ISO 9001 requires that you have procedures for identifying and eliminating the causes of actual or potential nonconformities in your products, processes, or the quality system.
Product and service nonconformance reports are the source of information leading to the corrective action that you should take to prevent the same or a similar problem from recurring. Situations may include the following:
Failures, malfunctions or nonconformities in incoming materials, processes, tools, equipment or facilities needed to produce your product or deliver your service, including the equipment and systems you use;
- Inadequate or non-existent procedures and work instructions;
- Non-compliance with procedures or work instructions;
- Inadequate process control;
- Poor scheduling;
- Lack of training;
- Inadequate working conditions;
- Inadequate resources, (human or material);
- Inherent process variability.
These conditions may be found by reviewing:
- Inspection and test records;
- Nonconformance reports;
- Observations during process monitoring;
- Audit observations;
- Field, service, or customer complaints;
- Regulatory authority or customer observations;
- Observations and reports by your personnel;
- Sub-contract problems;
- Management review results;
- Inherent process variability.
The same causes and conditions may indicate where preventive action is needed and where patterns or trends that may indicate the potential for nonconformities should be investigated. The degree of corrective or preventive action taken depends upon and is directly related to the risk, size and nature of the problem and its direct effects on product quality.
Corrective and preventive action reports should be part of the management review process.
Corrective action
Corrective action is taken to eliminate the cause of an existing nonconformity or other undesirable situation. There is a distinction between "correction" and "corrective action". Correction refers to repair or rework as is done to eliminate a nonconforming product situation whereas corrective action is taken to prevent recurrence of the situation.
Your procedures should describe how to implement corrective action, how it should be carried out and the effectiveness of the results verified.
It is important to implement procedures to deal with nonconformities discovered in any products that have already been delivered. You must determine whether the nonconformity is an isolated or a repetitive problem, and any actions to be taken, if necessary.
Corrective action to eliminate the cause of a nonconformity is not necessarily required every time or for isolated incidents of a minor nature, but a periodic analysis of nonconformance reports should be done to identify opportunities for process improvement.
Preventive action
It should be noted that corrective action is taken after nonconformities are identified. Preventive action is taken when a potential nonconformity is identified as a result of the analysis of records and other relevant sources of information, such as the following:
- Statistical process control documents;
- Customer complaints;
- Review product, process and quality system information,
- Risk analysis and risk assessment of products and processes.
Records relating to the product performance should be analyzed regularly, to detect trends and to identify areas of risk that may lead to nonconformities. The analyses should also determine how to prevent any identified potential problems.
Information on preventive action taken must be part of your management review to maintain and improve your quality system.
Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence of a situation or nonconformity. Preventive action is not necessarily required for all the potential nonconformities you have identified, but it should be considered if there are opportunities to improve your quality management system.
From:
www.isoman.com/CorAct.htm
[This message has been edited by Marc Smith (edited 27 June 2000).]
