ASQ-EED Tucson, AZ
Do You Have Corporate Visibility to your Quality andCompliance 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. • 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
Quality and Compliance 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 Tools: Metrics Right tool for job Flexible for direction and use Easy to 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
So Why Is That Important? Cost Considerations of anyQuality 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.
And Why Is That So Important? Typical OTS Software (Web-based Brand A, B,C, etc.) Ideal system (zero-client, web-based) Home – Grown System (ie.Elaborate Access Based system or similar) Manual System (ie. Paper / Excel, etc. ) Price Effectiveness, Efficiency Costs Configuration, Integration, Administration Training Maintenance, Costs Architecture Smallest Iceberg Lowest Cost Fastest ROI
Compliance Foot Print 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? DIRECTORS (Corp Governance, ...) • What audits are this company performing? • What were the findings and solutions? • Is there a culture of closed-loop continuous improvement? FINANCE (Reporting, Controls, SOX ) • What processes are out of control? • Are outdated, wrong processes being corrected? ENTERPRISE SOLUTION OPERATIONS (cGMP, ISO, …) Factory Floor (Defect Tracking, NCMR) Quality Department (CAPA, Audits) SUPPLY CHAIN (Procurement, Customers …) Procurement (Supplier Quality, Incoming Inspection) Customer (RMA, Complaints, ) REGULATORY (Sox, cGMP, 21 CFR Part 11, Reporting, Commitment Tracking, …)
Ideal Reporting Architecture 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. GRAPHS Users can generate….. CHARTS ..using ANY reporting tool ie: Reporting tool Agnostic Application Server Report Server Data Base Server
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
In Conclusion… SW for Fastest ROI (…the Smallest Iceberg) • 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 • 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.
Thank you • For more information on how CATSWeb is used in the Energy, Transmission, Distribution sectors, please contact: Trey Kirkpatrick, Northeast Utilities firstname.lastname@example.org • Come and see us at Exhibit Area • Visit us at www.AssurX.com