By Helmut Jilling, SQA Auditor

There is a common weakness in internal audits. The old element-based checklist method was easy to use - just a series of checklist questions and answers. But over time, the checksheets became less effective. Audits focused on the same few questions, again and again. They ceased to uncover other issues and improvements.

The ISO Process Approach is much better. It follows audit trails through the process and into related linked processes, but it is much harder to perform well. The major weakness is without checksheets, auditors have little guidance as to what to audit.

A solution is to develop tools and worksheets that provide auditors with guidance, but not specific questions. Worksheets should outline the necessary parts of a good process audit without limiting the auditor to a few specific questions and paths.

ISO/TS-16949 and other ISO 9001 based standards require audits be performed using a “Process Approach.” It is not enough to just audit the ISO standard, procedures or manufacturing. Audits must do more than check whether people “are following their work instructions.” Each process (Core and Support processes) in your Quality System should be thoroughly assessed for both conformance and effectiveness. Audits must assess how each process is performing to determine improvements.

For example:

• Is the process meeting objectives?
• Are customer needs being met?
• Are there bottlenecks?
• How effectively does it interact with other processes?
• Do people have good skills?
• Are work instructions clear?
• Are there areas where you can save time or money?

Audits need to address these areas and more if you want to improve your company’s processes and performance.

For more details and specific “how to’s” for the specific stages of process auditing and what you should have on hand for the audit report and closing meeting, download our white paper.

A key aspect of an effective and acceptable response to a Corrective Action Request (CAR) in a Quality Management System is the identification and statement of “Cause.”  A CAR is a procedure used in response to a nonconforming product, service or process.

The expectation from ISO guidelines is that the organization will investigate and resolve the process in their quality management system that:

• did not exist,
• failed, or 
• was weak to the point of allowing the identified problem to occur.

Often organizations identify “Cause” by restating what happened, rather than a statement of cause.  For example, a CAR was issued for active gages exceeding their calibration due date. The company’s response for “Cause” was:  “Quality Technician missed these gages when he/she did last month’s calibrations.” 

While this certainly is what happened, it does not address the process within the quality management system failed or why it failed.  An acceptable response may be:  “The organization did not provide adequate resources such as an effective data-based gage recall system. Instead, the organization relied upon a manual data review each month. Thus, it was possible that gages could be overlooked.”

The next step is to define effective short- and long-term corrective action.  Related to the example above, here are some possible corrective actions:

• Short-term:  Each month, the quality technician will meet with the quality manager and review next month’s gage calibration schedule as it now exists.  Once approved, the schedule will be broken down by production department.  Each sub-part of the schedule will be provided to the affected production supervisor.  Each production supervisor, in turn, will provide the list to the affected operators, the intent being to identify any gages that have not been listed or are missing.  Once the review is complete, the production supervisor will sign the list and return it to the quality technician.  The quality technician will update the list and execute the monthly calibrations.
• Long-term:  The organization will investigate currently available gage calibration software.  A selection will be made within the next two months; the selected system will be implemented within the next four months following delivery of the new system.  Three months following implementation, a special internal audit will be executed to assess the effectiveness of the new gage calibration process.

Generally speaking, “human error” is not an acceptable response. While there are cases where the person did not do what was required, these events need be the exception, not the rule. Companies benefit from an in-depth Cause analysis and process changes that prevent these failures from happening in the future, as well as a process for measuring the ongoing success of the new procedures.