Qs9000审核员培训教材（推荐英语版ppt185）.ppt

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 CATEGO

17、RIES: Quality management and leadership Quality system structure and control Product and process management Automotive sector specific requirements Plus customer specific requirements,Format Example,Element Number Title of Element Requirements: ISO based requirements Additional: Automotive interpret

18、ations,Quality Management track to monitor timely completion and conformance to requirements Have written customer approval or waiver on design changes Have customer review proprietary design changes,Product and implement a system for tooling management Permanently mark customer-owned tools and equi

19、pment so ownership is apparent,Customer-Specific Requirements,Chrysler-Specific Requirements Some requirements which go beyond the fundamental quality system requirements: Chrysler suppliers must be third-party registered by July 31, 1997 Shields, Diamonds, and Pentagon Critical Characteristics Guid

20、elines A complete annual inspection layout Internal quality system audits conducted at least once per year Design validation/production verification performed once per model year Nonconformances addressed with a written corrective action plan following the “7D” format,Customer-Specific Requirements,

21、Ford-Specific Requirements Some requirements which go beyond the fundamental quality system requirements: Ford suppliers are not required to be third-party registered at this time Control item parts identified with an inverted delta and have special requirements for Control Plans, FMEAs, etc. Custom

22、er approval of Control Plans and FMEAs Team oriented problem solving (8D) Statistical verification of job set-ups Quality Operating System,Customer-Specific Requirements,General Motors-Specific Requirements Some requirements which go beyond the fundamental quality system requirements: General Motors

23、 suppliers must be third-partyregistered by December 31, 1997 NAO suppliers shall verify that they are using the latest version of General Motors general procedures and other requirements at least annually Key Characteristics Designation System Problem reporting and resolution procedure UPC labeling

24、 for commercial service applications,MODULE 3,The Audit System,The Audit System,This module will discuss: The objectives of an audit program Types of audits Essential elements which are necessary for an audit system to operate effectively Factors which should be consideredwhen developing an audit sc

25、hedule Instances when normally scheduled audits should be supplemented with additional audits,Audit System : Management Tool,Provides formal feedback Reports on status and adequacy Provides management with confidence in product or service,Assessment and Audit,Assessment,A systematic investigation of

26、 the documented quality system and,the implementation of the quality system to determine,effectiveness.,Documentation Review,Comparison of quality,documentation to QS-9000,requirements to determine,adequacy.,On-Site Audit,Comparison of the quality,documentation to the,implementation of the,quality s

27、ystem to determine,effectiveness.,Audit System Objectives,To determine that a quality program has been developed and documented To verify that the quality program has been implemented and is being adhered to by the organization To evaluate the effectiveness of the quality program in meeting quality

28、requirements and achieving management goals To identify nonconformances and program weaknesses To ensure correction of identified or potential problems,Additional Functions of the Audit System,Provides feedback on regulatory requirements and potential litigation issues Provides unbiased evaluations

29、Promotes communications Evaluates areas not readily visible to management Formalizes corrective actions and process improvements,Audit Classifications,INTERNAL AUDITS (first party) EXTERNAL AUDITS (second party) EXTRINSIC AUDITS (third party),Classifications,Audits may be classified by scope and dep

30、th: Process audits effectiveness of the quality system. specific process or activity Product/service audits assessment of the quality system. product or service,Audit System Elements,Total management support, and commitment Manpower, funding, and facilities Authority, responsibilities, and organizat

31、ional independence Access to facilities, documents, and personnel Method for reporting results Access to appropriate levels of management Corrective/preventive action verification,Scheduling Audits,Regulatory documents Industry standards Corporate commitments QA program requirements Previous history

32、 of performance for the areas to be audited Industry experience,Scheduling Audits Additional Scheduling Factors,Regularly scheduled based on: Importance Complexity Status of activity Initiated early in the life of the activity Scheduled to assure adequate coverage Breadth and depth of scope ensure a

33、dequate evaluation Frequency adjusted based upon: Audit results Management direction,Scheduling Audits Supplemental Audits,Any time significant changes are made which could affect the program When it is suspected that the quality of an item is in jeopardy due to deficiencies in the quality program W

34、hen a systematic, independent assessment of program effectiveness is considered necessary If required, to verify implementation of corrective actions,MODULE 4,Auditor Qualification,Auditor Qualification,This module will discuss: Industry standards which address th requirements for auditing and audit

35、or qualifications Requirements for qualification of auditors How an auditor may maintain his/her proficiency Training requirements for auditors Evaluation requirements for auditors,ISO 10011,The focus of this course is on the requirements of ISO 10011. This standard consists of three parts: ISO 1001

36、1-1 Provides guidelines for performing an audit of a quality system of an organization. It allows users to adjust the guidelines described to suit their needs. ISO 10011-2 Describes the minimum criteria required to qualify audits to ensure that quality systems audits are carried out effectively and

37、uniformly. It also provides the method by which individual auditors compliance to the criteria should be judged and maintained.,ISO 10011,ISO 10011-3 Establishes a capability to provide overall management of the audit process for organizations which have an ongoing need to carry out quality system a

38、udits.,Auditor Qualification,Key element in the audit process Auditor capabilities directly impact audit results,Qualification Criteria,Education Completion of secondary education Communication skills Demonstrated competence Training Training to the extent necessary to ensure competence in skills re

39、quired for carrying out audits, and for managing audits: Knowledge and understanding of standards Auditing techniques Additional skills required for managing an audit,Qualification Criteria,Examination Competence should be demonstrated through written or oral exams Experience Four years full-time pr

40、actical workplace experience, at least two years of which should be in quality assurance activities Experience in the entire audit process Participation in a minimum of four audits of at least twenty audit days,Auditor Personal Attributes,Auditor candidates must: Be open minded Possess sound judgeme

41、nt,analytical skills, and tenacity Perceive situations realistically Maintain a broad perspective Understand the role of each individual,Auditor Abilities,Apply these attributes to: Obtain and assess objective evidence fairly Remain true to audit purpose Constantly evaluate the situation Treat perso

42、nnel in a way that achieves audit purpose Avoid distractions Commit full attention to the audit Handle stressful situations Arrive at acceptable conclusions Remain true to a conclusion,Evaluation Panel,Chaired by an individual currently active in managing significant auditing operations Evaluation p

43、anel should consist of not less than two members Determine that the candidate has acquired necessary knowledge skills Periodically review auditor performance,Evaluation Panel,The panel should use techniques such as: Interviews with candidate Evaluations of written work Discussions with former employ

44、ers, colleagues, etc. Structured testing for appropriate characteristics Role playing Observations under actual audit conditions Records of training and related examinations,Maintenance of Competence,Current knowledge of quality systems standards and requirements Current knowledge of auditing proced

45、ures and methods Participate in refresher training Have performance reviewed at least every three years by evaluation panel,MODULE 5,Human Factors Role in Auditing,Human Factors Role in Auditing,This module will discuss: Factors which can affect the ability of an auditor to obtain and assess informa

46、tion Why an auditor needs to understand human factors Organizations or individuals impacted by the results of the audit Methods which may be used by the auditor to deal with hostility Factors which may induce stress on the part of the auditor and methods for dealing with each,Introduction,Audit resu

47、lts depend upon: QUANTITY of information QUALITY of information AUDITORs ability to obtain and evaluate information,Audit Results,Audit results are of concern to: Management of the quality system The customer Management of the audited organization The personnel who accomplish the activities Regulato

48、ry or licensing agencies,Audit Stress,Results: Can reduce auditor effectiveness Can reduce information access,Audit Stress,Reactions: Progressive hostility Increasingly antagonistic Defensive reaction Sudden hostility Internal conflict Frustration Immediate hostility Direct conflict Avoidance,Audit

49、Stress,Considerations Approach Empathy and sympathy Compliance with local customs Objectivity and freedom from bias Audit ethics Reasonable doubt Impersonal reporting Value judgements Rapport Proprietary information Interview setting Minor conditions,Common Problem Areas,Resistance to change Volunte

50、ered information/tip-offs Internal conflicts Deception Diversion,Auditor Etiquette,Be open Use two-way communication Dont emphasize errors Dont focus on individuals When wrong admit it Respect organizational channels Foster an atmosphere of seeking to improve Believe statements but require proof,Aud

51、itor Etiquette,Dont hedge Keep your disruptions of others to a minimum Respect expertise Deal with frustration Make auditees responsibilities clear Be sure to differentiate between recommendations and requirements,MODULE 6,Audit Planning,Audit Planning,This module will discuss: Activities which take

52、 place during the planning phase of the audit process “Vertical slice” and “horizontal slice” sampling Uses for an audit checklist Items which should be considered orconsulted when preparing for an audit Methods for selecting audit samples,Audit Planning,Includes: Selecting an audit team Interfacing

53、 with the audited organization to obtain preliminary information Orienting the audit team Developing an audit plan Assembling a checklist,Team Selection,Number of personnel and collective team experience depends upon: Audit scope Available personnel Available time to perform the audit Need for speci

54、al skills or expertise,Benefits of a Knowledgeable Team,Less time and effort is required during the planning phase of the audit The investigation is more efficient and more effective Reporting is more meaningful Credibility is established with the audited organization,Team Size,Single person team is

55、 not recommended 2 or 3 person team is optimal Benefits of multiple-person teams: More experience and technical expertise Better focus on specific areas Synergy/brainstorming,“sounding boards”,Interfacing With the Audited Organization,Confirm the audit Obtain information Provide written notification

56、,Written Notification,Typically includes: A brief description of the purpose and scope of the audit Indication of the authority toconduct the audit Opening meeting time and date Tentative schedule of major audit activities Identification of the audit team members,Audit Team Orientation,Audit scope A

57、udit team capabilities and team member expertise Ground rules for the audit Specific issues, problem areas, and management concerns Activities and critical areas to be investigated,Audit Plan,Developed before document review Helps to determine effectiveness Helps in: Determining critical information

58、 and activities Identifying samples Maximizing use of time and manpower Provides an outline for approach Developed by team,Audit Plan Development,Identify purpose of the process under investigation and determine what should be accomplished Identify customer of the process Determine customer needs, e

59、xpectations, expected product Identify critical information Determine how to obtain information which provides an indication of process performance: In the allotted time With the given audit team,Sampling,An audit is a sampling process Audit results are impacted by the quality and quantity of information obtained Obtaining information Observing activities Interviewing personnel Reviewing documentation,Sample Methods,Statistical Population size Sample size Selective Problem areas Complex activities Significant risk,Sampling,Horizont