IMPACT OF PREVENTIVE AND CORRECTIVE ACTIONS IN QUALITY MANAGEMENT FOR TOTAL TESTING PROCESS

1. IMPACT OF PREVENTIVE AND CORRECTIVE ACTIONS IN QUALITY MANAGEMENT FOR TOTAL TESTING PROCESS Dr Ömer Güzel Biruni & Centro Laboratories, Istanbul 25 June 2014

2. Ensuring quality in all phases of the laboratory cycle “ Laboratories need to monitor and improve their procedures to ensure that they always deliver: for the correct patient, the correct test results, to the correct doctor ” MJA, 1996; 165: 125-126. Stewart J Bryant

3. Deviation in Quality our first response should be to protect the patient. • In a car accident : • Our first concern is usually to prevent other cars from crashing by marking the crash site with a red triangle. • Check if somebody has been injured. • Call policeandambulance. • Ask for help and provide first aid to injured persons

4. Corrective Actionsforaccident • Corrective actions can differ depending on the root cause of the accident. • If the driver was drunk, he should be included in a treatment program. • Similar treatment should be applied in the case of speeding. • If the cause of the accident was a bad road infrastructure, it should be repaired – road markings should be restored, road signs should be replaced, a new layer of asphalt may be needed etc. • The goal of corrective actions is to remove the root cause and prevent a concrete problem from ever happening again.

5. Preventive Actions for accident • Preventive actions are proactive. • Oriented towards a potential problem in the future. • Improve a process or a product to prevent a problem from ever happening. • Some of the preventive actions related to traffic safety could be: - increasing awareness of the harmful effects of alcohol and drugs, - high penalties for driving too fast or driving drunk, - replacing dangerous cross intersections with roundabouts - informational videos about the most common driving mistakes and difficulties, like incorrect lane changing, insufficient safety distance, safe overtaking, safe driving in tunnels, driving in bad weather conditions, etc.

6. Nonconformity

7. Laboratory should identify and investigate nonconformities during their daily routine procedures. • The purpose of the corrective and preventive action system is - to collect information, analyze information, identify andinvestigate testing and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. • Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with testing and quality problems, preventing their recurrence, and preventing or minimizing failures.

8. ASSESSMENT CRITERIA EVIDENCE FINDING STRONG POINT: The evidence shows an OVERFULFILMENT of the criteria NO REMARK: The evidence shows a FULFILMENT of the criteria WEAK POINT: The evidence shows that IN THE FUTURE there would be an UNDERFULFILMENT. Include a COMMENT in the report DEVIATION/NON-FULFILMENT: There is an UNDERFULFILMENT: - Severe underfulfilment: NONCONFORMITY - slight underfulfilment: OBSERVATION Possible IMPROVEMENT ACTION IMPROVEMENT ACTION OR PREVENTIVE ACTION CORRECTION &/OR CORRECTIVE ACTION

9. Corrective Actions • Immediate Correction:Any action taken immediately upon identification of the potential noncompliance 2. Root Cause:The source or origin of the noncompliance, as well as any contributing factors involved. 3. Root Cause Correction:The remedial corrective action implemented to address the source or root cause of the noncompliance that will preclude recurrence. The response to root causes should, at minimum, include changes to procedures,processes and/or training Root cause correction involves long-term prevention and process improvement rather than an immediate fix 4. Corrective Action Verification Plan:The plan to ensure that the committed corrective action has been implemented 5. Follow-up:An audit to ensure that the committed corrective action plan has been found to be effective as implemented.

15. Preventive Actions • Preventive actions are proactive and oriented towards a potential problem in the future. • Detecting potential nonconformance’s and eliminating them. • Preventive Actions improve a process to prevent a problem from ever happening. • Laboratories can benefit from employing risk-assessment techniques to lookat the preanalytical, analytical andpostanalytical testing phases. • Most critical issue is the correct identification and documentation of nonconformities in our daily practice. • Laboratory should establish a transparent system to identify the nonconformities.

17. Identification of LaboratoryErrors • Every laboratory has to develop a procedure for identification and evaluation of nonconformities. • The process development by it self is an educational tool. • Every step, every problem has to be recorded and evaluated. • The main purpose is different than Corrective and Preventive actions. • Laboratory has to identify the type and number of nonconformities which is detected before it has been reached to the patient as an error. • We did start our procedure in 2009 at pre analytic stage. • Generally it was accepted that most of the errors occur in pre analytic process. We did concentrate at this phase.

18. Thefirst form used in 2009 sampleprocessingdepartment

20. Identification of LaboratoryErrors • The second step was to establish separate nonconformity/erorfolow up forms for each department of laboratory. • Different forms for the needs of each department • Educational meetings with each department • Each incident has to be marked by a single tick to avoid time consuming writing and documenting activity as in the CPA process. • Major reason is to avoid paper work and bureaucracy. • Revision 1. published in Document Management System.

24. Error log form (sample processing)

25. Error log form (sample processing)

26. Each department processed their error log forms and reported monthly to quality department. • Quality Department processed each form from each department. Error Log Forms are consolidated as Error Log REPORTS. • Collected data will be processed for each department as “Improvement Reports” • High numbers of nonconformities were determined and actions were taken to prevent repeating/ improvement.

27. Error Log Form (Laboratory) Monthly Total June : 22 Monthly Total December : 165

30. Follow up of Improvement Reports • Persistentandincreasingnonconformitieswereevaluatedfirst. • Itemsto be examinedwill be evaluated in ImprovementReport. • RootCausesdefined. • Actionstaken. • Results of theactionstakencontiniouslyevaluated. • ResultsReported.

31. Improvement Report

32. Results of ImprovementReports • Formsare not usedproperly • Does not processedforpurpose • Incomplete data recording • General understandingwastocorrectnonconformities at occurance, andaccepttheseitem as naturalincident. • No recording as errors. Becausetheywereimmediatelyrecovered. • Educationalactivitiesforalldepartments

33. New Versions of Forms • All forms of all departments are revised to be processed properly. Revision 2. • New parameters and items added to forms. • Staff was loosing to to find out nonconfomity item. Needs easy reading • Format and content of forms are determined for easy acess.

34. Error log form (Laboratory) – 2nd Revision

35. Revision 3. • Forms are revised . • After new developments Revision 3. forms were circulated. • New forms are used more effectively. • New headlines are the names of processes: • Daily Routine Management • Pre Analytical Stage • Analytical Stage • Postanalytical Stage • Controls • Microbiology • Others

36. Error log form (Laboratory) – 3rd Revision

37. Educational Activities & Revision .4 • How to use new forms and the main purpose of this activity was explained to all staff. • Educational activities and daily practise of new forms gave new idea for Revision 4 • Name of the forms was changed ; Process Evaluation Form.

38. Process Evaluation Form (Laboratory) – 4th Revision

39. Corrective &PreventiveActions Form vs Improvement Form Eror in resultprocessing Data QC Manager & MedicalSpecialist • Erorwasdetected • Corrected • No effecttopatient • Correctreporting • Risk preventedbeforeoccuring • RecordedtoProcessEval. Form • Errorcould not be detected • Wrongresultreported • Negativeeffecttopatient • Risk occured Corrective & PreventiveAction Form Improvement Form

40. Errors caused nonconformity in 2013 C&P ActionForms

41. Errors caused nonconformity in 2014 C&P ActionForms

42. Risk Analysis • Continiousimprovementactivitiesare • documentedandbenefit of theseactivites • could be measured. • Morepracticalandmeasurableversion of • “ImprovementReport” is in progress • Possible Risk Factorsforeachdepartment • determined • To be abletocalculateRisks , Unitdefinition is • establishedforeach risk • Revision 5.

43. Process Evaluation Form (Laboratory) – 5th Revision

44. Risk Analysis • A new “Risk Analysis Form” is introduced to system. • Risks may be caused by non-conformities are documented in this form. • Monthly statistics for numbers of errors, patient, order, test, etc. Are evalated to calculate risk ratios. .

45. Risk Analysis Form Total number of samples Risk ratio Number of errors Risks

46. Risk Analysis Form Risk ratio per month

47. Examples of improvement activities

48. Examples of improvement activities

49. Examples of improvement activities

50. Examples of improvement activities