What data should you track to improve GMP quality culture?

To improve GMP quality culture, track data such as: 1.Compliance Metrics:Monitor adherence to GMP regulations and standards to identify areas for improvement.?? 2.Quality Incidents:Track incidents of non-compliance, deviations and corrective actions to address root causes.?? 3.Training Records:Keep records of GMP training completion to ensure workforce competency and awareness.?? 4.Audit Findings:Analyze audit results to identify trends, assess effectiveness and implement corrective measures.?? 5.Process Efficiency:Measure process performance metrics like cycle time and defect rates to identify opportunities for optimization.?? 6.Customer Feedback 7.Employee Engagement

Senior management and supervisors' commitment drives GMP quality culture. They set direction, influence employee attitudes, and demonstrate support for quality activities. Monitoring their communication, accountability, empowerment, and motivation of staff is vital. Use surveys, interviews, observations, and audits to assess leadership commitment effectively.

To improve the GMP Culture and ensure that it is embedded and built in within the Organization, this is mainly driven by how the leadership is committed to this goal, and how they are influencing it. Leadership need to ensure that the quality culture is linked to the organization`s mission, vision, and goals, then ensure that all senior management and supervisors are involved, have the same mindset, and ensure their accountability to the implementation, and this could be through supporting the below: - Empowering and motivating the staff to host the quality mindset. - Management reviews - Supporting Audits - QMS processes and Activities(Change Management, Risk Management, Deviation Handling, Complaints and recalls .. etc).

I strongly agree that the commitment and involvement of senior management and supervisors are pivotal for fostering a GMP quality culture. Their role in setting the organizational tone, communicating the quality vision, and demonstrating support directly influence employee attitudes and behaviors. Tracking the frequency and effectiveness of these communications, as well as assessing their support, accountability, and motivation efforts, is essential for gauging the health of the quality culture. Utilizing a variety of methods, including surveys, interviews, observations, and audits, helps collect comprehensive data to ensure ongoing improvement and alignment with quality goals.

según mi experiencia liderando un equipo, rastrear datos como el cumplimiento de normativas GMP, incidencias de calidad como defectos de fabricación, capacitación del personal en prácticas GMP, resultados de auditorías internas y externas, KPIs de calidad como tasas de retrabajo y retroalimentación del cliente sobre la efectividad de los filtros, ayuda a mejorar continuamente la calidad. Al analizar estos datos, la empresa puede identificar oportunidades de mejora, implementar acciones correctivas y preventivas, y mantener una cultura de calidad GMP sólida y orientada hacia la mejora continua.

Create written procedures or systems for the production process in order to measure your product against. Each step should be documented to be reviewed or to be verified and where applicable corrective action should be taken.

One thing that I found helpful is we should nurture GMP and GDP practices! Things which are not documented are not done even if the employee has performed so timely and correct reporting by the employee is a requirement for regulatory compliance. Regular discussion and interviews are key points here

I have seen valuable input from employees regularly. If the engagement increases, people will feel more contacted towards the infrastructure and there input will increase drastically. I call this method for the people, by the people. Once they start giving input in daily products, it's going to provide more insightful information to reduce the quality defects as we can understand what is causing red zones at micro level.

Although having the Leadership support is very important, implementation will never happen without the effective employee engagement and involvement. Employee ate the doers, they are the ones who will perform the tasks on the ground, so engaging them in the implementation will give them the sense of accountability and being part of the solution, also this will help in setting the effective actions rather than non-realistic or non-efficient ones, because they own the full experience and they know what is the best and most effective way of doing the tasks and solving every problem, so they will commit to the implementation because they set the actions.

Having refresher trainings on the core principles, including knowledgement assessment, is key to ensure the quality culture is put into practice. Staff engajament can be achieved with activities, such as team building and recognition. Having quality-focused goals and metrics as part of the performance evaluation and development is important to demonstrate the organization commitment to quality.

Garantir que o treinamento foi eficaz é essencial para que o produto ou servi?o seja de excelência qualidadee tenha resultado positivo. Assim fazer a verifica??o desses treinamentos garante o bom funcionamento e eficiência da produtividade.

Evaluating your training session will help you ensure that the training purpose has been achieved and also improve your training methods, plans, and criteria, also it will help you take the appropriate actions (e.g. repeating the session differently if needed). And It will help you identify the strengths that you can copy and focus on I your sessions, and the weakness that you need to work on and avoid. This will help you have effective trainings and impact.

Rubrics are another method of scoring quality system work product deliverables or process artifacts for effectiveness (e.g., training content and delivery). This tool uses a matrix of criteria vs. grading ratings and corresponding descriptions.

Tracking various indicators such as frequency and severity of deviations, errors, complaints, and audits findings, along with the organization's responsiveness in investigating and correcting root causes, is essential for maintaining and improving quality standards. Utilizing metrics, reports, dashboards, and audits provides a structured approach to collecting and analyzing this data, enabling organizations to continuously assess and enhance their quality performance. This data-driven approach is integral to fostering a culture of ongoing improvement and ensuring alignment with the expectations of customers, regulators, and stakeholders.

To assess whether the organization meets the quality requirements and expectations of its customers, and stakeholders or not, the Quality performance can help you do. It is very important to regularly monitor the Quality performance and take actions when needed to ensure compliance. Performance indicators differ from one organization to another considering the industry and objectives, but some examples are: deviations, errors, defects, complaints, recalls, and audits findings, RA compliance, changes, document control, customer satisfaction, .. etc. and you can use metrics, reports, dashboards to collect and monitor the data. This will help you monitor the Quality performance and assess the compliance level of your organization

Trend analysis of quality events is necessary, especially in highly regulated sectors, such as in the pharmaceutical industry. An example is to periodically review vendors quality issues and verify which are the most frequent problems, in order to work with the suppliers for improvements.

Qualidade é imprescindível. Caso ocorra uma falha, é de grande valia, que vejamos de imediato o que ocorreu. Sabemos que ninguém e cem por cento perfeito. Somente DEUS. COMPARA??O DESNECESSáRIO. Ent?o devemos fazer o nosso melhor, de ótima maneira, para que venhamos ter orgulho de nós e de toda a equipe.

For process improvements, Lean Six Sigma's DMAIC problem solving technique is applied to identify and address inefficiencies. This phase-approach concept consists of the steps Define, Measure, Analyze, Improve, and Control, in order to create effective solutions.