In general terms:
A nonconformity means there has been a deviation from a requirement. A corrective action plan or the corrective action process is an action(s) that needs to be taken to eliminate the root cause of that nonconformity or other undesirable situation. Nonconformities can occur in any process, product, or service and when they do occur, they should be corrected as soon as possible to prevent them from happening again.
When a nonconformity is identified, it is important to take quick and effective action to maintain compliance with requirements. Here are a few key steps to effectively manage a nonconformity.
When a nonconformity is identified, it is important to take quick action to isolate the nonconformity. This means identifying the root cause of the affected product, service and putting it under a control so that the nonconformity does not continue or spread. This may involve stopping production, removing finished products from the affected area, or taking other measures to prevent the nonconformity from spreading.
Determining the root cause analysis techniques for a nonconformity is critical to ensure that corrective and preventive actions are effective in preventing recurrence. To do this, we need to ask why the nonconformity occurred. This may be done using the ‘Five Whys’ method.
Once corrective and/or preventative actions (CAPA) have been agreed upon, action plans should be developed (including the details of who is responsible) for applying the corrective or preventative action(s) and the appropriate timing for the completion of such action(s). Allowances should be made for tracking the status of action reports until such action is completed.
Note: The records of actions, including the assignment of responsibility and appropriate timeframes should be maintained for a nonconformity. This will allow the tracking of the action status until corrected, closed out and verified as effective
A means of review and close-out should be followed to assess the status of action items. The review should be recorded against the action item for verification purposes.
A conformity report of all action items that remain outstanding after planned completion dates should be presented for discussion at management review meetings. These reports should be retained as ‘documented information.’ The report should also be signed and dated by the person who was responsible for addressing the issue.
This 10-page nonconformity and corrective action procedure can assist you to establish the required processes for identifying, documenting and analysing non-conformities and meeting the requirements of objective evidence by applying appropriate corrective or preventative actions.
This procedure can be applied to all non-conforming products, services, processes and any aspect of an AS/NZS ISO standard management system, inclusive of: