ABSTRACT
The quality system procedures in this process-approach system don’t resemble the standard operating procedures (SOP) in conventional quality systems. The quality procedures in this system have been designed to be user-friendly in all areas as to the identification of requirement, the definition of responsibility, work assignment, accountability, and process flow. For an auditor to spend more time on compiling the checklist than on doing the audit itself is absolutely unacceptable in economic terms. This, of course, is not the auditor’s problem, but how the quality system’s procedures have been laid out and integrated lend a user-friendly flow process in which what you need is right in front of you. Since internal audits are mostly done by in-house employees, it makes a big difference economically whether the auditor spends a few hours or a few days in accomplishing internal audits. I paid serious attention to this also when I planned the layout of my procedures, for I used to do audits at many companies in my forty years service and could not easily find where and how responsibilities were linked to work assignments in the conventionally written SOPs. Every quality operating procedure in this process-approach system is also a checklist, not only for the auditor, but also for the process owner and his supervisor as well. Note also the dramatic shift from conventional methods as to how we maintain continuous improvement in training employees whenever corrective action requirement points to the operators’ lack of understanding of their work assignment. The details of the audit process are the subject of this QOP.
