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Nonconformity and Corrective Action
Section 10.2 of AS9100D requires organizations to establish, implement, and maintain processes for identifying, evaluating, and taking action on nonconformities. The organization must also establish a process for preventing recurrence of nonconformities.
The organization must identify nonconformities as soon as possible. Nonconformities can be identified by the organization itself, by customers, or by other parties. Once a nonconformity has been identified, the organization must evaluate it to determine its severity. The severity of a nonconformity is determined by its impact on the organization's ability to meet customer requirements and applicable regulatory requirements.
If a nonconformity is determined to be significant, the organization must take action to prevent its recurrence. The organization must also take action to correct the nonconformity. The corrective action must be effective in eliminating the cause of the nonconformity. The organization must also take action to prevent the recurrence of similar nonconformities.
The organization must maintain records of all nonconformities, corrective actions, and preventive actions. The records must be maintained for a period of time that is specified by the organization.
The following are some tips for implementing section 10.2 of the AS9100D standard:
Establish a process for identifying nonconformities. The process should be documented and should include the following steps:
Define what constitutes a nonconformity.
Identify the sources of nonconformities.
Establish a method for reporting nonconformities.
Investigate nonconformities.
Evaluate the severity of nonconformities.
Establish a process for evaluating nonconformities. The process should be documented and should include the following steps:
Determine the cause of the nonconformity.
Evaluate the impact of the nonconformity.
Determine the corrective action that is needed to prevent recurrence of the nonconformity.
Establish a process for taking corrective action. The process should be documented and should include the following steps:
Implement the corrective action.
Verify the effectiveness of the corrective action.
Document the corrective action.
Establish a process for preventing recurrence of nonconformities. The process should be documented and should include the following steps:
Identify the root cause of the nonconformity.
Implement preventive action to eliminate the root cause of the nonconformity.
Verify the effectiveness of the preventive action.
Document the preventive action.
Maintain records of nonconformities, corrective actions, and preventive actions. The records should be maintained for a period of time that is specified by the organization.
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