Automotive Quality: Digital Transformation of TS 16949 Processes – A CQ Guide

Original Equipment Manufacturers (OEMs), Tier-1 and Tier-2 auto component suppliers and, the entire automotive ecosystem has been investing in R&D and innovation to tap into the opportunity posed by the future of mobility. But the fundamental requirement of quality, cost and delivery hasn’t gone away. By embracing a framework like TS 16949, companies in the automotive sector will be able to embrace Total Quality Management (TQM) requirements, even as they innovate and change at a breakneck pace.

Quality Management for the Future of Mobility

Over the last few years, the automotive sector has been going through rapid innovation and change. In fact, there is a whole new phrase – Future of Mobility – to describe the world of electric cars, self-driving vehicles, and semi-autonomous cars and trucks.

Today’s cars are packed with chips, sensors, IoT devices and several other technology components. In fact, the global chip shortage has delayed the delivery of new cars and trucks across the world.

OEMs, Tier-1 and Tier-2 auto component suppliers and, the entire automotive ecosystem has been investing in R&D and innovation to tap into the opportunity posed by the future of mobility. But for all these cutting-edge innovations to truly work, world-class quality management is paramount.

At ComplianceQuest, our focus is on serving quality and safety leaders, and we’re seeing that with all the unpredictability in the global business landscape, the nature and type of challenges faced by quality teams are becoming increasingly dynamic. Risks are multiplying and unexpected types of quality events are affecting the manufacturing lifecycle, making leaders look for better systems to ensure quality goals are met.

Needless to add, complying with regulations is becoming more complicated and time-consuming, making quality and compliance important points of discussion that are impacting bottom lines.

Of course, globalization has enabled businesses to lower costs and accelerate growth. But at the same time, it has also added a layer of complexity as it requires greater monitoring and management of facilities located in different geographic locations. Supply chains are becoming complex and the only way to get quality right is by proactively managing risks and quality performance across the entire value chain. The overall approach needs better access to data, documents and true collaboration.

A risk-based approach and quality compliance system conforming to management standards such as ISO 9001 have become essential for companies to become more efficient. ISO 9001:2015 recommends a proactive, risk-based approach where businesses prevent rather than just respond to quality events. This requires the support of technology and tools that make processes more transparent, traceable and automated.

As per the ISO website, “ISO/TS 16949, in conjunction with ISO 9001, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products.”

Proactive Quality Management in the Auto Sector

McKinsey points out that companies in advanced industries such as automotive that have adopted a smart-quality approach must also factor in complex and deep supply chains. The emphasis should shift to improvements in discrete manufacturing, building global service networks to address quality in the field, and regulatory compliance and standardization. Helping reshape the day-to-day quality operations of the value chain will be new technologies such as a connected Quality Management System (QMS) that takes care of the following aspects:

Seamlessly integrating with customer-related processes. This helps customer-facing teams by bringing in data from the CRM into the EQMS. By doing this, quality leaders have a better sense of customers’ evolving needs.
Automating The process of collecting data, running analytics on it, and preparing dashboards for monitoring so that various stakeholders have a finger on the pulse of data that really matters to them.
While regulatory compliance is critical, a connected quality system is designed to be flexible and scalable so that quality performance can have a positive impact on business metrics.

In the traditional approach, quality compliance was considered a cost, a regulatory requirement that could not be avoided. And so, compliance was more about reacting to events and minimizing damages. But, with the advancement of technologies, businesses can embrace modern process design techniques that facilitate flexibility and the implementation of a smart quality framework. This can help with reimagining how quality can be more cost-effectively, decreasing costs and ultimately improving a business’s bottom line.

automatically classify all findings from a ts 16949 audit

1.2 Data-Driven Quality Management: A 'Must Have' in the Auto Industry

According to a McKinsey survey, a smart quality system can result in:

Improved profits
Around 30% faster time-to-market
A more responsive supply chain and possibly better manufacturing output

A smart quality framework – with data and analytics at the core – also helps establish a culture of quality by empowering employees to boost customer satisfaction and reduce compliance risk. An effective smart quality framework aligns with an enterprise’s objectives of delivering on business goals and regulatory requirements unconditionally and cost-effectively. As a result, businesses are able to:

Improve Resource Utilization: A smart quality framework frees up resources to focus on adding value, innovation, and product improvement as automation takes care of repetitive tasks.
Access Data Better: By providing visibility into all processes and access to data for improved decision-making.
Reduce Compliance Burden: Automation and process integration also facilitates better document management that helps with regulatory compliance.
Accelerate Time-to-Market: With greater compliance, businesses can reduce deviations and nonconformance, which leads to shorter production and release cycle times.
Enhance Complaints Management: Digital tools provide real-time insights that enhance complaint management, enabling improved customer engagement and satisfaction.
Empower Employees: By providing employees with access to data and visibility into processes, a smart quality framework increases employee engagement in quality management and establishes a culture of quality.

Only by embracing technology and tools to implement a proven standard like ISO 9001, businesses can experience greater compliance, better quality performance, and increased competitive advantage.

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ISO 9001:2015 – The Essentials

ISO 9001:2015, one of the most recognized quality standards, focuses on improving satisfaction of all stakeholders of a business, including customers. It enables building a quality framework for ensuring consistency of the quality of goods and/or services. It takes a risk-based approach and encourages the automation of processes for greater transparency and accountability.

The standard is based on seven quality management principles, including having a strong customer focus, the involvement of top management, and a drive for continual improvement.

The ISO 9001:2015 is built on seven principles. These are:

Customer focus: Implementing the ISO 9001 QMS helps businesses understand their customers’ needs and links feedback and customers to the system to help businesses respond faster and more effectively. It also helps to reduce errors, thereby increasing customer confidence.
Leadership: ISO 9001 requires a commitment of the top management to implement and guide the rest of the organization.
Engagement of People:ISO 9001 recommends the establishment of a culture of quality that requires the involvement of every employee in proactively addressing risks to quality.
Process Approach:A proactive, risk-based approach requires a strong system with automated workflows and processes to empower employees and management.
Improvement:ISO standards lay stress on continuous improvement, constantly fine-tuning the system, and keeping pace with the changing business environment, company goals, and regulatory requirements.
Evidence-based Decision Making: Data acts as the fulcrum for decision-making, requiring visibility into processes and access to enterprise-wide data.
Relationship Management: Right from the management to the last employee, suppliers and the customer are linked through an integrated, enterprise-wide quality management system that ensures a holistic approach to quality.

The principles can vary in importance in different organizations and over a period of time, based on the growth stage, challenges, etc. the company is facing.

TS 16949 For Automotive Quality Management

Over time, there have been many transformations in automotive technology, with the increasing use of electronics. This is making the vehicles more complex and design is becoming a very critical element. Some of the requirements for the automotive industry is to manufacture reliable vehicles and components that can withstand varied terrain and climates. They need to have a long life with electronic components that can coexist without causing disturbance to each other. They cannot fail and must comply with strict quality standards governing component manufacturing and testing.

TS 16949 helps automotive companies manage these complexities and draw on global best practices for the design and manufacturing of automotive components by integrating the best practices followed in Europe and the US. Developed by the International Automotive Task Force (IATF), it draws from ISO 9001 and emphasizes continual business improvement through defect prevention, variation reduction, and waste in the supply chain.

By implementing TS 16949, automotive companies can:

Expand their reach to global markets
Prevent defects and reduce waste
Improve compliance

Automation of Key TS 16949 Processes

A solution such as ComplianceQuest is mapped to the ISO/TS requirements and helps with automating the workflows for greater efficiency and effectiveness of the Quality Management System.

Some of the areas where it improves effectiveness include:

Audit Management
Quality Policy Documentation & Communication
Leadership Commitment
Assigning Roles and Responsibilities
Integrated Risk Management
Advanced Analytics for Insight Gathering
Visibility into operational data
End-to-End Automation
Continuous Improvement

We have just migrated our change, complaint, audit and document management system onto the eQMS provided by Compliance Quest. Compliance Quest has given excellent support in providing customization to our specific QMS requirements and sustained guidance through the entire migration and integration process. We are receiving excellent feedback from the users on the interactive and easy-to-use interface. Data analysis & review and cross-functional collaboration can be done in real-time which has really enhanced our QMS. Highly recommended!

Sudharshan Shetty, Manager QA & Management Representative, CEAT Ltd

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Key Capabilities of ComplianceQuest

ComplianceQuest EQMS is a cloud-based, AI-enabled solution that helps build the smart framework required to make quality management effective and efficient. It helps with a variety of functions, including:

Audit Management
CAPA for continuing improvement
Change management
Complaints Management to create loyalty by addressing customer complaints smartly
Document management for relevant information to be within reach always
Equipment management for keeping the tools of the trade in top condition
Inspection management
Nonconformance management across departments and locations
Risk management
Supplier management
Training

Built on the Salesforce platform, ComplianceQuest helps businesses experience the benefits of automating their quality process across the enterprise right from design to continuous improvement.

AI-enabled Automation

We also built CQ.AI to help business leaders implement hyper-automation into their quality and safety processes. Formally, hyper-automation can be defined as an end-to-end approach to making use of an ecosystem of automation-related technologies to automate all business processes that can or should be automated.

It uses artificial intelligence (AI), machine learning (ML), robotic process automation (RPA), and other technologies to transform modern and legacy processes.

ComplianceQuest’s AI framework is designed to implement the following types of automation:

Task automation: Automating short-running, routine tasks for quick benefits. From a quality perspective, this could be as simple as automatically notifying a stakeholder once a CAPA is triggered or an ISO audit is scheduled with an e-mail notification.
Process automation: Orchestrating and automating long-running processes to deliver higher business value. Examples include eliminating redundant complaint records by detecting duplicates and automatically merging and closing them.
Augmentation: Empower knowledge workers with intelligent capabilities and enable self-service for customers. This could be spotting an ISO 9001 non-compliance that is fairly similar to an earlier one that was detected and automatically recommending escalation to CAPA.

Delivering Business Value in the Auto Sector

By implementing a next-generation software like ComplianceQuest, businesses are able to see the positive impact of better, smarter quality management on four areas:

Financial

Minimize (and possibly eliminate) fines, recalls, liabilities, financial litigations
Eliminate work slowdowns or even stoppages
Reduce the financial costs associated with scrap, waste, and rework
Reduce freight costs, chargebacks, product returns
Drive up both top-line and bottom-line

Brand Value and Customer Success

Enhance a company’s brand and reputation by delivering trustworthy products
Make it easier for the sales team to sell a proven product that customers love
Increase brand loyalty so customers keep coming back

Quality Performance

Decentralized repository for data, documents, content and processes
Ensure inefficient or broken processes are fixed quickly
Better collaboration between quality team and executive leadership with automated management reviews
Agile actions of quality issues that have been reported

Continuously monitor and analyze quality metrics and improve as needed

Operational Excellence

Greater collaboration between various teams
Drive efficiency into supplier, logistics, manufacturing & production and customer-facing processes
Agility and nimbleness across the quality workflow
Ensure data-driven and collaborative decision-making, so no time is wasted

ComplianceQuest enables businesses to implement a smart quality framework by integrating AI, Automation, and Data in the quality management process. By providing access to data and next-gen technologies, it enables businesses to implement a system of engagement and establish a culture of quality, aligning closely with ISO 9001 and TS 16949.