ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

8.5.2 Corrective Action

ISO 9001 Training - Key Explanation Points and Tips:

Corrective action is action taken to eliminate the cause of a detected nonconformity to prevent recurrence, whereas preventive action is action taken to eliminate the cause of a potential nonconformity or other undesirable situation, to prevent occurrence.

You must have a documented procedure for your corrective action process which must address the following control requirements:

Identify detected nonconformities that relate to your - products; QMS processes; resources; suppliers and outsourced work; product shipped to customers; customer complaints; cost of quality reports; and TGR (things gone wrong) reports.

Define your process for identifying nonconformities (see clause 8.3) and consider using appropriate problem-solving tools to determine the underlying root cause(s) of the nonconformity

Problem-solving tools may include - analysis of failure mode; capability studies; correlation diagrams; data collection; fishbone diagram (Ishikawa diagram); histograms; Pareto analysis; probability charts; stratification of data; graphic representations; etc. Ensure that personnel applying these tools are competent and trained.

Actions taken to eliminate the cause of nonconformity must flow from your problem-solving activity. Actions may involve changes to product, process, resources, documentation, controls, etc or any combination of these. Conduct follow-up tests to determine whether these actions have indeed eliminated the cause(s) of the nonconformity and prevented recurrence. You must keep appropriate records of these actions and follow-up activities

You must monitor your corrective action records on an ongoing basis, for any recurrence of the nonconformity you took corrective action on. If you found that the problem has occurred again, then perhaps your analysis of root cause may have been incorrect or incomplete.

Keep appropriate records of all corrective action steps. Ensure timely completion of any open corrective action or be prepared to provide evidence to justify its continued open status. Make your corrective action records available on request to customers and provide a summary report for management review.

All nonconformities may not necessarily result in corrective action. Evaluate the significance of nonconformities in terms of their impact on  - operating costs; cost of nonconformity and its correction; product performance; dependability; safety; regulatory requirements; affect on customers product and processes; any other risks; and customer satisfaction. Consider using cross-functional teams in such decision-making, including the involvement of your organizations designated customer representative (see clause 5.5.2.1).

Performance indicators to measure the effectiveness of the corrective action process may include reduction in - cycle time for correction actions, problem re-occurrence, open corrective actions, costs; and improvement in QMS productivity.