Assessment: Audits Learning Objectives

Assessment: Audits

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.

Problem Scenario

• You are the quality manager in your laboratory and you want to organize an internal audit.

• What steps will you take?

The Quality Management System

Assessment—Audit

• systematic examination of some part (or all) of the quality management system

• conformance with requirements

What is an assessment?

• Someone is asking:

Why perform an assessment?

• learn “where we are” in terms of quality management

• measure gaps

• need information for:

• planning and implementation
• monitoring
• continuous improvement

Auditing

• Gather information about:

• process, operating procedures
• staff, equipment, test methods
• environment, handling of samples
• quality control verification activities
• recording and reporting practices

Auditing

• compare findings with documented quality management system

• identify breakdown in system or departure from procedures

• do something with audit results

External Audit Report and Plan of Action

Value of Internal Audits

• prepare for external audit

• increase awareness

• opportunity for improvements

• preventive and corrective actions

• opportunity for continuing education

• meeting quality standards

Internal Audits: ISO Requirements

Conducting an Internal Audit

• develop plan

• write checklists

• opening meeting

• collect and analyze information

• record results

• conduct closing meeting

• report

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

Documents

• checklists

• develop forms for documenting corrective actions and reports

Audits Should Lead to Actions

Corrective and Remedial Actions

• These actions are the steps taken to improve a process or to correct a problem

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

Opportunity for Improvement Form

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.

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.

Questions? Comments?