¿Cuál es la forma más eficaz de diseñar un sistema de calidad para una empresa de nueva creación?

In my humble opinion, start with customer backward to deliverables, compliance processes, Design …etc When we start by translating customer requirements then we go backwards throughout the whole value chain, we build value and this could be easily translated into an effective QMS

The most effective way to design a quality system for a startup company is to start by understanding the company's unique needs and goals. What are the company's products or services? Who are its customers? What are the company's regulatory requirements? Once you have a good understanding of the company's needs, you can begin to design a quality system that is tailored to the company's specific circumstances.

- First, define clear quality objectives depending on your product and services. - Understand the requirements of your clients and stakeholders - Prepare the plan for risk management and its mitigation strategies - Work on the compliance related to your industry standards - Prepare the documents for all the processes

Entender profundamente as necessidades dos clientes é crucial, alcançado por meio de pesquisa, entrevistas e análise da concorrência. Definir objetivos claros e padrões específicos, usando o conceito SMART, é fundamental. Implementar processos robustos, treinando a equipe e monitorando a qualidade, é indispensável. Uma cultura organizacional voltada para a qualidade, com liderança comprometida e comunicação aberta, é essencial. A busca incessante por melhorias, através de acompanhamento interno e feedback dos clientes, garante a competitividade. A qualidade é um processo em evolução contínua, adaptando-se ao crescimento da startup para não apenas atender, mas superar as expectativas dos clientes e impulsionar o sucesso do negócio.

Designing an effective quality system for a startup requires a clear focus on simplicity, scalability, and customer-centricity. Start with a robust quality policy, identify key processes, establish clear documentation, and embrace a culture of continuous improvement. Ensure that quality is ingrained in every aspect of your operations from the outset, fostering trust, and setting a strong foundation for growth and compliance.

To establish Quality Management System in any company it is suggested to: 1) Draft Quality Policy considering the company vision. 2) Prepare Quality Objectives considering the customer requirements. 3) Write Quality Manual considering the framework of objectives and resources. 4. Establish core procedures to run Quality System (based on ISO 9001 or ICH Q10 for pharmaceuticals) 5. Train the staff

Identify your key stakeholders.  Who are the people who are most important to your company? This could include customers, employees, suppliers, and investors. Identify their needs and expectations, and make sure that your quality system is designed to meet those needs. Identify your key processes.  What are the processes that are critical to the quality of your products or services? Once you have identified your key processes, you can develop specific quality controls for each process.

Here again it’s very important to select a framework that is appropriate for your business needs, maturity and life stage. Going for demanding and challenging frameworks can make its very difficult and may even result in failure. Following competition or over ambitious marketing strategy may not always work. The real reason should be scalability, dependability, driving continuous improvement and ongoing compliance to relevant standards and requirements.

An important consideration is to ensure that the Executive Leadership team is fully supportive and endorses the importance of building a robust QMS, regardless of the stage of the organization. Ensuring a strong Quality Culture from the beginning is key to building a cross-functional QMS infrastructure and mission that everyone can stand behind and support.

We, ISO 9001 consultants, need to educate entrepreneurs to scaffold their procedures to be S.M.A.R.T.ly measurable. Some may think that QMS certifications only add value to mature companies, but when they get there, they will have a lot of trouble to remodel their processes. Validated frameworks bring confidence to customers, employees, and even investors.

Map out your control plan. At each station ask what information arrives, is created or leaves a workstation. Create a process flow that not only shows the movement of the assembly line but also shows the traveling information. With the control plan and process flow documented you can now easily go through and write the procedures needed to accomplish the physical and data transformation to final product. Finally work with individual workers to take an overarching station procedure down into the specific work instructions.

Start with a Vision, Mission and Objectives. Also build a House of Quality with People and Culture as a foundation. You might also lay out a simple Quality Management framework focussing on Customer Satisfaction, Continuous Improvement and Productivity. These basic systems should lead you to a advanced QMS subsequently. The core is the management commitment to Quality.

I find that flow charting processes with actions and responsibilities noted in the steps works well for those who are more visual, and where a process hands-over to another process (such as deviations to CAPA). From there, the detail can be flushed out in text for for an SOP. The flow chart can be an appendix to the final procedure.

It is imperative to ensure your internal processes are able to deliver on your customer expectations. As a companies grows an efficient process flow enables a small business to scale without bottle necks. Without continual review, adjustment and role expansion a process built for a small company won't translate into meeting the needs of a larger business.

Defining quality processes and procedures is a foundational step for startups in achieving their quality objectives and meeting customer needs. This phase: 1. Establishes a structural foundation for quality management. 2. Clarifies roles and responsibilities within the organization. 3. Allocates resources efficiently for quality-related tasks. 4. Drives continuous improvement through measurable targets. 5. Prioritizes a customer-centric approach for satisfaction. etc.

Implementing a QMS may face pushbacks. Especially because start-ups need flexibility and agility to get momentum into the market. But, as I mentioned above, the earlier a QMS becomes part of departments processes, the lower is the chance of resistance or neglecting postures in the future.

Engaging stakeholders should be done earlier in the process. Those will directly influence the way your processes are set up. Speaking about them during planning eliminates double work, e.g. rephrasing large sections of your procedures because of feedback received during rollout.

Implementing quality system, turns commitment to quality into action for organization. This phase involves translating quality processes into daily practices, and ensuring alignment among team members and multiple stakeholders like shopfloor teams etc. Key steps include effective communication, training, engagement, feedback learning, etc.

After having the full setup of your QMS completed, a full and intensive awareness campaign should be made for all members, to ensure that the system is clear, processes are fully understood, and the team is equipped to start implementing. Also, there should be a system for refreshment trainings, training after changes .. etc to maintain the clear alignment. Also make sure to track the KPIs of each process, to align on any improvements or changes needed.

One of important phase involves systematically assessing quality performance in which identifying areas for improvement. It relies on collected data, clear quality indicators and targets, customer satisfaction and feedback, continuous improvement, regulatory compliance, and transparency and accountability.

The sustainability of a quality system is more vital than its initial establishment. While quality systems are drafted under ideal circumstances, real-world production introduces inevitable turbulence. The system's durability is a litmus test of its efficacy in actual conditions. To maintain and enhance the system's performance, the regular measurement of quality metrics is critical. These metrics may be parameters like downtime, deviations, customer complaints, and variations. Effective monitoring empowers organizations to efficiently control their quality systems. In prioritizing sustainability over inception, businesses pave the way for long-term success.

Monitoring is key for each process, and the criteria should be integrated in each procedure. There are some standard KPIs that are always good to have, like cycle time and open items, and it's always good to talk about charts and define and document what those charts try to show and how the numbers are interpreted. Automate as soon as possible, to allow time-saving KPI calculation. Take the time you saved to verify the data and apply sanity checks before publishing the results. Most important: Establish thresholds and limits, and take actions!

Fortunately there are now technologies available to any size company that can easily provide a complete and compliant quality system with little capital cost. Cloud based quality system software is available as a hosted service that negates the need to actually buy what used to be prohibitively priced software with high cost annual “maintenance” fees that smaller companies could not afford. I recommend that a startup: 1: hire an experienced quality expert to manage the internal quality system 2: subscribe to a cloud- based QMS software that includes all the necessary quality systems regulatory requirements to implement the system. In many cases individual components can be subscribed to as needed by company and customer requirements.

In the context of a start-up company, a quality system is usually kept simple and flexible since it needs to accommodate possible (or even likely) changes in customer target, promises to customers, or even business model. In that context, the impulse to improve the quality system can come in two ways: - Bottom up: look at customer complaints, employees frustrations, mistakes and near-misses, etc. It will point you in directions of the processes to prioritise and your people should provide ideas. - Top down: define and track KPIs and look for those that are totally missed or need serious progress; look for must-do obligations of the business that are not fulfilled. Prioritise what needs managerial attention. And document along the way!

As someone who has worked in predominantly smaller companies and start-ups, it is much easier to see what is working and what is not working than in a larger company. Be realistic, as start ups are generally under resourced so you can't do everything at the same time. Look at the most important issues and ones that can cause non-conformities in audits. And as it is a small company, improvements can be made very quickly once the right Corrective or preventative action has been accurately established.

1- Follow the client requirements -example contract/ work order etc 2- Document the system based on point 1 3- Train resources on how to use system as mentioned in point 2 above 4- Audit/ Setup reward and recognition system 5- Continually improve the system 6-Repeat above 5 steps

Document the system.  It is important to document your quality system so that everyone understands what they are supposed to do. The documentation should be clear, concise, and easy to use. Train the employees.  Make sure that all employees are trained on the quality system and that they understand their roles and responsibilities. Monitor and audit the system.  It is important to monitor the quality system to ensure that it is effective. You should also conduct regular audits to identify areas for improvement.

Establishing a system for any newly started organisation will become a foundation! It must be a top driven approach for any organisation to adopt a system. Starting with a good system or bad system that is going to be a culture of tomorrow. Once culture becomes bad with a bad system then it would be very difficult to bring it back. So establish the system with 4 levels of documents. Level 1 - Ensure mgmt. is linking their long term vision, mission and objectives based on the context. Level 2 - Establish the processes with current challenges, standard requirements and CSRs. Level 3 - Create user friendly SOPs/WIs with applicable testing and inspection standards. Level 4 - Create easy to use and simple templates to use on a regular basis.

In my opinion there is a need for building a quality culture which is crucial as it ensures that all personnel prioritize delivering high-quality products or services, leading to increased customer satisfaction and loyalty.

The first step to implementing a quality system for a Start-up is to assess and reflect on what the business is all about and what it will look like in say 5yrs. Once there is clarity around the business model, decision makers can begin to assess the processes required, risks, resources and where applicable regulatory compliance requirements. This assessment and subsequent actions that come out of them will form the foundation of your quality system. This is an important first step to prevent the organisation from falling into the trap of either doing too little or doing too much, neither of which actually add value.