Key terms and concepts

non-conformance

A non-conformance in manufacturing means that something is wrong. A problem occurred during manufacturing and needs to be addressed.

A non-conformance can also occur due to Incoming Quality Control (IQC), for example receiving defective materials from a supplier at the loading dock.

repair/ correction

One or more actions taken to eliminate or fix a non-conformance.

A correction can be made in conjunction with a corrective action.

containment

One or more (optional) actions taken to minimize the impact of a non-conformance.

root cause

The actual cause of a non-conformance as determined by investigation and analysis.

A non-conformance can have more than one root cause. Multiple non-conformances can sometimes share the same root cause. When multiple root causes are identified, each must have its own corrective action plan.

corrective action

One or more actions to eliminate the root cause of a non-conformance. For example, repairing a defect or making an adjustment to fix what went wrong are corrective actions. A corrective action is taken to prevent a non-conformance from recurring.

A non-conformance can be simple or complex depending on what you want to resolve or prevent. In some cases, you may want to perform a root cause analysis to determine how a non-conformance occurred. In such cases, a corrective action includes executing one or more plans to eliminate the root cause (there may be more than one corrective action to resolve a root cause).

preventive action

An action taken to eliminate the cause of a potential non-conformance that hasn’t happened yet. (You corrected a problem but now you want to take steps to prevent another non-conformance from occurring.)

effectiveness check

The measurement or determination of whether your corrective and preventive actions were effective in their efforts to prevent or correct a non-conformance.

disposition decision

The decision the MRB makes when they decide how to deal with a non-conformance.

FRACAS

Failure Reporting Analysis and Corrective Action System.

Commonly referred to a "Closed Loop Reporting System". Instrumental in understanding how an equipment or system is performing in the field from a reliability and maintainability perspective.

• Born from the Defense industry. Now also prevalent in Automotive and Telecommunications industries

• Similar to CAPA, but more “failure centric” with a focus on fixing design flaws and manufacturing process problems

CAPA

Corrective and Preventive Action.

Improvements to an organization's processes taken to eliminate causes of non-conformances or other undesirable situations. It is usually a set of actions, laws, or regulations an organization must take in manufacturing, documentation, procedures, or systems to rectify and eliminate recurring non-conformances.

• Initially specific to the Medical Device industry (FDA)

• Ties to manufacturing and field service

• Now more prevalent in the Defense industry

MRB

A Material Review Board (MRB) typically refers to a group of people decide what should happen when non-conformances occur.

FRB

A Failure Review Board typically refers to a group of experts who have the authority to set priorities, establish schedules, assign responsibilities, and authorize funding to drive fixes to completion. 

QMS

Quality Management System is a set of policies, processes and procedures required for planning, development, and execution of a product or service. 

IQC

Incoming Quality Control is the process of controlling the quality of materials and parts for manufacturing a product before production starts.

AQM

Administrative Quality Management.