Archive for the ‘Document Control’ Category

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.

 

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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.

 

 

 

 

 

 

 

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Let’s be honest, nobody likes to receive a Corrective Action Report. Whoever is on the receiving end more than likely takes it personally and probably finds every reason under the sun to get out of taking responsibility for it and taking action to sort it. So, begins another day in the life of a QA man.

I see this all too often so hit on the option that is so simple if you are really facing this where ever you work – just give the form a different name!

We are all told when we undergo our auditor training that wonderful acronym of – Audits Uncover Defects In The System – so we should promote that on this occasion. Why not try a System Deficiency Note which trips off the tongue nicely as an SDN? In addition you could consider using System Enhancement Note for the PARs – but you’ll have to be quick to get any mileage out of that I guess 🙂 If you haven’t heard it is removed in the 2015 version, although I still think it can serve a purpose when recording action to mitigate ‘risk’.

I am sure many of you have already come to the same conclusion so share how you have retitled your CARs. Remember you can get more support in the form of training, the free App, virtual mentoring and videos by clicking through to the 9001 Support Centre.

ps: You can of course use the idea in any management system, not just quality.

 

 

 

 

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会議When 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.