1. Quality Management in 2023: What's Needed?
Burt Nanus and Warren Bennis, both experts on leadership, coined the acronym VUCA in 1987. It refers to the Volatility, Uncertainty, Complexity and Ambiguity in the overall business landscape in the U.S. The world wasn’t truly global then, and it is safe to say that the global economy has become even more complicated and interlinked these days.
Why are we bringing this up here? The reason is obvious.
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 is becoming increasingly dynamic. Risks are multiplying and unexpected types of quality events are affecting the manufacturing lifecycle, making leaders are 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.
1.1 Holistic Approach to Quality Management
McKinsey points out that pharmaceutical and medical technology (MedTech) companies that use next-generation tools and technologies are able to adopt a holistic and connected approach towards quality management.
A connected Quality Management System (QMS) takes care of the following aspects:
- It is seamlessly integrated with customer-related processes. This means it enables customer-facing teams and brings in data from the CRM into the EQMS. By doing this, quality leaders have a better sense of customers’ evolving needs.
- The process of collecting data, running analytics on it and preparing dashboards to monitor is truly automated, 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 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.
1.2 "Smart" Quality Management Framework for 2023
According to the 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 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: A smart quality framework provides 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.
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.
2. ISO 9001:2015 – A Modern Quality Management Standard
ISO 9001:2015, one of the most recognized quality standards, facilitates improved 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.
2.1 Key Principles of the ISO 9001 Standard
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.
ISO 9001 emphasizes the need for businesses to understand the context of their organization when implementing ISO 9001.
Identifying the context involves:
- Conducting internal/external audit
- Understanding the needs and expectations of the stakeholders
- Determining the scope of the Quality Management System
- Ensuring leadership commitment
- Document management
- Training management
- Defining organization roles, responsibilities, and authorities
- Identifying risks and opportunities
- Change management
- Communication and collaboration
A uniting factor across businesses is the need for digital transformation and automation for improved quality management and compliance with the ISO 9001 standard. Digital technologies such as AI, data analytics, and cloud are crucial for building an enterprise-wide culture of quality.
Looking to implement a modern EQMS solution to drive efficiency into the process of ISO 9001 compliance? Several companies across manufacturing, medical devices, healthcare, pharma, biotech, automotive and aerospace sectors use CQ to streamline, automate and digitally transform their ISO 9001 compliance workflows.
To know more, request a demo here:
https://www.compliancequest.com/online-demo/
2.2 Digital Transformation of ISO 9001 Processes
A solution such as ComplianceQuest is mapped to the ISO 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:
- Auditing: The auditing module of ComplianceQuest can help with a gap analysis to understand areas of opportunity. With CQ’s Audit Management Software, we ensure companies have the ability to build a flexible, scalable and configurable audit management workflow. Depending on the specific needs of your organization, you can automate a rapid audit process or configure a workflow for a complex audit. The end-to-end audit process is streamlined, with the latest data and documents available just a few clicks away. Collaboration with various stakeholders is also easy with a tool like ComplianceQuest.
- Quality Policy Documentation & Communication: Once the gaps have been identified, one of the first steps is to define the quality policy, align it with business goals, and ensure this is communicated to the entire organization
- Leadership Commitment: The need for the involvement of the leadership in ensuring the creation of a culture of quality cannot be highlighted enough. They lead from the front and facilitate close collaboration with the Quality Team to make informed decisions and improve responsiveness. An automated workflow helps to empower leaders with the data needed to make critical decisions related to improving their QMS.
- Assigning Roles and Responsibilities: Clarity of roles and responsibilities is a must for the employees to participate proactively in quality management. ComplianceQuest helps with alerts, notifications, and permission-based access, empowering employees to participate in the quality process.
- Integrated Risk Management: Access to enterprise-wide data provides insights into current and potential risks, helping to prioritize them, and mitigate risks.
- Quality Control Tower: A quality control tower provides all quality-related data for the business to make relevant decisions in a timely manner.
- Planning and Ongoing Operations: Visibility into processes helps to assess operations and modify them based on changing needs.
- End-to-End Automation: With ComplianceQuest EQMS, the entire quality management process including conducting CAPAs and RCAs, Non-Conformance Management, Change, Training and Document Management can be streamlined and automated.
- Continuous Improvement: This is one of the most important requirements of ISO 9001, requiring periodic monitoring of metrics to assess the effectiveness of the quality management system and improving continuously for better performance.
3. ComplianceQuest – Prefered EQMS Solution for ISO 9001 Compliance
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. ComplianceQuest provides several solutions that help organizations capture, monitor, and review information about both internal and external issues, including the performance of the organization, through reports, as well as suppliers with overall supplier ratings and scorecards.
It provides a connected, end-to-end quality management system that makes quality at the source possible, creating differential advantage through ComplianceQuest’s next-generation connected quality management system. It is also built to support multiple stakeholders, such as Quality, Manufacturing, Operations, Engineering, Management, and Suppliers.
You don’t realize how hard life is without a great quality management system until you have one. ComplianceQuest makes managing quality and all of its facets easier. Fact-based data is all there for you in one system. You can run reports and get on with the job you need to do.
Customer Quality & Compliance Director, Huhtamaki
