Shifting the Audit Process Paradigm by Chris Harbeck  

The current paradigm is that auditing is a process of deficiency: “What are the non-conformances?”  Audit summary reports rare;u provide much information beyond that.

In the performance of a Quality Management System audit, the auditor reviews a company’s various processes and assesses compliance to the applicable Standard, as well as the internally documented procedures.  The documented procedures themselves are also reviewed for compliance. Once complete, the auditor prepares a summary report.  In the closing meeting, the auditor lists the findings noted in the report (which are invariably only non-conformances), and then goes on to elaborate on them.  People will leave such a meeting with a bit of a negative outlook, and an appreciation that the audit is over.

But I’m sure that for all of the “deficiency” findings that are realized and discussed, there are at least as many activities that are being performed very well.  Some examples include:

  • Overall record maintenance and availability (acting as evidence) might be strong;
  • A consistency of processes and records in various manufacturing areas that lead to more efficient and effective management;
  • Methods for data collection and review that lead to meaningful improvements, either at the process level or at the company level;
  • Processes and record-keeping for Management Review, Internal Audits, Corrective Actions, and so on, that are effective and are properly maintained through to evidence of proper closure.

Discussion of these strong points would be just as valuable to an organization as discussing non-conformances.

Consider this analogy:  When you go visit your Doctor, and he says “You are sick, take this medicine”, you may leave with a negative feeling that you should be taking better care of yourself.  But if the Doctor says “You have a flu bug, and here is some medicine.  However, your blood pressure is good, your heart rate is good, your blood tests came back normal, and your cholesterol is good.”, then you are likely to leave with a better attitude that you are taking good care of yourself, but just need to get rid of the flu.

The term “Audit” should be replaced with “Assessment.”  Just like at the Doctor, when someone assesses your Quality System, you want to know the overall health of the system, not just a list of some (particularly minor) non-conformances.  No one looks forward to an audit if it is purely a deficiency process, and employees are likely to spend all of their energy making sure nothing is found to be wrong.  However, what if half of that energy could be spent on showcasing and expanding on what is done well, knowing that these activities would be reported on as well?  Just think of the improvement in attitude and process development that could happen if this were the case!

Performing and reporting an audit can be a self-fulfilling process.  Focusing only on deficiency may not break a cycle of negative results.  However, equal focus on positivity may increase activity that leads to further positive results.  I strongly believe in the importance of maintaining an audit process which assesses the overall health of the system, and highlights the good along with the not-so-good.

I believe that an organization’s Internal Auditors should practice this technique.  I am also hoping that certification bodies will begin to realize this as well, and will develop their auditors to provide an organization with a complete picture of how their Quality System is performing.  The organization will certainly appreciate it.

Audit results that characterize the full health of the Quality System could strengthen the partnership between an organization and their auditor.

 

C harbeckChris has 22 years of experience in Quality Assurance and Engineering, mainly in the plastics industry, with product lines that include Consumer Products, Home/Office Products, Lighting, Medical Devices and Automotive.  Chris is a certified Lead Auditor with valuable knowledge in the development, implementation, and maintenance of ISO9001 compliant Quality Systems.  He closely followed the changes that were incorporated into the new 2015 revision, and provided consulting services for beginning the transition within an organization.  Chris is currently gaining experience in the BRC Global Standard for Packaging and Packaging Materials, and will obtain auditor certification for this standard as well.  Chris passed the Certified Quality Manager Exam in 2004, and is a Senior Member of the American Society for Quality.

After working as the Director of Quality and Engineering for 13 years at Custom Plastics in Elk Grove Village, Chris recently joined BWay Corporation, and now heads the Quality Management activities at their plant in Elk Grove Village.  This is their largest plastics plant, manufacturing rigid containers and lids of various sizes for Food, Consumer, and Industrial products.  Their Executive office is in Oak Brook, and their Corporate office is in Atlanta.

Chris holds a Bachelor of Science Degree in Chemical Engineering from Clemson University, in Clemson, South Carolina.  While at Clemson, he accepted an invitation to join the Tau Beta Pi Engineering Honor Society.