CAPA Product Technical Description Pre-Install Introduction

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CAPA Product

Technical Description Pre-Install Introduction

Corrective Actions Preventive Actions

CAPA focuses on the systematic investigation of discrepancies (complaints, defects, failures and/or deviations) in an attempt to permanently solve the root cause and to prevent their recurrence.

Paul J. Fletcher January 3, 2013

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Agenda

 CAPA Product Introduction

 High-Level Architecture

 CAPA Web User Interface

 Data Model

 Installation and Configuration

 Licensing

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Closed Loop Quality

Full Traceability From Complaint Through Change

Change Request Revised

deliverables

Knowledge capture and reused Deliverable is

released

I am having a problem…

Issue/

Incident

CAPA

Thank you for the solution!

 Siemens CAPA module is designed to be use by any user.

 The user interface will require little or no training.

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Issues, CAPAs, Change Requests

Resolution Is An Evolution

There are many sources for an Issue

• Customer care

• Suppliers

• Production/plants

• Design reviews

• 3D Virtual Assessment

• Manufacturing Feasibility Studies

• …

Examples of Issues:

• I hear a noise in my car’s dash

• During a virtual assessment, we discovered these two parts do not fit

• The documentation/steps to install are incorrect

• There are over 50 customer complaints about the quality of the finish of this product

Issues

Problems/CAPAs

CR/CN

Closed as:

user error, not reproducible, question answered, etc.

Closed as:

user error, works as designed, etc.

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Issues and CAPA Quality Management

Issues

• Issues Management and the various types like Defects, Failures, Complaints and Non-Conformances are the first

step in the evaluation that may lead to a CAPA investigation and subsequently related to CR’s (Change Requests).

• CAPA focuses on the systematic

investigation of discrepancies (failures and/or deviations) in an attempt to

prevent their recurrence (corrective action) or to prevent occurrence

(preventive action).

• Teamcenter’s new CAPA solution will manage these processes within

Teamcenter

CAPA

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Many Sources For Issues, UI Tailored For User

Teamcenter Manages Lifecycle and Resolution

Teamcenter 9.1.x server(s)

Database File Storage

Web App Server Teamcenter

Community Visualization

Rich Client Thin/Web

Client

Office Client

iPad

CAD/NX

Process Simulate

Issues

Problems/CAPAs CR/CN

CAPA Web Client

All clients using

Teamcenter as a server should be creating

Teamcenter issues

These issues should be of the same type, or

similar types

EWI

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Agenda

 Data Model

 Licensing

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CAPA Software Module Defined

Software Deliverables

• Web UI Framework

• Teamcenter Data

• Issues and CAPA sub-types

• Issue + CAPA workflows

• Reports

• Schedules

• Style sheets

• Forms

CAPA Leverages

• TC common platform (workflows, sign-offs, inbox, search, escalations, email integration, etc.)

• Teamcenter’s Change Management (e.g., associating documents, items to an issue or CAPA, associating a schedule to a CAPA)

• Teamcenter’s Schedule Manager (to define the plan with timing to complete the CAPA)

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High-Level Architecture

CAPA Is An Addition To A Teamcenter

Install CAPA on the Teamcenter server

Majority of CAPA users will use the CAPA Web UI Or Microsoft Office

Rich Client Thin/Web

Client

Office Client

iPad

Teamcenter 9.1.x server(s)

Database File Storage

Web App Server Teamcenter

CAD/NX

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Agenda

 Data Model

 Licensing

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User Interface

Overall Layout

Command ribbon Application tabs

User information

Search

Launch Teamcenter

Help Logout

Navigation breadcrumb trail

Views of an object

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User Interface

Tables and Objects

Resize column

Blue text indicates selecting the object will do something – usually navigate to that object

Sequence columns via drag & drop

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Teamcenter CAPA Product Demonstration

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User Interface

Home page

Why is it here?

• The Issue list, CAPA list, and Dashboard all involve queries to load the data

• The greeting page provides a fast entry point into the CAPA web page

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User Interface

Tasks

Provides the user with a list of tasks they are to perform

This is the Teamcenter Inbox

“Tasks to Perform”

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User Interface

Issue page and commands

Purpose

• Provides the user with the list of open issues he/she has created, or actively participating in.

How is this list populated?

• Saved query called “My Issues”

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User Interface

CAPA page and commands

Purpose

• Provides the user with the list of open CAPAs he/she has created, or actively participating in.

How is this list populated?

• Saved query called

“My CAPA”

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User Interface

Issue and CAPA properties

Details

Attachments Web Links Related Items Related CAPAs Related Issues Related CRs

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User Interface

Issue and CAPA properties

Action Plans

Potential Causes Resolutions

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User Interface

Dashboard page

Purpose

Provide a high-level view of the issues and CAPAs within

Teamcenter

What can users do with it

• Reorder the dashboard elements around

• Select a chart piece and drill down

• See a listing of the data behind the chart piece

• Open the issue or CAPA from the dashboard

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User Interface

Search

Simple search

Issue, CAPA, Item, CR search Saved Searches

System Searches Inputs & Results

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User Interface

User Role

Users can change their role within the CAPA UI

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User Interface

Launch Teamcenter

For functions not available in the CAPA Web UI, we have provided the ability to launch a Teamcenter session.

The URL/link is easily configurable by a system administrator or installer.

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User Interface

Help

Special attention has been paid to the CAPA Help

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Deliverable Non-conformance

CAPA Engineering Change

Request

Feedback On A Deliverable

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Deliverable Non-conformance

CAPA Engineering Change

Request

Teamcenter Rich Client View Of An Issue/CAPA

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Teamcenter Rich Client View Of An Issue/CAPA

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Agenda

 Data Model

 Licensing

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Data Model

Issue

Issue

• 3 types

• Generic = C2Issue

• Nonconformance = C2IssueNonConf

• Complaint = C2IssueComplaint

• Forms

• No forms associated to an Issue

• Stylesheets

• Same style sheets used by Teamcenter clients and CAPA client

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Data Model

CAPA

CAPA type

• 1 type

• CAPA = C2Capa

• Forms

• Cause

• Resolution

• Stylesheets

• Same style sheets used by Teamcenter clients and CAPA client

• Action Plans (schedule)

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Data Model

Schedule

Schedule types

• 4 types

• Corrective

• Investigation

• Preventive

• Verification

• Forms

• No forms associated to an Issue

• Schedule Templates

• A user must create the 4 schedule templates

• Corrective_ActionPlan_Template

• Investigation_ActionPlan_Template

• Preventive_ActionPlan_Template

• Verification_ActionPlan_Template

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Agenda

 Data Model

 Licensing

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Installation

Overall Sequence 1. Setup

Teamcenter installation 2. Add CAPA

BMIDE package 3. Install CAPA

Web Application Server

Details in the CAPA

installation documentation

1

2 3

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Installation Guide

How to install CAPA This includes:

• Software and Teamcenter prerequisites

• Steps to install

• Verification procedures

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Installation and Configuration

CAPA Web page configuration

Document in a FAQ style format provides guidance on how to configure the CAPA application This includes how to configure:

• Contents of the applications

• Display text strings

• Dashboard queries and drill- down

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Agenda

 Data Model

 Licensing

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License Checks

Log In

During log in, the following license check will be performed:

Note: we do not check for a

Teamcenter consumer, occasional author or author license.

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Issue Management and Resolution Through Teamcenter CAPA – Summary

 New, web-based UI for defining issues and resolving these issue through the automated workflows

 Define and resolve issues within Teamcenter, relating it to PLM data

 Standardize and automate the process of issue resolution

 Capture the knowledge of how to resolve the issue within your PLM environment

 Issue resolution reports and dashboards

 Reduce Cost of Quality

Issue Database

Cost Of Quality

Questions or Comments

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Additional Information

Sales Center:

https://sales.industrysoftware.automation.siemens.com/sell/tecno matix/products/issue-management-capa/

Teamcenter Community:

https://mycommunity.ugs.com/products/qppv/capa/default.aspx