ISO 9000 Quality Management Systems Program Evaluation and

ISO 9000 Quality Management Systems Program Evaluation and Audit Verl ‘Andy’ Anders 1, Merle Pochop 2, Chad M. Laux 3 1 Industrial Specialist, Center for Industrial Research and Service, Iowa State University, Ames, IA 2 Field Specialist, Extension Outreach, Center for Industrial Research and Service, Iowa State University, Ames, IA 3 Graduate Research Assistant, Industrial Technology Program, Department of Agricultural and Biosystems Engineering, Iowa State University, Ames, IA EVALUATION BACKGROUND An organization’s quality management system is an allencompassing collection of processes to fulfill a) the customer’s quality requirements b) applicable regulatory requirements, c) aims to enhance customer satisfaction and d) achieve continual improvement of its performance in pursuit of the objectives stated above (ISO, 2005). This evaluation, or audit, will be performed to compare the quality management system of a light manufacturing facility, located in Iowa, to the International Standard Organization (ISO) Quality Management Systems-Requirements: ISO 9001: 2000. ISO 9000 series of standards are among the most widely known standards ever and are implemented by 634, 000 organizations in 152 countries (ISO, 2005). CIRAS The Center for Industrial Research and Service (CIRAS) is the industrial extension arm of Iowa State University. The CIRAS mission - to enhance the performance of Iowa industry - is an integral part of the history of Iowa State and ISU Extension Service (CIRAS, 2005). The client of this evaluation audit is a customer of our Iowa manufacturing facility. The client has mandated all of its suppliers become ISO 9000 certified, or compliant, by the end of 2005. The client gave the supplier permission to have CIRAS conduct a ‘compliance’ audit of the supplier’s quality management system. The evaluation team consists of 3 people from CIRAS and the Industrial Technology program in the Agricultural and Biosystems Engineering Department. OVERALL EVALUATION QUESTIONS Questions that guide the ISU evaluation team include: 1. How does the supplier’s quality management system meet the requirements of ISO 9001: 2000 standard? 2. What portions of the quality management system do not meet the standard? 3. How can the supplier become ‘compliant’ with the ISO standard based on the evaluation audit results? GANTT Chart of ISU QMS Evaluation Audit REPORT PLAN The evaluation report contains a written report consisting of: a) summary of findings and recommendation and b) description of ‘major’ and ‘minor’ findings. Major findings result in an evaluation audit failure and must be corrected before compliance can be issued. Minor findings do not result in evaluation failure but also require correction. If no majors and/or a set number of minors findings are found, compliance with ISO 9000: 2000 will be recommended for customer approval. CLIENT AND STAKEHOLDERS The sponsor is our Iowa manufacturing facility, now known as the ‘supplier’. The supplier is paying Iowa State University’s CIRAS (Center for Industrial Research and Service) program to provide the evaluation audit. TIMELINE CONCEPTUAL APPROACH The mode of evaluation is a mixed approach using Provus’s Discrepancy Evaluation Model (DEM), Eisner’s Expertise Model, and Stake’s Countenance Framework. The purpose of using DEM is to determine whether a discrepancy exists between the performance of the supplier’s quality management system and the standard (ISO 9001: 2000). The expertise approach is used because the evaluation judgments are also based on evaluator knowledge and expertise. Finally, the Countenance Framework is used to interpret the data whereby the QMS performance will be described and also judged based on the application of the ISO standard. DESIGN AND DATA COLLECTION PROCEDURES The data design is a descriptive study utilizing such measures such as: a) observation of company processes, b) study of existing company documents and records, and c) interviews of various evaluation audit participants. The data is collected during 2 site visits by the ISU evaluation audit team to the facility. Analysis is done through interpretation of the qualitative data utilizing the above mentioned Countenance Framework whereby inputs, processes, and outcomes will be described to look for congruence between intents (the supplier documentation of what company performance should be) and the actual performance. PRELIMINARY RESULTS Document Review Summary Sample Section RELEVANT STANDARDS Formal Agreements – CIRAS has an obligation to treat all company materials confidentially during evaluation audit Program Documentation – For a fair and complete assessment, the documentation in the audit is critical to assessing the program accurately to the ISO standard. Context Analysis – For the audit to have credibility with the customer, the evaluation will be done impartially. Evaluator Credibility – The supplier relies on the expertise and experience of the CIRAS team for a cost effective audit. REFERENCES CIRAS. (2005). The history of CIRAS. Retrieved May 23, 2005, from http: //www. ciras. iastate. edu/history. asp ISO. (2005). ISO 9000 for busy managers. Retrieved May 23, 2005, from http: //www. iso. org/iso/en/iso 900014000/understand/basics 9000/basics 9000_1. html