Archive for the ‘Uncategorized’ Category

No, I don’t mean running around the office shouting your head off about who’s done what wrong!

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This is all about making sure that you classify your corrective actions into one of three groups to aid subsequent analysis. Now, I should add before going any further, that this is my bespoke way of dealing with this issue but I find it really effective. Here is the first category:

SD – System Disregarded

A minor CAR here as the procedure is fine and current but, for whatever reason, staff occasionally decide not to follow bits of it (as opposed to blatantly ignoring everything). Perhaps they are not signing off all the boxes; stamping a document or filling in some information. You need to do a really good root cause analysis to find out why of course.

SI – System Inadequate

Another minor CAR and the most common as it refers to the system being out of step with what is actually happening in the office or on the shop floor. Invariably it is when you see the procedures not outlining what exactly happens out there. In one sense it is a good thing because it shows the processes are being developed – it’s just that someone forgot to tell the Quality Manager to amend the procedure! What do you mean that never happens where you work!

SN – System Needed

This is the worst case and a major CAR because there just isn’t system that you can evidence. For example there is no audit schedule so nothing else can follow without that; there is no contract review of sales orders against customer purchase orders or no management reviews take place etc etc.

Well, I hope you like the sound of that and can see the benefit. By all means tell me how you dress this aspect of your system by commenting below and remember that more useful support can be found at http://www.iso9001supportcentre.com.

ps: Some exciting news coming soon on the 9001:2015 training video front soon.

 

 

 

 

As I was about to start a Management Review session for a client the MD put his head round the door and stunned everybody by asking “Do you need me in this meeting”. This was before the new standard was published so it brought a smile to my face as I knew what changes were afoot. Changes that you, like me, doubtless welcomed as being a step in the right direction.

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Once we had all got sight of the new standard, most of us out there advising small SMEs began to wonder how MDs like my friend would cope with their new responsibilities. No longer could they simply declare, “If it’s quality then you need to talk to my quality man”.

The new section on Leadership is cleverly written to clearly differentiate between those duties the MD has to take on board and those he may delegate. However, if he has distanced himself in the past then doubtless many QA people will be giving him a crash course an all things 9001.

The changes will not affect those business where the workload is shared and the team addresses the relevant requirements of the standard knowing the boss had his finger on the pulse and is also chipping in with his contribution. However, they might be in the minority.

How do you you see this panning out where you work or with your clients? Will it also be the case that quality managers and indeed consultants will be excluded from an audit on the basis that the MD should be competent enough to hold a discussion by himself with the auditor?

Why not share your thoughts below.

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?

By way of introduction . . .

Posted: February 9, 2009 in Uncategorized

I have launched this blog as a means of keeping in touch with the various business network groups that we are involved in and hopefully to spark some discussion on the aspects of business that affect us all.  More later once I have found my way around.