Chapter 4 Prevention Versus Detection

1. Chapter 4 Prevention Versus Detection Prevention Versus Detection

2. Benefits of implementation of ISO 9001: ♦ Enhanced customer satisfaction and loyalty ♦ Reduced quality costs ♦ Increased competitiveness ♦ Improved internal transfer of know how ♦ Improved morale and motivation of staff Prevention Versus Detection

3. Certification of quality system to ISO 9001 as a “bonus” ♦ Tangible proof that the company’s quality system complies with internationally recognised standard ♦ Avoidance of multiple second party audits. ♦ Marketing edge. Prevention Versus Detection

4. Why quality costs are so important ♦ They are often large (10 to 20% of total turnover); ♦ They real volume of quality costs is usually unknown, as fewer than 40%of companies measure them; ♦ Majority of costs (often more than 80%)relate to failure and appraisal activity. ♦ Savings on quality costs may have significant Prevention Versus Detection

5. Categories of quality costs: • Costs of prevention • Appraisal costs • Failure and rectification costs Prevention Versus Detection

6. Prevention costs: • Implementation of quality system and subsequent quality planning • System verification activities (e.g. quality audits) • Management reviews of the system • Assessment of subcontractors • Training and education • Quality improvement programmes Prevention Versus Detection

7. Appraisal costs: • Verification of purchased products at subcontractor’s premises • Costs of inspection and/or monitoring • Cost of maintenance of records Prevention Versus Detection

8. Failure and rectification costs: • Cost associated with getting things wrong and subsequently putting them right. • Costs of corrective actions needed to eliminate the causes of nonconformance or other undesirable situations. Prevention Versus Detection

9. Establishing the quality costs data base: • Identify all quality costs; • Segregate the activities into prevention, appraisal, rectification; • System to record costs in each category; • Suitable accounting system, which would enable allocating the costs to activities and retrieval of data. Prevention Versus Detection

10. Which clauses in ISO 9001 have particularly preventative character? Prevention Versus Detection

11. Chapter 5 Quality System Documentation Prevention Versus Detection

12. Function and value of system documentation • provide concise set of requirements • facilitate consistency of quality activities • convey requirements simultaneously to all concerned personnel • facilitate effective change control • ensure permanence irrespective of personnel change • facilitate monitoring activities and quality system audits Quality System Documentation

13. Documents and records(ISO 9000:2000) Document – information and its support media Record stating results achieved or providing evidence of activities performed Quality System Documentation

14. Documents may be established in any form of type of medium (ISO 9001:2000 Clause 4.2.1 Note 3) • written texts • flow charts • drawings or sketches • series of sketches, drawings or photographs • audio tapes • video tapes, • master sample, etc. Quality System Documentation

15. Typical structure of quality system documentation Quality Manual Procedures Work Instructions External Documents Forms Quality System Documentation

16. General rule: The right document must be available at the right time the right place. Quality System Documentation

17. Purpose of quality manual • Communicate requirements • Describing and implementing the quality system • Basis for auditing • Ensuring continuity • Reduce learning curve • Demonstrating compliance to the standard • Prequalification and contractual purposes • Good piece of sales literature Quality System Documentation

18. Quality manual (ISO 9000:2000) “Document specifying the quality management system of an organisation” Quality System Documentation

19. Quality manual can (ISO 10013): • Be a direct compilation of procedures and other documents • Be a grouping or section of quality system documents • Be more than one document of level • Have a common core with tailored appendices • Be a stand alone document of otherwise Quality System Documentation

20. Typical contents of the quality manual: • quality policy • Introduction (objectives, scope of the QMS, company’s background) • Approval and amendment procedure • Explanation of terminology • Structure of system documentation • Overview of the quality system • Annexes Quality System Documentation

21. ProceduresISO 9000:2000 defines procedure as: “Specified way to carry out an activity or a process” Procedures may be : • Document • Informal Quality System Documentation

22. Procedure needs to answer the following questions: • What? • Why? • Who? • Where? • When? • How? In other words to define the process Quality System Documentation

23. Chapter 6 Introduction to Audits Introduction to Audits

24. “systematic, independent and documented process of obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled” ISO 9000:2000 Introduction to Audits

25. Purpose of the audit • to determine conformity • to determine the effectiveness • to provide opportunity to improve • to meet regulatory requirements • for certification Introduction to Audits

26. Reasons to conduct an audit • new suppliers • regular review of suppliers • contractual requirement • changes in the system • increased orders • quality problems Introduction to Audits

27. Benefits • Give the management confidence • Give customer confidence • Observe operational problems • Provide opportunity for improvement • Provide feedback for corrective and preventive actions Introduction to Audits

28. Classification of audits • First Party – by an organisation on itself for their own purposes • Second party audit – by an interested organisation on another organisation e.g. by customer on the supplier • Third party audit – by an independent organisation typically for certification. Introduction to Audits

29. Initial documentation review(Adequacy, desktop, intent audit) ? QMS Manual Audit Criteria = Use checklist Introduction to Audits

30. Benefits of initial documentation review • understand the system • assist planning • identify need for specialist skills • identify problems • provide opportunity to fill the gaps • assess readiness Introduction to Audits

31. Conformance (or implementation) audit ? QMS Manual = Work practices Introduction to Audits

32. Understand the difference ≠ Conformance with the audit criteria Legal Compliance Introduction to Audits

33. Types of Certification Audits • Initial or certification audit • Surveillance Audit • Re-certification Audit Introduction to Audits

34. ISO 10011 Guidelines for auditing quality systems • Part 1: Auditing • Part 2: Qualification criteria for quality systems auditors • Part 3: Management of audit programmes Introduction to Audits

35. Audit objectives Roles & responsibility - auditors’ - client’s - auditee’s Auditing Audit documents Audit completion Corrective action follow-up ISO 10011 – 1 Auditing Introduction to Audits

36. ISO 10011 – 2: Qualification criteria for quality systems auditors • Education • Training • Experience • Personal attributes • Management capabilities • Language • Selection of lead auditor Introduction to Audits

37. ISO 10011 – 3: Management of audit programmes • Organisation • Standards • Qualification of staff • Monitoring of auditor performance • Operational factors • Joint audits • Code of ethics Introduction to Audits

38. ISO 19011 Guidelines on quality and environmental (systems) auditing (will replace ISO 10011) 1 Scope 2 Normative reference 3 Terms and definitions 4 Fundamentals of auditing 5 Managing an audit programme 6 Auditing activities 7 Qualifications for quality & environmental management systems auditors Introduction to Audits

39. Fundamentals of auditing – General principles • Independence – the basis for the understanding & reliability • Ethical conduct – the foundation of integrity • Fair presentation – reporting truthfully and accurately • Evidence – the rational basis for conclusions • Due care – reasonable care in all matters Introduction to Audits

40. Management of audit programmes • Objectives and extent of the programme • Responsibilities, resources and procedures • Implementing the audit programme • Monitoring & reviewing an audit programme • Records • Combined Audits • Joint audits • Auditor qualifications and training Introduction to Audits

41. Auditing activities • Initiating the audit • Initial document review • Preparing for the on-site audit • On-site auditing activities • Reporting on the audit • Audit completion • Audit follow-up Introduction to Audits

42. Personal attributes Education, training, work and audit experience Competence Team leader Dual qualifications Evaluation process CPD Due professional care Audit team selection Language Qualifications for quality and environmental systems auditors Introduction to Audits

43. Chapter 7 Nonconformity Reports and Corrective Actions Nonconformity Reports and Corrective Actions

44. Nonconformity: “Nonfulfilment of a requirement” ISO 9000:2000 Nonconformity Reports and Corrective Actions

45. Be positive • Do not view nonconformity in a negative way • Uncovering nonconformity presents an opportunity for improvement though corrective action Nonconformity Reports and Corrective Actions

46. NCR • Report as per client’s procedure • No set rules • Commonly specific form • Some organisations require descriptive record within overall audit report Nonconformity Reports and Corrective Actions

47. Example of form Nonconformity Reports and Corrective Actions

48. Nonconformity Report • Clear and precise • Concise and accurate • Comprehensive • Describe problem • Explain the requirement • Reference the evidence Nonconformity Reports and Corrective Actions

49. Objective evidence • Factual evidence of differences between the Quality manual and procedures and the audit criteria • Factual evidence of differences between procedures and working practices • Lack of evidence to support implementation of various standard clauses • Lack of evidence to show continuous implementation of various parts of the system Nonconformity Reports and Corrective Actions

50. NCR • Report what was wrong • Explain the requirement that was contravened • To assist investigation • As self check, to avoid “inventing the requirements” Nonconformity Reports and Corrective Actions