Tag: qa

5W2H of Process Audits: What You Should Know

We’ve used 5W2H to discuss Product Quality Control before, and now we’re using this popular tool to provide insight regarding process audits.



Quality auditors are often certified and/or have other applicable training specific to the types of audits they perform.

Quality auditors must be professional, ethical and objective. They must be able to select appropriate quality and auditing tools and techniques and use them effectively in a variety of applications. In addition, they must verify, document and communicate results.


Per the ISO 9000 Quality Management Systems standard, a process is referred to as “a set of interrelated or interacting activities that transforms inputs into outputs.”


Auditors visit the supplier. Time on-site is allocated to observation and interviews.


According to Harvard Business Review, “in virtually every industry, companies of all sizes have achieved extraordinary improvements in cost, quality, speed, profitability, and other key areas by focusing on, measuring, and redesigning their customer-facing and internal processes.

Benefits of a process audit include:

Conducting an audit is perhaps the most effective way to gain insight into the inner workings of your business.

An audit will help you identify strong points and areas of weakness within your business, making it much easier to form a strategy for improvement and increased productivity.

Identifying defect opportunity points in the production process, enabling the creation of preventive measures to reduce the potential for nonconformities.

Evaluating process inputs and outputs allows for continuous improvement, higher quality and increased efficiency (reduced cost).


Jean Champlain, Pro QC’s Supplier Development Manager in Ningbo, China, identifies process audits in two ways. He first references a standard called VDA 6.3 that provides more detail regarding what a process is and how it works. Originally used in the automotive industry to support ISO/TS 16949, the following networks of processes were defined with each process having inputs and outputs. Processes are linked together in such a way that outputs from one process could be inputs for another process.

Process examples:

Employee Hiring
Employee Training
Vendor Selection and Management
Product Realization
Equipment Maintenance
Incoming Inspection

The requirement of process approach in ISO/TS 16949, for example, is that each process should be clearly identified in such way:

a) Inputs (What does this process need?)
b) Methods (How does it work? Work Instructions)
c) Monitoring (How do you control the performance?)
d) Responsible (Who is in charge of this process?)
e) Equipment (What tools are needed?)
f) Outputs (What is the expected result of this process?)

The second way in which we refer to a process audit is with a customized evaluation we designed to meet client needs. Our Manufacturing Process Audit focuses on processes that are more directly involved in the manufacturing of a specific product. More specifically, using our client’s specifications and drawings, we follow the manufacturing line step-by-step and check that each process is clearly identified and structured in the manner to produce the expected output, while identifying potential defect opportunity points throughout the process stream.

Understanding processes so that they can be improved by means of a systematic approach requires the knowledge of a simple kit of tools or techniques.

Quality tools frequently used include:

Cause & Effect Analysis
Pareto Analysis
Control Charts
Process Maps
Scatter Diagrams
Force Field Analysis
Statistical Process Control (SPC)

How Much?

Process audits vary depending on the time required. Variables include the size of the facility, process complexity, quality of existing documentation, etc.


For a more detailed quotation, contact us directly. Sample reports are also here.

This article was originally posted to Pro QC’s newsletter, V9I2. Due to positive feedback received, we have reposted here to our blog.

Pass the exam! Certification study tips…

passExamWe place significant value on industry certifications and actively look for engineers that have various quality related designations.

I recently volunteered to assist others during a local ASQ certification exam study session and noted the following tips to help ensure success:

Take the pre-test. Assess your strengths and weaknesses ASAP.

Most certification exam study guides offer example tests. Taking this as early as possible provides a realistic assessment of what you know and don’t know. It’s easy to be overconfident about how much you think you know, or get caught in the trap of focusing your studies on what you’re comfortable with.

Work out a study schedule to take you through to the exam date.  Set reminders in your calendar.

Most times, trying to “fit” studying in doesn’t work for people who already have a busy schedule.  But, setting appointments for yourself to study and organizing all of your efforts through to the exam will alleviate some of the anxiety caused by not being able to make time.  Use the exam’s body of knowledge and your pre-test results to organize your efforts.

Organize your study materials.  

Many exams allow you to use study materials during testing.  This can be a weakness to some who feel it will be an easier test.  Rather than highlighting and putting tabs on too many things, only make standout a few key areas where you know you’ll need help.  Also, remove the index.  Putting this next to you during the exam will save time and frustration from flipping back and forth.

Spend time reviewing the information with others.  Organize a study session.

Studying with others is beneficial for many reasons.  A big one is that it’s a motivator.  That alone is worth it.  But, also allowing yourself to openly discuss the body of knowledge for the exam and go over example questions requires work from more areas of your brain, which ultimately helps with understanding and retention. Organize a study group with your coworkers that may also be taking the exam, through the local association section/chapter, or even LinkedIn.

Review sample exam questions during scheduled periods of time.  

Don’t use all of your allocated study time to read the study guides.  Spend more time answering example questions so you can understand how they are asking the question and how they determine what the right answer is.  Many industry certification exams require much more than memorizing terms.  It’s the application of the concept that’s important to understand.

Take care of yourself.

It may sound obvious, but it’s easy to get caught up in the stress of things and cram the few nights before the exam or skip a meal here and there right before.  Exercise, sleep, and nutrition play a critical role in the brain’s ability to do its job.  Research supports that even 20 minutes of exercise right before an exam can boost your score.

Have fun.

It’s all about perspective.  And, it can be said that perspective does play a role in the result.

Top 5 – Quality Resources that Educate & Inspire

We’ve given some thought to quality resources we find particularly useful and that both educate and inspire…  Here are our top five:

American Society for Quality > Quality Tools

  • ASQ offers comprehensive content relating to various quality tools, conveniently organized by function.  You’ll find everything from histograms to stratification.  Regularly browsing through the tools is a great way to get inspiration for data analysis or better understand an existing collection.  The Knowledge Center is invaluable!

Chartered Quality Institute > Knowledge Hub

Lean Enterprise Institute > Webinars

  • LEI’s website offers a great deal of content relating to all things lean… They proclaim to try and answer the simple question of every manager, which is “What can I do on Monday morning to make a difference in my organization?”

Khan Academy 

  • This site has an amazing collection of videos… over 3000 in fact! While topics range from science to humanities, the math videos relating to statistics and probability are particularly helpful for those in the quality industry.

The Quality Toolbox

  • This is the one quality book you can’t do without.  It’s everything you need… and more.

And, we’ll add one extra invaluable resource to the mix…

Pro QC International > Quality Resources

  • We’ve tried to organize  resources accessible directly from our site.  We’ve incorporated quality terms, sampling and defect classification information and more. We are also working on a collection of educational videos addressing the most common questions we receive.

Ever wonder what happens during a product quality inspection?

Pro QC’s Shenzhen, China office provides an on-site demonstration of in-process and pre-shipment quality inspections.


Comments and suggestions are always welcome and appreciated!  Our goal is to provide valuable content to those interested in learning more about quality related concepts and processes that we have over 20 years of experience providing.