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1、INTERNAL AUDITING FOR,QS-9000,Welcome,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
2、,Auditing fundamentals The audit system Human factors role in auditing Audit preparation Audit performance Opening meeting Closing meeting Audit report Follow-up action Case study Exam,Exam (3-1/2 hours),1-1/2 hoursPart 1 (open book) Seven case studies Answer as the team leader If there is a nonconf
3、ormance, cite the closest element/subelement of QS-9000 15 minute break 2 hoursPart 2 (closed book) General questions about auditing Multiple choice/fill in the blank/true-false Part 3 (closed book) QS-9000 requirements Multiple choice/fill in the blank/true-false,MODULE 1,Introduction,Introduction,
4、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 g
5、rade 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 long-lived items: availability, reliability and maintainability (
6、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 t
7、hat 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 appraisa
8、l 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 Va
9、riances 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 proces
10、s support systems, such as electric power, compressed air, and water Adequacy and accuracy of test and inspection equipment Correctly identifying inspection and test criteria,Quality System,Definition: “The organizational structure, responsibilities, procedures, processes, and resources needed to im
11、plement 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,QS-9000 Overview,QS-900
12、0 Overview,This module will discuss: Quality system documentation The twenty elements that are ISO based The automotive sector-specific requirements The customer-specific requirements,QS-9000 Overview,Quality System Requirements QS-9000 Developed by Chrysler, Ford, General Motors Harmonizes Chrysler
13、s Supplier Quality Assurance Manual, Fords Q-101 Quality System Standard, and GMs NAO Targets for Excellence Founded on ISO 9001:1994, Section 4,QS-9000 Overview,QS-9000 applies to all direct internal and external suppliers to OEMs of: Production materials Production or service parts Heat treating,
14、painting, plating, or other finishing services,QS-9000 Overview,Quality system documentation Suppliers must establish, document, and implement effective quality systems based on QS-9000 All requirements of QS-9000 must be incorporated into the suppliers quality system (see quality system documentati
15、on progression),Quality System Documentation Progression,QS-9000 Overview,Quality system documentation (cont.) Level 1: Quality Manual Defines managements quality policy and commitment to quality Level 2: Procedures Specifies who does what, and when it is to be done Level 3: Instructions Specifies h
16、ow 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,QS-9000 - Quality System Requirements,CONTAINS 23 ELEMENTS THAT CAN BE GROUPED IN FOUR CATEGORIES: Quality management and leadership Quality system structure and control Product and process management Automotive sector specific requirements Plus customer specific requirements,Format E
