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The primary purpose of the Material Review Board (MRB) is to review and determine the appropriate disposition of nonconforming products. The MRB evaluates the nonconformities, decides whether the products can be reworked, used as-is, or must be scrapped, and ensures that corrective actions are implemented to prevent recurrence.

References:

"The Certified Quality Engineer Handbook" by Connie M. Borror.

ASQ Glossary: Material Review Board (MRB)

During a brainstorming session, when dominant members are stifling others, having each team member suggest one idea in turn can ensure that all voices are heard. This structured approach prevents dominant members from monopolizing the discussion and encourages participation from quieter team members.

In the provided FMEA table, the potential failure mode "No solder" has the highest severity rating (S = 9), making it the most critical failure that could affect the customer by causing an open circuit. Higher severity indicates a more significant impact on the customer, thus making it the most likely to be seen by the customer.

A system audit evaluates the overall quality management system (QMS) of an organization to ensure it conforms to established standards, such as ISO 9001.

This type of audit examines whether the processes and activities are effectively integrated and implemented to achieve quality objectives.

It focuses on the adequacy and compliance of the entire QMS rather than individual processes or products.

References: ISO 9001 and the ASQ "Quality Audits for Improved Performance" emphasize the role of system audits in assessing conformance to quality programs.

To ensure traceability from design and production through to end-user receipt and use, a company must develop a robust product identification system. This system involves assigning unique identifiers to each product or batch, which can be tracked throughout the entire supply chain. This allows for effective tracking of production history, quality control, and accountability in the event of product issues or recalls.

References:

"Traceability in the Food and Feed Chain" by IFSQN.

ISO 9001:2015, Quality Management Systems – Requirements

An absolutely objective way to measure risk does not exist. Risk assessment inherently involves some level of subjectivity due to the uncertainty and variability in processes and outcomes. While various tools and metrics (e.g., lean metrics, six sigma metrics, quality function deployment) can aid in evaluating and managing risk, none provide an entirely objective measure. Reference: "Risk Management: Concepts and Guidance" by Carl L. Pritchard, which discusses the challenges of achieving absolute objectivity in risk assessment.

Robustness in statistical conclusions often refers to the ability to draw valid conclusions even when certain assumptions are violated. One of the critical factors for robustness is high statistical power, which refers to the probability of correctly rejecting the null hypothesis when it is false.Reason: High statistical power increases the likelihood that the test will detect a true effect if it exists, thereby supporting the validity of the conclusions.

When a potential solution, such as adding reinforcements to packaging, is identified, the most appropriate action is to pilot the solution. Piloting allows the company to test the effectiveness of the solution on a smaller scale before full implementation, ensuring that it resolves the issue without unintended consequences.

In Six Sigma projects, the phases are defined by DMAIC (Define, Measure, Analyze, Improve, Control).

Control:

Ensures the improvements are sustained over time but does not primarily focus on implementing the solutions.

Define:

Focuses on defining the problem and project scope.

Improve:

This phase is where solutions are developed and implemented based on the analysis.

Verified causes identified in the analysis phase are used to create solutions during the improve phase.

Measure:

Involves quantifying the problem but not implementing solutions.

References: Six Sigma methodologies and project management resources.