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How can you optimize your organization's performance using GMP quality improvement tools and techniques?

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If you work in a regulated industry, such as pharmaceuticals, biotechnology, or medical devices, you know how important it is to comply with good manufacturing practices (GMP). GMP are standards that ensure the quality, safety, and efficacy of your products and processes. But GMP compliance is not enough to optimize your organization's performance. You also need to apply quality improvement tools and techniques that can help you identify and eliminate waste, defects, and errors, and increase customer satisfaction and profitability. In this article, you will learn how to use some of the most effective GMP quality improvement tools and techniques, such as:

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1 Process mapping

Process mapping is a visual representation of the steps, inputs, outputs, and resources involved in a process. It helps you understand how the process works, identify potential problems, and find opportunities for improvement. You can use different types of process maps, such as flowcharts, value stream maps, or SIPOC diagrams, depending on your goals and level of detail. Process mapping can help you reduce cycle time, improve efficiency, and ensure compliance with GMP requirements.

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Patty Franke-Nixon

Sr. Director @ Emergent BioSolutions | Strategic Quality Systems Leader
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Mapping out GMP processes helps identify redundancies and create opportunities for risk-based control points that allow streamlined, efficient operations. This allows SMEs to scrutinize the process to ensure the steps are value added/necessary, and effective in their purpose. This can lead to simplifying the process making it more cost effective to execute and reducing executional non-compliance or errors. Involving key stakeholder in the process also improves the collaborative partnership between Quality and operational units and supports a strong quality culture of continuous improvement.

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Dan Dearborn
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Process mapping can be challenging but there's no better way to visualize a process and identify areas for improvement, pain points, bottlenecks, etc.

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Jamison Souza

Técnico de Opera??es | Técnico em Petróleo e Gás | Operador de Processos Químicos | Operador de Painel | Supervisor de Produ??o
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Trata-se de uma ferramenta de planejamento e gest?o que, visualmente, demonstra o fluxo do trabalho dentro da empresa e os seus responsáveis e traz recurso que simplifica e transparece a cadeia de valor do seu negócio.

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Youssef Ech-chairi

Coordinateur QHS (Qualité, Hygiène, Sécurité alimentaire)
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Pour optimiser les performances de votre organisation avec les normes GMP : formez le personnel, documentez les procédures, gérez les risques, assurez des contr?les qualité stricts, validez les processus, surveillez les performances, visez l'amélioration continue, sensibilisez le personnel, effectuez des audits internes, et assurez-vous que les fournisseurs respectent également les normes GMP.

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2 Root cause analysis

Root cause analysis is a systematic method of finding the underlying causes of a problem or defect, rather than just treating the symptoms. It helps you prevent recurrence, improve quality, and reduce costs. You can use different tools for root cause analysis, such as the 5 whys, fishbone diagrams, or Pareto charts, depending on the complexity and nature of the problem. Root cause analysis can help you eliminate waste, improve reliability, and ensure customer satisfaction.

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Satyam Singh

Quality Engineer/Validation Engineer @ LTS Lohmann | Master's in Biochemistry
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We upgraded our printing process from manual to automated, using cameras for precise information placement. An initial batch rejection led us to a root cause analysis with the 5 Whys: Misaligned packets? Camera issue. Camera issue? Misaligned belt. The culprit: a misaligned belt causing camera misreading. We realigned the belt and prevented further delays.

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Linda Saniewski

Quality Assurance Manager at Cintas
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One thing I found helpful was performing a 5 why for people, process, and method. It helps identify a root cause. Fixing a symptom is not fixing the problem.

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Jamison Souza

Técnico de Opera??es | Técnico em Petróleo e Gás | Operador de Processos Químicos | Operador de Painel | Supervisor de Produ??o
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A análise de causa raiz deve ser usada sempre que uma situa??o n?o acontece conforme o planejado ou um problema se repete de forma constante. Alguns exemplos s?o as falhas de processos, recebimento de feedbacks negativos dos clientes, baixas de produtividade e paradas n?o programadas na produ??o.

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3 Statistical process control

Statistical process control (SPC) is a technique of using statistical methods and tools to monitor and control the variation and performance of a process. It helps you detect and correct deviations from the desired specifications, and maintain a state of control. You can use different tools for SPC, such as control charts, histograms, or scatter plots, depending on the type and amount of data. SPC can help you improve consistency, reduce rework, and ensure compliance with GMP standards.

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Angela Conn

Quality Assurance Manager at Bachoco USA (OK Foods)
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One thing I have found very helpful is to use statistical process control tools to measure / evaluate to current state of the process. Using those tools, you can then identify trends and biggest offenders to your process.this gives you a good place to start making a plan for improvement. I have found making decision /implementing changes based on data is the most effective at driving sustainable improvement.

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Jamison Souza

Técnico de Opera??es | Técnico em Petróleo e Gás | Operador de Processos Químicos | Operador de Painel | Supervisor de Produ??o
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O Controle Estatístico de Processos é usado especialmente para garantir previsibilidade e eliminar riscos ou surpresas, e padronizar e estabilizar os processos.

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4 Plan-do-check-act cycle

Plan-do-check-act (PDCA) cycle is a four-step model of continuous improvement that involves planning a change, implementing it, checking the results, and acting on the feedback. It helps you test and validate your ideas, learn from your mistakes, and make adjustments as needed. You can use the PDCA cycle for any type of improvement project, from small to large scale. PDCA cycle can help you achieve your goals, improve your processes, and sustain your results.

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Arjun Chandra Roy

Jr. Executive Quality Assurance Care nutrition Limited. Diploma in-Engineering ,Food Technology
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I think, Statistical process control (SPC) is a technique of using statistical methods and tools to monitor and control the variation and performance of a process. It helps you detect and correct deviations from the desired specifications, and maintain a state of control. You can use different tools for SPC, such as control charts, histograms, or scatter plots, depending on the type and amount of data. SPC can help you improve consistency, reduce rework, and ensure compliance with GMP standards

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Jamison Souza

Técnico de Opera??es | Técnico em Petróleo e Gás | Operador de Processos Químicos | Operador de Painel | Supervisor de Produ??o
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O PDCA serve para melhorar a gest?o de processos, levando um gerenciamento mais eficiente tornando um processo mais eficiente significa fazer da maneira mais simples, rápida e com menor custo, elevando a qualidade do resultado.

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5 Risk management

Risk management is a process of identifying, assessing, and mitigating the potential risks that may affect the quality, safety, or performance of your products or processes. It helps you prevent or reduce the impact of adverse events, and ensure compliance with GMP regulations. You can use different tools for risk management, such as risk matrices, FMEA, or HACCP, depending on the scope and severity of the risks. Risk management can help you protect your reputation, increase your confidence, and ensure customer trust.

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Linda Saniewski

Quality Assurance Manager at Cintas
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We use FMEA for our Risk Management . I have used it in other companies. It can be a daunting task to cover all aspects, however it created an excellent contingent plan for the company. A simple thing as a power outage gives leadership direction in how to move forward or have back up plans in place instead of shutting down.

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Jamison Souza

Técnico de Opera??es | Técnico em Petróleo e Gás | Operador de Processos Químicos | Operador de Painel | Supervisor de Produ??o
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A gest?o de riscos visa preparar a organiza??o para, em determinadas situa??es, se antecipar na escolha das alternativas mais viáveis a fim de que determinada ocorrência negativa seja minimizada ou até mesmo evitada.

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6 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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How can you optimize your organization's performance using GMP quality improvement tools and techniques?

1

2

3

4

5

6

1 Process mapping

2 Root cause analysis

3 Statistical process control

4 Plan-do-check-act cycle

5 Risk management

6 Here’s what else to consider

Quality Management

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How can you optimize your organization's performance using GMP quality improvement tools and techniques?

1

2

3

4

5

6

1 Process mapping

2 Root cause analysis

3 Statistical process control

4 Plan-do-check-act cycle

5 Risk management

6 Here’s what else to consider

Quality Management

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