Quality management in industry

Quality management is of strategic importance to industry, particularly in the pharmaceutical and cosmetics sectors, where quality management is central.

In Industry 4.0, quality is an implicit customer expectation, particularly in the pharmaceutical and cosmetics industries, where health and safety stakes are especially high. Critical for the business, quality management encompasses the tools, methods, and operational procedures of operational excellence that increase customer satisfaction whilst ensuring company performance and cost reduction.

In this article, we outline the 7 principles of the quality management system (QMS), which are pillars of an optimal quality strategy.

Adopting a customer-focused approach

The first principle of the quality management system is a customer-oriented focus, with the customer at the centre of the company's processes.

According to ISO 9000: “Organisations depend on their customers.” Products and services must therefore be adapted to customer requirements, which guide the company's actions, with the aim of building customer loyalty. To achieve this, companies must identify customer expectations and even anticipate them.

Leadership in industry

Leaders must create a climate of trust in which objectives and values are communicated clearly and precisely. They must define the strategy to be followed and create conditions that foster performance, by providing staff with the infrastructure, tools, and training needed to achieve the set objectives.

Within a complex system, each employee possesses key skills that must be recognised and valued. In other words, each employee must be aware of their added value, so as to improve their well-being and, in turn, their engagement. In parallel, it is essential to identify potential blockers and skills gaps to ensure team coherence.

This principle involves viewing the company as a set of interrelated processes, so as to analyse the overall coherence of the process and more readily identify areas for improvement.

Pursuing continuous improvement

Continuous improvement has become, in Lean Management, a key concept for ensuring long-term quality. It involves continually questioning processes in cyclical approaches, so as not to repeat mistakes that have already been corrected.

Evidence-based decision-making

Given that uncertainty can be high in decision-making processes, one of the principles of quality management is to draw on reliable data sources and evidence, and to make decisions based on objective analysis.

Relationship management: another aspect of quality management

Quality management affects all of a company's employees and partners, as it is linked to all processes. “Interested parties” or “stakeholders” refers to the various actors with whom the company collaborates. In addition to meeting customer requirements, companies must cultivate relationship management — that is, the relationships they maintain with suppliers, service providers, and other partners.

The 7 principles of the quality management system are applied through a set of tools. Among these tools is notably the PDCA method.

The Deming Wheel, also known as PDCA, is a continuous improvement approach, or Kaizen, used in Lean management and quality management. It is a sequential method for conducting and improving projects that enables work to be carried out efficiently and rationally by improving a company's internal processes.

The PDCA method — standing for Plan, Do, Check, Act — aims to repeat action cycles at each stage of a project or production chain in order to improve company performance.

This method consists of a succession of four distinct stages:

There are also other tools, such as the action plan, which enables communication on the progress of a project and the various actions that comprise it.

Quality management in the pharmaceutical industry

As mentioned previously, the quality approach in the pharmaceutical industry is crucial. The Pharmaceutical Quality System (PQS) is a management system put in place to direct and control quality within a pharmaceutical company. This system aims to guarantee the quality and efficacy of medicines, whilst improving the quality and productivity of the company.

In practice, the PQS consists of 4 elements to be applied throughout the lifecycle:

• A system for monitoring process performance and product quality

• A system of preventive and corrective actions

• A change management system

• A management review of process performance and product quality.

Quality management in the cosmetics industry

In the cosmetics industry, it is Good Manufacturing Practices (GMP) that govern quality management practices. These practices include regulations covering staff, premises, equipment, raw materials and packaging components, production, finished products, the handling of out-of-specification products and deviations, and waste.

In both the pharmaceutical industry and the industrial cosmetics sector, good practice guides exist — for example, for the sterilisation or disinfection of reusable medical devices.

The cosmetics and pharmaceutical industries, and industry more broadly, view quality management as a discipline aimed at meeting customer needs. The very notion of quality management is subjective and relies on a series of reference frameworks, specifications, and technical requirements. For a coherent implementation of quality management, it is essential to find the tools suited to one's type of industry and to maintain a consistent, results-based approach.

An article written by Emma Guignard