Final answer:
Personnel involved in various stages of product development must be aware of potential defects from not performing their roles correctly. No specific degrees are mandated, but the appropriate qualifications, which could include technical degrees or certifications and related work experience, are essential for their roles. The emphasis is on specialized abilities, training, and quality control to ensure adherence to quality standards.
Step-by-step explanation:
According to the Quality System Regulation (QSR), personnel involved in the design, manufacture, distribution, servicing, and reporting must be made aware of defects which may occur if they do not perform their job correctly. This is a key component of QSR to ensure that all personnel are kept informed of their roles and the potential impact of failure to adhere to quality standards. There is no specific requirement for personnel to have a Master's degree or higher, nor is there a specified frequency for procedure training such as once per year. However, the personnel must be qualified, meaning they should have the relevant education, experience, or training to perform their roles effectively, which could include degrees in technical fields or formal technical training/certification.
Job roles in such environments tend to require specialized abilities and training to operate complex equipment, where workers may earn an hourly wage and need little supervision but are responsible for particular processes or outcomes. The qualifications and skills required can range from BS in Engineering with related experience, sound knowledge of manufacturing techniques, process control, and familiarity with integrating technical designs in a production environment, as well as capabilities like LEAN Six Sigma implementation experience.
This approach highlights the importance of skilled labor as theorized by Davis and Moore, which suggests that jobs requiring higher levels of skill are of greater importance due to the scarcity of qualified individuals. Thus, effective quality control practices are essential for ensuring the integrity of production processes and products.