Archive for the ‘Quality Management’ Category

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.

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.