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March, 2000

This Month's Feature:

Audit Preparation

Last month, we learned that lack of audit preparation was a major cause of auditing time constraints. This month we will examine how we can be better prepared, removing that auditing constraint.

Audit preparation can be broken down into four categories:

• Knowledge of the standard (requirements)
• Knowledge of policies, procedures, work instructions and records
• Checklist development
• Auditee Notification

Each of these is instrumental in starting an audit well prepared and ready to go. The absence of any one, severely impacts audit timing. Let's look at each, in turn, and find out how we can best use them to prepare for the audit.

One important note: audit preparation must be done in advance of the audit. In most cases, that means auditor must take time days ahead of the audit for preparation. This also means to be a successful auditor, you might have to do some of the preparation on you own time! Most professionals find themselves in this situation. This professional development preparation would include such items as reading books on auditing, as well as the following categories.

 Knowledge of the requirements

This is the greatest area that the auditor can impact on his/her own time. Although I do not recommend you attempt to memorize the standard, you must have at least a working knowledge of it. A working knowledge means more that just know what is where, it also means you must be able to explain what it means. The best way to learn the standard is to read it, and read various interpretations of it. This is one reason we include "Element Understanding:" in each issue. 

(Continued on next page)

Featured Book:
Title: Meet the Registrar : Firsthand Accounts of ISO 9000 Success from the Registration Source
Author: C. Michael Taylor
Publisher: ASQ
Notes:  C. Michael Taylor interprets the standards and helps explain what the registrar is looking for during an audit. Quality system elements are discussed, as are management review and quality planning. It includes sample auditing forms and checklists. (Notes from ASQ).

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

Tips/Tricks/Laughter:
Auditor preparation takes time, as we are finding out this month. Here is a tip that might just help. About a week before the audit, the auditor(s) and the management of the activity being audited meet to discuss the level 1 through 4 documentation that is used by that activity. The object is not to influence or bias the audit, but to explain how the activity carries out their part of the quality system. From this meeting, the auditor goes away with an understanding of the activity and a fairly in-depth and accurate checklist. The auditee leaves with a better understanding of what the audit is for, and what evidence will be required. If both parties remember the reason for the audit is to get a good accurate snapshot of the quality system, the meeting can be very productive.

Observations from the field:

Ensuring effective corrections to internal audit nonconformances is not always an easy task. Many managers seem to spend more time trying to argue the validity of the nonconformance than it would take to make the correction. One method that often works, is to train all management as internal auditors. This allows them to see the audit as the auditor sees it. It also enables them to find and correct problems prior to an audit. It also helps them understand why auditors need some time for audit preparation.

http://www.nsf-isr.org

internal-auditor.com

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March, 2000

This Month's Feature continued:

Knowledge of policies, procedures, work instructions and records:

Knowing your own policies, procedures and work instructions is also vital in proper audit preparation. The first step is to become familiar with the structure of the documents. Learn where the document identification, revision levels, and approvals are located. Your policies and procedures for element 4.2 should contain this information.

Checklist development

A good checklist is important to a good audit. There are many "canned" checklists available. Most registrars are more than happy to provide you with a copy of the checklist they use. Even with these, there is some preparation required. Checklists contain generic information. You must add questions that pertain to your own procedures and work instructions. In order to do this, you must have already completed the two earlier points.

 Auditee Notification

Proper auditee notification will result in the auditee being better prepared for the audit. This will result in less time being spent waiting for the auditee to "get ready". Depending on the department, such things as records may have to be pulled and available for the audit. The auditee should also be able to provide access to personnel.

 By following these simple steps, your preparation time should be maximized, and you can spend more time actually auditing. With experience, you will probably need less preparation time. You will also find time per audit and time for audit reporting will also decease. Without a doubt, audit preparation is the key to successful audits.

 Good Auditing!

Internal Auditor Resources:
There seems to be a lot of confusion concerning the new update to ISO 900x. Quest Analytical (one of our sponsors) has a very good page on ISO 9000:2000. Visit them at: www.iso-9000-2000.com. They do a good job of explaining the new revision, and what you may have to do [and more importantly--what you don't have to do] to comply with ISO9000:2000.
This site, and others can be located on our links page at: http://www.internal-auditor.com

Questions and Answers:
Q - How many auditors do we need?
A - There is no set amount of auditors required. You certainly need enough to ensure you can adequately audit the entire system to ensure effectiveness of the quality system. One rule of thumb is 1% of employees, with a minimum of three.

Element Understanding:

4.17 Internal Quality Audits [Part 5]

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