January 2005

CHALLENGES FACED BY QUALITY PROFESSIONALS MONITORING AGAINST ISO 9001:2000

1. INTRODUCTION

During the implementation of the ISO standards 9001 and 9002:1994, quality professionals focused on the production of procedures and compliance with these. This was judged as being the most important demonstration of the implementation of a quality management system that claimed compliance with the 1994 standards. Focus was on showing that procedures were implemented as written without necessarily examining the effectiveness and efficiency of the outputs of such procedures. The very essence of the new standard relies on the fact that it is process rather than procedure based.

December 2003 saw the end of the grace period for change over from ISO 9001: 1994 edition to the ISO 9001:2000 model, a standard that differs significantly from its predecessor. The ISO 9001:2000 standard places more emphasis on processes than procedures and outputs rather than documents. However, it still requires documented procedures in such areas as documentation and records.

The new standard requires managers to understand the difference between processes and procedures in order to implement the process based Quality Management System (QMS). It also provides significant challenges in the way that quality professionals go about their business.

2. CHALLENGES FOR THE QUALITY PROFESSIONAL

2.1 Behaviour Changes

The new standard demands a greater degree of flexibility in the quality professionals’ approach. They will need to be able to evaluate the outputs of processes as a measure of the effectiveness or efficiency of the implementation of the Quality Management System (QMS) rather than check for procedure adherence.

The new approach tests the integrity of auditors to a greater degree since there will not automatically be a clear procedure trail to follow. With the introduction of the new standard it has been noted in the countries such as the UK that some companies have received the new certification without making the necessary transition from a procedure based to a process based system. Some company managers were totally unaware that they had been certified to the new system and what this entails. Certification has always been a thorny issue, but the temptation to supply certification just because it is requested must be resisted.

The compliance mindset that once existed needs to be replaced with a process mindset that can look at processes and assess the input/process/output model to evaluate the effectiveness of implementation of the QMS. A greater degree of open-mindedness as well as observation skills may be needed to evaluate processes rather than procedures.

2.2 Monitoring Process Changes

What is the effect on the process of monitoring in organisations? Quality professionals may need more preparation time to ensure that they understand the processes being evaluated, although their actual monitoring time at the organisation’s premises may be reduced. Those who provide a monitoring function must understand the difference between a process and a procedure. A process is an activity whereas a procedure is the method by which an activity (or process) is carried out.

The new standard requires a move away from “tick box” auditing to integrated management and auditing. The almost total focus on manufacturing by the previous revision of the standard requires a significant mind change from its customers. Aspects such as human performance are now an integral part of customer satisfaction, which is an important focus of the new standard. The quality professional is well placed to develop standards and specifications in human performance and to implement monitoring, reporting and corrective actions which lead to organisational learning.

Quality professionals need to understand that their monitoring activities must reflect the process approach just as the QMS must. Monitoring must cover performance indicators, the effectiveness of processes and an interview with the process owners to determine how they perform. In most organisations there will be a degree of compliance as well, depending on the industry standards that apply, but it is important to ensure balance. It is possible to be fully compliant but very inefficient if processes are not controlled.

2.3 Skills and Knowledge

Quality professionals may need to upgrade their skills in the technological arena since they will be called upon to assess many different forms of data. Instead of checking out that the procedure (the means to the end) is being faithfully employed, auditors will look at the output (the end) instead. If organisations monitor their objectives, the means to the end becomes less important than the end itself. When this happens, the monitoring function becomes that of fault investigation rather than the measurement tool. The aim should be the production of an automated lean QMS that provides fast and factual information to allow dynamic management decision making. Monitoring of the organisation should be based on risk and should take account of the degree to which controls can contribute to risk reduction.

To meet emerging challenges the quality professional needs to be fluent in top management processes and models. Quality professionals need to be able to interview process owners and find out whether they know how the organisations’ processes are controlled, what analysis and data they use to make business decisions and to see whether the data is valid. This may entail more in depth analysis of business results than before, including the ability to read business financial reports. This may also cause some hostility from the company who is used to a pure compliance/procedure based approach. Some understanding of systems theory would also help in the shift from procedure to process based monitoring.

2.4 Role and Authority

Quality professionals have to build and reinforce their role and status in organisations by learning the language of business, deploying quality methods in a more effective way and reducing all bureaucratic and non value added activities. The current role of the quality professional in the organisation, in some cases, needs to be redirected to where they can add more value.

For example, they can:

Quality professionals must therefore transform themselves from quality representatives to management representatives.

2.5 Education and Training

Education and training in quality methods are vital for a new generation of management, engineers and technicians. The quality professional is ideally placed to provide such training or contribute inputs to such training. Over time emphasis has shifted from quality education and training of personnel to production of QMS supporting documents to demonstrate standard compliance. The 2000 standard has a shift in focus and some retraining may be required.

2.6 Selection of Quality Professionals

Certification bodies have made it known that expectations have been raised. It is no longer about standardisation and compliance but more about improvement, customer focus and business objectives. The standard must cause a change in the way auditors are selected. In some cases internal auditors are selected for their independence and capability as auditors alone while they are not expected to be competent enough to give judgement on what is adequate for a department or activity that they are not familiar with. In these circumstances the inexperienced would rely on the entire adequacy being presented in the form of written specifications or instructions. As such they would operate only as adherence or compliance auditors. The new standard requires a knowledgeable expert in the standards and codes as well as business models and business results. This implies a mature person who has experience in other areas of business as well as quality.

2.7 Changes in the Quality Professional Toolkit

The change has brought a welcome innovation in the use of flow charts which can adequately describe a business’s processes and controls without the production of wordy QMS documents. The new standard defines documentation as being in any form or medium which means that the quality professional might be evaluating or producing digital photographs or other electronic media as part of their “objective evidence”. The new standard uses the approach that procedures may not be needed to control activities but they do need to happen in a controlled manner, which must be demonstrated. Use of models such as the EFQM business excellence model and Balanced Scorecard may also augment the traditional tools such as Statistical Process Control (SPC), Failure Mode and Effect Analysis (FMEA) etc.

3. CONCLUSION

Quality professionals face new challenges with the advent of the ISO 9001:2000 standard. They should view this as an opportunity to upgrade their skills and knowledge in order to make their rightful contribution to the enhancement of business practices. Today’s quality professionals are ideally placed to provide help to companies in the transition between the 1994 and the 2000 ISO standards.