“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives�
Who is CQ? Fastest growing Salesforce® based EQMS solution Gold Level Partner
OUR GO-TO MARKET • •
A highly flexible, 100% native Salesforce platform based EQMS We streamline • Quality Management • Compliance Management • Content Management • Collaboration Management workflows across the enterprise (internal and globally-based supply chain networks).
CORPORATE FACTS Customer Locations 500+
Locations
CORPORATE HEALTH Awards
NA, Asia, Europe
8 and growing
• Cash flow positive • EBITDA positive • Good cash position and continue to grow the reserve cash
Employees 55+
Channel Partners
• Operations continue to fund the company
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Top operational Priority for Automotive Manufacturers
Digital Transformation in the Automotive Industry
Improve manufacturing efficiency Ensures operations are in compliance Improve customer service Improve ability to deliver new products Better manage operational risk Improve supply chain responsiveness Achieve corporate social responsibility goals 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%
Source: LNS Research
Percentage Respondents
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CASE STUDY Solution Benefits
Challenge Company Fast Facts Industry: Automotive 2016 WW Sales: $44.8B http://www.contitech.us/ Location: Hannover, Germany + 90 locations
Project Fast Facts • Usage Scope: 5400 Users • Migration: Lotus Notes • Integration: SAP, SharePoint and Lotus Notes
Competition From most of the EQMS providers in the industry
Mobilize (Feb, 2017)
• Currently, largely uses QSI Lotus Notes based quality system that is ageing and is no longer supported • Contitech has disparate, access based, Excel based quality systems that do not provide harmonized process and/or corporate level visibility • Lessons learnt could not be consolidated and shared. • Supply chain quality was broken • Contitech continues to acquire more companies and the complexities continue to grow.
CQ Solutions Provided Audit
Equipment
CAPA
Inspection
Change
Nonconformance
Complaints
Supplier
Document
Training
• Only one instance of CQ is required even with the 9 BUs set up like separate entities with policies that meet the BUs unique requirements, including security. • System interface and approach of usage has been standardized, increasing transferability. • With CQs integration to “Lessons Learnt” database, information can be transferred to other BUs for best practices.
• Full suite of CQ EQMS offering across 91 locations impacting 40,000 employees • For the first time, all 9 BUs will have one consistent and harmonized quality system processes, including inputs and outputs. • System will be translated to 18+ languages • System will be integrated to SAP, SharePoint and existing Salesforce footprint. • Supplier portal allows for suppliers to interact with Audit, CAPA, COAs, Deviations, Escalations etc.
CQ Configuration (Mar – Dec 2017)
Implementation ( August, 2017 through March, 2018)
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Automotive Industry Landscape AUTOMOTIVE MARKET OVERVIEW The Automotive sector is experiencing dynamic changes and this has altered how the industry is monitored. Some big trends the industry is dealing with are: •
Intense regulatory scrutiny around emission- Demand for efficiency in energy and manufacturing
•
The race for connected and autonomous vehicles
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Vehicle electrification and hybridization
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IP global regulation management- Rise of copycat cars
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Digitization security due to vulnerability of plants to cyber attacks
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Factory automation and robotics
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Use of new materials- like lightweight carbon
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Increase in quality expectations, vehicle recalls and warranty costs. Demand for quality processes like IATF 16949:2016 and ISO 25252
IATF 16949 IATF 16949 is the most widely used international standard in the automotive industry and it geared to: • • •
Improve services and products Give a competitive edge Inspire trust
IATF 16949:2016 builds on ISO 9001:2015 to help automotive Original Equipment Manufacturers (OEMs) and suppliers to consistently produce quality products and meet/exceed customer needs. The new standard is focused on the following goals: QUALITY AND SAFETY
TRUST AND REPUTATION
IATF MANAGE COST AND STREAMLINE PROCESSES
16949:201 6
TAKE ADVANTAGE OF INTEGRATION AND EFFICIENCIES
MANAGE RISK AND SUPPLY CHAIN
AN EQMS THAT ADDRESSES QUALITY CHALLENGES UNIQUE TO THE AUTOMOBILE INDUSTRY Confidential. © ComplianceQuest. All rights reserved
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Top IATF 16949 Challenges New structure
Risk-based thinking
Continual improvement
Along with all new and revised standards, IATF 16949 follows a common structure designed around the plan-do-check-act cycle. The goal is to help companies that use multiple management systems and/or want to implement multiple ISO standards.
IATF 16949 places a strong emphasis on risk-based thinking. While earlier versions of ISO 9001 separated out preventive action, new standards require companies to account for risk at every stage of the process and a more proactive approach to risk mitigation, rather than a reactive one.
Companies must demonstrate continual improvement of quality management system (QMS) effectiveness. Key tools here include audit findings, corrective and preventive action and proactive data analysis.
Creating Management Accountability
Documenting IATF 16949 Compliance
Some of the biggest changes in IATF 16949 involve holding management responsible for audits. This means management should be closely involved in: • Ensuring completion of scheduled audits • Performing audits • Participating in monthly or quarterly reviews of audit data • Managing action plans and KPI target dates
When it comes to IATF 16949 certification, documentation is likely to be a significant challenge for many companies.
Process focus IATF 16949 contains fewer prescriptive requirements, providing more flexibility around how you document and implement your QMS. Instead, the standard focuses on whether and how your process ensures customer satisfaction.
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Who We Help and Where We Help Manager/Director/ VP of Quality/EHS Manager/Director/ VP of Engineering Manager/Director/ VP of Manufacturing Manager/Director/ VP of IT Manager/Director/ VP of Supply Chain • ExecutivesCEO/COO/CIO
Design Quality Customer Success Operational Quality Supply Chain Quality Risk and Compliance Confidential. © ComplianceQuest. All rights reserved
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ComplianceQuest Platform Dashboards, Reports
Enterprise Systems
CRM
Community
Collaboration
Mobile
Communication
Audit Management Software
CAPA Management Software
Change Management
Complaints Management System
Document Management Solution
Equipment Management Software
Incident Management
Inspection Management
Non Conformance Management
Risk Management
Supplier Management Solution
Training Management System
ERP
Validation
AI
Pre-Integrated
PLM
LIMS
Other
Platform Powered by Analytics/Portal
Object
Flow Builder
User Interface
Process Builder
Language
Authentication/Security/SSO
Compliance/Trust
Chatter (Social Collaboration)
Integration – APIs/Web Services
Validation (IQ and OQ)
Audit Trail, e-Signature - 21 CFR Part 11
Mobile
Multi-Tenant Architecture/Cloud/App Exchange Community Framework Confidential. Š ComplianceQuest. All rights reserved
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Supporting Tools and Resources
Salesforce AppExchange
Company Website
Video and Word
CQ Key Contacts
Salesforce Key Contact
https://appexchange.salesforc e.com/listingDetail? listingId=a0N3000000B5PNxE AN
www.compliancequest.com
• Solution Overview https://vimeo.com/213068 757 • Product Video https://vimeo.com/297732 836/2d7c999b26 • Discovery Questions • White Paper
Sales: Prashanth Rajendran pr@compliancequest.com
Eric Rosenstine Strategic ISV Partnerships Manufacturing 408 210-4002 erosenstine@salesforce.com
Marketing: Shalini Chowdhary shalini@compliancequest.com
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Target Industries Sweet Spot •
Highly regulated
•
Evolving compliance requirements
•
Meet ISO 9001 and other ISO certifications
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Manage quality and safety
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Manage risk
•
See quality as a competitive advantage
•
Align well in Salesforce industry clouds
Industries Industries
Aerospace and Defense
Regulations
Automotive
Regulatory compliance is one of the key drivers for the adoption of an EQMS solution. ComplianceQuest monitors and incorporates key regulations that impact our customers. • ISO 9001:2015 – General Quality System • AS 9100 – Aerospace and Defense • IATF 16949 - Automotive
Consumer Packaged Goods
Food and Beverage
• ISO 13485:2016 – Medical Devices Quality System • ISO 14971 – Medical Devices Risk • GMP / ICH Q10 – Pharma/Bio Quality System • FDA GxP – Life Sciences (Part 820/210/211)
General Manufacturing
Hi-Tech
• 21 CFR Part 11 / Annex 11 – ERES and Audit Trail • OHSAS 18001 / ISO 45001 – Safety • ISO 14000 – Environmental
Pharma/Biotech
Medical Devices
• ISO 27000 – Information Security • And more….
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(408) 458 8343
INFO@COMPLIANCEQUEST.COM