How to effectively rectify non-conformities in external audits

External audits of the quality management system are a common occurrence for enterprises. When addressing nonconformities identified during external audits, many problems often arise, mainly manifested as inadequate root cause analysis, failure to implement corrective actions, departments shirking responsibility, and so on. As a result, the implementation of corrective measures becomes a formality, and the identified nonconformities reoccur in future work. How to thoroughly rectify the nonconformities raised in external audits and improve the effectiveness of corrections? The author shares the practices of their unit to facilitate mutual exchange of working methods and promote continuous improvement of the quality management system.

01 Quality Department Pre-establishes Corrective Actions for Nonconformities

The Quality Department is the centralized management department for quality management system audits. The effectiveness of rectifying nonconformities from external audits reflects the quality of the operation of a unit's quality management system. To complete the rectification of nonconformities within the agreed timeframe, it is the responsibility of the Quality Department to organize relevant departments to develop corrective actions.

1. Clarify the Basic Format for Rectification

For rectifying nonconformities, our Quality Department, based on the requirements proposed by the second and third parties for rectification, has clarified the basic format for rectification. The specific content includes description of the nonconformity, root cause analysis, corrective actions, preventive measures, responsible unit, and completion time. This basic requirement is formatted into a table, so that anyone responsible for rectification will follow this requirement, avoiding arbitrariness and incompleteness in rectification.

2. Pre-establish Corrective Actions

Personnel responsible for auditing in the Quality Department should, based on the information learned during the audit and audit knowledge, pre-establish corrective actions for the identified nonconformities according to the basic rectification format. During the formulation of corrective actions, each nonconformity must be addressed individually, understanding the on-site audit situation at the time, communicating with accompanying personnel and responsible units, and gathering opinions and suggestions from multiple perspectives to ensure accurate root cause analysis, clear responsibility, and effective measures.

3. Send Pre-established Corrective Actions to Responsible Units for Review and Confirmation

Since the corrective actions are formulated by the Quality Department, there may be oversights or incomplete investigations. The Quality Department sends the pre-established corrective actions to the responsible units for review and further confirmation, allowing them to propose modifications or suggestions to improve the corrective actions. This approach not only compensates for the shortcomings of the Quality Department's measures but also shows respect to the responsible units, fostering understanding and proactive rectification.

4. Coordinate and Modify Corrective Actions

For the rectification of a nonconformity, different departments may have varying understandings. Some departments may not understand the corrective actions or even dispute the root cause analysis. This requires communication and coordination. The coordination process involves analyzing the causes and formulating corrective actions together with the responsible departments, which is also a process of relearning the standards. This coordination is especially important when a nonconformity involves multiple departments. Correct and reasonable opinions from departments should be adopted immediately, while unreasonable or incorrect opinions and suggestions should be patiently explained.

02 Hold Special Rectification Coordination Meetings

Generally, after completing the above work, it should be considered that there are no major issues, and the corrective action plan can be issued. However, practice has proven that holding special rectification coordination meetings is more effective.

1. The Quality Department is Responsible for Organizing Special Meetings

After each unit reviews the pre-established corrective actions, the Quality Department organizes relevant units to hold a special coordination meeting. Participants include the responsible departments and departments involved in preventive measures related to the rectification. If the nonconformities were raised by military audits, the military representative office stationed at the factory must also be notified to participate. It must be clearly stated that each participating unit must send a leader to the meeting, as the final corrective actions need to be confirmed to prevent post-meeting shirking of responsibility, which could affect the progress and effectiveness of rectification.

2. Several Important Notes Before the Meeting

Before the meeting starts, several important notes must be specially explained. Without these explanations, there may be disputes, arguments, and delays in the meeting.

⑴ Only discuss corrective actions, not whether the nonconformities are reasonable or right or wrong;

⑵ Do not discuss who is responsible; only discuss the problems within your own department without making excuses;

⑶ All identified nonconformities must be rectified without negotiation;

⑷ Approach nonconformities with a calm mindset, focusing on rectification, improvement, and enhancement.

3. Discuss Corrective Actions for Each Nonconformity One by One, Everyone Has Equal Speaking Rights

Regarding the proposed corrective actions for nonconformities, the Quality Department is responsible for reading them out one by one, verifying whether the root cause analysis is accurate, whether the measures are feasible and effective, and whether the completion time is sufficient. Everyone is allowed to express different opinions and suggestions, and on-site issues between departments are resolved. During this discussion, everyone has equal speaking rights. Through discussion, everyone gains a clearer understanding of the existing problems, a more accurate understanding of the standards, knows where the mistakes were made, and what should be done in the future. At the same time, problems are clarified, misunderstandings between departments are eliminated, and it also helps other departments with similar issues to take preventive measures.

4. Finalize and Issue the Rectification Plan, Complete the Rectification Work Within the Specified Time

After the special meeting discussion, the final corrective action plan is formed and issued to relevant units for implementation. The Quality Department is responsible for checking the implementation of corrective actions and conducting assessments according to the timeline, ensuring that the rectification work is completed as required, on time, and achieves the expected rectification effect.

Rectification of nonconformities from external audits is a continuation of the external audit work, and its effectiveness directly affects the quality of the quality management system operation. Many units directly assign the rectification tasks to the responsible units, which is theoretically correct. However, considering the specific circumstances of enterprises, our current approach works better. Its advantages are: first, everyone clarifies problems face-to-face, eliminating mutual blame and reducing shirking; second, everyone unifies their understanding, clarifies how to make corrections, and this also serves as a review of corrective actions, enhancing their operability; third, it reduces repetition during the rectification process, improving efficiency and effectiveness; fourth, it serves as a training on standards for everyone, deepening understanding of the standards and enhancing the consciousness of standard compliance.