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INTENRAL QUALITY AUDIT PRACTICES PRESENTED BY Dr S Chakraborty sambhuchakraborty

INTENRAL QUALITY AUDIT PRACTICES PRESENTED BY Dr S Chakraborty www.sambhuchakraborty.com. COURSE OBJECTIVES. Formal training for conducting laboratory Internal Audit to comply with requirement of ISO 15189 standard

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INTENRAL QUALITY AUDIT PRACTICES PRESENTED BY Dr S Chakraborty sambhuchakraborty

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  1. INTENRAL QUALITY AUDIT PRACTICES PRESENTED BY Dr S Chakraborty www.sambhuchakraborty.com I

  2. COURSE OBJECTIVES • Formal training for conducting laboratory Internal Audit to comply with requirement of ISO 15189 standard • Assist in implementing laboratory accreditation system as per requirement of accreditation body • To Qualify as Internal Auditor for doing laboratory Audit Internally • Can help in carrying out second Party audit web: www.quality-pathshala.com

  3. COURSE OUTLINE • Principles of Auditing • Audit Planning and execution • NC Reporting and system effectiveness • Checklist preparation • Close examination of requirements in laboratory accreditation • Case Studies web: www.quality-pathshala.com

  4. GENERAL PRINCIPLES OF AUDITING AUDIT OF laboratory QUALITY MANAGEMENT SYSTEM web: www.quality-pathshala.com

  5. DEFINITION Quality Management system audit is----------- Systematic and Independent Examination of activities to. • Verify compliance. • Judge Effectiveness-of quality management system web: www.quality-pathshala.com

  6. FORMAL DEFINATION A FORMAL activity carried out against policy, quality manual and procedures to INDEPENDENTLY examine OBJECTIVE EVIDENCE and verify compliance or otherwise with SPECIFIED REQUIREMENT and also judge EFFECTIVENESS web: www.quality-pathshala.com

  7. INTERNAL VERSUS EXTERNAL AUDIT • External auditor - has to stick to the norm - will almost exclusively report on non- conformities - examines a limited scope of services web: www.quality-pathshala.com

  8. INTERNAL VERSUS EXTERNAL AUDIT Internal auditor • has to detect non-conformities, • but can also report on other issues • covers the complete scope • is unrelated to the audited section of the organization, • knows the inner workings of the organization web: www.quality-pathshala.com

  9. THE INTERNAL AUDIT PROCESS • Scheduled Audits • programme managed by Quality Assurance Officer • examine documents, results, processes • identify problems • improve • Unscheduled Audits • investigate problem • improve web: www.quality-pathshala.com

  10. WHY INTERNAL AUDITING? • Is QMS implemented exactly as intended ? • To investigate a problem - why did it occur ? - how can it be resolved ? - how can it be prevented in future ? • Identify opportunities to improve • Does the QMS meet requirements of standards ? web: www.quality-pathshala.com

  11. AUDIT STAGES STAGE-I : ADEQUACY/INTENT • Is the system defined ? • Is the system documented as per standard • Quality Manual versus ISO 15189 requirement web: www.quality-pathshala.com

  12. AUDIT STAGES STAGE-II :COMPLIANCE/IMPLEMENTATION • Is the documented system Implemented ? • Is the specified requirement is full fill • Objective evidence of activities versus the manual/procedures web: www.quality-pathshala.com

  13. AUDIT STAGES STAGE- III : EFFECTIVENESS • Is the implemented system effective ? • Is the desired Output/objective Achieved • Objective evidence of the effectiveness of the quality system web: www.quality-pathshala.com

  14. QUALITY AUDIT TYPES • 1st Party - WE auditing our own system (Internal) • 2nd Party - WE auditing our subcontractor (External)- vendor laboratory, suppliers • 3rd Party - We being audited by an Certification Body-laboratory web: www.quality-pathshala.com

  15. AUDIT SCHEDULE • Annual • Address all elements of the quality system - not all departments • Frequency ? -critical areas web: www.quality-pathshala.com

  16. DOCUMENTS USED IN INTERNAL AUDITING • Checklists • Non conformance & Corrective action request forms • Audit report forms web: www.quality-pathshala.com

  17. DOCUMENTING THE AUDIT PROGRAM • Internal audit procedure (s) • selection and training of auditors • scheduling audits • responsibilities of auditors • preparation, conducting and reporting on audits • identifying, resolving and following up corrective actions • reporting audit results to management web: www.quality-pathshala.com

  18. EFFECTIVE AUDITING Gather evidence about compliance with quality management system or standard web: www.quality-pathshala.com

  19. EFFECTIVE AUDITING • Gather information about: • organization structures , job description, various process and sub process of the department, internal customer or interrelationship matrix, laboratory management system, MIS, Departmental standard operating procedures, web: www.quality-pathshala.com

  20. AUDIT TERMINOLOGY AND USES SPECIFIED REQUIREMENTS FOR QUALITY MANAGEMENT SYSTEM AUDIT: Can be stated as follows : • Customer requirements • Quality System requirements - Quality manual - SOPs/Procedures/Work instructions - ISO 15189 Standard requirement • Legal requirements-statutory, regulatory or industry body • Regulation of certification body web: www.quality-pathshala.com

  21. AUDIT TERMINOLOGY AND USES OBJECTIVE EVIDENCE : • Evidence which exists • Uninfluenced by emotion or prejudice • Can be stated • Can be documented • Is about quality • Can be quantitative (countable) • Can be qualitative (measured by degree) • Can be verified web: www.quality-pathshala.com

  22. AUDIT TERMINOLOGY AND USES OBJECTIVE EVIDENCE (SOURCE): • Available from • Quality Manual and other documents • Quality records • Statement of Auditee • Objective evidence need to be • Verifiable • Traceable web: www.quality-pathshala.com

  23. AUDIT TERMINOLOGY AND USES AUDIT SAMPLE : Need to representative from • People • Work station stages/Process • client records • Documents • General Records web: www.quality-pathshala.com

  24. AUDIT TERMINOLOGY AND USES • NON CONFORMANCE : This is a judgmental term, in that we are stating that the quality system, or part of it, does not comply with requirements. Action is required! Noncompliance must be substantiated with observations or findings, and backed by objective evidence. web: www.quality-pathshala.com

  25. AUDIT TERMINOLOGY AND USES NONCONFORMITY : • Non fulfillment of a specified requirement • Condition averse to quality • Specified requirements: • Conditions of contract • ISO 15189 standard • Quality manual • Procedures • Legal requirements • Specified opinion by auditee web: www.quality-pathshala.com

  26. AUDIT TERMINOLOGY AND USES JUDGING SYSTEM EFFECTIVENESS : Based on conclusions from audit findings web: www.quality-pathshala.com

  27. AUDIT TERMINOLOGY AND USES 1.Intent: “Have you said what you do?” Do the defined or documented processes adequately express your approach?   2.Implementation: “Have you done what you said?” Do the observed and recorded practices show compliance with the stated intent?   3.Effectiveness: “Have you done it well?” Do the results of the process indicate the desired outcomes have been achieved? web: www.quality-pathshala.com

  28. AUDIT TERMINOLOGY AND USES REPEATED NON CONFORMANCE : • This may also be an example that corrective action is not effective • Effectiveness of system web: www.quality-pathshala.com

  29. AUDITORS CRITERIA Knowledge of specified requirement: • Collecting objective evidence for compliance or otherwise • Drawing representative sample • Asking right questions. web: www.quality-pathshala.com

  30. AUDITORS CRITERIA (GENERAL) • Following Audit Trails • Recognizing non conformances • Judging effectiveness • Audit Frequency web: www.quality-pathshala.com

  31. AUDITORS CRITERIA (GENERAL) Knowledge of specified requirement : • Knowledge on ISO 15189 standard, • Knowledge on local govt. statutory & regulatory body such as pollution control board, various medical & licensing department for operation of Laboratory web: www.quality-pathshala.com

  32. AUDITORS CRITERIA (GENERAL) Collecting objective evidence: • Collect objective evidence against each audit sample • Objective evidences may be any quality system document reference • Objective evidence may be any client record, general record, any data, equipment label, physical observation etc. web: www.quality-pathshala.com

  33. AUDITORS CRITERIA (GENERAL) Auditor should know the characteristics of representative sample, so that audit finding lead to the fact of the system. Auditor will do the audit by asking open ended question. Drawing representative sample : Asking right questions : web: www.quality-pathshala.com

  34. AUDITORS CRITERIA (GENERAL) • Following AUDIT TRAIL : AUDIT TRAIL : A record of transactions in an information system that provides verification of the activity of the system. The simplest audit trail is the transaction itself. If any adverse event is happened, when it is happened, who reported, what happened web: www.quality-pathshala.com

  35. AUDITORS CRITERIA (GENERAL) • Recognizing non conformances : • To know the condition of non conformances and reporting non • conformance • Judging effectiveness : • Auditor shall determine and judge the effectiveness of the quality • system web: www.quality-pathshala.com

  36. AUDITORS CRITERIA (GENERAL) Audit Frequency : Auditor should determine from the audit findings the frequency of audit web: www.quality-pathshala.com

  37. THE AUDIT LIFE CYCLE The audit life cycle is often referred to as P.E.R.C • Planning • Execution and Preparation • Reporting/Recording • Close out :Follow up/closing of Non conformance/confirmation of corrective action web: www.quality-pathshala.com

  38. 1. Audit Plan 2. Develop Checklists Conducting the Audit 3. Opening Meeting 4. Gather Evidence 5. Record Result 6. Closing Meeting 7. Audit Report web: www.quality-pathshala.com

  39. AUDIT PREPARATION AUDIT PLANNING & PREPARATION FOR THE AUDIT web: www.quality-pathshala.com

  40. AUDIT PLANNING CHECKLIST BENEFITS: • Keeps audit objectives clear • Evidence of audit planning • Maintains audit pace and continuity • Reduces auditor bias • Reduces workload during audit DRAWBACKS : • Checklists tend to lose value if they are: • Tick lists • Questionnaire • Prepare them as aides-memoir web: www.quality-pathshala.com

  41. AUDIT PLANNING CHECKLIST PREPARATION 1. Convert clauses of the standard into questions 2. Using these questions and the quality manual • Plan what to look at and why i.e. look for • Consider sample sizes web: www.quality-pathshala.com

  42. AUDIT EXECUTION ASKING RIGHT QUESTION : • Do not ask close ended question, ask open ended question • Close ended question : where your are directly asking for objective evidences, where you are not getting scope for verifying the scope • Close ended question : give me your adverse event record, where is your maintenance record, show me your purchase register etc web: www.quality-pathshala.com

  43. AUDIT EXECUTION • Open ended question : where question creates opportunity for further opening of the question to verify the system and methodologies • Open ended question : what is your Quality control policy, how do you transport sample in the laboratory from site web: www.quality-pathshala.com

  44. AUDIT EXECUTION • ASKING RIGHT QUESTION/OPEN QUESTION There are 7 Friends • Who (does it) • What (is done) • Where (is it done) • Why (is it done) • When (does it get done) • How (is it done; often is it done) • Show me web: www.quality-pathshala.com

  45. AUDIT EXECUTION 7 Friends in other way (6 W and 1 H) - Who - What - Where - When – Which - Why - How web: www.quality-pathshala.com

  46. AUDIT SKILLS AUDITING SKILLS : • It is fact finding technique • Not fault finding - ASK - VERIFY - OBSERVE web: www.quality-pathshala.com

  47. AUDIT SKILL • Horizontal audit :This examines one element in a process on more than one item. It is a detailed check of a particular aspect of the documentation and implementation of the quality management system or examination processes. • Vertical audit : • This examines more than one element in a process, on one item. web: www.quality-pathshala.com

  48. AUDIT SAMPLE AT PHLEBOTOMY ROOM web: www.quality-pathshala.com

  49. REPORTING Taking Notes • Recording audit sample examined for Dept. audited • Person contacted –laboratory clauses involved • Area seen - Process stage involved • Documents examined- Records verified • Audit trails identified/followed • Compliance/Non compliance • Reference of non compliance web: www.quality-pathshala.com

  50. REPORTING NOTE TAKING • Notes could be used as reference for: - Immediate investigation - Investigation later - Use by a colleague - Subsequent audits • Notes must therefore be : - Legible - Retrievable - Positive reporting helps to determine depth in Auditing, Basis for - selecting samples and judging system effectiveness. web: www.quality-pathshala.com

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