CT Medical ineffective Quality management contributes to ISO Audit Failure

The purpose of this research is twofold. One is to investigate and outline the causes of the ineffective quality management concerning the calibration of equipment that contributes to ISO audit failures. Further, the research endeavors to describe the measures and approaches medical facilities should take to ensure that their medical devices are managed based on the quality management systems set by the ISO 13485.

Poor FM0343 paper work filling, FM343 is the initial set up form that is use to set up calibration requirements for each equipment, it shows the location of the equipment, calibarion set points, tolerances, calibration intervals etc( in Creganna during the Audit it was found out that some equipment are calibrated using verbal use and nothing noted down for what the requirements are totally in violation of the standard operating procedure and in violation of ISO13485.

During the audit it was found out that some equipment was calibrated below products set point for example if a product melt point is 600 deg F the equipment was calibrated to 400 deg again this is a big nonconformance,

During the Audit it was found out that some equipment was being used and calibration is expired this is a big nonconformance as our process and ISO requirement states that an equipment must be used that in compliance to set standards

Poor system of monitoring calibration, the scheduling system is not always showing what is due and the calibration tech is not effectively monitoring the calibration system to ensure the calibration dues are done on time.

Out of tolerance are not being addressed properly, it was found out that if an equipment is found to be out of tolerance and get adjusted and pass, -the necessary steps of ensuring the products built prior to be known that the equipment was out of tolerance are quarantine and thoroughly inspected to ensure they are good and meets customer requirements or totally get rejected and scrapped properly.

Also, it was found out that equipment that when an out of tolerances, the process of ensuring the problem doesn’t happen again or a process of knowing when it going to be out of tolerance again was not addressed right using proper way of CAPA system.

It was also found out that one equipment number was used on one or two equipment thus leading to confusion during calibration due whereby if there are more than one equipment sing the same number without knowing, one will be calibrated and the other wont because the ID used was double allocated and not monitored. This will lead to an equipment being used when it is not calibrated.

It was found out that some small equipment tends to be locked by operators and that leads to not being found when time for calibration is comes around and the operators tend to not border check if the tool is within calibration. (calipers, Small Rulers etc.)

It was also found that calibration certs were not being thoroughly checked as it was found out that calibration vendor passed an equipment that according to the data it was supposed to have been failed.

Also, it was found out that calibration vendor was using expired standards (equipment) to carry out calibration of our equipment. Not only they missed during their review but also was missed in our end during QA review. This is a big non- conformance

It was also found out that some equipment didn’t have calibration certs even though the sticker says it is calibrated.

It was also found out that an equipment was calibrated the same day and expires the same day, technician mistake but not only they didn’t realize but we also didn’t realize until the Audit came around.

Please add points on each and every section of this uploaded paper, the above is the problems that are contributing to Audit failures, i have written the paper but i need more points . Please add points to the uploaded paper only on the body of the paper , Add sources as much as you can . Thanks

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