Archive for the ‘Quality Policy’ Category

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.

Understandably a lot of focus is put on getting the quality system ready for that final audit but the need to do likewise around the site shouldn’t be overlooked. Whilst some may view these as very basic, those undertaking this audit for the first time might benefit from the prompt.

Housekeeping is an obvious one for starters. Go round the shop floor and have a tidy up – assuming it isn’t already engrained in the company culture that is. First impressions are important as they say. Get old machinery and parts out of the way and redundant stock and work in progress sorted. The same applies for office space as well so don’t forget to check that it all looks reasonable and make sure nobody has ferreted away old procedures if you have had to issue hard copies.

Walk round and convince yourself that, by what ever means you have adopted, orders are clearly identified. Rectify any areas where you are left scratching your head before the auditor does likewise. Also check that documentation relevant to these orders is in place and legible and hasn’t ‘wandered’.

The system itself should be sorted but no harm in getting someone to do a final sense check. Go through the master manual of documents to make sure nothing is missing or you’ve not generated some spurious revisions by some erroneous cross references. Don’t forget the intranet if you base your system on that as well. Check all the links work before you end up enduring that embarrassed silence when the auditor can’t make any progress through your system. Might be worth checking the backup regime whilst you’re at it to ensure the save has been validated i.e. would it work if called upon.

Ensure the Quality Policy is displayed around the place and that staff have a basic understanding of it. A good place to display it is on the log-on screen of your IT system if that is possible. Ensuring you have done all your internal audit programme and at least one Management Review meeting should be a given. However, don’t be afraid to do another MR meeting as the system gets up and running during that pre-audit period if it helps control the workload.

Finally, don’t forget your colleagues as you are going to need their help on the day. Make sure you have communicated the programme for the day to them so they know when and where the auditor will visit. Explain that you as the Management Representative (or your delegated colleague) will be with the auditor at all times but only as a guide and observer since the auditor will want to talk to them. Obviously tell them to keep to the area under discussion and politely respond to the questions and clearly ‘avoid going off on one’ if you know what I mean!

That way everybody is ready for the visit and the site looks its best – but then it always does, doesn’t it?

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.

It is pleasing to hear that these guides are actually starting to make a difference to my subscribers with one recently responding:

“So far you have already helped me with our supplier quality management and prompted me to add audit corrective actions onto the database I use for product non-conformances so I can review them all together. I couldn’t wait for the last one to arrive”.

I have therefore now uploaded more samples from this series that are aimed at Management Representatives of companies using the standard so as to support them as they manage and develop their system.  With subscribers now on board in Germany, Italy and China you too can check out content before subscribing.

The latest topics added include Control of Non-Conforming Product, writing the Quality Policy; setting Quality Objectives and using a Skill Matrix for training records.  Others will follow on Sales orders, Works orders and Document Control.  The full series will grow into an indispensable guide for the Management Representatives and Quality Professionals alike.  Check out one on Quality Objectives here:

You can find the full set of samples on Utube on the QualityAuthority channel or go to the web site to take up the free subscription for the full series of ISO 9001 Training Guides.

Where do you put the manual when you are creating a quality management system? Some start with it so that it maps out what procedures and work instructions or standard operating procedures need to be written. Others leave it till the end so they can capture all that has been created in the second and third tiers. Personally I prefer the latter.

Either way, as I prepare to do some training videos on two of the major elements of the manual – quality objectives and how to link them to the policy – I began to wonder what form manuals take nowadays. Not that far back we all religiously slaved through the standard regurgitating the wording back into our manual as if we might hypnotize auditors into thinking we had understood what the standard was asking us to address.  Couple that with Times New Roman font and we thought we had a winner.

Fortunately things have progressed and most take the opportunity to produce a slimline version that looks the part in this day of advanced desk top publishing techniques.  I came across this article that gives a good overview of how you should select the content so have included the link here.  What’s your style and preference and just how slim is slim?  What have you dared to put to an auditor in the past?

ps: As for the videos they will be part of my ISO 9001 Training Guides and you can subscrive for free here.