asq-eed tucson, az

Download ASQ-EED Tucson, AZ

Post on 15-Jan-2016

19 views

Category:

Documents

0 download

Embed Size (px)

DESCRIPTION

ASQ-EED Tucson, AZ. Do You Have Corporate Visibility to your Quality and Compliance Program?. Paul Fricke, CQMgr, CQA AssurX, Inc. Lessons learned: Even small actions taken, based on complete information, can deliver HUGE benefits to organizations…and vice versa. - PowerPoint PPT Presentation

TRANSCRIPT

  • ASQ-EEDTucson, AZ

  • Lessons learned: Even small actions taken, based on complete information, can deliver HUGE benefits to organizationsand vice versa.

    Technology never for technology sake

    Related Quotes: Not everything that counts is counted, and not everything that is counted counts - Albert EinsteinIt is not what you dont know that hurts you, its what you know for sure that isnt so - Joseph JuranOne fact is worth a thousand opinions AnonymousComplex problems have simple easy to understand wrong answers - AnonymousWhy 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 changeRisk Balanced approaches requiredClear, Efficient, Effective, and Timely communication / information is essentialSystems and Process must be compliant and forward looking

    Quality and Compliance Tools:

    Right tool for jobMetricsEasy to useFlexible 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

    PriceEffectiveness,Efficiency CostsConfiguration,Integration, AdministrationTrainingMaintenance,CostsIdeal 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, )

    ENTERPRISESOLUTION

    Compliance Foot Print

  • Zero client software to install (and none IS installed)Any Operating System (Windows, Solaris, Apple, Linux, UNIX, etc.) Any Web Browser (Internet Explorer, Netscape Navigator, Opera, etc.)Zero Script Errors, DLL Hell, or Java Virtual Machine problemsZero platform issues when extending to Suppliers, Customers or PartnersFastest Response Times in the Industry (less than 2 seconds!) CATSWeb True Zero Client = Zero Compatibility Problems(Actual errors from http://javascript.internet.com with Internet Explorer 6.0.2800.1106)What Is Zero-client?

  • Ideal Reporting ArchitectureUsers can generate..Application Server Data Base ServerReport Server GRAPHSCHARTSONE-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 toolie: Reporting tool Agnostic

    Chart1

    853

    1385

    1596

    352312

    1275

    862

    431

    000

    000

    000

    000

    000

    Customer Complaints Total

    Customer Complaints Critical

    Customer Complaints Safety Issues

    Customer Complaints Overview

    Sheet1

    Customer Complaints TotalCustomer Complaints CriticalCustomer Complaints Safety IssuesCustomer Complaints TotalCustomer Complaint ElectricalCustomer Complaint MechanicalCustomer Complaints Other

    Jan8538Jan521

    Feb138513Feb670

    Mar159615Mar546

    April35231235April13319

    May127512May246

    June8628June224

    July4314July130

    Aug0000Aug000

    Sept0000Sept000

    Oct0000Oct000

    Nov0000Nov000

    Dec0000Dec000

    Sheet1

    000

    000

    000

    000

    000

    000

    000

    000

    000

    000

    000

    000

    Customer Complaints Total

    Customer Complaints Critical

    Customer Complaints Safety Issues

    Customer Complaints Overview

    Sheet2

    000

    000

    000

    000

    000

    000

    000

    000

    000

    000

    000

    000

    Customer Complaint Electrical

    Customer Complaint Mechanical

    Customer Complaints Other

    Customer Complaints by Type

    Sheet3

    Sheet3

    853

    1385

    1596

    352312

    1275

    862

    431

    000

    000

    000

    000

    000

    Customer Complaints Total

    Customer Complaints Critical

    Customer Complaints Safety Issues

    Customer Complaints Overview

    521

    670

    546

    13319

    246

    224

    130

    000

    000

    000

    000

    000

    Customer Complaint Electrical

    Customer Complaint Mechanical

    Customer Complaints Other

    Customer Complaints by Type

    Chart2

    853

    1385

    1596

    352312

    1275

    862

    431

    000

    000

    000

    000

    000

    Customer Complaints Total

    Customer Complaints Critical

    Customer Complaints Safety Issues

    Customer Complaints Overview

    Sheet1

    Customer Complaints TotalCustomer Complaints CriticalCustomer Complaints Safety IssuesCustomer Complaints TotalCustomer Complaint ElectricalCustomer Complaint MechanicalCustomer Complaints Other

    Jan8538Jan521

    Feb138513Feb670

    Mar159615Mar546

    April35231235April13319

    May127512May246

    June8628June224

    July4314July130

    Aug0000Aug000

    Sept0000Sept000

    Oct0000Oct000

    Nov0000Nov000

    Dec0000Dec000

    Sheet1

    000

    000

    000

    000

    000

    000

    000

    000

    000

    000

    000

    000

    Customer Complaints Total

    Customer Complaints Critical

    Customer Complaints Safety Issues

    Customer Complaints Overview

    Sheet2

    000

    000

    000

    000

    000

    000

    000

    000

    000

    000

    000

    000

    Customer Complaint Electrical

    Customer Complaint Mechanical

    Customer Complaints Other

    Customer Complaints by Type

    Sheet3

    Sheet3

    853

    1385

    1596

    352312

    1275

    862

    431

    000

    000

    000

    000

    000

    Customer Complaints Total

    Customer Complaints Critical

    Customer Complaints Safety Issues

    Customer Complaints Overview

    521

    670

    546

    13319

    246

    224

    130

    000

    000

    000

    000

    000

    Customer Complaint Electrical

    Customer Complaint Mechanical

    Customer Complaints Other

    Customer Complaints by Type

  • Solution

    A central location with standardized processes Adaptable to users, clients, and suppliersOne 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) designScalability Runs on any browser version or type, any client operating system and does not require mu