This presentation explains the requirements for control of inspection, measuring, and test equipment. This includes a calibration program that satisfies FDA's Quality System Regulation (QSR), ISO 13485:2003, and ISO 13485:2016. The presentation defines accuracy, precision, and traceability. After explaining the concepts, it moves to an analysis of the requirements from each of the quality management standards. Implementing these requirements requires attention to detail, accurate records, and effective systems. Manufacturers must understand the requirements so they can develop and implement effective processes and procedures. In addition to the specific requirements, the presentation includes examples from FDA Warning Letters, information from FDA's Quality System Inspection Technique (QSIT), and the Medical Device Single Audit Program (MDSAP) Audit Model.
Corrections and removals, C&R, can be a confusing topic because it is intertwined with design changes, device improvements, and recalls. In addition, C&R includes some complicated technical definitions that could create exemptions to reporting. However, misapplication can result in a Warning Letter. The regulations are not always clear, especially when contrasted with Part 7, which sets the rules for FDA's involvement in recalls. The definitions of the terms don't even agree.
Process validation is an important element in medical device manufacturing. This presentation looks at the underlying statistical concepts to perform an effective process validation. The presentation examines elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485:2016.
The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".
When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA?
Calibration is an essential component of every Quality Management System (QMS). An effective system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement.
Many companies use attribute sampling plans at incoming, in-process, and final inspection. The common approach uses ANSI/ASQ Z1.4. There is an alternate, however, that may reduce cost. Sampling plans based on ANSI/ASQ Z1.9 can reduce cost by requiring smaller sample sizes.