🗊 Assessment: Audits

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Assessment: Audits
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Assessment: Audits

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Learning Objectives At the end of this activity, you will be able to: Develop a process to prepare your laboratory staff for an external audit. Plan and manage an internal audit. Discuss how to use results from a laboratory audit. Advocate for the importance of taking corrective actions.
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Learning Objectives At the end of this activity, you will be able to: Develop a process to prepare your laboratory staff for an external audit. Plan and manage an internal audit. Discuss how to use results from a laboratory audit. Advocate for the importance of taking corrective actions.

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Problem Scenario You are the quality manager in your laboratory and you want to organize an internal audit. What steps will you take?
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Problem Scenario You are the quality manager in your laboratory and you want to organize an internal audit. What steps will you take?

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The Quality Management System
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The Quality Management System

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Assessment—Audit systematic examination of some part (or all) of the quality management system conformance with requirements
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Assessment—Audit systematic examination of some part (or all) of the quality management system conformance with requirements

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What is an assessment? Someone is asking:
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What is an assessment? Someone is asking:

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Why perform an assessment? learn “where we are” in terms of quality management measure gaps need information for: planning and implementation monitoring continuous improvement
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Why perform an assessment? learn “where we are” in terms of quality management measure gaps need information for: planning and implementation monitoring continuous improvement

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Assessment: Audits , слайд №8
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Assessment: Audits , слайд №9
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Auditing Gather information about: process, operating procedures staff, equipment, test methods environment, handling of samples quality control verification activities recording and reporting practices
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Auditing Gather information about: process, operating procedures staff, equipment, test methods environment, handling of samples quality control verification activities recording and reporting practices

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Auditing compare findings with documented quality management system identify breakdown in system or departure from procedures do something with audit results
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Auditing compare findings with documented quality management system identify breakdown in system or departure from procedures do something with audit results

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Assessment: Audits , слайд №12
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Assessment: Audits , слайд №13
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External Audit Report and Plan of Action
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External Audit Report and Plan of Action

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Value of Internal Audits prepare for external audit increase awareness opportunity for improvements preventive and corrective actions opportunity for continuing education meeting quality standards
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Value of Internal Audits prepare for external audit increase awareness opportunity for improvements preventive and corrective actions opportunity for continuing education meeting quality standards

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Internal Audits: ISO Requirements
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Internal Audits: ISO Requirements

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Assessment: Audits , слайд №19
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Assessment: Audits , слайд №20
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Conducting an Internal Audit develop plan write checklists opening meeting collect and analyze information record results conduct closing meeting report
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Conducting an Internal Audit develop plan write checklists opening meeting collect and analyze information record results conduct closing meeting report

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Establishing an Audit Schedule conduct regularly more frequent audits for problems or areas needing improvement over time audits should look at all of the quality system essentials
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Establishing an Audit Schedule conduct regularly more frequent audits for problems or areas needing improvement over time audits should look at all of the quality system essentials

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Documents checklists develop forms for documenting corrective actions and reports
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Documents checklists develop forms for documenting corrective actions and reports

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Audits Should Lead to Actions
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Audits Should Lead to Actions

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Corrective and Remedial Actions These actions are the steps taken to improve a process or to correct a problem
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Corrective and Remedial Actions These actions are the steps taken to improve a process or to correct a problem

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Taking corrective action using problem-solving team: investigate root causes develop appropriate corrective action implement corrective action examine effectiveness record all actions and findings monitor
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Taking corrective action using problem-solving team: investigate root causes develop appropriate corrective action implement corrective action examine effectiveness record all actions and findings monitor

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Opportunity for Improvement Form
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Opportunity for Improvement Form

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Assessment: Audits , слайд №30
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Assessment: Audits , слайд №31
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Summary Assessment is important in monitoring the effectiveness of the laboratory quality management system. Both external and internal audits yield useful information. An outcome of assessment is finding root causes of problems and taking corrective actions.
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Summary Assessment is important in monitoring the effectiveness of the laboratory quality management system. Both external and internal audits yield useful information. An outcome of assessment is finding root causes of problems and taking corrective actions.

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Key Messages All laboratories should establish an internal audit program. Conducted on a regular basis, it will provide information for continual improvement. Problems become opportunities for improvement.
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Key Messages All laboratories should establish an internal audit program. Conducted on a regular basis, it will provide information for continual improvement. Problems become opportunities for improvement.

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Questions? Comments?
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Questions? Comments?

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