five star quality consultants implementing iso 9001 corrective and preventive action

Five Star Quality Consultants

Implementing ISO 9001

Corrective and Preventive Action


Corrective and Preventive Action ISO 9001:1994, Clause 4.14.1 General

• The supplier shall establish and maintain documented procedures for implementing corrective and preventive action.

• Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of problems and commensurate with the risk encountered.

• The supplier shall implement and record any changes to the documented procedures resulting from corrective and preventive action.


Corrective and Preventive Action ISO 9001:1994, Clause 4.14.2 Corrective Action

• The procedures for corrective action shall include:

a ) The effective handling of customer complaints and reports of product nonconformities;

b ) investigation of the cause of nonconformities relating to product, process, and quality system, and recording the results of the investigation (see 4.16);

c ) determination of the corrective action needed to eliminate the cause of nonconformities;

d ) application of controls to ensure that corrective action is taken and that it is effective.


Corrective and Preventive Action ISO 9001:1994, Clause 4.14.3 Preventive Action

• The procedures for preventive action shall include:a ) the use of appropriate sources of information such

as processes and work operations which affect product quality, concessions, audit results, quality records, service reports, and customer complaints to detect, analyze, and eliminate potential causes of nonconformities;

b ) determination of the steps needed to deal with any problems requiring preventive action;

c ) initiation of preventive action and application of controls to ensure that it is effective;

d ) confirmation that relevant information on actions taken is submitted for management review (see 4.1.3)


Corrective and Preventive Action ISO/DIS 9001:2000, Clause 8.5.2 Corrective Action

• The organization shall take corrective action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective action shall be appropriate to the impact of the problems encountered.

• The documented procedure for corrective action shall define requirements for:

a ) identifying nonconformities (including customer complaints);b ) determining the cause of nonconformity;c ) evaluating the need for actions to ensure that nonconformities

do not recur;d ) determining and implementing the corrective action needed;e ) recording results of action taken;f ) reviewing of corrective action taken.


Corrective and Preventive Action ISO/DIS 9001:2000, Clause 8.5.3 Preventive Action

• The organization shall identify preventive action to eliminate the causes of potential nonconformities to prevent occurrence. Preventive actions shall be appropriate to the impact of the potential problems.

• The documented procedure for preventive action shall define requirements for:

a ) identifying potential nonconformities and their causes;

b ) determining and ensuring the the implementation of preventive action needed;

c ) recording results of actions taken;

d ) reviewing of preventive action taken.


Corrective and Preventive Action Corrective Action

• Corrective action must be considered when nonconformances are detected in:

• Product

• Processes

• In-coming materials

• Services

• Customer Complaints

• Systems

• The amount and extent of the corrective action is determined based on the risk generated by the problem


Corrective and Preventive Action Corrective Action

• Document as precisely as possible what the actual nonconformance is and where it is located.

• Analyze all available data and determine the root cause that allowed the nonconformance to occur.

• Develop action steps to correct the nonconformance and change the systems in place to prevent recurrence.

• Document in procedures the changes to the systems.• Train the employees on the procedure changes.• Audit the corrective actions to ensure all have been

completed and are working effectively.


Corrective and Preventive Action Preventive Action

• Preventive action results after analysis of quality data in an effort to prevent nonconformances from occurring

• Sources of data normally include:• process and product data

• concessions

• internal quality audits

• quality records

• inspection, measurement and test data

• service reports

• customer complaints



• Analyze available data and determine what the root cause of the potential nonconformance is

• Document as precisely as possible what potential nonconformance and what the presumption is based on.

• Develop action steps that need to be put in place to prevent a nonconformance from occurring.

• Prepare documented procedures to describe the system or operation

• Train the employees on the procedures.



• Audit to ensure the action steps have been completed and are working effectively.

• Report the preventive action in the management review and have it included in the records of the management review.

• Analyze data after the preventive action is complete to determine the effectiveness in preventing the potential nonconformance


Corrective and Preventive Action Corrective and Preventive Action

• Sometimes it is difficult to decide if something is corrective or preventive action.

• Corrective Action: Mending the fence and filling in the holes to keep the dog contained in the yard

• Preventive Action: Build a chain link fence with a 18” concrete foundation and install an electronic pet fence 6’ inside the fence, which will also prevent the dog from jumping over the fence, before purchasing the dog.

five star quality consultants implementing iso 9001 corrective and preventive action

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