Archive for the ‘Non-Conforming Product’ Category

Having gone to all that trouble to set up your Approved S&S system I know a lot of you then struggle trying to agree what course of action you should take to bring them into line should they fail to perform. ¬†After all, you don’t really want the hassle of sourcing an alternative – assuming there is one of course!

Understandably, you are not in a position to storm in and lay the law down for a company that you have no jurisdiction over. ¬†You wouldn’t like it if a customer did it to you I’m sure. ¬†However, this is where you start to work the magic of a 9001 QMS.

Are the basics in place?

By this I mean the list with suitable criteria for inclusion; a clear indication of who you will monitor for performance; what you will check; what metrics you will set and how you will control this part of the 9001 QMS. ¬†If you need to refresh these aspects then I suggest you click this link and go look at the training videos “9001 – The Collection”. ¬†A sample is included below if you are new to them:


Also remember that you need to be operating a robust Non-Conformance System so you have the right facts on which to base your case.

How to get them to read the performance metrics

First off make sure you are producing regular performance data which usually means once a month, although this can be flexed either way dependent on throughput. ¬†In addition to sending out an individual report of OTD,¬†Quality and say Concessions why not appeal to the supplier’s ego and list them in a league table against the other suppliers.

Combine all three ratings into one index and place the suppliers from top to bottom, but shade out all names bar the one you are compiling the report for as that way you don’t create any undo hassle between companies. ¬†I know a lot of suppliers who don’t react when they see just their own performance report, but change totally when they see how they compare with their rivals.

Choose your Weapons

Now to the sharp end.  Here are five courses of action I have used or seen used in the past so adapt them for your own business:

  • If you see a poor performance over three consecutive reports against your required targets then raise a CAR on them as clearly their system (or the people running it more like) aren’t responding to your reports which are effectively ‘complaints’. ¬†Simply follow the same process as you would for internal CARs.
  • If stock happens to be tested as part of your subsequent order processing but fails, even though the supplier certifies on a similar test that it has passed, then get agreement for a third-party to retest it as part of your Goods Inwards procedure. ¬†Do this for an agreed period of time or number of receipts before putting them into stock and charge the supplier for the costs incurred. I accept that this smacks of ‘manufacturing’ and ‘engineering’, but try an adapt it for your business.
  • Instead of dealing with random deliveries and quality at Goods Inwards insist on a pre-delivery inspection at their works by one of your staff or a nominated agent on repeated offenders so that you can filter out the rejections before they arrive. ¬† Clearly this impacts on resources and cost, but if it puts the performance back on track? Why not get them to bear some of the costs.
  • On the basis that you know others that are buying from this supplier, why not form a collective to tackle the issues on the basis that a group carries more weight than an individual. ¬†You have to approach this one carefully dependent on your relationship with the other companies but it is worth considering.
  • Finally, in this age of social media, have you checked if the supplier is on Twitter or Facebook? Forward thinking companies do this so they can hear what the customer has to say. ¬†I think you might have something to add there don’t you? ¬†Do not underestimate the power of social proof – or in this instance the lack of it. ¬†Having customers give negative comments on these platforms is not good, so is likely to solicit a reaction. ¬†Be careful though in what and how you say things, we don’t want lawyers involved now do we!

One parting shot

Ok I know some people will say that all this is unfeasible when the issue is with a sole supplier and you can’t do without them etc etc. ¬†I appreciate you have to be careful on the commercial front but, surely, isn’t it even more imperative that you find a working solution in that case? ¬†Views on that one welcomed in the comments box below.

Remember the basics of 9001 like this are covered in my free training videos. The full range of service from me are on my website.

Well, I guess many of you quality professionals are looking at the highly publicised failures within this particular business sector with your head in your hands, totally at a loss to explain how such serious issues can ever have been created.

As we know 9001 offers the basic framework by which to control business processes but above that you have far more onerous systems such and medical, aerospace, automotive and, of course, food.  How can such basic requirements as sourcing and identifying beef fail to the point that horse meat is allowed to enter the food chain.  Now OK the testing required may be expensive but there must be a possibility that a sampling process would suffice.  Mind, with all the testing that is now being carried on I wonder what the quality costs are running at now?

The supply should be controlled by the approved supplier list process backed by clearly defined purchase orders and adequate inspection on receipt.  The fact that all this seems so basic might suggest to some that a deliberate policy of ignoring the agreed procedures can be the only explanation.  One can understand some may be nervous of conducting a root cause analysis with that hanging over them as it may clearly be a complex situation. Looking at this article below it also appears that the recriminations are starting to fly. Just click the picture to open the full article.

Food scare

Whether there is another agenda involved here or not, make sure you quality principles remain intact where ever you work.  More advise as to how to achieve that at the ISO 9001 Support Centre.

It’s good to see this quantified in a recent piece of research instigated by the CWI (Charted Quality Institute) and CMI (Charted Management Institute) that states the impact on GDP which equates to 6%.

Who comes out on top?

It actually offers a UK Quality Comparison Table that shows Manufacturing at the top but makes the case that the Public sector could do better if it adopted the quality approach.  Some of us have been saying that for some time and I refer you to an earlier blog here.

However I digress.  As Simon Feary, CQI CEO, says:

‚ÄúThis research quantifies the contribution of quality management to the UK economy for the first time and in doing so shows that we cannot afford to forgo the huge economic, business and employment potential that it provides.‚ÄĚ

‚ÄúThese findings should send a powerful message to organisational leaders that quality management needs to be fully implemented in all organisations and to policy makers that they need to create an environment in which quality management is encouraged and can thrive.‚ÄĚ

The way to get the most from your QMS

One of the key areas where a good, well maintained QMS should assist is in the removal of waste and variation both of which can be costed to help get the message across to senior management.  In addition the non-conformance system can have all its elements assigned a cost whether it is the obvious cost of scrap components, rework or simply the time taken to process each record.

In addition, you may also be familiar with the concept of Quality Costs whereby the cost of Preparation, Inspection and Failure again drives awareness as to how the cost of lax controls and processes can harm a business.  At least, armed with this information, you can then move on to reverse the trends.

How to get the full picture

This is the link to the CQI press release and from the site you can get the full report.  However, for those with less time here is the article on this piece of CQI QMS Research from my CQI magazine that also contains three case studies.  If you want any help in putting some costs to your business operations through your QMS then I am more than willing to help.  Contact details are on my web site so just get in touch.

There should now be no doubt that a good QMS really can put pound notes on the bottom zone.  Spread the word people.

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.

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.