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April, 2000

This Month's Feature:

Observations/Findings/Noncompliances

During the course of an audit, there are several terms that are used quite frequently. In many cases, they may also be used interchangeably. This, not being an English lesson is not going to focus on which term is proper and which is not. Instead, let's focus on what they mean to the auditor and the auditee.

• Methodology observation
• Quality audit observation
• Noncompliance observation

In October's issue, we looked at the various methods used to find objective evidence. One method discussed was observation. This relates to the methodology observation, listed above. Here we use the skill of observation to either confirm that the quality system documentation is being followed, and is effective, or confirm that a noncompliance issue exists.

According to ISO 8402 a quality audit observation is a "statement of fact made during a quality audit and substantiated by objective evidence." This could be an output of the methodology observation. Once again this is nonjudgmental. Statements of facts are used to judge, but they are neutral.

During the internal audit, we may find things that for some reason we can't judge, even if we are sure a noncompliance exists. Perhaps there is not enough information to make a determination, or perhaps the issue is out of scope (see January's issue).

(Continued on next page)

Featured Book:
Title: Quality Audits for Improved Performance
Author: Dennis R. Arter
Publisher: ASQ
Notes: A single source of information on the basics of quality auditing. It includes ideas and techniques, based on ISO 9000. Every step of an audit is covered and supported with examples, making this book an ideal reference. (Notes taken from ASQ)

You can order this book from internal-auditor.com at: http://www.internal-auditor.com/books.htm.

Tips/Tricks/Laughter:

Make a big deal out of internal auditing! If you place great emphasis on the internal audits, employees will tend to take them more seriously. By placing emphasis, I mean publicize it well. Ensure all personnel know who the internal auditors are, and where they will be. Special bump caps, and/or vests may also help. The object is to show everyone that internal audits are more than just a "necessary evil". If you view internal audits as just that, your quality system is in "BIG" trouble! Internal auditing should be viewed as a significant tool in your organizational growth.

Observations from the field:

In December's issue, we discussed one method to keep internal auditors. Here is another. Make internal auditing a big deal for the auditors. Don't just pull them off the line, have them conduct an audit, and return them to the line a couple of hours later. Give them time to prepare, and provide a tremendous lunch! Being an auditor is a major disruption, let them know you care, and appreciate their efforts. You might want to even consider arranging a special event now and then just for them! Also involve them in the internal audit planning and scheduling. Some companies also include them in the corrective action team. By making the internal auditing meaningful to the auditors and showing you appreciate their time, commitment and energy, you will be making major strides in keeping your internal auditors.

internal-auditor.com

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April, 2000

This Month's Feature continued:

Another situation may be that a situation is technically in compliance, but conditions exists which could lead to future noncompliance. In all three cases a noncompliance can't be written, yet the situation needs to be addressed. This is where the noncompliance observation is used. Unlike the methodology, or quality audit observation, the noncompliance observation is judgmental in nature. The key here is you want some type of action.

Findings:
A finding can also be several things. Mostly, it is the same as the quality audit observation. Another definition is a noncompliance issue. Once again, the first definition does not necessarily need addressing, where as the second requires action.

Noncompliances:

A noncompliance exists where there is a non-fulfillment of a requirement. This requirement may be regulatory, or possibly a requirement of the organization's quality system. This term is also identified as a nonconformance. This is a judgmental term, in that we are stating that the quality system, or part of it, does not comply with requirements. Action is required! Noncompliances must be substantiated with observations or findings, and backed by objective evidence.

Noncompliance may be classified based on severity. Major and minor are the most common classifications. It is important to note that there is no requirement to classify noncompliances. Some organizations deliberately avoid classifications to prevent the feeling of failure on the part of audited activities. Others use them to prioritize corrective actions.

Because of the various definitions of the above items, you might want to develop your own definitions. As you build your quality system and begin to audit it, use your definitions consistently. This should help eliminate confusion and lead to better corrective actions, and a more realistic quality system.
Good Auditing!

Internal Auditor Resources:
Discussion lists are invaluable resources. A discussion list is where a group of folks discuss, via email, various aspects of the subject matter. The ISO 9000 Discussion List is very profitable in learning about ISO 9000, its application, and auditing.
Everything you should know about the ISO 9000 list can be found at the following location: http://www.qualinet.com/listserv/about-iso9000.html.

This site, and others can be located on our links page at: http://www.internal-auditor.com

Questions and Answers:
Q - We are a small company and plan on performing our internal audits only once per year. At that time we would essentially close the shop for a day and conduct the internal audits. Could this be sufficient?
A - That's tough to answer, but on the surface, I would have to say no. Internal audits must be based on the "status and importance" of the area being audited. I do not think that once per year would satisfy the intent of this part of the element. I also don't think that once per year would meet the need of the quality system.

See December 1999's issue for more information.

Element Understanding:

4.17 Internal Quality Audits [Part 6]
" Follow-up audit activities shall verify and record the implementation and effectiveness of the corrective action...". This area seems to catch a few folks. Just what is meant by "Follow-up audit activities"? Each company, or auditor seems to have a separate interpretation. But basically this refers to those activities that follow-up an audit corrective action. This may include, but not limited to such activities as follow-up audits, formal corrective action close outs and post-corrective action meetings. The key here is to have a process that verifies the corrective action was implemented and is effective. This process needs to also generate some form of record. Next month we will discuss "...implementation and effectiveness...".

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