Archive for the ‘ISO 9001 Training Guides’ Category

Well it is fair to say that not everything works out as you planned it.  Having launched the App three years ago and having amassed around 2200 followers in over a 120 countries that may seem an odd statement to make.

file.jpgHowever, despite those impressive stats there is one that dwarfs both of those – simply nobody appears to want to interact with this cutting edge technology in relation to 9001.  Having placed videos up there, podcasts, surveys and much more there still appears to be a reluctance to communicate. Fair enough, some companies won’t allow mobile phones to be used at work for work but it still came as somewhat of a shock as I developed the content over the years.

Never mind, onwards and upwards as they say. I intend letting all my 9001 Supremos know of this and tell them that my main activities will now be centred around this blog  That can be the usual posts or videos, presentation and the like. You of course already know that now 🙂

If you have subscribed to it then by all means do tell why it might not have lived up to expectations.

Finally, may I take the opportunity to wish you all the best and every success for 2017 and remember – Make Your Quality Stand Out! Some exciting items coming to this blog in the New Year and as always check out the latest from the Support Centre here.

 

 

 

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.

 

 

 

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!

Now this is a crucial part of your QMS mainly because it is often the area that auditors start with in order to gauge how well the system is being maintained.  If you think about you can understand why as it defines several aspects all in one document.

How is the system fairing; are things getting better or worse; how committed are the senior management; do you table good data for review, have you logged issues and ideas in order to move the system forward.  There is so much it can do for your system it pays to get it right.

Non ConformancesFirst off make sure the right people are invited and more importantly attend.  If the top person is away then set a date when he or she is available.  Issue the agenda in line with what is listed in 9001 but add to it so it reflects what is happening to your business.  Don’t be afraid if the number of items get into double figures as this is your one chance to get everything discussed.  Having said that you are not constrained to holding just one a year , so if two or even three are needed because of the importance and or workload then go for it.  Certainly as a company moves towards the stage 2 audit it makes sense to have several on the books before the auditors come in.

Now comes the need to prepare all the data – and that can be quite daunting and time-consuming for people running a system for the first time.  This is where you need to hone your spreadsheet skills, assuming that you can extract the data in the first place.  Many companies are tethered to mainframes and struggle to access the all important records but you need to find a way. In addition try to get a measure of throughput so you can quote percentages rather then absolute figures.

Remember it is what it says – a REVIEW – and a balanced one at that so praise the successes and sort the failures. Make sure you graph up your data to show trends over a relevant period of time, ideally the current calendar or financial year.  Don’t just focus on what has happened since the last meeting as you might miss something important. A picture is far better than loads of tabulated records or, heaven forbid, a random verbal report!

Percentage NCPDon’t forget to use the system in that any areas of the QMS that are failing should a CAR (Corrective Action Report) issued to control whatever action you have decided to take.  Any ideas for improvement should go on a PAR (Preventive Action Report). Those in aerospace will also have the joy of working though the PEAR metrics in addition to the basic quality objectives – all good fun.  As for the minutes, make sure they are clear and concise with clear ownership of action points to a person and an agreed date of completion.

Allow yourself plenty of time for the meeting to ensure a full and constructive discussion.  By reviewing trends rather than specific records you will often find that this triggers some really good creative discussion as people step back and have a good look at the system as a whole. Finally, don’t rush things at the end because you are running out of time. Be brave and suggest an adjournment and organise a second session – it’s that important.

If you are struggling for guidance on 9001 in general then don’t forget the free videos here.

I often get asked this as sites get close to bringing in the auditor so I put together this summary of what I would expect to see in relation to the five main paragraphs so it is possible for anyone to gauge if they are ready.

How much of the system?
The QMS should have been operational for at least 4 – 6 months with quality records created in every section of the system.  A full set of controlled procedures, work instructions and forms should be in use backed by an effective record retention system.  Evidence of controlled issue of such documents either electronically or as hard copy needs to be visible.

Clearly at least one Management Review meeting needs to have been undertaken with minutes on file and adequate resources in place – especially the Management Representative! An effective Quality Policy and objectives should in place and understood by staff.  The scope needs to be adequately declared with a note of exceptions from Section 7 and the company should be able to demonstrate an effective means of communication to the staff, perhaps a newsletter, notice board items or briefing sessions.

A full set of training records need to be on file for employees plus a means to determine training needs and requirements e.g. a skills matrix. The relevant aspects of infrastructure and environment would be addressed as appropriate and a current Organisational chart visible for all to see how they fit into the structure.

Where it really counts
Operational procedures should be complied with in Sales, Purchasing, Design, Calibration and Production and control of identification and status evident throughout the company. You need to be adhering to your Approved Suppliers and Subcontractors List with adequate inspection from Goods Inwards, In process through to Despatch.  Customer property needs effective control if relevant along with preservation of product in stock, in process and on despatch.

All internal audits have to be completed in accordance with your schedule by a qualified auditor and corrective action reports documented and action in a timely manner. Evidence of Quality Objectives and their measurement is required so as to demonstrate continuous improvement and you must have effective control and analysis of non-conforming product.  Finally, clear evidence of customer satisfaction data collection and evaluation should be present.

Help is at hand
After all that if the Management Representative wants some moral support then he can subscribe to the free 9001 Training Guides. You can find a full set of samples on Utube on the QualityAuthority channel or click on this link to go to the web site to take up the free subscription for the full series of ISO 9001 Training Guides.

Over the years there have been many instances when I see sites pin their ‘flying colours’ to the mast after their audit and it makes me wonder because I know for a fact that the site in question has major issues,  For example, the system hasn’t been managed for months; internal audits haven’t been done and customers have raised serious concerns.  So how come a third party can give it such a glowing report?

In fact I can remember one such site where I was called in to do a resurrection job because a major customer had serious doubts over the certification body whose certificate hung so proudly on the wall.  After a little bit of digging I came to the conclusion that the customer was right.  I couldn’t put up any defence, the system was in a mess – so who was helping who?

This is a timely comment in view of the latest, and some say controversial, version of ISO17021 coming out last month.  The standard now sets out requirements for auditor competence as well as the actual auditing of a system. Its purpose is to set the standard for certification bodies so as to increase the level of trust associated with the role in certification.  They have two years to bring it to fruition so it will be interesting to see if we see a reduction in the number of ‘flying colours’ in that period.

My belief has always been that an auditor should be offering a balanced assessment of a QMS, but if there are any deficiencies, particularly glaring ones, then they shouldn’t shy away from their responsibilities and should report the issues accordingly and look for suitable corrective action.  It does nobody any favours just to keep that certificate on the wall when all around it is falling down. Can you share any similar horror stories?

Tips on auditing are part of my ISO 9001 Training Guide videos currently available on free subscription.