What is meant by Process Approach Auditing and What questions should be asked?

[wak125]

Could some one elaborate what is real meant by Process approach auditing, I know the definition written in ISO standards, but I want to know what type of questions should be raised to Auditte under Process Approach

[Marc]

There are a lot of existing discussion threads here on Process Approach. You might want to read through some of the existing related threads and then come back here for more specific answers.

The types of questions which would be asked would depend upon the specific process, and would be about the specific process.

Note that this entire forum (Process Audits and Layered Process Audits) is discussions about the Process Approach.

[wak125]

Thnaks Marc for your guidence and support

[Marc]

If you have any more specific questions, please don't hesitate to ask.

[pthareja]

Without deving into nitty gritty of Technicals: And to add some Humour.

There are several approaches people use-
a) The Index approach:
Start from clause 4
4.1 Have you formally tested your Quality Management System?
Do you have Outsourced Processes?
Just keep on reading lines in the standard and jot down the list of Questions which ultimately line up as a check list.
Go to next clause say 4.2.1

b) The Departmental Approach
Choose the 1st Process
Material Purchase (and Finish up clauses 7.4.1, 7.4.2 and 7.4.3). How it is procured, Tested, Stored, Issued and so on.

Go to next department: Production.
The Processes of the organisation should have been Flowcharted. Just follow the pointers if they are there to direct, and determine the route.

c) The Site Vist Approach
It is similar to Management by wandering around. Auditing is damn easy. Any bad company will give lot of L.H's. (Loop Holes) Big ones.It will be a cake walk in them.

d) The Process Approach:
It is the Right approach. Study a process with respect to the 'system approach to Quality Management'
It is the recommended process of methodically and meticulously following the Audit Trails. Whether the processes have addressed to fulfilment of 'Critical to Quality' requirements/ areas?
It follows a structure which constantly upgrades in terms of questions asked. Meeting customer's requirements --> Obectives --> Planning ---> Criteria of meeting at Conceptual level ---> The requirement of Continual Improvement ---> features of getting your prcesses identified for world class levels.

I am sure you can find some questions to assure the process approach is sustained.

Priyavrat Thareja
www.thareja.com
.
set up of

[Helmut Jilling]

Originally Posted by wak125

Could some one elaborate what is real meant by Process approach auditing, I know the definition written in ISO standards, but I want to know what type of questions should be raised to Auditte under Process Approach

I would take Marc's advice and explore this forum. There is much discussion about the process approach.

However, there are three categories to address:

1. Audit the metrics for a process, and inputs and outputs.
2. Audit the sequence of the actual process itself.
3. Audit the processes which link and support to this process (training, documents, records, calibration, audits, etc..

[michellemmm]

Originally Posted by Helmut Jilling

I would take Marc's advice and explore this forum. There is much discussion about the process approach.

However, there are three categories to address:

1. Audit the metrics for a process, and inputs and outputs.
2. Audit the sequence of the actual process itself.
3. Audit the processes which link and support to this process (training, documents, records, calibration, audits, etc..

Excellent!!

I would also ask:
-- How the process contributes toward quality and/or business objectives...
-- If there are any CI projects; CARs or PARs.

[Jon B]

The highlights of Process Approach auditing are very insightful and concise.

I would also want to know if there were any standardized methods for operating each process (whether procedures, instructions, or whatever form they might take). Then I would audit to gauge the Process Owner and stakeholder's understanding of the process, how they've been qualified to perform their roles in the process (training, experience, etc.), and their perception on how well the process is working (inputs received from other processes, outputs delivered to other processes, performance measures).

In relation to the previous recommendations, if performance metrics were not being acheived, I'd want to know the plan that was in place to improve performance (if any) and if any of the Owner/stakeholders were involved.

Just some additional thoughts.