Inspections, Compliance, Enforcement, and Criminal Investigations
Guide to Inspections of Medical Device Manufacturers
Manufacturers must assure all inspection, measuring and test equipment (including mechanical, automated or electronic inspection and test equipment) is suitable for its intended use and is capable of producing valid results. This would normally be done through installation, operation and performance qualification of the equipment. Automated equipment must also assure the software has been validated for its intended use. Verify this type of equipment has been routinely checked, calibrated and inspected according to the written procedures and documented as having been done.
Verify there are written procedures for calibration, inspection, checks and maintenance for this type of equipment. Verify that the procedures include provisions for handling, preservation and storage of this type of equipment to assure its accuracy and fitness of use is maintained. Verify these activities are documented.
Verify written calibration procedures include specific directions and limits for accuracy and precision. Review records of calibration records to verify equipment meets the required limits for accuracy and precision. When the limits are not met, there should be written provisions for remedial action to reestablish those limits and to evaluate whether there was any adverse effect on the device's quality. Verify these remedial actions and evaluations are documented.
Verify inspection, measuring and test equipment have calibration standards traceable to a known national or international standard. If national or international standards are not practical or available, the manufacturer must use an independent reproducible standard. If no applicable standard exists, the manufacturer must produce and maintain an in-house standard.
Verify calibration records are displayed on or near each piece of equipment or readily available to personnel using such equipment and responsible for calibrating the equipment and that they include the following:
a. equipment identification
b. calibration dates
c. next calibration date
All manufacturers of medical devices must establish and maintain procedures to verify all products meet specifications. Acceptance activities include, but are not limited to inspection and test, certificates of analysis, and supplier audits.
The firm must define the activities for receiving, in-process, and final acceptance of all parts, components, and materials that will become part of the finished device or part of the manufacturing process. NOTE: the definition of the word "product" now means components, manufacturing materials, in-process devices, finished devices and returned devices.
Receiving acceptance activities must include procedures for acceptance of incoming product. Firms do not need to inspect each lot, batch or item. However the firm must have a defined method of evaluating whether that lot, batch, or item meets the established specifications. The decision of whether to accept or reject the product must be documented.
In-process acceptance activities may be conducted at appropriate points in the process to ensure in-process specifications have been met. The firm must have written procedures that include, but are not limited to, descriptions of equipment needed, required methods, and acceptance criteria. There must be procedures to ensure in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals have been received and documented.
Final acceptance activities should be performed for each production run, lot, or batch of finished devices. These activities should include, but are not limited to, descriptions of any equipment required, the methods used to perform the activity, and the acceptance criteria. Finished devices must be controlled until released.
Finished-device acceptance activities must include a review of the DHR to ensure the device was processed and completed per the DMR. The review must be performed by a designated individual. The results, including the individual's signature must be documented.
Acceptance activities must be recorded. The records must include the activities and dates performed, the results, the signature of the individual(s) conducting the activities, and the equipment used, if appropriate.