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

There are a lot of existing discussion threads here on Process Approach (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=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 (http://elsmar.com/Forums/forumdisplay.php?f=118)) is discussions about the Process Approach.

Thnaks Marc for your guidence and support

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

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 (http://www.thareja.com)
.
set up of

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:


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

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:


Audit the metrics for a process, and inputs and outputs.
Audit the sequence of the actual process itself.
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.

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.

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.


Good points and welcome to the Cove.

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

Are we talking about an internal audit? we could tell you all kinds of questions to ask, but that wouldn't really help you perform a process approach audit.

Firstly, it helps to know something about the process you're going to audit - otherwise you won't know how to deal with the answers - right or wrong.

If you don't know the process, find someone who does (and is impartial) and when going through the various documents which are necessary for good control, get them to tell you what's important about the process. You should be able to develop your questions from that. Alternatively, use the kinds of questions the process supervisor might ask - it's not rocket science.

The 'Process Approach' is one of starting with the inputs, what's planned to happen and following the natural flow of the process, taking into consideration the controls required to ensure a 'good' result (to the plan) - the output. Those controls may be various - people, equipment, methods and/or environment etc.

Try that!

My organization is going for ISO 17020 accreditation. I like to integrate my system since the organization is already registered to ISO 9001. Now, my ISO 17020 auditor says we can't integrate the same clauses of both the standards since ISO 9001 is based on process approach but ISO 17020 is based on inspection.
Need feedback in this regard.

My organization is going for ISO 17020 accreditation. I like to integrate my system since the organization is already registered to ISO 9001. Now, my ISO 17020 auditor says we can't integrate the same clauses of both the standards since ISO 9001 is based on process approach but ISO 17020 is based on inspection.
Need feedback in this regard.

He's right, but you can integrate the common clauses and continue to manage the specific clauses as stand alones like you are now....that's why it is called "integration". Take a look at "PAS 99" for guidance.

17020 requires that you have a "Quality System"....how can ISO 9001 not be integrated.

Additionally Section 7 of ISO 17020 is what ISO 17020 is about...Providing Inspection Services....which is a Product.