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Administrator  526 Posts
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Hi Everybody, I have run across a wide body of views from CABs to auditors that view 4.1 is not an auditable clause. However, by auditing the balance of the clauses in the Standard, one could then say that 4.1 has been audited. Your thoughts? Cheers. Checkmate. |
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Super  243 Posts
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hi checkmate, very interesting question as 4.1 is the overall (ie general) requirements so you could say by auditing all other clauses you have automatically audited 4.1 here's the but i look at 4.1 as the basis of my audit check list or the introduction to my audit. During my opening meetings i reference clause 4.1 to show or identify what i am 'looking for' in relation to an audit. certainly within my clause check list i include 4.1 to show that has been audited, but you are correct that i don't specifically target this clause, but then again i do not target any specific clause instead look to the process and what clauses are covered within that process Hope this helps,  However, this post is of my own thoughts or advice and may not be representative of the IRCA, any professional body or individual; before acting on any advice given by me please ensure that it is appropriate & sutiable to your requirements Mr. Jingle |
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Expert 523 Posts
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Hah - by absolute coincidence I have just made a comment about how under-audited clause 4.1 is on the "procedure based management system" forum Now you'll see, Mr J, that I do agree that few people seem to get their heads round it sufficiently to know what conformance/non-conformance actually looks like, so it basically gets audited the way you've suggested. Basically if everything else looks OK enough, 4.1 is met as an amalgamation of constituent parts I'm not sure i agree with that, as Rohit got me thinking about how the "process approach" is deemed to have been met, understood and incorporated. My view is that (clause 4.1 aside) we can happily build our QMS around the remaining requirements, more-or-less ignore the "process approach", and still demonstrate conformance on just about all clauses (save for the minor irritation of 4.2.2 c) Whilst I do agree that you can only really take an overall view on conformance to clause 4.1 after having taken at least a summary (stage 1) view of the whole QMS, you'll note that if we study the sub-clauses of 4.1 there are numerous references that require a demonstrable understanding and incorporation of the process identification, monitoring, measurement etc. Now personally i do not think that any of the other individual clauses require that understanding to be demonstrated particularly, and consequently to take the view that 4.1 is met after we've seen broad conformance to the other elements of the standard misses this fundamental assessment principle This has just today started taking shape in my mind, and I think I'm only just starting to make sense of it all, as I've always previously seen clause 4.1 as a bit peripheral and perhaps almost pointless, but I think I'm beginning to understand it's fundamental intent. Not that it gets adopted that way Let me know what you think Regards, Shaun I blog at http://blog.capablepeople.co.uk/ |
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Super UAE
492 Posts
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Hi Checkmate, I agree with you that if you have audited other clauses expect clause 4.1 --------implies that you have taken care of clause 4.1 by default to some extent. But if you audit this clause separately then it can be more prodcutiive, why I am saying this because as audit is done on sampling basis their all chances that you might miss auditing for example, how the organizations are controlling their outsourced processes (if any) the other one is how the interactions between the processes has been established. Rohit Bakshi Abu Dhabi |
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Super UAE
492 Posts
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Hi Checkmate, I agree with you that if you have audited other clauses expect clause 4.1 --------implies that you have taken care of clause 4.1 by default to some extent. But if you audit this clause separately then it can be more prodcutiive, why I am saying this because as audit is done on sampling basis their all chances that you might miss auditing for example, how the organizations are controlling their outsourced processes (if any) the other one is how the interactions between the processes has been established. Rohit Bakshi Abu Dhabi |
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Super 243 Posts
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Hi all, Personnal i have made a determined effort not to specifically audit a singular clause as i consider this an extension of, or at least in danger of becoming a procedure type audit this is why i use 4.1 as the overall (ie general) requirements, then consider the processes, once i have audited the process then i determine which clauses are applicable or have been addressed. As such i base my audit report by commenting that item xx of clause 4.1 requires [blankity blank] and this has been addressed by the auditing of clause (s) xyz, would you agree that if you were to base an audit on specific clauses instead of processes then there is a danger of the audit becoming a procedure type audit? Hope this helps, However, this post is of my own thoughts or advice and may not be representative of the IRCA, any professional body or individual; before acting on any advice given by me please ensure that it is appropriate & sutiable to your requirements Mr. Jingle |
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Administrator 526 Posts
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HI all, When discussing this subject (4.1) in class, I tell my students to close their eyes, then imagine what could be needed in a quality managment system; identify 5 or 6 keys activities, issues for success, then open their eyes and write about it in plain language. After this exercise, we compare the notes with 4.1. In the main, the notes are amazingly similar. I look at 4.1 as the global vision to a quality management system with the balance of the Standard laying out it deliverables. I believe that 4.1 can in fact be audited; but, saying this, audited to the broadest of process-based disciplines and approaches. Cheers. Checkmate. |
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Super 243 Posts
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Hi Checkmate another point of view - if you are considering 4.1 in respect of auditing and auditability could it be said that by considering 4.1 you are infact delving deeper, even to the consideration to 1.1 as we are 'auditing ' to the whole of ISO 9001 or the compliance to iso 9001- when considering exclusions and whether or not those exclusions are justified then you have audited clause 1.2. even within 4.1 a it does refer to the application in 1.2 - then is clause 1.2 auditable? i need a coffee . . . Hope this helps, However, this post is of my own thoughts or advice and may not be representative of the IRCA, any professional body or individual; before acting on any advice given by me please ensure that it is appropriate & sutiable to your requirements Mr. Jingle |
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Administrator 526 Posts
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Hi Mr. Jingle. And, at the risk of taking this discussion even a bit further, try mind-mapping the Standard with 4.1 as its nucleus; quickly, I believe one will discover 'all' points are reached ... even 1.2 ... perhaps. Cheers. Checkmate. |
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Super UAE
492 Posts
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Hi Checkmate, In my opinion most of ther bullet points ( a to f) of subclause 4.1 are taken care off during the documentation (QA Manual and qms procedures) review by the auditors. And during the actual audit (site) the auditor has to verify the implementation and the effectiveness. Rohit Bakshi Abu Dhabi |
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Super INDIA
209 Posts
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Dear All, The clause 4.1 simply describes the process approach adopted in the standard. One may audit clause 4.1 but that will be severely limit the audit process. In fact the clause links to other processes in the qms, for which specific requirements are given. It will be worthwhile to use clause 4.1 as a broad check list, after all, we are auditing only processes. A. Deobhakta |
Posted - 15 May 2008 15:04
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