A documented process control system shall be implemented for:

A documented process control system is crucial for ensuring consistent quality assurance in the production of soldered electrical and electronic assemblies. Implementing such a system provides a structured framework that outlines the processes and procedures necessary to achieve and maintain quality standards throughout manufacturing.

This involves defining the criteria for acceptable quality levels, monitoring process performance, and documenting outcomes to create a traceable record of quality assurance efforts. By having a robust process control system, organizations can identify deviations from established quality standards and apply corrective actions as needed, ensuring that the final products meet the required specifications and reliability.

While personnel training, process improvement, and inspection procedures are all important facets of manufacturing and quality control, the primary focus of a documented process control system is centered on assuring quality throughout the production process. Without a solid quality assurance foundation, efforts in training, improvement, or inspection may not yield the desired level of product reliability and performance. Thus, a documented process control system is instrumental in establishing a quality assurance culture within an organization.