Use of Corrective Actions in Management of Human Errors in Analytical Laboratories.pptx

Use of Corrective Actions in Management of Human Errors in Analytical Laboratories of chemistry diviion

1. Use of Corrective Actions in Management of Human Errors in Analytical Laboratories Aleš Fajgelj 1 , Marko Giacomelli 2 and Georgios Takoudis 3 1 IAEA, Department of Nuclear Sciences and Applications, Vienna, Austria 2 Institute of Occupational Safety, Ljubljana, Slovenia 3 Greek Atomic Energy Commission, Aghia Paraskevi, Greece Training Workshop on Quality Assurance for Nuclear Spectrometry F1-TR-52968, 19-23 June 2017 Vienna, Austria

2. Some cooperations International Union of Pure and Applied Chemistry (IUPAC) ISO Committee on Reference Materials (ISO REMCO) International Bureau of Weights and Measures (BIPM); Consultative Committee for Amount of Substance — Metrology in Chemistry Co-operation on International Traceability in Analytical Chemistry

3. Quality management principles Interested Part ies Requirements Management responsibility Measurement analysis improvement Resource management Product realisation CONTINUAL IMPROVEMENT OF QUALITY MANAGEMENT SYSTEM Interested Parties Satisfaction Product Input Output

4. 4 of 58 Process in Analytical Laboratory

5. {system} set of interrelated or interacting elements design and development set of processes that transforms requirements into specified characteristics and into the specification of the product realisation process project unique process consisting of a set of co-ordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements, including the constrains of time, cost and resources procedure specified way to perform an activity product result of a process software intellectual product consisting of information on a support medium offered product product submitted to a customer external to the offering organisation process system of activities which use resources to transform inputs into outputs service intangible product that is the result of at least one activity performed at the interface between the supplier and customer hardware, processed materials tangible products Concepts relating to product or process

6. characteristic distinguishing feature quality characteristic inherent characteristic of a product, process or system derived from a requirement traceability <metrology> property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standard, through an unbroken chain of comparisons all having stated uncertainties traceability (also trackability) <general> ability to trace (track) the history, application or location of that which is under consideration [dependability] collective term used to describe the availability performance and its influencing factors: reliability performance, maintainability performance, and maintenance support performance Concepts relating to characteristics

7. {requirement} need or expectation that is stated, customarily implied or obligatory conformity fulfilment of a requirement nonconformity nonfulfilment of a requirement Concepts relating to conformity 

8. preventive action action taken to eliminate the cause of a potential nonconformity or other potentially undesirable situation correction action taken to eliminate a detected nonconformity corrective action action taken to eliminate the cause of a detected nonconformity or other undesirable situation action taken to eliminate the cause of a nonconformity Concepts relating to conformity Continual improvement

9. ISO 17025 clauses: § 4.8: Complaints § 4.9: Control of non- conforming work § 4.10: Corrective actions § 4.11: Preventive actions ISO 17025 vs. ISO Guide 34 ISO Guide 34 clauses: § 4.7: Customer service (4.7.2) § 4.8: Control of non-conforming work and/or RMs § 4.9: Corrective actions § 4.10: Preventive actions

10. The difference Corrective Action something has gone wrong don’t let it happen again local in nature prevent recurrence reactive Preventive Action something might go wrong don’t let it happen at all global in nature prevent occurrence proactive Actions for improvement!

11. Corrective action procedure When? There is doubt about the lab’s compliance of the operations with the policy of the Quality System. The problem would recur. Procedure Accurately define the existing problem Investigate the most probable cause Determine accurate corrective action Implement corrective action Follow up / effectiveness / closure But, a CA for every NC is OVERKILL!

12. Preventive action procedure Accurately define a potential problem Investigate all potential causes Identify the most probable potential cause Determine accurate preventive action Implement preventive action Follow up / effectiveness / closure Or Specific point during management review meeting

13. SOP Complaints Non-conformances Corrections Corrective Actions Preventive Actions EQC IQC Staff observations Ideas for improvement

14. Form

15. IAEA example

16. Analytical task The laboratory environment Method & SOP Attention subsystem Automatic subsystem Activation Interruption Info Info Search Search Analytical task and cognitive process system

17. Knowledge-based Malicious Reasoned Routine Rule-based Skill-based Reckless Sampling Analysis of test portions Calculation & reporting Commission Omission Violations Mistakes Lapses Slips Method & SOP Steps of analytical process and potential types of errors

18. 1) Validation of the method and SOP formulation 2 ) Training analysts and proficiency testing 3) Quality control 4) Supervision OOS test result Human error of an analyst Quality assurance system of an analytical laboratory 18 The Swiss cheese model

19. IAEA Regional TC Project RER0033 “Supporting Quality Assurance for the Measurement and Monitoring of Radioactivity in the Environment “ 9 to 12 October 2012, IAEA HQ, Vienna The use of in-depth analysis of CCs to investigate root causes for potential human errors. Creation of compiled (anonymous) list Identification of preventive actions to reduce or minimize human errors in similar situations in other laboratories in the future.

20. Corrective actions list TYPE   NO.   DURATION   CONTACT   TITLE     POTENTIAL HUMAN ERROR   CC   1   3 months   Laboratory 1   Poor performance of LSD spike at TRP     Y   CA   2   14 days   Laboratory 1   Failure of computer system to update weekly QC Charts     N   CA   3   1 month   Laboratory 1   Americium contamination in screening.     Y   CA   4   2 months   Laboratory 1   Unescorted workmen in HESL (Room 1-6) caused room contamination     Y   PA   5   3 months   Laboratory 1   Improved procedure for UO2 powder dissolution.     NA   CC   6   1 week   Laboratory 1   Contaminated UF6 cylinders from Lab1 to ITU     Y   PA   7   1 week   Laboratory 1   Initiation of repeat measurements     NA   CC   8   6 months   Laboratory 1   Delays in reporting Sample Analysis     N   CA   9   1 month   Laboratory 1   Pu separation chemistry problems (QC observation 918 & 920)     Y   CAPA   10   1 week   Laboratory 1   SIMS sample Id tracking problem     Y   CA   11   2 weeks   Laboratory 1   Mixup of EM Gamma Screening Sample IDs (series 20578)     Y   PA   12   3 months   Laboratory 1   Reliability of Clean Lab Ventilation Control System     N   CC   13   3 months   Laboratory 1   LSD-18, high rate of defects     N   CA   14   1 month   Laboratory 1   U/Pu products IDMS control and other Pu Chemistry problems     Y   CC   15   2 weeks   Laboratory 1   Complaint about Lab1 "not following" instructions     Y   PA   16   1 month   Laboratory 1   Review and lessons learned from special samples 7566-7569     NA   PA   17   2 weeks   Laboratory 1   Communication of priorities customer-Lab1-OperationalUnit     NA   CC   18   1 month   Laboratory 1   Data Reporting Error, Gamma Spectrometry, Lab1 Series 7378     Y   CC   19   1 week   Laboratory 1   Defective spikes from LSD-20 reported by Lab1-TRO     Y   CC   20       Laboratory 1   Poor performance of OSL LSD spike at TRP     Y   CA   21   8 months   Laboratory 1   Frequent QC failures of standards in nuclear mass spec lab     Y   PA   22   7 months   Laboratory 1   U and Pu standard solutions used in the nuclear laboratory     Y   EXCEL File

21. Potential human errors Σ 90

22. Type of incident

23. Duration to solve

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