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A Practical Guide to Designing the Process Approach
By Batalas

The ‘process approach’ of ISO 9001: 2000 has caused a great deal of consternation amongst many in the quality profession. It is understandable that there should be some concern. The combination of a broad definition of a process, the description of a ‘process model’ shown in the standard, and a considerable volume of process theory generated from every quarter has left many quality managers scratching their heads.

The Batalas guide to designing the process approach is based upon our practical experience in the field of designing, implementing and improving business processes. We do not apologise for making our approach seem very simple. Simple it may seem but it is far from simplistic. While it may seem simple it does require a good degree of effort to implement effectively.

We will start by de-mystifying many of the issues surrounding the process approach.

Eliminating the mis-information

1. There is no need to re-write your procedures as processes
Processes describe what we do and procedures (describe) how we do it. We are confident that most organisations, having invested a mountain of effort in writing procedures, will not want to re-invent or re-configure this work. The standard requires some mandatory documented procedures, and if your organisation feels that its additional procedures help to communicate and control quality, then they can stay as they are.

2. There is no requirement for process mapping
The standard makes no reference to process mapping. Detailed process mapping of all aspects of an organisation can be very complex and is rarely cost effective.

3. The purchase of process mapping software is not necessary
For most organisations the time spent using complex mapping software does not outweigh the benefits derived. Whilst software generally provides a good visual basis for displaying processes a great deal of time is spent flowcharting existing procedures. Only a worthwhile proposition if you believe this effort is justified!

4. There are no specified processes
The standard makes reference to a number of processes but does not use the word ‘shall’ to denote any as being a mandatory requirement. In fact the standard makes it quite clear that it is not the intention to dictate structures or content of a QMS. There is also no need to name processes with reference to clauses of the standard. We know of no organisation who currently refer to ‘product realization’ or ‘management responsibility’ as named processes. What you choose to call your processes is unique to your organisation.

5. You do not have to invent processes to meet the requirements of the standard
The requirements of the standard tend to reflect good management practices therefore the vast majority of well-run organisations already have processes in place. They may not realise this and they probably will not have formalised a series of inter-linked activities as a process, and they may not call these processes exactly as referred to in the standard.

Understand the intent of the process approach

ISO9001: 2000 defines a process as a set of interrelated or interacting activities which transforms inputs into outputs. This definition is so broad that the number of processes within a single organisation could be anywhere from a single process to many thousands. Clearly these may be extreme scenarios but deciding the most appropriate middle ground for an organisation can be very difficult. It is best to forget the definition for a moment and go back to the intent of the standard.

For many organisations quality management systems have been seen as documented procedures describing the way the organisation carries out routine tasks. The ’94 standard did very little to dispel this view and often this resulted in the overly bureaucratic systems which discouraged change. Moreover, senior management often had very little interest in the QMS, considering it the domain of the quality manager.

The new ‘2000 standard has attempted to overcome these difficulties by introducing the process approach. The idea behind this approach, which has been around for many years, is to directly link business objectives with all aspects of the QMS. As business processes are the way in which business results are achieved then this provides the much-needed explicit link. If each business measure and objective can be related to a process(es) then it is not difficult to see that this will engage all levels of management in the QMS. Furthermore, as continual improvement should be the goal of every chief executive (every manager knows that next year’s targets will be more difficult to achieve than this year’s) then overlaying these measurable objectives onto business processes is relatively easy.

Getting started

Start with high level processes
A commercial organisation has a small number of high level processes. It has to develop and introduce new products and services, generate enquiries, convert these enquiries to orders, satisfy these orders, and finally collect payment. It also has to manage its assets, whether they be people, facilities or information. We suggest that naming the processes is an important aspect of process definition. Using functional names such as sales, marketing and accounts does not indicate what the process is aiming to achieve. Thus use titles which reflect the objective of the process.

Review what the organisation measures
The focus of any organisation can be found by what it measures. These are the process measures an organisation must use as a start point. Typical measures could be:

- Sales order conversion rate
- Orders delivered on-time
- Customer satisfaction
- Payment withheld due to invoice errors

Link processes, measures and procedures
Each process has to have an input, output, controls and resources. It is also useful to identify process measures for each process. These are relatively easy to identify:

Inputs/outputs define the start/finish of the process e.g. satisfying a customer order has to have an input of a customer order and the output may be the customer receiving delivery of the product or service.
Resources relate to that required in the conversion of input to the output. This is likely to include people and could involve other facilities, equipment etc. We suggest that a simplification of resources be used unless you wish to analyse these in more detail.
Controls are likely to include procedure, work instructions, records etc.

By linking the outputs of each defined process as inputs to one or more processes it is possible to create a diagram (with some additional explanatory text) to satisfy the ISO 9001: 2000 requirement for ‘… sequence and interrelationship of processes…’

The next task is to assign procedures to the defined processes. If you have kept your process definition at a reasonably high level then you are likely to have more procedures than processes. Do not worry about this, as this is entirely normal. If you have some processes with no procedures you will need to ask why this is the case.

You may wish to document additional procedures, although there is no requirement to do so beyond the 6 mandatory procedures stated within the standard.

Process measures need to be added to each process. Start by using the existing business performance measures. Again, do not be surprised if some processes have more than one performance measure. The interesting situation is when you have processes with no measures and measures with no process!

Add a performance measure only if it would be useful to the organisation to assess the effectiveness and efficiency of the individual process. But it may indicate that your process definitions are inappropriate and you may consider redefining some processes to include other (less) critical processes.

If you have a business measure, which has no process, you have to consider whether the measure is appropriate to the QMS. Generally, the QMS should include all operational measures, however, some measures, particularly those that are strategic, such as ‘market share’ could be excluded. However, operational measures without process are definitely a cause for concern. A further review of process definitions may indicate that additional processes may be required.

Before generating a raft of new measures it is worth noting that the really important performance measures in any organisation are already in place. To add to these requires careful consideration. To add more than 10% to 20% additional measures would probably be unrealistic.

Check your process model against the requirements of the standard
To meet the requirements of the standard you will need to ensure that the mandatory 6 procedures are in place along with the required records. All these should be evident from the descriptions of your processes.

Also, remember, wherever the standard refers to a process e.g. communication, continual improvement etc. it s not necessary to have processes with these names. Examples of how you may deal with some of these issues are:

Continual improvement
All organisations have continual improvement top of the management agenda. They set continual improvement objectives each year and these are reflected in business plans and budgets. These objectives can be used as measurable objectives for each process.

Management review can be seen to aid continual improvement (an agenda item) and therefore evidence of management review meeting minutes will be sufficient.

The standard specifically asks for communication of responsibilities, authorities, and the effectiveness of the QMS to be made. Many organisations have a range of communication media e.g. team briefing, intranet, notice boards, job descriptions, appraisals etc, all of which can show evidence of compliance.

Auditing Implications

The most significant change to the ‘2000 standard is the issue of auditing. Certification bodies have realised this and as a consequence they have provided training for their existing auditors. They make no secret of the fact that they have released many auditors who are not up to the task.

Unfortunately external auditors are not the only ones facing change; internal auditors are faced with exactly the same problem. Many requirements of the standard can not be met with documented procedures alone and therefore even internal auditors will need to know the standard. If this sounds too daunting then the alternative is to use a two-tier approach. This involves less skilled auditors conducting audits against documented procedures and more skilled staff assessing processes for effectiveness, continual improvement and other more judgmental aspects of the standard.

Transition to ISO/TS16949: 2002

For any organisation making the transition from QS9000, TS16949: 1999 or ISO 9001/2: 1994 to ISO/TS16949: 2002 they will note that they face slightly different problems. Whilst the new automotive standard is based upon ISO 9001: 2000 the additional automotive specific elements have a more prescriptive approach. Consequently, the ‘open’ requirements of ISO 9001: 2000 are supplemented by a small number of requirements which involve the word ‘shall’ in conjunction with a process. Again, this does not mean that there has to be a process named, for example, ‘empowerment and motivation of staff’. The empowerment and motivation of staff can be included in, say, the process for people management, a performance measure of which could include ‘motivation’.

In Summary

The process approach is based upon good management practice and therefore its adoption and effective implementation should improve organisational performance. Involving top management in the design of the high level processes will demonstrate that the QMS will benefit all aspects of performance and increase customer satisfaction.

The major pitfall is to invent a process model that satisfies the standard but is too alien, or too complex, for managers and staff to understand and implement. Use what is to hand as these are already important to the organisation. Add only processes, procedures and performance measures which will benefit the organisation. When this has been completed there will be little, if anything, to add to meet the requirements of the standard.



This article is an extract from The Auditor, a Batalas publication. Batalas is the world’s leading independent trainer of quality management systems auditors, with courses delivered in 10 different languages in 14 countries. For more information on Batalas please contact +44 (0)1527 525250 enquiries@batalas.co.uk, www.batalas.co.uk.







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