Essential Audit Questions




















Performance Improvement Solutions for Your Business Needs July 2009







In this issue



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Welcome to Sustaining Edge Solutions E- Newsletter



Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers.



If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know.



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Essential Audit Questions
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All experienced auditors have their own favorite questions to ask when auditing. Some auditors struggle with what are the most important audit questions to ask, including are my favorite questions providing the right objective evidence?

Let’s take a look at what audit questions can help to evaluate your organizations effectiveness and overall performance. The following are some valuable examples.

1. How do you access product or service requirements?

Everyone has a product or service they perform. It can be internal or external, and it can be as simple as passing it on to your fellow co-worker on an assembly line. Standards such as ISO 9001 require that product information, for example documentation be available at points of use. Having access to this information is extremely valuable and the ability to describe how the requirements are carried out.

Specific questions relating to requirements include:

  • Are the product requirements complete?
  • How do you ensure that correct versions are available?
  • How do requirements get reviewed prior to acceptance?
  • How do you know that the product meets the stated requirements?
  • What happens when changes are made to product requirements, and how are you informed?

2. How are problems identified and prevented?

Correcting a problem can be simple. Define, identify the cause, and take the necessary action. However, preventing it from occuring can be more of a challenge. Examples include:

  • How do you document problems/corrective actions?
  • How is the data reviewed and is trending being conducted?
  • How do you communicate ideas for improvement?
  • Are statistical methods being used?
  • How do you record preventive actions?
  • Do you use a formal problem solving method?

3. How are customer complaints handled?

Customer complaints do happen. Customer complaints represent a large risk as well as a valuable opportunity to improve the organization-it all depends on how the complaints are handled. This is especially relevant to “customer touch point” personnel such as sales people, customer service representatives, technical personnel, and top management.

The auditor must find proof of a systematic approach to dealing with complaints. This typically will include defined responsibilities for logging and tracking customer complaints (internal and external)clear problem statements with all relevant facts included, logical analysis and problem causes, and actions that address the causes. Here are a few related questions:

  • What method is used to capture complaints?
  • What tools are used to identify the causes of complaints?
  • What is the largest complaint category in your respective area?
  • How are personnel trained to prevent complaints?
  • How are customers made aware of actions on their complaints?
  • Has the number of complaints changed over time?

4. How does top management review the organization’s performance?

Top management should regularly analyze data and trends that show current performance. Is your company becoming more efficient, effective, more competitive, and better at pleasing customers?

ISO 9001 specifically requires management review, with defined inputs and outputs. This does not mean that a separate review is the answer. Creative companies integrate operational reviews and the more timely and action-oriented the review is the better the results. Here are some related audit questions:

  • Who is involved in reviewing the organization’s performance?
  • Are documented actions visible and resources identified?
  • Are comprehensive records kept and distributed?
  • Are all the required inputs and outputs addressed?
  • Documented evidence of continual improvement recorded?
  • How are all personnel made aware of the actions and decisions?

These process audit questions are just a few examples of what may work for your organization. The best questions for you to ask depends on your organizations priorities, risks, and customer requirements. Focus your audit process on what is relevant, and you will achieve tangible results.



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ISO/TS 16949:2009 Automotive Standard Published
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Developed by the International Automotive Task Force (IATF), the ISO/TS 16949:2009 standard, in conjunction with ISO 9001:2008, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products. It is applicable to sites where customer- specified parts, for production and/or service, are manufactured.

The revised ISO/TS 16949:2009 standard does not introduce any new or changed requirements from ISO/TS 16949:2002. The revision is based on the updates made to the ISO 9001:2008 standard. Minor changes were made to ISO 9001 to provide clarification, greater consistency, resolution of perceived ambiguities, and improved compatibility with ISO 14001, which relates to environmental management systems.

Also, the IATF Auditor Guide for ISO/TS 16949 Now Available from AIAG. Organizations can benefit from auditing competency criteria guidance originally developed for Certification Bodies and their auditors.

The Automotive Industry Action Group (AIAG) has been granted the rights to distribute the International Automotive Task Force (IATF) Auditor Guide for ISO/TS 16949 to companies worldwide. This document provides clear and concise details concerning how to demonstrate compliance to customer requirements established through the third party audit process.

To obtain a copy of ISO/TS16949:2009 and/or the IATF Auditor Guide for ISO/TS 16949, visit the (AIAG) Website.



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ASQ 2009 Service Quality Conference
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The American Society for Quality (ASQ) is holding its 18th Annual Service Quality Conference on October 5- 6, 2009 in Long Beach, California. The conference theme is Service Quality: Surviving the Economic Storm.

It is a challenging time for you and your organization. You’re competing in a shrinking marketplace, and you have fewer resources at your disposal. How can you attract new customers, keep your current customers, and improve your bottom line?

Walter Tighe, President of Sustaining Edge Solutions, is a speaker at this event. The topic of the presentation is “Finding lost profits in your service processes”. A detailed agenda is being created by ASQ and we will provide an update in next month’s newsletter.

Conference registration is $400.00 per ASQ member, for early bird registration good until July 31, 2009. Click here for on-line registration and information.



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Measurement Processes and Quality in Education
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All the quality processes in the world won’t help a company whose measuring equipment and measurement processes are out of control. Especially in manufacturing, maintaining accuracy in measurement equipment is essential to ensuring a quality end product.

ISO 10012 specifies the requirements for a measurement management system that can be used by an organization performing measurements as part of the overall quality management system, and for ensuring that metrological requirements are met. To help users get the best out of the standard, the requirement clauses are followed by text boxes containing relevant guidance.

ISO 10012, Measurement management systems – Requirements for measurement processes and measuring equipment, can be used by organizations to meet the requirements for measurement and measurement process control in ISO 9001:2000 (Quality management systems) and ISO 14001:2004 (Environmental management systems) – although its use is not a requirement of either – or it can be implemented independently of these standards.

The standard will prove useful when customers and their suppliers need to specify product characteristics, as a technical reference underpinning legislation and regulations, and as a tool in assessment and auditing of management systems. However, its use in third-party certification is not a requirement, but a matter of agreement between the interested parties.

Quality management for the education sector.

ISO has published specific guidelines for organizations in the education sector wishing to benefit from the implementation of ISO 9001:2000, the improved version of ISO’s quality management system standards.

ISO/IWA 2: Quality management systems – Guidelines for the application of ISO 9001:2000 in education, contains the full text of ISO 9001:2000, followed by specific text making the standard easier to understand and implement in the education sector.

While ISO 9000 users already include educational establishments of all types, the guidelines are aimed for organizations at all levels, providing all types of education, including: elementary, medium and higher; special and adult education; distance and e-learning.



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Training Courses
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training

To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units.





NEW: Web-Based ISO 9001 and 14001 training starting later this month!

Understanding & Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor

Documenting Your Quality Management System



Understanding & Implementing AS9100B:2004

AS9100B: 2004 Process Based Internal Auditor

Documenting Your Quality Management System



Understanding and Implementing ISO/TS16949:2002

ISO/TS16949:2002 Process Based Internal Auditor

Documenting Your Quality Management System



Understanding and Implementing ISO14001:2004

ISO14001:2004 Process Based Internal Auditor



The Five Pillars of a Lean Workplace Organization

Continuous Process Improvement

Lean Six Sigma


All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?



Contact Us




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