ISO 9000 Quality Systems Handbook

September 28th, 2009 By The Quality Manager

The latest edition of the ISO 9000 Quality Systems Handbook is the sixth revision of this excellent book by David Hoyle.

It has been updated to cover the changes in ISO 9001:2008 that I have already covered in this blog.

In my view, this is all you need to understand and apply ISO 9000 to your business whether it’s in pursuit of ISO 9001:2008 certification or just business improvement in general. Of course, if you’re a quality consultant and auditor like me you’ll find this weighty tome invaluable.

David’s style, and approach in general to the ISO 9000 series, has always been constructive but direct. If he thinks the standard is unclear or ambiguous, as it is in many places, he says so, why he thinks so, and how best to deal with these failings. In this edition he has even considered the views of John Seddon, a long time critic of ISO 9001 (see his book The Case Against ISO 9000).

The ISO 9000 Quality Systems Handbook now has a new structure.

Part 1 Before You Start puts the ISO 9000 family of standards into context, defines quality and why it is important to organisations. It introduces the management principles on which the standards are based. There is a whole chapter on stakeholders, the importance of whom will become much more apparent when the new version of ISO 9004 is available. This part ends with a practical guide to the use of the ISO 9000 family of standards.

Part 2 Approaches to Achieving, Sustaining and Improving Quality covers six different approaches to getting to the level of quality that will lead to sustained success, the benefits and drawbacks of each approach.

Part 3, 4, 5, 6 and 7 deal with Complying with ISO 9001 Sections Requirements. These are the sections most people will turn to who are trying to achieve ISO 9001 certification. It’s a little bit odd that David couldn’t have put another Part in front of these so that they were numbered the same as the ISO 9001 sections! Each requirement is explained in terms of What Does This Mean? Why Is This Necessary?, How Is This Demonstrated?, so that you not only get to know what the standard says but why it says it and what you need to do to comply with it.

Part 8 System Assessment Certification and Continuing Development provides tools to help you prepare for assessment, how assessments are conducted and how to progress beyond ISO 9001 certification.

It remains to be seen what the effect of the new version of ISO 9004 will be (called ISO 9004:2009 though it’s struggling not to become ISO 9004:2010!). In the meantime, beyond obtaining a copies of ISO 9000:2005 and ISO 9001:2008, this is the only other publication you might need.

Posted in Certification, David Hoyle, ISO 9000, ISO 9004, John Seddon | No Comments »

My GTD System (2009)

September 23rd, 2009 By The Quality Manager

The first thing to say about my implementation of David Allen’s systematic approach to Getting Things Done is that it is a constantly evolving system to meet my needs. As my needs change and as I gain more insight into GTD and how it may help me in any particular situation my system gets modified to a greater or lesser extent.

So my system may not suit you and perhaps to help you understand why my system is configured this way I need to describe how I work “at the business of life and the game of work”.

I have been a freelance quality management consultant for the last twenty years. I work for a variety of clients of varying sizes – the smallest was three people – all the way up to large government departments of hundreds of people. More often than not, because of the size of these clients, it’s just one client at a time. At the moment I have two clients, both fairly large and one, a utility company, requires my services more or less full time for at least three months. The other one is a government department, but this is just a small consultancy requirement of about one day a month.

In addition to looking after these clients, I have all the responsibilities of running a small business – keeping accounts, training, keeping up to date generally, maintaining a website and this blog. Plus all the usual responsibilities that go with being a husband and a father.

I’ve had a GTD system of sorts for over 20 years. I’ve always been “relatively” organised and I had a paper organiser long before anyone knew what one was. Mine was an A4 binder with dividers for calendar, action lists, projects and reference material. Don’t forget that David Allen didn’t invent GTD out of fresh air. He looked at what worked and pulled it together into a systematic approach. There’s much in GTD that we already do without realising it’s part of the GTD system.

In about 1984, I went on a training course based on the Time Manager system. This, like the Time Design system that David worked with before devising GTD purported to be a way of managing your time to get things done. It had Key Areas, a bit like GTD’s Horizons of Focus, Tasks and Activities (GTD Next Actions), Calendar, Notes, Contacts etc.

I worked this system for several years with some success but it never really coped well with the increasing amount of stuff that was starting to hit me and all of us as we got into the 90s.

I became aware of David Allen around 2000 through finding a few of his ideas on the Internet. Many of these basic principles are still on the DavidCo website as free downloads. These include how to configure a paper organiser, how to set up a tickler file, etc.

Then I bought David’s Getting Things Done and read it cover to cover in a few days and began implementing the system. In many ways this was just revamping my old A4 binder but now I was using A5. For a while I used my old Time Manager binder but eventually I replaced it with an A5 Filofax.

This Filofax is set-up with the following dividers and has been unchanged now for several years:

  1. Plastic protector covering Mindmap showing the layout of the Filofax
  2. Plastic pocket to collect odd scraps of paper, bills etc.
  3. Notes/In with blank ruled sheets containing notes taken (and some blank sheets)
  4. Calendar Section with Weekly checklist for the current week, Monthly checklist for the current month, Annual checklist for the year (birthdays and anniversaries) and printed pages from Outlook, one week over two pages, for at least 13 weeks
  5. Action Lists, currently including Agendas, Anywhere, Calls, Computer, Errands, Home, Listen, Office, Online, Read, Waiting For, Someday/Maybe
  6. Projects (each section preceded by a list of the Projects in that section) Business Projects, Home Projects, Personal Projects, Someday/Maybe Projects
  7. Reference containing useful lists and other material
  8. Spare forms
  9. Contacts

Although I use Outlook, my system is essentially based around the forms in my Filofax. These forms are updated by hand but they are also held electronically in a folder on my PC called Filofax.

The subfolders in Filofax match the paper Filofax and the Filofax folder also fits onto an 8MB USB memory stick that I can take from computer to computer.

This configuration has remained unchanged for over two years now and seems likely to stay with me for some time.

The next major update will be when I start to develop my Areas of Focus now that I’ve got Next Actions and Projects under control.

Posted in Areas of Focus, My GTD System | No Comments »

Giving Good Audit Feedback

September 22nd, 2009 By The Quality Manager

My favourite quotation that sums up the way too many auditors behave is that “auditors are sent in after the battle to bayonet the wounded!”

That’s just what it feels like to many people having a daily struggle against demand outstripping supply and management that doesn’t seem to care. Then in comes the auditor and tells them what they already know – there too much for them to do and they haven’t got the right staff with the right training and the right tools to do the job effectively let alone efficiently.

That said, when I’m auditing I believe it’s important to communicate both conformity and nonconformity as the audit progresses. When summarising the audit findings at the closing meeting, or at any interim feedback meeting, it is sometimes too easy to lay most of the emphasis on nonconformity.

I use a simple mechanism to ensure feedback is balanced between areas of both conformity and nonconformity. This also reminds me to seek out areas of good practice as well as areas that need improvement.

Instead of describing findings “good” and “bad” I try to categorise them as “good” and “could be better.” I use a simple format to communicate this mixture of feedback. A sample is shown in the table below.

Areas of Good Practice Areas for Improvement

 ISO 9001
1. All staff audited have defined objectives. Many of the objectives are not easily measured. 5.4.1
2. Management reviews are conducted every three months. A record of the output from the last management review has not yet been produced. 5.6.1
3. Records of the evaluation of suppliers are well-controlled.   7.4.1
4. Design reviews are conducted at appropriate stages in the design activities. Records of these reviews do not show that agreed actions have been completed. 7.3.4
5.   Customer satisfaction is not measured. 8.2.1
6. Problems in the field are analysed and resolved to remove the immediate cause of the problem. Further analysis to determine the root cause of problems would serve to prevent their recurrence. 8.5.2

The left column keeps the entries numbered. From there, the next column details the areas of good practice. The next column describes the areas for improvement. If I’m auditing against a particular standard (such as ISO 9001) then I usually include the relevant clause number in the final column on the right.

Although this feedback can be typed and presented as a document at the closing meeting, I prefer to write it on a flipchart. In this way I can ensure that everyone at the closing meeting can see the feedback. In addition, I often reveal the feedback line by line, keeping the rest of the feedback covered to ensure everyone stays focused as each individual finding is presented.

In the example shown in Figure 1, each of the entries except three and five shows balanced feedback. Entry three includes only an area of good practice—no improvements were suggested. In the case of entry five there was no mitigating good practice to offer following the audit. Customer satisfaction was not being measured at all. This is nonconformity against ISO 9001 clause 8.2.1, as shown in the final column on the right.

Those who are being audited appreciate this balanced feedback approach. The approach also encourages us as auditors to seek areas of good practice during the audit and offer praise where it is appropriate.

I also receive clear feedback on our findings at the closing meeting. The entire findings are presented in this feedback format as an overview. Therefore, there will be no surprises in the audit report that is prepared and delivered later. Nothing is included in the audit report that was not covered in this balanced feedback offered in the closing meeting.

I believe this approach makes me a better auditor and gives audits a more constructive tone.

Posted in Audits | No Comments »

GTD Tips, Tricks and Tools – The MoSCoW Rules

September 16th, 2009 By The Quality Manager

Though not really part of the GTD systematic approach, the MoSCoW Rules, often applied to priorising in project management, can be useful in helping you decide what order to do the tasks on your lists.

“MoSCoW” in this context stands for “Must o Should Could o Won’t”

Firstly, what tasks MUST you do today? These should be at the top of your list and headed “MUST DO TODAY”. Draw a line under this list.

Secondly, what tasks SHOULD you do today? These appear next on your list and are headed “SHOULD DO TODAY”. You should only tackle these when all your MUST DO list has been completed. Draw a line under this list.

Thirdly, what tasks COULD you do today, but only if you have the time and you’ve done all the MUST do, and SHOULD do tasks? List these under the heading “COULD DO TODAY” and draw a line below the list.

Finally, what WON’T you do today? Writing tasks on this list helps you to confirm that they’re not as important as anything in the three categories above. Also, it reminds you that if you catch yourself doing one of these tasks, you should stop and go back the top of your lists and work down again.

Working through these lists top down should motivate you to get the MUSTs and SHOULDs done so that you can feel good about doing some of the COULDs but not feel bad about not doing any of the WON’Ts!

Posted in MoSCoW Rules | No Comments »

BS EN 16001 Energy Management

September 14th, 2009 By The Quality Manager

BSI is adding to the range of standards you can be certified to by releasing BS EN 16001 Energy Management Systems.

This standard recognises that businesses need to become more energy efficient to be competitive.

This new standard, which follows the Plan, Do, Check, Act approach of previous management standards, such as BS EN ISO 9001, BS EN ISO 14001, and more recently BS EN 12001, provides:

  • A structured approach to identifying your energy-related assets

  • A framework for controlling, monitoring and measuring your energy consumption

  • A means to identify opportunities to cut energy costs and increase energy efficiency

The standard defines the requirements of an energy management system (EnMS).

BS EN 16001 can help you to:

  • Reduce operating costs by controlling in-house energy costs

  • Improve your reputation by demonstrating that you are controlling greenhouse gas emissions

  • Deal with the growing amount of legislation including the Carbon Reduction Commitment which becomes mandatory in April 2010 for organisations using more than 6,000MWh/yr

An energy management system, designed around BS EN 16001, will help to embed best practice energy management into normal operations, everyday decisions and behaviour.


BS EN 16001 can be obtained from the BSI Shop priced £100 (£50 to BSI Members).

There is also a companion guide BIP 2187:2009 Energy Management Principles and Practice providing expert insights on implementing BS EN 16001 and having an effective energy management system in place. This is £30 (no discount for BSI Members) and offers a practical and easy to follow introduction to the technical considerations, human factors and management aspects of energy saving in commerce, industry and the public sector.

Posted in BS EN 16001 | No Comments »

GTD Tips, Tricks and Tools – The Tickler File or Bring Forward File

August 26th, 2009 By The Quality Manager

What it consists of

The TICKLER FILE or BRING FORWARD FILE consists of 43 folders:

31 daily folders labelled “1″ to “31″

12 monthly folders labelled with the months of the year

The daily folders are kept at the front, beginning with tomorrow’s folder (for the example used in Getting Things Done where today is October 5th, this would be the folder labelled “6″).

The remaining daily folders (in the example, “7″ to “31″) are filed behind this followed by the monthly folder for next month (in the example, this would be “November”) and then the daily folders already used (in the example, “1″ to “5″). Finally there would be the remaining monthly folders for the remaining 11 months (in the example, “December” to “October”.

So you would end up with a set of folders (following the example) labelled thus:

[6]
[7]
[8]
[9]
[10]
[11]
[12]
[13]
[14]
[15]
[16]
[17]
[18]
[19]
[20]
[21]
[22]
[23]
[24]
[25]
[26]
[27]
[28]
[29]
[30]
[31]
[November]
[1]
[2]
[3]
[4]
[5]
[December]
[January]
[February]
[March]
[April]
[May]
[June]
[July]
[August]
[September]
[October]

How it works

  1. Each day, empty the daily folder for that day into your in-basket.
  2. File the empty folder at the back of the daily folders (in the example, “6″ is emptied and placed behind “5″ to now represent November 6th).
  3. When the next monthly folder is reached (in the example, “November” after “31″ has been emptied) the monthly folder is emptied into your in-basket and then filed at the back of the monthly folders to represent that month next year.

Tips and Tricks

Be sure to update your Tickler File every day and if you’re going away for a few days process all the folders ahead for the days you’ll be away.

Use the folders to file:

  • travel documents and tickets for events on the day you’ll need them
  • bills on the days you need to pay them
  • print out reminders for each birthday and anniversary and file them in the appropriate month to be moved into the appropriate day in due course. It’s a good idea to file reminders a few days ahead (especially if the due date is at the beginning of a month) to ensure you get a card and present ahead of time

There is a free factsheet on the Tickler File available on the David Allen website. There is also a set of 43 sturdy plastic letter size file folders, open on three sides. The GTD Tickler files are blue-grey with black trim and appropriately labelled (in five languages!) Please note that this is expensive to ship as the folders weigh over 5 pounds. Although the folders are letter size, they take A4 papers quite happily.

You can, of course, easily make and label your own set of folders but they are unlikely to last as long as these strong, purpose built folders.

Posted in Bring Forward File, Tickler File, Tips, Tools, Tricks | No Comments »

ISO 9004:2009

August 24th, 2009 By The Quality Manager

The latest draft of ISO 9004 has received broad approval and the final draft of this International Standard (FDIS) is due to be released at the end of August 2009 with the publication of the revised standard in October or November 2009.

ISO 9004 has a new title “Managing for the sustained success of an organisation – A quality management approach” and is shorter than its predecessor, ISO 9004:2000 at 44 pages compared to 56. This reduction is in part due to the removal of the ISO 9001 text that appeared at the start of each section. Although ISO 9001 and ISO 9004 are still “a consistent pair” of standards, ISO 9004 no longer has the same clause by clause naming as ISO 9001. This helps to emphasise that it is not a guide to ISO 9001.

The contents of ISO 9004 (at the draft stage) are:

1. Scope
2. Normative references
3. Terms and definitions
4. Managing for the sustained success of an organisation
5. Strategy amd policy formulation, planning and deployment
6. Resource management
7. Process management
8. Monitoring, measurement, analysis and review
9. Improvement, innovation and learning
Annex A – Self-assessment tool
Annex B – Quality management principles
Annex C – Correspondence between ISO 9004-2009 and ISO 9001:2008
Bibliography

The aim of ISO 9004 is to help users of ISO 9001 to obtain long-term benefit from a broader, in-depth, quality management system (QMS) based on their existing QMS. It uses the same quality management principles as ISO 9001. It is not to be used for assessment or certification purposes.

ISO 9001 focusses on customers. ISO 9004 extends the focus to include all interested parties including society, suppliers, employees and shareholders.

One of the main areas of comment on the ISO 9004 draft has been the relationship between the main body of the standard and the guidance on self-assessment in the annex. This self-assessment is based around 5 maturity levels (now, where have we come across that before?)

  1. Beginner – focus is on products, processes are ad-hoc, results not predictable, improvement actions forced by customers
  2. Proactive – QMS implemented, corrective and preventive actions well-organised
  3. Flexible – process management implemented, predictable results, strategy focussed on customers and some other stakeholders
  4. Progressive – balanced focus on all stakeholders, consistent positive results, continual improvement based on learning and sharing of knowledge
  5. Successful - capable of maintaining good performance over time and developing further in the long term

From this it would seem that an organisation that has just been certified to ISO 9001 would not be higher than Level 2.

In addition to the ISO 9004 standard, a guide to this self-assessment tool is being produced along with an implementation guide for ISO 9004:2009.

When the final draft International Standard (FDIS) is available further detail will be provided.

Posted in ISO 9001:2008, ISO 9004:2009 | No Comments »

GTD Tips, Tricks and Tools – The Two-Minute Rule

August 19th, 2009 By The Quality Manager

Would you like to extend your life by 6 months? Then follow this simple rule: “If you can get an action done in less than two minutes then do it now!”

This works because it will take you longer than two minutes to write it down on one of your lists of NEXT ACTIONs, recall it when it’s appropriate, figure what it’s about and get in done – so just do it, or as someone I knew used to say JUST F****** DO IT or JFDI.

This can be as simple an action as “I need to refill my fountain pen”. By the time you’ve written that on your list you could have done it so just do it!

Once you’ve got to the DO phase you’ve only three options:

  1. DO it now if the action takes less than two minutes.
  2. DELEGATE it to someone else if you’re not the most appropriate person to do it.
  3. DEFER it by putting it into your system on one of your CONTEXT lists as something to be done later.

Some people seem to get hung up on what they can do in exactly two-minutes. It’s not the time that’s important, it’s the principle. It doesn’t matter whether it’s a minute or ten – it’s just a rule of thumb. If you think you can get it done “in the moment” then get it done and out of the way.

It’s a useful technique to use when you’re doing your WEEKLY REVIEW. You may want to restrict the cutoff to one minute if you haven’t got much time or extend it to ten if you’ve got plenty of time.

The two minutes isn’t a hard and fast(!) 120 seconds. Use your common sense. Perhaps another way to phrase the rule is “if you can do the action in less time than it would take to put it on your list, retrieve it at a later date, and do it then. Do it now”

If you use the GTD Outlook Add-In then the latest version has a built-in Two Minute Timer and the David Allen Company has one in their store.

Posted in Contexts, Defer, Delegate, Do, Two Minute Rule, Weekly Review | No Comments »

Preventive Action, Corrective Action and Correction

August 17th, 2009 By The Quality Manager

What’s the difference between corrective action and preventive action? Are separate procedures required by ISO 9001?

The corrective action process is a problem-solving process and the preventive action process is a risk-analysis process.

Corrective action

Corrective action is defined in ISO 9000 as “action taken to eliminate the cause of a detected nonconformity or other undesirable potential situation” and notes that corrective action is taken to prevent recurrence. ISO 9000 also points out that corrective action differs from correction which is defined in ISO 9000 as “action to eliminate a detected nonconformity”. Put simply, if something has gone wrong then the action you take to fix that instance is correction. For example, if a part comes off the production line with a screw missing, then putting the missing screw back is correction. The action you take to stop it happening again is corrective action. Using the same example, making sure the correct number of screws are supplied for each part would be corrective action. It gets confusing when that is referred to as preventing a recurrence. In ISO 9000 terminology that action is not preventive.

Correction

There has to be a problem for you to take corrective action. If no problem exists but there is a possibility that a problem might occur, preventing that potential problem is preventive action.

Preventive action

Preventive action is defined in ISO 9000 as “action taken to eliminate the potential causes of a nonconformity or other undesirable potential situation”. ISO 9000 distinguishes preventive action from corrective action by noting that “preventive action is taken to prevent occurrence” as opposed to recurrence which characterises corrective action. In the example used above, planning the production of the part to ensure that all the screws are fitted would be preventive action.

A risk management process is a good example of preventive action. Assessing the impact and likelihood of a risk occurring and taking action to prevent occurrence is preventive action.

Other examples of methods for identifying potential nonconformities are:

  • trend analysis for process and product characteristic (where a worsening trend indicates a potential problem)
  • monitoring of customer feedback
  • evaluation of problems in similar processes or products
  • planning of new processes and products

Procedure RequirementsNote that in the above discussion, reference is made to ISO 9000 and not ISO 9001. ISO 9000 contains the concepts and terminology on which ISO 9001 is based and is essential reading to gain a full understanding of ISO 9001.

On the question of procedures, ISO 9001:2008 makes it clear that a procedure is required for corrective action and also a procedure is required for preventive action. But there is no stipulation that these should be separate documents (see the NOTE 1 under 4.2.1 in the standard). However, the combination of a corrective action procedure and a preventive action procedure into a single document is not recommended as it then becomes more difficult to clearly separate the two distinctly different approaches. You may also find it difficult to demonstrate to an external assessor that the processes are separate and that you actually perform both types of action.

Posted in Corrective Action, ISO 9001, ISO 9001:2008, Preventive Action | No Comments »

Do

August 12th, 2009 By The Quality Manager

DO is the final phase of the Five Phases of Mastering Workflow.

Now that you’ve COLLECTed and PROCESSed everything that has your attention, ORGANISEd all the open loops to make sure that OUTCOMEs and NEXT ACTIONs have been decided on and REVIEWed everything to ensure that it’s current, you now have to decide what to DO.

To make the right choices, you need to think about where you are (CONTEXT), how much time you have (CALENDAR), how much energy you have, and what your priorities are.

If you’ve listed your NEXT ACTIONs according to CONTEXT as we discussed in ORGANISE, it should be easy to identify what actions you could accomplish by looking at the appropriate list. Pick something off the appropriate list that you have the time and energy to DO.

We will return to priority at some future date when we look at the HORIZONS OF FOCUS but for now we’ll just identify what these horizons are:-

  • RUNWAY – Your current NEXT ACTIONs (look at these daily)
  • 10,000 FEET – Your PROJECTS (look at these weekly)
  • 20,000 FEET – Your responsibilities (look at these monthly)
  • 30,000 FEET – one to two-year goals (look at these quarterly)
  • 40,000 FEET – three to five-year goals (look at these annually)
  • 50,000 FEET – career, purpose, lifestyle (look at these annually)

This has been a very quick run through the Five Phases, so feel free to post any questions as comments. In the meantime take a look at the Five Phases of Mastering Workflow from David Allen’s site for free and don’t forget the basic manual on how GTD works in David Allen’s Getting Things Done.

Posted in Calendar, Collect, Contexts, Do, Horizons of Focus, Next Actions, Organise, Outcome, Process, Weekly Review | No Comments »