ISO 9001 Lead Auditor Training

Module 6 Conducting On-site Activities 

Nonconformity Example 2
In Clean Room B4, a technician was preparing a standard formulation SF35 on the Lab workbench.

Various files and documents and uncovered food were seen on the workbench in violation of department procedure CP-001.

ISO 9001 Auditor Training - It is not always possible to make statements brief. It is more important to get all the facts. The example above is a breach of an internal procedure and is an implementation nonconformity (there is a procedure, but it is not being implemented).

Nonconformity Example 3
Requirement: Contract 89530 requires the prior approval by the client for all changes to welding procedures.

Finding: Welding procedures WP-994/C, WP-179/E and WP-758/U, used to complete contract 89530, have been changed without this approval.

This statement could be made even briefer, but all the facts are there and it is retrievable. It is a violation of the prime specified requirement, “the contract”, and is a nonconformity of implementation.

Nonconformity Example 4
Requirement:The Chief Draftsman stated that all draftsmen and engineers based their choice of limits and fits on Newall only.

Finding: A draftsman calculating tolerances on a collar box bush, part number CBB 88, for contract APH/49/D0, stated that he used BS 1916 because Newall did not work for this application.

ISO 9000 Training - The objective evidence here is all based on what people have said. However, it is admissible in both cases because the persons are talking about their responsibility. It is partly a nonconformity of implementation. There is a procedure, but at least one person is not working to it. It is also a nonconformity of effectiveness because the procedure as stated by the manager is not effective for all applications.

Nonconformity Example 5
The relevant version of the document is not available where the work is done.

For completeness, an unacceptably written nonconformity is included. We do not know what documents, what issues, or where the documents are supposed to be. There is a conclusion reached without any evidence to back it up. It is a partial quote from the Standard, which in general, should be avoided unless it adds information. In other words, it was a total waste of time for the auditor to write it.

The number of nonconformities that can arise during an audit can be numerous. However, it is unlikely that they are all equally serious. The auditor needs to be able to differentiate between those that are serious and those that are less so.

In order to help with this analysis, there are three questions the auditor can ask:
1. What could go wrong if the deficiency remains uncorrected?
2. What is the likelihood of such a thing going wrong?
3. Is it likely the system would detect it before the customer is affected?

Most Registrars classify nonconformities as either major or minor and have their own defined criteria for each severity level.

It is also common practice for auditors to raise opportunities for improvement that are points of concern, but for which there is insufficient objective evidence to raise a nonconformity. Opportunities for improvement are an additional way by which auditors can be seen as being helpful.

Minor Nonconformity
The definition of a MINOR nonconformity:
• Failure to conform to a requirement which (based on judgement and experience) is not likely to result in QMS failure
• A single observed lapse or isolated incident
• Minimal risk of nonconforming product or service

Examples:
• A drawing marked up with unauthorized changes
• A purchase order released without review and approval
• An inspection instrument past its calibration date
• A training record not available

Minor nonconformities have little likelihood of allowing nonconforming product or service to be delivered or causing a breakdown of system control. It does indicate that there are occasional lapses that must be formally addressed through corrective action.

Major Nonconformity
The definition of a MAJOR nonconformity:
• Total breakdown of system, control, or procedure
• Absence of an ISO 9001 requirement
• A number of minors related to the same clause
• An nonconformity that would result in probable shipment of nonconformity or un-inspected product
• A condition that may result in the failure or materially reduce the usability of product for intended purpose;
• A nonconformity that experience and judgement indicate will likely result in QMS failure or materially reduce its ability to assure controlled processes and products

Examples:
• No documented procedure for any required element of the standard
• Document changes routinely carried out in an unauthorized manner
• Critical purchases made from unevaluated suppliers
• Product shipped without required inspection and tests
Majors represent serious problems in the system that must be addressed with attention and resources on a priority basis. It puts the business at risk with customers and the Registrar.

ISO 9001 Auditor Training - Registrars will not certify a company if Majors exist. These must be addressed in a timely manner and to the Registrar’s satisfaction.

On surveillance audits, the registrar may threaten to suspend an organization’s certificate and later revoke it, if the organization fails to address the major, does not address it in a timely manner, or just superficially corrects it.

Between these two extremes a number of less serious nonconformities, when considered together, may identify a system failure and hence a Major nonconformity.

The auditors need to consider all the evidence available to see whether there a process or sub-system of the QMS is failing. It is the combination of all the evidence that will contribute to the informed judgement that the auditors will be required to present to the organization.

"Understanding ISO 9001" provides a detailed explanation of each ISO 9001 clause (requirements).

ISO 9001 FAQ provides answers to commonly asked questions about the ISO 9000 family of quality management standards.