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November, 1999

This Month's Feature:

Audit Scope and Sample Size

Internal Audits are forms of samplings. When we perform an internal audit, we usually do not look at all the records. We select a sample and examine them. If we are auditing 4.18 (Training), we probably would not look at every training record, there wouldn't be enough time. Instead, we examine a predetermined amount. We might even predetermine whose records we will open.

Scope:
We base our scope on various parameters. The most common are:

  1. Time
  2. Status
  3. Importance
  4. Resources
  • Time:

Time is the greatest enemy to internal audits. February's issue is dedicated to Time Management. Time is also the largest constraint on audits. Most organizations could not afford to have internal auditors examine every piece of objective evidence. Most internal auditors also have other duties that must be performed. They would not have time to do both, if they had to audit everything.

  • Status:

As time goes by, and audits are performed, it becomes clear that certain activities are having trouble staying in compliance. This is also evidenced by reject rates, customer complaints, scrap reports, and the like. Audits for activities like these must be thorough enough to guide the activity back into compliance…and beyond.

  • Importance:

Some activities are more critical to the operation than others. A failure in these areas may have catastrophic results on product, or customer relations. These activities also require a deeper audit.

Resources:

(Continued on next page)

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Title: Internal Quality Systems Auditing

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Notes Professional guidance for managing and performing effective and efficient internal quality system audits. This book addresses who does what, why, when and how.

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

Tips/Tricks/Laughter:

"After several rounds of non-conformance free internal audits in a particular department, the Lead Auditor schedules an impromptu internal audit. However, at the scheduled audit time, the entire internal audit staff, and the plant manager throw a mini-party for the department. They bring a cake of congratulations, pizza, and soft drinks to show the department how much they appreciated the continued hard work."

Don't be afraid to show activities that clearly take the quality system to heart, that you appreciate their efforts. It doesn't have to be a party, but it should be something worth while and meaningful for that activity. What ever you decide to do, it is vital that management with executive responsibility be visibly involved.

One last thought: Although we will take up audit scheduling later, never, never, never use impromptu audits to "catch" activities! You will destroy any credibility your system may have.

Observations from the field:

Send out checklists to the auditee prior to the audit. This will enable them to understand what the audit will be looking for, and to help identify the objective evidence required. The auditee can also use the checklist to help write procedures, work instructions, etc., in making changes. The checklist can also be invaluable in preparation for second, or third party audits.

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You can be a part of internal-auditor.com. Your submissions help make this publication work. You can send all contributions to: David Bradley, Ruth Ellen Carey Communications, 3698 Heathwood E., White Lake, MI 48383 USA. You can also email them to contribution@internal-auditor.com. If we use your contribution, we will either provide you with a free on-year subscription, or extend your subscription for one year. Good Auditing!


internal-auditor.com
www.internal-auditor.com

a function of the Manufacturing and Industrial Resource Center
www.rec-communications.com

Page 2 of 2

November, 1999

This Month's Feature continued:

Resources:

Internal Audit resources also determine the scope of an audit. Time, personnel, distance to the audit, all have an impact on how much auditing can occur. If your auditors are well trained, and experienced they might be able to audit an activity with less resources than an untrained and inexperienced group of auditors.

Sampling:

Each of these items play an important role in determining audit scope and sample size. But there is more than just those. There are two types of audits. Each are determined by the sampling size of the audit.

  • Vertical Slice:

A vertical slice audit is one in which the audit is very focused on one thing. Perhaps one part of an activity, or perhaps only one element within an activity. In this audit, the sample size is large, but relatively few sample groups are taken. For example, you might check every print being used in a department. The sample size is 100%, but only one group was selected.

  • Horizontal Slice:

A horizontal slice audit is one in which the audit is sampling a wide number of requirements, but not spending a lot of time on any one requirement. The size of the individual sample is relatively small, but many sample groups are taken. An example of this type of audit would be a department audit of all related elements, or perhaps auditing 4.5 throughout all departments. There is not enough time to check everything, so sample size is kept small. The difference here would be, for example only checking one print throughout the entire facility (ensuring you are using the same version of the print).

Each of the above determine our scope and sample size of our audits. As auditors, we need to be aware of the scope, and the sample size. This will ensure we audit to plan and schedule. It will also lead us to audits that move our organizations in a direction of continuous improvement.

Internal Auditor Resources:

The American National Standards Institute, or ANSI, has an online method of providing information on the latest national and international standards-related activities. Their site address is:

http://web.ansi.org/.

If your QMS is based on QS-9000, you need to check out the Automotive Industry Action Group. They are the information and education arm for QS-9000 requirements. They can be reached at:

http://www.aiag.org/

Questions and Answers:

Q-Where can I get formal internal auditor training?

A-Most consulting companies, and some registrars offer training for internal auditors. Internal-auditor.com may offer some form of training in the future. Your best bet may be to contact your local MEP center. Most of them offer courses in internal auditing without heavy pushing of additional sales. Keep in mind that formal training is not required, but usually recommended for effectiveness.

Q-How do I get certified as an internal auditor?

A-First of all, you do not need certification...only trained. If you desire certification, or if your employer requires it, visit: http://www.internal-auditor.com/ home page. We have more information and links there.

Element Understanding:

4.17 Internal Quality Audits [Part 2]

"…and to determine the effectiveness of the quality system." Last month, we discussed "planned arrangements". We mentioned that the planned arrangement were elements of your quality system. Audits are more than verification of the system. This is the continuous improvement section. If your quality system is effective, there would be evidence that quality goals are being met, and those goals are updated to reflect the "raising of the bar". Key measurables, such as reject rates, customer complaints, internal corrective action requests, quantity and severity of nonconformances are all indicators of effectiveness. In order to have an effective quality system, all of the above must show continual progress.

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Last updated: March 30, 2002.