Enterprise Wide Quality Management Made EasyTony Tan – American RENOLIT Corp LABob Herdoiza – CEBOS
Enterprise Wide Quality Management System
• Introduction• Industry issues & challenges• CEBOS overview• Enterprise quality management• Company Case study• Integration• Why quality• Q & A
Agenda
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Industry Issues and Challenges
New product development
Demanding customer requirements
Continuing pricingand margin pressures
Global consolidationand alliances
Intense shareholder pressures
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Manufacturers
Customer compliance
Regulatory compliance
Product quality concerns
Product safety concerns
Recalls
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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
Enterprise Wide Quality Management System
More Recalls
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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.
Mattel Does Damage Control After New Recall
Toyota Recall
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.
Jan 26, 2011
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• 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)
Compliance
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• 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
Legislation
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Enterprise Wide Quality Management System
FDA Quality System Requirements
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http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm
Corrective and preventative
actions
Records, documents,
change controls
Equipment and facility controls
Production and process controls
Material controls
Design controls
Management
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• Software company• Seventeenth year• Hundreds of deployments - thousands of
users• Currently supporting 12 languages• Serve vertical markets of QAD• Registered to ISO 9001:2008
CEBOS Overview
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• Comply with quality standards (ISO, TS, AS, FDA, etc.)
• Automate required business processes• Integrate related quality processes and QAD
CEBOS Overview
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CEBOS’ MQ1
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Integration
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“To achieve Best-in-Class performance, companies must… implement Quality Management Systems at an enterprise wide level…“ --Aberdeen Group August
2008
Why Important?
Enterprise Wide Quality Management System
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?
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• Enables higher customer satisfaction• Reduces product planning time• Reduces time to market• Reduces non-conformances
Driving Results
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• 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
Customer Case Study - American RENOLIT
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• 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
Customer Case Study - Business Problem
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• Document control• Corrective/preventive action (CAPA)
management• Employee training tracking• Audit management • Project management• Shop floor inspection management• APQP documentation management
Customer Case Study - Specific Areas Targeted
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• CEBOS MQ1 software• 13 modules highlighting:
- Documents- Problem solver- Audits- Human resources- Data collection- Work manager- APQP- E-sync
• Integration from QAD to MQ1
Customer Case Study - Solution
Enterprise Wide Quality Management System
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
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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
Customer Case Study - Results
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Customer Case Study - Results
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• Configured for simple for end users
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Customer Case Study - Results
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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
Customer Case Study – Lessons Learned
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QAD & QMS Integration Framework
Enterprise Wide Quality Management System
Enterprise Quality Mangement Systems
QAD & MQ1 - Module Roll Outs
Suppliers
ShippingInventory
Quality AssuranceManufacturing
QAD MQ1
MRP &CRP
Planning Workbenches:Master SchedulingProduction Scheduling
Business Intelligence
PBO Interfaces & Integration
BOM, Blender Sheets
E-SyncODBC QAD - Item Master
QAD - Work Orders, Lot, QtyQAD - Inspection Plan
APQPControl Plan
Process Control (std conditions)
Notebooks
Data CollectionPBO Integration
Process Condition & Seimens PLCsQA Inspection
Tablet
PLCs,Barcoding
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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.
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.
• 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:• 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.
• 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.
Sample Integration Points
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• 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/
Next Steps
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Bob Herdoiza, CEBOS
Tony Tan, Renolit
Questions & Answers
Enterprise Wide Quality Management System