Chapter 2: Advanced QMS for Dummies
Organizations today face many challenges that change how business is conducted. Businesses are buffeted from all sides by severe global issues such as supply chain disruption and skilled labor shortages. Organizations also face health and safety challenges, risks brought on by climate change, geopolitical upheaval, and sustainability problems.
Amidst these unprecedented factors, the quality environment also has its own challenges. They include the:
- Burden of massive and growing regulations
- Constant change and heavy business complexity
- Patchwork collection of manual and aging quality systems
- Unrelenting demand for higher quality at lower cost
- Immediate and severe public consequences of poor quality
Quality professionals are stepping up to meet these challenges and improve quality management practices to ensure their organiza- tion can thrive. A quality management system can be a phased investment. In fact, many organizations begin with standard process improvements to streamline document control, audits, and corrective actions (CAPA). As these processes gain accep- tance, new capabilities and management controls can be added to improve supplier quality, new product introduction, and quality analytics. The next section reviews these steps.
Embarking on a Quality Journey
This section looks at the stages of maturity that an organization passes through on its journey to exceeding customer expectations.
In working with hundreds of customers, ETQ has observed four stages of maturity on the quality journey, as shown above: Ignite, Accelerate, Expand, and Transform. (The Transform stage is the culmination of the other three.) This model provides a valuable framework for organizations to approach their quality challenges. The following sections review each stage so that you can evaluate where your organization is at this time.
Stage 1: Ignite
This is where most organizations start on the quality journey, as they prepare to move away from paper- and spreadsheet-based processes.
The goal of this stage is to build a strong quality foundation, streamline key processes such as audits, corrective actions, doc- ument management, and change management, and a system to ensure all stakeholders are trained. At this stage, the orga- nization likely recognizes that there’s an opportunity to reduce their quality costs while also improving their ability to maintain compliance.
Most QMS implementations begin with improving document control and change management processes, addressing audit management, building workflows for corrective action manage- ment, and ensuring all key stakeholders are trained.
Challenges that organizations face in the Ignite stage include:
- Manual and disconnected processes
- A lack of centralized systems
- A lack of audit follow-up
- Uncontrolled or inconsistent documentation
- An absence of training for employees
- A struggle to achieve regulatory compliance
TACKLING SYSTEM FRAGMENTATION AT KIMBERLY CLARK
Personal care giant Kimberly-Clark replaced over 630 separate and fragmented quality systems with one globally harmonized EQMS from ETQ and saw an 80 percent improvement in new product introduction cycle time. Now, their one quality management system integrates quality, supplier quality, safety, and environmental workflows. “By digitizing and standardizing our safety, environment, and quality processes, we have been able to boost employee productivity, product quality, and customer satisfaction,” says Benjamin Bollenbacher, Director, Supply Chain Digital Capabilities, Kimberly-Clark.
Do you recognize your organization? Focusing on remediating these problems will go a long way to promoting trust and main- taining your brand reputation as you move into Stage 2.
Stage 2: Accelerate
As organizations move to the second stage of the quality journey, they may still experience some of the same challenges as Stage 1. However, they’ve taken strong and positive steps to automate their QMS systems and improve quality in the organization. As their quality program matures, their goals will evolve, and the demands may increase.
In the Accelerate phase, the goal is to enable process flows between functions and systems, capture data at its source, leverage that data everywhere, and produce actionable information. Without the right quality management processes in place, trying to meet these goals can be challenging.
Challenges that organizations face in the Accelerate stage include:
- Manual data entry across many non-quality systems
- User-unfriendly data silos
- A lack of standardized practices
- A lack of visibility
- An inability to gather customer feedback
- Inconsistent or time-consuming decision-making
One of the positive changes that results from progressing through this stage is the ability to manage customer complaints. Com- plaints aren’t isolated events; they occur due to failures at any number of points across the business ecosystem. Therefore, cus- tomer complaint management must be integrated into a larger QMS framework that includes non-conformance reporting, cus- tomer returns (RMA), corrective action and supplier corrective action reporting, and risk management tools.
The key to progress in this stage is finding solutions that can integrate with your existing systems and lay the groundwork for stage 3, for example, customer relationship management (CRM) and enterprise resource planning (ERP).
Do you think about monitoring customer complaints as a direct way to lower costs and protect revenue? If not, try it! As part of your ecosystem, tracking customer complaints is one of the best ways to discover problems you’re not yet aware of. In fact, research on ROI shows a 30 percent reduction in time spent man- aging complaints when customer complaints management is integrated into the larger QMS framework.
Stage 3: Expand
The goal in this stage is to integrate internal and external stakeholders (especially organizations’ suppliers) into the quality process, extend their quality program to encompass environmen- tal, health and safety (sometimes known as EHSQ convergence), and provide value-added data analytics to all processes. At this phase of the journey, you’ll map out solutions to more complex quality and compliance challenges.
Challenges that organizations face in the Expand stage include:
- Lack of visibility into supplier quality performance
- The rising costs of coordinating in-process changes with internal stakeholders
- Reporting systems that are manual and disconnected from the quality process (for example, health and safety reporting)
At this stage, organizations can integrate the complete ecosystem of stakeholders. They can use quality processes to mitigate risks like supplier defects and recalls.
Organizations in this stage rely on the emerging technology associated with Quality 4.0, such as machine learning and auto- mated business optimization solutions. See Chapter 4 for more information.
See how Nutrien built the foundation of its culture of safety with ETQ Reliance.
Stage 4: Transform
At this stage of the quality journey, organizations are looking to unlock competitive advantages by becoming more proactive, mak- ing quality a strategic initiative, and focusing on consistent global harmonization of their integrated quality management system. To achieve these higher quality goals, organizations will be forced to overcome some significant hurdles to operational excellence.
Challenges that still face organizations in the Transform stage include:
- A change in the regulatory environment may impede products from reaching the market when planned.
- New teams not participating. The distribution, services, and customer success teams should be brought into a closed- loop process to prevent quality escapes and ensure continuous improvement in new product development.
Having progressed to the Transform stage, you can now meet the challenges your organization faces with the right tools and insights from analytics gathered across the organization.
Ultimately, as you integrate your QMS with key manufacturing, test, and measurement data, or customer relations management systems, you’ll create a digital thread that connects the shop floor to the top floor of your organization. By embedding quality assurance at every stage of the product lifecycle, you can ena- ble improved data-driven decision making throughout the entire process and produce better, more consistent products in less time and with fewer resources. Transform means you’re managing risk, you’ve expanded digital transformation to quality, and you’ve been able to harmonize processes globally across the organization.
No matter where your organization is in the quality journey and what pain points you’re currently experiencing, your goal should be to find technology solutions that will scale as your quality management processes and needs mature.
Measure where you are on your quality journey with ETQ’s Quality Journey Assessment tool.
Satisfying IT Requirements
To meet the needs of their organizations, IT departments will benefit from a cloud-native QMS that provides the following capabilities:
Remote workforce support: The Software-as-a-Service (SaaS) model is built for the anywhere, anytime access needs of a distributed workforce. Because a SaaS-based QMS can be accessed remotely, it’s a natural fit to help employees adjust to the disruptions of remote work. With a SaaS solution, employees can access essential data, perform vital tasks, and collaborate seamlessly in the cloud.
- Decreased IT burden and costs: Under the SaaS model, operational responsibility lies with the vendor. The vendor manages the environment, ensures continuity of services, and addresses users’ needs, enabling IT to focus on more strategic initiatives. In addition, centralized updates and patches eliminate the need to make changes to local systems and servers. This lowers the maintenance and overhead burden on IT staff, a significant advantage for businesses with a shrinking IT footprint.
- State-of-the-art security: Vulnerabilities exist in every IT environment, but for most organizations, a cloud solution
with a premier host like AWS with an end-to-end encryption cycle is the optimal choice for data security. - Easy scalability: When performance demands grow and functional requirements change, you can easily add new licenses, features, and storage without the huge restructuring and implementation costs and infrastructure investments associated with on-premise solutions.
- 24/7 application usage monitoring: Seeing how and when teams use applications gives you valuable insight into your processes, utilization, and how to optimize your technology.
Don’t forget that you need to choose a flexible QMS to adapt easily as your business processes change. It must be easy to configure layouts and workflows with no coding required — minimizing the IT burden.
A cloud-native QMS can bring organizations to a higher level of quality. By providing a QMS that’s easy to use and delivers more information to users, organizations can make better decisions about quality. This significantly improves productivity and maximizes the role of quality as a competitive differentiator.
Read the white paper: “Finally, a QMS IT Will Love” for more insights on the role IT plays in deploying your QMS software.
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