process. This helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste.
usually performed within the production area. The performance of such in-process controls should not have any negative effect on the quality of the product or another product. In-process inspection and testing should be performed by monitoring the process or by actual sample analysis at defined locations and times. The results should conform to established process parameters or acceptable tolerances.
All complaints and other information concerning potentially defective products must be kept and reviewed according to written procedures. In order to provide for all contingencies, a system shall be designed to recall, if necessary, promptly and effectively products known or suspected to be defective from the market.
Change control within quality management systems and information technology systems is a process—either formal or informal—used to ensure that changes to a product or system are introduced in a controlled and coordinated manner.
Self-inspection is basically a method of objective overall review of one’s own operation on aspects that may have on quality effect on quality assurance. In general, self-inspection aims at identifying defects whether of critical, major or minor nature.
Line clearance is a structured procedure for ensuring that the equipment and work area are free of products, documents and materials from the previous process that are not required for the next scheduled process, and that the equipment is clean and ready for the next scheduled process.
A result that does not follow the expected trend, either in comparison with other stability batches or with respect to previous results collected during a stability study.