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How can you meet stakeholder needs while meeting GMP requirements for Industrial Design projects?

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Industrial design projects often involve multiple stakeholders, such as clients, users, manufacturers, regulators, and investors. Each stakeholder may have different needs, expectations, and preferences for the design outcome. How can you balance these diverse and sometimes conflicting demands while ensuring that your design meets the Good Manufacturing Practice (GMP) requirements for quality, safety, and compliance? Here are some tips to help you navigate this complex and challenging process.

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Abiero Origa

??Manufacturing Manager, Sustainable Transport, EV Enthusiast
Hamit Kazanci

Industrial Designer | Design Researcher | Mentor & Lecturer

1 Understand the GMP context

GMP is a set of standards and guidelines that ensure that products are consistently produced and controlled according to quality criteria. GMP covers aspects such as design, development, testing, validation, documentation, production, distribution, and post-market surveillance. Depending on the industry and the market, your design may need to comply with different GMP regulations, such as FDA, EMA, ISO, or ICH. You need to understand the specific GMP context of your project and how it affects your design decisions, such as materials, components, processes, features, functions, and aesthetics.

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Hamit Kazanci

Industrial Designer | Design Researcher | Mentor & Lecturer
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This is one of the key reasons why Design briefs are in place and these generally ( supposed to) co-created documents are usually tied to design process agreements or design agreements to ensure certain standards are going to be followed and make sure all stakeholder's expectations are outlined before all the core creative process starts with the teams.

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2 Involve stakeholders early and often

One of the key principles of industrial design is user-centered design, which means that you design for and with the people who will use your product. This requires engaging with your users and other stakeholders throughout the design process, from research to prototyping to testing to feedback. By involving stakeholders early and often, you can gain insights into their needs, preferences, pain points, and expectations. You can also communicate your design vision, rationale, and constraints, and solicit their input and approval. This way, you can create a design that meets stakeholder needs while meeting GMP requirements.

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Gabriel Martins Gaiofatto

Industry Process Consultant, Design & Simulation Solutions - Dassault Systèmes | Engenheiro de produ??o | CATIA
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O usuário tem de ser principal do produto, aplicar técnicas de "user experience" e validar as vontades e intera??es do usuário com o produto, traz grande valor des de o início do projeto traz grandes benefícios. Um ambiente colaborativo que traga a mesma vis?o as pessoas envolvidas, facilita e torna a comunica??o mais eficiente, e a rastreabilidade dos requisitos ao longo do ciclo de vida gera melhor entendimento e comprimento desses requisitos.

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3 Adopt a flexible and iterative approach

Industrial design projects are often complex and uncertain, requiring constant adaptation and refinement. You need to adopt a flexible and iterative approach that allows you to test and validate your design assumptions, learn from your failures, and incorporate feedback and changes. You also need to be prepared to deal with unexpected challenges, such as technical issues, regulatory changes, or stakeholder conflicts. By adopting a flexible and iterative approach, you can avoid wasting time and resources on designs that do not meet stakeholder needs or GMP requirements.

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4 Document and justify your design choices

One of the essential aspects of GMP is documentation. You need to document every step of your design process, from the initial concept to the final product. You need to provide evidence that your design meets the quality, safety, and compliance criteria of GMP. You also need to justify your design choices and explain how they address stakeholder needs and expectations. By documenting and justifying your design choices, you can demonstrate that your design is not only creative and innovative, but also reliable and compliant.

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Gabriel Martins Gaiofatto

Industry Process Consultant, Design & Simulation Solutions - Dassault Systèmes | Engenheiro de produ??o | CATIA
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N?o apenas documentar, mas manter a continuidade digital do produto por todas as etapas gera ainda mais valor para essa informa??o. A continuidade digital também garante q uma mudan?a realizada seja propagada para todas as fases posteriores. Exemplo: uma mudan?a em um requisito de fura??o, automaticamente alterar o design e isso já é refletido para o CAE.

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5 Seek expert advice and support

Industrial design projects often require multidisciplinary collaboration and expertise. You may not have all the knowledge and skills to deal with every aspect of GMP. You may need to seek expert advice and support from other professionals, such as engineers, quality managers, regulatory consultants, or auditors. By seeking expert advice and support, you can ensure that your design meets the technical, legal, and ethical standards of GMP. You can also avoid costly and risky mistakes that could compromise your design quality and reputation.

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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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Abiero Origa

??Manufacturing Manager, Sustainable Transport, EV Enthusiast
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Meeting stakeholders' needs while adhering to Good Manufacturing Practice (GMP) requirements in industrial design projects involves several key considerations: 1.Early Stakeholder Engagement: Involve stakeholders from various departments (production, quality control, regulatory affairs, etc.) early in the design process to understand their needs, preferences, and regulatory requirements. 2.Clear Communication: Maintain transparent communication channels with stakeholders throughout the project to ensure alignment with their needs and expectations. 3.Risk Assessment 4.Compliance Integration 5.User-Centric Design 6.Flexibility and Adaptability 7.Training and Education 8.Continuous Improvement

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How can you meet stakeholder needs while meeting GMP requirements for Industrial Design projects?

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3

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1 Understand the GMP context

2 Involve stakeholders early and often

3 Adopt a flexible and iterative approach

4 Document and justify your design choices

5 Seek expert advice and support

6 Here’s what else to consider

Industrial Design

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How can you meet stakeholder needs while meeting GMP requirements for Industrial Design projects?

1

2

3

4

5

6

1 Understand the GMP context

2 Involve stakeholders early and often

3 Adopt a flexible and iterative approach

4 Document and justify your design choices

5 Seek expert advice and support

6 Here’s what else to consider

Industrial Design

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