Abstract No: An ISO 9000:2000 Quality Management System Implementation Model

Transcription

1 Abstract No: An ISO 9000:2000 Quality Management System Implementation Model Second World Conference on POM and 15th Annual POM Conference Cancun, Mexico, April 30 - May 3, Mustafa S. Shraim, Ph.D. Principal Consultant SQPS PO Box Columbus, Ohio Tel: (614) Fax (614) mus@shraimqps.com Keywords: Quality Management Systems, ISO 9000:2000, Process-Approach Abstract Empirical research has shown that effective internal systems directly impact performance. However, many organizations either have no official quality management system (QMS) or have not re-certified their QMS to the new revision of ISO 9000 standard. The ISO-9000:2000 standard can be of great value if its requirements, including customer-focus, process-approach, and management commitment, are effectively implemented. However, such requirements presented challenges for implementation. This paper presents an implementation model by incorporating basic total quality management principles with the process-approach concept required in ISO 9000:2000. Management review and data analysis will be shown to be the vital processes of the proposed model.

2 Introduction Attaining initial certification to the ISO 9001:2000 standard can be a challenge to many organizations. However, the challenge to establish a sustainable and efficient quality management system can sometimes be overlooked. Becoming certified to a quality management system standard such as ISO 9000 will not solve all quality problems, particularly if the standard is used as a checklist for compliance. However, an efficient and sustainable QMS through leadership and participative management is likely to address and permanently solve quality problems. The ISO 9000:2000 revision presents new challenges to existing quality management systems. These challenges include the process-approach concept, customer-focus, management commitment, and continuous improvement. The process-approach concept, or managing the system in terms of interrelated processes, is particularly important when it comes to implementation. As described under clause 0.2 of ISO 9001:2000, the standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness and efficiency of the quality management system (QMS) to enhance interested party satisfaction by meeting interested party requirements. Additionally, clause 4.1 requires that the organization must both identify processes needed for effective operations and determine the sequence and interactions among such processes.

3 While many organizations and practitioners welcome such approach, some are still uneasy about incorporating such changes, which, in many cases, require reengineering the existing QMS. This uneasiness may be due to one or more of the following: Lack of understanding of the process-approach concept which results in resistance to change Lack of confidence in getting certified again under the new revision High implementation costs Needs Analysis for Model Development Quality Digest magazine statistics showed that, as of November 2003, only 34% of organizations certified in the U.S., originally certified to the 1994 revision, have re-certified to the 2000 revision. This is a low percentage considering the fact that after the middle of December of 2003, all certifications to the 1994 revision would have expired. Unlike the 1994 revision, the ISO 9000:2000 standard requires that an organization s QMS be managed in terms of interlinked processes. Failure to do so may result in having adverse effects on quality. For example, in an attempt to consolidate suppliers to save money, an alternate material might be purchased. If the variability of this material (from lot to lot) is large when compared to the original material, then inconsistent final product is likely to be produced resulting in dissatisfied customers.

4 To gain a competitive advantage in the increasingly global marketplace, organizations must produce quality goods and services better and faster with less. According to Feigenbaum (1999), using fact-based monitoring systems within a more structured approach is critical in quality development and reduction in quality costs. Juran (1992) estimates about one-third of what organizations do consists of work previously done. This structured approach can be viewed as an integrated system of interlinked processes, which, if implemented appropriately, self-adjusts. The proposed model incorporates such approach. Empirical research has shown that internal quality systems impact the performance of organizations. Surveys reported in Cook and Verma (2002) indicate that internal quality management systems impact service quality, which in turn affects the organization s performance. Integrated, efficient, and customer-focused systems can greatly improve the organization s competitiveness. Kontoghiorghes and Dembeck (2001) concluded that, among other factors, satisfaction with internal processes, effective communication channels within and between work teams, and ISO 9000 certification, are the most important variables when it comes to quality improvement in marketing service organizations. Satisfaction with internal processes was also found to be strongly associated with ISO 9001 achievement and a structure that can be improved and requires measurable processes. Sebastianelli and Tamimi (2003) identified obstacles when it comes to implementing total quality management

5 (TQM) initiatives. These obstacles include lack of customer focus, lack of quality planning, among others. The proposed QMS model was developed to address a number of issues regarding the implementation of an efficient and sustainable QMS. The proposed model: Incorporates the total quality infrastructure including, management of customer relations, processes, resources, and data, as well as leadership and strategic planning. Is augmented with performance measurements and visibility in operation as referred to in the ISO 9004:2000. This non-contractual standard emphasizes that for leading and operating an organization, management should do so in a systematic and visible manner. Incorporates the Model of a Process-Based Quality Management System, which is included in the ISO 9004:2000 standard. In other words, the proposed model decomposes the clauses of product realization, management responsibility, resource management, and measurement, analysis, and improvement into lower-level processes. For example, product realization is broken down into feasibility review, planning, purchasing, supplier evaluation, and so on. Can be used, with some adjustments, as a tool to effectively implement the ISO 9001:2000 requirements. The model starts with all possible inputs from interested parties, particularly the customer. Suppliers can also be

6 viewed as customers in the sense that they require timely release of order requirements, forecasts, and other related needs. As the model shows, all other processes are established to address such requirements directly or indirectly. In other words, the organization s internal processes must be established according to customer expectations. That is, all forms of customer input must be identified first followed by developing the appropriate processes (along with their interactions) to address such input. For each process identified, resource needs, both human and physical, must be fulfilled adequately. Model Development Figure 1 below, which is the starting point of the proposed model, shows how interested party inputs are categorized. Feedback may come from different sources: customers, employees, and suppliers. Customer feedback can be can then be broken down into performance ratings / surveys, complaints, and audit results. For customer orders, a feasibility review is conducted. Therefore, immediate processes to handle customer inputs include feasibility review /order processing, complaint management, handling of information such as ratings, surveys audit results. As mentioned above, the model links processes that make up the QMS starting with input from interested parties. In this section, a brief explanation of the entire

7 model will be given. Table 1 shows the linkage between ISO 9001:2000 requirements and the processes in the proposed model. Start Employees 3rd Party Input Interested Party Input? Feedback Source of Feedback? Suppliers Customer Order Customers Complaints Type of Feedback? 2 nd Party Audits Performance Ratings / Surveys Figure 1: Identification of Interested Party Input I. Decisions: In some instances, where a decision is to be made, a form of evaluation needs to be established. The nature of this evaluation depends on the complexity of the decision as well as the nature of the business. The following are the decision-based points that are included in the proposed model (Figure 2): Interested Party Input : The interested parties in this case are the external parties; namely, customers, employees, suppliers, and third-party organizations that perform audits (e.g. registrars, government regulatory bodies).

8 o Supplier input could include issues such as timeliness of order releases, forecast, delivery issues, among others. This input can be added at this point. o Employee input could include suggestions for improvement, satisfaction survey results, etc. o Third-party input refers to results of audits conducted by a third party for purposes of certification and/or regulations o Customer order refers to any time communication is made for the purpose of ordering product or service, which could be either new or existing business. o Customer feedback refers to all instances of customer communications except for placing orders. For all input possibilities, the organization must establish adequate processes to handle them in an efficient manner. The feedback from suppliers, employees and third-party audit results can proceed to the management review. Prior to this, an immediate review or action by the appropriate personnel may be needed. Type of customer feedback: From the QMS point of view, this can be either results of surveys/ratings, registering complaints, or customer audit results. For nonconformance resulting from audit and complaints, rootcause analysis might be required.

9 Project / Order Feasible: Once an order or a quote request is received from customer, a feasibility review must be conducted. This is equivalent to the contract review under the 1994 revision of ISO If the order or project is not feasible, the customer may be contacted to resolve differences, if possible. Material / Information Available: After the project / order is deemed feasible, planning for its production starts. If materials / information or resources, required as input for the order or project, are not available, then it may be procured from approved suppliers. Type of Order: When an order is a new project that requires design, then all design activities and process planning must take place before proceeding to production. Nonconformance: This refers to any nonconformance found as a result of the customer feedback or in testing the product or service. II. Processes / Activities: The list in Table 1 includes all processes included in the model and their linkage to the ISO 9001 requirements. III. Results: There are 12 points on the proposed model where process output can be measured. As shown in Table 2, these locations are designated with letters leading into the Data Analyses and Reporting process.

10 Table 1: Processes of Proposed Model vs. ISO 9001 Requirements Process / Report in proposed model Equivalent ISO 9001 requirement Setting up / adjusting Process for Production 7.1 Planning of Product Realization Project / Order Feasibility Contacting Customer to Resolve 7.2 Customer-related processes Differences Design of Product or Service 7.3 Design and Development Purchasing / Receiving Materials Supplier Evaluation Planning / Scheduling Production Making Product / Developing Service Testing Product / Service Delivering Product / Service 7.4 Purchasing 7.5 Production and Service Provision 7.6 Control of Measuring and Monitoring Devices 8.1 General (Measurement, Analysis, & Improvement) Data Analysis and Reporting 8.2 Measurement and Monitoring 8.4 Analysis of Data 5.2 Customer Focus 5.6 Management Review Management Reviews 5.2 Customer Focus 6.1 Provision of Resources 6.2 Human Resources Determining Resource Needs 6.3 Infrastructure 6.4 Work Environment Updating / Conducting Internal Audits 8.2 Measurement and Monitoring Updating / Improving QMS 4.1 General Requirements 4.2 Documentation Requirements 5.1 Management Commitment 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, Authority, and Communication Initiating / Monitoring Continuous Improvement Projects 8.5 Improvement Nonconformance Evaluation 8.3 Control of Nonconforming Product Investigation and Correction 8.5 Improvement

11 ID A B C D E F G H I J K L M N Table 2: Process Results of the Proposed Model Description of Results Results of audits conducted by a third party Summary of infeasible projects / orders Results of timeliness of delivery to the customer Results of testing product or service Results of throughput/ takt time / availability, etc Supplier Evaluation results Customer satisfaction results from ratings, surveys, and complaints Nonconformance and corrective / preventive actions summaries Continuous improvement projects QMS status Resource needs / utilization Internal audit results Supplier input (surveys, requirements, etc) Employee input (suggestions, survey results, etc) Discussion and Concluding Remarks One of the first steps in establishing an efficient and sustainable QMS is to evaluate existing practices. The aim here should be to map out existing processes as they are implemented. For example, if we are trying to map out the complaint management process, we may start with identifying the means through which customers register their complaints (i.e., who receives them, types of complaints, how they are logged in, etc.) by utilizing flow charts. This can prove important in later stages, as loopholes, non-value-adding activities, and control points can be identified and addressed. After mapping out each of the processes individually, it is important to link such processes in fully integrated system. There can be no single model that fits all organizations. Anttila et al. (2001) best described it in his book as follows: The aim of ISO 9000 standards is not to force uniformity on the QM approaches of different organizations, but rather to provide

12 innovatively applicable guidelines for the continuous improvement of business performance. However, the proposed model can be utilized as roadmap for establishing the required processes starting with customer requirements. The proposed model underscores the importance of the management review process, whose input includes results identified in Table 2. The process identified as the input for Management Review is Data Analysis and Reporting. This process can be viewed as an extensive set of activities performed by many at different levels of the organization. First, it is important to decide on the measures, frequencies, forms, responsibility, and affected personnel for each items identified in Table 2. In addition, timeliness of disseminating such data to the affected personnel can be vital in ensuring that actions are taken appropriately. The proposed model has been used by the author in a number of QMS implementation projects, particularly ISO 9001-based projects. Adjustments were then made for each situation to fit the nature of the organization. On-going results from such implementations have shown success in initial certification, on-going utilization of such system as well as performance.

13 Figure 2: The Proposed QMS Implementation Model References Anttila, J., and Vakkuri, J. ISO 9000 for The Creative Leader, Tanner-Paino Oy, Finland, Cook L. S., and Verma, R Exploring the Linkages between Quality System, Service Quality, and Performance Excellence: Service Providers Perspectives. Quality Management Journal 9 (2):

14 Feignbaum, A. V The New Quality for the Twenty-First Century. The TQM Magazine 11. no. 6: Juran, J. M Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services. New York. Free Press. Kontoghiorghes, C., and Dembeck, D Prioritizing Quality Management and Sociotechnical Variables in Terms of Quality Performance. Quality Management Journal 8 (3): Phillips-Donaldson, D. On Leadership, Quality Progress, Volume 35, No. 8, August Sabestianelli, R., and Tamimi, N Understanding the Obstacles to TQM Success. Quality Management Journal 10 (3): The ISO 9000 Registered Company Database, Quality Digest, December ANSI/ISO/ASQ Q9004:2000, Quality Management Systems Guidelines for Performance Improvement, Quality Press, Milwaukee, Wisconsin, 2000.