todd_ramon
Registered
In an ISO 13485 audit, we were asked for our contract manufacturer's performance validation reports for a sterile packaging process. We require that our contract manufacturers submit these reports (through quality agreements) for us to review. I was confident that the reports were complete and accurate. While reviewing the reports, the auditor requested calibration records for the equipment used in the process. We discovered that one of the key parameters had not been calibrated. This was an immediate finding. We were so surprised by the contract manufacturer's obvious oversight that we didn't even think to contest it in the audit. After the audit, we began to reflect. Our quality agreement with the contract manufacturer states that they are responsible for calibration. My question for the Cove is "To what extent are we responsible for contract manufacturer calibration?" As I begin to wonder, are we also accountable if a contract manufacturer fails to calibrate their equipment in a timely manner or if the calibration is not performed correctly? I don't see this as a reasonable expectation. This is why we have established the quality agreement. Should we have received a finding from our notified body? We routinely audit this CM and have sampled their calibration records with no issues.
By the way, the equipment was later calibrated and found to be within tolerance.
By the way, the equipment was later calibrated and found to be within tolerance.