【正文】 INTERNAL AUDITING FOR QS9000 Wele Restrooms Breaks Registration sheets Phones Evaluations For assistance after this course... Introductions ? Name ? Company ? Title/Position ? Current responsibilities ? Experience in quality systems ? Experience in auditing ? What do you expect to learn from this course? Agenda ? Auditing fundamentals ? The audit system ? Human factors role in auditing ? Audit preparation ? Audit performance ? Opening meeting ? Closing meeting ? Audit report ? Followup action ? Case study ? Exam Exam (31/2 hours) ? 11/2 hours Part 1 (open book) ? Seven case studies ? Answer as the team leader ? If there is a nonconformance, cite the closest element/subelement of QS9000 ? 15 minute break ? 2 hours Part 2 (closed book) ? General questions about auditing ? Multiple choice/fill in the blank/truefalse Part 3 (closed book) ? QS9000 requirements ? Multiple choice/fill in the blank/truefalse MODULE 1 Introduction Introduction ? This module will discuss: ? Definition of quality ? Cost of nonquality ? Cost of quality ? Prevention costs ? Appraisal costs ? Quality system Definition of Quality Quality = ? Definitions of Quality ? Dictionary A characteristic or attribute of something。 property。 a feature. Excellence。 superiority. Degree or grade of excellence. ? Deming Quality has meaning only in terms of the customer, his needs, what he is going to use it for. Continuous improvement. Definitions of Quality ? Juran Fitness for use/fitness for purpose as seen by the user. For longlived items: availability, reliability and maintainability (the “ abilities” ). ? Regulated Industries Meeting specifications or requirements. Definitions of Quality ? Crosby Conformance to requirements. ? Ishikawa Products and services which are economical, most useful, and always satisfactory to the consumer. ? ISO 8402 The totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs. Costs of Nonquality ? Waste due to scrap or rejected items ? Reperformance of work ? Inefficient use of resources ? Service and warranty costs ? Customer loss of confidence ? Loss of market share ? Liability costs Cost of Quality ? Prevention and appraisal costs ? Costs to prevent nonconformances ? Costs to evaluate quality ? Nonquality costs ? Internal failure costs ? External failure costs Variables Affecting Quality ? Accuracy in identifying customer requirements and expectations ? Adequacy of raw materials ? Adequacy of product design ? Competency of personnel ? Variances in process equipment ? Adequacy of measures taken to prevent damage to the product after production Variables Affecting Quality ? Control of production conditions, such as cleanliness, humidity, and temperature ? Control of changes in design or in customer requirements ? Control of production process support systems, such as electric power, pressed air, and water ? Adequacy and accuracy of test and inspection equipment ? Correctly identifying inspection and test criteria Quality System Definition: “ The anizational structure, responsibilities, procedures, processes, and resources needed to implement quality management.” ISO 8402 Types of Quality Systems ? Internal Quality System ? Implements policies and objectives ? Includes quality control functions ? Includes quality assurance activities ? External Quality System ? Provides assurance specifically for the customer MODULE 2 QS9000 Overview QS9000 Overview ? This module will discuss: ? Quality system documentation ? The twenty elements that are ISO based ? The automotive sectorspecific requirements ? The customerspecific requirements QS9000 Overview ? Quality System Requirements QS9000 ? Developed by Chrysler, Ford, General Motors ? Harmonizes Chrysler’ s Supplier Quality Assurance Manual, Ford’ s Q101 Quality System Standard, and GM’ s NAO Targets for Excellence ? Founded on ISO 9001:1994, Section 4 QS9000 Overview ? QS9000 applies to all direct internal and external suppliers to OEMs of: ? Production materials ? Production or service parts ? Heat treating, painting, plating, or other finishing services QS9000 Overview ? Quality system documentation ? Suppliers must establish, document, and implement effective quality systems based on QS9000 ? All requirements of QS9000 must be incorporated into the supplier’ s quality system (see quality system documentation progression) Quality System Documentation Progression QS9000 Overview ? Quality system documentation (cont.) ? Level 1: Quality Manual Defines management’ s quality policy and mitment to quality ? Level 2: Procedures Specifies who does what, and when it is to be done ? Level 3: Instructions Specifies how the work should be performed by one individual or function ? Level 4: Records and Other Documentation Provides the objective evidence of implementation and results Comparison of Quality System Requirements TOPIC Chrysler Ford GM Supplier39。s quality policy X Supplier39。s business plan X Training X X X Process monitoring instructions X X X Evaluating subcontractor supply base X X Approved materials X X X Control of purchased production materials X X X Quality Planning X X X Resources for quality planning X Pla