Feedback on Document Control Procedure

[JuhoS]

Dear all,
I've been lurking in the corners of Cove for the past month or so, and have found this forum extremely useful. In fact, I would be completely lost without it.


Now that I have started drafting ISO9001 quality manual and the accompanying procedures, I would really appreciate feedback on the first drafts on the procedures.


To give a brief background. We are a non-profit based in New-Delhi, India, with a staff of approximately 50 people, working on a community based model of financial inclusion across South Asia. We are looking at getting our implementation process certified. The process consists of an extensive baseline study and a dozen or so different trainings and workshops and lasts approximately one year. We implement through a local partner who is our contact with the communities (customers) we work with.


I have been given fairly strict deadline from the management (end of the year) to implement ISO9001:2008 compatible QMS. Unfortunately the interest is strictly to get the certificate, not necessary to look at the ways in which the QMS will benefit the organization in the long run. I am obviously aware that the approach is completely skewed but for various reasons this is the situation and there is very little I can do to change that. This means that we want to have the bare minimum of documentation in order to have less chances for nonconforming.


Taking this into consideration, I would really appreciate any feedback on first of the procedures: Control of documents (please find attached).


I am having some issues with the control of external documents. Now, this probably sounds stupid but why do I need to specifically control any external documents if I have made it clear that they are not part of the organizations QMS? E.g. if the document is not written in our letterhead, then every employee will identify it as not belonging to our QMS. I am probably missing something crucial here...


Apologies for the lengthy post and thanks in advance!


Juho

[Wes Bucey]

I'm in a rush and don't have time to look through your attachment, but the text of your post indicates you are on the right track.

External documents MUST be included in your Document Control System ONLY if they impact your operation.

Thus, a purchase order for a product or service your organization supplies (a request for aid?) MUST be included.

Similarly, some other organizations you look to for donations or assistance may have "guidelines" on what data needs to accompany your request - those are also external documents you must control since they have deadlines, data lists, etc. which must be met or the request is delayed until they are provided.

Not EVERY external document needs to be in your system, but certainly SOME might.

[SteelMaiden]

I started reading, the first thing I saw was that only electronic documents are controlled. This might well be, but i'd suggest you take another look. You do need to control (as Wes said) external documents that specify requirements, such as customer owned documents. Make absolutely sure that you are not going to have any hard copies that you will need to control. If not, more power to you. I will try to visit your document later on, right now I have a meeting.

[Geoff Withnell]

Juho,
Since you have chosen to exclude paper documents from your control system, this means that if someone prints out a copy of a document, and uses it for their work, they are using an uncontrolled document and are not in compliance with ISO. This is fine, if using electronic documents works. But it usually doesn't, people like paper docs. Are you really prepared to forbid their use?

Geoff Withnell

[ScottK]

In Reply to Parent Post by Geoff Withnell

Juho,
Since you have chosen to exclude paper documents from your control system, this means that if someone prints out a copy of a document, and uses it for their work, they are using an uncontrolled document and are not in compliance with ISO. This is fine, if using electronic documents works. But it usually doesn't, people like paper docs. Are you really prepared to forbid their use?

Geoff Withnell

I've passed many audits with an electronic system that made provisions for paper documents to be printed as needed and discarded after use.
The rule says documents must be controlled... it doesn't say you can't use an uncontrolled copy of a controlled document to do a task.
But make darn sure that uncontrolled copy is current.

[Geoff Withnell]

In Reply to Parent Post by ScottK

I've passed many audits with an electronic system that made provisions for paper documents to be printed as needed and discarded after use.
The rule says documents must be controlled... it doesn't say you can't use an uncontrolled copy of a controlled document to do a task.
But make darn sure that uncontrolled copy is current.

A semantic question? If the system makes provision for use of paper documents, (controls their use), in what way are they "uncontrolled"? A controlled document is one that we know, because it is being used within the system set up for this purpose, is correct. The paper documents you speak of are in fact controlled documents. I assume you have audit controls or some other mechanism in place to assure that paper docs are not printed, and then just used indefinately? The document control system exists, not to pass an assessment, but to make sure the docs in use are the correct, up to date info. It doesn't matter if you call them "uncontrolled" or "controlled". If your system has made sure they are correct, then they are in reality "controlled documents". If someone is using the wrong doc, it doesn't matter if it is stamped "For Reference Only" or "Uncontrolled". The chance for error still exists. And this is far more important than the chance for an assessment finding.

Geoff Withnell

[Brunetta]

I took a moment to briefly look at the attachment and have some questions. I am short on time here though so I am including the first one to get you started. If I have more time later I will post some more, but I see similar possible redundancies/non-value added internal requirements throughout the document. Also, I would caution you to not discount the fact that you may need to keep an obsolete document at somepoint.

Reference Section 1.2.4:
"All controlled documents are reviewed yearly...prior to management review meeting..."
Question:
Are you introducing an additional internal requirement to review documents here? If you are, and from the management position that you have described, then make darn sure any additional requirements above and beyond what ISO 9001 requires is of added value to your organization.
Thoughts behind the question from my experiences:
What is the purpose of a document review...to ensure the documents are adequate in translating high level generic policies (ISO 9001) to real/your world specifics. This implies more than just a cursory read through and someone saying yup they are still good. In our QMS system, document review for adequacy is a necessary part of an internal audit process...during a desk audit. Perhaps you can reduce a redundancy in your system by thinking about how a natural progression of one process can suffice to cover a requirement. I cannot advise you for sure because I am only looking at one facet of your system and not the system as a whole.

[ScottK]

In Reply to Parent Post by Geoff Withnell

A semantic question? If the system makes provision for use of paper documents, (controls their use), in what way are they "uncontrolled"? A controlled document is one that we know, because it is being used within the system set up for this purpose, is correct. The paper documents you speak of are in fact controlled documents. I assume you have audit controls or some other mechanism in place to assure that paper docs are not printed, and then just used indefinately? The document control system exists, not to pass an assessment, but to make sure the docs in use are the correct, up to date info. It doesn't matter if you call them "uncontrolled" or "controlled". If your system has made sure they are correct, then they are in reality "controlled documents". If someone is using the wrong doc, it doesn't matter if it is stamped "For Reference Only" or "Uncontrolled". The chance for error still exists. And this is far more important than the chance for an assessment finding.

Geoff Withnell

Well, Geoff - the way you phrased your first response there led me to believe that you felt that a paper copy in an electronic sysytem is, by nature, uncontrolled.
Yes - we control the copy by putting the rules in place in the procedure and then it becomes controlled....thought there are some auditors who would see it otherwise so the phrasing of the procedure has to be clear.