Presenting Quality Management

Chapter one, Advanced QMS for Dummies:

As a quality professional, you’re constantly under pressure to cut costs, increase margins, respond to changing business needs, and exceed quality expectations for your organization and your customers. An investment in quality management could be the answer to the question, “how do we do things faster, smarter, and more efficiently?”

Quality management is a necessity for every organization that wants to stay competitive in today’s dynamic marketplace. As a result, leading organizations recognize quality management as a strategic initiative and are increasing their investment in quality.

A focus on quality helps organizations improve their processes and products while also enhancing the overall customer experience. A quality management system unlocks opportunities for organizations to deliver the best possible product, gain a competitive edge, and reduce costs. This chapter looks at quality management systems and why these systems are critical for business success in today’s market.

Recognizing Why Quality Matters

Quality matters because it’s essential to your customers. They decide if your quality meets their standards. They are the final arbiters, and no amount of effort from you will convince them otherwise if you haven’t delivered a quality product.

A study by FirstInsight.com bears this out. They found that 53 percent of consumers rate quality as the most crucial factor in purchasing decisions, not price (at 38 percent).

Reducing risk

Advanced quality management powered by the right electronic quality management system (EQMS) links quality to strategic business objectives. It ensures that complete, timely, and accurate quality data is available to the decision-making team empowered to address quality requirements and processes. As a result, the end user, customer, or buyer receives superior quality, service, and value. A QMS drives quality throughout the organization and integrates the entire business by assuring quality in all stages of the product lifecycle, including R&D, production, procurement, service, financial reporting, information technology, and marketing.

A QMS helps the organization meet the demands of all stakeholders, meeting both regulatory requirements and the needs of the customer. It helps limit a variety of business risks across an organization.

On the flip side of that coin, poor quality can potentially have a negative impact on all parts of your business. These risks include:

• Lost revenue due to product delays, warranty claims,
  and recall
• High costs associated with excess rework, waste, and scrap
• Increased compliance costs
• Failed, time-consuming audits
• Wasted time spent on managing document revisions, training employees, and tracking corrective actions
• Customer dissatisfaction and a move to competitors
• Tarnished brand reputation and a loss of business valuation

A product recall or FDA finding could set your organization back to the point where it cannot recover. Proactively putting quality plans and processes in place using QMS software to prevent quality issues and recover effectively is a wise investment.

Focusing on regulatory compliance

Can an advanced QMS help with regulatory compliance? The answer is yes. It can:

• Identify, access, and evaluate laws and regulations
• Maintain a central repository of laws, regulations, records, and associated documentation for your organization’s legal obligations
• Keep records of regulatory body inspections and implementations
• Easily stay up-to-date on changing regulations
• Produce reports required by regulatory bodies such as OSHA and the FDA
• Collect data required for planned and surprise audits

• Building a culture of quality for continuous improvement

In recent years, quality has become the gold standard for buyers. Quality is the strategic determinant on where people spend their money, in both the consumer and commercial worlds. Because their choices are limitless, buyers can afford to scrutinize and compare products. Meanwhile, companies can get stinging customer reviews and social media pressure to get it right or risk damaging their reputation and trust with their customers. Business has never before been able to hear the voice of the customer so directly. Quality has never mattered more than it does today.

A vital first step in establishing a quality management program is to create a culture of quality. A true culture of quality is woven into the fabric of an organization, not created by regulation or management supervision. Instead, it arises from the shared commitment of everyone in the organization.

Employees’ skills and knowledge become even more critical because a quality culture requires that every employee contributes to maintaining quality and continuous improvement. All employees need to take a proactive approach to continuous improvement. The organization should move away from seeing the quality function as the enforcer of quality and enable and encourage all employees to become agents of change and business transformation throughout the organization.

Consider some of the ways you can make quality part of the DNA of your organization:

Start at the top; encourage top management to support and empower employees to pursue quality and take ownership to address problems when they arise.

• Communicate with and educate employees about why quality matters.
• Train your employees in quality management processes.
• Make quality metrics available to all stakeholders to see and internalize.
• Invest in employees who are committed to quality.
• Understand how quality data is key to making important business decisions.
• Support open discussions among employees about quality and steps to take for continuous improvement.
• Communicate your quality standards to your suppliers by sharing your culture of quality goals and monitoring via supplier ratings.

Check out this article to discover how Kaiser Aluminum drives a culture of quality by focusing on one key metric

Taking the Leap to Digital Transformation

Both the pandemic and the post-pandemic economy have accelerated the urgency to implement programs that deliver cost savings, efficiency gains, and digital transformation benefits.

According to a 2020 McKinsey Global Survey of executives, the pandemic “accelerated the digitization of their customer and supply-chain interactions and of their internal operations by three to four years. And the share of digital or digitally-enabled products in their portfolios has accelerated by a shocking seven years.” Organizations that invest in these efficiency gains are positioning themselves to emerge as stronger entities.

Another key driver of digital transformation is the hybrid workplace. With more employees working remotely and some business models drastically altered, everyone must access, share, and process documents and workflows online. Spreadsheets and paper-based systems no longer suffice.

Reviewing the cost of doing nothing

Inaction is never a sound business strategy. Many organizations try to get by with tools they already have on hand, managing quality with spreadsheets, homegrown systems, documents on shared drives, and even paper-based tracking. These approaches are inefficient, error prone, and difficult to adapt when quality goals change. They don’t integrate with other systems such as ERP, CRM, and critical manufacturing quality control systems. Even worse, they lack automated workflows and analytics that allow managers to speed problem resolution and gain visibility into quality trends. Without trend data, critical items will be missed. Higher defect rates, failed audits, and increased waste and scrap all mean that the cost of doing nothing will prove more costly than using a QMS.

Do you know the cost of poor quality? According to the American Society for Quality, “poor quality in a thriving company will be about 10-15 percent of operations. Effective quality improvement programs can reduce this substantially, thus making a direct contribution to profits.”

Read this article to learn how a QMS can reduce the cost of quality

See the white paper “Why the Cost of Doing Nothing is a Quality Concern” 

Leaving paper and SharePoint behind

Some companies opt to move from paper to SharePoint or another shared file system. On the surface this might seem like a good way to digitize paper processes without spending much money. However, this may not be the best choice, because SharePoint doesn’t provide the needed flexibility. It’s a flat system that makes it challenging to drill down to find files needed for an audit. SharePoint lacks the workflow controls needed to ensure the review, approval, and training necessary for good quality. It’s also difficult to get the real-time data needed to answer questions and make decisions. Another critically important issue is being able to prepare and respond to ISO and FDA audits. Manual processes make these preparations cumbersome and take more time than necessary. According to ETQ, those organizations who implement a QMS say they cut audit prep time in half. They also simplify the audit response with traceability between related processes and easy access objective evidence. This greatly reduces the audit burden on the quality team.

Find out more about the costs and risks of relying on manual and spreadsheet-based processes and compare SharePoint with a QMS 

Looking at the promise of Smart Manufacturing

Smart Manufacturing is part of Industry 4.0. It involves integrating the entire manufacturing ecosystem so that it can rapidly respond to any need that arises and manage systems more accurately and autonomously. It’s critical to have an advanced QMS as a foundational technology in the Smart Factory environment. A QMS serves as a digital thread in the entire product life cycle. This transformative platforms leads to lower costs and increases productivity through business process automation and predictive data for quality optimization. In Chapter 4, we look in more detail at Industry 4.0 and its impact on manufacturing.

Adhering to Quality Standards

Adherence to quality standards is a fact of life for manufacturers. If you do a really good job of it, you’re also setting your organization up to make continuous improvements, which becomes a value driver for the organization.

Dealing with multiple standards and increasing regulations

Quality standards and regulations pose a host of challenges for manufacturers. For example:

• Most organizations don’t have the luxury of focusing on only one regulation. They have to comply with several, including ISO 9001, ISO 13485, industry or geo standards. A QMS must have the ability to adapt and handle many standards.
• Most businesses face a continuing increase in regulations (perhaps leading to more standards), which isn’t abating anytime soon. In fact, six new manufacturing regulations have been added every month for the last thirty years! So, a
  QMS must be flexible enough to make changes quickly.
• The continuous changes to standards increase the cost to comply. Having a QMS that will facilitate change management and streamline processes reduces this cost.

The ISO 9001 standard and certification requires documented quality processes that show an organization can satisfy its customers, meet regulatory requirements, and achieve continuous improvement.

Some common quality management standards include:

• Industry: ISO 9001
• Medical devices: ISO 13485, MDSAP, EU MDR (MIR), MedWatch/eMDR
• Life Sciences: 21 CFR Part 11 and Annex 11
• Food safety: FSMA, HACCP
• Several for automotive including IATF 16949 and AEC-Q100

Automating documentation and audit preparedness

In order to put parameters around quality, standards, methodologies, and guidelines (including ISO, Six Sigma, and cGMP) have been put into place. Getting organized to meet industry standards can create a challenge for your organization if you’re using manual tactics. Your QMS should have all the tools and processes to make your compliance easier and faster.

One thing to consider is the fact that there’s increased focus on management accountability. Make sure your documentation clearly defines roles and responsibilities. A QMS makes this easier.

Having a QMS offers many benefits when it comes to standards and filing. An important one is audit preparedness. An advanced QMS gives you:

• Document control: You can centralize your documents and ensure a smooth change process.
• Change management: You can have a single place to request changes, an automated process with business rules to approve changes based upon change type and scope.
• In addition, change management provides a mechanism to communicate and track the status of any actions to implement changes (including revisions to documents related to that change).
• Employee training: You can make sure all staff members
  have the necessary competence and awareness.
• Audit management: These capabilities help you verify that documented procedures are followed.
• Reporting and analytics: These tools make sense of all the data and provide a high-level picture of risk (also, you can easily access data at an auditor’s request).
• Nonconformance and corrective and preventive action (CAPA): You can manage problems more efficiently and trigger any necessary changes to documents, procedures, or quality requirements.

Selecting an Advanced QMS

Let’s begin by defining a quality management system (QMS). The American Society for Quality (ASQ) defines a QMS as a formal system that documents the structure, processes, roles, responsibilities, and procedures required to achieve effective quality management. QMS software offers a centralized means of managing, automating, and tracking your quality management efforts. Increasingly, advanced QMS systems are recognized for their value in providing quality data and insights critical to business optimization and digital transformation (see Chapter 5 for more about that).

QMS systems are based on the idea that any process can cause defects in a product or service when handled by any business area. Therefore, a QMS should integrate and automate quality assurance processes across the full ecosystem.

Today, massive changes to every part of the business environment have increased the need for an advanced QMS. When you’re choosing advanced QMS software, use these criteria to evaluate potential solutions:

• The system must be flexible. You need to be able to optimize internal and supplier management processes for operational excellence and to establish a culture of quality.
• The system should be web-based to eliminate inefficiencies. Web-based software enables users to access all forms, workflows, and applications (including administration)through a web browser, potentially across many geographic locations. (Check out Chapter 4 for more information.)
• Applications must be configurable. To encourage use of the system, you must be able to configure your QMS to support your organization’s needs today and in the future.

The system should be able to handle advanced business rules without customization. For example, the system should be able to route business processes differently based upon either user inputs or inputs through integrations with other business systems in your ecosystem. In addition, since there may be variations in business processes across your organization, the system should allow those processes to be harmonized in one place.

The reporting capabilities must be extensive. It’s critical that you’re able to make sense of your data. Analytics capabilities cannot be an afterthought. (See Chapter 5.) Integration with other systems must be easy. It’s vital that you can break down information silos and share data organization-wide. (See Chapter 3 for more details.) The system must be able to scale. Taking quality enterprise-wide requires that you can scale as you grow.

The end user experience must be both intuitive and flexible. Understanding user needs means that the system can adapt to the way you work.
The system supports secure collaboration with external partners. It’s vital to be able to be able to bring your suppliers fully into the quality management process.

Throughout this book, we examine why pursuing advanced quality management should be at the heart of your business strategy and how advanced QMS software can accelerate this process.

Each week we will share with you a chapter in the book. If you’d prefer to read the book at your own pace download here.