Archive for the ‘Auditor’ Category

Delighted to announce that I have uploaded six new videos that take you on a gentle stroll through the new standard as part of the series “Amanda Asks About Auditing”. We literally flip through the standard as I explain what’s different and where some of the existing items from 9001:2008 have been relocated.

Here’s a quick trailer so you can see what I mean and get a feel as to how we cover it all. It’s quite funky as well!

You can check out the full series here where you will also catch a glimpse in the VIP area of another video idea that we are working on.

Be great to hear what you think when you’ve had chance to watch it.

 

 

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 ūüôā

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.

Companies certified to ISO 9001 could have a surprise in store when the standard eventually gets revised from the 2008 version to that of 2015. Ok, so there is now an alleged delay I hear in that we won’t see this published until the autumn now but don’t rest on your laurels. ¬†You need to get ahead of the game on this one and hear’s why.

Some say it is the most significant change they have seen to the standard

However, companies will doubtless leave it to the last-minute thus putting themselves under pressure having less time to talk it through with staff ¬†and then introduce all the changes required of them.¬†Certainly the Owner,CEO or MD is being asked to be more hands on in the running of the system so that’ll come as a shock to most. ¬†No longer can it be bolted onto the business or simply viewed as a delegated task for one unsuspecting member of staff. ¬†Also, have they seen the significant changes in relation to that person’s role anyway or the documents that are removed and the processes that are added? Will they understand how to introduce risk management for example.

What action can I take?

Well, I am already chatting to certified companies to paint a picture as to what is coming their way with the new standard. I have attended sessions with no less than three certification bodies and am about to undertake my auditor transition course. I trust you are making similar arrangements whichever side of the fence you see yourself.

A good place to start

Here is¬†a trailer of my¬†recent webinar “9001:2015 – What’s All the Fuss About” to set the scene for you.

If you see the need to chat further then email me at pete@iso9001supportcentre.com and remember that you can also see it on my App in the Masterclass section. Just search on Apple or Android for :9001 Support”.

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 ‚ÄúWell 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‚ÄĚ.

When you ask if there is any other document containing this information then you are told ‚ÄúNo, we‚Äôve always done it that way‚ÄĚ. 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‚Äôt 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 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?

Nowadays people tend to be comfortable with the idea of electronic signatures, not so much a password controlled image that is but just a name added usually to the footer of the document. It more often than not is the person who has written it which, in order to get the job done, is the QA person.

Personally, I am not convinced this works on two levels. The need to demonstrate documents have been reviewed before issue and the perhaps more nebulous one of instilling ownership with the process owner with a view to making it an effective process.

It is for both these reasons that I recommend that you adopt a double wet signature approach. First off, the process owner ‘authorises’ the procedure in that he or she accepts that it reflects how the process works in their department. Then the QA Representative ‘approves’ it in that it complies with the document control procedure and would stand up to audit.

If it get’s left to the QA person how do you know the head of department is happy with what has been written. They may not have even seen it!

Nothing beats signing off a document to get ownership, so I would always recommend that you consider this approach. Do you agree?

I must confess to being quite surprised and disappointed at the number of times that I still hear the story about the 9001 auditor who dutifully conducts the surveillance audit but never goes out of the office.  Gallons of tea or coffee seem to be consumed together with a significant number of your custard creams, bourbons or garibaldis.

The kicker here is that whilst the company inevitably gets through the audit with little or no admonishments, the owner or CEO is left to pick up the tab but often feels disillusioned (or some have said cheated). ¬†This is because, being interested in more than just the ‘badge’ – which is commendable, they know the shortcomings in their system and are looking for the opportunity to discuss possible ways of dealing with them – but it needs the auditor to pick them up first. ¬†Certainly, if they never even go for a look round then the chances are slim.

Here’s how it impacts on the Management Representative

Such omissions make the life of the management representative even harder as the rug is pulled from under his or her feet when their protestations about what the auditor will see when he comes in all goes up in smoke. ¬†“What was that all about?” comes the reply from colleagues. ¬†See, we can just wing it.

Now, I appreciate that auditors must not cross the line and move into consultancy mode. ¬†However, I always looked forward to those guys who would engage in the business and suggest alternative ways of working or even leave you in no uncertain terms that certain aspects must be addressed even though you didn’t want to hear it. ¬†You ended up moving the system forward together.

So, how come we still end up in this day and age with this situation? ¬†Well, dare I say ‘anything for an easy life’ comes to mind and I must stress that can apply to both parties. ¬†Perhaps the prospect of loosing a site if they takes umbrage to their auditor raising numerous NCRs could be another issue.

But what can you do?

Well, that’s the tricky one isn’t it because retaining the certification is clearly of paramount importance. ¬†However, you could have a quiet word at the opening meeting or failing that with your certification body and perhaps ask for a new auditor next time. ¬†There doesn’t seem to be any formal feedback system on this one – although I’ll stand correcting. ¬†I always find that strange seeing as the standard places a great deal of emphasis on customer satisfaction.

Time to practice what gets preached perhaps because, after all, such a situation does devalue all the hard work you’ve put in, even the standard itself and will not¬†prevent second party audits from being heaped on you as the customer sees less and less value in that certificate hanging on the wall.

Be interested to hear your experiences, but excuse me for now as I’ve got a brew on – and whose just cleared us out of all the Rich Tea then? ¬†I swear I’m going to put a lock on that biscuit tin!