enterprise wide quality management made easy tony tan – american renolit corp la bob herdoiza –...

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


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


• 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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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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm

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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


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?


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



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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• Configured for simple for end users

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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 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


http://www.qad.com/erp/Life-Sciences/

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Bob Herdoiza, CEBOS

[email protected]

Tony Tan, Renolit

[email protected]

Questions & Answers


mailto:[email protected]

mailto:[email protected]

enterprise wide quality management made easy tony tan – american renolit corp la bob herdoiza –...

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