Posts Tagged ‘Quality Management’

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 🙂

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.

 

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.

 

 

 

 

 

 

 

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.

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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.

 

 

 

 

ShredderYou doubtless pondered over this when transitioning or installing the 2015 version. If you were transitioning, should you commit to not only the manual but the mandatory six through the jaws of your shredder as well. (Yes, I know Preventive Action went anyway but let’s run with it yeah)

In reality,  having talked to my sites during that period, they were retained as useful documents and the temptation to run amok resisted. It was a bit like some of us 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. But what of companies getting certified for the first time with 9001:2015?

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 their heads round the requirements in QA.

As for the rest that really depends on the skills and knowledge of the team 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.

 

 

 

 

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 “Well 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”.

When you ask if there is any other document containing this information then you are told “No, we’ve always done it that way”. 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’t 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!

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?

That might seem an odd question but it was the one that CQI’s CEO Simon Feary asked of the local Yorkshire Group recently when we met at Leeds earlier this month.  Simon is currently ‘on tour’ going round the various regional groups to get feedback on this issue.  He also wanted to let members know that he has a vision whereby the CQI will become a ‘must join’ body in 2016.

But why?

Well, you may remember some time back there was a certain report issued stating that there could be a serious amount of money added to UK PLC if more companies made use of a quality management system (QMS) within their businesses.  There was a strong feeling that this would seriously raise the profile of the quality professional, but what happened – nothing.

Likewise, over recent years there have been numerous failures within businesses that can be taken as good examples as to what can happen without the controls that a QMS brings to a business.  Remember the financial meltdown of 2008, that oil spill in the Gulf of Mexico, the contaminated baby food in China, the fiasco with the food supply chain here in the UK, the irregularities with the tender process for a UK main line rail route and so on and so on.  However, what was the outcome as regards us Quality professionals – nothing.

Why was there so little interest?

You begin to wonder what has to happen in order to get the Q word used and accepted as a must have in the future, so why was it met with such apathy. The belief is that the media don’t really understand what quality is, after all how would you describe it?  The common threads that come through from these disasters is the ‘risk to the brand’ and the ‘high costs’ incurred – not forgetting that lives were lost both as victims and management.  Some would argue it also brought, and may still bring, some of the businesses perilously close to the edge.

On a much smaller scale, I recall offering an article to my local respected business newspaper on the benefits of 9001 to SMEs only to be asked – what’s 9001?

Do you know the way forward?

So, have you any ideas as to what the Quality community needs to do to make itself sexy?  Let’s be hearing from you via this blog.

CQI article – November 2012

This latest in the line of good content coming out of the CQI reflects on what they and I can only describe as a missed opportunity following the recent report on how much buisnesses adopting a Quality Management System in the UK could yield the GDP.

Having been asked to a meeting at BIS, Simon Feary talks us through the lacklustre response from them that basically revolves around their stance that they don’t see it as their role to tell business what to do. Maybe not in terms of operational specifics but surely some support and encouragement as to what might be a useful gconcept. Give me strength.