Comprehensive information on laboratory audit as it relates to Quality Assurance and Total Quality Management.

1. DR LUKMAN SHITTU
DEPT OF CHEMICAL
PATHOLOGY
DR LUKMAN SHITTU
DEPT OF CHEMICAL PATHOLOGY
LABORATORY AUDIT
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2. OUTLINE
INTRODUCTION
TYPES OF AUDIT
INTERNAL AUDIT
EXTERNAL AUDIT
SUDDEN
ESSENTIAL RE
RESPONSIBILITY
WITNESSING
ISO REQUIRED
INTERNAL AUDIT
OBJECTIVES
AUDIT PROCESS
EXTERNAL AUDIT SUMMARY REFERENCES
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3. INTRODUCTION….
Assessment can be defined as the systematic examination of some part
(or sometimes all) of the quality management system to demonstrate to all
concerned that the laboratory is meeting regulatory, accreditation and
customer requirements.
• Assessment is an important element of the 12 quality system essentials
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4. INTRODUCTION……
12 QUALITY MANAGEMENT ESSENTIALS.
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5. INTRODUCTION……
• Assessment can be achieved by;
• Laboratory accreditation.
• External quality assessment or proficiency testing.
• Laboratory audit.
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6. INTRODUCTION…
• LABORATORY AUDIT is defined as a planned and
documented activity performed in accordance with written
procedures and check-lists to verify by investigation, and
the examination and evaluation of objective evidence, that
applicable elements of a quality assurance programme
have been developed, documented and implemented.
•
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7. INTRODUCTION….
• Audit is an essential part of the quality assurance program
of a laboratory.
• A quality assurance program covers all aspects of the
service provided.
• Audit is a means of assessing whether one is achieving
one's stated objectives.
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8. INTRODUCTION….
• Total Quality Management involves comprehensive quality
assurance programme which must include The Quality System
Essentials, with the development, documentation and
implementation of General Guidelines and Standards Operating
Procedures (SOP) .
• Internal Audit is a component of TQM and involves the process of
Monitoring and Evaluation of the implementation of developed
guideline and SOP.
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9. TYPES OF AUDIT…
• INTERNAL AUDIT
HORIZONTAL AUDIT
VERTICAL AUDIT
• EXTERNAL AUDIT
• SUDDEN AUDIT
• WITNESSING/EXAMINATION AUDIT
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10. TYPES OF AUDIT…
EXTERNAL AUDIT:
• Assessments conducted by groups or agencies from outside
the laboratories are called external audits.
• They can include assessments for the purpose of
accreditation, certification or licensure
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11. INTERNAL AUDIT
• A type of assessment of a laboratory where staff working in one area of the
laboratory conduct assessments on another area of the same laboratory.
• This provides information quickly and easily on how the laboratory is
performing and whether it is in compliance with policy requirements.
• Both horizontal and vertical audits should be carried out.
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12. HORIZONTAL AUDITS:
• Checking one aspect of the Quality System (for example,
equipment), for all the associated requirements.
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13. QualitySystem
Essential
HORIZONTAL AUDIT
1
Documents &
Records
2.
Management
Reviews
3
Organization
& Personnel
1.Is there an
approved
organogram
2.Are there
appropriate
personnel
3.Are there
personnel
files
4.Do
personnel
files contain
CVs
5.Do
personnel
files contain
other
records
6
4
Client
Management
& Customer
Service
5
Equipment
1.What
equipment are
available
2. the
equipment
functioning
3.Are they
regularly
maintained
4.When is
the next
Expected
date of
routine
maintenance
5.Is there a
maintenance
contract
6 Internal Audit
7 Purchasing &
Inventory
8 Process
Control and
Internal &
External
Quality
Assessment
9 Information
Management
1
0
Corrective
Action
1
1
Occurrence/Inci
dent
Management &
Process
improvement
1
2
Facilities and
Safety
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14. TYPES OF AUDIT….
VERTICAL AUDITS:
• Test samples are selected at random from work that has recently passed through
the laboratory and each operation associated with those samples is checked.
• The route of entry into the audit system when performing vertical audits can be
varied, for example, by selecting different items (test reports, worksheets or
retained samples) on different occasions
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15. VERTICAL ASSESSMENT: The Assessment or Audit of a particular patient request:
From sample collection to result release,using all or most of the quality system essentials
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16. TYPES OF AUDIT…
UNSCHEDULED AUDITS
• In addition to the planned programme, it may be necessary to carry
out unscheduled audits whenever there is reason to doubt the
effectiveness of the Quality System.
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17. TYPES OF AUDIT…
WITNESSING/ EXAMINATION AUDIT
• An examination (test) procedure, currently being carried out in the laboratory
and randomly selected is witnessed as it is performed.
• To ensure that what is being done reflects what is described in the procedure,
• And that the person carrying out the examination has a good understanding of
all aspects of the procedure.
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18. INTERNAL AUDIT…
• ISO REQUIREMENT:
• ISO standards put much emphasis on internal audits, and for those seeking
accreditation under ISO, internal audits are required. ISO requirements state
that:
• the laboratory must have an audit programme;
• the auditors should be independent of the activity;
• audits must be documented and reports retained;
• results must be reported to management for review;
• problems identified in the audits must be promptly addressed and appropriate
actions taken
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19. INTERNAL AUDIT…
OBJECTIVES OF AUDIT
• Audits are planned to establish that:
• management objectives are met in full.
• all staff are carrying out their assigned duties and responsibilities satisfactorily.
• procedures detailed in the Quality System manual are being followed
• Audits are designed to reveal the extent to which the laboratory complies with
requirements in all the aspects examined.
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20. INTERNAL AUDIT
• ESSENTIAL REQUIREMENTS OF AUDITS
• Audits should be carried out according to a pre-planned programme devised
by the Quality control committee headed by the laboratory director.
• Auditors should be nominated by the Quality control committee as the persons
responsible for carrying out audits.
• Audit procedures should be documented and all results recorded.
• Corrective action should be initiated to resolve all non-compliances identified
within an agreed timescale.
• Such corrective action should be effective and completed promptly.
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21. INTERNAL AUDIT…
• AUDITOR:
• is a technically qualified individual who evaluates the activity being audited.
• Any knowledgeable person in the laboratory can perform internal audits, not
just the manager or supervisor. E.g. HODs, Pathologist & their designated reps
like the CMLS e.t.c.
• It is very important, and required by ISO standards, that the auditors are
independent of the area audited.
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22. INTERNAL AUDIT..
• Criteria for Selection of Auditors
• Must have technical skills in the area being audited.
• Must understand the laboratory’s QMS
• Must be able to pay attention to detail
• Must be able to communicate effectively and diplomatically
• Must be trained – in-house/ external
• Poor auditors = Poor audit
• The laboratory may hire a consultant for internal audit process
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23. INERNAL AUDIT..
• VALUES OF INTERNAL AUDIT:
• The internal audit is a valuable tool in a quality management system. An internal
audit can help the laboratory to:
• prepare for an external audit;
• increase staff awareness of quality system requirements;
• identify the gaps or nonconformities that need to be corrected—the
• opportunities for improvement;
• understand where preventive or corrective action is needed;
• identify areas where education or training needs to occur;
• determine if the laboratory is meeting its own quality standards
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24. INTERNAL AUDIT…
• AUDIT PROCESS:
• There are five key questions in the audit process:
• what should we do?
• what do we do?
• Are we doing what we should be doing?
• Can we improve what we do?
• Have we improved?
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25. INTERNAL AUDIT..
• THE QUALITY MANAGER or other designated qualified personnel should organize the
internal audit following these steps:
• develop a formal plan
• prepare a checklist based on selected guidelines or standards
• meet with all staff and explain the audit process
• select staff to serve as auditors
• collect and analyze information
• share results with staff
• prepare a report
• present the report to management
• retain the report as a permanent laboratory record
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26. INTERNAL AUDIT
• During audits, information is gathered about:
• processes and operating procedures
• staff competence and training
• equipment
• environment
• handling of samples
• quality control and verification of results
• recording and reporting practices.
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27. INTERNAL AUDIT
• Audits should include the evaluation of steps in the whole laboratory path of
workflow.
• They should be able to detect problems throughout the entire process.
• The findings are compared with the laboratory’s internal policies and to a
standard or external benchmark. Any breakdown in the system or departure
from procedures will be identified.
• The advantages of internal audits are that laboratories can perform them as
frequently as needed, and at very little or no cost.
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29. INTERNAL AUDIT..
• SELECT AREA FOR AUDIT.
• Focus on defined areas of the laboratory activities, identified by issues such as customer
complaints or quality control problems.
• horizontal or vertical.
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30. INTERNAL AUDIT…
ESTABLISH A SCHEDULE.
• ISO 15189:2007 [4.14.2] states:
The main elements of the quality management system should normally be subject to internal audit
once every twelve months
• In general, audit regularly
• consider three to six-month intervals between audits.
• If audits reveal specific problems, it may be necessary to include more frequent audits.
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31. INTERNAL AUDIT..
CHECKLISTS AND FORMS USED
When developing checklists for internal audits:
• Take into account any established national policies and standards.
• Ensure checklists are easy to use and include areas for recording information.
• Forms will be needed for recording corrective actions and for making reports.
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32. A SAMPLE CHECKLIST FOR AUDIT
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33. SAMPLE CHECKLIST
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34. INTERNAL AUDIT…...
RECORDS OF AUDIT:
• The laboratory should maintain detailed documentary records of all audits to
provide management with a continuous history of performance and a means of
identifying particular areas of weakness.
• Records should be kept by the Quality Manager and they may be checked
during inspections by accreditation bodies.
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35. INTERNAL AUDIT….
CONTINUOUS MONITORING
• Continuous monitoring is the key element to success in the quality system.
• It is through this process that we are able to achieve the continual improvement that is our
overall goal.
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36. EXTERNAL AUDIT
Assessments conducted by groups or agencies from outside the laboratory are called external audits.
• EXTERNAL AUDITORS:
• Health authorities;
• Accreditation bodies are organizations that provide accreditation or certification.
• Public health programmes, or by agencies that provide funding for programmes. (WHO) Polio
Initiative regularly assess disease-specific laboratories according to their own standards with
their own checklists.
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37. EXERNAL AUDIT
• THE STANDARDS
• In conducting external audits, the assessors will verify that laboratory policies, processes and
procedures are documented and comply with designated standards.
• Different standards can be used for the assessment processes, ranging from international
standards to a locally developed checklist.
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38. EXTERNAL AUDIT…
• PREPARATION
To be ready for the external audit, it is necessary to:
• plan thoroughly and carefully;
• organize everything ahead of time, including documents and records, to save valuable time
during the audit;
• make all staff aware of the audit, and arrange schedules so that all staff needed for the audit will
be available.
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39. EXTERNAL AUDIT..
AUDIT REPORT AND PLAN OF ACTION.
• After the audit, the recommendations of the assessors are often presented as a verbal summary to the
laboratory management and staff, which are then followed by a thorough written report.
After the external audit has been completed the laboratory should:
• review the recommendations of the assessors;
• identify gaps or nonconformities, learning where benchmarks or standards were not fully met;
• plan to correct the nonconformities
• record all results and actions taken
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40. EXTERNAL AUDIT….
• ACTIONS AS A RESULT OF AUDIT:
• Audits should lead to actions—this is why laboratories conduct them, to further the process of
continual improvement in the laboratory.
• Audits identify opportunities for improvement (OFIs).
• Both preventive and corrective actions are steps taken to improve a process or to correct a
problem.
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41. SUMMARY
Assessment is important in monitoring the effectiveness of the laboratory quality management
system.
Both external and internal audits yield useful information.
Audits are used to identify problems in the laboratory, in order to improve processes and
procedures.
An outcome of assessment is finding root causes of problems and taking corrective actions.
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42. REFERENCES.
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