To meet ISO 9000 certification requirements, as well as QS-9000 requirements as an automotive
supplier, Stuart will have to develop a comprehensive quality manual. Based on broad ISO 9000:2000 categories, the following might be an outline of the content of a quality policy and procedures manual:
1 Scope 2 Normative references 3 Terms and definitions 4 Quality management system 5 Management responsibility 6 Resource management 7 Product realization o 7.1 Planning of realization processes o 7.2 Customer-related processes o 7.3 Design or development o 7.4 Purchasing o 7.5 Production/service operations o 7.6 Control of measuring and monitoring devices 8 Measurement, analysis and improvement o 8.1 Planning o 8.2 Measurement and monitoring o 8.2.1 Customer satisfaction o 8.2.2 Internal audit o 8.2.3 Measurement and monitoring of processes o 8.2.4 Measurement and monitoring of product o 8.3 Control of nonconformity o 8.4 Analysis of data o 8.5 Improvement o 8.5.1 Planning for continual improvement o 8.5.2 Corrective action o 8.5.3 Preventive action
The Plant Manager is responsible for ensuring the success of the quality management system by providing the necessary resources and reviewing system performance. There should be statements in the manual concerning: Management commitment, customer focus, management’s part in developing the quality policy, quality planning administration, and management review of results. There was no discussion of ISO category 6. More information is needed on human resources and physical resources, as it relates to the quality system, including: Provision of resources, human resources, facilities, and work environment.
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https://www.coursehero.com/file/25586779/Chapter-7-Case-studydocx/ A number of sub categories are included under ISO category 7, Product Realization. o 7.2 Customer-related processes - Identification of customer requirements, review of product requirements, customer communication processes may be carried out by the Marketing and Sales department when they conduct market research to understand customer needs and handle customer complaints. o 7.3 Design and/or development requirements include: Design and/or development planning, development inputs, development outputs, development review, development verification, validation and control of design and/or development changes. Since most products are custom-designed with the customer, the cross-functional teams that include members from Project Engineering, Quality Assurance, Manufacturing, and Sales would be involved in all of these requirements. Team roles and responsibilities would have to be “spelled out” in the manual. o 7.4 Purchasing - was not specifically mentioned in the discussion held with SIMC employees. However, the manual must cover aspects of: Purchasing control, purchasing information, verification of purchased products. o 7.5 Production and service operations - are the responsibility of line personnel and QA department staff. They include product and process procedures for operations control, identification and traceability, customer property, preservation of product and validation of processes. o 7.6 Control of measuring and monitoring devices - would come the gage R&R and related activities that are the direct responsibility of the QA department.
Category 8, Measurement, analysis, and improvement, also includes numerous sub-categories
that would have to be included in the manual. Generally, these appear to be well covered by SIMC’s current practices. However, processes and procedures would have to be documented for inclusion in the manual. o 8.1, Planning - activities required to design and maintain the measurement and analysis systems. This is assumed to be performed by the Q.A. Department and cross-functional teams, depending on the system. More information is required.
o 8.2 Measurement and monitoring - of customer satisfaction (Marketing and Sales department), internal audit (Q.A. department), measurement and monitoring of processes (Manufacturing and Q.A. departments) and measurement and monitoring of product (Manufacturing and Q.A. departments).
o 8.3 Control of nonconformity - Nonconforming products are reworked or disposed of according
to specific procedures. Products that do not fully comply with requirements are not shipped
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https://www.coursehero.com/file/25586779/Chapter-7-Case-studydocx/ without customer authorization. (Q.A. Department and cross-functional teams when nonconformities are detected.)
o 8.4 Analysis of data - performed by various department and cross-functional teams, using a variety of contemporary tools to simplify and optimize the product while also focusing on reducing production cost and waste. These include Quality Function Deployment, Geometric Dimensioning and tolerancing, Design for Manufacturing and Assembly, Value Engineering, Design of Experiments, Failure Mode and Effects Analysis, and Cost/Performance/Risk Analysis.
o 8.5 Improvement - Planning for continual improvement, corrective action, and preventive action processes would have to be documented. (Manufacturing department)
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