Most Nonconforming in Audits

If you were to pick clauses from the ISO 9001 standard to be on your “Most” list, which ones would you select? I’ve chosen 6.1 as the most difficult to audit, 4.1 as the most ignored in audits, and 4.2.3 as the most nonconforming in audits. This article is on clause 4.2.3. The other two clauses are covered in separate articles in this newsletter.

Most Nonconforming in Audits- 4.2.3

In my experience, more audit nonconformities are written against document control than any other element of the ISO 9001 standard. Why is that? Because Control of Documents, clause 4.2.3, applies to all areas, is easy to mess up, and very visible to the auditor.

A common nonconformity is the use of uncontrolled documents. Employees may see the need for new instructions or forms and overlook placing them under document control. Or, they may think certain types of documents don’t have to be controlled, for example, training materials, job aids, or guidelines. But, clause 4.2.3 says, “Documents required by the quality management system shall be controlled.”

Another typical nonconformity is the use of a prior revision level of a document. Employees may print off a copy of the document for their personal use and not replace it when the new revision is released. In some cases, it is because they saved a copy to their computer desktop for ease of access, and don’t realize that the master copy will change and make their desk top version obsolete.

And then there are controlled documents that no longer match actual practices. Managers may be accustomed to changing a process whenever they think it is necessary. However, instead of making changes to the applicable documents for review, approval, and possible training, they just modify the process. As a result, employees are observed not following the approved process documents.

Another document control issue is the use of personal job notes or cheat sheets. Employees often make notes on how to perform their job, especially if written instructions aren’t available, supplied instructions are incomplete or complex, or the job training was inadequate.

On the surface, use of cheat sheets would seem to be helpful. However, these job notes may not accurately describe the tasks, may be in conflict with written instructions, or would not be approved by management if they reviewed them.

As mentioned earlier, clause 4.2.3 states that documents required by the quality management system must be controlled. So, if cheat sheets are needed by employees to carry out their activities, these cheat sheets would be viewed as documents to be controlled.

To control a document means it must be approved prior to use, updated as necessary and re-approved, and identified with the current revision status. Cheat sheets become authorized documents if they are controlled. If not, auditors will see them as nonconformities.

Employees do not like their cheat sheets being called nonconformities, especially if the corrective action is to just discard the cheat sheets. The existence of cheat sheets may indicate they are needed, so simply removing them might be a mistake.

Instead, find out why some employees need the cheat sheets and take the appropriate action, e.g., improve training, provide mentoring, add the cheat sheets as controlled documents, or include the reference information in existing documents.

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