Archive for the ‘Quality System’ Category

canstockphoto43475088Reviewing how certain sites are coping with the new ‘2015’ format for internal audits has occasionally flagged up some interesting issues.  Some have taken the ‘interview’ style with top management quite literally and reported them along the lines of ‘I asked/ he said’ which just doesn’t come over well when you read it back. You need to summarise the discussion in a way that allows you to report it in the usual factual way rather than it turning into a play.

Of more importance, you still need the objective evidence. You can’t be asking questions then reporting it back as ‘It was stated that etc’. So, what to look for?

Clearly a major document should be the SWOT analysis for the Context of the Organisation. I covered this in a video on a recent post. Also you would expect to see some document that has the needs and requirements of interested parties and the recent reviews and actions if necessary. When you come onto Leadership itself ask them to explain using document that already exist – objectives, policy, critical support process risk review etc.

The need for objective evidence is still their whatever the audit. More helpful tips and support as always can be found at the ISO 9001 Support Centre. Just click through.

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
*audit schedule
*training skills matrix
*corrective action register
*complaints register
*non-conformance register
*calibration register
*form amendment record

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. You are already avoiding it with operational documents like a PO. The one template is used to create many orders and you don’t put that through change control every time do you because the order number is the second tier ID.

A working solution if you are in this situation is to add a ‘Working Copy’ (WC) date to the form in addition to the Revision reference and date. This becomes the second tier ID. You can then simply save the form as another version indicated by the latest WC in the title. It is handy if you state there is a WC version on your index BUT without including the ever changing date.

These ‘updated’ forms wouldn’t get added to your Form or Document Amendment Record because you are just being filled in. The forms saved title and the latest working date on the form clearly show the form’s status 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 but in order 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.

 

 

 

 

ShredderIf you already have a system in place you are doubtless pondering as you look towards the 2015 version whether to bang not only the manual but the mandatory six through the jaws of your shredder as well. (Yes, I know Preventive Action goes anyway but let’s run with it yeah)

The likelihood as I see it, having talked to my sites, is that they will be retained and the temptation to run amok resisted. It’s a bit like some of us now being allowed to get our hands our pension pot to do with as with please isn’t it. You so want to but you hold back.

The manual if written properly (i.e. in say 8 – 10 pages max) is a good marketing tool and the procedures are useful support for those getting there heads round the requirements in QA. However, what to do if you are installing your system?

I think that really depends on the skills and knowledge of the team (yeah, no management representative either doing all the work) who will look after these processes. In my opinion, if they know them inside out then there would appear to be no need to burden them with procedures provided adequate records are being retained to evidence control of each process. However, if they are lacking experience, there is no doubt that there is a good case for writing them. As with all parts of the standard – if not having a procedure risks the process falling over, then you need one.

I have to get my head round how to upgrade the 9001 Training Guides to accommodate the extra requirements and the general move-around of existing procedures so by all means let me know what you would like to see and in what format.  The current version for 2008 are here if you’ve never seen them and would like help with that version.

 

 

 

Companies certified to ISO 9001 could have a surprise in store when the standard eventually gets revised from the 2008 version to that of 2015. Ok, so there is now an alleged delay I hear in that we won’t see this published until the autumn now but don’t rest on your laurels.  You need to get ahead of the game on this one and hear’s why.

Some say it is the most significant change they have seen to the standard

However, companies will doubtless leave it to the last-minute thus putting themselves under pressure having less time to talk it through with staff  and then introduce all the changes required of them. Certainly the Owner,CEO or MD is being asked to be more hands on in the running of the system so that’ll come as a shock to most.  No longer can it be bolted onto the business or simply viewed as a delegated task for one unsuspecting member of staff.  Also, have they seen the significant changes in relation to that person’s role anyway or the documents that are removed and the processes that are added? Will they understand how to introduce risk management for example.

What action can I take?

Well, I am already chatting to certified companies to paint a picture as to what is coming their way with the new standard. I have attended sessions with no less than three certification bodies and am about to undertake my auditor transition course. I trust you are making similar arrangements whichever side of the fence you see yourself.

A good place to start

Here is a trailer of my recent webinar “9001:2015 – What’s All the Fuss About” to set the scene for you.

If you see the need to chat further then email me at pete@iso9001supportcentre.com and remember that you can also see it on my App in the Masterclass section. Just search on Apple or Android for :9001 Support”.

For any small company the requirement to appoint someone to look after the QMS can be a difficult decision. Invariably someone takes it on in addition to there main job which is bad enough, but the most difficult choice is when the Production Manager draws the short straw.  Surely, it is a blatant conflict of interest so shouldn’t be entertained?

However diligent they may be and competent in their QA skills, there will surely be occasions when they are faced with a choice – get deliveries out each day irrespective of the fact that non-conformances should be raised for one thing or another. At Goods Inwards, allowing receipts to proceed when they should be investigated further because the pressure is one to get the material allocated and used.

Keeping instruments in use perhaps when they are known to be out of calibration or damaged because withdrawing them would stop the production line.  The list goes on and on and I’m sure you have seen and could add many more scenarios. On top of that he is excluding himself from being able to audit so many aspects on the internal audit schedule because he is clearly not impartial to the workings of the process.  

So, care needs to be exercised when making the selection.  Production staff have enough to do already so look around the company and see if this role can be an opportunity for someone to show their potential perhaps. There is saying that if you want a job doing well then give it someone who is busy, but on this occasion perhaps not.

Have you ever faced that situation?  How have you got the company to reconsider? Please share.