How much time does the QA Representative need up to that Stage 2 audit?

Posted: January 12, 2014 in ISO 9001, Management Review, Quality, Quality Management, Quality System, Training
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BarryNot surprisingly, this is a very common question from companies during my time on site whilst I am creating the QMS.

First, let us assume the the company has someone who they are putting forward as the QA Representative – not always the case I know.  Also let us work on the basis that this person (you?) has another job, a main job, around which they have to find the time to look after the system. Now, there is a 4 – 6 month period ahead of you that involves a stage 1 audit before ending with the stage 2 audit.

To cope in this second phase when the system has been launched and staff start to work in accordance with it, I always suggest a day a week is required.   This is based on the fact that there will be invariably be at least 2 audits a month to do because the 12 month schedule has to covered in half the time.  On the first traunch of audits there will be CARs raised so they all have be be communicated, actioned – and chased?. There is all that data to locate and analyse on a regular basis; perhaps the approved suppliers list to amend because new suppliers are being sourced and then that Management Review meeting to fit in – and aren’t the majority of the actions going to be for you!

On top of that you have to make sure you know your way around the system, whether it is hard copies or an intranet or both, so you can speak about it with confidence when the auditor is on site. Don’t forget that procedures will need amending and perhaps forms as well so the whole change control process needs time allocating to it.

Mmm, quite a bit to do. It is important that the company and the staff see this commitment on a regular basis as you endeavour to make it all part of the company culture. I find a day a week to be a good test of that Management commitment, but I feel it is a fair and realistic allowance. What’s your experience?

If all that sounds a daunting prospect don’t forget help is at hand in the form of site visits, mentoring over the web and auditor training at the 9001 Support Centre.

ps: Next time I’ll move onto the commitment after the stage 2 when it’s all died down a bit – or has it?

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