Posts Tagged ‘ISO 9001’

I have uploaded a video that was taken when I presented this as a talk at the Sheffex Exhibition in Sheffield back in November 2017. I sincerely hope that most of you won’t have to read it because you will have transitioned or at least are on your way.

However, on top of the certification bodies telling me that at the end of 2017 some 25% hadn’t even started, I am now hearing of companies that are in that position plus certification bodies are running out of dates and auditors. You will see a brief summary of the benefits of 9001 but, as they didn’t start the recording at the start, you need to know that the three management styles I refer to at the beginning are:

headless chickens
blue a***d flies
and busy fools

What follows is a review of the new requirements and then a simple strategy to get you upgraded to the new 2015 version. Along the way you may also get the feeling that the technical gremlins were out in force as well – and you’d be right ūüôā

Be good to hear feedback from as to your experience of the transition where you work and remember that there is more useful information at the iso 9001 support centre.

 

Peter&Helen WB smallIt can take a while to get a case study completed ¬†– but isn’t it worth it! Read on . . .

Turner Hire & Sales Ltd have been established in South Yorkshire since 1972 hiring and selling industrial plant from their branches at Rotherham, Wath, Worksop and Sheffield. The company decided they needed to give their customers a clear signal of their desire and determination to provide an even better quality product and service. This led them to look at the international quality management standard ISO 9001 and search for a local consultant.

In doing so Managing Director Mick Holmes came across another Rotherham based Chamber member, Pete Thornton-Smith of the 9001 Support Centre at Thornbank on Moorgate, at a Quality Conference in Sheffield back in 2014. They soon struck up a good understanding of the work required and how to ‚Äėmake it happen‚Äô.

Mick makes the point, ‚ÄúI always feel much more comfortable working with local experts and found that whoever I asked, one name kept getting recommended, so Pete was subsequently engaged to work with Quality Manager Helen Hollingworth and began working with Turner Hire late 2014 and we are delighted with the outcome‚ÄĚ.

‚ÄúPete demonstrated a vast amount of knowledge as regards the standard but more importantly, how to work with us to ensure that we installed an effective system that everyone understood. A jargon free area if you will. In addition, we threw him a few curve balls it has to be said, but he calmly dealt with them and returned them with interest‚ÄĚ.

Mick goes on to say ‚ÄúThe certification of compliance with ISO 9001:2008 recognises that the policies, practices and procedures of our firm ensure consistent quality in the product and service that we provide to our customers. With this certification, our customers can be confident that Turner Hire & Sales Ltd is dedicated to maintaining the highest efficiency and responsiveness in achieving our ultimate goal ‚Äď guaranteed customer satisfaction‚ÄĚ.

‚ÄúAchieving the certification was a smooth and natural progression for the company, because it essentially formalised the structures, standards and processes we already had in place. Having gained certification for all our sites at the end of 2015 with ISOQAR, we are in a much stronger position commercially and have been delighted to see the benefits that Pete talked about early on in the project‚ÄĚ. Peter and Helen are pictured with the certificate.

It goes without saying we would recommend Chamber members to collaborate together as much as they can and if you need 9001 (and 14001 or 18001 for that matter as we do) then Pete‚Äôs your man. He really does ‚ÄėLighten the Load‚Äô.

You can contact turner Hire and Sales on 01709 828444, www.turnerhire.com or email them on enquiries@turnerhire.com

As always Pete can be contacted at the ISO 9001 Support Centre on 01709 301303 or via his website www.iso9001supportcentre.com or email at  pete@iso9001supportcentre.com

 

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
*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 ‚ÄėWorking Copy‚Äô (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‚Äôt 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 ūüôā 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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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 Рif 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.

 

 

 

You Need A Management REVIEW Not A Meeting!

A lot of companies take the easy route here I guess and assemble the good and the mighty around a table to perform the Management Review – yet nowhere in the standard does it state you need a meeting.

Now I agree that it would take a strong lead to suggest that you do it in any other way, but provided you have a clear set of data in a suitable form plus the output as a set of clear notes, actions and dates then you can if you wish. Just chill out over a coffee or grab the opportunity when the required people are free.

This could allow you to effectively chunk down the elements of the QMS to smaller pieces say every month rather than the long drawn out session each year. Bearing in mind the typical attention span of some of your team I wonder which would be more effective? Go on give it some thought and break the mould. Please do share if you already do something unconventional as regards your MR.

Now if you want to see some outlandish ideas as to a location then check this out – http://ow.ly/T5IhZ

First off, I need to say a quick ‘welcome’ to the new members of this group.¬† Many thanks for coming on board after seeing the blog. This is where we kick around some fresh ideas about 9001.

Now this time,¬†instead of telling a story in the usual format, I¬†have decided to throw a case study into the mix.¬† Let’s¬†see how well you respond to the challenge of actually putting your knowledge¬†into practice.¬† It’s just a bit of fun but, in all seriousness, I am sure you like me want to keep your skills honed and there is no better way in my opinion.

Bear in mind these two questions and leave your replies in the box at the bottom:

a. Would you raise a CAR based on what you know already and if so what would it be and which paragraph would you raise it against.

b. Are there any other areas where you are thinking there is a possible CAR but would seek out more evidence before making a decision?

CASE STUDY STARTS

The company is a single site and fabricates cabinets out of metal sheet by using a computerised laser cutting machine; a forming press; general machining and TIG and MIG welding.

You discuss the control of documents with the QA Representative and start by asking to see the Index and Change Control system. You are handed the Quality Manual and told that the index is at the back in an appendix. You verify a list of procedures only but note that there is no revision number included, only the title. When you query this you are told ‚ÄúWell if we added that then every time we amend a procedure then we would have to amend the manual which would be a real bind‚ÄĚ.

When you ask if there is any other document containing this information then you are told ‚ÄúNo, we‚Äôve always done it that way‚ÄĚ. You ask to see a copy of the relevant procedure for Document Control but are told they have never been told they need one which is when you spot it is not on the list.

You enquire as to how the procedures are authorised and reviewed before issue and how the company then communicates with staff that amendments have been made. You are shown that each procedure has the author’s name typed into the footer of each procedure with the date of issue and that staff aren‚Äôt told of amendments.

New or amended procedures are filed in the main binder with a copy in each of the 4 departmental binders (Sales and Purchasing office, Drawing office, Warehouse and shop floor) and the old version shredded.

CASE STUDY ENDS

I look forward to hearing your opinions and I will send an Amazon voucher as a thank you to whoever I feel puts together the best case.  Make your Quality stand out!