Quality assurance is a central part of quality management, holding immense significance for businesses. By continuously evaluating and improving their products, services and operations, organisations can increase customer satisfaction, productivity, and competitiveness, all while complying with legal and regulatory requirements.

This article summarises various discussions between Kevin Keymeulen, Quality Responsible at the IBE-BVI Group, and Leo Goeyens. It highlights the importance of quality assurance, and the essential steps needed to implement it effectively.

Quality assurance is dynamic; from a previously limited concept it developed into the internationally recognised standard ISO 9001:2015

ISO 9001 was first introduced in 1987 as a quality management system framework applicable across industries and developed in response to the international demand for a universal quality standard. It has since undergone four major revisions: 1994, 2000, 2008, and 2015. These updates have incorporated new management principles, improved clarity, and adapted to evolving business practices.

The 2015 update to ISO 9001 was a major overhaul, designed to bring the standard in line with current management methods. It placed greater emphasis on risk-based thinking, leadership involvement, and a process-oriented perspective. Additionally, it highlighted performance evaluation and ongoing improvement, fostering a proactive approach to quality management that adapts to today’s rapidly evolving business environment.

These updates aim to strengthen organisations’ ability and to consistently meet customers’ needs, improving their overall performance. As a result, ISO 9001 has become one of the most widely used quality management standards in the world.

Quality management relies on seven principles; this deserves a few words of explanation

The seven principles of quality management are as follows:

-                   Customer Focus: prioritize customer needs and satisfaction,

-                   Leadership: establish unity of purpose and direction within the organization,

-                   Engagement of People: involve and motivate employees,

-                   Process Approach: manage activities as interconnected processes,

-                   Improvement: continuously enhance measurable performance,

-                   Evidence-Based Decision Making: base decisions on data and analysis, and

-                   Relationship Management: foster positive relationships with stakeholders.

According to Kevin, these principles are essential for ensuring high-quality work. For example, Customer Focus is not limited to meeting expectations; it also involves understanding the unique challenges of each client, allowing us to tailor our services and achieve tangible results. Effective Leadership drives us toward excellence. When management places a high value on quality, it fosters an atmosphere of professionalism, where employees take ownership of their work. This leads the team to follow clear guidelines, promoting cooperation among technicians, administrative staff, and other stakeholders.

When every member of the team contributes to resolving problems, we can quickly identify and solve them, improving the quality and speed of our services.

The Process Approach ensures that each step, from sample collection to report delivery, is well defined and regulated, reducing the chance of errors. Continuous Improvement keeps us at the forefront by incorporating the latest testing methods and technologies and encourages us to consistently evaluate and enhance our procedures. By analysing data, we can pinpoint the reasons for recurring packaging failures, leading to improved processes. Furthermore, maintaining strong relationships with suppliers and calibration labs is crucial for the accuracy of our testing equipment. These principles are not mere abstractions; they form the foundation of our laboratory’s reputation and success. The key to our ongoing improvement is embedded in our procedures: we draw insights from feedback or post-audit improvement measures.

IBE-BVI's recent implementation of an Odoo platform for Quality Management Software (QMS) and Laboratory Information Management System (LIMS), which actively supports many of these principles, is a clear example. In particular, the powerful data collection, in real time analysis, and reporting capabilities of our platform significantly enhance Evidence-Based Decision Making, allowing us to make well-informed, data-driven choices. The Process Approach is embodied in the platform's customizable workflows and automation capabilities, ensuring standardized and traceable testing and quality procedures. Implementing ongoing enhancement relies on tracking nonconformities, training of employees, maintenance (and calibration) of equipment and identifying areas for enhancement. This way, we can actively optimise our procedures. Additionally, the platform promotes Engagement of People by providing shared dashboards and communication tools that foster collaboration and transparency among team members. Additionally, Relationship Management is strengthened by integrating supplier and calibration data. Overall, Odoo helps streamlining operations, improving quality, and supporting strategic decision-making.

To implement these principles, SWOT analyses might be effective tools

SWOT stands for: Strengths, Weaknesses, Opportunities, Threats. Conducting a SWOT analysis allows an organisation to evaluate its internal capabilities, external possibilities, and potential challenges. This comprehensive understanding can aid in strategic planning and decision-making.

Kevin is convinced that SWOT analyses are powerful tools that offer a structured approach for identifying an organisation’s strengths, weaknesses, opportunities, and challenges. These analyses can simplify strategic planning and decision-making, aligning with principles such as Evidence-Based Decision Making and Continuous Improvement. Moreover, SWOT analyses support a comprehensive understanding of the organisational environment, making them valuable tools for ensuring successful implementation of quality management systems.

However, conducting SWOT analyses requires regularly revised and updated resources and their effectiveness can be limited if not approached with a specific, strategic mindset. The quality of the results depends on the quality of the inputs from stakeholders. Without a focused and well-informed approach, it may not directly translate into actionable change.

In Kevins’s opinion different approaches, such as the PDCA-principle (Plan-Do-Check-Act) or a root cause analysis, could prove more effective. He believes SWOT analyses are less interesting or less practical than PDCA, as they primarily offer a static snapshot of an organisation’s internal and external factors, without providing a clear and structured approach for taking action or solving problems. In contrast, PDCA is a dynamic, iterative process that focuses on continuous improvement, leading organisations through planning, implementation, evaluation, and refinement of solutions.

Root cause analysis digs deeper into specific problems to identify underlying issues, enabling targeted corrective actions. While SWOT can help identify areas for attention, it often lacks the immediate focus on actionable steps and ongoing cycle of improvement that make PDCA and root cause analysis more engaging and effective for driving tangible change.

However, the complementarity of both cannot be denied. SWOT teaches you where the organisation stands and identifies points of attention. PDCA is a way to start working with action points. PDCA cannot replace SWOT, but it helps make what you see in SWOT concrete and actionable.

How are audits carried out by the Belgian official body BELAC?

BELAC, the Belgian Accreditation Organisation, is in charge of ensuring that Belgian organisations engaged in testing, calibration, inspection, certification, and other conformity assessment services adhere to the necessary standards in various sectors. Its primary function is to evaluate organisations against globally recognised standards, such as ISO/IEC 17025 (testing and calibration) or ISO/IEC 17020 (certifying bodies).

The audits conducted by BELAC are intended to verify that the accredited organisations operate according to the relevant standards, and to ensure that their (standardisation) processes and results are accurate, reliable, consistent, and trustworthy.

The development of a shared understanding between auditors and those being audited is essential. Without alignment, communication can deteriorate, resulting in misconceptions or unnecessarily pessimistic assessments. BELAC usually designates a lead auditor to oversee the entire process, with one or more technical experts who concentrate on the specific details. This approach promotes impartiality and fairness. Despite these safeguards, tension can still arise if expectations aren't clearly managed or if the audit is perceived as overly critical. Nevertheless, when conducted respectfully, the process not only validates quality and competence but also triggers continuous improvement and international recognition.

The audits offer several advantages, including assurance of high quality and adherence to regulations, which enhances the reputation of the certified entity. The process also highlights inefficiencies or areas for operational improvement. Conducting audits can be quite labour-intensive, requiring substantial planning from the organisation. It also involves resources and pretty high costs.

Is the assessment of quality control favourable or unfavourable?

Quality assurance reviews typically have a favourable impact on businesses. They help them uphold high standards, refine procedures, minimise mistakes, and boost client happiness. Despite this, they are often perceived negatively due to the associated expenses and additional administrative burdens.

A typical example is the onboarding and training of new personnel. It takes time and resources, but it ensures that new staff members are fully competent. This ultimately saves time and money in the long term.

Kevin would like to emphasise another aspect of quality assurance. It is not only the BELAC audits that are important. Daily lab work, training, reporting and documentation, and both internal and customer audits are all crucial components of a robust quality system. These activities are essential for ongoing enhancement, which is vital for staying relevant and competitive.

Few months ago, we successfully passed a customer (active in the pharmaceutical industry) audit. Successfully completing an audit for a new client not only confirms that our laboratory adheres to rigorous quality guidelines; it also establishes a solid foundation for a mutually beneficial cooperation, built on trust. This brings us back to basic principles, mentioned earlier.

It's important to recognize that a comprehensive quality assurance system is vital for fostering a culture of continuous improvement within the organization. A proactive approach to quality assurance not only satisfies regulatory and customer expectations but also drives innovation, efficiency, and continuous growth within the organization.

Quality assurance can generate new developments

The Belgian Packaging Institute offers a wide variety of certified tests and standard checks. The team’s experts are always available to provide clarification on any test findings. If an analysis performed at the lab on food-contact materials reveals excessive levels of a particular chemical, it would be reasonable to expect a client’s request for clarification. The IBE-BVI team members have the expertise to clarify these topics and even organise seminars on the latest legislation and associated testing methods..

Moreover, it is entirely plausible that the results of accredited tests can have a substantial impact on the development of new materials or products by a company’s R&D department. The results of several drop tests and chemical analyses carried out by researchers at IBE-BVI have already in the past improved the design of packaging for small biscuits as well as for the performance of nutrient filtration systems.

IBE-BVI has been invited to participate as a testing laboratory in a project related to the forthcoming Packaging & Packaging Waste Regulation (PPWR), highlighting the importance of sustainable and reusable packaging solutions. We assess their performance, durability, and practicality, helping stakeholders find innovative, environmentally friendly solutions that meet their needs. Collaborating with support groups such as Valipac, we contribute critical data and insights to aid in the research and development process, ultimately facilitating the transition toward more sustainable packaging systems aligned with upcoming regulations.

Please contact Kevin Keymeulen (kevin.keymeulen@ibebvi.com) for specific questions.