Raising non-conformities during an audit

Raising non-conformities during an audit

After the audit is completed, the auditors will convene a meeting where they will discuss their findings and exchange notes. There are two forms of non-conformities- Major and minor. When recording nonconformities, it is very important to detail the objective evidence that was collected and the particular section of the criteria document that is not being fulfilled. 

During the auditors’ meeting, every auditor will state the non-conformities encountered and against the criteria for audit. 

The need for sharing notes is if the same non-conformity cuts across many departments or processes, it is raised as one. This also helps the organization when doing extent analysis.

 Examples;

You audit an organization and you find that they are contravening clause 6.1 of the ISO 9001:2015 standard – Actions to address risks and opportunities.

Let’s say, 3 out of 6 departments have identified the risks and opportunities in their departments and come up with actions to address risks and opportunities, then only one non-conformity will be raised for the other 3 departments as opposed to 3.

In another scenario, still under clause 6.1, all the departments have identified risks and actions to address them but there are no opportunities, again, this is one non-conformity that cuts across all the departments. Not 6 non-conformities.

You audit an organization and realize that they have not trained any firefighters in the organization. This is contravening a legal requirement – Occupational safety and Health- thus this is raised as one non-conformity for the organization.

There those non-conformities that will not cut across any two departments as they are unique to the process/department. When auditing a hospital pharmacy and you find out they are issuing expired medication to the patients that non-conformity will only apply to them because they are the only ones in the hospital who issue drugs. It’s important to note that even if it is a big hospital with many pharmacies that are still under the same process.

The core functions of an organization tend to have nonconformities unique to their functions but they can share in other non-conformities as well. 

Major non-conformities 

A major non-conformity is raised when there is a serious failure to comply with the requirements of the management system that is likely to have a significant adverse effect on the quality or safety of service or product. These usually occur when;

  1. Non-compliance to any legal requirement- (Statutory and Regulatory requirements)
  2. One or more requirements of the management system standard have not been fulfilled- anywhere in the standard where it states “shall” and the organization is not fulfilling that requirement, which translates to a major.
  3. Absence of procedures which are required for the management system. I.e. lack of a procedure for control of non-conforming products. 
  4. A total breakdown of a procedure- This occurs mostly when the procedure is present, but what is being done has nothing to do with the procedure. 
  5. Hazard causing non-conformities- when non-conformity results in a hazard. Auditing a kitchen and you find out there is no fire fighting equipment in place. 
  6. When there is a level of significant doubt the management system put in place is unable to result in the required or intended output
  7. A minor non-conformity has not been corrected within a stipulated time, it is then escalated to a major non-conformity.
  8. When in a particular process, a minor non-conformity keeps reoccurring each time there is an audit

Minor non-conformities 

A minor non-conformity is raised when there is a single observed lapse in the system that has been identified in a procedure/process required as part of the clients’ management system.

After raising the non-conformities, the auditors present them to the client in detail during the closing meeting. The auditors should give time for clarification if the client is not clear on what has been presented. A time period for corrective action is then agreed upon. This will differ from one certification body to another. 

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