Posts Tagged ‘Internal Audit’

No, I don’t mean running around the office shouting your head off about who’s done what wrong!

canstockphoto17671331

This is all about making sure that you classify your corrective actions into one of three groups to aid subsequent analysis. Now, I should add before going any further, that this is my bespoke way of dealing with this issue but I find it really effective. Here is the first category:

SD – System Disregarded

A minor CAR here as the procedure is fine and current but, for whatever reason, staff occasionally decide not to follow bits of it (as opposed to blatantly ignoring everything). Perhaps they are not signing off all the boxes; stamping a document or filling in some information. You need to do a really good root cause analysis to find out why of course.

SI – System Inadequate

Another minor CAR and the most common as it refers to the system being out of step with what is actually happening in the office or on the shop floor. Invariably it is when you see the procedures not outlining what exactly happens out there. In one sense it is a good thing because it shows the processes are being developed – it’s just that someone forgot to tell the Quality Manager to amend the procedure! What do you mean that never happens where you work!

SN – System Needed

This is the worst case and a major CAR because there just isn’t system that you can evidence. For example there is no audit schedule so nothing else can follow without that; there is no contract review of sales orders against customer purchase orders or no management reviews take place etc etc.

Well, I hope you like the sound of that and can see the benefit. By all means tell me how you dress this aspect of your system by commenting below and remember that more useful support can be found at http://www.iso9001supportcentre.com.

ps: Some exciting news coming soon on the 9001:2015 training video front soon.

 

 

 

 

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?

Over the years there have been many instances when I see sites pin their ‘flying colours’ to the mast after their audit and it makes me wonder because I know for a fact that the site in question has major issues,  For example, the system hasn’t been managed for months; internal audits haven’t been done and customers have raised serious concerns.  So how come a third party can give it such a glowing report?

In fact I can remember one such site where I was called in to do a resurrection job because a major customer had serious doubts over the certification body whose certificate hung so proudly on the wall.  After a little bit of digging I came to the conclusion that the customer was right.  I couldn’t put up any defence, the system was in a mess – so who was helping who?

This is a timely comment in view of the latest, and some say controversial, version of ISO17021 coming out last month.  The standard now sets out requirements for auditor competence as well as the actual auditing of a system. Its purpose is to set the standard for certification bodies so as to increase the level of trust associated with the role in certification.  They have two years to bring it to fruition so it will be interesting to see if we see a reduction in the number of ‘flying colours’ in that period.

My belief has always been that an auditor should be offering a balanced assessment of a QMS, but if there are any deficiencies, particularly glaring ones, then they shouldn’t shy away from their responsibilities and should report the issues accordingly and look for suitable corrective action.  It does nobody any favours just to keep that certificate on the wall when all around it is falling down. Can you share any similar horror stories?

Tips on auditing are part of my ISO 9001 Training Guide videos currently available on free subscription.

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.

I have been getting a bit of auditing done myself around a site or two these past couple of weeks which made the videos on auditing in the first of the series of ISO 9001 Training guides somewhat opportune. After all, I must practice what I preach!

With interest growing nicely for the videos I have decided that there’s no harm in putting a few out there for public consumption hence the release below that looks at five common mistakes when auditing.

As well as the need for the obvious ‘controlled’ approach there is also a requirement for the auditor to enter the arrangement in, shall we say, a ‘constructive’ frame of mind. Something that sometimes get overlooked.

Mind, if you are sat there thinking that you could add to this list based on your experience then please do. That way we can offer even better advice to those working on ISO for the first time. It’s for that reason that I’ve started a forum group on LinkedIn so feel free to join the ISO 9001 Training Forum on LinkedIn to further exchange ideas and opinions and build a useful resource.

The full range of guides can be accessed for free from my web site here.