Enterprise Wide Quality Management System
Enterprise Wide Quality Management Made Easy
Tony Tan – American RENOLIT Corp LA
Bob Herdoiza – CEBOS
Enterprise Wide Quality Management System
Agenda
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Introduction
Industry issues & challenges
CEBOS overview
Enterprise quality management
Company Case study
Integration
Why quality
Q&A
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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
Intense shareholder
pressures
Customer compliance
Regulatory compliance
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Enterprise Wide Quality Management System
Recalls
Johnson & Johnson issued a
massive recall Friday of over-thecounter drugs including Tylenol,
Motrin and St. Joseph's aspirin
because of a moldy smell that has
made people sick.
Jan 15, 2010
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Enterprise Wide Quality Management System
More Recalls
Mattel Does Damage Control
After New Recall
Aug 15, 2007
…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 Recall
Jan 26, 2011
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.
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Enterprise Wide Quality Management System
Compliance
• Industry standards
- TS 16949
- ISO 9000
- ISO 13485
• Regulatory
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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)
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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
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Enterprise Wide Quality Management System
FDA Quality System Requirements
Corrective and
preventative
actions
Production and
process controls
Design controls
Management
Equipment and
facility controls
Material controls
Records,
documents,
change controls
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm
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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
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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
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Enterprise Wide Quality Management System
CEBOS’ MQ1
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Enterprise Wide Quality Management System
Integration
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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
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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
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?
Enterprise Wide Quality Management System
Driving Results
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Enables higher customer satisfaction
Reduces product planning time
Reduces time to market
Reduces non-conformances
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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
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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
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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
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Enterprise Wide Quality Management System
Customer Case Study - Solution
• CEBOS MQ1 software
• 13 modules highlighting:
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Documents
Problem solver
Audits
Human resources
Data collection
Work manager
APQP
E-sync
• Integration from QAD to MQ1
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Enterprise Wide Quality Management System
MQ1
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- Module Roll Outs
Quality Management System - CEBOS MQ1
- Licensed Modules
• Audits
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Customer, Process, Product, Safety Audit
Customer & Supplier Mgmt
Document Mgmt
E-Sync
Maintenance
Problem Solver
Gage
Human Resources
Tooling
APQP – Advanced Product Quality Planning
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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
Enterprise Wide Quality Management System
Customer Case Study - Results
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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
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Enterprise Wide Quality Management System
Customer Case Study - Results
• Configured for simple for end users
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Enterprise Wide Quality Management System
Customer Case Study - Results
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Enterprise Wide Quality Management System
Customer Case Study – Lessons Learned
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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
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Enterprise Wide Quality Management System
QAD & QMS Integration Framework
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Enterprise Quality Mangement Systems
QAD & MQ1
- Module Roll Outs
QAD
MQ1
Planning Workbenches:
Master Scheduling
Production Scheduling
PBO Interfaces & Integration
MRP &
CRP
ODBC
E-Sync
QAD - Item Master
QAD - Work Orders, Lot, Qty
QAD - Inspection Plan
APQP
Control Plan
Process Control (std conditions)
Data Collection
PBO Integration
Process Condition & Seimens PLCs
QA Inspection
Business Intelligence
BOM, Blender Sheets
PLCs,
Barcoding
Tablet
Notebooks
Suppliers
Inventory
Manufacturing
Quality Assurance
Shipping
Enterprise Wide Quality Management System
Sample Integration Points
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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:
Bidirectional Transaction Data
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:
Bidirectional Transaction 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.
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Enterprise Wide Quality Management System
Sample Integration Points
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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.
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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.
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Calibration 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 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.
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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.
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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
http://www.qad.com/erp/Life-Sciences/
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Enterprise Wide Quality Management System
Questions & Answers
Bob Herdoiza, CEBOS
bob.herdoiza@cebos.com
Tony Tan, Renolit
tony.tan@renolit.com
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