Effective Process Audit Questions

 Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                                 March 2014


This Month
* Effective Process Audit Questions
* Common Myths of Management Systems
* ISO Six Sigma Improvement Methodology
* In the News
* Training Courses




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Our newsletters provide information on business management systems and process improvement methods.  These systems include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard, and others.  Subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions regarding content, or have a subject of interest for a future newsletter, please let us know.   

Effective Process Audit Questions           

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. This can include are my favorite questions providing the right objective evidence?


1. How do you access product or service requirements?


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

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 occurring 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.

Looking for more effective audit questions, contact us


 Common Myths of Management Systems                  


An article written by Mark Ames discusses the many myths and misunderstandings related to the implementation of management system standards such as ISO 9001. Belief in these myths is the most common barrier to the use of management system standards and, in addition, the greatest cause of frustration and diminished benefits on the part of users. 

Understanding these myths can help organizations choose to adopt a management system and ultimately achieve the intended benefits embedded within all management system standards. The purpose of the article is to identify and debunk the most common myths surrounding management system standards.

Management systems don’t add value but I have to have one because my customers want me to have one.

Management systems provide bottom-line cost savings and improved profitability and performance through embedded preventive practices. Organizations of any size performing activities of any kind that are considering adopting a management system standard can expect to see increased value to customers and greater return on investment through appropriate discipline and communication.

Points to consider

  • Management systems help organizations avoid mistakes and save resources, time, and money.
  • Organizations that are not achieving value from their management systems may not be clear on their true purpose and may be just going through the motions.
  • Excessive documentation can and will reduce the management system’s value to the organization and its customers and should be considered counterproductive.

Management systems are a net cost to my organization.


Studies have shown that preventing a problem is less expensive-and in many cases much less expensive-than dealing with the consequences after a problem occurs. If an organization implements a management system standard and its net cost increases, the organization needs to examine and reconsider its approach to implementing the management system.


Points to consider

  • Excessive costs associated with management systems often come from an organization’s failure to take ownership of the completed management system. This is particularly true if there is a lack of ownership on the part of top management.
  • If you create a system that you are unwilling to work with on a daily basis, it will provide little or no value, and, in fact, may be a net cost to the organization.

Management system standards do not allow my organization to be flexible and innovative.


During management system implementation, the organization will need to make decisions that allow it to remain flexible where flexibility is important, while at the same time providing enough structure to ensure good discipline where discipline is needed.


Point to consider

Management systems are written in a way that serves any organization. If an organization has an inflexible management system that ties the organizations hands, it is because the management system was created that way. Careful decisions are required to balance the need for discipline and structure on one hand and the need for flexibility on the other.


Management system certification is not required; therefore, my organization doesn’t need it.


Management system standards contain a collection of best practices that have evolved over the last 200 years. Management systems provide a pragmatic, systematic methodology for organizations, helping them achieve results for themselves and their customers. Certification of a management system by an internationally recognized accreditation body (such as the ANSI-ASQ National Accreditation Board-ANAB) will verify the successful adoption of the imbedded preventive practices and will foster confidence in customers and stakeholders.


Points to consider


Management systems provide a clear path and associated transparency related to an organization’s methods, measurements, and results, thus providing confidence in the organization’s ability to meet both customer and legal requirements. It is likely that management system standards will become increasingly important in the future because they provide:

  • A proactive methodology for meeting legal, regulatory and other related obligations.
  • Internal financial and other benefits associated with the preventive practices embedded in each management system standard.
  • Benefits to customers, stakeholders, and the broader marketplace that is communicated when the certification is issued by a certification body accredited by an internationally recognized accreditation body.


What your organization should not do.


Your organization should not implement a management system and associated procedures just because they have been developed and successfully used by another organization. No two organizations do things in exactly the same manner. What works for one organization will not achieve the same success for another.


The worst-case scenario is that you use and implement a documented management system that another organization has used. This system does not represent your organization, its language, or how you deliver your products and services. This type of method will only confuse your personnel and decrease its purpose and value; including increasing your operating costs.




Put simply, management systems prevent problems. They work efficiently and effectively whenever organizations can get past the myths addressed in this article. A clear understanding that the end result may be a fundamental change in how the business operates will help organizations make the transition from reactive management to preventive management. Use of management systems standards and the associated accredited certification process should reduce costs, improve results, improve customer satisfaction and provide confidence to customers, stakeholders, and organizations. 


ISO Publishes Six Sigma Improvement Methodology              


We recently found that clients are not aware of this document and want to take this opportunity again to inform our readers about these important documents available.  

Six Sigma is a data-driven method for improving business and quality performance, has been published as a two-part ISO standard.

Six Sigma was originally developed by Motorola in 1986 to ameliorate manufacturing processes with the goal of products free of defects (i.e., 3.4 errors per million). Today, the methodology is applied in many sectors of activity by organizations large and small for all types of process and services to:

  • Drive process improvement and make statistically based decisions
  • Measure business results with a level of reliance
  • Prepare for uncertainty
  • Combine high returns and benefits in the short, medium and long-term
  • Remove waste, defects and errors.


Although Six Sigma has existed for some time, bringing its best practice together under an ISO standard helps solidify and consolidate the methodology. The ISO brand is respected and recognized worldwide, and thus provides an added layer of confidence. Moreover, publication of Six Sigma methodology in an ISO standard will boost international uptake of the methodology in a coherent form, reduce fragmentation, and provide users with harmonized best practice,” concluded Dr. Boulanger, President of JISC-Statistics and co-chair of the subcommittee that developed the standard.


The new standard, ISO 13053:2011, Quantitative methods in process improvement – Six Sigma, deals exclusively with the application of Six Sigma to ameliorate existing processes and is published in the following two parts:

  • Part 1: DMAIC methodology, describes the five-phased methodology DMAIC (Define, Measure, Analyze, Improve and Control), and recommends best practice, including on the roles, expertise and training of personnel involved in such projects.
  • Part 2: Tools and techniques, describes tools and techniques, illustrated by factsheets, to be used at each phase of the DMAIC approach.

Both documents can be applied to all sectors and organizations. You can purchase the standard by your country through the ISO Website.  

In the News      

Aerovation, Inc.  Achieves ISO 9001 Certification


We are proud to announce that our client Aerovation, Inc. has achieve ISO 9001:2008 certifcation.  Aerovation, Inc. located in Tucson, Arizona has provided technical expertise since 2000 in Aeronautical Engineering, Aircraft Development, Aerospace Structures and Systems Testing, Aerospace Propulsion Systems Testing, Aircraft Modifications, and Mission Systems Integration. A successful certification process was achieved with National Quality Assurance, (NQA) one of the largest and most respected ISO registrars in the world. For more information regarding Aerovation, Inc. services contact Paul Finn, President.

FDA Inititiates Supply Chain Pilot Program

The U.S. Food and Drug Administration is announcing the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.

The goal of the program is to enable the FDA to evaluate resource savings that will allow the agency to focus imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply.

For more information visit the FDA Website.

Manufacturing Technology Orders End 2013 on Strong Note


December U.S. manufacturing technology orders totaled $491.89 million according to AMT – The Association For Manufacturing Technology. This total, as reported by companies participating in the USMTO program, was up 9.9% from November and up 11.8% when compared with the total of $439.90 million reported for December 2012. With a year-end total of $4,939.58 million, 2013 was down 5.1% compared with 2012.

For information on U.S. manufacturing orders by region visit the AMT Manufacturing Website.

Training Courses

To see the course description, schedule, and on-line registration click on the course title below. We deliver onsite training for all these courses and customized training to fit your specific needs.  We offer group discounts.  


View all our Courses

View Our Web Based E-Training Courses   

ISO 9001 Quality Management

Understanding and Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor 

Documenting Your Management System

AS9100 Aviation, Space and Defense

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100C:2009 Process Based Internal Auditor

Documenting Your Management System 

ISO/TS 16949 Automotive

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System 

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI 

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor 

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor 

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

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One Response to “Effective Process Audit Questions”

  1. It’s good to know that one organization shouldn’t use a management system just because it worked for another organization. According to my knowledge, it’s important for ISO professionals to use trainings and continuing education so they can constantly use modern methods to improve management systems. Your article explained complicated aspects of ISO in a clear and concise way, so thanks for sharing!

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