The Evolution of ISO 9000 Software

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1 Information and communication technologies and Quality software: from recording nonconformities to managing for performance management system Implementation 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 nonconformities to seeking performance. 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 management packages, or have become part of larger organizations, so today, the number of suppliers of software products specifically designed to address ISO 9000 issues is somewhere in the region of 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. Today, the number of suppliers of software products specifically designed to address ISO 9000 issues is somewhere in the region of Many more companies now implement 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 external specialist who has little influence on real quality issues. It is this scenario that this article explores and highlights 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 document 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 BY ADRIAN BURR Many more companies now implement their quality systems using standard software for management ISO Management Systems July-August

2 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 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 (0) aburr@tmsc.co.uk Web and quality standards. Over the years, the software has changed from this type of backroom analysis system to software that defines the organization and provides online key indicator information for measuring management 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 categorization shown in Figure 2. What do I mean by this? Several of the large management software companies now produce modules for ensuring that processes are defined in terms of their process inputs and outputs, as well as for providing management 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 assurance 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 management function as it is defined as price, timeliness and technical performance which means that quality includes such measures as cash flow and profitability. 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 company 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 administration in a developed country and setting up sales forces by large, continental, geographic regions. The management systems required to make this work can readily be set up and simulated for successful operation prior to the change using business process design and simulation software. 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 The scope of packages has changed dramatically Software now exists too for linking overall systems to applications used for individual processes within the business. These systems may be dedicated to individual areas, but are more likely to include elements from several parts of the company, including stock management, customer relationship 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. (Continued page 20) Figure 1: The original categories of ISO 9000 software solutions (1998 survey) Reprinted from Cutting through the Paperwork 1998 tmsc 18 ISO Management Systems July-August 2003

3 CLASS PROVIDES USES PRODUCT TYPE Training Development Management Workflow Process improvement Process mapping, modelling and control Benchmarking Quality tools Computer-based knowledge and information, a mechanism for managing training and skills assessment and attainment Training elements plus project planning features and self-assessment Quality systems support software. Issue, version, release control, activity management and scheduling of audits and calibration etc. As support, but with built-in control of the flow of documents and activities Includes control elements and methods for assessing process improvement and preventative activities A method of identifying and managing processes Software to measure where the company, section operation, methodology is at. Specific tools for process and improvement activities e.g. SPC, QFD, FMEA etc. Prior to introduction of a new technique and then for retraining and reinforcement To create a system based on the specific standard on methodology To develop and maintain a system To maintain a system To maintain process management To document the processes or to use as a live control system for the organization To develop a system or method and identify strengths and weaknesses To manage one part of the overall system PRODUCT SCOPE ISO 9001 Version, issue, and release control of all types of documents. Where the company has a design element Particularly provides design management and project control 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 The software industry guidelines Software development companies QS 9000, ISO/TS ISO Health and safety Any or all Includes the above, plus process management and particular mechanisms for supply chain management Environmental managmement system standard. This is sometimes included in a quality package and is included here for completeness The document control for health and safety is often similar to that required for quality Software not designed to meet a particular standard and with features that could be used for any Automotive industry Standard Configurable Tailorable FLEXIBILITY 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 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. A basic database and screen design is provided, but the screens, fields, and reports can be tailored to match the individual needs. There is usually a limitation to this and it is often done by the supplier at a cost Check for a comparison between your quality system and the package. Configure to match an existing system. Usually provides guidelines for those who do not have existing systems 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 possibly other computer systems ISO Management Systems July-August

4 Types Business design Business operations Quality is no longer required as a separate system Process management Real-time control Measures to ensure real-time control 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 manufacturing 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. Figure 2: Current software categories for management (2002 survey). PRODUCT TYPES Process mapping Simulation Cost analysis Business planning Sub-Types ERP Intranet management systems Financial and costing systems Application add-ins Business process definitions Flow charting products Key indicator measurement and analysis The example shown in Figure 3 is typically for individual product manufacture 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. Management 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-gathering systems, as well as for analyzing the information gathered. Real-time control Measurement Assessment Data collection systems Process controllers Process set-up systems Calibration Data collection, storage and analysis Audit management Benchmarking Assessment Once a whole system is in place, then the need for assessment against appropriate standards and benchmarking 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 provide a report showing where your 20 ISO Management Systems July-August 2003

5 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 management are provided as part of the main software infrastructure and define the procedures as part of their own structure. This means that flexibility in the structure of software is required to enable the customer to redesign the functionality according to the changing operations of the company. The only stand-alone quality software now appears to be calibration, audit management (and nonconformity management) and benchmarking. 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 processes of an organization and link the appropriate operations software to the different processes with appropriate business indicators built in to allow Figure 3: Business management system based on quality principles. ERP & financial systems analysis Business process Process set-up Centralized system database providing set-up and data storage for traceability Process monitoring and control including ata, process parameters, scrap and waste management, inspection data Key Set-up Information Collected data improvements Process supervision and status review ISO Management Systems July-August

6 Quality software has evolved from detecting and recording nonconformities to helping organizations to achieve performance. 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 packages that are on the market. The current systems also have not resolved all the problems associated with compliance with many different cultures and as many companies become more worldwide in their out- The need for simple methods of translation and associating documents in different languages and scripts requires some solution look, the need for simple methods of translation and associating documents in different languages and scripts requires some solution. Quality has become part of management 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-effective manner while maintaining technical performance to specification, 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. 22 ISO Management Systems July-August 2003