Insite MES (Manufacturing Execution System)

Insite MES (Manufacturing Execution System)

Submitted in partial fulfillment of the requirements for the degree of

Master of Technology in Information Technology

For 3rd Semester

By

CHANNABASAPPA
(Roll No: D1082-MTE-25384)

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Table of Contents

Content Page No:

Abstract : 3
Introduction : 4
Design Considerations : 5
System Analysis : 6
Component Design : 8
Appendix : 15

1. ABSTRACT

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The Insite-MES (Manufacturing Execution System) is an ASP.NET web application used to

track and report on Insite Products for manufacturing different Medical devices. The application
stores data in a SQL Server application database. The system generates reports using SQL
Server Reporting Services.

Insite-MES (Manufacturing Execution System) is developed using Microsoft Stack over the
.NET 3.5 Platform to support the manufacturing activities around the milestones for different
medical products. The Application is built using WCF (Windows Communication Foundation) so
that the application is easily pluggable to User experience and Database. The Application data
is stored in the SQL Server 2005. SQL reporting services is leveraged to run the Pre-
determined reports.

2. Introduction

2.1 Purpose

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The purpose of Insite-MES (Manufacturing Execution System) web application is to track

and report on Insite Products for manufacturing different Medical devices. The application
stores data in a SQL Server application database. The system generates reports using SQL
Server Reporting Services.

2.2 Scope
a) This (iMES FrameWork) is Web based Thin Client intra net application using Insite Data
server for database modeling which is a product of Camstar. It is an n-Tier SOA architect
web Application. This system is for manufacturing industries where the business analysts
study the manufacturing flow of the products. Each process undergone by the product is
defined as transaction and record of all transactions is maintained. This yields in
manufacturing of better quality products in reduced time. Here all web pages are
dynamically constructed using the defined Xml for each page and transaction to the Insite
database is through Xml.

Modules:

1. Transaction 2. Maintenance

3. Data Collection 4. Resource

b) This (Camstar FrameWork) is another supportive Web Application Provided by Camstar,

this is a thin client web application completely driven by Web Services. This application is
particularly used for Administration task of Shopfloor and as well for transaction. The
transaction page is created by drag & drop the objects on the web form . Objects are
created by using Insite data server

Architecture: It is Insite Service driven. It uses Insite application from Camstar where we
can create different types of objects and set relationship to generate the database and
creates the Web service as Business Component. In development process of Camstar
framework and the transaction page Infragestics controls are used which is integrated with
Camstar InsitWebApplication framework.

3. Design Considerations

Insite-MES (Manufacturing Execution System) is developed using ASP.NET, SQL Database

and SSRS to deliver reports.
Web servers are in a Web Farm and Hardware Load balanced for High availability and
failover. This allows maximizing business continuity for the application.
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As the processing requirement of the Application is not intense, we decided to put the SQL
Server Database on a shared cluster environment.
Future plan for this application is to migrate it to MOSS environment utilizing Performance
Point Server for Dashboard Application and Database remain same on SQL Server.

3.1 Design Decisions

Access to the Application is through Encryption of User credentials. By using this Security
mechanism gives the added benefit for users to modify the access to application through a
request via Encryption and Decryption of UserID and Password.

3.2 Assumptions
• Every part number will have one and only one sampling plan (for any given sample type)
• This design only covers Sampling plan for PMT and FDT testing. PQA sampling plan is
not covered in this phase.
• Sampling setup screen only available to lead/supervisor. Security through Menu Setup
of employee.
• Sampling plan is assumed to be setup before migrating GSL log book data into sampling
log table.

4. System Analysis

Insite-MES (Manufacturing Execution System) is available in three distinct environments to

support Development, Testing and Production.

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System Architecture
All the components of the application are designed to have redundancy to ensure that there is
high availability. Hardware and Software components used and their configuration set are
described in the next section. The following diagram presents a view of the logical organization
of the application.
Application is designed to be a 3 tier and the high level architecture diagram is as shown below.

Hardware and Operating System

SQL Server databases are maintained within the shared SQL Server 2005 clusters and the
Web Services are virtual machines managed by GTS and maintained separately.
The hardware configuration is similar to the following specification

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Web Server Applications

The web servers are each running the following services:

CPU: Dual core, 64 bit

Memory: 2 GB RAM (minimum)
15 GB operating system drive (min) and 10 GB data
Disk space:
drive (min)
Operating System: Microsoft Windows Server 2003, Standard Edition
• ASP.NET web application
• .NET 3.5 framework
• SQL Server 2005 Reporting Services

4.1 Software Tools and Technology

Languages : C#.

Framework Knowledge : .Net Framework 2.0, 3.5

Web Technologies : C#.NET, ADO.NET, ASP.NET. AJAX Controls.

IDE : Visual Studio.NET 2008

Application / Web Servers : Microsoft IIS 6.0

RDBMS : MSSQL SERVER 2005

Operating System : Win XP professional, Win 2k Server

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5. Component Design
This component design describes changes necessary to support GSL sampling
requirements for FDT testing.

Spec Setup
• SamplingPlan flag (True/False)
If set to true, trigger sampling logic to identify what lots need test samples
• Spec.SampleType (Value) (FDT, PMT)
Determines what test requires for sampling logic

Sampling Trigger
• System can trigger sampling logic from oven load screen - Finish button for
defined spec step.
If for a spec/step (ex: Sterilization) spec.samplingplan flag is set to true
From “Oven Load” screen (used at this step)
On clicking “Finish” button – system applies “FDT Sampling
Requirements” logic to each lot in an oven load run.
• System can trigger sampling logic (FDT Sampling Requirements) from “Move”
transaction at specific step/spec where Spec.SamplingPlan flag is set to true.

Sampling plan setup

System will allow operator to create or update sampling plan.
• Select/Enter sampling type
• Select/Enter sampling plan
• Enter/Edit Notes
• Add/Remove part numbers
• Add/Edit Comments

System will allow operator to Add/Edit/Delete sampling rule.

• Add/Edit/Delete sampling Test Method
o Check/Uncheck quarter rule
o Enter frequency – editable field
o Check/Uncheck 100% inspection rule

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Create/Search/Update Sampling Plan

Sample Type Select plan type Sample Plan Select Plan or Enter New Search

Add Comments Update Plan Create Plan

Search

System allows operator to search current sampling plan. Sample Type and Sample Plan
are required fields to search plan.
• System will populate Notes field.
• System will populate all the parts associated with plan.
• System will populate all the associated plan rules.

Create Plan

System allows operator to create sampling plan.

• Sample Type and Sample Plan Name are mandatory fields to create new plan.
• Notes and Comments are optional when creating a new plan.

System enters new record in mntSamplingPlan table.

• samplingType (M)
• samplingPlan (M)
• samplingNotes (O)
• samplingComments(O)

Update Plan

Updating plan allows operator to record Notes and Comments.

Add/Remove Part Number

System allows operator to add or remove parts for a selected sampling plan.

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Add Part Number Min Lot Qty Max Lot Qty Sample Qty

X
X

X
X Update Parts

Update Parts
After adding/removing parts from parts grid, operator hits button to update
parts in mntSamplingPlanParts table. If removed, system deletes from this table.
• samplingType
• samplingPlan
• Part Number
• Min Lot Qty
• Max Lot Qty
• Sample Qty

Before adding part, system validates –

• Entered part number is valid part number in the system.
• Min lot qty, Max lot qty & Sample qty are valid numbers.
• For the selected sample type & sample plan (spec drawing) part number should
not exist on different sample plan in mntSamplingPlanParts table.
Example: Sample Type “FDT”,
If PartA exists on sample plan1, system should not add partA on sample
plan2
System will throw appropriate Error message.

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Apply/Edit Rules

System will allow operator to record/edit sampling rules for selected sample type/plan.

Plan Rule

Test Current 100 %

Quarter Frequency
Method Counter Inspection
1st 2nd 3rd 4th
TM 177 50 30
TM 402 20 10
TM 406 50 30
TM 388 10 10

Add
Save

System will allow operator to add/remove sampling plan rule.

For a selected sample type/plan, system requires test method to add a new rule in table
mntSamplingPlanDetail table.
• samplingType (M)
• samplingPlan (M)
• testMethod (M)
• firstQuarter
• secondQuarter
• thirdQuarter
• fourthQuarter
• frequency
• currentCounter
• inspectionFlag

System allows operator to check/uncheck quarter and 100% inspection columns for
selected test method.
System allows operator to add/edit frequency (number) into frequency column.

Note: “Current Counter” column will be populated/updated through sampling logic.

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FDT Sampling Requirements

For each lot/container in sterilization, system will find lot(s) that needs FDT testing based
on following rules.

• Sampling for production work orders only

• If sampling plan not found, system writes it to error log
• Only one entry for a lot/container in sampling log table for each sampling type
• If sampling plan details not found (i.e., no test method setup), system writes it to
error log
• System will apply sampling rules in following sequence –
o QTR rule
o 100% inspection rule
o Frequency rule
• System writes sampling data in following three tables.
o Record each lot to sampling log table “mntSamplingLog” sequenced log
key ascending order.
o Record first lot of the quarter to sampling qtr log table “mntSamplingQtr”.
o Record each error to sampling error table “mntSamplingError”.
o System will populate GSL hold flag to TRUE for sample requested lots.

mntSamplingLog Table –
• sampleType
• samplePlan
• ovenLoadRun
• container
• partNumber
• qty
• currentStep
• sampleDate
• currentReqQty
• currentSubQty
• totalReqQty
• totalSubQty

mntSamplingQtr Table –
• sampleType
• samplePlan
• ovenLoadRun

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• container
• partNumber
• qty
• sampleDate

mntSamplingError Table
• sampleType
• samplePlan
• ovenLoadRun
• container
• partNumber
• qty
• currentStep
• sampleDate
• errorMsg

6. Appendix
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The following table identifies any documents referred to within this document, including the
document name and the author, status of the document, and description/location of the
document.
Document/Author Version Description/Location
Statement of Work for Phase II Final Statement of work that bounds the
project at a very high level.
MES Phase II – Software Requirements Latest Information about summarized
Specifications (SRS) business requirements.
PCO-002 Latest Project change control request

Oven Screen & GSL Testing Latest Design spec for oven screen and GSL
testing requirements

Item Description
21 CFR Part 11 Title 21 Code of Federal Regulations governing Electronic records and
Electronic Signatures.
API Applications Program Interface. A method to interface to a piece of software
through a defined call, passing arguments in a prescribed order.
MDS Medical Device Suite.
MES Manufacturing Execution System. System or systems that facilitate
management of manufacturing.
NDO Named Data Object within InSite.
OOB Out-Of-Box. Used to describe off the shelf functionality provided by software.

RDO Revisioned Data Object within InSite

SOW Statement of Work.
UOM Unit Of Measure.
VB Visual Basic(.Net) is an object-oriented programming language from
Microsoft
WIP Work in Process.
GSL General Services Laboratory
PMT Process Monitoring Testing
FDT Finish Device Testing
Micro Microbiology Laboratory

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