QM: 8.5.2 Corrective Action, 8.5.3 Preventive Action

8.5.2	Corrective Action
8.5.3	Preventative Action

8.5.2 Corrective Action

The organization has a comprehensive corrective action plan. Corrective actions are taken to eliminate the cause of nonconformities in order to prevent recurrence according to corrective action procedure.

Inputs to the system include nonconforming products, customer complaints, audits (internal and external), change controls, supplier corrective actions and Quality System nonconformance or any other condition, which is adverse to quality or which has the potential for product/process involvement. Product or process failure is an indication that the process or system was not followed, or is inadequate. Any employee of the company can initiate a corrective action request.

Determining and implementing of corrective action includes the following stages:

Reviewing nonconformities (including customer complaint)

Determining the cause of non conformities

Evaluating the need for action to ensure that nonconformities do not recur

Determining if additional nonconforming product exists based on the nonconforming causes and the appropriate actions to take, if required

Determining and implementing action needed (it also included following down corrective action requirement to a supplier when it is determined that the supplier is responsible for nonconformity)

Records of results of action taken

Reviewing the effectiveness of corrective action taken and

Specific actions where timely and/or effective corrective actions are not achieved.

The results of the corrective action are summarized and trended to identify opportunities for improvement. This information is reviewed in management meetings.

8.5.3 Preventive action

Preventive actions are determined to eliminate the cause of potential nonconformities in order to prevent occurrence according to preventive action procedure.

Process mapping and risk assessment is considered an integral part of the preventive action system. In addition the need for preventive action is determined as the basis of information and data regarding capability and performance of processes, product nonconformity rates, customer complaints and quality system audit findings. Such information and data are collected and analyzed for unfavorable trends.

Preventive action is used to identify continual improvement opportunities and include the following:

Determining potential nonconformities and their causes (through process mapping and risk assessment or continuation of corrective action)

Evaluating the need for action to prevent occurrence of nonconformities

Determining and implementing action needed

Records of results of action taken; and

Reviewing effectiveness of the preventive action taken.

The results of preventive actions are reviewed for effectiveness and relevant information is presented at the management review meeting.

Though identification of Corrective and Preventive action follow different system, once the need is identified a common system is used to process both the actions. Forms, logs and other documents and records for processing of corrective and preventive action are same.  Corrective and Preventive action database includes: information related to the problem, the root causes, correction to the problem, corrective action taken, revision to documents and follow-up action to ensure effectiveness.

Note: Two separate documents can be adopted for addressing corrective action and preventive actions however the basic steps of implementation for both are same.