Crab Logger

HACCP Verification Procedures

The Virginia Cooperative Extension has released a publication discussing the validation of blue crab retort processes. The development and implementation of a Hazard Analysis Critical Control Point (HACCP) plan is a required step for these retort processes. In the publication, we learn about: What a retort cook process validation is Why this process matters How…

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…