The Manufacturing Corrective Action Procedure outlines the responsibilities and methods for identifying causes of nonconformities, initiating corrective action(s) and performing follow-up to ensure that the corrective action(s) have been effective in preventing the reason for the nonconformance. This procedure applies to all causes of nonconformities relating to product, process, and quality system discovered during production, post-sale or during internal quality audits. (6 pages, 962 words)

When an employee determines that a situation requires corrective action, that employee should fill out a Corrective Action Request and submit this to the Quality Manager. The assigned person should investigate the problem to determine the underlying or root cause or causes and record the results of the investigation on the request form. Keep in mind in order too effectively review the corrective action for its effectiveness, some actions may require a one- or two-month period for the action to be in place. Because of this, corrective actions may remain open for a period of time after the action is taken.

Manufacturing Corrective Action Responsibilities:

The Quality Assurance Manager is responsible for tracking the status of corrective actions, reporting on corrective actions taken (at Management Review meetings, for example) and for ensuring that the corrective action procedure is accurate, communicated, understood, and effectively implemented.

All Employees are responsible for identifying nonconforming conditions and initiating corrective actions, investigating, and recording the cause of nonconforming conditions when assigned, and implementing corrective actions in accordance with this procedure.

Manufacturing Corrective Action Definitions:

Corrective action – Action taken to eliminate the cause(s) of an existing nonconformity, defect, or other undesirable situation to prevent recurrence. The distinction between correction (such as repair, rework, or adjustment) and corrective action is that the former relates to the disposition of an existing nonconformity, whereas corrective action relates to the elimination of the causes of the nonconformity.

Root cause – Most fundamental reason for the failure or inefficiency of a process; most basic reason for a defect or problem in a product or process.

Nonconformity – Departure of a quality characteristic from its intended level or state that occurs with severity sufficient to cause an associated product or service not to meet a specification requirement; non-fulfillment of specified requirements.