Document Review Problems

Hi,

I hope getting in this forum can help me. It has been a month now that we had the document review. We are done with the other process and I have revised their documents. However, I just realized that I don't have basis in conducting document reviews. What I was told about document review's from our other branch's QMR is to review the documents, see if the process is applicable. But I still don't get it anyway. I just thought that quality matrix will help but I don't get the relation of it (containing clauses of the certain process e.g.dispatching process).

Hi There,

Sorry I am a bit confused by what the question is.

What exactly don't you get?

The review process? The purpose? The requirements?

If you could clarify, I would love to try to help.

Hi Nikki,

I am referring to the document review process

Obviously any quality document will require ongoing reviews e.g. a procedure (SOP) to ensure what it says is actually what is happening in practice. For my SOPs I have a history section (at the end) indicating what the change is after the review. This also references a document change number (DCN) from a DCN database which also records the change.


I hope this helps.

Steve

Hi

In order to comply ISO9001 minimal requirement on documentation, there are 7 mandatory documented procedures :
-Control of documents
-Control of records
-Internal audit
-Control of nonconforming product
-Corrective Action
-Preventive Action
-Quality Manual

And besides that, major process like HR, Purchasing, Value added process (Production & service), Storage and other control process are highly advisable to get all control method documented too (Procedure, SOP, Work instruction, Checksheet, Product specifications and etc).

I am doing document review too. Hope the info helps.

We have a spreadsheet listing all current internally generated documents within our QMS, which includes the 7 required listed above and a boatload of SOPs. Among other things, the spreadsheet includes the name of the owner of the document and a review month/year. The first of each month, the documents that are due for review are sent out with a cover letter asking for review. The owner of the document then verifies if the document is still valid and up to date. The cover letter is returned, indicating any needed action or approval as is. If no change is required, the document controller then changes the due date on the spreadsheet. No markup on document needed. If changes are needed, the document is revised by the owner and sent through the normal approval process.

Documents are on a 3 year cycle for review, but of course can be revised any time the process changes. I have found that if you wait for the owner to update the document when changes are made, the document never gets changed.

That's our system and it works well for us. Because of the sheer number of documents we have, spreading it out over 3 years makes the system manageable.

Hope this is what you were looking for and it helps.

SheiLaJP said:

I am referring to the document review process

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Am I understanding correctly: you'd like to establish a formal procedure for document reviews?

This is another one of those things that you have to decide.

With some companies, "document review" (as in "I reviewed this document"), is nothing more than going over it. The value of such cursory reviews, however, is questionable.

To add value, there has to be some requirements. So, for example, you might have the following requirements:

1. Meets requirements of (insert your doc-control procedure) for identification, legibility, etc.
2. Meets requirements of ISO9001
3. Is comprehensive and feasible
4. Does not conflict with other procedures, requirements, or practices

Now that you've got requirements established, it is clear what people should be doing when they attest to having "reviewed" a document: i.e. check that, to the best of their knowledge, the requirements are met.

In practice, however, this might be overkill to actually prescribe in every case...

I have seem many approaches to periodic review of process documents that range from a fixed period (one or two years) to as-needed.

There is no single correct way to do this. The fact is, there are two mind sets:

- Assume everything is all right when something is not
- Assume there is something wrong when everything is all right

Periodic document reviews can get caught up in these two basic errors, which are identifiable as alpha and beta errors (though I always get the two confused with their meaning, so I didn't identify it here - sorry). The first can happen through sheer familiarity. That is why I like to hear that internal auditors are approaching their system audits using the process approach, in which a transactional basis of review - that is, walking through the process from beginning to end with the procedure in hand - determines whether the procedure is still accurate. The outsider's viewpoint can very often reveal those head-slapping issues that leave people asking "How did I miss that??"

I hope this helps!

SheiLaJP said:

Hi Nikki,

I am referring to the document review process

Click to expand...

There is nothing in the document review process for someone who is not having the background and experience of the concerned process document being reviewed......

Sheila,

Ask, and help as necessary, the process owners to engage their process team members in reviews of their procedures for accuracy. Accuracy is what actually happens.

Once the procedures are approved, ongoing use and monitoring of the processes (for effectiveness - see 8.2.3) and update of their procedures will make sure the procedures remain accurate.

Note here the importance of the work before the procedure. It's more important to review and approve the process itself.

We should not kid ourselves with inaccurate or unrealistic procedures. We guard against this by continuous reviews of our procedures for accuracy when each is compared to their process.

Best wishes,

John