Posts Tagged ‘auditor’

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!

Anybody going around a company performing a quality audit might be forgiven for thinking such issues lie within the 18001 health and safety scheme – but 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?

So you need to do some internal audits for 9001 – but can you just be ‘competent’ as it states in the standard or is it worth going the whole hog and becoming ‘qualified’?  Certainly those of you who want to make a career of auditing are advised to take those few days away from the office on a UKAS approved course complete with an examination at the end.

However, what about those of us who will only ever conduct internal audits on our own system on our own site? Rather than the sterile classroom session wouldn’t it be better to get someone in to run bespoke sessions using your own system? That way you could use your own processes to help demonstrate the principles and, more importantly, ask questions to gain understanding as regards your own issues on site – get answers to to your specific questions so you can implement what you learn straight away. Sound good to you?

The formalities of this training can still be covered – session notes, multi-choice examination (even an open book one) plus a certificate of attendance for your training file. The question then is where do you look for such a session?

Well, having been asked on numerous occasions, I am now offering three half day sessions to do just that. The first is at my office in Rotherham, South Yorkshire to ensure you have a grasp of the principles. Then two more sessions follow but at your premises.  Here we get down to:

  • scheduling
  • preparing
  • conducting
  • and reporting audits

followed by how to raise and handle Corrective Action Reports through to a satisfactory conclusion.

All this closely linked to your system using your processes and terminology. You can even help set the agenda as I want the content to really be relevant to your situation. You will also receive copies of my report to take away “The five most common mistakes when doing internal audits”.

Finally, those last two sessions on site can be taken as a full day if you prefer and should distance be an issue then we can do them virtually over the web so you don’t need to miss out.

So, being competent will suffice if you know where to look – and now I guess you do – click here.

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.