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Effectively Closing Laboratory Assessments

Effectively Closing Laboratory Assessments. Resolving Findings and Deficiencies Once and For All!!! Prepared and Presented by: Jack Farrell Analytical Excellence, Inc. September 22, 2010. Objectives. Present some laboratory assessment facts and perceptions

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Effectively Closing Laboratory Assessments

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  1. Effectively Closing Laboratory Assessments Resolving Findings and Deficiencies Once and For All!!! Prepared and Presented by: Jack Farrell Analytical Excellence, Inc. September 22, 2010

  2. Objectives • Present some laboratory assessment facts and perceptions • Raise awareness on the challenge of repeat findings and potential solutions • Discuss ways of performing corrective actions • Process • Root Cause • Closing • Suggest a step by step process for improvement

  3. Setting the Stage • Ineffective corrective action programs • Are one of the top 10 common findings in “regulatory” laboratory accreditation assessments (actually top 3) • Are one of the biggest challenges for laboratory management • Provide one of the biggest opportunities for improvement

  4. Setting the Stage • Assessments are a snapshot of the laboratory operation (They are not intended to find everything) • Re-occurring findings and deficiencies are a big problem • Assessors and accrediting bodies do not take kindly to laboratories not taking comprehensive corrective actions • The Quality Systems approach to corrective actions requires that findings be fixed in all areas of the operation

  5. Setting the Stage • Ineffective corrective action processes • Appear to be top contributing factors to • Assessment inconsistencies • Repeat findings • Management and QA officer frustration • Appear to be a significant rate limiting step in achieving accreditation or approval in some programs (DoD ELAP) • An effective corrective action process is integral to management system success

  6. Repeat Findings • What is a “repeat finding”? • A finding (deficiency) previously observed in an evaluation, is again observed in a subsequent evaluation in the same or other areas of the laboratory. • May or may not have been addressed locally. (Fixing the Symptom) • Can be a real source of irritation • Is definitely a source of “rework” and “increased cost” to both laboratories and regulators • A symptom of Quality System failure

  7. Repeat Findings • Are prevalent in the majority of NELAP assessments • ABs have differing definitions • Are an issue in the DoECAP program • Routinely get escalated to “critical” • Appear to be an issue with ALL programs • Can be easily addressed by embracing the Quality Systems approach

  8. Repeat Findings • Common areas and findings • SOP detail and content (most prevalent) • Matching practice • Contain all steps and procedures • Calibration, QC, sample preparation • Handling matrix spike results • Missed critical steps • Records • Administrative records (temperatures, balances) • Manual integration • Case narrative documentation

  9. Repeat Findings • It is management’s responsibility to take each finding and make sure that it is not occurring in any other area of the laboratory • Corrective action must address the problem in all areas and for all applicable staff • Regulatory agencies need to develop a policy on handling (and eliminating) repeat findings • Laboratories need to aggressively and continuously address findings in a systematic manner

  10. Addressing Repeat Findings • Regulatory policy should include • A definition • A measure of importance or severity • Consequences • Encouragement for elimination • Communication • Assistance mechanisms • Include a measure of practicality

  11. Addressing Repeat Findings • Laboratory management initiatives • Management commitment • Employee awareness • Detailed policy and/or procedure • Address in systematic manner • Training, tools and procedures • Add to internal audit checklist • Feedback and re-training • Persistent enforcement of policy Continued Emphasis & Encouragement

  12. Addressing Repeat Findings • Internal audits are one of the most important tools that management has to determine how the operation is functioning • Corrective actions are the best mechanism for • Continuous improvement • Assuring that you are not fixing the same problems time after time – and re-inventing the wheel • Spotting trends and establishing a preventive action process • Maintaining accreditation requirements • Using the CAP is mandatory – it is not optional

  13. One Program’s Solution One of the most significant and valuable enhancements to accreditation offered by the DoD ELAP is actually in the “process” of accreditation (not in the QSM) The DoD ELAP has a much stronger emphasis on improvement and on corrective action than most other “regulatory” programs (by virtue of using ISO/IEC AB procedures)

  14. Paradigm Shift • DoD ELAP process change • Strong focus on closure of corrective actions • Root cause analysis • Submission of objective evidence • Implementation and effectiveness • Accreditation awarded only after successful closure • Multiple submissions costs! • Use of periodic surveillance visits – annually

  15. Paradigm Shift • Taking real advantage of this “enhancement” necessitates a significant shift in “thinking” • This requires • Tenacity and persistence in embracing management systems • Looking at the long term – not just the now! • Not just providing a corrective action plan – “see you in two years” • A measure of “Trust” but with Verification Managing an Effective Corrective Action Process

  16. So… let’s focus on the corrective Action Process

  17. Corrective Action Process • The problems with most corrective action processes are • They only look at the short term – the quick fix • These “solutions” don’t last (repeat findings) • The process is not used for all corrections – it lacks a comprehensive approach • It is only used by select management – it is not a “grass roots” program • It does not address the root cause (repeat findings) • All staff are not trained and encouraged to use the process • There is no follow through and monitoring (repeat findings)

  18. Symptoms vs. Root Cause • Most assessment findings are symptoms of something more basic • Findings usually can be linked to failure in one or more elements of the Quality System • Most findings occur in more than one area of the operation • Identifying the root cause(s) can be confusing, complex and very frustrating

  19. Root Cause Analysis • There are lots of complex tools in the world of “Management Systems” • Cause and effect diagrams (CED) • Interrelationship diagrams (ID) • Current Reality Trees (CRT) • Praedo Charts (PC) • …and more • Tip: Watch out for Analysis to Paralysis

  20. Root Cause Analysis • Clearly define the deficiency. • Ask some questions… • Why did this occur? • What contributed to the event? • How did this happen? • Has this occurred before? • Why did the previous solution fail? • Which of the foundation systems is affected? • Once you think you have the cause…Ask Why again! • Asking Why – 5 times.

  21. Large Group Exercise • Identify the Root Cause #1 Error corrections are not performed according to the quality manual and the NELAC Standard in the QA department, metals extractions and sample receiving. [4.12.1.5 f; 4.12.2.3] So, what are the potential root causes?

  22. Large Group Exercise • Identify the Root Cause #2 The laboratory has failed the last three PT samples for Silver. No documented corrective actions were provided. [5.9.1 b (grey box 43); 4.1.5 k; NELAC 2.7.2; 2.7.4] What are the potential root causes?

  23. Large Group Exercise Failed Benzene PT Analysis • Reported for Benzene – 43.2 ug/L • PT Acceptance Range – 45.2 - 54.5 ug/L • Passed other volatile hydrocarbons • Calibration check (CCV) – within limits • LCS – within limits No apparent reason for failure (?)

  24. Large Group Exercise Let’s Look Closer! TargetReportedAccept. Range • Benzene 43.2 45.2 - 54.5 • Toluene 76.6 75.1 - 90.6 • Ethylbenzene 135 131 - 162 • Xylene 52.5 51.7 - 65.2 All pass except Benzene, but all others low in range; low bias indicated

  25. Large Group Exercise

  26. Root Cause Analysis • Be practical • Need to balance being comprehensive with diminishing returns • Don’t just fix the symptoms…fix the system • There are very few corrective action responses…where …there is no apparent reason… • Document the solution and monitor the change • Don’t be afraid of going back and looking deeper…

  27. How to Effectively Address Corrective Actions • Understand the finding • Read the citations and the requirements • Ask questions, clarify, look for interpretations (Use the closing conference and the relationship with the AB) • Here you have a decision to make… • If you think the assessor misunderstood, make your case • Prioritize the needed corrective actions (Methods, data, QC, records then documents, SOPs) • Assign responsibility and timing for completion (Make it reasonable and practical but timely)

  28. How to Effectively Address Corrective Actions • Conduct a Root Cause Analysis (Random vs. Systemic) • Findings are usually symptoms of something deeper • Look at past assessments (internal and external) • Ask Why…again and again… • Look for patterns • Depth and breadth • Other testing areas • Support areas • Multiple analysts • Look across the operation – global • Usually more than one cause • Be critical

  29. How to Effectively Address Corrective Actions • Define and document the corrective action (Don’t overly complicate the matter – keep it simple!) • Process or procedure change • Documentation change • Training or attitude adjustment • Some combination of all three • Gain signoff and approvals

  30. How to Effectively Address Corrective Actions • Train all appropriate personnel on changes • This is an important step (largely ignored) • Do not just assume that staff reads • New or updated SOPs • Change documentation • Work instructions • E-mails • Invest in face-to-face training sessions • Don’t hesitate to “reinforce” the obvious! • Document the training

  31. How to Effectively Address Corrective Actions • Implement changes in all areas necessary • Don’t let the “need for documentation” drive timing and implementation • Make procedural changes using memo to file or quick change process • Define a “sunset” for formal document change • Update appropriate documents and forms

  32. How to Effectively Address Corrective Actions • Monitor for implementation and effectiveness • This is one of the places that corrective action processes fail! • Verify implementation and effectiveness (suggest within 30-45 days) • Monitor over the next several months (old habits are hard to break) • Include in future internal audits • Check other areas or analysts • Follow through and revisit often

  33. Closing Corrective Actions Steps to successfully addressing and closing corrective actions • Analyze – define the root cause. Determine if a random event or a system failure. • Make operational change(s) (if warranted). • Document the changes (memo/policy/change order/training notes). • Train all appropriate staff. Document the training. • Update SOPs to reflect proper practice. • Verify that the changes have been implemented and are effective. • Revisit until you are sure the solution has taken.

  34. The Last Word – For Now! • Using the CAP is mandatory – it is not optional • Don’t do this just to pass audits • There are lots of benefits to customers, operations, morale and the bottom line • Strong corrective actions are the best mechanism for • Continuous improvement (ISO 17025:2005) • Not having to fix the same problems time after time – and re-inventing the wheel • Spotting trends and establishing a preventive action process • Employee buy-in

  35. The Last Word – For Now! • Embrace a Quality Management System approach to corrective action and improvement. • Eliminate repeat findings. We know what the problem is … Recognition is the first step… So, we can make it go away!!

  36. Thank You! Questions and Comments

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