Posts Tagged ‘ISO9001’

ShredderYou doubtless pondered over this when transitioning or installing the 2015 version. If you were transitioning, should you commit to not only the manual but the mandatory six through the jaws of your shredder as well. (Yes, I know Preventive Action went anyway but let’s run with it yeah)

In reality,  having talked to my sites during that period, they were retained as useful documents and the temptation to run amok resisted. It was a bit like some of us being allowed to get our hands our pension pot to do with as with please isn’t it. You so want to but you hold back. But what of companies getting certified for the first time with 9001:2015?

The manual if written properly (i.e. in say 8 – 10 pages max) is a good marketing tool and the procedures are useful support for those getting their heads round the requirements in QA.

As for the rest that really depends on the skills and knowledge of the team who will look after these processes. In my opinion, if they know them inside out then there would appear to be no need to burden them with procedures provided adequate records are being retained to evidence control of each process.

However, if they are lacking experience, there is no doubt that there is a good case for writing them. As with all parts of the standard – if not having a procedure risks the process falling over, then you need one.

 

 

 

 

You Need A Management REVIEW Not A Meeting!

A lot of companies take the easy route here I guess and assemble the good and the mighty around a table to perform the Management Review – yet nowhere in the standard does it state you need a meeting.

Now I agree that it would take a strong lead to suggest that you do it in any other way, but provided you have a clear set of data in a suitable form plus the output as a set of clear notes, actions and dates then you can if you wish. Just chill out over a coffee or grab the opportunity when the required people are free.

This could allow you to effectively chunk down the elements of the QMS to smaller pieces say every month rather than the long drawn out session each year. Bearing in mind the typical attention span of some of your team I wonder which would be more effective? Go on give it some thought and break the mould. Please do share if you already do something unconventional as regards your MR.

Now if you want to see some outlandish ideas as to a location then check this out – http://ow.ly/T5IhZ

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!

BarryNot surprisingly, this is a very common question from companies during my time on site whilst I am creating the QMS.

First, let us assume the the company has someone who they are putting forward as the QA Representative – not always the case I know.  Also let us work on the basis that this person (you?) has another job, a main job, around which they have to find the time to look after the system. Now, there is a 4 – 6 month period ahead of you that involves a stage 1 audit before ending with the stage 2 audit.

To cope in this second phase when the system has been launched and staff start to work in accordance with it, I always suggest a day a week is required.   This is based on the fact that there will be invariably be at least 2 audits a month to do because the 12 month schedule has to covered in half the time.  On the first traunch of audits there will be CARs raised so they all have be be communicated, actioned – and chased?. There is all that data to locate and analyse on a regular basis; perhaps the approved suppliers list to amend because new suppliers are being sourced and then that Management Review meeting to fit in – and aren’t the majority of the actions going to be for you!

On top of that you have to make sure you know your way around the system, whether it is hard copies or an intranet or both, so you can speak about it with confidence when the auditor is on site. Don’t forget that procedures will need amending and perhaps forms as well so the whole change control process needs time allocating to it.

Mmm, quite a bit to do. It is important that the company and the staff see this commitment on a regular basis as you endeavour to make it all part of the company culture. I find a day a week to be a good test of that Management commitment, but I feel it is a fair and realistic allowance. What’s your experience?

If all that sounds a daunting prospect don’t forget help is at hand in the form of site visits, mentoring over the web and auditor training at the 9001 Support Centre.

ps: Next time I’ll move onto the commitment after the stage 2 when it’s all died down a bit – or has it?

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.

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!

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.

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 – and 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.

Travelling round a variety of businesses as I do I come across a wide range of, how should I put this, well styles of audits reports I guess.  However, there is still a tendancy for an audit report to be written like a story.  You know paragraph after paragraph with no obvious breaks or sections.  Important comments lost in the text instead of being brought out for the attention of the reader.  A reliance still on the general statement “orders were checked and found to comply” and then CARs, if raised, lost in the body of the report without even a summary somewhere to indicate the number raised.

Now even the above falls into that trap so here it is simply formatted to enable easier assimilation:

  • paragraph after paragraph with no obvious break or sections
  • important comments lost in the text instead of being brought out for the attention of the reader
  • A reliance still on the general statement “orders were checked and found to comply”
  • CARs, if raised, lost in the body of the report without even a summary somewhere to indicate the number raised

You get the idea I’m sure.  Now in my experience it is far better to use a tabular approach like below which has headings such as:

9001 para ref – Requirement – Findings (with Objective evidence) – Result – CAR No – Summary

Audit Report

Use your imagination and create a form that will double both as a checklist and the final report when typed up and will want to be read because the information is neatly laid out.

It goes without saying that you need (no, must) include the document references you checked on the audit so that if anyone else has to check through the report then they can go see what you saw on the day.  The number of times this is not included still surprises me.

Add a separate column to clearly show the number of the CAR and whether it is a major or a minor.  Major is a total failure of the system whilst minor is simply a glitch.  Also use it for Observations if you want.  At the end of the report put a summary of the general state of the system plus a review of the number of major and minor CARs and observations.

Go to it.  Lack of objective evidence is one of the 5 most common mistakes when doing internal audits.  Check them all out here and visit the web site for more resources to help the Quality Professional.

The use of flowcharts causes much discussion, with everyone having an opinion as to the best style and structure. However, what’s all the fuss about when they are not even mandated as part of a QMS?  9001 states that the QMS can be recorded on any format so why not carry on doing what we always did and write those text based diatribes from yesteryear.

Flowchart

A picture speaks a thousand words

Well, for one, those of use running systems should always be developing them towards best practice.  With the emergence of a visual representative within the lean philosophy there has been growing pressure to move other management systems into line.  Secondly, the solely text based system is no fun to read, particularly if  formatted as if paper was going out of fashion, and a nightmare to write thus failing to address the requirement in the standard for ‘effective communication’ to those involved.

Now admittedly we could veer off here into learning patterns, but most would agree that a visual procedure wins hands down being more popular as a learning tool with most people. They also prove more efficient in trouble shooting a process in the first place when people get down to mapping it out.

Another serious disadvantage is that it doesn’t effectively depict ownership too well as they tend to be written in the sequence of the process so it jumps around the relevant departments and personnel.  A flowchart works far better with its ‘swimming lane’ approach as you can see ownership move before your very eyes.  Users can also scan it quickly to see how much of the process drops into their lap!

Personally I don’t advocate spending endless hours making sure you have the right symbol for absolutely every box, make do with a basic set that everyone understands.  However, it is useful to bring out key operations like Hold points with a symbol and colour that catches the eye.

Finally, for those with the skill, you can hyperlink the various operations in the process to any other part of the system.  Could be related procedures, forms, work instruction – just about anything that the user needs to have at their disposal.  That with a cool format makes them far more likely to be accepted and read.  Would you agree?