Ensuring quality of products and services is a challenging venture for many companies. Applying basic aspects of quality management, including quality planning, control, assurance and improvement form the starting point. For companies in life sciences, healthcare and cosmetics industries, quality management is a comprehensive task. That’s why we offer support in various aspects of quality management.
What is a quality management system?
Few sectors are exposed to risks more than life sciences and medical (devices) industries, issues with quality or patient safety can result in high human toll and legal claims. The purpose of a quality management system (QMS) for these companies is to bring their products or services onto the market in a safe, consistent and high-quality manner. This process consists of various types of quality-related activities:
Quality Planning: translation of the companies quality policy in tangible requirements, a roadmap to implement these within a specified timeframe and key process indicators to measure them
Quality assurance: prevention of errors in product manufacturing processes to ensure quality, for example via audits and tests during the process.
Quality control: detection of quality-related issues in products or services after manufacturing, for example via inspection.
Continuous improvement: continuous improvement processes are focused on ongoing improvement of products and processes, via continuous testing, evaluation and adjustment.
The International Organization for Standardization (ISO) governs the international standard for quality management systems: ISO 9001:2015. By applying this standard, companies can verify they are meeting quality requirements. Among others, ISO 9001 states that companies need to clearly understand customer requirements and that need to manage and continuously improve internal processes – like documentation, equipment, software, management, design and production – to meet quality requirements. ISO 9001:2015 is based on specific quality management principles:
- customer focus
- engagement of people
- process approach
- evidence-based decision making
- relationship management
What are the (key) components of a quality management system?
The right processes will help companies to ensure optimal quality. It is of key importance to have an accurate, up-to-date document management system in place to make sure all process information is retraceable. In addition, a comprehensive training system ensures that all employees are informed and trained in a timely manner in the processes they are involved in as well as in changes to these processes.
A quality management system consists of following components:
- CAPA (corrective and preventive action): the organization must have a process in place to implement corrective and preventive actions linked to a non-conformity. A corrective action is undertaken to address a non-conformity. A preventive action is taken to anticipate potential non-conformities
- Change management and control: when the organization wants to make changes to processes, this has to be done in a controlled way, i.e. change control.
- Design and development: the organization needs to implement a design and development process to describe design and development of products and services.
- Deviation handling: when non-conformities are detected, proper action must be taken to log and remediate the issue and its effects on the quality of products and services.
- Document management: all processes must be described in policies, standard operating procedures, et cetera. In addition, documents must be controlled during their lifecycle.
- Internal audits: the organization must organize internal audits to investigate the status of the quality system, frequency needs to be planned in advance.
- Leadership and management: this is essential to establish and maintain a company-wide commitment to quality and for the performance of the quality system.
- Maintenance and calibration: making sure that infrastructure and instruments are working correctly and where required, compared against a traceable reference device and or standard
- Management review: quality management system must be monitored by management. Management reviews must be held with a specific frequency.
- Performance evaluation: measuring the efficiency and effectiveness of processes and resources
- Root cause analysis: method for discovering originating factors of a deviation.
- Supplier management and quality assurance: quality of products and services sourced from external suppliers must be controlled.
- Training: the organization needs to ensure that all employees receive proper training and education concerning topics that are related to their job and function.
Why is quality management so important?
Of course, the importance of quality of your products and services is a no-brainer. By keeping a close track on all important amendments in quality requirements and regulations, you will reinforce your company’s immune system and keep control of risks associated with quality and safety. In addition, quality management has an important purpose from a business perspective. Quality is good business sense and will increase the profitability of your business. Many constituent processes that you will build within your quality management system, also support customer satisfaction. If you combine this with insights on safety, supply chain and finance, you have a powerful instrument to help understand why your company misses out on deals or orders, and how to solve this problem.
How do you implement a quality management system?
The advantages of quality management are clear, but how do you set up a quality management system? Be aware of the fact that a quality management system needs to be supported by the entire organization of your company. And you need to make sure that it’s just right for your own business. Prevent implementation issues for your quality management system and make sure to create a thorough roadmap including the following steps:
- Stakeholder analysis: what is allowed and what isn’t?
- Map out existing aspects: which (key) components – e.g. processes, tools, documentation – are already available and how can they be integrated into the new quality management system?
- Project planning: assign a board committee and make sure to plan frequent reports. This is also the perfect moment to point out progression issues during set-up of your quality system.
- Kick-off: make sure to plan meetings with all stakeholders to inform them about the progress and the delivery of their specific constituent processes.
Continuous improvement in quality management
There are two types of continuous or continual improvement in quality management. First, there is the gradual incremental improvement that helps you to deliver a better product in a consistent way. Secondly, there is the ‘breakthrough’ improvement. This means that you focus on major improvements in certain key areas to address issues radically and deliver a whole new level of product quality.
QbD’s quality management approach: risk-based, pragmatic and structural
Our quality management experts help companies to guarantee full compliance of their products and/or services. In this quality management process, we always work according to a risk-based approach, focusing on what’s really important. And by working in a pragmatic, structured way and meticulously documenting every aspect, we guarantee optimal reliability of your quality management procedures.
Our balanced team of seniors, mediors and juniors helps you to set up or optimize your quality management processes. Our experts offer advice and support on validation, qualification and tech transfers. We assist large companies during their quality management for projects or the transformation of products, and help small companies work efficiently during production.
Are you planning to improve your quality management, but don’t know where to start? We are happy to advise and assist you during this process. With the right guidance and support – based on your specific needs – we set you up so that you will be able to manage your quality independently once we are finished.