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 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.

 

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 ‚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.

 

 

 

 

 

 

 

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 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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šľöŤ≠įWhen 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 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.

 

 

 

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!