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.
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.
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.
Although customer property and the management and handling of customer-supplied material is not important for FDA, that is clearly not the case for MHLW. And, preservation of products is important in all regulatory environments, so create a robust SOP with sufficient granularity to address all Article 52 requirements.
Identification and traceability are basic foundations associated with product realization, manufacturing, and ultimate distribution of finished medical devices. And the device world takes generally accepted identification and traceability requirements, and places them on steroids.
“Failing to properly plan is a plan for failure”—truer words could not have been written when it comes to the design and manufacture of medical devices that are safe and effective.
“Failing to properly plan is a plan for failure”—truer words could not have been written when it comes to the design and manufacture of medical devices that are safe and effective.
The key for successfully complying with MO 169 is not rooted in comprehending the similarities of the Japanese regulation to ISO 13485:2003, but in understanding, embracing, and complying with the differences.
The key for successfully complying with MO 169 is not rooted in comprehending the similarities of the Japanese regulation to ISO 13485:2003, but in understanding, embracing, and complying with the differences.
There are two takeaways this week: One, if you have not commenced with building a requirements matrix for your organization, stop the procrastination and start building the matrix, today. And two, ensure specific regulatory requirements find their way into your procedures.
There are two takeaways this week: One, if you have not commenced with building a requirements matrix for your organization, stop the procrastination and start building the matrix, today. And two, ensure specific regulatory requirements find their way into your procedures.
