ASQ-EEDTucson, AZ

Lessons learned:

Even small actions taken, based on complete information, can deliver HUGE benefits to organizations…and vice versa.

Technology never for technology sake

Related Quotes:

“Not everything that counts is counted, and not everything that is counted counts” - Albert Einstein

“It is not what you don’t know that hurts you, it’s what you know for sure that isn’t so” - Joseph Juran

“One fact is worth a thousand opinions” – Anonymous

“Complex problems have simple easy to understand wrong answers” - Anonymous

“Why and How are words so important they cannot be used too often” - Napoleon Bonaparte

Paul Fricke, CQMgr, CQA

AssurX, Inc

Do You Have Corporate Visibility to your Quality andCompliance Program?

The World Today:

Do more with less (people, dollars, time)

Things will continue to change

Risk Balanced approaches required

Clear, Efficient, Effective, and Timely communication / information is essential

Systems and Process must be compliant and forward looking

Quality and Compliance

Tools:

Right tool for job

Metrics

Easy to use

Flexible for direction and use

Process Requirements

Configuration / Administration can be put in the hands of Process Owners which improves the effectiveness. It should have the following: • Forms• Fields • Workflows• Signature Controls• Warning & Escalation Rules• Entity based Restrictions• Queries & Filters• Ready ability to Interface with corporate systems• etc…

Configurations should be

“Point & Click”

and DO NOT…

require Programming

or changes to core code

Cost Considerations of any Quality System The GOOD (obvious costs)

SOFTWARE PRICE / DEVELOPMENT COST of Quality System

SOFTWARE PRICE /DEVELOPMENT COST of full audit trail & edit history

The BAD (dangerous costs) EFFECTIVENESS COST– Cost of insufficient visibility, incomplete analysis, and poor decision making. (i.e. scrap, rework, inventory, litigation, morale, reputation)

PROCESS COST (EFFICIENCY) – Time & effort expended from entering, (re)recording, organizing maintaining, updating, sending, extracting, reading the edit history, analyzing issues and actions,

The UGLY (nagging Costs) INSTALLATION & DEPLOYMENT COSTS– (i.e. days, weeks or months?)

CONFIGURATION & ADMINISTRATION COSTS - Time & expertise to set up, configure, and administer the system. As the quality system matures and new processes or requirements come about, how costly is it to improve the tool (add, modify, connect it to other systems, etc.)

VALIDATION COSTS – Cost to validate server and client workstations

TRAINING COSTS – Time & effort necessary to understand and use the system

PERFORMANCE & MAINTENANCE COSTS – Resources to support and maintain the system as well as the speed, reliability of the system.

OPPORTUNITY COSTS – Costs associated with valuable resources that could be devoted to something more value added.

So Why Is That Important?

And Why Is That So Important?

Manual System (ie. Paper / Excel,

etc. )

Home – Grown System

(ie.Elaborate AccessBased system or

similar)

Typical OTS Software

(Web-based Brand A, B,C, etc.)

Architecture Smallest Iceberg Lowest Cost Fastest ROI

Price

Effectiveness,Efficiency

Costs

Configuration,Integration,

AdministrationTraining

Maintenance,Costs

Ideal system (zero-client, web-

based)

REGULATORY (Sox, cGMP, 21 CFR Part 11, Reporting, Commitment Tracking, …)

FINANCE (Reporting, Controls, SOX )

What processes are out of control?

Are outdated, wrong processes being corrected?

DIRECTORS (Corp Governance, ...)

What audits are this company performing?

What were the findings and solutions?

Is there a culture of closed-loop continuous improvement?

MANAGEMENT (Tone, Forecast, Disclosure…)

What are our my biggest risks for not meeting forecast?

Where should I focus resources to reduce bottlenecks?

What are my employees suggesting we should being doing to improve and eliminate potential fraud?

OPERATIONS (cGMP, ISO, …)

Factory Floor (Defect Tracking, NCMR)

Quality Department (CAPA, Audits)

SUPPLY CHAIN (Procurement, Customers …)

Procurement (Supplier Quality, Incoming Inspection)

Customer (RMA, Complaints, )

ENTERPRISE

SOLUTION

Compliance Foot Print

Ideal Reporting Architecture

Users can generate…..

CSMSApplication Server

CSMS

Data Base

Server

Report Server

Customer Complaints Overview

0

10

20

30

40

Jan

Mar

May July

Sept

Nov

Customer Complaints Total

Customer Complaints Critical

Customer Complaints Safety Issues

Customer Complaints Overview

Jan Feb Mar April May June

July Aug Sept Oct Nov Dec

GRAPHS

CHARTS

ONE-CLICK REPORTING – Ideal to have links anywhere and launch reports using ANY and multiple web based reporting applications, enabling you to preserve your investment and use the best tool for suit the needs.

..using ANY

reporting tool

ie: Reporting tool Agnostic

Solution

A central location with standardized processes

Adaptable to users, clients, and suppliers

One database and interfaces allows rapid access to information and dashboards

Demo

Metrics – Drill Down

Corrective Action Metrics

Executive Dashboards

Corporate Visibility - Executive Dashboard KPI

Corporate Visibility - Executive Dashboard KPI

Corporate Visibility – KPI Metrics

Instant Trends in the Form

Quick Query Within the Form

Queries From Within Forms

Effectiveness Reports

In Conclusion… SW for Fastest ROI (…the Smallest Iceberg)

Reporting SW – Best of breed as opposed to hard-selected

Comprehensiveness – All inclusive (non-modular) design

Scalability – Runs on any browser version or type, any client operating system and

does not require multiple databases for multiple sites making it faster to deploy and easier

to manage

Configurability / Flexibility – Point & click configuration of Forms, Fields, Lists,

Escalation Rules, Signature controls, workflows, entity based restrictions (without ANY

changes to base code) increases value, reduces training.

Customization & Integration – Connectivity with ANY system, in REAL time

Intuitiveness - Easy to use with comprehensive help and configurable interface

requires less training.

Reports – Design input form with required parameters/fields

Trending – Decide if automatic, scheduled or on-demand

Charting/Analysis – Pareto, effectiveness, metrics based on thresholds

Query/Filters – Max ROI when accessible from where it is needed

Thank you

For more information on how CATSWeb is used in the Energy, Transmission, Distribution sectors, please contact:

Trey Kirkpatrick, Northeast Utilities

kirkptm@nu.com

Come and see us at Exhibit Area Visit us at www.AssurX.com