To anyone that can elaborate,

I probably know this answer already, but need some oppinion of others.

What exact documents are required to be on a Control of Documents List?, even if I have a seperate Auditing System that controls its own documents, example (Audit Checklist, Findings Worksheet, Defined procedures per system, etc).

Do these have to be on a Controlled List or are some of these documents just reference for use and auditors come with there own questions.

Please give me an example or explain with reason.

Thanks,
Sylvan

To anyone that can elaborate,

I probably know this answer already, but need some oppinion of others.

What exact documents are required to be on a Control of Documents List?, even if I have a seperate Auditing System that controls its own documents, example (Audit Checklist, Findings Worksheet, Defined procedures per system, etc).

Do these have to be on a Controlled List or are some of these documents just reference for use and auditors come with there own questions.

Please give me an example or explain with reason.

Thanks,
Sylvan

Sylvan:
You're correct that we've hashed this out before. A quick search will bring something to light, I've no doubt. I'm sure our fellow (and fellowess) Covers will bring their collective wisdom, and I'll offer this:-

A Controlled list isn't required. Control of documents is required, which can mean simple concepts. You already have a system for controlling documents defined. If your procedure says that you have list then you will either have to change the procedure, or list your documents!

It appears from your post that your audit procedure descibes the documents used when auditing, but does it describe how the documents are controlled?

Your other question about documents has me confused. Auditors normally produce a checklist of questions on a form which is a controlled (approved) document. There should be no (zero) documents which are 'reference only' and still used (by auditors especially) as part of the documented quality management system.

Has this helped?

I knew my instinct was correct.

I do have my Controlled Documents as being in a list and I have to identify them. Which other way would be easier? Give example please.

In internal auditing, I think I just overthinked the system. I am as this moment trying to develop my internal audit procedure and which documents are to be used during the notetakings when conducting. (sorry)

Sylvan,

Also remember that if you are implementing ISO 19011 for internal audit process for an organization registered or compliant to one of the ISO 9001:2000 based quality management systems (TS 16949, AS9100, etc) the requirements of Clause 8.2.2 requires records that indicate that your organizations meets stated requirements and usually encompass the following:

• Audit Schedule
• Audit Reports
• Corrective actions associated with audit findings of nonconformity
• Follow-up activities including verifications of CAPA actions taken and reporting of the verification results
• Audit records required by contract and/or regulatory requirements.

To anyone that can elaborate,

I probably know this answer already, but need some oppinion of others.

What exact documents are required to be on a Control of Documents List?, even if I have a seperate Auditing System that controls its own documents, example (Audit Checklist, Findings Worksheet, Defined procedures per system, etc).

Do these have to be on a Controlled List or are some of these documents just reference for use and auditors come with there own questions.

Please give me an example or explain with reason.

Thanks,
Sylvan


Some people use a master list approach, and some people are using a master document approach. If you have a master document, procedure, wi, form, etc., and that document is the latest version, then all copies that match that doc and date are also controlled. It is easier than maintaining and comparing to a list.

Well yes I am controlling my documents with a master. So you're saying if a master is available, I do not really need a master list identifying what I have overall?

Thanks for your reply.

Your master list is the minimum you are expected to maintain. If you have some things not on the list, that's okay.

Nor does your master list need to show the revision numbers of everything. It's just meant to show what documents you are expected to keep and control against loss, unauthorized change, using outdated revision, how long to keep them, means for disposal, etc. A table in a process document's appendix or attachment can do the job.

It's okay to have revision numbers on paper copies, and it's okay to have documents stored on a computer drive. Just be ready to describe how the documents are protected against loss: computer documents can be read-only password protected and data can be backed up. If your procedures are on computer, you'll need to have some effective method of ensuring only the most recent of revisions is viewable in the place people go to retrieve them. Notes don't follow this rule, but a schedule would.

You're right not to overthink this. The object is to have a plan for what documents are required to be kept, how they will be managed, and follow the plan.

I hope this helps!

Well yes I am controlling my documents with a master. So you're saying if a master is available, I do not really need a master list identifying what I have overall?

Thanks for your reply.

The standard does not require a master list anymore. Many people still use that method, but it is a rather outdated holdover of earlier systems. Now, with our networks and paswords, doc control could be made much easier and simpler.