Originally posted by Dawn:
Do you have a blank sample of one of these audits I could take a look at? I have tried to do this but failed.
I've emailed you to send me a fax number and I will send the audit schedule right over to you.
To give you some insight:
1) Some things you will audit by element, and follow-up by looking for objective evidence, such as 4.1 Management Responsibility, and 4.3 Contract Review. Typically, those "elements" are in and of themselves "functions."
2) In our facility, we would audit manufacturing - we have the following relevant elements: 4.8, 4.9, 4.10, 4.12, 4.20. In other words, all of these "elements" can be audited while checking out what goes on in the entirety of manufacturing. To demonstrate how this helped - We USED to audit, say 4.10 - and go through the shop looking to see that we met it. Then, we would audit 4.11 - and go through the shop again. Then 4.12 - you see the monotony of the situation? On the same audit trail, auditing by function, I can check jobs to see if they have process control instructions (4.9), if it has been inspected/tested (4.10), if an appropriately calibrated tool has been used to inspect it (4.11), if the inspection and test status is readily apparent (4.12), if the results have been recorded (4.16), and, if applicable, whether the appropriate statistical data has been compiled (4.20). So, on one pass through the shop, I am now looking for a variety of elements, instead of making 5 or 6 different passes through the shop auditing each element. (I only wish I had realized this sooner.)
3) You can verify 4.16 while auditing just about every function with exception of lunch and break!
4) While checking out nonconforming product (4.13), you should also be checking out 4.14, and of course, 4.16.
5) 4.2, 4.5, and again, 4.16 should all be relevant during an audit of the Document & Data Control functions.
It has really made for a much smoother audit flow. Of course, you are flipping back and forth through the QSA making notes and verifying compliance, but again, it is much easier to look at ALL RELEVANT ELEMENTS that are occurring in a specific function, than to repeatedly visit a function over and over and over again as you go through the QSA element by element. Also, you change the flow of the audit from one to the next, too.
I hope I have provided some insight.
[This message has been edited by ALM (edited 27 April 2000).]