Archive for the ‘Quality Manual’ Category

ShredderIf you already have a system in place you are doubtless pondering as you look towards the 2015 version whether to bang not only the manual but the mandatory six through the jaws of your shredder as well. (Yes, I know Preventive Action goes anyway but let’s run with it yeah)

The likelihood as I see it, having talked to my sites, is that they will be retained and the temptation to run amok resisted. It’s a bit like some of us now 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.

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 there heads round the requirements in QA. However, what to do if you are installing your system?

I think that really depends on the skills and knowledge of the team (yeah, no management representative either doing all the work) 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.

I have to get my head round how to upgrade the 9001 Training Guides to accommodate the extra requirements and the general move-around of existing procedures so by all means let me know what you would like to see and in what format.  The current version for 2008 are here if you’ve never seen them and would like help with that version.




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?

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.

Where do you put the manual when you are creating a quality management system? Some start with it so that it maps out what procedures and work instructions or standard operating procedures need to be written. Others leave it till the end so they can capture all that has been created in the second and third tiers. Personally I prefer the latter.

Either way, as I prepare to do some training videos on two of the major elements of the manual – quality objectives and how to link them to the policy – I began to wonder what form manuals take nowadays. Not that far back we all religiously slaved through the standard regurgitating the wording back into our manual as if we might hypnotize auditors into thinking we had understood what the standard was asking us to address.  Couple that with Times New Roman font and we thought we had a winner.

Fortunately things have progressed and most take the opportunity to produce a slimline version that looks the part in this day of advanced desk top publishing techniques.  I came across this article that gives a good overview of how you should select the content so have included the link here.  What’s your style and preference and just how slim is slim?  What have you dared to put to an auditor in the past?

ps: As for the videos they will be part of my ISO 9001 Training Guides and you can subscrive for free here.