Archive for the ‘Preventive Action’ Category

Anybody going around a company performing a quality audit might be forgiven for thinking such issues lie within the 18001 health and safety scheme Рbut think again.  It beholds us all not to disregard a situation that impacts adversely on employees health and safety within the workplace.

Now this goes beyond the statutory (law as on the statute books) and regulatory (as required by an organisation) stipulations in 9001 which are there in relation to the product or service being provided.  For example, producing vehicles need you to comply with all the relevant requirements to get a vehicle on the road such as MOTs, Road Tax and perhaps Certificates of Compliance dependent upon where the vehicle originated.

However, if on walking around the workshop as you conduct your audit ( assuming you do get out of the office of course ) you spot a set of jacks or ramps with a vehicle hosted in the air but clearly in a more than precarious position you are at liberty to bring it the attention of the site representative.

How about¬†walking around a paint¬†spray shop full of paint and vapours only to find an unprotected oxy-acetylene welding rig bang ( sorry ) in the middle of it all;¬†bar stock in racks with the heaviest stored at the top instead of the bottom or the FLT¬†driver lifting these down by balancing them on the forks because they don’t use pans on the racks;¬†a dirty and noisy shop floor where operators have no option but to eat their snap ( sorry, food for those south of Birmingham) by their machines¬†because there are no canteen facilities or¬†a work space¬†where heavy components¬†have¬†to¬†be hand carried because¬†of the lack of lifting tackle.¬†Now, these may seem far-fetched and I’d agree except for the fact I have seen them! I’m sure you can think of others.

So, even though it doesn’t sit formally inside your audit, remember to raise such issues to be, literally, on the safe side. Imagine how you would feel if you walked away from site then the next day you heard of an accident related to what you witnessed the day before. ¬†You have a duty as a quality professional and it is also another means of adding value to the audit.

ps: If you feel incomfortable because you haven’t got¬†a definitive section of¬†9001 to lean on then why not suggest it as a preventive action?

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 Рand 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 ‚Äď 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 Рespecially 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.

One of the most confusing aspects for management representatives to get their heads round when taking on a quality system has to be the concept of Corrective, Preventative and Preventive action.  As they return weary eyed from their auditor course and laden with notes and forms they have to be clear which one to implement and when. I have recently had this conversation again with a client so thought it worth repeating here.

It’s here where we start

Corrective action is the one that invariably gets used first.  If you raise a non-conformance you tackle the one more often than not isolated product or service affected to get it resolved so the order can move forward.  If you raise a CAR on an audit then whatever sample you have viewed and taken as objective evidence to justify a CAR needs tackling.  Both these are immediate actions to stabilise the product, service or system.

Now system failures require you to¬†prevent¬†the problem recurring – it’s happened – but how do you ensure you are not faced¬†with¬†the same issue in the future. ¬†That is the Preventative Action. ¬†It might take a bit¬†longer¬†to both think of it, implement it and to test it remembering that you need something concrete to prove to yourself that it has worked. ¬†It is worth adding that if your root cause¬†analysis on your non-conformances¬†reveals¬†a recurring theme,and I recommend¬†three¬†occurrences¬†over a short space of time here, ¬†then you should move that issue onto a CAR as well¬†because¬†it is no longer an isolated instance. ¬†There is no need for absolutely every non-conformance to lead to a CAR – unless of course the customer¬†concerned¬†demands it!

Don’t make this mistake

Just stating ‘staff to be¬†retrained’ or ‘procedure to be changed’ or ‘additional data to be recorded’ isn’t sufficient on its own. ¬†You need to be sure that changes have been¬†implemented¬†and followed so you need to use subsequent¬†quality¬†records as objective evidence. Perhaps in the above scenarios – a short test to demonstrate understanding; an audit on the problem area or a measure of the new data being recorded. ¬†The other point to remember of course¬†is that the action may fail to be¬†effective¬†in which case you need to start¬†again¬†and think of an alternative.

The missing piece

So where does Preventive Action come in?  The distinct difference here is that nothing has gone wrong with the product, service or system Рyet!  However you have spotted a likelihood of failure unless you take action to prevent it.  So your inspectors are working OK but in dimly lit premises so you feel it is only a matter of time before their judgement is compromised so the lighting arrangements are reviewed; machinery or transport is overlooked and so struggling more and more to perform prompting for a maintenance schedule to be created or a member of staff is clearly unsure of a new process so you quickly arrange additional training.

It is a totally different situation hence it should have its own place  Рand form of course Рin the system.  All aspects of ISO 9001 are featured in the free ISO 9001 Training Guide videos with samples available by clicking the link.