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.

Correction/ Remedial Action, Corrective Action and Preventive Action

ISO 9001:2008 standard requires an organization to establish a procedure for implementation of Corrective Action and Preventive Action.

Whenever a problem is encountered it is addressed in three phases:

Correction (Remedial Action)

Corrective Action

Preventive Action

The above phases are defined as:

Correction (Remedial Action): Remedial action is action proposed or taken to remove nonconformity. Or in simple words, ‘action taken to rectify a problem’.

ISO 9000:2005 Defines Correction, 'action to eliminate a detected non conformity.'

Corrective Action: Corrective action is action planned or taken to stop something from recurring. It could be a one-off event (special cause variation), a recurring event or an inherent condition (common cause variation). Corrective action can, therefore, be considered to be an instrument of both process control and process improvement.

Corrective action forms part of every process rather than being a separate process.

Traceability is required in order to find the root cause of a problem and take corrective action to prevent its recurrence.

ISO 9000:2005 Defines Corrective action, 'action to eliminate the cause of a detected nonconformity or other undesirable situation.'

Preventive action is action proposed or taken to stop something from occurring. When actual problems do not exist but there is a possibility of failure, however unlikely, the action of preventing the occurrence of this failure (or any problem for that matter) is a preventive action.

Preventive action though being a standalone process (may include tools such as process mapping and risk assessment) may also be initiated after identification of nonconformance and becomes part of corrective action.

ISO 9000:2005 Defines Preventive action, 'action to eliminate the cause of potential nonconformity or other undesirable situation.'

Different examples are sighted to explain Correction, Corrective Action and Preventive Action initiated through an incident.

A person suffers a heart attack:

Actions	Category
Goes to doctor	Correction/Remedial Action
Doctor gives first aid	Correction/Remedial Action
Doctor examine and prescribes different tests	Root cause analysis
Doctor treats and prescribes medicine	Correction/Remedial Action
Patient adopts a healthy lifestyle	Corrective Acton
Patient identified his friends and family at risk of heart disease	Preventive Action
Family and friends of patient starts living a healthy lifestyle	Preventive action

A person slips on wet stairs in office:

Actions	Category
Person given first aid and sent to hospital for further treatment	Correction/Remedial Action
Wet floor dried to prevent any further accident	Correction/Remedial Action
EHS officer investigates the matter	Root cause analysis
Cleaning of Floor rescheduled to non-office hours or times of less traffic	Corrective Action
EHS officer recommends anti slip mat and strips to be used in staircase, use of Caution Signs such as ‘Wet Floor, Be Careful’ recommended during cleaning procedures	Corrective Action
EHS officer inspects all the staircases in the plant and other locations and recommends use of  anti slip mat and strips and Caution Signs	Preventive Action

A market complaint resulted in recall

Action	Category
Market complaint reported and verified by quality and sales department, immediate recall initiated	Correction
Investigation performed by inter-departmental investigation committee and identified the cause as	Root cause analysis
Change in manufacturing step recommended	Corrective Action
Sampling plan modified for stringent control	Corrective Action
Implementation of risk assessment for new and upcoming process for risk identification	Preventive Action If risk assessment is already practiced no PA initiated

Reference:

ISO 9000: 2000: An A–Z Guide by David Hoyle

ISO 9000:2005 Quality management system: Fundamentals and Vocabulary

http://www.batalas.co.uk/how-to-guides/auditing-iso-basics/difference-correction-corrective-action-preventive-action/