Process audits are highly focused, but their effective techniques are not always understood. Because there is no sanctioned process audit standard, anyone can claim to be doing process audits. Also, the use of process auditing techniques such as tracing is not limited to process audits or process-based management systems.

What Is a Process Audit?

A few years ago, when I was presenting information on process audits, a representative of a major corporation told me it had been doing process audits for several years. When I asked him to explain the auditors’ techniques, he said they took samples of the product at the end of the line, and then measured the length, diameter and weight. Based on results, they approved or rejected the lot.

Is that what a process audit is to you? I hope not, because what was described is more like final inspection or a product or service audit.

Two months ago, another representative of a major corporation explained its auditors did process audits and did not use checklists. She sent a document used to audit one of her corporation’s processes. The auditing documentation was not called a checklist but was a list of regulatory and industry requirements by clause for a specific process, such as labeling. That sure sounds like a checklist.

Is auditing a process by clause requirements or elements a process audit? Probably not because most standards and regulations do not consider the dynamic nature of a process. When the audit criteria are the specific requirements of a standard, only key elements or critical controls are verified.

Requirements may include:

• Written procedures
• Record keeping
• Verification of customer orders

A list like this does not include evaluation of inputs being changed into outputs.

Quality related definitions of a process, such as those found in ISO 9000 or the ASQ Glossary, as well as general dictionary definitions, support the dynamic nature of a process and what it would mean to audit a process (see “Definitions of Process”).

Definitions of “Process”

• A progressive forward movement from one point to another on the way to completion: the action of passing through continuing development from a beginning to a contemplated end: the action of continuously going along through each of a succession of acts, events or developmental stages: the action of being progressively advanced or progressively done: continued onward movement. Webster’s Third New International Dictionary, unabridged. Merriam-Webster, 2002, http://unabridged.merriam-webster.com, April 9, 2006.
• A set of interrelated work activities characterized by a set of specific inputs and value-added tasks that make up a procedure for a set of specific outputs. ASQ Glossary, www.asq.org/glossary.
• A set of interrelated or interacting activities that transforms inputs into outputs. ISO 9000, Quality Management Systems—Fundamentals and Vocabulary, third edition, 2005, clause 3.4.

Definitions of “Process”

• A progressive forward movement from one point to another on the way to completion: the action of passing through continuing development from a beginning to a contemplated end: the action of continuously going along through each of a succession of acts, events or developmental stages: the action of being progressively advanced or progressively done: continued onward movement. Webster’s Third New International Dictionary, unabridged. Merriam-Webster, 2002, http://unabridged.merriam-webster.com, April 9, 2006.
• A set of interrelated work activities characterized by a set of specific inputs and value-added tasks that make up a procedure for a set of specific outputs. ASQ Glossary, www.asq.org/glossary.
• A set of interrelated or interacting activities that transforms inputs into outputs. ISO 9000, Quality Management Systems—Fundamentals and Vocabulary, third edition, 2005, clause 3.4.

auditors use models and tools such as simple flowcharts, process maps or process flow diagrams.

In the process diagram (see Figure 1), the boxes in the center could represent a flowchart of the sequential steps. Flowcharts typically identify inputs, people, activities or steps, measures and outputs. The auditor normally gets this information from a procedure or flowcharts provided by the audited organization.

During the first part of the audit, auditors should record current customer names, order numbers, routing numbers and project numbers so they can link and verify process steps during the audit.

Processes can be described using the process elements I call PEEMMM (see Figure 2):

• People involved.
• Equipment needed.
• Environmental requirements.
• Measures to test or monitor.
• Methods to follow.
• Materials used or consumed.

The process elements are used to ensure all aspects of a process are being evaluated and serve as an aid in developing a flowchart. These same process elements (also called causal groupings) are used to create cause and effect or fishbone diagrams for evaluating the causes of problems.

A way to link the process elements and standard elements (requirements) is to create a tree diagram (see Figure 3), so named because of the branching effect.

Another tool is a turtle diagram (see Figure 4), which combines the process diagram with the process elements. It looks like a turtle with a head, tail, and four legs.

When auditing a process, the auditor should also look for the plan-do-check-act (PDCA) cycle, which is a good test to ensure the process can be controlled with or without a written procedure.

Auditors determine whether there is a plan or predetermined method—do people know how to do the activity, is there is a check or measure to determine acceptance and is action taken when outputs are not right? Typical interview questions are shown in Figure 5 (p. 73).

The use of process techniques is a natural steppingstone from conformance to performance auditing. When collecting evidence, auditors also will observe performance issues that would be of value to management.

Auditors should report process performance indicators that support improvement efforts. These include:

• Waiting
• Redoing
• Deviating
• Rejecting Traveling excessive distances

All process performance issues should support improvement programs such as lean, ISO 9001, or Six Sigma.

Most organizations still are auditing a process or a group of processes by element or clause and missing out on the value of process auditing and techniques. Process auditing provides added value by evaluating how processes flow, their controls and risks and the achievement of objectives.

Auditors and management can benefit by using process techniques to better test and evaluate system controls. For more information on process auditing, check the ASQ website (www.asq.org) for books, e-learning classes, and instructor-led classes.

REFERENCES

1. J.P. Russell, editor, The ASQ Auditing Handbook, third edition (formerly called The Quality Audit Handbook), ASQ Quality Press, 2005, p. 17.

2. Dennis Arter, Quality Audits for Improved Performance, third edition, ASQ Quality Press, 2003.

About the author

J.P. Russell is an ASQ Fellow and a voting member of the American National Standards Institute/ASQ Z1 committee. He is a member of the U.S. Technical Advisory Group to Technical Committee 176, the body responsible for the ISO 9000 standard series. Russell is the managing director of the internationally accredited Quality Web-Based Training Center for Education, www.qualitywbt.com, an online auditing, standards, metrics, and quality tools training provider. A former RAB and IRCA lead auditor and an ASQ Certified Quality Auditor, Russell is author of several ASQ Quality Press bestselling books, including Process Auditing Techniques; Internal Auditing Basics; ISO Lesson Guide 2015: Pocket Guide to ISO 9001:2015; and he is the editor of the ASQ Auditing Handbook.

Reader comment:

I participated in my first audit several months back and was so disappointed and felt the entire effort was a waste of my time and the auditees. It wasn’t a process focused audit, it was simply a waste. What is described here is exactly how I foresee proper audits being done… completed in a way that is not threatening to those being audited. The methods described here related to process improvement, I fully support this approach. –Megan, 06-06-2014

This article was first published in ASQ Quality Progress Standards Outlook column June 2006.

To develop process auditing skills, enroll in Process Auditing and Techniques from our course catalog: http://www.qualitywbt.org/catalog.aspx/catalog.aspx