Posts Tagged ‘Corrective action’

canstockphoto23069450
Let’s be honest, nobody likes to receive a Corrective Action Report. Whoever is on the receiving end more than likely takes it personally and probably finds every reason under the sun to get out of taking responsibility for it and taking action to sort it. So, begins another day in the life of a QA man.

I see this all too often so hit on the option that is so simple if you are really facing this where ever you work – just give the form a different name!

We are all told when we undergo our auditor training that wonderful acronym of – Audits Uncover Defects In The System – so we should promote that on this occasion. Why not try a System Deficiency Note which trips off the tongue nicely as an SDN? In addition you could consider using System Enhancement Note for the PARs – but you’ll have to be quick to get any mileage out of that I guess 🙂 If you haven’t heard it is removed in the 2015 version, although I still think it can serve a purpose when recording action to mitigate ‘risk’.

I am sure many of you have already come to the same conclusion so share how you have retitled your CARs. Remember you can get more support in the form of training, the free App, virtual mentoring and videos by clicking through to the 9001 Support Centre.

ps: You can of course use the idea in any management system, not just quality.

 

 

 

 

.

Just What Makes A Good Audit Sample?

Now if you are responsible for internal audits at your place of work there is a fair change you are limited for time. You therefore accept that you are only going to check a sample in relation to the process being audited – but just how many records does that mean?

Now, I am not getting into a discussion here as regards statistically valid numbers, more of deploying some common sense based on what I have seen over the years. You, like me, start off with good intentions so perhaps half a dozen orders may get sampled at the start, then that reduces to three or four but as time goes on you fall into one of two traps.

You start picking just one order out and worse still you keep using that one to satisfy several questions on your checklist/ flow chart as both time and energy start to ebb away.

Ok, well that ‘s understandable on the basis that it tails off at the end, but the real issue is if you only ever start with one order right st the beginning. So, what then is the rule of thumb?

I am a great believer in the rule of three so do my best to use that at the start. Hopefully you find all three are good so move on, but if not do remember to resample before writing out that CAR. If the second sample re-enforces your view that there is something untoward then fair enough, but at least you have given it a fair chance.

One final point. If what you find is simply of an admin nature – signature missed, reference number missing or paperwork misfiled – can I suggest you get it sorted during the audit rather than being dogmatic and raising that CAR. That helps all concerned 🙂

However, I am not suggesting for one moment that my numbers are set in stone so do share how you deal with this part of the audit process.

This is not a new subject as such on this blog but one that needs constant attention. So many companies I work with don’t get how important it is to allow sufficient time on corrective action when they come to fill in the form.

The correction and containment is the immediate and short term action that needs taking to resolve whatever problem has been flagged up. You then move onto using the 5 whys to determine the root cause as to why you had it.  It is absolutely critical to get this right and investigate what is the real cause so that the subsequent correction action doesn’t chase the wrong reason.

Then comes the corrective action to stop it happening again.  In addition to an action, which might be feasible in a matters of ‘days’, you need to allow time so that the people involved ( not the auditor ) can convince themselves the action has been effective.  Then you call back the auditor. Now this might take ‘weeks’ or even ‘months’, particularly if linked to a subsequent report or meeting.

For example, you appoint someone to cover some duties that have fallen over. Fine, that might be done very quickly – but how do you know the person is going to be effective?  You give them a month or two to demonstrate that backed with some report or presentation into management. A process falls over so you agree to add an extra control to prevent it happening again.  That is introduced immediately – say via a computer procedure – but you need time to demonstrate the problem has been effectively sorted.

The two actions on a CAR form are not both quick fixes so that you can get them off your back.  Whilst the standard requires you to deal with them in a timely matter, it is not the green light to shortcut the process. Corrective Action needs time.

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!

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.

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 – yet!  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  – and form of course – in the system.  All aspects of ISO 9001 are featured in the free ISO 9001 Training Guide videos with samples available by clicking the link.