Quality management is a key factor for any business that wants to improve its performance, customer satisfaction, and profitability. But how do you implement a quality management system (QMS) in your industry? In this article, we will explore some of the best practices for setting up and maintaining a QMS that suits your specific needs and goals.
The first step to implementing a QMS is to define your quality objectives. What are you trying to achieve with your QMS? How will you measure your progress and success? Your quality objectives should be SMART: specific, measurable, achievable, relevant, and time-bound. They should also align with your business strategy and vision.
All organisations involved in clinical trials must have a Quality Management System (QMS) in place to support their clinical trial activities. This ensures that trial systems meet the requirements of clinical trial legislation and associated guidelines and that processes are consistently applied. The extent and complexity of the QMS depend on the size and nature of the organisation. Essential features include documented written procedures, adequate staff training, and quality control and quality assurance procedures.
The next step is to choose a quality standard that provides a framework and guidelines for your QMS. There are many quality standards available, such as ISO 9001, Six Sigma, Lean, or Total Quality Management. Depending on your industry, you may also have to comply with specific regulations or requirements. You should research and compare different quality standards and select the one that best fits your industry and objectives.
Six Sigma is usually applied to manufacturing, but the same principles work beautifully when applied to people! A great place to start is quantifying strengths/preferences/purpose of each unit (team, individual, etc.).
An essential element of any clinical trial system includes: ? Having clear written procedures in place to ensure the system functions properly. ? Ensuring that roles, responsibilities, and required tasks are clear to all parties involved. ? Providing proper control, review, and when necessary, changes to the system. ? Defining the standards to be followed in the quality system (e.g., ICH-GCP, European Directives, etc.).
Once you have chosen a quality standard, you need to document your processes and procedures that support your QMS. This includes identifying your key processes, defining your roles and responsibilities, establishing your quality policies and manuals, and creating your quality records and forms. Documenting your processes and procedures helps you to ensure consistency, clarity, and accountability in your QMS.
Written procedures can take the form of policy documents, Standard Operating Procedures (SOP), work instructions (WI), or guidelines. The complexity of the quality system depends on the type of organisation. In some cases, adopting a hierarchical approach to quality systems, which is common for global pharmaceutical companies or large full-service provider CROs, may be appropriate. Policies are the top-level documents that stipulate the key system objectives. SOPs are high-level documents that describe actions to be taken under specific circumstances. WI) are lower-level documents that provide detailed instructions on procedure performance. Forms, templates, and records can also provide evidence of conformance.
Your field employees should have the right to help: making this step collaborative with your team will help increase engagement and adoption of new processes exponentially.
A QMS is only as good as the people who implement it. Therefore, you need to train and communicate with your staff about your QMS and its benefits. You should provide regular training sessions, workshops, and feedback sessions to educate and engage your staff in your QMS. You should also communicate your quality objectives, policies, and results to your staff and encourage them to participate and contribute to your QMS.
Make sure feedback loops are in place and your culture allows for full transparency on disagreements/thoughts/feelings of your team. Your people derserve to feel heard, and they will be much more open to growing/improving processes.
To ensure that your QMS is effective and efficient, you need to monitor and measure your performance against your quality objectives and standards. You should use various tools and methods, such as audits, inspections, surveys, reviews, and reports, to collect and analyze data on your QMS. You should also use key performance indicators (KPIs) and quality metrics to track and evaluate your QMS.
This is the step that will make or break the effectiveness of the new system. Without monitoring, feedback, and analysis, all of the previous steps will have been in vain.
The final step to implementing a QMS is to continuously improve your QMS based on your monitoring and measurement results. You should identify and address any gaps, issues, or opportunities for improvement in your QMS. You should also implement corrective and preventive actions, as well as improvement projects, to enhance your QMS. You should also review and update your QMS regularly to ensure that it remains relevant and effective for your industry and objectives.
The phrase “the final step” makes it sound like this isn’t an ongoing process. It is ongoing. If you ever reach a point where you think you’re done, you might be missing something. Markets/behaviors/culture is constantly shifting, and keeping your teams adaptable requires continuous feedback.