If documents and records do not exist, are illegible, or lack accuracy and detail, then all bets are off when dealing with the regulatory gods in Japan.
If documents and records do not exist, are illegible, or lack accuracy and detail, then all bets are off when dealing with the regulatory gods in Japan.
Training is one of the areas that result in many non-conformances being issued during quality system audits.
Training is one of the areas that result in many non-conformances being issued during quality system audits.
Corrective action should never be considered a bad thing; in fact, a fully functional approach to CAPA can result in a viable tool for driving organizational change.
Corrective action should never be considered a bad thing; in fact, a fully functional approach to CAPA can result in a viable tool for driving organizational change.
When it comes to identifying and controlling nonconforming product, place significant emphasis on the need for a robust system, premised on well-written procedures. It is always a bad thing for nonconforming product to find its way into the supply chain.
When it comes to identifying and controlling nonconforming product, place significant emphasis on the need for a robust system, premised on well-written procedures. It is always a bad thing for nonconforming product to find its way into the supply chain.
Be proactive and create just one procedure for corrective action and preventive action (CAPA). Medical device manufacturers must actually pursue PA and have documented evidence of their efforts. After all, if PA is not documented in writing, it never happened.
Be proactive and create just one procedure for corrective action and preventive action (CAPA). Medical device manufacturers must actually pursue PA and have documented evidence of their efforts. After all, if PA is not documented in writing, it never happened.
A corrective action procedure requires a significant amount of intelligent thought to ensure all aspects required of an effective corrective action process are captured. Plan ahead and incorporate the preventive action requirements (Article 64) into the corrective action procedure; thus, creating a CAPA procedure.
Make sure that the procedure scripted by your organization addresses all of the requirements associated with “Improvement” (Article 62). Since most medical device manufacturers get the complaint management piece right, let’s focus on what is often missed.
Do not be that organization that gets stuck buying green catheter handles, when the requirement is for white. Article 61 does not tell device manufacturers what data needs to be collected and analyzed. It is completely up to each organization to decide. Remember, your organization, your data, so you decide what data is important.
The control of nonconforming product should never be an onerous task. Keep it simple by never allowing non-conforming product to make its way into your organization’s supply chain. While UAI is convenient, eventually the use of such concessions is going to break your heart.
It is not enough for device manufacturers to simply clone a QMS or develop procedures employed for device manufacturing. Manufacturers must be able to gauge the effectiveness of their policies, procedures and processes, and provide objective evidence that their approach to quality and the manufacturing of devices is effective.
