Last updated on Jan 30, 2024
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Define quality objectives and criteria
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Implement quality control methods and tools
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Document and report quality control results
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Review and evaluate quality control performance
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Implement quality improvement actions
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Monitor and adjust quality control process
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Here’s what else to consider
Quality control is the process of ensuring that the products or services delivered by an organization meet the standards and expectations of the customers and stakeholders. Maintaining quality control over time is crucial for achieving customer satisfaction, competitive advantage, and continuous improvement. However, quality control is not a one-time activity, but a dynamic and ongoing practice that requires constant monitoring, evaluation, and adjustment. In this article, you will learn some of the best strategies for maintaining quality control over time in the context of quality management.
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- Mritunjai Shukla Senior Manager Quality Control with expertise in chromatography, spectroscopy, compliances and QC functions.
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- Joseph Jendrus Associate Director, Quality - Polysaccharide Vaccines Environmental Monitoring at Merck
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- Amit Ballal CSSBB | LA ISO9001 | Auditor IATF16949, ISO14001, 45001, 50001 | Lead Implementer ISO27001 | Proficient in Quality…
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1 Define quality objectives and criteria
The first step in maintaining quality control over time is to define the quality objectives and criteria that will guide the quality management process. Quality objectives are the specific and measurable goals that reflect the desired outcomes of the product or service delivery. Quality criteria are the standards or requirements that define the acceptable level of quality for each aspect of the product or service. Defining quality objectives and criteria helps to establish a clear and consistent vision of quality, align the expectations of the customers and stakeholders, and provide a basis for measuring and evaluating quality performance.
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Invest in training programs to enhance the skills and knowledge of employees, enabling them to produce high-quality work and adhere to established quality standards. Additionally, it is crucial to document successful practices and share them with the team. This helps standardize processes and ensures that best practices are consistently followed.
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- Heerain Piplani, MBA Medical Device Executive in Operations | Contract Manufacturing | Supply Chain
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You want to create a process-driven mindset to understand and improve Quality. This applies to both transactional & data driven processes.One example of a data driven process would be an assembly line. You'll need to define your product & process specifications. Then define how much variation in each of those specifications is allowed while still meeting Customer's needs.Once this setup is complete, you'll need a set of tools (gages, measurement analysis) to track how your process is doing within it's range. This is process monitoring.The penultimate step is to setup alerts which gives a signal around process drift. Once your alert gives you a signal, you need a system to respond/track/control your specification and process.
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2 Implement quality control methods and tools
The second step in maintaining quality control over time is to implement the appropriate quality control methods and tools that will help to monitor and verify the quality of the product or service. Quality control methods and tools are the techniques or instruments that are used to collect, analyze, and report quality data. Some of the common quality control methods and tools are inspections, tests, audits, checklists, charts, graphs, and statistical process control. Implementing quality control methods and tools helps to identify and correct quality problems, prevent defects and errors, and ensure compliance with the quality criteria.
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- Mritunjai Shukla Senior Manager Quality Control with expertise in chromatography, spectroscopy, compliances and QC functions.
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Define quality objectives, Prepare all necessary SOPs which shall be aligned with regulation and update time to time whenever any updation is there in regulations. Training program shall be in place based on TNI. Develop the culture to follow the procedures strictly with transparency and honesty. For each problem, proper investigation shall be done and based on root cause analysis CAPA shall be taken. Monitoring the effectiveness of CAPA shall be ensured. System of Internal audit shall be in place. Audit observation shall be addressed.Reassess Quality strategies to adress evolving challenges and high standards. Work on continual improvement process. Customer feedback shall be taken.
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- Jeffrey Salonga MSIEM, CIE, AAE, CLSSBB Compliance Engineer/ Quality Engineer /Auditor/ Process Improvement
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Implement an appropriate and applicable Quality Control methods and tools to monitor and verify the quality of the products and services overtime. Study and choose the tools that will give not only the best results but also the desired results. Tools can includes inspections, checklists, charts, graphs and audits that can be use to collect and analyse data.
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- Anthony Phun QUALITY / QAQC MANAGEMENT
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Maintaining quality control can be implemented by quality control inspections conducted by qualified QC inspectors who will then report results in predefined check sheets or inspection report sheets.It should be noted that the results of these QC inspections are not too be arbitrarily decided upon as the QC inspectors are ruled by the quality standards in place for this specific process or project. This ensures the quality is uniformly acceptable.
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3 Document and report quality control results
The third step in maintaining quality control over time is to document and report the quality control results that will provide evidence and feedback on the quality performance. Quality control documentation and reporting are the processes of recording, organizing, and communicating the quality data and information. Some of the common quality control documents and reports are quality plans, quality records, quality reports, quality certificates, and quality reviews. Documenting and reporting quality control results helps to demonstrate and validate the quality achievements, inform and update the customers and stakeholders, and support decision making and improvement actions.
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- Eze Samson Chibueze, MLS(ASCPi)cm Medical Laboratory scientist ||CORU || IVD Application Specialist || Experienced in Quality and Biorisk Management || Committed to Elevating Standards in Medical Laboratory Diagnostics and Advancing Laboratory Excellence
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Accurate record-keeping of inspections, tests, and assessments provides a historical perspective on product or service quality. Comprehensive documentation enables the identification of trends, patterns, and potential areas for improvement. Reporting these results to relevant stakeholders, including management and quality teams, facilitates data-driven decision-making. Clear communication of quality control outcomes is vital for maintaining accountability and fostering a culture of continuous improvement within an organization. Regularly analyzing and sharing these documented results ensures that corrective actions can be taken promptly, contributing to sustained high-quality standards.
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- Jeffrey Salonga MSIEM, CIE, AAE, CLSSBB Compliance Engineer/ Quality Engineer /Auditor/ Process Improvement
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Documenting and reporting quality control results ensures that the organisation has transparency, accountability and continuous improvement. Documenting the quality control results creates a trail and history of activities allowing a traceability of actions taken. While, reporting provides data to identify areas of improvement, improves collaboration and engagement and fosters transparency.
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4 Review and evaluate quality control performance
The fourth step in maintaining quality control over time is to review and evaluate the quality control performance that will assess the effectiveness and efficiency of the quality management process. Quality control review and evaluation are the processes of comparing, analyzing, and judging the quality data and information. Some of the common quality control review and evaluation techniques are benchmarking, gap analysis, root cause analysis, and cost of quality analysis. Reviewing and evaluating quality control performance helps to measure and compare the actual versus the expected quality outcomes, identify and understand the strengths and weaknesses of the quality management process, and determine the opportunities and needs for improvement.
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- Eze Samson Chibueze, MLS(ASCPi)cm Medical Laboratory scientist ||CORU || IVD Application Specialist || Experienced in Quality and Biorisk Management || Committed to Elevating Standards in Medical Laboratory Diagnostics and Advancing Laboratory Excellence
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Reviewing and evaluating quality control performance is a crucial aspect of ensuring consistent product or service excellence. It involves systematic assessments of adherence to established standards, identifying areas for improvement, and recognizing successful practices. Regular audits, data analysis, and feedback loops contribute to a comprehensive evaluation process. By actively monitoring and addressing deviations, organizations can maintain and enhance the effectiveness of their quality control measures over time, fostering a culture of continuous improvement and excellence.
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- Rajamani Iyer Head of QA @ AstraZeneca (British-Swedish MNC) | Pharmaceutical Industry | Simplification Expert | GxP Auditor| CSV | Regulatory Compliance | Team Management | Improving Quality Metrics
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Review and evaluation of QC performance is important to step to workout on Improvement part. Tools like 5 Why ,Fishbone help to identify the RC to take actions.
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5 Implement quality improvement actions
The fifth step in maintaining quality control over time is to implement the quality improvement actions that will address the gaps and issues identified in the quality control review and evaluation. Quality improvement actions are the changes or modifications that are made to the product, service, or process to enhance the quality performance. Some of the common quality improvement actions are corrective actions, preventive actions, and continuous improvement actions. Implementing quality improvement actions helps to resolve and prevent quality problems, increase customer satisfaction and loyalty, and achieve the quality objectives and criteria.
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- Eze Samson Chibueze, MLS(ASCPi)cm Medical Laboratory scientist ||CORU || IVD Application Specialist || Experienced in Quality and Biorisk Management || Committed to Elevating Standards in Medical Laboratory Diagnostics and Advancing Laboratory Excellence
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Begin by identifying specific areas for enhancement through data analysis, customer feedback, and internal assessments. Develop clear objectives and action plans, involving relevant stakeholders in the implementation process. Regularly monitor progress, adjusting strategies as needed. Encourage a culture of continuous improvement, fostering open communication and collaboration within the organization. By consistently refining processes and addressing identified issues, businesses can elevate their overall quality and meet or exceed customer expectations.
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Identifying areas for improvement is just the first step. You need to act on these insights. This might involve training staff, updating procedures, or investing in new technology. Remember, improvement is a continuous process, not a one-time effort. Even small, incremental changes can lead to significant improvements over time.
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6 Monitor and adjust quality control process
The sixth and final step in maintaining quality control over time is to monitor and adjust the quality control process that will ensure the relevance and suitability of the quality management process. Quality control monitoring and adjustment are the processes of observing, measuring, and modifying the quality management process. Some of the common quality control monitoring and adjustment factors are changes in customer requirements, stakeholder expectations, market conditions, organizational goals, and regulatory standards. Monitoring and adjusting quality control process helps to adapt and respond to the changing environment, maintain and improve the quality performance, and sustain the quality culture and commitment.
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- Joseph Jendrus Associate Director, Quality - Polysaccharide Vaccines Environmental Monitoring at Merck
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One tool that aims to enhance product quality, identify potential deviations early and facilitate continuous improvement in the manufacturing processes is Continuous Process Verification (CPV). In the context of manufacturing, CPV refers to an ongoing and systematic approach to monitoring and ensuring the consistency and quality of a production process. It involves real-time or periodic assessments of various parameters, such as Critical Process Parameters (CPPs) and product attributes, to confirm that the manufacturing process remains within predefined specifications.
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- Andréia Faria Quality Management | Chemistry | Management Systems | Quality Control | Quality Assurance | Technical Services | Laboratory | ISO 9001, 14001 and 45001 | Audit | Pharmaceutical Industry
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Regular process deviations must be challenged for opportunity for process improvements. As well as customer requests and competitor practices.
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Quality control is not a 'set and forget' process. As your organization evolves, so too should your quality control processes. This means continuously monitoring performance and being ready to adjust your strategies as necessary. For example, if customer feedback indicates a change in their needs or expectations, your quality control criteria might need to evolve accordingly.
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7 Here’s what else to consider
This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?
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- Amit Ballal CSSBB | LA ISO9001 | Auditor IATF16949, ISO14001, 45001, 50001 | Lead Implementer ISO27001 | Proficient in Quality, Core tools, Lean Six Sigma, QMS, EMS, EnMS, OHSMS, etc
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- Frequently audit products/services your organization provides. Develop the competence of auditors continually, and bring in auditors with different perspectives to identify further areas of improvement.- Do assessments to evaluate customers' perceptions of your product/services such as through surveys, market analysis, data, feedback, etc. Based on the above, determine areas to work on to further enhance and keep enhancing the quality.
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- Eze Samson Chibueze, MLS(ASCPi)cm Medical Laboratory scientist ||CORU || IVD Application Specialist || Experienced in Quality and Biorisk Management || Committed to Elevating Standards in Medical Laboratory Diagnostics and Advancing Laboratory Excellence
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Implement regular inspections, conduct thorough training for staff, establish clear quality standards, solicit and act on feedback, and continually optimize processes based on performance data. Regularly reassess and adapt your quality control strategies to address evolving challenges and maintain high standards.
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- Marcos Vega CEO en MVCONSULTING S.A. | Presidente Clúster de Impulso Tecnológico | LinkedIn Top Voice Gestión empresarial
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La mejor estrategia para mantener los controles es involucrar a la gente.Sin cultura de la calidad, no hay calidad.Las personas deben saber no sólo lo que tienen que hacer, sino cuál es su impacto y cómo su actividad contribuye a la calidad. Ahora, con el conocimiento solamente no alcanza. Deben sentir que tienen un propósito, que su trabajo es importante, que se sienten valorados y que su recompensa es buena.No es fácil, pero es el camino.
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