Archive for the ‘Management systems’ Category

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, the audit schedule, training skills matrix, corrective action register, non-conformance register and the form amendment record itself. 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.

A working solution if you are in this situation is to add a ‘Working Copy’ date to the form in addition to the Revision reference and date. All these date changes get included in your index which itself can now work on a ‘Working Copy’ date but only when these nominated forms get updated. For everything else it goes up a revision.

They wouldn’t get added to your Form Amendment Record because you are just filling them in but would clearly show what ‘working’ version was current 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. However, just 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.

 

 

 

 

 

 

 

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.

The use of flowcharts causes much discussion, with everyone having an opinion as to the best style and structure. However, what’s all the fuss about when they are not even mandated as part of a QMS?  9001 states that the QMS can be recorded on any format so why not carry on doing what we always did and write those text based diatribes from yesteryear.

Flowchart

A picture speaks a thousand words

Well, for one, those of use running systems should always be developing them towards best practice.  With the emergence of a visual representative within the lean philosophy there has been growing pressure to move other management systems into line.  Secondly, the solely text based system is no fun to read, particularly if  formatted as if paper was going out of fashion, and a nightmare to write thus failing to address the requirement in the standard for ‘effective communication’ to those involved.

Now admittedly we could veer off here into learning patterns, but most would agree that a visual procedure wins hands down being more popular as a learning tool with most people. They also prove more efficient in trouble shooting a process in the first place when people get down to mapping it out.

Another serious disadvantage is that it doesn’t effectively depict ownership too well as they tend to be written in the sequence of the process so it jumps around the relevant departments and personnel.  A flowchart works far better with its ‘swimming lane’ approach as you can see ownership move before your very eyes.  Users can also scan it quickly to see how much of the process drops into their lap!

Personally I don’t advocate spending endless hours making sure you have the right symbol for absolutely every box, make do with a basic set that everyone understands.  However, it is useful to bring out key operations like Hold points with a symbol and colour that catches the eye.

Finally, for those with the skill, you can hyperlink the various operations in the process to any other part of the system.  Could be related procedures, forms, work instruction – just about anything that the user needs to have at their disposal.  That with a cool format makes them far more likely to be accepted and read.  Would you agree?

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.

Well who would have thought it. That recent report by Sir Philip Greene has condemned Government procurement practices as ‘shocking’. He then goes on to quote examples that are just too bizarre for words. Yes I know this is nothing new but uncontrolled and inefficient processes, coupled with a lack of understanding and ownership and performance measures, just appear to be rife.

Wouldn’t you just love to get amongst it all and sort it all out. The framework is there with ISO and businesses have to comply so why should politicians be exempt. Now today I read that whilst Sir Philip raised concern over the current practice of payment within five days to suppliers, to the point of negotiating later payments, the latest Enterprise Czar Lord Young wanted prompt payment to SME to be retained.

You could have a field day.   I have to admit that can’t quite see frustrated Quality professionals marching on Downing Street, but come on where would you start?

When putting together a quality system it goes without saying that you will need to build in numerous measures relating to various processes around the business. Now most of these will often be new to a site so you need to carefully explain what is required and why. However you enter into this phase almost taking for granted that the basic measures of a companies finances, throughputs and performance will already exist so you can just build on them – not so it appears.

It always takes you by suprise when these basics have been overlooked so you end up spending time foraging for ways to get them defined as well. A considerable amount of financial information often exists but is invariably secreted away in a financial package that only a few people have access to, whilst planning and throughput information may be hampered by being within a very manual system so making it very labour intensive to extract. At worst, this can even prevent a regular review of performance by the management team.

You therefore need to be ready to establish early on just what exists before you try to add the ISO elements. This is simply achieved by asking such questions as:

How many order lines get booked in off purchase orders, processed through the factory and delivered to customers each month? This is crucial for the non-conformance part of the standard where you ideally need to quote the occurence of problems as a percentage of throughput.

What percentage of order lines do not meet planned margin? Any salesman I have ever known wants to be knowing that immediately so a dynamic report as each order line is closed is better than having to wait for the month end.

How many days does it take to issue a quotation? This is a good potential quality objective that links back to customer satisfaction but it is suprising how many companies are happy to expend time and energy creating elaborate quotes then forget to measure how effective their process really is.

There are many more so what would be your particular favorites?

ps: The one concerning margins can be converted in to a really cool quality objective with a killer customer focus. If you need help with your quality system then get in touch via the web site.

Companies who install quality management systems are often left to their own devises once the system is installed. To me this is the time when they need the practical support so they get their house in order before the audit. Having worked with many sites to put a system in, I have been very staggered by the lack of good stuff out there so have decided to do something about it. Check it out via this ISO 9001 Training Guides link and let me know what you think. The main web site is here.