IATF 16949:2016 Clause 8.2.3.1.3 Organization manufacturing feasibility

As per definition given in clause 3.1 Manufacturing Feasibility can be defined as analysis and evaluation of a proposed project to determine if it is technically feasible to manufacture the product to meet customer requirements. This includes but is not limited to the following (as applicable): within the estimated costs, and if the necessary resources, facilities, tooling, capacity, software and personnel with required skills. including support functions are or are planned to be available.

Manufacturing feasibility analysis is an assessment conducted to evaluate the practicality, viability, and effectiveness of a manufacturing process or project. It involves analyzing various factors to determine if a product can be manufactured efficiently, at the desired quality level, within budget, and meeting the required timeline. The analysis helps organizations make informed decisions regarding the feasibility of producing a specific product or component.A manufacturing feasibility analysis typically considers the following key aspects:

1. Product Design: Evaluating the design of the product to ensure it is suitable for manufacturing, considering factors such as complexity, materials, size, and assembly requirements.
2. Process Capability: Assessing the capability of the manufacturing processes to produce the desired product, including evaluating the available technology, equipment, and tooling. It involves determining if the required processes can achieve the desired quality, precision, and production volume.
3. Cost Analysis: Analyzing the estimated costs associated with manufacturing the product, including materials, labor, equipment, tooling, maintenance, and overhead expenses. The analysis helps in assessing the financial viability of the project and identifying cost-saving opportunities.
4. Resource Availability: Evaluating the availability of necessary resources, such as raw materials, skilled labor, facilities, and equipment. It includes assessing the organization’s capacity to meet production demands and potential constraints related to resource availability.
5. Supply Chain Considerations: Assessing the organization’s supply chain, including the sourcing of materials, components, and suppliers. Evaluating the reliability, capacity, and quality control measures of the supply chain is essential to ensure a smooth manufacturing process.
6. Quality Assurance: Considering quality control and assurance measures, such as inspection, testing, and compliance with industry standards or customer requirements. Evaluating quality processes helps ensure that the manufacturing process can consistently produce products that meet the desired quality standards.
7. Production Volume: Assessing the production volume requirements and determining if the manufacturing process can meet the required production rates within the desired timeline. This analysis includes evaluating cycle times, production efficiency, and scalability of the process.
8. Risk Assessment: Identifying potential risks and challenges associated with the manufacturing process, such as technical complexities, market demand fluctuations, regulatory compliance, and supply chain disruptions. Developing risk mitigation strategies helps minimize potential setbacks.
9. Environmental Impact: Assessing the environmental impact of the manufacturing process, including waste generation, energy consumption, emissions, and sustainability considerations. Evaluating environmental factors helps organizations align with environmental regulations and promote sustainability practices.
10. Legal and Regulatory Compliance: Ensuring compliance with applicable laws, regulations, and industry standards governing the manufacturing process. This includes adhering to safety regulations, intellectual property rights, and any specific industry requirements.

By conducting a comprehensive manufacturing feasibility analysis, organizations can assess the practicality and viability of a manufacturing project, mitigate risks, optimize costs, and make informed decisions about proceeding with the manufacturing process.

8.2.3.1.3 Organization manufacturing feasibility

Using the multidisciplinary approach, organization must analysis to determine if it is feasible that the organization’s manufacturing processes are capable of consistently producing product that meets all of the engineering and capacity requirements specified by the customer. The feasibility analysis must be conducted for any new manufacturing or product technology and for any changed manufacturing process or product design. The organization must validate through production runs, benchmarking studies, or other appropriate methods, their ability to make product to specifications at the required rate

Manufacturing feasibility (which includes risk analysis), is an assessment of your organization’s capacity and capability to effectively and efficiently provide the customer specified deliverables. The risk analysis should include programming timing; resources; development costs and investments; potential for, and effects of, possible failures in processes, including your suppliers. You should also consider financial and profitability risk. The results of your assessment must be recorded on the applicable APQP form. While conducting the Manufacturing feasibility the organization must determine the following:

Technically:

• Are we technically competent to make this new product?
• Do we have the desired technology?
• If feasibility is reviewed with technically qualified personnel?
• Do we need external support for manufacturing the product and if yes, what will be the cost?

Manufacture:

• If our existing manufacturing facility has the capability to produce the new product?
• Have we ever produced a similar kind of product before?
• Can we produce products as per customer quality level?

Customer Requirements:

• Do we have the customer Requirements?
• Do we know the difference and inter-relation between Customer requirements (CR) and Customer specific requirements (CSR)?
• Have we understood Customer Requirements?

Capacity:

• What is our existing capacity?
• Do we have spare capacity?
• Do we assess capacity considering existing OEE? If yes, if data of OEE is accurate?

Support Functions:

• While monitoring feasibility, have we identified and mapped all the support functions which support the main process?
• Considering Supplier and job worker as a key support function, do we identify their capacity and capability?
• Do we ask support functions like Suppliers to conduct their feasibility and share data?

Skilled Personnel:

• For tax benefits, new facilities are set up at a remote location, do we identify the availability of skilled manpower.
• Do we map the skill needed for new technology?

Cost:

• Do we know the actual cost of an existing similar product?
• Do we know the Cost of New technology?
• Do we know the cost of any New Manufacturing Process?
• Do we know the Cost of the new facility addition?
• Do we know the Cost of Software addition?
• Do we know the Cost of new tooling?
• Do we know the Cost of new skilled manpower needed?

Conducting manufacturing feasibility analysis

To conduct a manufacturing feasibility analysis and determine if an organization’s manufacturing processes are capable of consistently producing a product that meets all engineering and capacity requirements specified by the customer, you can follow these steps:

1. Review customer requirements: Gain a thorough understanding of the customer’s engineering and capacity requirements specified for the product. This includes design specifications, performance criteria, dimensional tolerances, production volumes, delivery schedules, and any special characteristics defined by the customer.
2. Assess process capability: Evaluate the capability of the existing manufacturing processes to meet the engineering requirements specified by the customer. Consider factors such as equipment capability, process stability, process controls, and historical performance data. Assess whether the current processes have the potential to consistently produce the required product features within the specified tolerances.
3. Evaluate capacity and scalability: Determine if the organization’s manufacturing processes have the capacity to meet the customer’s specified production volumes. Assess the current production rates, cycle times, and available resources to identify if the processes can handle the required capacity. Consider scalability options and assess the organization’s ability to ramp up production as per customer requirements.
4. Identify gaps and constraints: Identify any gaps or constraints that may prevent the existing manufacturing processes from meeting the customer’s engineering and capacity requirements. This may include limitations in equipment capabilities, skill levels of the workforce, supply chain constraints, or process bottlenecks. Clearly document these gaps and constraints for further analysis.
5. Analyze process capability improvements: Evaluate potential improvements to the existing manufacturing processes that can enhance process capability and meet the customer’s requirements. This may involve process optimization, equipment upgrades, automation, quality control enhancements, or training programs for the workforce. Assess the feasibility, costs, and potential impact of these improvements on meeting the specified requirements.
6. Conduct process validation: Implement process validation activities to verify the capability of the manufacturing processes. This can include conducting capability studies, such as process capability indices (Cpk), gauge repeatability and reproducibility (GR&R), or statistical process control (SPC) methods. Use these validation results to determine if the processes can consistently produce the product within the specified engineering and capacity requirements.
7. Engage in customer collaboration: Collaborate with the customer throughout the feasibility analysis process. Seek clarification, feedback, and alignment on the requirements. Share the organization’s analysis findings and improvement plans to gain customer input and approval, ensuring that all parties are aligned on the feasibility of meeting the specified requirements.
8. Develop an action plan: Based on the feasibility analysis findings, gaps, and improvement opportunities, develop an action plan to address any identified shortcomings. Define specific actions, timelines, responsibilities, and resources required to enhance the manufacturing processes and capabilities. Ensure the action plan aligns with customer expectations and provides a roadmap to consistently meet the specified engineering and capacity requirements.
9. Continuously monitor and improve: Establish a system for ongoing monitoring, measurement, and improvement of the manufacturing processes. Continuously track process performance, conduct regular audits, and gather customer feedback to ensure compliance with the engineering and capacity requirements. Use this information to drive continuous improvement initiatives and address any deviations or opportunities for further optimization.

By following these steps, organizations can conduct a manufacturing feasibility analysis to determine if their manufacturing processes are capable of consistently producing a product that meets all the engineering and capacity requirements specified by the customer. This analysis enables organizations to align their capabilities with customer expectations and drive continuous improvement in manufacturing processes.

Validation to make product at the required rate

Validating the organization’s ability to produce products to specifications at the required rate can be achieved through various methods. Here are some steps to validate and ensure production capability:

1. Define validation objectives: Clearly define the objectives of the validation process. Identify the specifications, quality requirements, and production rates that need to be achieved. This will provide a clear focus for the validation activities.
2. Select appropriate validation methods: Determine the most suitable validation methods based on the specific product, process, and customer requirements. Some commonly used methods include production runs, benchmarking studies, pilot runs, small-scale trials, or simulation exercises. Choose the method that aligns best with the organization’s capabilities and resources.
3. Conduct production runs: Perform full-scale production runs to validate the organization’s ability to meet the specified requirements. Monitor and collect data during the production runs, including process parameters, product quality measurements, and performance metrics. Analyze the collected data to assess conformance to specifications and identify any deviations or areas for improvement.
4. Benchmarking studies: Conduct benchmarking studies to compare the organization’s production performance with industry standards, best practices, or competitors. This can involve gathering data from similar processes or products and analyzing performance metrics such as cycle times, scrap rates, productivity, and quality indicators. Identify areas where improvements can be made to meet or exceed the required production rates and specifications.
5. Pilot runs or small-scale trials: Perform pilot runs or small-scale trials to test the production process and assess its capability to meet specifications and required rates. This allows for fine-tuning of the process parameters, identification of potential issues, and validation of the proposed improvements before full-scale production.
6. Simulation exercises: Utilize computer simulations or virtual models to mimic the production process and evaluate its performance. Simulations can help identify bottlenecks, optimize process parameters, and assess the production rate and quality. Validate the simulation results by comparing them with actual production data to ensure accuracy.
7. Analyze and interpret data: Analyze the data collected during the validation activities. Evaluate the process capability, adherence to specifications, and production rates. Identify any trends, outliers, or non-conformances that may affect the ability to produce products to specifications at the required rate. Use statistical methods and process control tools, such as control charts and capability indices, to aid in the analysis.
8. Implement corrective actions and improvements: Based on the findings from the validation activities, implement necessary corrective actions and process improvements to address any identified issues. This may involve adjusting process parameters, modifying equipment, providing additional training, or enhancing quality control measures. Continuously monitor the effectiveness of the implemented improvements.
9. Monitor production performance: Continuously monitor the production performance after the validation activities to ensure ongoing adherence to specifications and required rates. Establish key performance indicators (KPIs) and track them regularly. Implement a system for data collection, analysis, and feedback loops to enable proactive identification and resolution of any deviations from the desired performance.
10. Document and communicate results: Document the results of the validation activities, including the data collected, analysis performed, and the actions taken to address any issues. Communicate the findings to relevant stakeholders, including customers, internal teams, and management. Share the validation results as evidence of the organization’s ability to produce products to specifications at the required rate.

By following these steps, organizations can effectively validate their ability to produce products to specifications at the required rate. This ensures that the production processes are capable, efficient, and aligned with customer expectations.