How do you assess the risks and costs of quality failures and defects?

Calculate costs: Determine the financial implications of quality failures and defects. This involves estimating the direct costs associated with rework, scrap, warranty claims, and customer compensation. Additionally, consider indirect costs like lost sales, decreased productivity, damaged reputation, and increased customer acquisition costs.

To assess the risks and costs of quality failures and defects, the Cost of Quality (CoQ) framework is used, which includes both the Cost of Good Quality (CoGQ) and the Cost of Poor Quality (CoPQ). CoGQ encompasses prevention and appraisal costs, such as costs for quality planning, training, and inspections. CoPQ covers internal and external failure costs, including scrap, rework, returns, and warranties. By analyzing these costs, organizations can identify areas with high defect costs, prioritize interventions, and invest in prevention and appraisal activities to reduce the occurrence of defects, ultimately leading to a more efficient and cost-effective quality management process.

Prioritize risks: Rank the identified risks based on their potential impact and probability. This allows you to prioritize your efforts and resources towards mitigating the most significant risks first.

The Risk Priority Number (RPN) is a key metric used to assess the risks and costs associated with quality failures and defects in the Failure Mode and Effects Analysis (FMEA) process. RPN is calculated by multiplying three factors: the severity of the potential failure, the likelihood of the failure occurring, and the likelihood of detecting the failure before it reaches the customer. This numerical value helps prioritize which potential failures require immediate attention based on their impact on safety, functionality, customer satisfaction, and costs. By focusing on issues with the highest RPNs, organizations can strategically allocate resources to mitigate risks and reduce the overall cost of quality failures.

Statistical Process Control (SPC) is a method used to assess the risks and costs of quality failures and defects by monitoring and controlling a process through the use of statistical techniques. SPC involves plotting data in control charts and analyzing these charts to detect any signs of process variation that may lead to quality issues. By identifying variations early, whether they are due to common causes (inherent to the process) or special causes (external factors), SPC helps in taking timely corrective actions. This proactive approach reduces the likelihood of defects, minimizes quality-related costs, and ensures a more consistent production process.

Quality Function Deployment (QFD) is a structured approach used to assess the risks and costs associated with quality failures and defects by translating customer needs into specific engineering or operational requirements. It involves the use of matrices, often referred to as the "House of Quality," to visually relate customer desires to the means of achieving them. QFD helps in prioritizing product or service features based on customer importance and competitive comparisons. This prioritization assists in identifying and focusing on areas that could lead to significant quality failures if not addressed, thereby guiding resource allocation to mitigate risks and reduce the potential costs of non-conformance.

Design of Experiments (DoE) is a systematic method used to assess the risks and costs of quality failures and defects by evaluating the effects of multiple input variables on an output of interest. DoE enables the identification of critical factors and their interactions that could lead to quality issues, through a series of controlled tests. By understanding these relationships, organizations can optimize their processes to minimize defects, improve quality, and reduce costs. This approach allows for a more efficient allocation of resources by focusing on changes that have the most significant impact on quality, thereby mitigating risks associated with product failures and defects.

Using Risk assessment tool, prior to experimental will provide us a broad scope. With DOE Taking the effective trials within our design space, we will have risk mitigation plan with zero defect throughout the product life cycle and management

External source of risk Regulatory risk Patent risk Revision in NPPA norms Latest studies indicating the updates in regulatory pathway or strct measures will add a unexpectedly risk Changing the development strategy also but very limited