Posts Tagged ‘Document Control’

As I go round the sites of the smaller SMEs then one aspect that can get the biggest moan is the need to put every form update though change control. Now this might seem scandalous to the purists amongst you but for a small company, say 50 or less and without a dedicated QA resource, it all adds to the angst of maintaining a 9001 system.

 

paperoverload canstockphoto12283596

The forms that get the headlines are those that tend to be ongoing lists, you know the approved suppliers list, the audit schedule, training skills matrix, corrective action register, non-conformance register and the form amendment record itself. When any of these just get updated or added to then to have to put them through the formal change control cycle can start to act as a barrier.

A¬†working solution if you are in this situation is to add a ‘Working Copy’ date to the form in addition to the Revision reference and date. All these date changes get included in your index which itself can now work on a ‘Working Copy’ date but only when these nominated forms get updated. For everything else it goes up a revision.

They wouldn’t get added to your Form Amendment Record because you are just filling them in but would clearly show what ‘working’ version was current which, after all, is the main requirement

Clearly if you change the format and structure of the form by adding and deleting data boxes then the template becomes another revision and would go through change control. However, just to manage lists then this provides a working alternative with everything still in control.

Do any of you face this administrative situation where you work or where you have installed systems? If so please give me some feedback and remember that more 9001 support is available at the 9001 Support Centre.

 

 

 

 

 

 

 

šľöŤ≠įWhen it comes to authorising and approving procedures do you just type them and bang them out or do you print them and see to it that they get physically signed off?

It really surprises me how many systems I see like the first. There is no evidence of you having taken responsibility for either of these requirements. No names, departments, nothing. ¬†When I query¬†this I tend to get told well “I’m the only one who writes them”; “I show them the relevant manager first” or “We can’t wait that long to get them issued”. However, without some accountabilty how do you address the requirement to authorise and approve documentation on issue or amendment?

Now, sometimes I see the authors name typed in and perhaps with a date in the footer of the document which is better than nothing. ¬†Strictly speaking though you would have to evidence that the ‘author’ is the only person with access to the system to create and amend documents which is a bit of a faff. However, you still can’t evidence that the process owner has had any input into what is strictly his or her domain.

Far better to include two signatories with the process owner (often the Head of Department) ¬†authorising it and the QA person approving it. ¬†That way the process owner takes responsibility for releasing information as to what happens on his or her patch. Without that,¬†and I have seen this, you get the response¬†“Well I wasn’t asked about it or shown it before it was issued”. The QA person should approve it so as to run the rule over it for adequate contact and auditability.

Now in this day and age you can obviously have, provided again that suitable control exists, electronic signatures to save the physical  printing. Would be interested to know what you do so please share your experiences. More helpful support at the 9001 Support Centre.

 

 

 

 

Nowadays people tend to be comfortable with the idea of electronic signatures, not so much a password controlled image that is but just a name added usually to the footer of the document. It more often than not is the person who has written it which, in order to get the job done, is the QA person.

Personally, I am not convinced this works on two levels. The need to demonstrate documents have been reviewed before issue and the perhaps more nebulous one of instilling ownership with the process owner with a view to making it an effective process.

It is for both these reasons that I recommend that you adopt a double wet signature approach. First off, the process owner ‘authorises’ the procedure in that he or she accepts that it reflects how the process works in their department. Then the QA Representative ‘approves’ it in that it complies with the document control procedure and would stand up to audit.

If it get’s left to the QA person how do you know the head of department is happy with what has been written. They may not have even seen it!

Nothing beats signing off a document to get ownership, so I would always recommend that you consider this approach. Do you agree?