chang Daniel Ding Chiyong Kim Melissa Javier Glenys Pina

The following tasks were completed during this phase, Interviewing Project Sponsor, Project Scope, and History

PHASE IB - Project Planning

09/29/02 10/11/02

Evelyn Chang Daniel Ding Chiyong Kim Melissa Javier Glenys Pina

The following tasks were completed during this phase, Background, Problem statement, Previous work, Methodologies and glossary

PHASE IIA - Project Management

10/12/02 10/21/02 Evelyn Chang Glenys Pina

The following tasks were completed during this phase, Project Team and Roles, WBS, Project Milestones, Preliminary Project Plan, Baseline Plan

PHASE IIB - Project Management

10/17/02 10/21/21 Evelyn Chang Melissa Javier Glenys Pina

The following tasks were completed during this phase, Feasibility Studies, and Risk Management

PHASE IIIA – Analysis

10/22/02 11/08/02

Evelyn Chang Daniel Ding Melissa Javier Glenys Pina

The following tasks were completed during this phase, Stakeholder Identification, and Requirements Gathering

PHASE IIIB – Analysis

11/09/02 11/28/02

Evelyn Chang Chiyong Kim Melissa Javier Glenys Pina

The following tasks were completed during this phase, Documenting and Modeling Requirements, Requirement Specification, and System Qualification

PHASE IVA - Design

11/22/02 12/03/02

Evelyn Chang Daniel Ding Chiyong Kim Glenys Pina

The following tasks were completed during this phase, ERM Model, Structure Chart, User Interface Design, Database Design, and System Architectural Models

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2.2.3 Preliminary Project Plan

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2.2.4 Baseline Plan

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2.3 Feasibility Study: Cost Benefit Analysis

2.3.1 Economic Feasibility

TANGIBLE BENEFITS WORKSHEET

HMI

Year 1 through 5

A. Cost Reduction or Avoidance $ 12,000

B. Increased Flexibility 7,000

C. Increased Speed of Activity 12,000

D. Improvement in management planning or control 18,000

TOTAL Tangible benefits $ 49,000

ONE-TIME COSTS WORKSHEET

HMI

Year 0

A. Development Costs $ 17,000

B. New Hardware 12,000

C. New Software 3,000

E. User Training 2,500

TOTAL One-Time Costs $ 34,500

RECURRING COSTS WORKSHEET

HMI

Year 1 through 5

A. System Software Maintenance $ 17,000

B. Incremental data storage required 1.500

C. Incremental Communications 2,000

D. Supplies 1,000

TOTAL Recurring Costs $ 21,500

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2.3.2 Feasibility Analysis

Year of Project

0 1 2 3 4 5 TOTALS Net Economic Benefit $0 $49,000 $49,000 $49,000 $49,000 $49,000 Discount Rate (11%) 1.0000 0.9009 0.8116 0.7312 0.6587 0.5935 PV of Benefits $0 $44,144 $39,769 $35,828 $32,278 $29,079 NPV of all BENEFITS $0 $44,144 $83,914 $119,742 $152,020 $181,099 $181,099 One-time COSTS ($34,500) Recurring Costs $0 ($21,500) ($21,500) ($21,500) ($21,500) ($21,500) Discount Rate (11%) 1.0000 0.9009 0.8116 0.7312 0.6587 0.5935 PV of Recurring Costs $0 ($19,369) ($17,450) ($15,721) ($14,163) ($12,759) NPV of all COSTS ($34,500) ($53,869) ($71,319) ($87,040) ($101,203) ($113,962) ($113,962) Overall NPV $67,137 Overall ROI (overall NPV / NVP all COSTS) 0.5891 Break-even Analysis Yearly NPV Cash Flow ($34,500) $24,775 $22,320 $20,108 $18,115 $16,320 Overall NPV Cash Flow ($34,500) ($9,725) $12,594 $32,702 $50,817 $67,137

Project break-even occurs between years 1 and 2

Break-even fraction - ((22,320 - 12,594) / 22,320) = .4358

Actual break-even occurred at 1.44 years

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2.3.3 Break-Even Point Analysis

-40000

-20000

0

20000

40000

60000

80000

Year0 Year1 Year2 Year3 Year4 Year5

Yearly NPV CashFlowOverall NPV Cash Flow

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2.4 Risk Management

Project Size

The project has a budget of nearly $ 70,000.00. The number of members on the project

team is 5. The HMI for NIRO Fluid Bed Processor involves a number of parties. The basic data

for the system is readily available so the creation of the system will not be a large undertaking.

Project Structure

The project involves upgrading the HMI for NIRO Fluid Bed Processor with ISQL

database software, which is available for analysts to examine and study. Therefore, the

requirements for the project are highly structured and easily obtainable.

Time Constraints

1. The duration of this project lasts weeks, months, or even years. During such a long

period, many changes may occurs, most of which are difficult to predict. Such changes

may have a significant impact on project costs, technology, and resources. The longer

the duration of the project, the more uncertain are the execution times and costs.

2. This project is complex in nature, involving many interrelated activities and participants

from both within the organization and outside it (e.g., suppliers, subcontractor). (Our

example is highly simplified for the purpose of easier demonstration.)

3. Delays in completion time may be very costly. Penalties for delays may amount to

thousands of dollars per day. Completing projects late may result in lost opportunities

and ill will as well.

4. Project activities are sequential. Some activities cannot start until others are completed.

Systems Interdependence

The system is composed of more than 100 parts. It is mutually dependent only to its

components that made it to a system and not to any other system. In order for the NIRO Fluid

Bed Dryer to fully be functional, the components have to be commissioned upon then the

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installations of the parts. Without these components that the system is interdependent with,

the entire system is not functional.

Quality

The quality to produce drug depends on the operations of the system. The system has

to be maintained orderly and meet all its calibration dues. For security health reasons, the

equipments have to be tested and qualified before making any processes.

Clarity

Before the processes are being executed, any confusion to the system is already been

eliminated during the validation phase of the project. The validation phase helps in eliminating

unnecessary or confusing features of the system to avoid risk to the process. Otherwise, if the

confusion is this present upon execution of a process, the operator has to re-train to fully

understand how the system works.

Efficiency

For security issues, every drug company must produce efficient quality of drug products.

Without efficiency of the system due to over due of the calibration or out of tolerance of the

equipment, the batch products are not secured to be in compliant to the FDA’s regulation.

Thus, may caused fatal results upon taken by the patients. All parts of the equipment have to

be calibrated, maintained and properly cleaned.

Traceability

It is important to have back up copies of all the history of equipment. Tracing files

manually is a tough job. The system is designed to store information that could easily be

traced.

There are some instance that when making drug batches, there are pass and reject

tablets. In case where the FDA request for a copy of the file months ago, it is easy to supply

the needs if the system can trace the procedures.

In order to track the previous document of a specific procedure, the administrator can

go back to day and time the product was made.

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Familiarity with Technology or Application Area

The development group is familiar with the technology that will likely be used to

construct the system. However, the user group is not familiar with the application area since

they don’t understand the technical diagrams and the components in the system. Furthermore,

they are intimidated to use the system due to this lack of understanding.

Project Size

The project is huge. Since the basic data for the system is readily available, the creation of the system will not be large undertaking. Section 1.01 Risk: High

Project Structure

The requirements for the project are highly structured and obtainable. The existing HMI for NIRO Fluid Bed Processor is available for analysts to examine and study. Section 1.02 Risk: Medium High

Time Constraint

The duration of this project lasts 12 months period. During such a long period, many changes may occurs, most of which are difficult to predict. Such changes may have a significant impact on project costs, technology, and resources. The longer the duration of the project, the more uncertain are the execution times and costs. Section 1.04 Risk: High

System Interdependence

The good feature about this system is that it is not interdependent among other system but dependent to its components, such as process airflow, atomizing air, etc. Without these components that the system is interdependent with, the entire system is not functional. Section 1.05 Risk: Low

Quality

For health reasons, the quality of the product is extremely important. Section 1.08 Risk: Extremely High

Clarity

Before the processes are being executed, any confusion to the system is already been eliminated during the validation phase of the project. The validation phase helps in eliminating unnecessary or confusing features of the system to avoid risk to the process. Section 1.06 Risk: Low

Efficiency For security issues, every drug company must produce efficient

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quality of drug products. Without efficiency of the system due to over due of the calibration or out of tolerance of the equipment, the batch products are not secured to be in compliant to the FDA’s regulation. Thus, may caused fatal results upon taken by the patients. All parts of the equipment have to be calibrated, maintained and properly cleaned. Section1.07 Risk: Extremely High

Traceability

It is important to have back up copies of all records. When making drug batches, there are pass and reject tablets. In case where the FDA request for a copy of the file months ago, it is easy to supply the needs if the system can trace the procedure. In order to track the previous document of a specific procedure, the administrator can go back to day and time the product was made. Section 1.09 Risk: Medium High

Familiarity with Technology or Application Area

The development group is familiar with the technology that will likely be used to construct the system, since they will simply upgrade current system capabilities. The user group is not familiar with the application area. The users who operate the systems slightly understand the technical diagrams and the components in the system. Section 1.03 Risk: Medium Low

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3. Project Analysis

3.1 Stakeholder Identification

Machine Operators

Machine Operators are very important stakeholders to the system because they interact

with the system in a constant daily-basis. They interact with the system automatically by

using the different screens. They are responsible for monitoring and controlling the production

of materials. Machine operators have access to the operator’s screen, air preparation screen,

alarm screen, and trend screens.

Management Personnel (Department Supervisors and Department Managers)

Department Supervisors and Managers have access to the system according to their

department. They are responsible for monitoring and controlling the production of materials.

They have access to the operator’s screen, air preparation screen, alarm screen, and trend

screens. They are also authorized to abort and to halt batches.

Stakeholders

Maintenance Personnel

Management Personnel

Machine Operators

Electrical Engineers

Department Supervisors

Department Managers

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Maintenance Personnel

Maintenance Personnel has the same level of interaction as the trained operator. In

addition to the automatic interaction they can manually control the system. They can start and

stop all machine motors, and open and close all valves to perform system maintenance on a

daily basis.

Electrical Engineers

Electrical Engineers have full access to the system. They have administrative access to

the system, such as the ability to create new user accounts, reset user passwords. Electrical

Engineers also troubleshoot hardware and application problems, as well as, networking

problems. They also maintain the communication between the two servers (ISQL server and

terminal server).

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3.2 Gathering Requirements

3.2.1 Interviewing (Informal)

See Attached.

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3.2.2 USE-CASE Scenarios

A Use Case Scenario is distinctive interaction that a user has with the system in order to

achieve a particular purpose. It provides the basis of communication between the sponsors and

the developers in planning the project. The Use Case Scenario captures some user-visible

functions. A diagram is created soon after to have better picture.

Actor: Machine Operator

HMI System: The trained operator is in front of the HMI system, which displays

different options the user can select from.

Main System Interface: After selecting the login option from the HMI System, the

HMI main system interface displays the login screen.

Login Screen: The Machine Operator uses the virtual keyboard to input his/her User-

ID and password. The User-ID and password are compared to the one stored on the database.

If the wrong user name and/or password are entered, an error message will be display, and

he/she will be asked to re-enter the information. If User-ID and password are verified, the

machine operator is logged on to the system and with his/her proper level of authorization and

security.

Logon to System: Once the machine operator is logged on to the system, he/she will

be able to select from a list of displayed options: inflation/deflation of the container and filter

gaskets, raising and lowering of the dryer filter, and spray test.

Perform Task 1: The machine operator press the INFLATE/DEFLATE FILTER

GASKET button on the screen to inflate or deflate the filter sealing gasket and the upper

container gasket and the inlet plenum gasket.

Perform Task 2: The machine operator presses the RAISE or LOWER button on the

screen to raise or lower the exhaust air filter. The operator clicks and holds the button to

actuate the cylinder. This method is useful to install the exhaust filter and the filter gasket.

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Perform Task 3: The machine operator presses the ON button on the screen to turn on

the Fluid Bed chamber light.

Perform Task 4: Press the FILTER SHAKE button on the screen to initiate the shake

sequence. Once the button is activated the system will automatically close the appropriate

dumpers stroke the cylinders. If the batch is loaded and running the activation button will

shake the bags. If the funning is not running the activation button will shake the filters as an

end of batch shake.

Perform Task 4: The machine operator press the AIR PREP UNIT button on the

screen to view the air preparation screen, process outputs for chilled water and steam supply,

the dew-point and dry bulb temperatures, face and the by-pass temper position as well as the

actual inlet temperature.

Perform Task 5: The machine operator presses the CLEAR button on the screen to go

back to the main menu.

Perform Task 6: the machine operator presses the RECIPE VIEW BUTTON on the

screen to display the current or last recipe run on the system.

File Records: The machine operator press the BATCH REPORT on the screen to view

the batch report for the current run.

Print Screen: The machine operator presses the PRINT SCREEN button on the screen

to print batch report.

Cancel a Task 1: The machine operator press the WIP SYSTEM button on the screen

to operate automated wash sequence.

Cancel a Task 2: The machine operator press the PRODUCT PULSE button on the

screen when available to close the air flow damper and reposition the valve to its original

position.

Log Off: The machine operator presses the LOG OFF button on the screen to end the

batch.

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Actor: Maintenance Personnel

HMI System: The system administrator is in front of the HMI system, which displays




Login Screen: The System Administrator uses the virtual keyboard to input his/her

User-ID and password. The User-ID and password are compared to the one stored on the

database. If the wrong user name and/or password are entered, an error message will be

display, and he/she will be asked to re-enter the information. If User-ID and password are

verified, the machine operator is logged on to the system and with his/her proper level of

authorization and security.

Logon to System: Once the system administrator is logged on to the system, he/she

will be able to select from a list of displayed options: process airflow, air prep airflow,

atomizing air, solution flow, or inlet temp on the operator’s screen.

Task 1: The system administrator presses the PROCESS AIRFLOW button on the

screen to display the controller window, then press the ENTER button when finish.

Task 2: The system administrator presses the AIRPREP AIRFLOW button on the

screen to view or change the process set point, then press the ENTER button when finish.

Task 3: The system administrator presses the ATOMIZING AIR button on the screen

to view or change the controller outputs, then press the ENTER button when finish.

Task 4: The system administrator presses the SOLUTION FLOW button on the screen

to view or change the process variables, then press the ENTER button when finish.

Task 5: The system administrator presses the SHAKEUP SETUP button to view the

several shake parameters.

Task 5: The system administrator presses the SHAKEUP TIME AND SHAKE DOWN

TIME button to control the up and down time of the shake cylinder during the shake cycle.

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Log Off: The maintenance personnel press the LOG OFF button on the screen to end

the batch.

Actor: Management Personnel (Department Supervisors and Department Managers)

HMI System: The Management Personnel is in front of the HMI system, which displays




Login Screen: The Management Personnel uses the virtual keyboard to input his/her






Logon to System: Once the management personnel are logged on to the system,

he/she will be able to select from a list of displayed options: process airflow, air prep airflow,

atomizing air, solution flow, or inlet temp on the operator’s screen.

Task 1: The management personnel presses the CONFIGURE button on the screen to

display the I/O simulation switch, which allows for operator training with all processor I/O

disabled.

Task 2: The management personnel press the ABORT button on the screen to end the

batch.

Task 3: The management personnel press the RECIPE EDIT button on the screen to

edit a recipe.

Task 4: The management personnel press the EDIT FUNCTION button on the screen

to edit a value or create a recipe.

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Log Off: The management personnel press the LOG OFF button on the screen to end

the batch.

Actor: Electrical Engineer

HMI System: The Electrical Engineer is in front of the HMI system, which displays




Login Screen: The Electrical Engineer uses the virtual keyboard to input his/her User-

ID and password. The User-ID and password are compared to the one stored on the database.

If the wrong user name and/or password are entered, an error message will be display, and

he/she will be asked to re-enter the information. If User-ID and password are verified, the

machine operator is logged on to the system and with his/her proper level of authorization and

security.

Logon to System: Once the Electrical Engineer is logged on to the system, he/she will

be able to select from a list of displayed options: process airflow, air prep airflow, atomizing

air, solution flow, or inlet temp on the operator’s screen.

Task 1: The electrical engineer presses the PID tuning button on the screen to access

the control loop tuning, such as setting the control loop’s GAIN, RESET and TIME. The control

tolerance and deviation alarm time settings are also set/on these screens.

Task 2: The electrical engineer presses the CHANGE PASSWORD button on the screen

to change current users’ password for the system.

Task 3: The electrical engineer presses the WINDOWS button on the screen to retrieve

the batch files, report and the alarm files.

Log Off: The electrical engineer presses the LOG OFF button on the screen to end the

batch.

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Actor: IT Personnel

HMI System: The IT Personnel is in front of the HMI system, which displays different

options the user can select from.



Login Screen: The IT Personnel uses the virtual keyboard to input his/her User-ID and

password. The User-ID and password are compared to the one stored on the database. If the

wrong user name and/or password are entered, an error message will be display, and he/she

will be asked to re-enter the information. If User-ID and password are verified, the machine

operator is logged on to the system and with his/her proper level of authorization and security.

Logon to System: Once the IT Personnel are logged on to the system, he/she will be

able to configure the network connection of the system.

Log Off: The IT Personnel presses the LOG OFF button on the screen to end the batch.

Actor: Validation Specialist

HMI System: The Validation Specialist is in front of the HMI system, which displays




Login Screen: The Validation Specialist uses the virtual keyboard to input his/her






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Logon to System: Once the Validation Specialist is logged on to the system, he/she

will be able to commission the system requirements and specifications.

Log Off: The Validation Specialist presses the LOG OFF button on the screen to end the

batch.

Actor: ISQA Compliance Specialist/QA Specialist

HMI System: The ISQA Compliance Specialist/QA Specialist is in front of the HMI

system, which displays different options the user can select from.



Login Screen: The ISQA Compliance Specialist/QA Specialist uses the virtual keyboard

to input his/her User-ID and password. The User-ID and password are compared to the one

stored on the database. If the wrong user name and/or password are entered, an error

message will be display, and he/she will be asked to re-enter the information. If User-ID and

password are verified, the machine operator is logged on to the system and with his/her proper

level of authorization and security.

Logon to System: Once the ISQA Compliance Specialist/QA Specialist is logged on to

the system, he/she will be able to document the procedures and specifications of the system.

Log Off: The ISQA Compliance Specialist/QA Specialist presses the LOG OFF button on

the screen to end the batch.

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3.2.3 Brainstorming

Ability to Acquire Production Data in

Full Resolution

User Friendly

Security and Authentication

Ability to Acquire Production Data in

Real Time

Application Role

Touch Screen HMI

Available 24/7 Redundancy

Ability to Raise Alarms

Can be customized for Any Assembly

Line

Reduce Expenses and Resources in Assembly

Line Control and Monitoring

Privacy of Proprietary Information

HMI Layout Design

Email Notification

Computerized Production

Line Control

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Categorization

Speed

• HMI Layout Design • Ability to Acquire Production Data in Real Time

Convenience

• Computerized Production Line Control • User Friendly

• Email notification

• Available 24/7, Redundancy

• Touch Screen HMI

Security

• Security and Authentication

• Application Role

• Privacy of Proprietary Information

Efficiency

• Ability to Acquire Production Data in Full Resolution

• Ability to Raise Alarms

Benefits

• Reduce Expenses and Resources in Assembly Line

Control and Monitoring

Future Enhancement

• Can be Customized for Any Assembly Line

Name

Name

Name

Name

Name

Name

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Prioritization

Convenience Security Efficiency Speed Benefits Future

Enhancement

Evelyn 15 30 30 15 5 5 100 Daniel 30 30 30 10 0 0 100 Glenys 20 20 20 20 10 10 100 John 20 20 20 20 15 5 100 Melissa 20 10 20 50 0 0 100

Total 105 110 120 115 30 20 Ranking of Priorities:

1. Efficiency

2. Speed

3. Security

4. Convenience

5. Benefits

6. Future Enhancements

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3.3 Documenting Requirements

3.3.1 Functional Requirements

The functional requirements of the Human-Machine Interface, commonly known as the

Graphical User Interface (GUI), are concerned with the various devices representing each

physical Air Handler, Dust Collector, Temperature Transmitter, and Pressure Gauge, etc., which

makes up a system. The interface utilizes multiple colors and animation for depicting specific

components of each piece of equipment. Also, the interface is developed in a series of arranged

row placed one above another type of structured menu for easy accessing to all system

components. This makes the system a user-friendly interface.

The interface is tagged to connect to the project network. The interface is designed to

collect data from the network to the controller via the Industrial SQL Server. It is also designed

from the interface application to the primary network controller to allow inputs. On the other

side of the token, the additional feature of the interface is that it allows a system user to alter

set points within the pre-configured limits and the ability to view dynamic data only.

Depending to the level of security, the operator performs specific operations based on

role definition. The functional requirements of the security of the system should have the

logical and authority checks to ensure that only authorized individual can access to the system.

The authorized individual accessing the system can update, or modify set points. The system

has the ability to create unique user identification and passwords. This password is encrypted

when entered and stored on the system. This password expires and also protects screen

lockout.

The functional requirements of the database of the system are the ability to collect

massive data in lesser time and to generate reports. The system collects data at a rate less

than 10 minutes intervals; the system collects another data and stores at an interval of less

than an hour. A new feature that will be implemented is the built in pulse beat that notifies via

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Alarm if there is a loss of communication between the Industrial SQL Server and the PLCs in

the field.

The reporting tool is another recurring problem of the system. A new feature is created

to have the ability to generate on screen or hard copy of batch reports. The system provides

the ability to produce a Data Report that includes time and corresponding temperature (in min,

max, avg.), humidity (in min, max, avg.) and the direction of the airflow. It also provides the

ability to show the conditions of a room by selecting a room and a day and to show the number

of alerts and alarms generated for a day by selecting the day. Also, the ability of the system is

to be able to query for minimum of 6 months per room.

The Audit Trailing is considered functional requirements for electronic records and

signatures. Its availability to retain records of history and could detect invalid or altered

records is an important aspect for the company. The system have secure computer generated

audit trails for all data that records user identification, the date and time of operator entries

and the nature of the action, e.g. creation and modification of E-records. The availability of the

electronic or hard copy of the report is important for review and reporting purposes. This

requirement is complying with the stringy rule of the FDA in the 21 CFR Part 11.

The most important of the functional requirements is saving and backing-up the data.

Losing data is the worst scenario of any company. It is a lost. The system is capable of having

the regular back up stored in a separate storage device over the network for safety

precautions. Besides from backing up the system, the system has the ability to restore

electronic records and data and generates accurate and complete copies of records in electronic

and paper forms. The backed up files are retrievable upon request.

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3.3.2 Non-Functional Requirements

The Non-functional requirements of the system are the Hardware components, the

Operating system and the Network connections. These Non-functional requirements are used

to meet the certain requirements to install the Interface, called InTouch® and the database,

called Industrial SQL. The server used for back up and storage of multi-million dollars worth of

files has certain requirements to meet. The requirements should at least support and serve 10

concurrent users.

The requirements for the server: 1 PC with P350 processor and 256 MB of RAM;

Microsoft NT 4.0 Server (Intel) with Service Pack 5; Microsoft Transaction Server 2.0 or higher,

MTS is a component of the Windows NT 4.0 Option Pack; Microsoft Internet Explorer 4.01 or

later; SQL Server and utilizes 7.0. An additional requirement for the server for Clients for each

of the 10 PCs: Microsoft Windows NT and Microsoft SQL Server 7.0 Client connectivity utility.

The hardware components should at least meet the minimum requirements or better.

The performance of the system depends on the availability of the parts. The minimum

hardware required to run the system at average performance is: 100 MHz Pentium processor,

32 MB of RAM plus 8 MB per 5K tags, and 100 MB free hard disk space. Otherwise, a

suggested system required is 200 MHz Pentium or greater, 8 MB of RAM per 5K tags, and 500

MB free hard disk space.

The Operating system should at least meet the minimum requirements or better. The

Operating System required to function the system properly is: MS Win 95 SP1/ 98 SE/ NT 4.0

SP5 or greater. A recommended Internet Explorer 5.0 for better quality. Windows NT 4.0 is

required for the installation of the Industrial SQL Server application. Otherwise, the other non-

functional requirements are for the interface application.

For any standard Network connections, the system should support any standard

NetBIOS network: Ethernet 10/100, Novell, Token Ring, Arcnet, etc. DECnet, Serial and

TCP/IP.

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3.4 Modeling Requirements

3.4.1 USE-CASE Diagram

O p e ra to r In te r lo c kS c re e n s

W a s h In P la c eIn te r lo c k s

T re n d M e n u a n dT re n d S c re e n s

S e le c t R e c ip eS c re e n

S o lu t io n P u m pC le a n W in d o w

P u m p T e s tW in d o w

S e c u r ity S c re e n A la rm s

R e c ip e V ie w

W a s h In P la c e

R e c ip e E d it S c re e nV ie w O N L Y

B a tc h R e p o r t V ie wS c re e n

S o lu t io n P u m pP u rg e W in d o w

P u m p M o d e S e le c tW in d o w

F lu id B e d T re n d s

A ll O p e ra to r L e v e lS c re e n s

L o o p In p u tW in d o w

L o o p T u n in gS c re e n s V ie w s

O N L Y

F ilte r S h a k eP a ra m e te rs U p /

D o w n T im e

A ll M a in te n a n c eL e v e l S c re e n s C o n f ig u re W in d o w

P L C I /O S im u la t io n

R e c ip e N a m e sE d it W in d o w

R e c ip e E d it

D ry e r B a tc h A b o r t

F il te r S h a k eP a ra m e te rs

S c re e n

R e c ip e A la rm sV ie w a n d E d it

A l l S u p e rv is o rS c re e n s

L o o p T u n in gS c re e n s

C o n f ig u reP a s s w o rd

D ry e r B a tc h A b o r t

C o n f ig u re U s e r

E x it to W in d o w s

N e tw o rk in g

C o m m is s io n in g

D o c u m e n ta t io n

O p e ra to r S c re e n(L E V E L )

M a in te n a n c eP e rs o n n e l S c re e n

S u p e rv is o r a n d /o rM a n a g e r S c re e n

E le c t r ic a l E n g in e e rS c re e n

M a c h in eO p e ra to r

IT P e rs o n n e l

V a lid a t io n S p e c ia lis t

IS Q A /Q A S p e c ia lis t

M a in te n a n c eO p e ra to r

E le c t r ic a l E n g in e e r

M a in te n a n c e P e rs o n n e l

< < E X T E N D E D > >

< < E X T E N D E D > >

<<E

XTE

ND

ED

>>

<<E

XTEN

DED

>>

<<EX

TEN

DE

D>>

<<E

XTE

ND

ED>>

M a in ta in in gD a ta b a s e

D a ta b a s e D e s ig n e r

<<E

XTE

ND

ED>>

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >

< < IN C L U D E > >< < IN C L U D E > >

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3.4.2 DFD Diagrams

3.4.2.1 Grammatical Analysis

The goal of designing and developing a Human-Machine Interface is to create a

convenient way for trained operators to monitor and control equipments of the facility from

their personal computers. It provides the ability to produce reports for analysis of productions

and also has functions of backing-up the critical data, and restoring for any unexpected

accidents. Our new HMI has an easy configuration and profoundly improved alarm handling

performance, will greatly improve the quality of your information while reducing the

configuration time.

Monitoring and controlling is an important task, so the operators must login with their

valid passwords to use the system. The authentication process allows the system to determine

who is using the system. This is important for the company to keep track of the operators’

history so that it could detect invalid or altered records. Old versions of HMI had similar

abilities but they just had only one login name and password, so it was not possible to find out

who logged in and when. But our new system allows multiple users and has a log-writer to

generate the electronic records and signatures. System administrators are allowed to create

new users with their level of security and passwords through User Management Panel, which

helps to maintain the users of the system. Depending on the level of security, operators

perform specific operations based on role definition. When a user logs in, one session is made.

The password is encrypted when entered and stored on the system. The session expires after

certain period of time and also protects screen lockout. The authorized individual can update,

or modify set points. The log-writer has ability to make multiple log files, which means it

maintains the log files with multiple small files instead of a big one for faster report production

and easier storage maintenance.

The operators will be trained to use the system, but untrained users may be able to

operate the system as well. So, the user interface of the system will not be complicated as old

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versions. The interface mostly consists of physical Air Handler, Dust Collector, Temperature

Transmitter, and Pressure Gauge. The interface is designed to collect data from the network to

the controller via the Industrial SQL Server. It is also designed from the interface application to

the primary network controller to allow inputs. The additional feature of the interface is that it

allows a system user to alter set points within the pre-configured limits and the ability to view

dynamic data only. The Industrial SQL Database Server collects massive data - corresponding

temperature, humidity and the direction of the airflow - to generate reports.

The system backs up data regularly and stores a separate storage device over the

network. Besides from backing up the system, the system has the ability to restore electronic

records and data and generates hard copies of records.

BLUE: VERB RED: NOUN

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3.4.2.2 Context Diagram AS-IS Context Diagram

0 .0H M I

O p e r a to r

M a n a g e r

M a c h in eO p e r a to r C o m m a n d s

R e s u l t s

M a n a g e m e n t R e p o r t s

C o n t r o l

TO-BE Context Diagram

0 .0H M I

O p e ra to r

M a n a g e r

M a ch in e

O p e ra to rC o m m a n d s R e s u lts

M a n a g e m e n t R e p o rts

C o n tro l

IS Q L

S a ve d D a ta

C o n tro l D a ta

C o n tro l O p e ra tio nE le c tric a lE n g in e e r

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3.4.2.3 General DFD TO-BE System

Operator

ElectricalEngineer

Manager

MonitoringSensor Device

New User Data

Operator Command

Real-timemachine data(user format)

Request for Data

ISQL

Saved Results

1.0Translate and

Transfer OperatorCommand

MachineController

3.0Retrieve Real-

time Data Real-timeMachine Data

O.C. for R

4.0Control

Machine

O.C.for C

ControlCommand

8.0Update

Database

Request forUpdating2

Request for Updating

5.0ProduceReports

Data for Reports

Management Reports

User Log File

2.0Update User

Log File

CurrentUser Data

Formatted User Log Data

User Data File

User data

7.0Create User

Formatted New User Data

6.0Backup and

RestoreRequest for

Backup and RestoreBackup Command

DB BackupFile

Formatted DB Data

DB Raw DataData for Restore

Request for Updating M.P.

Request forUpdating C.P.

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3.4.2.4 Decompositions TO-BE Decomposition 1.0 Translate and Transfer Operator Command

1.1Translate Operator

Commands

1.2Authentication

Process

1.3Transfer Operator

Commands

Operator CommandsLogin Data

Login Data

User Data

UpdatedUserData

OperatorCommands

Machine ControlCommands

Request for Data Commands

User Data File

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TO-BE Decomposition 1.2 Authentication Process

1.2.1Receive Login

Data

Login Data

1.2.2Verify User

1.2.3Approve Login

User Data

Updated UserData

FormattedLogin Data

Current UserInformation

User Data File

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TO-BE Decomposition 2.0 Update User Log File

2.1Recieve Request

for Updating

2.2Check User Log

File

2.3Create New Log File

User LogFiles

2.4Update User Log

Operation Data

User Data

Updated Data

Request for new log file

New Log File

UpdatedData

FormattedData

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TO-BE Decomposition 3.0 Retrieve Real-time Data

3.1TranslateOperator

Commands

3.2Request for Update

3.3Receive Machine

Data

Request for Data Commands

User Data(Monitor)

Update Database

Update User Log

Request forMachine Data

Machine Data

FormattedReal-time Data

3.4Display

Real-time Data

Real-time Information

MonitoringSensorDevices

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TO-BE Decomposition 4.0 Control Machine


Commands

4.2Request for Update

4.3Transfer

Control Commands

Request forMachine Control

Commands

User Data(control)

Update Database

Update User Log

Operator Commands

Control Commands

MachineControllers

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TO-BE Decomposition 5.0 Produce Reports

5.1Retrieve Dataand Transfer

5.2Produce User

Reports

5.3Produce Machine

Reports

5.4Generate

Management Reports

Request for Reports

UserData

MachineData

Machine Data

User Data

User Reports

Machine ReportsManagement

Reports

User DataFiles

ISQL

User LogFiles

User Log Data

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TO-BE Decomposition 6.0 Backup and Restore

6.1TransferRequest

6.2Backup

Database

6.3Restore

Database

DB BackupFile

Text Backup Data

ISQL

DB Data

Backup Data

Request for Backup

Request forRecovery

Old DB Data

System Commands

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TO-BE Decomposition 7.0 Create User

7.1Receive New

UserInformation

7.2Verify New

User

7.3Update User

Data File

User Data

Request forVerification

New User Information

FormattedNew User

Information

User ListUser Data

Files

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3.4.3 Data Dictionary

Data Identifier

Description

Login Data UserName + Password

UserName {[A | B | C |…| a | b | c |…]}

Password {[A | B | C |…| a | b | c |…| 0 | 1 | 2 |…| ~ | ! | @ | # |…]}

New User Data UserName + Password + Employee ID + Name + Address + Phone Number + Email Address + Security Level

Name FirstName + LastName + (Middle Init.)

Address Street + ([“Suite #” | ”Apt #” | “Room #”]) + City + State + Zipcode

Phone Number (1) + Area Code + Number

Email Address UserName + @ + Valid Domain Name

Valid Domain Name

Host + . + Type of Domain

Type Of Domain [“com” | “org” | “edu”]

Security Level [“Machine Operator” | ”Maintenance” | ”Electrical Engineer” | “Manager” | ”Supervisor” ]

FirstName {[A | B | C |…| a | b | c |…]}

LastName {[A | B | C |…| a | b | c |…]}

Operator Command

Command + (Initial Value)

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Data Identifier

Description

Command [“INFLATE” | “DEFLATE” | “RAISE” | “LOWER” |“ON” | “OFF” | “FILTER SHAKE” | “CLEAR” | “RECIPE VIEW” | “PRINT” | “WIP” | “LOG ON” | “LOG OFF” | “PROCESS” | “ENTER” | “CHANGE PASSWORD”]

User Log Data Time + UserName + Operation

Time Year + Month + Day + Hour + Minute + Second

Operation Operator Command + (Error)

Error Error Number + Error Message

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4. System Specifications

4.1 Requirement Specification

The Requirement Specifications are usually developed directly by the request of the

customers. The Requirement Specification specifies the fundamental requirements of the

system in terms of WHAT the system must do. This requirement is divided into subsections:

4.1.1 Structured English

Process 1.0 Translate and Transfer Operator Command

- Receive Operator Command

- Verify Operator Commands

- If Operator Command is Login Then

Send to 1.2 Authentication Process

Else

Send to 1.3 Control Process

Process 1.2 Authentication Process

- Receive Login Data

- Verify UserName and Password from User Data File

- If UserName and Password match Then

Approve Login

Else

Deny Login

- Update User Log File

Process 2.0 Update User Log File

- Receive Updated Data

- Check if Log File available

- If Log File is not available

Create a new User Log File

- Write Updated Data to Log File

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Process 3.0 Retrieve Real-time Data



- Receive Machine Data

- Display Machine Data

Process 4.0 Control Machine



- Send Command to Machine Controller

Process 5.0 Produce Reports

- Retrieve User Data

- Retrieve User Log Data

- Retrieve Machine Data from ISQL

- Generate Management Report

Process 6.0 Backup and Restore

- Receive System Command

- IF System Command is for Backup

Back up Database

Else IF System Command is for Restore

Restore Database from Backup File

Process 7.0 Create User

- Receive New User Data

- Verify New User

- If already exist Then

Show Error Message

Else

Update User Data File

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4.1.2 Decision Trees

Is this aValid User?

DoUserName

andPasswordmatch?

What kind ofUser?

YES

Make a validsession

Denied Access

YES

NO

NO

Is thisControl

Command?

Is this avalid user

info?Ope

rato

r

Create

User

Manager

Create New User

Reenter validuser info.

YES

NO

Control Machine

Display MachineData

YES

NO

PrintManagement

Report

Is thisBackup?

What type ofCommand?

Engine

er Backup and

Restore Backup Data

Restore Data

YES

NO

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4.1.3 Decision Tables

Decision Table: Login Process

Decision Table: Operation Process

Rules Conditions

1 2 3 4 Is this a valid session?

Y Y N N

Do username and password match?

Y N Y N

Actions Process Session

X X - -

Make Session

- - X -

Deny Access - X

Rules Conditions

1 2 3 4 5 6

What kind of user?

Operator Operator Manager Manager Engineer Engineer

Is this a control command?

Y N Y N Y N

Actions

Control Machine

X

Display Machine Data

X

Print Report X X

Process Engineer Commands

X X

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Decision Table: Engineer Process

Rule Conditions

1 2 3 4 5 6 7 8 What type of command?

CU CU CU CU BR BR BR BR

Is this user info valid?

Y Y N N Y Y N N

Is this backup? Y N Y N Y N Y N

Actions

Create New User

X X

Reenter valid user info.

X X

Backup data X X

Restore data X X

CU: Create User BR: Backup and Restore

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4.2 Functional Specification

Functional specification denotes the behavior of the system and how its components are

integrated. These specifications therefore describe HOW the system has been designed to

obtain the WHAT specified in the Requirement Specification.

Interface Requirement - The system has an interface (HMI), which would operate and

perform a process. The interface should be user-friendly and allow users to navigate various

graphical screens without interference to the process being executed. It has constant network

connectivity. It allows the Industrial SQL Server to collect data from the primary network

controller.

Database Requirement – The system database is the central storage of critical data;

the system has the support for the Universal Time Code to eliminate issues with time zones

and daylight savings; the system is capable to remote buffering data at the I/O device server,

so that the data can still be stored at a later time if connection to I/O is lost.

Back up and Support Requirement – The system is capable of having the software

and data it contains regularly backed-up to a separate storage device over the network.

Alarm Management Requirement – The alarm in the system will initiate when a

communication connection loss to any controllers. The system will automatically display new

alarms regardless of where the operator is within the interface.

Reporting Requirement – the system will provide the ability to produce a Data Report

that will include time and corresponding temperature (in Min, max, avg.), humidity (in min,

max, avg.) and/or airflow direction. The system is capable of generating screen shot reports

and hardcopy. The system has the ability to produce the history of the alarms.

Performance Requirement – The system runs on NT 4.0 and Windows 2000

operating system. The systems also automatically adjust for daylight saving time change.

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4.3 Design Specification

The Design Specification method describes how the systems have been designed in

terms of the components that build it. It describes each single component in terms of purpose,

specific characteristics and configure for the correct functioning. One of the design functions is

how the system treats software architecture as a set of run-time entities, including tasks and

external input/output elements, which interact either via messages or shared data structures.

Every task has a single thread of execution and represents program units that may be

executed concurrently.

In this project, the interface, InTouch application, is designed to allow users to create

an application in Windows 95/98/2000 (or later) and run the application on the Windows NT

4.0 SP4 (or later) operating system or vice versa. The application is interchangeable and runs

on either platform without requiring conversions of either application. It even allows Managers

and Supervisors the ability to view a continuous HMI application process in real time.

In addition, the interface (InTouch application) is also designed to support OCX controls,

ActiveX controls and Object Linking and Embedding (OLE). This method could easily select and

add OCX and ActiveX controls to any application windows and toolbar to handle control events.

The system has an interface (HMI), which would operate and perform a process. The

interface should be user-friendly and allow users to navigate various graphical screens without

interference to the process being executed. It has constant network connectivity. It allows the

Industrial SQL Server to collect data from the primary network controller.

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5. Qualification

Qualification is the validation phase, which is part of every production projects. The

main purpose of having validated project documents is to secure that equipment being

configured in the facility is properly installed and meet all the necessary requirements and

specifications. Thus, does not produce any impact to the production of drugs. Validation

process is divided into 3 types: Installation Qualification (IQ), Operational Qualification (OQ),

and Performance Qualification (PM).

5.1 Installation Qualification (IQ)

The purpose of this IQ documentation is to generate proper documentation as evidence,

that all the hardware and software components are properly configured according to the

approved requirements and specifications. The Validation specialists provide this documents in

direct compliance with the FDA.

The purpose of the IQ is to demonstrate that all of the expected components are

present and properly configured, that all of the instruments have the expected accuracy and

precision and that the services (power, connections, etc.) are appropriate for the correct

functioning of the system. Any exceptional conditions encountered during the IQ that could

impact process integrity or product reproducibility, are identified, investigated, and

documented (including justification, correction, and any necessary re-qualification studies).

A written IQ protocol is provided by the Validation Specialist/Validation Engineers to

follow the steps of configurations. Prior to conventional operations, the protocol, which is the

systematic method in checking the static attributes of the system, has to be performed. The IQ

protocol describes all the important major/minor components of the system. These include

system and equipment operation, maintenance, cleaning and/or sanitization.

After the installation of the system is completed, it is commissioned to verify and

confirm that the design specification is being followed. Engineering drawings, manuals, data

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sheets, and purchase orders is used to document proper installation and placement. An

evaluation is confirmed for proper connection and installation of supporting services and

components, such as filters, piping, valves, gauges, controls, etc., calibration scope for control,

monitoring (HMI), and recording instruments, such as pressure gauges, temperature sensor,

timers, differential pressure transmitter, etc. that could impact the efficacy, integrity and

quality of the product, that supports the system utilities, such as water, steam, electric, etc.

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5.2 Operational Qualification (OQ)

The purpose of the Operational Qualification (OQ) is to demonstrate that the system

behaves as specified in the expected conditions and that its components are properly

integrated. After satisfactory completion of the system and/or equipment IQ execution, OQ is

performed to check the operational tests, measurements, and control tolerances of key

parameters that are critical for the proper operation of the system.

A written OQ protocol is implemented to test objectives, methodologies, and acceptance

criteria, which it involves in testing and measuring of the system’s key operational parameters

upon the execution. The operational data obtained from the instruments, indicators, gauges,

and sensor upon testing is monitored and evaluated. “Any "worse case" challenges to the

system/equipment are defined and incorporated into the testing strategy to challenge the

system/equipment capacity (Control)”.

Prior to the protocol execution of the OQ to all critical process instrumentations, all the

process, control, monitoring and recording instruments, such as pressure gauges, temperature

sensors, timers, etc., that could impact the product integrity, quality, or effectiveness are

calibrated. The calibration of the process instrumentation that is being used to gather the

qualification data is checked at the end of the study to establish confidence in qualification. Any

equipment found out of calibration at the end of a process validation study indicates that the

process has not been operating in a state of control and cannot be considered validated. Any

exceptional conditions encountered during the OQ are to be identified, investigated, and

documented (including justification, correction, and any necessary re-qualification studies).

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5.3 Performance Qualification (PQ)

Performance Qualification is performed after a successful completion of the Installation

and Operational Qualifications (IQ/OQ) execution. Prior to execution, the test objectives,

methodologies, and acceptance are well defined in the PQ documentation. The purpose of the

PQ is to demonstrate if the system operating with input parameters produces the results that

satisfy the pre-established specification. In providing the assurance of the process, the critical

systems or processes requiring PQ is validated. This purpose is to test the ability of the system

or process to perform the intended function (over time) within the defined upper and lower

process variable limits. It is important that if OQ could be executed for system component, PQ

always must be done for complete system (Control).

The performance of the steam sterilization, crucial utility systems (HVAC, Purified USP

Water System), and cleaning and sanitization is being studied in PQ. A sufficient number of

replicate studies are performed to demonstrate the ability of the system/equipment to achieve

reproducible results. Testing may include analysis for chemical, physical, and microbiological

constituents. Any exceptional conditions encountered during the PQ will be identified,

investigated, and documented, which includes justification, correction, and any necessary re-

qualification studies (Control).

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6. System Design

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6.1 Structured Chart

1.0Translate

and TransferOperator

Command

3.0RetrieveReal-time

Data

8.0Update

Database

5.0ProduceReports

2.0Update User

Log File

7.0Create User

6.0Backup and

Restore

1.1TranslateOperatorCommand

1.2Authentic

ationProcess

1.3TransferOperatorCommand

1.2.1ReceiveLoginData

1.2.2VerifyUser

1.2.3Approve

Login

2.1Recieve

Request forUpdating

2.2Check

User LogFile

2.3Create

New LogFile

2.4Update

User Log


Command

3.2Request

for Update

3.3ReceiveMachine

Data

3.4Display

Real-timeData

4.0ControlMachine

4.1TranslateOperatorCommand

4.2Request for

Update

4.3TransferControl

Command

5.1Retrieve

Dataand Transfer

5.2Produce

UserReports

5.3ProduceMachineReports

5.4Generate

ManagementReports

6.1TransferRequest

6.2Backup

Database

6.3Restore

Database

7.1Receive

New UserInformation

7.2Verify New

User

7.3Update

User DataFile

Operator Commands

Request

Operator Commands

Login Data

Login Data

Login Data

User Name UserName

Current User Data

Request for Update

Current User Data

UserData Request

Formmatted User Data

Operator Commands

Operator Commands

Update DataCommands Machine Data Realtime Data

Operator Commands

Realtime Data

Operator Commands

Commands UserData

Command Request

Machine Data

User Data

User DataMachine Data

User Report MachineReport

Reports

Management Report

System Commands

System Commands

Commands RequestBackup

RequestRestore

User Data

User Data

New User Info.Request forVerification

New User Info.

User Data

Requestfor Update

USER DATAFILE ISQL

Update Info.

New User Info.

USER LOG FILE

Formmatted User Data

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User Interface Design

6.1.1 AS-IS User Interface Design

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6.3.2 TO-BE User Interface Design

See Attached

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6.2 Database Design

6.2.1 AS-IS Database Design

The “InSQL Service Control” utility was launched to start the InSQL Server:

Pressed “GO”, and then “Yes” to confirm the start:

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The following shows all services started up with no errors:

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6.2.2 TO-BE Database Design

The benefits of the new and enhanced database have the following features and functionality:

New Features Functions

Dynamic Configuration This feature has room for modification and additions to the InSQL without restarting the InSQL.

UDT Date Time Stamps for All Data

This feature eliminates problems with time zones and daylight saving by supporting the Universal Time Code.

Manual Data Import/Logging

It supports storage of externally collected data – e.g., CSV data, remote data collector, etc.

Insert/Update Capability on Stored Data

This feature allows modification of stored data – maybe incorrect date due to faulty I/O device. But, keeps an audit trail of the changes, and the user have the option of reporting against the original or the changed data.

Dynamically Re-route I/O Server Source

This feature allows for redundant I/O servers for InSQL – i.e., the switching of I/O sources does not have to be done at the InTouch terminal level. Various Redundancy Architectures will be provided.

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7. System Architectural Method

7.1 System Architectural Method (AS-IS Model)

New Production Network

SQL Server Workstation Industrial SQL Server Terminal Server

Router

System Architectural Design

Network Controllers(previously installed)

Network Controller(new)

Bus Hub

Field Controllers(previously installed)

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7.2 System Architectural Method (TO-BE Model)

New Production Network

SQL Server Workstation Industrial SQL Server Terminal Server

Router

Network Controllers(previously installed)

Network Controller(new)

Bus Hub

Field Controllers(previously installed)

Bus Hub (New)

Field Controllers (New)

(Project Proposed)

HMI HMI

HMI

HMI HMIHMIHMI

HMIHMI HMI HMIHMI

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8. References

Mody, Rashesh. From Buttons & Dials to Object-Oriented Graphics & Portals: A Short History of

the Windows-Based Human Machine Interface. IAN Instrumentation & Automation News. p.5.

(eds) October 2002

Verma, Harsh, Ph.D. Lecture on UML and Use Cases for Object-oriented Analysis. MIT E-

Commerce Architecture Project. 2002

IEEE Std 1074-1991. IEEE Standard for Developing Life Cycle Processes. New York, NY:

Institute of Electrical and Electronics Engineers, 1991.

Institute of Electrical and Electronics Engineers. IEEE Standard Computer Dictionary: A

Compilation of IEEE Standard Computer Glossaries. New York, NY: 1990.

IRIS Networks of Centres of Excellence Project Proposal. Human-Machine Interfaces Theme.

October 2000.

Caron, Richard. System Features Description v1.0 Final. Building Management Systems. 22

April 2002.

Caron, Richard. Required Specification for Purchased System v1.0 Final. Building Management

Systems. 20 May 2002.

Evans, Michael W. & Marciniak, John. Software Quality Assurance and Management. New York,

NY: John Wiley & Sons, Inc., 1987.

IRIS Networks of Centres of Excellence Project Proposal. Human-Machine Interfaces Theme.

October 2000.

Kim, Porter. Package Configuration Specification v1.0 Final. Monsen Engineering Company. 16

September 2002.

Mody, Rashesh. From Buttons & Dials to Object-Oriented Graphics & Portals: A Short History of

the Windows-Based Human Machine Interface. IAN Instrumentation & Automation News. p.5.

(eds) October 2002.

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Povanda, Thomas, Eng. Industrial SQL Server Version 8.0. PF Laboratories BMS Upgrade

Project. 2002.

Pressman, Roger S. Software Engineering: A Practitioner’s Approach, 5th edition. 2001

Rusyniak, John M. MP-6 Fluid Bed Processor Operation and Maintenance Manual. Niro

Incorporated. Columbia, MD. September 1999. Rev. 0.

Verma, Harsh, Ph.D. Lecture on UML and Use Cases for Object-oriented Analysis. MIT E-

Commerce Architecture Project. 2002.

Wonderware FactorySuite InTouch 7.1/7.11 User Guide, Rev. C, July 1999.

Wonderware FactorySuite InTouch 7.1/7.11 Reference Guide, Rev. C, July 1999.

Wonderware FactorySuite IndustrialSQL Server Administration Guide, Rev. A, 15 May 2002.

Wonderware FactorySuite IndustrialSQL Server Database Reference, Rev. A, 15 May 2002.

Wonderware MaintenanceSuite Introduction, PN 06-2077, March 2000.

http://www.rspa.com/spi/glossary.html

http://agilemanifesto.org/principles.html

http://www.extremeprogramming.org/what.html

http://www.agilealliance.org/articles/articles/IntroToXpTomKubit.pdf

http://www.inf.vtt.fi/pdf/publications/2002/P478.pdf

http://www.db.stanford.edu/~burback/watersluice/node69.html

http://www.jodypaul.com/SWE/LCM/index.html

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9. Extra Work

Title Quantity Page

Introduction: 1 History 6 Project Planning: 1 Previous Works 11 Methodologies: 3 Extreme Programming (XP) – Agile Approach 17 WINWIN Spiral Model 19 Methodology Selection Matrix 20 Documenting Requirements: 2 Functional Requirements 54 Non-Functional Requirements 55 System Specifications: 2 Functional Specification 77 Design Specification 78 Qualifications: 3 Installation Qualification (IQ) 79 Operational Qualification (OQ) 81 Performance Qualification (PQ) 82 System Design: 2 User Interface Design 85 Database Design 89 System Architectural Model: 2 AS-IS System Architectural Model 90 TO-BE System Architectural Model 91

Documents

Computer Information System Department - New …eac2/Main Files/HMI_FINAL.pdfComputer Information System Department New Jersey Institute of Technology Newark, NJ 07102 Human Machine