Process Audits
I developed a checklist for process audits that includes 2 'categories' of questions: the first section is questions that we ask about every process, such as:
-- is the process clearly defined?
-- is there sufficient documentation/information for effective operation and control of the process?
-- are there sufficient resources provided for the process?
-- has criteria for effectiveness been determined?
etc.
Then the second section is process-specific, that is, if we are auditing the Order Management process, we ask questions from 7.2 in the Standard; if we are auditing the Design process, we ask questions from 7.3. Setting this up for each Key Process (there were 8 I believe) was not difficult, and it only has to be done once.
These checklists ensure that all of the processes are being audited in a 'closed loop' way, and that we are ensuring that the process itself is in control and effective, and that it meets the requirements of ISO 9001.
Caveat: the auditors use the checklists as a guide only, and more experienced auditors don't need them much at all. These are not the questions that the auditors ask; they are simply a reminder of what to look for. The auditors ask questions about the procedures and sub-processes that support the Key Processes (I like the method of writing questions directly on the procedures, esp. if those procedures are flowcharted and have plenty of white space.)
Comments on this method?
Julie