China’s Copious International fell short on submitting medical device reports and tracking complaints, as well as validation procedures, a Feb. 5 to Feb. 8 inspection of the firm’s Guang Dong, China facility revealed.
The Chinese firm’s MDR procedures didn’t define time frames for submitting reports to the FDA, and it didn’t record complaints related to products on the U.S. market, according to the seven-item Form 483.
The firm’s CAPA procedures didn’t include adequate requirements for investigating the cause of nonconformities relating to products, processes or the quality system, or for implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.
Validation was found to be lacking for equipment management control procedures for revalidating equipment, and not all test results were available for certain test operators.
In addition, document control procedures were sloppy in that document changes weren’t validated by appropriate personnel, and not all changes were recorded correctly.
In-process product inspection control procedures fell short when it came to ensuring that sampling plans were based on a valid statistical rationale.
For example, the sampling methods didn’t adequately define the sampling rate for tightened or reduced sampling levels.
Read the Copious International Form 483 here: www.fdanews.com/11-15-18-copiousintlinc483.pdf.
Equipment Adjustment and Calibration
Equipment adjustment is an important part of QSR-compliant operation. Under §820.70(g)(3), “Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments.”
This requirement can be covered by including this information in procedures and work instructions, documents that should be readily available to employees performing these tasks.
Companies need to determine which pieces of equipment have an inherent limitation or an allowable tolerance and what that limitation or tolerance is. Then they must determine, for each piece of equipment, whether that information needs to be available to staff and how it should be presented. Documentation showing that these determinations were made and their justification should be maintained.
It’s also important that devicemakers then audit this as part of their overall equipment audit program. In the course of this audit, companies need to verify that the equipment has an inherent limitation or allowable tolerance, and that the information is either visibly posted or readily available. They should confirm that the information is contained in a controlled document and record the document number and revision so that it is clear to FDA investigators. They also need to trace to the document’s review and approval in the document control system under §820.40.
Calibration is another important factor in the operation of equipment that includes any sort of measuring function. Under §820.72(a), devicemakers are required to “establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained.” The FDA expects to see a rational schedule established for calibration activities as well as documented evidence of adherence to that schedule. Calibration is often paired with other routine maintenance for convenience.
ISO standard 13485:2016 includes similar requirements. It states, “As necessary to ensure valid results, measuring equipment shall be calibrated or verified, or both, at specified intervals, or prior to use.”
Excerpted from the FDAnews management report: Three Phases of QSR-Compliant Equipment Control.