enterprise wide quality management made easy riya cao – qad bob herdoiza – cebos tony tan –...

Enterprise Wide Quality Management Made EasyRiya Cao – QADBob Herdoiza – CEBOS Tony Tan – American RENOLIT Corp LA

Enterprise Wide Quality Management System

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The following is intended to outline QAD’s general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, functional capabilities, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functional capabilities described for QAD’s products remains at the sole discretion of QAD.

Safe Harbor Statement


• Introduction• Industry issues & challenges• CEBOS overview• Enterprise quality management• Customer case study• Integration• Why quality• Q & A

Agenda


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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

Recent Legislation

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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

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


CEBOS’ MQ1


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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

• Best in class manufacturers consistently demonstrate:- Solid visibility and control across the organization- Minimal scrap, rework, and returned materials- Good communication across the organization- Standardized processes- Operational metrics tied to financial metrics

Why Important?


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• Document management• Statistical process control• Dashboards• Corrective/preventive actions/non-

conformances• Advanced product quality planning

including FMEA

Enabling Solutions


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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• Modules

- Documents- Problem solver- Audits- Human resources- Data collection- Work manager- APQP- E-sync

• Integration from QAD to MQ1

Customer Case Study - Solution


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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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QAD & QMS Integration Framework


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• Reduce compliance risk

• Drive accountability

• Improve product quality and safety

• Optimize operational effectiveness

• Reduce waste

Why QMS


2008

Corrective and Preventative

Actions

Records, Documents,

Change Controls

Equipment and Facility Controls

Production and Process Controls

Material Controls

Design Controls

Meeting FDA QS Requirements

Life Science Compliance

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EAMQAD EA

QMS

PLM QAD EA

QMS

QAD EA

Management


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Metrics Affected


Process Benefit Value

Integration •Real time inventory control driven by quality events

•Automation

•Data integrity

•Improved compliance

•Eliminate double entries

•Eliminate user errors

•Improve efficiency

Enterprise Quality Management

•Closed-loop quality management

•Compliant to FDA QS

•Paperless quality processes & records

•Enterprise wide quality accountability

•Improved compliance

•Improved product quality and safety

•Optimize operational effectiveness

•Reduce waste

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• Ask your account manager to arrange an Integration Q−Scan

• Stop by the CEBOS booth in the EXPO center 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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Riya Cao, QAD

[email protected]

Bob Herdoiza, Cebos

[email protected]

Tony Tan, Renolit

[email protected]

Questions & Answers


mailto:[email protected]



enterprise wide quality management made easy riya cao – qad bob herdoiza – cebos tony tan –...

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