Re: I'm still not grasping the idea of Process Based Internal Audits ISO 9001:2000
Good morning all.
I wanted to ask for some clarification and feedback from you all on process based auditing. We are a NADCAP (ISO/IEC 17025) accredited materials testing laboratory. Currently we comply with NADCAP requirements for monthly internal auditing:
18.5 Per NADCAP requirements, on the first Monday each month the Quality Manager shall select for audit not less than one job that was previously reported in the previous month from any client file to satisfy the acceptable codes listed in AS7101. The test codes must be audited on an annual basis.
18.5.1 The audit shall include verifying the following elements:
* Job Entry Process
* Test Procedures and Equipment
* Calibration and Certification of Equipment Used
* Recording of Test Results
* Audit of Test Results
* Clerical Transcription of Test Results
This audit process is performed post testing as a form of product audit, ensuring that all items were addressed appropriately for a specific test/analysis.
Over the next few weeks, however, I want to develop a process based periodic internal audit program for our facility which will include SOP, COP, and MOP processes. The idea is to have internal audits more involved with in process testing.
We have hundreds of different test procedures which fall under many various test types which we are accreditted for. For process based auditing, should these different testing types be generalized into a "testing" process. My thinking is that a lab section audit would occur, auditing the testing process in general.
This would take into account the inputs (specimens, data, personnel, etc), evaluate the process (what's done, how, where, when, etc), and the output (valid test results, test certificate etc).
I'm a bit confused however, as to how to approach this...since the function of a complete test passes through multiple departments and multiple processes...should the audit encompass the entire cycle, or should the processes be broken out and evaluated seperately? Some of the things that I need to consider:
1) Job Entry
2) Analysis Configuration Generation-(creating an electronic data set within our system that contains all applicable requirements-client/specification)
3) Instrument/Tool Calibration
4) Instrument/Tool Maintenance
5) Lab Test Supply Procurement & Control
6) Technical Support Review
7) Facilities Maintenance & Environmental Controls
8) Customer Services (client communication)
9) Shipping & Recieving
10) Materials & Documentation Retention
11) Document Control
12) Corrective & Preventive Actions
13) Final Inspection (Reports)
14) Training
15) Test Procedures (Validity vs Specifications/Client Reqs)
16) Management Review
There is a lot to consider, and to be quite frank I'm not entirely sure of how to approach it. My understanding is that each process is evaluated separately and in this way it is ensured that each process contributes appropriately to the testing function and interacts effectively with the other processes? Hoping for some advice/feedback from those of you more experienced with process based auditing.
