correction

Corrective Actions

Corrective Actions (CA) are another critical aspect of a quality management system.  These are improvements made to a process or product in order to eliminate the cause(s) of non-conformances.  The concept of CAPA (corrective and preventive actions) is discussed in 21 CFR 820.100, ISO 9001 (clause 8.5.2) and GMP. Corrective Actions can be initiated in…

FDA

Non-Conformances

Both 21 CFR 820 and ISO 9001 require a company to have control over their non-conforming product.  According to the FDA, “each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements.”  Essentially, a company must have a procedure in place that addresses the identification, documentation, evaluation, segregation and…

FDA

Quality Plan

In 21 CFR 820 Subpart B, the FDA states “Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured.  The manufacturer shall establish how the requirements for quality will be met.” A quality plan states the goals your company has to improve…

FDA

FDA Inspections

If your company holds a 510(k) on a device, the FDA may perform an inspection of your facility for any number of reasons including routinely scheduled investigations or response to a reported problem.  These inspections are supposed to happen at least once every two years.  There is no requirement, though, for the FDA to give…

FDA

Device History Record

The FDA requires manufacturers to maintain Device History Records (DHR).  Within ISO 13485, there isn’t a specific requirement for a DHR, but it does require the manufacturer to create all of the individual records the FDA requires the DHR to contain.  The Device History Record is meant to be a collection of records containing all…