How to make your Audit Report a good read

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

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.

Ever wondered what soft skills you need for that QMS?

Once you are in the driving seat of that QMS you soon start to realise that there is more to running that 9001 system than just knowing the standard inside out and being qualified to do the internal audits. You are the key person in your organisation and to be effective you will need to develop the so called soft skills – and fast!

Mulling over exactly what these skills might be with some of my quality colleagues we came up with the following guidelines that you might want to consider.

Approach the task with a thorough knowledge of the processes where you work, that all important eye for detail backed up with sound data analysis and problem solving. Develop a simple and effective system for people to buy into. Be determined and assertive as you take on the role of leader but remember there will be times you have to be the negotiator or the diplomat.

Communicate in a variety of styles as befits the situation. Have the ability to be the trainer, mentor, presenter and – most importantly – the listener. Be seen by your peers as credible, trustworthy, passionate yet patient if required and fully integrated into the management team.

Develop your own ideas in innovative and open minded ways and be inspirational to those around you. Finally, ensure you retain your sense of humour at all times and grow a thick skin for when you hit difficulties. Accept the need for humility for those times when you make a mistake – as you will!

Now, perhaps that sounds a bit of a daunting prospect but you’re not alone. Fortunately there are people available to help you on this journey. The need to mentor quality representatives exists so check out this initiative here if you recognise that you might need help along the way.

“9001 – The Collection” if you want to learn cool stuff in a hurry

Recognising that businesses need information as quickly as possible in order to implement it and gain benefits,  I am now offering the full set of ISO 9001 Training Guide videos under the banner “9001 – The Collection”.  Rather than work through the free series each fortnight for six months you can be in total control of what you watch and when you watch it.

The aim is still the same, to lighten the load for the beleaguered Management Representatives who are often left to run the system on their own. You will hear me empathise with that situation here in the video taken from the new website:

Below are a selection of the comments I have received from subscribers of the free series and I feel they are testament to the warmth of feeling being displayed towards these videos:

* The videos are fabulous.  Your blog is a goldmine – and that and your videos have been a particular help to me.  Your clear communication style is wonderful, and one I want our audit team to try and emulate. You’ve gone viral here at Midland. Thank you for making this available and sharing your knowledge.  I hadn’t intended to write a fan letter, sorry I went on, but I wanted you to know your work is much appreciated. JB, Chicago, USA

* I would just like to say how informative and professionally set up your videos are, they really are priceless. TM, Kent, UK

* I would just like to start off by saying that I am thrilled to have your programme help me with my ISO journey that I have recently been put in charge of implementing at my company.  I am very new to all this and you are a saving grace to me.  I can’t thank you enough for your valuable insight. NW, California, USA

* Thanks Pete, the blog and the videos are actually a gold mine. Thanks a tonne , I  have recently been appointed as the MR for my organisation and I did not know where to start. JWT, Nairobi, Kenya

* I commend you for providing a wealth of great information that is easy to follow and gets you thinking about those methods in implementing good auditing techniques.  I especially like the Audit Methodology sections to help re-enforce the concepts and create new ideas on how to improve upon ones system. These are great refresher courses for all auditors at any level.  Thanks again, I look forward to receiving more information and reading your blogs.TL, Ohio, USA

* At the outset, I must thank you and congratulate you for your work. The guides are simply too good. The guides will help me conduct Internal Process Audits and design and improve upon the various checklists on the shop-floor. Looking forward for to a great association with you. AP, India

* And last but by no means least, thanks for the support videos.  What a fantastic idea!  They’re actually good too! MW, North Yorkshire, UK.

The new site has free samples for you to view so all you need to do is click onto “9001 – The Collection” so you can take advantage of them as well.

ps: By the way, subscribers to this blog should email me using the link at the very bottom of that website for news of a special discounted offer on The Collection!

It doesn’t say you have to use Flowcharts – does it?

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.

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?

Get your Site sorted as well as the System for that Stage 2 audit

Understandably a lot of focus is put on getting the quality system ready for that final audit but the need to do likewise around the site shouldn’t be overlooked. Whilst some may view these as very basic, those undertaking this audit for the first time might benefit from the prompt.

Housekeeping is an obvious one for starters. Go round the shop floor and have a tidy up – assuming it isn’t already engrained in the company culture that is. First impressions are important as they say. Get old machinery and parts out of the way and redundant stock and work in progress sorted. The same applies for office space as well so don’t forget to check that it all looks reasonable and make sure nobody has ferreted away old procedures if you have had to issue hard copies.

Walk round and convince yourself that, by what ever means you have adopted, orders are clearly identified. Rectify any areas where you are left scratching your head before the auditor does likewise. Also check that documentation relevant to these orders is in place and legible and hasn’t ‘wandered’.

The system itself should be sorted but no harm in getting someone to do a final sense check. Go through the master manual of documents to make sure nothing is missing or you’ve not generated some spurious revisions by some erroneous cross references. Don’t forget the intranet if you base your system on that as well. Check all the links work before you end up enduring that embarrassed silence when the auditor can’t make any progress through your system. Might be worth checking the backup regime whilst you’re at it to ensure the save has been validated i.e. would it work if called upon.

Ensure the Quality Policy is displayed around the place and that staff have a basic understanding of it. A good place to display it is on the log-on screen of your IT system if that is possible. Ensuring you have done all your internal audit programme and at least one Management Review meeting should be a given. However, don’t be afraid to do another MR meeting as the system gets up and running during that pre-audit period if it helps control the workload.

Finally, don’t forget your colleagues as you are going to need their help on the day. Make sure you have communicated the programme for the day to them so they know when and where the auditor will visit. Explain that you as the Management Representative (or your delegated colleague) will be with the auditor at all times but only as a guide and observer since the auditor will want to talk to them. Obviously tell them to keep to the area under discussion and politely respond to the questions and clearly ‘avoid going off on one’ if you know what I mean!

That way everybody is ready for the visit and the site looks its best – but then it always does, doesn’t it?

How to check if you are ready for that 9001 audit

I often get asked this as sites get close to bringing in the auditor so I put together this summary of what I would expect to see in relation to the five main paragraphs so it is possible for anyone to gauge if they are ready.

How much of the system?
The QMS should have been operational for at least 4 – 6 months with quality records created in every section of the system.  A full set of controlled procedures, work instructions and forms should be in use backed by an effective record retention system.  Evidence of controlled issue of such documents either electronically or as hard copy needs to be visible.

Clearly at least one Management Review meeting needs to have been undertaken with minutes on file and adequate resources in place – especially the Management Representative! An effective Quality Policy and objectives should in place and understood by staff.  The scope needs to be adequately declared with a note of exceptions from Section 7 and the company should be able to demonstrate an effective means of communication to the staff, perhaps a newsletter, notice board items or briefing sessions.

A full set of training records need to be on file for employees plus a means to determine training needs and requirements e.g. a skills matrix. The relevant aspects of infrastructure and environment would be addressed as appropriate and a current Organisational chart visible for all to see how they fit into the structure.

Where it really counts
Operational procedures should be complied with in Sales, Purchasing, Design, Calibration and Production and control of identification and status evident throughout the company. You need to be adhering to your Approved Suppliers and Subcontractors List with adequate inspection from Goods Inwards, In process through to Despatch.  Customer property needs effective control if relevant along with preservation of product in stock, in process and on despatch.

All internal audits have to be completed in accordance with your schedule by a qualified auditor and corrective action reports documented and action in a timely manner. Evidence of Quality Objectives and their measurement is required so as to demonstrate continuous improvement and you must have effective control and analysis of non-conforming product.  Finally, clear evidence of customer satisfaction data collection and evaluation should be present.

Help is at hand
After all that if the Management Representative wants some moral support then he can subscribe to the free 9001 Training Guides. You can find a full set of samples on Utube on the QualityAuthority channel or click on this link to go to the web site to take up the free subscription for the full series of ISO 9001 Training Guides.

When passing an ISO 9001 audit with ‘flying colours’ flatters to deceive

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.

Be clear on the three ‘actions’ in your ISO system

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.

Who’s up for getting Whitehall ISO approved?

Well who would have thought it. That recent report by Sir Philip Greene has condemned Government procurement practices as ‘shocking’. He then goes on to quote examples that are just too bizarre for words. Yes I know this is nothing new but uncontrolled and inefficient processes, coupled with a lack of understanding and ownership and performance measures, just appear to be rife.

Wouldn’t you just love to get amongst it all and sort it all out. The framework is there with ISO and businesses have to comply so why should politicians be exempt. Now today I read that whilst Sir Philip raised concern over the current practice of payment within five days to suppliers, to the point of negotiating later payments, the latest Enterprise Czar Lord Young wanted prompt payment to SME to be retained.

You could have a field day.   I have to admit that can’t quite see frustrated Quality professionals marching on Downing Street, but come on where would you start?

ISO 9001 Training Guides videos start to make a difference

It is pleasing to hear that these guides are actually starting to make a difference to my subscribers with one recently responding:

“So far you have already helped me with our supplier quality management and prompted me to add audit corrective actions onto the database I use for product non-conformances so I can review them all together. I couldn’t wait for the last one to arrive”.

I have therefore now uploaded more samples from this series that are aimed at Management Representatives of companies using the standard so as to support them as they manage and develop their system.  With subscribers now on board in Germany, Italy and China you too can check out content before subscribing.

The latest topics added include Control of Non-Conforming Product, writing the Quality Policy; setting Quality Objectives and using a Skill Matrix for training records.  Others will follow on Sales orders, Works orders and Document Control.  The full series will grow into an indispensable guide for the Management Representatives and Quality Professionals alike.  Check out one on Quality Objectives here:

You can find the full set of samples on Utube on the QualityAuthority channel or go to the web site to take up the free subscription for the full series of ISO 9001 Training Guides.