1. Enterprise Wide Quality Management Made Easy
Enterprise Wide Quality Management System
Enterprise Wide Quality Management Made Easy
Tony Tan – American RENOLIT Corp LA
Bob Herdoiza – CEBOS 1

2. Agenda Introduction Industry issues & challenges CEBOS overview
Enterprise Wide Quality Management System
Agenda
Introduction
Industry issues & challenges
CEBOS overview
Enterprise quality management
Company Case study
Integration
Why quality
Q & A

3. Industry Issues and Challenges
Enterprise Wide Quality Management System
Industry Issues and Challenges
New product development
Product quality concerns
Product safety concerns
Continuing pricing and margin pressures
Demanding customer requirements
Manufacturers
Global consolidation and alliances
New Product Development – innovation, new demand, rigorous testing, 510Ks, IDE, etc
Product Quality – No. 1 concern – must be SAFE, must be EFFECTIVE
Increasing Sophistication of Customers – knowledge is more available, people taking charge of their healthcare, forced to learn more about their treatment options in this day and age
Evolving Reg Requirements: Top pressure is compliance, with regulations varying by country/region, product/type, classification etc.
Continuing Pricing/Margin Pressures: Managed care/hmos forcing prices down, increased global competition
Global Consolidation
Intense shareholder pressures
Customer compliance
Regulatory compliance

4. Recalls Enterprise Wide Quality Management System
Johnson & Johnson issued a massive recall Friday of over-the- counter drugs including Tylenol, Motrin and St. Joseph's aspirin because of a moldy smell that has made people sick.
Jan 15, 2010

5. More Recalls Enterprise Wide Quality Management System
Mattel Does Damage Control After New Recall
Toyota Recall
Aug 15, 2007
Jan 26, 2011
…a world-wide recall Aug. 1 of about 1.5 million Mattel toys believed to contain lead contamination, including items featuring such popular characters as Elmo and Big Bird.
Toyota Motor Corp said it would recall more than 1.7 million vehicles worldwide, bringing total recalls to nearly 16 million since late 2009 and dealing a blow to its efforts to restore its reputation for quality.

6. Compliance Industry standards Regulatory TS 16949 ISO 9000 ISO 13485
Enterprise Wide Quality Management System
Compliance
Industry standards
TS 16949
ISO 9000
ISO 13485
Regulatory
FDA 21 CFR Part 210 & 211
FDA 21 CFR Part 820
FDA’s Quality System Inspection Technique (QSIT)
FDA Bioterrorism Act of 2002
Hazard Analysis and Critical Control Point (HAACP)
•21 CFR 820 –Quality System Regulations
-21 CFR –Purchasing controls
-21 CFR –Complaint files
-21 CFR 820 has no references to customer
•ISO 13485:2003 -Medical devices -Quality management systems -Requirements for regulatory purposes
-7.2 Customer-related process
-7.4 Purchasing
-7.5 Production and service provision
-8.2 Monitoring and Measurement
-8.5 Improvement
•Drug/Device or Biologic/Device Combination Products
21 CFR 210 & 211 – Drugs
21 CFR – Biologics
13485 is in part designed to produce a management system that facilitates compliance to the requirements of customers and—preeminently—various global regulators. While being certified to does not fulfill the requirements of either the FDA or foreign regulators, the certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world. Therefore, certification serves to create a management system that can be thought of as a framework on which to build compliance to various regulatory and customer
13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices.
Benefits of Dual Certification: & Medical device manufacturers can benefit from being both 9001 and certified. While such manufacturers are not required to have 9001 certification, it can bring further business benefits, because it focuses on business aspects that are good for all businesses—for example, the emphasis on customer satisfaction and continuous process improvement that a management system omits. Manufactures of medical devices also will need to acquire 9001 certification if they want to branch out to other industries, as certification will not be honored where 9001 is required.

7. Enterprise Wide Quality Management System
Legislation
U.S. Congress passed the Consumer Product Safety Commission Reform Act, H.R.4040
3rd party laboratory test to ensure safety standards
Searchable database on reports of safety hazards

8. FDA Quality System Requirements
Enterprise Wide Quality Management System
FDA Quality System Requirements
Corrective and preventative actions
Design controls
Production and process controls
Management
Material controls
Equipment and facility controls
personnel training and qualification;
controlling the product design;
controlling documentation;
controlling purchasing;
product identification and traceability at all stages of production;
controlling and defining production and process;
defining and controlling inspection, measuring and test equipment;
validating processes;
product acceptance;
controlling nonconforming product;
instituting corrective and preventive action when errors occur;
labeling and packaging controls;
handling, storage, distribution and installation;
records;
servicing;
statistical techniques;
Records, documents, change controls

9. CEBOS Overview Software company Seventeenth year
Enterprise Wide Quality Management System
CEBOS Overview
Software company
Seventeenth year
Hundreds of deployments - thousands of users
Currently supporting 12 languages
Serve vertical markets of QAD
Registered to ISO 9001:2008

10. CEBOS Overview Comply with quality standards (ISO, TS, AS, FDA, etc.)
Enterprise Wide Quality Management System
CEBOS Overview
Comply with quality standards (ISO, TS, AS, FDA, etc.)
Automate required business processes
Integrate related quality processes and QAD

11. Enterprise Wide Quality Management System
CEBOS’ MQ1

12. Enterprise Wide Quality Management System
Integration

13. Enterprise Wide Quality Management System
Why Important?
“To achieve Best-in-Class performance, companies must… implement Quality Management Systems at an enterprise wide level…“ --Aberdeen Group August 2008

14. What is BIC?
Aberdeen Completed Research on Best in Class Manufacturers
Findings & Definition – What is Best in Class?:
99% products in compliance
98% complete and on-time shipments
98% first pass yield
What are the Drivers to Being Best in Class?
Ensure Customer Satisfaction
Reduce Cost of Good & Bad Quality
Increase Profitability and Competitive Advantage

15. What is BIC?
What Were the Actions that Drove Achievement of Best in Class?
Create Visibility of Quality Processes (Ops/Suppliers)
Implement Business & QMS at an Enterprise Level
Establish Integration from Business System and QMS
What are the Enablers to Be Best in Class?

16. Driving Results Enables higher customer satisfaction
Enterprise Wide Quality Management System
Driving Results
Enables higher customer satisfaction
Reduces product planning time
Reduces time to market
Reduces non-conformances

17. Customer Case Study - American RENOLIT
Enterprise Wide Quality Management System
Customer Case Study - American RENOLIT
Manufacturer of plastic films
International company with over 4,000 employees spanning 30 manufacturing and sales locations globally
Los Angeles site is one of the facilities that manufactures film for the medical industry
Some applications of our film go into blood bags, IV, dialysis, nutritional, cardiovascular, biotech, collection and urological drain bags

18. Customer Case Study - Business Problem
Enterprise Wide Quality Management System
Customer Case Study - Business Problem
Stand alone non-integrated systems
Excel spreadsheets primary automation tool
Unable to view trends across the organization
Correct information was often difficult to locate
User and IT management high
Inconsistent processes / not standardized

19. Customer Case Study - Specific Areas Targeted
Enterprise Wide Quality Management System
Customer Case Study - Specific Areas Targeted
Document control
Corrective/preventive action (CAPA) management
Employee training tracking
Audit management
Project management
Shop floor inspection management
APQP documentation management

20. Customer Case Study - Solution
Enterprise Wide Quality Management System
Customer Case Study - Solution
CEBOS MQ1 software
13 modules highlighting:
Documents
Problem solver
Audits
Human resources
Data collection
Work manager
APQP
E-sync
Integration from QAD to MQ1

21. Enterprise Wide Quality Management System MQ1 - Module Roll Outs
Quality Management System - CEBOS MQ1
Licensed Modules
Audits
Customer, Process, Product, Safety Audit
Customer & Supplier Mgmt
Document Mgmt
E-Sync
Maintenance
Problem Solver
Gage
Human Resources
Tooling
APQP – Advanced Product Quality Planning
Control Plan (FMEA & PPAP)
Process Planning & Control (Standard Conditions)
Inspection Plan (QA & Mfg Test Plan)
Data Collection
Work Mgmt
Completed
Partial / In Process
Concept & Development

22. Customer Case Study - Results
Enterprise Wide Quality Management System
Customer Case Study - Results
Central data repository for all locations
Improved data for business decisions
Analysis capabilities across the organization
Consistent / standardized processes
Streamlined processes
Flexible reporting and process configuration

23. Customer Case Study - Results
Enterprise Wide Quality Management System
Customer Case Study - Results
Configured for simple for end users

24. Customer Case Study - Results
Enterprise Wide Quality Management System
Customer Case Study - Results

25. Customer Case Study – Lessons Learned
Enterprise Wide Quality Management System
Customer Case Study – Lessons Learned
Document, Agree and Approve Processes
Management Involvement and Commitment
Defined Objectives Tied to Personnel Goals
Upfront Focus on One Module at a Time
Pilot
Appoint a Passionate Champion Per Module
Detailed Roll Out to End Users

26. QAD & QMS Integration Framework
Enterprise Wide Quality Management System
QAD & QMS Integration Framework

27. Enterprise Quality Mangement Systems QAD & MQ1 - Module Roll Outs
Planning Workbenches:
Master Scheduling
Production Scheduling
E-Sync
ODBC
QAD - Item Master
QAD - Work Orders, Lot, Qty
QAD - Inspection Plan
MRP &
CRP
APQP
Control Plan
Process Control (std conditions)
PBO Interfaces & Integration
BOM, Blender Sheets
Notebooks
Data Collection
PBO Integration
Process Condition & Seimens PLCs
QA Inspection
Tablet
PLCs,
Barcoding
Business Intelligence
Suppliers
Shipping
Inventory
Quality Assurance
Manufacturing

28. Sample Integration Points
Enterprise Wide Quality Management System
Sample Integration Points
Incoming Inspection:
Bidirectional Transaction Data
Upon purchase order receipt of an item that requires inspection in QAD a data collection event will be created in MQ1 with reference to the item number, lot and supplier.
Upon completion of the data collection event the results will be updated in QAD by transferring the inventory to the appropriate location based on the results of the inspection.
In-process Inspection:
A data collection event will be created for a work order operation that is an inspection operation and the status is changed to “Q” (in Queue).
Upon completion of the data collection event the results will be updated in QAD identifying the disposition.  If the product has passed inspection it will be moved to the next operation, if the product does not pass the update will be based on the status: rework or scrap along with the appropriate reason code.
Problem Solver with Lot Inventory Data:
If a problem (NCMR, CAPA, Customer Complaint) is generated in MQ1 and the inventory needs to be quarantined, the lot inventory data in QAD will be updated with the appropriate inventory status code. 
If an inventory item is moved from inventory to a MRB location in QAD and the inventory status is not a quarantined status then an NCMR will be generated in MQ1.  Item number and lot number information will be passed to MQ1.

29. Sample Integration Points
Enterprise Wide Quality Management System
Sample Integration Points
Problem Solver for Customer Complaints If an issue is created in Call Maintenance and the category is customer complaint then a CPR Type Customer Complaint will be created in MQ1. When the complaint is closed in MQ1 it will update the issue in QAD Call Maintenance.
Training Record Interface:
Transaction execution validation
A verification from QAD will be performed when an operator logs into a job using labor feedback by work order, a check will be made into MQ1 for the employee’s training records to verify that the employee is current on the training for this operation for the product.  If the employee is current in the training they will be allowed to proceed with the transaction, if the employee is not current an error message will appear and the employee cannot continue.
Calibration Record Interface:
A verification from QAD will be performed when an operator logs into a job using labor feedback by work order and enters a machine, a check will be made into MQ1 for the machine/equipment to verify that the calibration is current.  If the equipment/machine is current in with calibration they will be allowed to proceed with the transaction, if the calibration is not current an error message will appear and the transaction cannot continue.
Master Data:
Unidirectional from QAD to MQ1
Items
Suppliers
Customers
This data will be transferred from QAD to MQ1 using eSync.  QAD will be the system of record.

30. Next Steps Stop by the CEBOS Table for a demo
Enterprise Wide Quality Management System
Next Steps
Stop by the CEBOS Table for a demo
Review and download information on the QAD Life Sciences website

31. Enterprise Wide Quality Management System
Questions & Answers
Bob Herdoiza, CEBOS Tony Tan, Renolit