The Evolution of ISO 9000 Software

Today, the number

of suppliers of software

products specifically

designed to address

ISO 9000 issues is

somewhere in the region

of 70-80

man

ageme

nt sy

_stem

Implementation

Information and

communication

technologies and

The number of ISO 9000 software support packages

has diminished as more and more organizations

implement their quality systems using standard

software for managing the business. This evolution

mirrors the evolving perspective of quality, reflected

in the ISO 9000:2000 series, from avoiding

non-conformities to seeking performance.

Quality software:

from recording

nonconformities to

managing for performance

Many more companies now imple-ment their quality systems using standard software for management and integrate the need to keep quality records with the tools for the users. This makes quality a management activity rather than that of some

exter-nal specialist who has little influence on real quality issues.

It is this sce-nario that this article explores and high-lights the different types of software available today, as compared with the types used in the early stages of ISO 9000 development. The article also explores where we might be going next…

Background

Quality management software was once based around the need to docu-ment what an organization did so that nonconformities could be detected during the audit process. The scope of such software, shown in

Figure 1, reflected the requirements of the 1987 editions of the ISO 9000

tMSc

carried out the first full review of software to support ISO 9000 in 1991 and found only around 15 software packages. As the 1990’s progressed, so the number of products available worldwide soared to over 150 at its peak. Many of the companies that

produced them have either changed to become suppliers of mainstream manage-ment packages, or have become part of larger organiza-tions, so today, the number of suppliers of software products specifically designed

to address ISO 9000 issues is some-where in the region of 70-80.

The scope of packages has also changed dramatically. While in the early 1990’s the majority concentrated on document management, training and compliance management, the most recent systems provide enterprise design and management solutions based on the principles of mapping the work through the organization along the lines presented in the ISO 9000:2000 series.

BY

A

DRIAN

B

URR

Many more companies

now implement their

quality systems using

standard software for

management

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quality standards. Over the years, the software has changed from this type of “ backroom analysis ” system to software that defines the organiza-tion and provides online key indica-tor information for measuring man-agement success. This is in line with the process-based standard that we now have in ISO 9001:2000, and is reflected in the change in the catego-rization shown in Figure 2.

What do I mean by this? Several of the large management software com-panies now produce modules for ensuring that processes are defined in terms of their process inputs and outputs, as well as for providing man-agement with the success indicators that give it the information required to develop the company effectively and receive early warnings when things are not progressing well.

The software includes all the necessary inputs and entries for the task to be completed.

This is then a complete business or

enterprise management system and not just a system for “ quality assur-ance ” which is, after all, only one of the management functions. However, if one applies the Deming definitions of quality, then “ quality management ” could be regarded as the only manage-ment function as it is defined as price, timeliness and technical performance – which means that quality includes such measures as cash flow and profit-ability.

Let us know look at some examples of this evolution in quality software, applied to specific business processes.

Business design

More often than not, a business case must be made for any new com-pany or any major change in the way that a company operates and this can be achieved using business planning software. A frequent example these days is given by a company that has decided to move its manufacturing operations to a developing country

on the other side of the world, while maintaining management and admin-istration in a developed country and setting up sales forces by large, conti-nental, geographic regions.

The management systems required to make this work can readily be set up and simulated for successful opera-tion prior to the change using business process design and simulation soft-ware. Packages provide mechanisms for then sharing this design with the new operations to enable them to start up with realistic business targets and known sources of variation.

Business operations

Software now exists too for linking overall systems to applications used for individual processes within the business. These sys-tems may be dedicated to individual areas, but are more likely to include elements from several parts of the company, including stock management, customer relation-ship management, and an element of the financial controls for the company.

Many of the major ERP (Enterprise Resource Planning) solutions take this approach and ensure conformity to quality standards in that measures and key indicators are drawn from the results of the actual operations carried out through the software. An example is where a call centre logs the time for every call along with the effectiveness measure, such as whether a follow-up call is required, or the satisfaction level of the caller.

Adrian Burr produced the first report on quality management software in 1992 and, over the intervening years, has maintained a knowledge of the packages available and their capability, offering reports to assist in the selection of software and consultancy to guide companies into using appropriate solutions. He is also co-author of Statistical

Methods for Software Development

(ISBN 1-85032-171-X), a book on how to write software using quality principles. Adrian Burr is now managing director of the British software company tMSc Ltd. which produces statistical solutions for die casting and other process industries, as well as management reporting systems

Adrian Burr, tMSc Ltd., Blois Meadow Business Centre, Steeple Bumpstead, Haverhill, Suffolk CB9 7DU, United Kingdom.

Tel. + 44 (0)1440 730211. E-mail [email protected] Web www.tmsc.co.uk and

www.spctrainer.co.uk

The scope of packages

has changed dramatically

(Continued page 20)

Figure 1: The original categories of ISO 9000 software solutions (1998 survey) Reprinted from “Cutting through the Paperwork ” – 1998 © tMSc

PRODUCT TYPE

Training Computer-based knowledge and information, a mechanism

for managing training and skills assessment and attainment Prior to introduction of a new technique and then for retraining and reinforcement Development Training elements plus project planning features and

self-assessment

To create a system based on the specific standard on methodology

Management Quality systems support software. Issue, version, release control, activity management and scheduling of audits and calibration etc.

To develop and maintain a system Workflow As support, but with built-in control of the flow of documents

and activities To maintain a system Process improvement Includes control elements and methods for assessing process

improvement and preventative activities

To maintain process management Process mapping,

modelling and control

A method of identifying and managing processes To document the processes or to use as a live control system for the organization Benchmarking Software to measure where the company, section operation,

methodology is at.

To develop a system or method and identify strengths and weaknesses Quality tools Specific tools for process and improvement activities e.g. SPC,

QFD, FMEA etc. To manage one part of the overall system

PRODUCT SCOPE

ISO 9001 Version, issue, and release control of all types of documents. Particularly provides design management and project control

Where the company has a design element ISO 9002 Version, issue and release control of production documents Manufacturing and services where the main

operation is delivery of a product or service without design input

ISO 9000-3 The software industry guidelines Software development companies QS 9000,

ISO/TS 16949 Includes the above, plus process management and particular mechanisms for supply chain management Automotive industry ISO 14001 Environmental managmement system standard. This is

some-times included in a quality package and is included here for completeness

Health and safety The document control for health and safety is often similar to that required for quality

Any or all Software not designed to meet a particular standard and with features that could be used for any

FLEXIBILITY

Standard Software provided as a standard product. Features available to set up the software. Configuration is limited to setting the standard data, usually by the end user

Check for a comparison between your qual-ity system and the package.

Configurable The main screens can be configured to match the terminology that you commonly use, and the database may have a few fields added on individual screens. The way in which the software works is fixed.

Configure to match an existing system. Usually provides guidelines for those who do not have existing systems

Tailorable A basic database and screen design is provided, but the screens, fields, and reports can be tailored to match the indi-vidual needs. There is usually a limitation to this and it is often done by the supplier at a cost

Systems that do not match an existing software profile may best be implemented by these packages

Bespoke Software produced to match a user requirement Design to match existing systems and pos-sibly other computer systems

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The example shown in Figure 3 is typically for individual product manu-facture where the control system is set up from a centralized system that provides both process and product design, as well as production planning capability.

The set-up system also plans and targets limits of operation and so might include some mechanism for analysis for process optimization.

The process control system not only controls, but also records its own operation and saves this information together with product identification information for long-term traceability, as well as analysis of the results for further process improvement.

In this scenario, there is no need for operating procedures as the system itself defines the operation. Manage-ment screens provide a view of current status, and supervisory procedures may be necessary to define what is done under specific circumstances. These guides are usually in the help files for the system itself.

However, there are requirements for linking the system to other related processes such as the measurement management systems.

Measurement

Measurement systems take into account the need for calibration and the management of that activity, as well as the base units for gathering information at the time interval appropriate to the process. There are systems for designing the data-gather-ing systems, as well as for analyzdata-gather-ing the information gathered.

Assessment

Once a whole system is in place, then the need for assessment against appropriate standards and bench-marking against best practice is required. The systems delivering these functions tend to be stand-alone, or provided by a third-party company which will gather your data and pro-vide a report showing where your

PRODUCT TYPES

Types

Sub-Types

Business design Process mapping Simulation Cost analysis Business planning Business operations ERP

Intranet management systems Financial and costing systems Application add-ins

Process management Business process definitions Flow charting products

Key indicator measurement and analysis Real-time control Data collection systems

Process controllers Process set-up systems Measurement Calibration

Data collection, storage and analysis Assessment Audit management

Benchmarking

Figure 2: Current software categories for management (2002 survey).

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Real-time control

Measures to ensure real-time con-trol consist of real-time information being gathered from the business. These types of systems tend to be specialized for different industries. An example might be a manufactur-ing company that uses a real-time control system for its manufacturing process that is given its settings from a production planning system. The calculation of settings is provided by knowledge of the variety of products being manufactured, and target and specification settings are provided against which success of the control system will be measured.

Quality is no longer

required

as a separate system

company is in comparison with the rest of the organization.

Conclusions

Quality is no longer required as a separate system for most companies and operations. The tools for manage-ment are provided as part of the main software infrastructure and define the procedures as part of their own struc-ture. This means that flexibility in the structure of software is required to enable the customer to redesign the functionality according to the chang-ing operations of the company.

S

The only stand-alone quality soft-ware now appears to be calibration, audit management (and nonconfor-mity management) and benchmark-ing. Most other software is built into the standard working practices of the company.

What next

?

The current generation of software enables the user to redesign the pro-cesses of an organization and link the appropriate operations software to the different processes with appropriate business indicators built in to allow

Centraliz

ed syst

em

database

providing

set-up

and da

ta

storage

for trac

eability

analysis ERP & financial

systems

Business process

Figure 3: Business

management system based on quality principles.

Process monitoring and control including

ata, process parameters,

scrap and waste management, inspection data

Process supervision and Process set-up Key Set-up Information Collected data improvements

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look, the need for simple methods of translation and associating documents in different languages and scripts requires some solution.

Quality has become part of man-agement responsibility, as was defined in the original quality standards. The management standards we now have in place help to ensure that a job is done in a timely, cost-effec-tive manner while maintaining technical performance to speci-fication, compliance with health and safety regulations, and the skills and motivation of the people doing the work – as well as doing all this in a way that minimizes risk to the environment.

The software now integrates many of the standard operating procedures and provides the tools for ensuring that quality is continually improving. The next area of development may build on recent innovations in data analysis that provide improvement opportunities.

The need for simple

methods of translation

and associating

documents in different

languages and scripts

requires some solution

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managers to make informed decisions. The next generation will take the new functionality of available operating systems and change the venues of the use of software, but beyond that there are many ways of integrating systems more effectively.

Document management is still a requirement for many

companies that need to define processes which are not computer or software oriented. Also, most companies have singularly failed to go completely paperless (though there are a few examples of companies which have largely

achieved this). Where paper flow and design information is to be shared, then the control of versions and the ability to distribute these effectively is still not widely available in the pack-ages that are on the market.

The current systems also have not resolved all the problems associated with compliance with many differ-ent cultures and as many companies become more worldwide in their

out-Quality software has evolved from detecting and recording nonconformities to helping organizations to achieve performance.