Root Cause Analysis

Root Cause Analysis

Within various aspects of a quality management system, there is a directive to evaluate the root cause of an issue – this could be risk management, investigations, non-conforming material, corrective actions, etc.  There is a specific process to this concept, along with methods to achieve the answers. A root cause is a factor, or combination…

Hammer

Preventive Action

The next logical discussion is the second half of the Corrective and Preventive Action (CAPA) subject.  According to ISO 9001 section 8.5.3, Preventive Actions identify and eliminate the causes of potential nonconformities in order to prevent occurrence.  These are proactive measures, instead of the reactive steps taken for a Corrective Action. The main goal for…

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…