Featured Book of the Month:

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)

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

This Month's Feature Article

When we think of internal auditing, we tend to think of auditing a single building. Most manufacturing companies are single-site facilities, although many have several buildings, they are still really single sites. Typically, the auditors know the auditees, the processes and activities that are being audited. Objective auditing can be difficult. 

Multi-site auditing is usually far different. Many of the internal rules that you apply to regular internal auditing are not applicable with multi-site internal auditing. It is common for the auditors to have little contact with the auditees prior to the audit. Many of the processes and activities are new to the auditors and they may have limited exposure to audited site. In some cases, the site might be in another state, or even country. Because of this, auditing multiple sites might be closer to 2nd, or 3rd party auditing. In every case, the internal audit contains the same three major components:

• Audit Preparation

• Audit Conduct

• Audit Reporting

Let's look at each of these and see what an internal auditor needs to do in order to have a successful and effective internal audit of multiple site.

Audit Preparation:

Every audit needs adequate preparation in order to be successful. The auditor must be familiar with the audit criteria (the standard, the organizational documentation and any other requirements that will be used to determine conformance), auditing methodologies (interviewing, observation and examination), and of course the processes of the activity being audited. When auditing multiple sites, you need to be familiar with the documentation and records of the site you are auditing. Many companies have variations in documents from one site to another.  Maintaining a separate file for each site could be a great help remembering which site has which documentation. 

Audit preparation actually occurs both at the auditor's home site, and the site to be audited. The level of preparation at each site will differ depending on how much information is available at the audited site. Normally audit preparation at the auditor's site (off-site) will be limited to understanding the higher level documentation (level I and level II). Checklists can be partially developed at this time as well.

Once the auditor arrives on site, there will still be some preparation required. A review of documents not available off site may be necessary. Also, the audit plan might not be finalized until the opening meeting. Final checklist revisions might be in order as well.

One last thing in multiple site internal audit preparation. There will undoubtedly be more coordination and communication between the auditor and the auditee. This is even more important if overnight lodging, or transportation arrangements must be made. 

Audit Conduct:

Conducting the audit will be much the same as with a normal internal audit with one exception. The auditor will probably not be as familiar with the activities and the employees as they would be auditing their own site. This may not be a problem. In fact, it might be advantageous because it helps remove bias in auditing. 

A good place to begin the audit is to perform what many auditors call "the drive by". When you first arrive, drive around the lot, paying attention to the shipping/receiving areas. Look for things that seem out of place, or where it seems there has been an unusual amount of recent activity. These are clues.

Normally, the opening meeting is a bit more formal during than a normal internal audit. The audit itself is not really much different. The same audit techniques that are used in normal internal audits still apply. Here  however, until the auditees are used to your auditing style, and until you are used to the auditees, you might have some trouble getting them to open up to you.

One last thing about conducting the audit. In many cases, the auditee thinking is that you represent a higher level of management and they might be a bit suspicious. They might perceive that you are a "spy", and that may take time to overcome. Do not fall into the temptation of "letting things slide" to get on their "good" side. Protect the integrity of the audit.

Audit Reporting:

Here again, the primary difference in auditing multiple sites is that the audit reports tend to be a bit more formal. In many cases, the closing meeting is considerably more formal as well. One thing to be careful here is to make sure the audit report gets completed in a timely manner and distributed appropriately. Also, make sure there are no surprises in the report.

Summary: 

Auditing multiple sites requires different resources than auditing your own site. Auditors that might be great at auditing the "home" location, might not do as well auditing a remote site. The rules are the same, but the practical application might be different. Auditing multiple sites can be rewarding, and effective, if approached correctly. Don't go in with a "better than you" attitude. Be sincere, be professional, be yourself. 

As always...Good Auditing!

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www.nsf-isr.org

Q – Do my internal auditors need to be formally trained?

A – It depends on several factors. First, and foremost, do they need to be formally trained? If using internal auditors that are not formally trained will result in your internal audit program not achieving its goals, then they require formal training. Now, this next part is a bit tricky. If you are ISO/TS 16949:2002, and if you have either Ford, or GM as one of your customers, they have specific requirements regarding the training of internal auditors. In any extent, your internal auditors must be competent, which is a different requirement than just being trained.

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With ISO 9001:2000 and ISO/TS 16949:2002, you are required to do a lot with your processes. Most organizations elect to "map" their processes as a method of meeting the requirements. But take your "map" deeper. It would not take a lot of additional effort to develop what metrics you would use to determine process effectiveness and efficiency. You can build them into the process map.

Also, this would be an ideal time to develop the checklists necessary for auditing the process. It would make auditing the process much easier and would allow the metrics to be rolled into the checklists. It builds harmony within the QMS and makes the QMS much more real.

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ISO 9001:2000 Clause 7.2.3 Customer communication

"The organization shall determine and implement effective arrangements for communicating with customers in relation to

a) product information,"

"Product information" is a critical part of the communication between an organization and its customer(s). In making the "effective arrangements" for communication, the organization must first understand all of the points in which there is communication (in either direction) regarding product information. We tend to think of only the sales, or complaint ends, but it goes much deeper than that. At what stages, and at what points at each stage does the customer communicate product information to us, or we to them. Your arrangements must include all potential instances of product information communication.

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September 2002’s question:

You are auditing the process for handling nonconforming product. The Quality Engineer keeps meticulous records on nonconforming product disposition. You notice it is common for a part to be disposition as conforming. When asked about this, the Quality Engineer states that sometimes the gauges erroneously fail good parts. Evidently she sees a change in your facial expression and quickly adds that because of the manner in which the gauge errors it will only fail good parts. It is physically impossible for the gauge to pass a nonconforming part. When the gauge does fail a good part, the gauge is adjusted, and records are kept.

The answer:

This is a complex issue for a couple of reasons. First deals with the audit scope. Can we check out a calibration and accuracy issue if we are auditing nonconforming product? This is a political issue that each company would have to resolve. If it is out-of-scope, you might only be able to write an observation and hope that it gets addressed. If it is within scope, then you will be able to deal with it.

The second issue is the gauge itself. Part of the question here is: "Can the gauge be trusted?" Inspection records should verify the claim that it only erroneously fails good parts. The records could also indicate whether it indeed has passed nonconforming parts. If any passed nonconforming parts are discovered, then there is a serious problem. If there is no evidence of passing nonconforming parts, then the gauge still needs to be evaluated for effectiveness and suitability. This could be the difference in whether it is a nonconformance, or just an observation.

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Independence Day

Here in the US, we celebrate Independence Day (July 4th) this month. This is the anniversary of day we declared independence from England back in 1776. It is, as you can imagine a national holiday. Independence Day is important to this country, and its citizens. But the notion of an "independence day" falls into just about every aspect of our lives. Immigrants often refer to their "independence day" as the day they arrived in this country. Many individuals celebrate an "independence day" the day their credit cards are finally paid off. My daughter claimed June 22nd, as her "independence day", because she finally became 18 years old (30 years from now, she might think otherwise). 

Many QMS' also have an "independence day". One company I consulted with declared their independence on the last day of my contract. Now, the QMS was totally theirs and I was out of the picture. They did not need me anymore It was planned that way from the start. Companies should not need consultants to hold their hand forever. The plan should always be for the company to accept ownership and control over the QMS and make it work for them. Alas, many companies have dependent QMS'. They are dependent on outsiders and are stifled by lack of company ownership. Some have no ownership, which is worse.

As auditors, we are commissioned to find areas where our QMS is dependent and help find ways to liberate the QMS so it can achieve the beneficial results we need. Help your QMS celebrate its "independence day"!

Dave

...Good auditing!

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Because this site uses information from many different sources, it must be pointed out that any advice, tips, information, etc., provided should be regarded as opinion and not fact! What works well for one company may be a disaster for another. Also, what one registrar, or auditor may allow, another may not. As always, reflect on what you read, see if it fits into your own quality system, and if it conflicts with your auditor...you've got to make a decision